Shell - Lance Gooberman€¦ · Web viewoffice of administrative law. initial decision. oal dkt. no. bds 10905-99s. agency dkt. no. --david samson, attorney general of new jersey,

State of New JerseyOFFICE OF ADMINISTRATIVE LAW

INITIAL DECISION

OAL DKT. NO. BDS 10905-99S

AGENCY DKT. NO. --

DAVID SAMSON, ATTORNEY GENERAL OF

NEW JERSEY,

Complainant,

v.

LANCE L. GOOBERMAN, M.D., AND

DAVID BRADWAY, M.D.,

Respondents.

____________________________________

Douglas J. Harper, Deputy Attorney General, for complainant (David Samson, Attorney General of New Jersey, attorney)

John S. Sitzler, Esq., for respondent Lance L. Gooberman, M.D.

Michael E. Riley, Esq., and Irwin L. Lifrak, Esq., appeared for respondent David Bradway, M.D., during the hearings (Riley & Lifrak, attorneys); David Bradway, M.D., filed a pro se brief1

Record Closed: June 19, 2002 Decided: November 15, 2002

BEFORE JEFF S. MASIN, ACTING CHIEF ALJ:

On October 1, 1999, the Attorney General of New Jersey (hereinafter referred to as either

“Attorney General” or “complainant”) filed a complaint with the New Jersey State Board of

Medical Examiners (“Board”). The Complaint alleged that between 1995 and 1999 respondent

physicians Lance Gooberman, M.D., (“Gooberman”) and David Bradway, M.D., (“Bradway”)

engaged in acts of gross malpractice, repeated gross malpractice, professional negligence,

professional incompetence and professional misconduct, in violation of their professional

11 Dr. Bradway relieved his counsel following the conclusion of testimony on the last day of hearings. He filed a pro se brief and summation.

NEW JERSEY IS AN EQUAL OPPORTUNITY EMPLOYER


responsibilities and in derogation of N.J.S.A. 45:1-21 (b) (c) and (e). The respondents filed

answers to the initial complaint. Thereafter, an amended complaint was filed on June 22, 2000,

and a second amended complaint was filed on December 19, 2000. A Third Amended

Complaint was filed on August 23, 2001. A Fourth Amended Complaint was filed on February

28, 2002.

The Board determined that the case constituted a contested case and transferred the initial

complaint to the Office of Administrative Law (“OAL”) on December 17, 1999, pursuant to

N.J.S.A. 52:14B-1 to –15 and N.J.S.A. 52:14F-1 to –13. Extensive discovery followed the

transmittal, motions were filed and rulings were made. Hearings were held on thirty-six dates

between January and August 2001. Following completion of the hearings, the parties filed

briefs, the last of which was received on June 19, 2002, on which date the record closed. Due to

the exceedingly complex nature of this case, the massive record and the substantial time

commitments of this judge to administrative responsibilities as Acting Director of the OAL, it

has been necessary to obtain several extensions of time for the filing of this initial decision.

Additionally, on October 9, 2002, counsel for Dr. Gooberman filed a motion to reopen the record

to allow the introduction of additional evidence regarding a recently released study of UROD. 2

The response to that motion was filed on October 25, 2002. On November 1, 2002, I notified

counsel by a letter Interlocutory Order that the motion was granted, but that the admission would

be limited to the document, without any additional testimony.

The Complaint

Ultra Rapid Opioid Detoxification

The central focus of this case is the method of treatment that the respondent doctors

employed between 1995 and 1999 for the detoxification of approximately 2,350 persons addicted

to opiates.3 4 Since at least 1995, Dr. Gooberman, later joined by Dr. Bradway, has employed a

procedure referred to as Ultra Rapid Opiate Detoxification, known as “UROD.” This procedure

involves the placement of a person addicted to either heroin (diacetyl morphine) or methadone 22McGregor, Ali, et al., A comparison of antagonist-precipitated withdrawal under anesthesia to standard inpatient withdrawal as a precursor to maintenance Naltrexone treatment in heroin users: outcomes at 6 and 12 months, Drug and Alcohol Dependence 68 5-14 (2002).3 Opioids are a generic class of drugs; opiates all come directly from the poppy plant. All opiates are opioids. 4 The respondents and the Board have entered into a consent order, pursuant to which the respondents have ceased providing UROD in New Jersey, pending the outcome of the present hearings.

- -2


under general anesthesia, followed by the introduction into the patient of several drugs that are

antagonistic to opiates (hence termed “antagonists”), as well as the implantation under the

patients’ skin of a pellet containing the drug naltrexone, which is itself an opiate antagonist.

Between the two respondents, they have performed nearly 2,350 UROD procedures, reportedly

accounting for roughly a quarter of the reported UROD procedures performed throughout the

world as of 1999. In the UROD procedure, antagonist drugs are employed to block the opiates

from attaching onto, and thereby affecting, the mμ receptors located on cells in the locus

coeruleus region of the brain, so that opiates such as heroin cannot affect the patient. According

to the theory behind the treatment, the antagonists introduced during the procedure by

introgastric tube place the patient into immediate withdrawal, as the antagonists “knock off” any

heroin already affecting the receptors. These antagonists are effective in the short term,

operating for a period of several hours. Experience demonstrates that persons seeking to

withdraw from opiates often cannot carry through with an opiate withdrawal, at least in

substantial part due to its severe physical and concomitant psychological effects during the first

extreme portions of the withdrawal process. Therefore, the theory behind UROD is that the

initial use of antagonists administered while the patient is anesthetized will allow the addicted

patient to go through the early extreme portion of the withdrawal process in an accelerated

manner while under general anesthesia. This allows the patient to avoid a conscious experience

of the most difficult portion of an altogether unpleasant process, thus giving the patient a better

opportunity to carry on with the withdrawal and reach a stage where he or she is hopefully able

to continue to refrain from opioid use.5 The naltrexone pellet is implanted to provide a longer-

term block, reportedly lasting up to sixty days.

UROD is a variation on a procedure known as Rapid Opiate Detoxification (“ROD”).

ROD has generally been performed in a hospital or other medical facility and has involved an

overnight stay. The “Ultra” aspect of the Gooberman procedure is that it is performed while the

patient is anesthetized. In Gooberman’s method, UROD is an outpatient procedure and the

patient is released to the care of a “caretaker” and is generally not retained overnight in any

treatment or monitoring facility, be it a hospital or outpatient care facility6.

The Charges

5 More will be said later as to the need for post-withdrawal follow up in order to continue an abuser’s path to continued abstinence.6 Generally, the caretaker is a family member, significant other or friend, and on occasion, a person paid to serve in that capacity.

- -3


The Complaint alleges that “UROD/ROD is neither a medically established nor

recognized” treatment for opiate addiction. According to the Complaint, it is instead a

“relatively new, highly controversial procedure,” which has not attained approval or acceptance

from any governmental or professional body and is not recommended by such groups. The

Complaint quotes from a 1996 unofficial report of the National Institute on Drug Abuse

(“NIDA”), which contends that UROD “is currently without ethical, medical, scientific or

financial justification as a clinical detoxification treatment.” Further, if UROD is subsequently

proven safe and effective with rigorous scientific investigations, it might have limited use in the

treatment of “extremely high risk patients.”7 The Complaint acknowledges that UROD/ROD is

provided in the United Kingdom and in some other portions of the United States, but asserts that

where it is performed, the procedure involves the presence of an anesthesiologist and patient

retention overnight with the availability of appropriate critical care physicians. The Complaint

asserts that the methods utilized by Drs. Gooberman and Bradway deviated from these

characteristics and instead involved the discharge of patients who were seriously limited in their

ability to walk, talk, communicate, care for themselves, breath properly, etc., and who were

released to the care and supervision of untrained and unsupervised family or friends (the

“caretakers”) who took the patients to a hotel or a residence that same day. This procedure

reportedly placed these patients in a dangerous situation that has, in fact, either directly or

indirectly caused or contributed to the deaths of seven patients (hereinafter referred to as the

“mortalities”) within a period of between approximately six and one-half hours up to seventy-

one and a half hours following discharge, and the need for emergency hospital treatment for

“dozens” of patients, of whom the complaint specifies only two specific patients (the

“morbidities”).8 The Complaint claims that the mortality and morbidity experience demonstrates

that as employed by Gooberman and Bradway, the UROD procedure constitutes “a clear and

7 This contention has been included in each of the several amended versions of the Complaint.8 The parties agree that the mortality rate for the respondents’ UROD patients was .03%. This calculation only deals with the seven deaths that the Attorney General charges resulted directly or indirectly from UROD; any deaths of their patients that may have occurred at any time for other reasons are not included and are not relevant to this case. It should also be noted that Dr. Herbert Kleber testified that the annual death rate among heroin addicts is between 2 and 4%. It also must be noted that, while the Complaint alleges that “dozens” of patients have required emergency room treatment and/or hospitalization within 24 hours after receiving UROD, the Complaint only identifies two such “morbidity” cases. While, as will be discussed, the reference to “dozens” of such patients going to emergency rooms was drawn from an answer given by Dr. Gooberman at a Board hearing, in terms of any attempt to determine whether the doctors’ treatment of such individuals presents issues of negligence, malpractice and incompetence, the generalized statement about “dozens” of morbidity cases is, by itself, entirely unenlightening. Dr. Gooberman’s explanation for the quote, discussed in the body of this opinion, may or may not accurately reflect the actual patient experience. However, except for the evidence presented as to Messrs. Perez and Hendrix, who are the two persons identified in the Complaint, and the doctors’ testimony about patients who went to emergency rooms seeking removal of the opiate blocking naltrexone pellet, apparently because they desired to use heroin, the Attorney General has not presented any evidence to support the fact or the implications of the charge that “dozens” of serious “morbidity” cases existed. On several occasions during the hearing, this judge noted this deficiency in the proofs, but no others were identified by name or by evidence.

- -4


imminent danger to the public’s health, safety and welfare.” Further, it alleges that the doctors’

employment of UROD involves deviations from the accepted standards of medical care existing

in the medical practices of addiction treatment and anesthesiology, and the regular occurrence of

gross malpractice, negligence and professional misconduct. More specifically, the Complaint

lists twenty-one deviations from the accepted standards of these two professional disciplines.

The details of these allegations will be explored in the body of this opinion, but in order to allow

a better understanding of the detailed expert testimony offered by both parties, these alleged

deviations are set forth here as reported in the Complaint.

As to Addiction Medicine

a. The implantation of a Naltrexone pellet without knowing by objective data the duration of action of the antagonist provided under the circumstances and how much heroin or other opiates are blocked on a daily basis.

b. The failure to affirmatively arrange for post-detoxification counseling as an essential component of rehabilitation.

c. The failure to properly establish inclusion and exclusion criteria for those patients undergoing the procedure.

d. The failure to distinguish between those patients for whom alternative forms of detoxification would be appropriate.

e. The failure to clearly and appropriately identify death as a risk factor in the informed consent form signed by patients.

f. The creation and implementation of a complete waiver of patient confidentiality including, but not limited to, an acknowledgement of the right in Dr. Gooberman to publicize medical data and treatment provided to the patient within the public media. Said waiver, when viewed in relation to Dr. Gooberman’s media (billboard) advertising stating the procedure offered is confidential, is both a deviation from accepted standards and a deceptive and misleading practice.

g. The failure to adequately provide for patient aftercare with appropriately trained health care personnel.

h. The establishment of an aftercare, post-discharge protocol which contemplates non-physicians prescribing or dispensing multiple medications in response to patient complaints without prior consultation with a physician.

- -5


i. The use of fentanyl transdermal patches, which were not established as either a necessary or appropriate drug within the UROD/ROD procedure provided by respondents which accordingly introduced an experimental risk into said procedure without appropriate patient consultation and informed consent.

j. The failure to provide safe and effective procedures and personnel to ensure safe and effective patient recovery and continuation of appropriate addiction treatment.

k. The creation and implementation of what effectively was an experimental procedure without adequate disclosure of the experimental nature to patients and without obtaining their informed consent.

As to Anesthesiology

a. The administration of ketamine, midazolam and propofol on a manner in which doses were not related to the patient’s weight as well as titrated to the patient’s response to the drug.

b. The administration of anesthetic agents so as to produce unconsciousness during a highly stressful period without appropriate knowledge of the effects of said drugs and their interactions with other drugs administered.

c. The failure to adequately preoperatively assess patients’ cardiac, respiratory, hepatic, and renal systems to determine their ability to tolerate the exceptional stresses of the UROD/ROD procedure.

d. The administration of fentanyl in a fashion such that the procedure was rendered investigational or experimental in nature without appropriate patient disclosure and consent.

e. The simultaneous provision of a procedure which is the medical equivalent of general anesthesia in an outpatient setting for as many as six patients through CRNAs and critical care nurses subject to overarching medical supervision by a non anesthesiologist and without the presence of a critical care physician.

f. The failure to provide adequately for the management of possible anesthesia emergencies such as difficult airways.

g. The failure to provide safe and adequate care post discharge through adequately trained health care professionals and appropriate safeguards.

- -6


h. The premature discharge of patients.

i. The establishment of a protocol and practice which contemplates non physicians, namely critical nurses, receiving telephone calls from care givers and deciding whether additional, or different, medications should be prescribed based on presented symptomatology without prior physician consultation.

j. The failure to provide safe and adequate post discharge procedures and personnel to ensure safe and effective patient recovery from anesthesia and detoxification procedures.

EVIDENCE

The complainant presented testimony from a series of family, friends and domestic

partners of the seven patients who died within a short time of undergoing the UROD procedure,

as well as from family members of two patients who required hospitalization after undergoing

UROD and who survived.9 Each of these witnesses accompanied a particular patient to Dr.

Gooberman’s Merchantville facility and was with the patient in the hours after his or her

discharge. For the decedents listed below, information is provided regarding the date of their

UROD treatment, the time of discharge and date and time of death, cause(s) of death attributed

by the medical examiner/coroner and information included in the toxicological report rendered as

to each. In addition, as to each, some pertinent information presented in the testimony of the

particular loved one, friend, etc., and other witnesses, is included. Additional facets of these

persons’ testimony, touching on subjects such as informed consent and aftercare, will be

presented later in this opinion, as well as other pertinent material.

While these comments regarding each of the decedents touch on the caretaker and

decedents’ or other patients’ experiences with the respondents and with UROD, and while

additional specifics will be addressed during the course of this opinion, as a general matter, a

history of each person’s experience can be summed up thusly. The patient and those with whom

he or she traveled arrived at the Gooberman office in Merchantville, New Jersey at around 7:00

A.M. on the day of the appointment. After meeting with a representative of the office and also

with either Dr. Gooberman or Bradway, and signing a Consent to Treatment form usually 9 At the specific request of their caretakers, the Attorney General requested that the identities of two of the patients be protected. This request was granted, without objection.

- -7


witnessed by the accompanying caretaker, the patient went to an inside area for treatment. The

caretaker was given an approximate time to expect the patient to be recovering from the

anesthesia and was given a number of prescriptions for injectible medication and for pills

(prefilled sandostatin syringes, trazodone, clonidine and/or baclofen). These prescriptions were

in each case filled at the Towne Pharmacy down the street from the Gooberman office, each

filled during the time that the patient was undergoing the procedure. In each instance, the

caregiver and any other accompanying person(s) returned to the office in the early to mid-

afternoon. They each observed the patient to be very weak, sleepy, unsteady and unable to walk

without support. In each case, after a period of time during which they waited for the patient to

be released to them, they left the facility, with a set of written instructions, to take the patient to

either a local hotel/motel or to a private residence, generally either the patient’s or the caretaker’s

or that of another relative. In each instance the description of the condition of the patient during

the car trip and then afterwards in the motel room or at the residence is largely similar. The

patient remained weak, had difficulty speaking, experienced difficulty breathing, was unable to

walk without significant support, had to be assisted to the bathroom, vomited quite often and

often suffered projectile vomiting and had substantial diarrhea. The general pattern of events

was such that the caregiver(s) were extremely concerned about the condition of the patient and at

some point called the doctors’ office for assistance. In some instances these calls produced visits

to the patient by someone from the doctors’ office, at other times assurances that the pattern of

difficulties observed by the caregiver was “normal” and that the patient would be all right.

Eventually, the patient either expired in the home or the motel room, or was removed to a

hospital where death occurred. In each instance, the caregivers testified that they never gave the

patient any illicit drugs after the procedure, never saw the patient take any illicit drug and did not

give or observe the patient to take any prescription medication not prescribed by the doctor or his

office. The caretakers each claimed that the patients were so weak and unable to function that

they could not have taken any illicit drug, even during the short, although in some cases longer

periods, when the caregiver did not have the patient in his or her sight.

1) G.W., 40 years old, was treated on September 29, 1995. Mr. W. left the Gooberman

facility at approximately 11:30 A.M. that day and died at 8:11 a.m. on October 2, 1995, some

sixty-eight hours and eleven minutes after discharge. According to the postmortem report

prepared by the Chester County, Pennsylvania Coroner, the cause of his death was “acute

necrotizing pneumonia.” The report lists “diagnoses” as acute necrotizing bacterial pneumonia,

- -8


acute pulmonary edema and congestion, acute superficial gastric erosions, moderately

pronounced mucinous degeneration of the anterior mitral leaflet and a history of heroin abuse.

The toxicological report lists blood concentrations of Phenobarbital, diazepam and temazepam.

Jean B., who was the domestic partner of Mr. W., had lived with him for seven years as

of the time of his death. Beginning in 1991, he was affected with chronic continuous migraines

several times a week and could not obtain any medical relief from the severe pain. Ms. B.

reported that, as a result, “we turned to heroin” and W. became addicted to the drug. He used it

for about one and one-half years before he died. He also had used cocaine before 1993 on an

irregular basis, as well as marijuana, although she claimed that he had stopped these drugs before

he started to use heroin.

According to Ms. B., by 1995, Mr. W. was in “poor health.” After four and one-half

years of frequent migraines, he could not sleep or digest his food well, and seemed to be

degenerating. He had no physician care in 1995. He decided to go “cold turkey,” but his three

or four attempts failed. He felt that because of the incessant pain he had to have heroin in order

to function. She attempted to obtain methadone for him, but there was no clinic nearby. They

then saw Dr. Gooberman on television, talking about his detoxification procedure.

Ms. B. testified that after going with Mr. W. to the Gooberman clinic on September 29,

1995, she first was permitted to see Mr. W. at the clinic at about 11:00 a.m., after the UROD

procedure was completed. He was lying face up on the table. She assumed that he was

“sleeping off” the anesthesia. She spoke to Dr. Gooberman before W. was discharged. He

advised that the procedure was completed, but that W. was having some difficulty, was vomiting

and was not recovering as rapidly as usual from the anesthesia. His bed was needed for another

patient and he was moved down the hall to another bed. He was discharged to her care in mid-

afternoon. She recalled that he was unable to stand, even if assisted and a staff member “half

carried him” into the visiting area. He was “very groggy,” not fully conscious. B. spoke to

Gooberman about what to do, as, in B.’s description, W. was not reviving properly. The doctor

offered to put them up in a motel overnight so that he could continue to treat W. By 5:00 p.m.

they were at the motel. His status had not changed noticeably. She “nearly had to drag him into

the room.” He was put in bed. Later that evening, Gooberman stopped by the room. She cannot

recall if he had given her any medications earlier that day. At the time of his first visit to the

- -9


room that evening, Gooberman supplied her with suppositories and instructed her how to use

them. He also administered something, but as W. could not swallow, she cannot recall how he

did that. The doctor remained for about ten to fifteen minutes and, after waking W. to see how

he felt, Gooberman left, indicating that he would return in the morning. Gooberman came to the

room either that one time, or perhaps a second time, that evening.

When W. awoke the next morning his condition was nearly the same, although he was

“more awake” and for longer, but not considerable, periods. He was also in great pain. His

breathing was “convulsive,” and she heard “rasping in the lungs.” Most of the time he slept and

was unresponsive to her. She does not recall if he was nauseous and vomiting.

Gooberman came to the room again on September 30, this time accompanied by another

doctor, whom the parties stipulate was Colin Brewer, a practitioner of UROD from London,

England, who was visiting with Gooberman at that time. Gooberman may have given her

medications for W. at that visit, but she does not recall giving W. any medications. During the

course of that day, his condition “improved and deteriorated.” He was awake for longer periods,

but she heard what sounded like fluid in his chest. She spoke to Gooberman, as she was greatly

concerned that W. did not seem to be showing significant signs of improvement and he was in

pain during the few occasions when he was awake. According to the witness, Gooberman

expressed to her his unwillingness to continue to treat W. He “advised her that she had to take

responsibility for W.,” but “she did not know how.” She insisted that Gooberman continue to

treat. He agreed to pay for one more night in the motel, but advised that he would not be

returning to see W. He suggested that they return home and go either to a doctor or to a hospital.

Their home was two hours away. It is possible that Gooberman did return later that evening with

medications, but she is not certain about that.

W. remained in essentially the same condition the rest of the day. She gave W.

Phenobarbital suppositories that night, medication that Gooberman had supplied. They departed

the motel at 11:00 a.m. on October 1. She “carried” W. out to the car. They returned home,

arriving at about 1:00 or 2:00 p.m. She put him on a sofa bed and stayed with him. He was able

to take some fluids, but was not able to walk. She does not recall if Gooberman called or if she

called him. W. stayed awake more often and for longer periods. She told W. that she was

concerned that he was having symptoms precursory to pneumonia. She wanted to take him to a

- -10


hospital, but apparently because both of their families had “horrendous” experiences with

hospitals and “Western medicine” had failed him for four and one-half years in helping him with

his problems, he was “confident” that a hospital “would only make things worse.” He was

unable to get out of bed or to bring up phlegm. Most of the time, he was unresponsive.

On October 2, W. was still in bed, unable to sit and experiencing “jerky” breathing. He

was able to take some fluids, and still refused to go to a hospital. B. cannot recall if there was

any contact with the Gooberman office. Later in the day, W. was not “responsive most of the

time,” but at about 7:00 p.m. he was responsive and said that for the first time he felt like

himself. She thought that they could make it through on their own. She went into the kitchen

and about five minutes later found him completely still on the sofa bed. He was not breathing

and after several cycles of CPR, during which some dark fluid came out, she was convinced that

he was dead. An ambulance came, but the technicians were unable to revive him.

Ms. B. denied that she gave W. any drugs other than those prescribed by Gooberman

after W. was discharged. He could not get out of bed to secure any himself. There were none in

the living room. She was with him “nearly around the clock.”

2) Frank Stavola, 43 years old, underwent the procedure on December 23, 1996. He left

the facility at about 3:30 p.m. and died that same evening at 10:07 p.m. at his parents’ home.

The Monmouth County Chief Medical Examiner originally reported the “diagnosis” as cerebral

edema, pulmonary congestion and edema, status post treatment in a detoxification center

including sandostatin, trazodone and clonidine, obesity, hepatosplenomegaly and bilateral

hydroceles. He later changed the cause of death from “pulmonary and cerebral edema due to

pending further examination” to “pulmonary and cerebral edema due to drug use (morphine,

cocaine, fentanyl and nordiazepam).” Microscopic diagnoses were cerebral edema, pulmonary

congestion and edema with focal anthracosis, early cirrhosis with fatty change and chronic

persistent hepatitis, minimal focal myocardial fibrosis and tubular necrosis.

Mr. Thomas Raffield, who became a good friend of Mr. Stavola’s after they originally

met through a business relationship, learned of Stavola’s heroin addiction in the late 1980’s.

Stavola never spoke of cocaine. Several “cold turkey” detoxification attempts were made over a

period of about six years. Raffield had seen a documentary on UROD as practiced in England

- -11


and later saw Gooberman’s billboard on McCarter Highway in Newark. He accompanied

Stavola and Stavola’s father to the Gooberman clinic.

When the men returned to the clinic at about 2:00-2:30 p.m., they first saw Frank in a

bed, in a fetal position. He appeared unconscious. They tried to talk to him, but he did not

respond. A “rattling” sound was heard, “like a lot of phlegm.” Told that he was doing “alright,”

and that the “process was ongoing,” the men returned to the waiting room. Another person in the

waiting room waiting for her boyfriend to finish his treatment saw people walking Frank around,

wearing a diaper. They then saw him several times, but he seemed unconscious. While there

was “no significant change,” he was nevertheless discharged at about 3:30 p.m. He was dressed

and wheeled to the car where he could not get in himself and had to be placed in. He could not

stand unassisted. His responses to them were grunts and groans. The rattling sound continued.

The three men drove to Frank’s parents’ home in Atlantic Highlands. His lungs sounded

as if he was gurgling, as if they were wet. Asked how he was feeling, he made virtually no

response. He did make a “smart remark” about some comment that someone in the car made

about signs on the road, and they were glad that he was coming around. Otherwise, he appeared

to be sleeping the whole time. They arrived at the house at around 5:00 p.m. He was

unresponsive and could not walk by himself. They took him upstairs and put him in bed. He did

not speak. He was sweating very heavily and his breathing was labored.

Mr. Raffield was present at the parents’ home for a part of the time that Stavola was there

following their return from the Gooberman clinic, and while there, he neither gave drugs to

Stavola or saw him take any.10 He has no way of knowing if Stavola took any drugs while he

was not in his presence. When he returned to the house later that evening, Frank’s mother said

that she did not think that Frank was doing very well. They called Gooberman’s office and

spoke to someone, telling that person that Frank was non-responsive. Told that a Christmas

party was going on, they cursed at the person on the phone and Gooberman got on the line

immediately. They told him about the rattling and sweating. He told them to get him into a

standing position and he would cough up the phlegm. He also told them to give him a shot.

When they got him up, he vomited. They told him to hang on and he would be okay, but when

they came back to him, he was not breathing and had no pulse. While they waited for the 10 Mr. Raffield had to leave the house for a while to go to his home in Cranford, as Stavola’s parents had asked that he spend the night at their home with Frank. The parents were also present at the house.

- -12


emergency services to arrive in response to a 911 call, Raffield, who had military training in first

aid, tried CPR for twenty minutes without success.

3) Mark Beigelman, 31 years old, was treated on March 12, 1997, released after 2:00

p.m. and died that same day at 11:40 p.m. Dante Ragasa, M.D., the medical examiner for the

Burlington County Medical Examiner’s Office, originally listed the cause of death as “visceral

congestion” and the “manner of death” as “pending studies.” He later amended the cause of

death to “multiple drug intake, post detoxification therapy.” The amended diagnosis was

cardiomegaly (400 grams) with biventricular dilatation and focal fatty infiltration of

myocardium, no arteriosclerosis nor infarction, mild visceral congestion, status post

detoxification therapy, with toxicology findings of non-lethal levels of heroin, cocaine

metabolite, naloxone, naltrexone, fentanyl, methadone and ketamine.

Mr. Beigelman’s mother testified that sometime before March 1997 she learned that her

son, who lived with her, had an addiction to heroin. He admitted only this addiction, and

reported no addiction to any other drug. He went to a methadone clinic for a couple of months,

but told his parents that he wanted to stop using drugs altogether. He learned of Gooberman and

eventually went to him. After he was discharged, the family went to a motel in Mt. Laurel. He

was eventually transferred to a hospital where he expired.

Describing her observations when she first returned to the Gooberman clinic at about

3:00 p.m. following Mark’s UROD, Mrs. Beigelman recalled that Dr. Gooberman came out to

her and told her that Mark was “okay.” When she went inside to see him, he was asleep in bed,

with tubes attached. When she touched him, he was very cold. She returned to the waiting room

and later he was brought out. He looked “terrible,” sweaty and very shaky. He did not speak,

and his breathing was very hard. He sat in the waiting room and she tried to speak to him, asking

how he felt. He replied that he was very cold and had pain in his body, especially his legs. He

could not stand up by himself and instead he lay flat on the couch. He was supported under each

arm and they placed him in the car. She sat in the back with him and they went to a motel, which

the parties stipulated was located in Mt. Laurel. While at the motel, Beigelman felt very bad,

cold, sweaty and with continued pain in his leg. They were able to get him into a first floor room

and into bed. He had to be assisted to the bathroom.

- -13


In the motel, Mr. Beigelman experienced nausea and vomited something very dark. In

the very early evening, his mother called Gooberman’s office. At a point, she heard a gurgle and

told her husband that they had lost their son. The police were summoned. He was removed to a

hospital, where Gooberman came as well.

4) On April 16, 1998, M.J., 44 years old, underwent the UROD administered by Dr.

Bradway. He was released at about 2:30 p.m. and died at his parents’ home before 8:30 a.m. on

April 17, 1998. Manual A. Bergnes, M.D., pathologist located in Jeffersonville, Pennsylvania,

performed an autopsy. He did not list a cause of death in his report, pending the receipt of a

toxicology report. He did note an anatomical diagnosis of severe acute pulmonary edema, mild

myocardial hypertrophy with ventricular dilatation, recent implantation of subcutaneous

‘capsule’ in left lower abdominal quadrant, and vascular congestion of abdominal viscera. The

toxicology report listed findings of fentanyl, naltrexone, and β-Naltrexol in the blood.

Mr. J.’s mother testified that she had known of his addiction to heroin since 1978.

Besides heroin, Mrs. J. was aware that he had “tried” everything, possibly including Xanax. She

did not believe that he was addicted to cocaine. Several times he detoxified “cold turkey” at her

home. He would “succeed,” then attend NA meetings, but ultimately would relapse. In 1996, he

suffered a stroke. In 1997, he detoxed at an inpatient facility in California. His insurance paid

for nineteen of what were supposed to be twenty-eight days in-patient.

In 1998, Mr. J. saw a billboard advertising Dr. Gooberman’s services and arranged to

receive UROD. His mother, having unpacked his luggage at their home the night before the

procedure, denied that he used heroin that night, although she did not know if he used prior to

coming to her home that evening.

Describing what occurred when she and her husband returned to the clinic at 11:30 p.m.,

Mrs. J. noted that her son was not yet ready for release at that time. At about 12:30 p.m. he was

brought to the door of the waiting room, with one person supporting him under each arm. His

lips were very swollen. He mumbled rather than talked, saying that that he was “okay.” To his

mother he did appear to be “okay.” J. was walked around for a while and was periodically

brought out to his parents, each time supported. He never walked on his own. At times, he

appeared extremely tired. She could hear comments coming from the recovery area, such as,

- -14


“Come on M., get up.” At 2:30 p.m. he was presented to his parents in a wheelchair, supposedly

ready for discharge. A male attendant told her husband to bring the care around and the

attendant placed M. in the front seat. He seemed “alright,” and they went directly home. In the

car he slept on and off and said things such as, “Tell my brother R. never to do this.” R. did not

use drugs. M. drifted “in and out.”

The family arrived home at about 3:30 p.m. M.J. could not walk on his own and his

parents supported him and took him upstairs. He could not undress himself and was exhausted.

He was starting to communicate, but was very tired. He complained about a pain in his stomach

and began to vomit by 4:00 p.m. After he was given clonidine, he began to experience “huge,

projectile vomiting,” all over the bed, walls, and rugs. He did this three to four times. He

complained of stomach pains in between these sessions of vomiting. She gave him sandostatin

injections as per the instructions she had received at the clinic. He was twitching, was nervous

and very uncomfortable, with back pain as well. His lips were blue and he coughed and

experienced difficulty breathing.

At 10:15 p.m., Dr. Bradway called and Mrs. J. described exactly what had happened. He

told her that everything was under control. He told her to give him oral trazodone, but he

vomited it up immediately. She then went to bed, thinking he would be calm, but fifteen to

twenty minutes later he called out, “Mother, mother.” He was sitting up, his hands held out, red,

hot and enormously swollen. He had extreme difficulty breathing. She called Bradway, but did

not get him immediately. She perceived that this was a crisis and repeated her call to Bradway,

not knowing what to do. Bradway called at 11:20 p.m. She told him that M. was coughing

terribly, his lips were purple and he was having trouble breathing. Bradway told her that perhaps

he was hyperventilating and that she should get a bag and asked if they had an inhaler in the

house, but she could not find one. As her husband took the phone, she held M., who lapsed into

unconsciousness. She called 911. As she knew CPR, she started to try to resuscitate him. She

heard gurgling in his chest. He died in her arms. EMTs arrived at about 11:45 p.m.

5) Lester Kindig, 50 years old, was treated on July 2, 1998, released that afternoon at

4:00 p.m., and died on July 3, 1998, at 12:17 a.m. Dr. Robert Segal, the Chief Medical Examiner

for Camden County who also served as an Assistant Medical Examiner for Burlington County

and was on duty at the time of Mr. Kindig’s death, listed the cause of death as “adverse reaction

- -15


to drugs and rapid opiate detoxification.” His pathologic diagnosis was “rapid detoxification of

methadone and heroin addiction using general anesthesia and multiple medications, acute opiate

intoxication with morphine, methadone and Fentanyl in the blood, bilateral pulmonary

congestion and edema, pleural adhesions . . . .” The toxicology report rendered by Chief

Toxicologist Reng-lang Lin, Ph.D., of the New Jersey State Toxicology Laboratory, lists ethanol,

nordiazepam, morphine (free), diazepam, methadone, fentanyl and lidocaine in the blood.

Jan Klein, Mr. Kindig’s fiancée, met him in 1978. At some point in time she became

suspicious that something was wrong and although he first denied that there was a problem, in

1994 he acknowledged that he was addicted to heroin. She observed him injecting heroin. In

fact, he had been a heroin addict in the early 1970’s and had quit. Although she was aware that

at times he took valium for blood pressure problems, she did not see him taking it when he was

using heroin and she claimed that she never learned that he was using any other illicit drugs.

However, on cross-examination she acknowledged that at one time earlier in their friendship she

was aware that he used cocaine, “recreationally.” He tried to quit heroin himself and went to

London to undergo the detoxification program offered by the Center for the Investigation and

Treatment of Addiction (“CITA”). After a period of rehabilitation, he relapsed in late 1997.

After she confronted him, he tried to quit “cold turkey” several times. He never was able to get

past the first two and one-half to three days.

Mr. Kindig was told about Gooberman by friends who had seen him on television and he

then saw the doctor on television as well. Kindig came to New Jersey with Klein and a friend of

his, Mr. G., who was also coming to be detoxed. On the morning of the UROD, Kindig injected

heroin in the hotel where they stayed. She did not know whether anyone at Gooberman’s office

had told Kindig to use the drug before the procedure. He flushed his remaining heroin down the

toilet in front of her before they departed for the office, saying, “it’s out of my life now.”

Ms. Klein returned to the clinic at about 2:10 p.m. Another patient’s wife told her that

they had Lester up walking about a half hour earlier. When she went back to see him he was

lying on a gurney in his clothes. She tried to talk to him but he was agitated and did not want to

talk to her. He was tired and sleepy and said that he was cold. She stayed with him until about 3

p.m. when he was taken to the car. She did not see him walk at any time; he just lay on the

gurney.

- -16


When it was time to go to the car, they got Mr. Kindig into a wheelchair and tried to talk

to him periodically, but he did not want to be bothered. They managed to “scoot his butt’ into

the car and once Mr. G. was also down at the car, they returned to the hotel. During the trip,

Kindig was listless, “like a zombie.” He kept saying “too soon” and that it was not like the “first

procedure,” presumably a reference to the London experience. In response, Klein told him that

“they were the doctors” and “this is it.” G. was either half asleep or passed out. Neither man

could speak clearly. With the assistance of Mike Bortnicker (known as “Big Mike”), a former

dialysis technician, gym instructor and former addict who was an associate of Dr. Gooberman

and who sometimes served as a paid caretaker, she managed to get Kindig out of the car. Klein

and Bortnicker leaned Kindig against the wall and assisted him to the elevator and into the room

at about 4:00 p.m. G. was placed in the next room. Placed in the bed, Kindig simply wanted to

be left alone. Up to this time no medications were given. While in bed, Kindig called her

several times and complained that his hair and clothes smelled. He was wearing a diaper. After

she administered medication, Mr. Bortnicker told her not to run each time he called. When he

complained about being restless, Bortnicker said that she could give him two baclofen pills,

which she did. Kindig kept saying he had to spit. He seemed to settle down at around 9:00 p.m.

She did not go to sleep until later.

Nothing happened after she gave him the medications until she went to sleep on the

couch. She could observe that his stomach was rising and falling. She awoke at 8:57 a.m. She

discovered that Kindig had died.

Ms. Klein denied that, other than the prescribed drugs, any drugs or alcohol, were given

to Kindig after he was discharged.

6) Victor Melendez, 30 years old when treated on May 26, 1999, was released at 2:55

p.m. and died on May 29, 1999, at 2:25 a.m. The autopsy report was prepared by Dr. Yvonne I.

Milewski of the Office of the Chief Medical Examiner of the City of New York. She listed the

cause of death as persistent nausea, diarrhea and vomiting, with ulcerative esophagitis, gastric

ulceration, gastrointestinal hemorrhage, mediastinitis and dehydration; and new onset

generalized seizures and hyperpyrexia complicating rapid opiate detoxification. An “additional

factor” listed was hypertensive heart disease. Dr. Milewski listed several final diagnoses. These

- -17


included: chronic intravenous drug abuse/opioid dependence, with a history of methadone use of

300 mg. daily for two years; post-abdominal wall implantation of naltrexone pellets; partial tear

(microscopic) of esophageal muscularis and extensive acute hemorrhage of paraesophageal and

mediastinal soft tissue consistent with esophageal tear and mediastinitis; marked dehydration

with pre-renal azotemia and cardiovascular instability characterized by persistent tachycardia,

hypertension, episodic bradycardia/electromechanical dissociation and ventricular dysrhythmias

and ulceration of the epiglottis. She also noted that Melendez had marked steatosis, focal

hepatocellular necrosis, inflammatory and portal changes consistent with alcoholic liver disease

and hypertensive heart disease with left ventricular hypertrophy (heart weight 450 grams) and

left ventricular interstitial and perivascular fibrosis, and was asthmatic. The toxicology report

lists methadone, diazepam, trazodone, and metabolites of methadone in the blood and

methadone, amphetamines and benzodiazepines in the urine.

Mr. Melendez’ brother Anthony, a certified physical trainer, testified that he was aware

of his brother’s addiction in the early 1980’s and that he had on several occasions gone to clinics,

hospitals and rehabilitation centers, as well as going “cold turkey.” Victor had a heavy addiction

to heroin and became addicted to methadone in May 1998, obtaining his methadone on the

streets.

Anthony and other family members and Victor’s girlfriend transported Victor to the

Gooberman clinic to undergo UROD. After Victor went in for the treatment, Mr. Melendez left

and returned to the clinic at approximately 2:30 p.m. While in the waiting room he observed a

man come out who was unbalanced and stumbling and needed assistance to walk down the hall.

This man was wearing a diaper. When he asked if he could see his brother he was told that

Victor was still in recovery. He asked again ten minutes later and asked if he was okay. He was

told that Victor was groggy and tired. Allowed in to see him, they found him in a wheel chair

with his back to Anthony. When Anthony circled the chair, he saw that his brother did not look

like himself. He appeared very exhausted, with his cheeks sunken in. He whispered, “Get me to

a bed.” An aide said loudly, “Victor, lets go, your brother is here, they want to go home.”

Victor’s head was shaking. The aide said, “they all come out like that.” Anthony replied, “he

doesn’t look right to me.” He was advised to take his brother to a hotel. He went to get the car

and two men picked up Victor and placed him in the car. When Victor was told that he was

going to be taken to a motel, he said in a very low voice, “This ain’t right, take me to a hospital.”

- -18


The clinic aides told Anthony not to worry, “all was going to be all right. He’ll be fine.” In the

car he was weak and trembling and kept saying that “this is not right, take me to a hospital.”

When they arrived at the hotel, they asked for a wheelchair, placed him in it and took him to the

room. He looked at them with a grin on his face and gave a “thumbs up,” “No more drugs.”

Anthony was not present at the hotel for long, as he had to go home. He returned to the

hotel the next evening at about 11:00 p.m. on May 27. He found the room a mess, with vomit all

over the sheets and lamp and high up on the walls, almost to the ceiling. Victor had a blank

stare, but was happy to see Anthony. He told Anthony, “this ain’t right.” As he had to leave for

Puerto Rico the next morning, Anthony could not stay and they left shortly after. They

transported Victor home to his mother’s home in the Bronx, and on the ride he kept vomiting and

saying, “It hurts, hurts, stomach hurts.” He urged that they take him to a hospital at least four

times during the ride. They arrived home at about 1:00-1:30 a.m. As Victor could not walk,

they assisted him step by step to the second floor and placed him in the bed.

Sharon Gonzalez, who was Victor’s girlfriend for four years and is a certified home

health aide, testified that she was at the motel with Victor after Anthony left. Victor vomited

continuously. A phone call was placed to the Gooberman office and the family members were

told that Victor was “okay.” He kept vomiting and complaining of back and stomach pain and

cramps. Another phone call was made to the office later in the evening and a receptionist

answered. Diapers were delivered to the motel. When Victor began to throw up blood, office

personnel assured that this was due to the tube that had been placed in his throat during the

procedure and that “everything would be fine.” However, he kept vomiting until the morning.

Mike Bortnicker came to the motel at about 10:00 a.m. and stayed for twenty minutes, but Victor

would not respond to him. They told Mike that they would need more medication as they were

preparing to take Victor home. Medicine was sent to the motel by the pharmacy. Bortnicker

told them that Victor would be all right. However, he stayed about the same throughout the day,

vomiting regularly. He wanted to go to a hospital; however, the family kept telling him that the

doctors had advised them that he would be all right. When they returned home, Victor urinated

blood and they called Gooberman’s office and were again assured that he would be okay. When

he experienced fast breathing that would not slow down and his pulse was “not normal,” an

ambulance was called. At the hospital, Victor was given ten milligrams of methadone. No other

drugs were given to him other than those prescribed by Gooberman.

- -19


Michael Bortnicker recalled that he had gone to the motel to follow up on Melendez and

found that he was sick, vomiting a lot and retching. He asked Melendez if he was okay and

Victor shook his head, but would not speak. He characterized Melendez as a “tough guy,”

neither a whiner nor a complainer, and Bortnicker did not see anything wrong with the fact that

he did not speak, although in his experience it was unusual for a patient who was awake not to

talk. Bortnicker called over to the office and advised that Melendez was quite sick. However, he

was not concerned that his life was in danger, as quite a few of the patients he dealt with were

sick after the procedure.

Mr. Melendez was eventually transported to Montefiore Hospital, where he died. Ms.

Gonzalez denied that, other than those prescribed by the respondent, Victor was given or used

any drugs after discharge. The parties stipulated that Anthony did not supply any illicit drugs to

Victor subsequent to discharge.

7) Lisa Flowers was twenty years old when treated on June 26, 1999. She was

discharged at 11:30 a.m. and died at 5:53 a.m. on June 27, 1999, in the hospital, where she had

been taken from a residence in Toms River. Ms. Flower’s autopsy was performed by Dr. Lyla E.

Perez for the Ocean County Medical Examiner’s Office. She determined that the cause of death

was an acute myocardial infarction following rapid detoxification. She found that the decedent’s

heart had myocardial fibers that showed contraction band necrosis and lysis. In the absence of

coronary disease and given the age of the decedent, Dr. Perez concluded that the acute changes

found in the myocardium were related to the rapid detoxification. Of the drugs used in the

UROD procedure, only propofol, also known as diprivan, appeared in the PDR as causative of

ischemia and myocardial infarction; however, the cause and effect relationship was “unknown.”

The toxicology report from the New Jersey State Toxicology Laboratory lists morphine (free)

and fentanyl as found in the blood, and fentanyl in the stomach.

Jessica Martirano was a friend of Ms. Flowers. Flowers was dating Jessica’s cousin and

had a child with him, but the child died. Martirano learned of Lisa’s addiction in 1998, about a

year after the child’s death. Jessica observed Lisa using heroin.

- -20


On June 26, 1999, Ms. Martirano and a cousin accompanied Ms. Flowers to Dr.

Gooberman’s office from Toms River, New Jersey. Flowers sniffed a bag of heroin in the office

parking lot. Martirano testified that Flowers told her that a nurse or receptionist at the office had

instructed Lisa to “come comfortable.” Flowers took this statement to mean that she should use

her normal amount of heroin so as not to come to the procedure “sick.” Flowers was just getting

over pneumonia and was an asthmatic.

The witness and her cousin returned to the clinic at about noon at about which time she

first saw Lisa, who was being discharged. She was seated in a wheelchair, appeared to be

heavily medicated, and did not talk. She could not stand by herself. Her cousin and an orderly

placed her in the car. She “looked sick” and tired. In the car on the way to Toms River, she

flipped from side to side, said that she was hot and then cold and that she had to go to the

bathroom and had diarrhea. Although Jessica did not actually see this, she was aware that her

cousin gave Lisa a shot. Lisa said that the people at the clinic were “very bad people.” She was

alternately awake and asleep.

When they returned home they got her out of the car and up the stairs. She could not

walk by herself. Once she was upstairs and was placed in a bed, she complained of nausea. She

was constantly hot, then cold and thirsty. Later that evening she appeared convulsive and her

eyes started to roll and her skin took on a different color. She seemed to breath in, but not out.

Her face was blue and she could not breathe or talk. She either slept or kicked the blanket off.

Her mother dialed 911. As instructed on the telephone they tried to turn her on her side. Lisa

vomited perhaps a pint of a dark green substance. While they waited “a long time” for the

emergency personnel to arrive, her cousin’s sister attempted CPR. Lisa was taken to a hospital.

Martirano denied that Flowers either received or took any drugs other than those

prescribed by the doctor during the time following her discharge until she was transported to the

hospital. She did not see her cousin provide any drugs to Flowers either. She also denied that

her cousin ever told her that he had advised Gooberman’s office that Flowers had ingested

twelve bags of heroin after the procedure.

In addition to these patients, who died within at most about seventy-two hours after

receiving UROD, evidence was also presented about two patients who did not expire, but

- -21


experienced significant medical problems within a short time of receiving UROD and had to be

hospitalized as a result. These “morbidity” patients were Christopher Hendrix and Samuel

Perez.

Mr. Hendrix received UROD from Dr. Bradway on July 13, 1999. According to his

father, Chris is now thirty-five years old and hospitalized in Atlanta.

In October 1998, his father was aware of his son’s addiction to methadone. Chris wanted

to get off the drug. He had also used heroin and cocaine. Learning of Gooberman’s

detoxification process through either an advertisement or the Internet, Chris and his father

arranged an appointment with the doctor for UROD and journeyed to Merchantville.

Following a preliminary conversation with Dr. Bradway, Mr. Hendrix left the clinic and

returned at about 2:30-2:45 p.m. Personnel walked his son down the hallway. He was “very

pale,” “very, very weak” and could barely walk. He had to be held while going to the car. They

drove to a motel, arriving at about 3 or 3:30 p.m. Chris was too weak to respond when his father

tried to talk to him. In the car he was groggy, sleeping and did not speak. Once in the motel, he

went to bed. At about 9:00 p.m. he started to vomit. His father remained in the room with him

the whole time. Chris also had diarrhea. His father injected him three times, in accordance with

the instructions he had received earlier. He tried to give his son pills, but Chris vomited them up.

A phone call was placed to the doctor, but no call was received in response. Continued vomiting

and diarrhea occurred. By 2:00 a.m., Chris had to be moved to a different bed as the first was

saturated. Chris was sweating severely, was not speaking and seemed to be almost unconscious.

In addition, his vomit seemed to be bloody, an appearance different from that which had been

observed as late as 11:00 p.m. At 2:00 a.m., his father called the answering service, which told

him to call the office at 7:00 a.m. Vomiting continued until that hour. At 7:00 a.m., the father

spoke to Dr. Bradway, who said that he would send a staff person over to the motel.

At 10:00 a.m., someone arrived and called Dr. Bradway. The father insisted that he

needed help with his son, and Chris said “now.” The father was told to bring Chris to the clinic.

He was still almost comatose. At the office, Hendrix told the doctor that he needed fluid.

Bradway told the father that he was going to place his son in a hospital. An ambulance arrived

and removed him to West Jersey Hospital, where he remained for seven or eight days, first in a

- -22


regular room and later in critical care. Hendrix was placed on a respirator and was given

medication through a cut under the collarbone, as they could not place I.V. lines in his veins. His

father was told that his son had aspirated vomitus and had aspiration pneumonia.

Lissette Munoz is the brother of Samuel Perez. He told her that he was addicted to

heroin, was on methadone, was very sick and needed help. In June 1999, they sought out Dr.

Gooberman’s services. Mr. Perez in now in prison.

On June 16, 1999, the witness went with her brother and other close relatives to the

Gooberman clinic. Dr. Bradway spoke with the family prior to and then performed the

procedure. They were told that he might experience diarrhea and coughing. She can recall no

reference being made there to the possibility that her brother might have to go to a hospital.

The procedure started at about 8:30 a.m. When the family returned at about 4:30 p.m.

and saw Samuel he was “out of it” and had to be awoken. He was not able to respond to her

husband when he tried to speak to him. He mumbled and appeared drowsy. She did not see him

walking around at the clinic. He was placed in a wheelchair, taken out to the car and they then

proceeded to her house, where they had to drag him out of the car. They arrived home at about

5:00 p.m. He was placed on a mattress on the floor, undressed. He remained on the floor for the

entire night, “out of it,” mumbling and saying that he felt like he had diarrhea. In accordance

with instructions, he was given a syringe and was helped to the bathroom by her husband.

By the morning, Mr. Perez was coughing. He was given sips of water, but no other

drugs. A call was placed to Dr. Gooberman’s office at 7:00 a.m., but no one answered. Samuel

was by then coughing, producing mucous and spitting out blood. As his condition worsened and

Gooberman did not call back, her parents decided to take their son to the hospital, where he

remained for two or three weeks.

In addition to these testimonies, the respondents presented the testimony of UROD

recipients who described their experience. Morris Mizrachi, who owns his own business and has

a wife and three children, underwent UROD performed by Dr. Gooberman in March 1997. He

was a long-term heroin addict who, after relapsing following a clean period of twelve years,

attempted to detox on many other occasions, both through “cold turkey” and in hospital settings.

- -23


He described his history of unsuccessful attempts to stay off drugs, and the difficulties

encountered in detoxification. He was ultimately recommended to Dr. Gooberman by a physician

who told him that if he could not go through another clonidine detoxification or a methadone

program that he ought to see Gooberman. He described his going to see Dr. Gooberman as a

“last resort.”

Mr. Mizrachi described his UROD experience. He was not told to come to the office

“comfortable,” but he did use heroin about seven hours before and cocaine about three hours

before arriving. He discussed the procedure with Dr. Bradway, although ultimately Gooberman

actually did the procedure. He was told that UROD was not an all-encompassing treatment, but

only a start. He was not told that UROD was experimental, but was told that “thousands” of

URODs had been performed. He was told that others who had undergone UROD had died, but

does not believe that he was told that others who had not used illicit drugs after UROD had died.

He did sign a publicity waiver. He was told that when he awoke from the anesthesia, it would be

like the fourth day of a heroin detoxification. He was told about the pellet and given a choice

whether to have it implanted or not. He agreed to the procedure. He was told that despite the fact

that he would not get high, if he used heroin or cocaine after UROD, there was a good chance

that he would overdose. He signed a consent form. He believes that he was aware that the AMA

did not sanction UROD and that insurance would not pay for it, both facts that “scared” him. He

woke up from the anesthesia feeling worse than he ever had. He became violent, and he was told

that he punched people. He punched a hole in the bathroom wall. He could not stand or walk by

himself, was able to speak and was “somewhat drowsy.” He thinks that some measure was taken

of his physical abilities before he was discharged, but he does not recall walking the

circumference of the office. After about twenty minutes (as he recalled), he was taken by Mike

Bortnicker to a hotel. He felt horrible and had diarrhea, nausea, and uncontrolled vomiting. He

was very tired, confused and cold. However, he never thought that his life was in danger. He

was in the hotel for two days and was then driven home (his wife having agreed to take him in).

He was sick at home for a week or two. He realized he had to change his life. He took

naltrexone every day. He attended meetings every day. He described himself as physically and

emotionally sick for two months. He still attends meetings and has turned his life around 180

degrees from where it was.

- -24


Jennifer Faulk, another former Gooberman patient, was a heroin addict since age 15.

Having attempted to detox and go through rehabilitation on several occasions, the then twenty-

three-year-old saw Gooberman’s billboard in Newark while she was going to buy drugs.

Gooberman performed her UROD. He explained the procedure to her on the telephone and in

person, telling her of the serious danger of death if she used cocaine after UROD and telling her

not to have the procedure if she was going to use cocaine afterwards. He also explained that,

while post-UROD heroin use would not be fatal, it was “dangerous.” A naltrexone pellet was

implanted and she has gone back for other inserts. He advised her that she had to get a sponsor

and “go to ninety meetings in ninety days.” He also gave her a book with “all the meetings and

nights.”

Ms. Faulk, whose sister also underwent UROD, is “doing great” and has been sober for

four years.

The Expert Witnesses

In addition to fact witnesses, both the Attorney General and the respondents presented a

number of expert witnesses. These witnesses addressed a variety of often highly technical

issues, including, among others, such central questions as whether UROD is a safe procedure;

whether it was and/or should now be considered “experimental” or whether it is now or was an

accepted detoxification procedure; whether any or all of the deaths of the seven patients or the

two morbidities were directly caused or contributed to by the UROD procedure and what

standards of care may be applicable to the doctors’ UROD practice. In regard to the question of

the relationship, if any, between the patients having undergone UROD and their subsequent

demise, the establishment of the cause of each patient’s death was explored, with considerable

divergence as to the conclusions to be drawn. In view of the undisputed fact that each of the

deceased died within seventy-two hours of having undergone a UROD procedure that was

performed by either Dr. Gooberman or Dr. Bradway, all agree that there is no question as to the

existence of a “temporal relationship” between the occurrence of the procedure and the deaths.

Whether that temporal relationship is the only relationship or, more ominously, there is also a

causal relationship, and whether there was any negligence on the part of either or both

respondents is a major area of contention between the several experts and the respondents

- -25


themselves. It is also important to note that, while the most dramatic and arguably most

important concern in regard to the Gooberman/Bradway practice of UROD is whether the

procedure as practiced by them caused or contributed to deaths and/or morbidities, this case also

deals to a large degree with the question of whether particular aspects of the doctors’ practice

violated the applicable standards of care. This question exists separate and apart from the

possibility that death(s) resulted from their activities.

As the many expert witnesses addressed themselves to a wide variety of issues during

their testimony and their review of relevant documentation, the discussion of that testimony has

been grouped, as much as possible, in order to understand the experts’ analyses of these

concerns. As such, the following is a description of the experts and some information as to their

qualifications.

Complainant’s Experts

Robert Segal, M.D., a pathologist licensed as a physician in New Jersey for thirty years,

has served as the Camden County Medical Examiner for fifteen years. He has also served in the

medical examiner’s offices in Philadelphia, Atlantic and Burlington Counties. He is certified by

the Board of Pathology. He now lectures at the University of Pennsylvania. Doctor Segal was

admitted as an expert in clinical, forensic and anatomical pathology qualified to give opinions as

to the findings at autopsy and the cause(s) of death. The cause of death is determined by

investigation into what happened to the individual, the autopsy findings, laboratory studies,

consultations and special examinations. Dr. Segal, who has performed thousands of autopsies,

does approximately fifty a year that are drug related.

Lori Karan M.D., is a Board Certified internist licensed in the State of California. She

was admitted as an expert in addiction medicine. Dr. Karan serves as an assistant adjunct

professor with a dual appointment in the Departments of Medicine and Psychiatry at the

University of California in San Francisco (“UCSF”), with emphasis in the Department of

Chemical Pharmacology and Experimental Therapeutics. Dr. Karan is a Fellow of the American

College of Physicians and has extensive experience detoxifying addicts in clinical settings at a

facility associated with Johns Hopkins. She has held previous academic positions at the Medical

- -26


College of Virginia and has trained medical students, residents and post-doctoral fellows in

addiction medicine.

Dr. Karan has served on national committees and published articles concerning addiction

medicine. She is an executive board member and active participant in the American Society of

Addiction Medicine (“ASAM”). She has received a research award from the National Institutes

of Health. She is currently affiliated with the Haight-Asbury Clinic.

Reng-Lang Lin, Ph.D., Chief Toxicologist and Laboratory Director for the New Jersey

State Toxicology Laboratory, was admitted as an expert in toxicology, the ingestion, elimination

and absorption rates of drugs and their lethality or toxicity. He has been employed at the New

Jersey State Toxicology Lab since 1983. The witness holds a Ph.D. in Biochemistry from

Oklahoma State University and served a post-doctoral fellowship at the University of Wisconsin-

Madison. He also served in the Illinois Department of Health and was assistant chief of

toxicology in the Cook County Medical Examiner’s Office. Dr. Lin has served as a clinical

professor in forensic toxicology at the University of Medicine and Dentistry of New Jersey

(“UMDNJ”).

Dr. Lin is not a pathologist and he described himself as “somewhat familiar with

physiology.” He can determine whether a drug is lethal or not, but he is not the person who

performs the testing. A pathologist is the medical expert who determines the lethality of a

particular dose to a person with a particular condition. The lethality of a dose for a particular

individual can be affected by genetic and other factors.

Clifford M. Gevirtz, M.D., was admitted without objection as an expert in

anesthesiology and the UROD procedure. Dr. Gevirtz is a Board Certified anesthesiologist

licensed in New York State since 1981. He specializes in anesthesiology and pain management.

He holds a Bachelor of Science from Rochester, a Masters in Public Health from Tulane and a

M.D. degree from Tulane. He is a clinical associate professor of anesthesiology at Mt. Sinai

Medical School in New York City. He consults on hundreds of pain management matters a year

and is involved in the clinical practice of anesthesiology, participating in about 800-1,000

procedures a year.

- -27


Dr. Gevirtz has directly performed 185 UROD procedures at Metropolitan Hospital

Center in New York City and has supervised and proctored another seventy procedures. He was

involved in creating a protocol for UROD procedures for the Center for the Investigation and

Treatment of Addiction (“CITA”) and he modified the protocol several times during the years

1996-97. He has taught the UROD procedure in several hospitals in the United States and in the

Commonwealth of Puerto Rico.

Dr. Gevirtz is currently associated with UltraMed, which acts as a referral service for

candidates for the UROD procedure. He has also been involved in research and development of

medical patches. He proctors and trains the personnel at new sites established by UltraMed.

UltraMed referred about fifty clients for UROD in the past year and was compensated for these

referrals. If, because of an adverse outcome of this case for the respondents, UltraMed were to

receive as 600 additional referrals a year, it would naturally stand to gain significant additional

compensation.

Herbert D. Kleber, M.D., is a professor of psychiatry and the director of the Division of

Substance Abuse at Columbia University College of Medicine. As all of the experts for both

parties attested, Dr. Kleber is a recognized authority on the treatment of drug abusers. The

doctor served as an expert consultant to the Board of Medical Examiners in connection with its

investigation of the Gooberman/Bradway UROD practice and was a participant in the

investigative hearing conducted by the Board on September 2, 1999, at which hearing Dr.

Gooberman testified and during which Dr. Kleber asked some of the questions posed to

Gooberman. The doctor first became involved in the Attorney General's and State Medical

Board’s activities regarding Doctors Gooberman and Bradway when he was contacted by Deputy

Attorney General Harper, who was then seeking advice on how to interpret certain findings. He

first provided written material in a report of September 10, 1999.

Dr. Kleber was first licensed in New York State in 1961. Dr. Kleber was associated with

Yale University from 1966 through June 1989, at which time President George H.W. Bush asked

him to become the Deputy Director of the White House National Office on Drug Policy. He

served in that capacity until November 1991 when he joined the faculty at Columbia University.

His current responsibilities at Columbia include clinical, research and academic functions. He

founded the Division on Drug Abuse, which now has a staff of 100 and currently is running

- -28


between 18 and 20 research projects and receives $12 million a year in federal grants. Dr.

Kleber is in charge of training on substance abuse for the medical school and for psychiatric

residents and post resident fellows.

Until recently, Dr. Kleber was also the Executive Vice President of the National Center

on Drug Abuse.11 He is an author, co-author or editor of numerous publications. He is a member

of the National Academy of Sciences’ Institute on Medicine and is a Fellow of the American

College of Neuropsychopharmocology. He received an award from the ASAM in spring 1999 in

recognition of his research to advance substance abuse treatment. However, Dr. Kleber is not a

member of ASAM, and has chosen not to take ASAM’s examination for certification in

addiction therapy. He is also not Board Certified in psychiatry and is not a pharmacologist.

Dr. Kleber has been treating addicted individuals for over thirty-five years. His textbook

is widely used and one of the best selling for students. He has personally detoxified or

supervised the detoxification of over 3,000 individuals. By detoxification, he means to refer to

the process of ridding the body of a substance(s) to which the person has become dependent.

Another term for this process is “withdrawal.” While at Yale he formulated protocols for the

detoxification of opioid dependent persons.

Lawrence Gerald Kushins, M.D., testified as an expert in anesthesia and the dangers

associated therewith. Dr. Kushins is a licensed physician and professor of anesthesiology at

Robert Wood Johnson Medical Center, where he serves as chief of the anesthesia service and as

acting department chairman, in which capacity he supervises nurse-anesthetists and

anesthesiologists. He is Board Certified in anesthesiology and critical care medicine. Kushins

conducts an active clinical practice in which he administers anesthesia approximately 1,000

times per year. During the last five years, he has conducted a full-time clinical practice while

also teaching at Robert Wood Johnson Medical School. He has previously served in academic

positions at the State University of New York, Stony Brook, Long Island Jewish Medical Center

and New York University Medical School, as well as at the University of Florida. He has

published approximately ten articles and six book chapters.

11 In addition to his research, the doctor treats addicts and sometimes detoxifies addicts. He devoted himself full-time to his work at the medical school in bio-medical research. He has a grant and will need to enroll a number of addicted patients into his study. It is possible that the grant would be terminated if not enough addicts were obtained.

- -29


Defense Experts

Dr. David E. Smith, M.D., was admitted as an expert in pharmacology, toxicology and

addiction medicine, also known as addictionology. Dr. Smith holds an M.D. degree from the

University of California, San Francisco (“UCSF”) and holds a Masters from that institution in

pharmacology and psychopharmacology. In 1967 he started the Haight-Ashbury Free Clinic in

San Francisco and is now its president and medical director. The clinic is a non-profit

organization with twenty-two sites in the Bay Area, to which 50,000 clinic visits are made yearly

by uninsured individuals. It provides primary medical care and addiction treatments services,

including detoxification and aftercare. It has an active research program and is part of the NIDA

Clinical Trials network. In this role, it is involved in on-going work on medicines being tested

for their efficacy in addiction treatment, such as buprenorphine and long-acting naltrexone.

Dr. Smith has also served as the medical director of the Betty Ford Center’s Professional

Program. His time is spent one-third in treating addicts, one-third in research and one-third in

teaching. He has published nearly 350 articles and has been the author, co-author or editor of

fifteen books. He served as the president of ASAM from 1995-97. He has also served part-time

as the director of the State of California’s own addiction programs. He has testified as an expert

witness over 250 times.

Dr. Smith has never personally performed a UROD procedure. However, he has referred

people to others for UROD.

John T. Cooper, Jr., M.D., an expert in anatomic, clinical and forensic pathology, holds

a medical degree from the University of Texas Health Sciences Center. He has served as a

hospital pathologist and as a medical examiner in Phoenix, Arizona. Dr. Cooper also has worked

as a coroner’s pathologist in a private pathology group in Stockton California and has conducted

a private practice in which he has performed many “second look” forensic autopsies. He has

testified as an expert witness in both criminal and malpractice cases. Dr. Cooper is Board

Certified in each of the areas in which he was accepted as an expert.

While serving in Phoenix, Dr. Cooper performed an autopsy on a young female who died

a few hours after undergoing ROD/UROD.

- -30


David Lew Simon, M.D., a licensed physician practicing in Mansfield, Connecticut, was

accepted as an expert in addiction medicine, anesthesiology and UROD. Dr. Simon graduated

from the Medical College of Virginia in 1987. He is Board Certified in anesthesiology and

practiced in that specialty until 1992, when he shifted his focus to addiction medicine. He is

certified in addiction medicine by ASAM and is a Fellow of the National Academy of Medical

Examiners. At one time, Dr. Simon was a member of the ASAM Public Policy Committee. He

has published an article on the rationale of naltrexone therapy.

Dr. Simon is both a colleague of Drs. Gooberman and Bradway in the field of addiction

medicine and a competitor of the respondents in the provision of UROD, providing an anesthesia

assisted detoxification that he calls Intensive Narcotic Detoxification, or “IND,” which he

characterized as being basically the same procedure as UROD. Dr. Simon’s practice was

conducted as Nutmeg Intensive Rehabilitation Center in Connecticut. Simon personally

performed about 250 UROD procedures between November 1996 and April 2000. During these

procedures, either he supervised the services of an anesthesiologist working as an independent

contractor or had a nurse anesthetist perform the anesthesia service in another 250 procedures.

His organization does not now perform UROD. Instead, it refers candidates for the procedure to

hospitals and to other providers.

Frank T. Maziarski, CRNA, testified as an expert witness for the respondents

concerning the duties and responsibilities of Certified Registered Nurse Anesthetists (“CRNAs”),

including their responsibilities in the area of critical care nursing and the maintenance of patients

and their discharge. Maziarski, a CRNA for over thirty-five years, licensed in New York State

and the State of Washington, holds a B.S. and a Masters in Physiologic Psychiatry from the

University of Nebraska. He served as Director of Anesthesia Education at the United States

Army Academy of Health Sciences at Fort Sam Houston and Director of Anesthesia at Madigan

Army Medical Center in Washington State. He was associate Director at Walter Reed Army

Medical Center and Director of Anesthesia at Beaumont Army Medical Center in El Paso, Texas.

He has recently been accepted into the American College of Forensic Examiners, an organization

of legal nurse consultants dedicated to the study and advancement of forensic examination of

patients’ charts, legal documents and court proceedings. He has taught in the residency program

at the University of Washington and as an associate professor at Drake and at Nebraska

- -31


Wesleyan. He has testified as an expert for both the government and the defense in malpractice

cases in Washington State and North Carolina.

Mr. Maziarski acknowledged that he was not familiar with the specifics of the certifying

process for CRNAs in New Jersey. However, he described a CRNA as an advanced nurse

practitioner. A nurse anesthetist has critical care responsibilities and is required to know cardiac

function, how to read an EKG, how to intubate and use various types of equipment and advanced

life support procedures.

Maziarski conducts a private practice in clinical anesthesia and consults on legal matters

regarding nursing. He is not certified as a critical care nurse, but was trained in that field thirty

years ago and has experience in operating rooms and has directed critical care nurses in recovery

rooms. He also is required by state law and his professional organization to take review courses.

Jennifer Richards, R.N., is a registered nurse now employed as a Medicare nurse case

manager, but she was formerly employed as a critical care nurse in Dr. Gooberman’s office. Ms.

Richards worked as an operating room nurse at Kennedy Hospital and eventually went to work

for Gooberman. She was involved in both the monitoring of patients during UROD and in

bringing the patients out from under anesthesia and in discharging them. She also was involved

in interviewing patients prior to their undergoing the procedure.

Rosemary Capelli, R.N., a teacher at the Nursing College of New Jersey and a licensed

nurse with a master’s degree in Arts and additional course work towards a Ph.D., was requested

by former counsel to Dr. Gooberman to review the protocols and nursing resumes of those who

worked at the Gooberman clinic.

Frank Ragone, R.N., served as a critical care nurse in the Gooberman clinic from 1997-

99. Mr. Ragone is licensed by the States of New Jersey and Pennsylvania. He holds an

associates degree from Camden County College. He started to work part-time for the

respondents in 1997 and later worked full-time. He had first met Dr. Gooberman at Lady of

Lourdes Hospital and was interested in the work that the doctor was doing. He began to train

with Gooberman three days a week for two weeks, first observing the procedures. He spoke to

the nurses, CRNAs and doctors. He then started to participate. He assisted with medications and

- -32


basic care and monitoring. He was advised of protocols and guidelines utilized in the facility

and was given much to read. He received written dosing orders for each patient. Standing

orders were in place. He compounded anesthesia drugs, mixing them together.

In addition to these responsibilities, Mr. Ragone explained that after the patients were

discharged he called them on a daily basis, preferring to speak to the patient, although he often

ended up speaking to the caretakers. These calls continued on a once-a-day basis for a week and

then three times a week or whatever was needed as a follow-up. When patients had complaints,

he worked from the standing orders and prescribed drugs.

Rebuttal Witnesses

Complainant’s rebuttal expert was Bunyad Haider, M.D., a cardiologist licensed by the

State of New Jersey. Dr. Haider has served as a full professor of Medicine at New Jersey

Medical School in the Department of Cardiovascular Diseases for approximately eighteen years

and is vice chair of the Department of Medicine. He conducts research, teaches and conducts a

clinical practice, in which he specializes in interventional cardiology. Dr. Haider is Board

Certified in Internal Medicine and Cardiovascular Diseases. He has authored chapters in

textbooks and published many papers. He has performed research on cardiac related

hypertension. The doctor has no experience in performing UROD, although he is familiar with

the procedure.

Respondent’s sur-rebuttal expert was Robert Katz, M.D., a clinical cardiologist licensed

in Pennsylvania and California, is associated with Presbyterian Medical Center in Philadelphia,

which is a part of the University of Pennsylvania Health Systems. Dr. Katz has thirty-one years

of experience as a cardiologist. He cares for patients, reads angiograms, echocardiograms and

does clinical noninvasive work, but not catheterizations, which are invasive. He is a graduate of

Middlebury College and Howard University Medical School and is Board certified in internal

medicine and cardiology. He has served as an assistant professor of clinical medicine at the

University of Pennsylvania.

- -33


In addition to these experts, the respondents each were qualified as experts in the field of

addiction treatment and UROD. Each explained about their background and experience in these

areas.

Lance L. Gooberman, M.D., was admitted as an expert in UROD. He received his

M.D. degree in Juarez, Mexico. He is not Board Certified in Internal Medicine, but practiced in

that field until 1996. He then practiced primary care medicine and worked nights in the

emergency room in West Jersey Hospital’s Eastern Division in Berlin. His interest in addiction

medicine emerged in 1987. He has been certified in addiction medicine by ASAM since 1990

and ultimately converted his practice to that field. He is himself a recovering methamphetamine

addict, having used drugs until February 1987.

In the early 1990’s, Dr. Gooberman began to see a reduction in emergency room cases

involving methamphetamines and a rise of heroin cases. Traditional detoxification methods

were expensive, programs were hard to get into, especially as managed care limited admissions

and durations thereof, and the programs were not very successful. He did a lot of reading on

what could be done for these addicts and attended conferences. He was advised of work

performed in Austria by Dr. Loimer, which involved precipitated withdrawal. Thereafter,

Gooberman helped to form a committee at West Jersey Hospital Detox Center where he had

been precipitating some patients’ withdrawals. The procedure involved the use of naltrexone to

precipitate withdrawal, basically, the method utilized by Dr. Kleber at Yale. Prior to this,

Gooberman had been using sedatives such as phenobarbital and clonidine and he tried to make

the patients’ withdrawal comfortable, which it was not. The success rate was low, more than

half signed themselves out and of those who made it through the withdrawal, they usually

relapsed within a day or two due to their discomfort.

Dr. Gooberman detailed other experiences with precipitating withdrawal at Cooper

Hospital, where even heavily sedated patients would “come off the bed” and require “a lot” of

people to control them. The situation proved too nursing-intensive and, based upon suggestions,

the patients were then admitted to ICU or the intermediate care floor, rather than the regular

floors. Additional suggestions were made that if the patients were intubated the need for so

many nurses would be alleviated. One nurse could handle two, rather than one patient.

However, there were complaints that these patients were not in extremis and did not belong in

- -34


ICU beds. In addition, some had severe diarrhea, and the smell was bothersome. Nurses also

had bad “attitudes” toward drug addicts.

Dr. Gooberman was aware that Medicaid was paying $3,200 per patient and the hospital

was making a 50% profit on the procedures. He thought that if he could get the necessary

equipment, personnel and drugs he could do the procedures in an office setting. Although he

found that Medicaid would only pay $45 for procedures done in the office, he proceeded to set

up the office with all the proper equipment, essentially establishing an ICU. He then tried some

procedures in this setting. While no one in ASAM had previously done this procedure, he did

speak to Colin Brewer in England, a well-known addiction specialist who was performing

precipitated withdrawals and who had determined that octreotide would stop the severe diarrhea.

This produced a major change, as it assisted with maintaining proper electrolyte and fluid

balances.

David Bradway, M.D., who was the attending physician on five of the seven mortality

cases and for the two morbidity cases, has been licensed as a physician in New Jersey since

1977. For a time in the early 1980s he voluntarily surrendered his license to practice medicine as

a result of an opiate addiction problem and sequelae related thereto. Prior to his suspension, he

attended UMDNJ and had a residency in nuclear medicine at the University of Pennsylvania. He

served as an emergency room physician for one and one-half years. He worked as a software

engineer from 1982-89 at RCA in Moorestown. His medical license was at first partially

restored and he practiced internal medicine in 1984 and 1985. The license was fully restored in

1987. He practiced with Dr. Gooberman in the general practice of internal medicine from 1987-

89 while also receiving a masters degree in mathematics from Drexel University. In 1990, he

opened his own practice in Magnolia, New Jersey. He now practices full time in the fields of

general medicine and family practice. He is on staff at West Jersey Hospital.

Dr. Bradway began to perform UROD in November 1995. Dr. Gooberman called,

explained the procedure and invited him to witness it. His own history peeked his interest in a

possible mode of detoxification. He had had some training before 1995 in anesthesia, in medical

school for two months at Beth Israel Hospital in Newark. He also read texts on pharmacology

and had learned in medical school between 1972 and 1976 how to intubate, extubate, evaluate

and do histories, physicals and follow-ups after anesthesia. While he served as an emergency

- -35


room physician, his skills in anesthesiology were frequently needed. However, after 1985 and

until 1995 he did not have any experience with anesthesia. He has been re-certified in advanced

cardiac life support on several occasions. He is not Board Certified in Emergency Medicine, as

it was not a Board Certified specialty at the time that he was doing that work.

Dr. Bradway testified that after observing the UROD as performed by Dr. Gooberman

and determining that it was a reasonable procedure, he began to train in the procedure under Dr.

Gooberman’s supervision. Gooberman employed him to perform URODs sometime in late 1995

or January 1996. He was paid by the hour. He was trained in the various medicines and their

administration and purpose. On several occasions, an anesthesiologist was present when the

procedure was performed. Bradway understood that, as a licensed physician, he would be

supervising a CRNA. He was trained in the array of equipment used in UROD. The work was

performed in what was essentially an intensive treatment unit. He did perform some of the

intubations himself, although in general these were done by the CRNA. He first performed a

UROD procedure on his own in February or March 1996 and thereafter did them regularly on his

own, although at times both he and Gooberman were present. His role as the attending physician

was to oversee all aspects of the procedure and be primarily responsible both before and after

and to follow-up on discharge.

Detoxification and the NIDA Report

The unofficial NIDA report, issued on February 23, 1996 during the earlier phase of Dr.

Gooberman’s 1995-99 provision of UROD, is a key element in the conclusions about UROD

asserted in the Complaint and a discussion of its conclusions and significance played a prominent

role in the hearings. However, as UROD, whatever its efficacy, safety and/or acceptability,

purports to be only a means of detoxification, it is first helpful to relate some of the evidence

presented regarding the several approaches to treatment for opioid addicted individuals,

including the necessary element of detoxification.

Dr. Herbert Kleber explained that there are both “maintenance” and “drug-free”

approaches to treatment. 12 Maintenance can involve switching a person from the drug of 12 Although he had no role in writing the NIDA report, Dr. Kleber was consulted by Barbara H. Herman, Ph.D., the Director of NIDA’s Clinical Opioid Medications Program, Clinical Trials Branch, an author of the report who asked him some questions and to whom he provided some articles from the literature. The other author of the Report was Dorynne Czechowicz, M.D., associated with the Treatment Research Branch at NIDA. Several consultants are listed

- -36


dependency to an opioid considered safer for maintenance. Such a drug may be methadone, or

recently, buprenorphine. However, if, the goal is to allow a person to abstain from opioids,

rather than to maintain one on a “safer” opioid, then there are several approaches to the

detoxification of an addicted person. Detoxification is considered the preliminary or first step in

treatment of the addiction. Generally, the method of detoxification having the least risk for the

patient should be chosen. This is determined by what Kleber referred to as both “theoretical”

and “practical” considerations. The theoretical consideration involves an assessment of the

patient’s state of health, looking at, among other factors, his/her liver and heart function. Certain

means of detoxification are more stressful than are others. There is no single rule about what

method to use. The practical considerations include cost and availability of a modality of

treatment in the community. One method involves abstinence from the drug. Another involves

giving the addicted person a narcotic antagonist, such as naltrexone. A third method involves the

entry of an addicted person into an in-patient treatment facility or attendance at Narcotics

Anonymous (“NA”) meetings. The bulk of the treatment process is aimed at allowing an

addicted person to refrain from the use of opioids. The adage regarding opiate addiction is “easy

to get off/hard to stay off.” Relapse prevention tools include psychiatric counseling, “12-step”

and cognitive approaches. All these are part of the treatment of the addiction.

The witness described the process of withdrawal from opiates. Heroin is diacetyl

morphine, meaning morphine with two acetyl groups attached. Withdrawal from morphine starts

about twelve hours after the last dose and peaks after about thirty-six until about seventy-two

hours after its start. It generally lasts for from five to seven days with lingering aspects thereafter

sometimes lasting over a period of weeks or months. These can include trouble sleeping and

irritability. Withdrawal from methadone generally peaks at four to six days and lasts for eight to

ten days, but the symptoms of withdrawal may linger for quite a long time thereafter.

Dr. Kleber explained that there are three main categories of detoxification protocols. One

of these involves the use of the drug clonidine, which alleviates 80% of the symptoms of opioid

withdrawal, but which, if used alone, does not shorten the period of withdrawal. A second

protocol involves the use of buprenorphine. This drug is not yet on the market for use in drug

withdrawal.

as well. These include three professors of psychiatry and two other physicians, whose areas of specialty are not designated.

- -37


A third protocol involves the use of clonidine and naltrexone. This is a rapid

detoxification method, or ROD. Naltrexone is used to precipitate withdrawal after a

pretreatment with clonidine, a drug that diminishes the withdrawal symptoms. In effect,

naltrexone binds to the mų receptors in the brain, thereby not allowing the opiate to do so, and in

fact displacing morphine already on the receptors, thereby inducing withdrawal. Clonidine is

commonly used here and abroad, but naltrexone is not and the ROD process is not commonly

employed. By the end of the 1980’s, a naltrexone precipitated withdrawal lasted for two days.

This procedure, which Dr. Kleber initiated at Yale, did not employ general anesthesia. On the

other hand, UROD, as employed by the respondents and by some other practitioners, does

employ general anesthesia.

The theory behind UROD arose because of limitations that Kleber and his associates

found in their experiments with the clonidine/naltrexone process. The use of antagonists in

detoxification is impacted by the rate at which the antagonist can be given, due to the severity of

withdrawal symptoms that are by administration of the antagonist. At first naloxone, naltrexone

and clonidine were used in a two-day procedure, however, Dr. Colin Brewer, working in

London, reduced the time to a day-and-a-half by sedating the patient with clonidine. However,

the more naltrexone given to the patient, the more severe were the withdrawal symptoms. It was

Dr. Loimer, practicing in Austria, who first used anesthesia. He used large doses of

benzodiazepine and anesthesia. This was the first ROD procedure. Over the past ten years,

those employing anesthesia in detoxification have used different methods of anesthetizing the

patient, some using propofol, some barbiturates, some ketamine, and some nitrous oxide. The

theory behind the anesthetized withdrawal was that by stripping the opiates off the receptors

while the patient was anesthetized, the detoxification could be accomplished within one to one

and one-half days. However, according to Dr. Kleber, experience now shows that severe

withdrawal symptoms can be experienced for up to two weeks.

Naltrexone is an FDA approved drug for withdrawal. It has 140 times the affinity for the

mμ receptor that heroin has, thus, if naltrexone binds to a receptor 140 times the usual amount of

heroin needed to bind to the cell is necessary for it to overcome the effect to the naltrexone. Oral

naltrexone is a relatively quick acting drug that is approved for maintenance treatment.

However, naltrexone does not work very well if injected. Another drug, naloxone, is an

- -38


injectable drug used mainly in the treatment of drug overdoses, since it works faster than oral

naltrexone.

Turning to the NIDA Report, Dr. Kleber explained that NIDA is a part of the National

Institutes of Health, charged to research the causes and prevention and treatments for all forms of

addiction. It funds 85% of all research on drug abuse in the world. Dr. Kleber’s understanding

is that the NIDA report was produced after the Israeli Ambassador to the United States asked

NIDA for information about UROD and for its position regarding UROD. One of the leading

proponents of the UROD technique has been Dr. Andre Waismann, M.D., from Israel.

Reportedly, the procedure was being utilized in Israel to treat soldiers.

Initially, the authors of the NIDA Report acknowledge that “the major problem” in

assessing UROD and “rendering a firm scientific opinion” about UROD is the lack of

randomized, single or double-blind controlled studies and the limited database as to the

procedure. In addition, different practitioners utilized different medications in the procedure,

thus it is “difficult to systematically determine which medication may be responsible for

alleviation of opiate withdrawal symptoms.” In the absence of significant research, the

possibility that UROD might be useful for detoxifying opiate dependent individuals relatively

quickly, that is, within one to four days, must “remain a ‘medical impression.’ ”

Significantly, the authors report that there is a risk of death from UROD. They conclude

such because they state that death can occur either directly, from inadvertent overdose of the

anesthetic agent, or indirectly, due to aspiration of emesis during naloxone-precipitated

withdrawal. They then state “opiate detoxification has no known mortality risk in uncomplicated

cases,” and, as there is such a risk from UROD, “it is our view that such additional studies

should be undertaken only in very carefully considered and rigorously designed studies.”13

The authors of the NIDA study conclude that there is no evidence that UROD is superior

to any other detoxification technique in preventing relapse and that it is not a cure for opiate

addiction. While they concede that if UROD is proven safe and effective it may be beneficial for

“very high risk patients who would refuse longer detoxification procedures (I.e. 2 versus 5 days),

13 Among the sources for the conclusion that there is no risk of death in uncomplicated detoxification utilizing methods other than UROD are Dr. Kleber’s letter to Dr. Hermann, dated February 7, 1996, and page 99 of an article by R. Mattick and W. Hall, Are detoxification programmes effective? The Lancet 347: 99-100 (1996).

- -39


to serve as a bridge towards longer term relapse prevention,” they conclude that on a risk/benefit

analysis UROD is unacceptable as a detoxification procedure.

The authors’ review of the literature regarding naloxone-induced reversal of high-dose

anesthesia led them to studies that they assert demonstrated “a small but significant incidence in

cardiovascular complications including cardiac arrest and pulmonary edema following

intravenous (i.v.) administration of naloxone to surgical patients.” The authors highlight (in bold

letters) a report of a “life threatening adverse event (pulmonary edema) when UROD was used

involving i.v. administered high dose naloxone.” This event was reported in 1995 by San, et al.14

In addition to the conclusions already stated, the authors of the NIDA report also

concluded that UROD was an “elaborate” procedure and that there were “less elaborate” and

“less expensive” detoxification methods available. The “elaborate nature” of the procedure was

its need for intensive care or operating room inpatient facilities “equipped with appropriate

medical and nursing staff and equipment . . . especially if anesthesia (versus moderate doses of

sedative) is used.” Other detoxification procedures do not require these types of personnel and

equipment. Cost-wise, the report states that a one to two day UROD procedure with six month

follow-up was $5,000, or, as reported by Dr. Kleber, about $7,500 in New Jersey. Costs for a

thirteen-day period of inpatient therapy with stabilization from other substances and methadone

treatment is said to be $3,705 and for inpatient detoxification about $285 a day, and rapid

detoxification using clonidine and naltrexone is reported to cost $1,425 for five days.

The NIDA report also concludes that there are no double-blind studies indicating that

UROD procedures are more successful in decreasing relapse than are longer duration treatments.

In summarizing their conclusions, the authors of the NIDA Report conclude that “based

on the available information, it appears that the UROD anesthesia method is currently without

ethical, medical, scientific, or financial justification as a clinical detoxification treatment at the

present time. . . .” (Italics added.) It concedes the possibility that if proven safe and effective

UROD might be of some use in the treatment of “extremely high risk” opiate addicted persons

who would turn down other, more conventional procedures . . .,” but suggests that “additional

14 The conclusion drawn by the authors of that report and the adoption of it as an example of the risk associated with UROD will be the subject of further analysis and criticism later in this opinion.

- -40


research evaluating UROD should be undertaken only in very carefully considered and

rigorously designed studies.”

Dr. Kleber agreed that as of February 1996 the conclusions expressed in the NIDA

Report accurately reflected his views regarding UROD. He acknowledged that as of that date he

had not observed or participated in a UROD detoxification. He denied that the report was

“hastily prepared,” after the Israeli inquiry was passed on to NIDA by the State Department.

In 1998, Dr. Kleber surveyed all of the literature on UROD and has tried to keep up with

the literature since then. There are only about twelve scientific articles on the process. Dr.

Kleber opined that ROD does not as yet have a widespread acceptance and asserted that

“recognized addiction experts” are “generally in agreement” that UROD is considered an

“experimental procedure” and will be so until research is done that allows for a full consideration

and assessment of the risks and benefits of the procedure. There have been no good controlled

studies of it and no good long-term study with outcomes. There is not yet any way to define the

benefits of the process and compare them to its risks.

In September 1998, Dr. Kleber submitted a grant application to NIDA and was eventually

awarded the grant that funds the Columbia University study, which is intended to provide the

study and test of UROD that has been up to now lacking. The grant funds a comparison study by

means of a random assignment of three methods of detoxification: 1) by use of clonidine; 2) by

use of clonidine, buprenorphine and naltrexone; and 3) by accelerated rapid opioid

detoxification, or AROD, another name and acronym for the procedure employing general

anesthesia that is also known as UROD. According to Kleber, this study will be the first

controlled study of the safety and efficiency of these procedures, as well as the risk/benefit ratio

and related studies as to the effects on the body, such as hormonal changes and the effect of sleep

while undergoing withdrawal. The portion of the study involving AROD was to involve thirty

patients, however, that study was delayed by Columbia’s Institutional Safety Board due to

reports concerning deaths occurring in relation to withdrawal under anesthesia. Dr. Kleber has

personally observed a UROD procedure, one of the two just performed at Columbia.

As a form of detoxification, ROD can be performed on an outpatient basis, although the

first day can be difficult. Opioid withdrawal is inherently stressful. Complications may be

- -41


associated with pre-existing disease, such as certain cardiac problems, acute hepatitis or

pneumonia. Significantly for issues addressed later in this case, Dr. Kleber described persons

with such conditions as “already compromised.”

As noted earlier, Dr. Kleber was listed in the NIDA Report as a source for the proposition

that there was no risk of death associated with other methods of detoxification in uncomplicated

heroin withdrawal. He testified that there were no mortalities reported in the English language

literature. Before 1995, there was also no mortality associated with UROD. However, as the

UROD procedure has been spreading worldwide, in the period between 1995 and 1999 reports

have emerged regarding increasing numbers of deaths associated with UROD. The major risks

associated with the procedure are cardiac problems, including arrhythmias and dysrhythmias. In

addition, pulmonary problems are common, including irregular breathing patterns. In addition,

there can be a persistence of severe withdrawal symptoms for one to two weeks, including

persistent vomiting and diarrhea. Electrolyte abnormalities and decreased potassium could affect

the heart rhythm. Each of these risks poses a possibility of death. While the total of such visits

is unknown, these risk elements have led to emergency room visits.

Dr. Kleber identified and discussed a number of papers and articles written since the

NIDA Report. Some of these looked at the physiological changes that occur during UROD. A

1999 article by Pfab, Hirtl and Zilker, Opiate Detoxification under Anesthesia: No Apparent

Benefit but Suppression of Thyroid Hormones and Risk of Pulmonary and Renal Failure,

published in Clinical Toxicology 37(1), 43-50 (1999), (hereinafter referred to a as the “Pfab

article” or “Pfab”), based on a study of twelve patients, concluded that opiate detoxification

using anesthesia and high, repetitive doses of opiate antagonists had no obvious benefits and

high risks. According to the Abstract of that report, all of the patients had moderate to severe

opiate withdrawal symptoms and none completed detoxification within the first forty-eight

hours. The method used suppressed thyroid hormones and there was one pulmonary failure and

two renal failures.

Dr. Kleber discussed another article, Profound Increase in Epinephrine Concentration in

Plasma and Cardiovascular Stimulation after μ-Opioid Receptor Blockade in Opioid-addicted

Patients during Barbiturate-induced Anesthesia for Acute Detoxification, authored by Kienbaum

- -42


et al.15 This article discussed UROD performed in a different manner than that practiced by Dr.

Gooberman or, for that matter, in Dr. Kleber’s study, as the anesthesia employed by the authors

was a barbiturate. The key conclusions of the study were that UROD produced a very large

increase (30-fold) in the catecholamine epinephrine in plasma, and “profound” cardiovascular

alterations. The authors suggested that due to the attendant cardiovascular changes, UROD

“should be handled by trained anesthesiologists or intensivists.”

Summarizing the literature since the issuance of the NIDA Report, Dr. Kleber concluded

that the consensus is clear. Practically every paper issued since the NIDA Report, even those

most favorable to UROD, has concluded that there are no controlled studies of UROD and a

definitive long-term study is needed. Additionally, more and more papers are concluding that,

contrary to the prevalent thinking in the early 90’s that UROD was a safe and effective

procedure, in fact the procedure is much riskier than originally thought. This is due to the

growing evidence that significant hormonal changes take place during the procedure. In

addition, even UROD advocates such as Colin Brewer have shown that the withdrawal

symptoms continue for at least a couple of weeks after the procedure.

Kleber summarized several issues regarding UROD by indicating that persons providing

UROD either are or should be aware of the risks associated with the procedure. This is because

of the publication in reputable journals of the several reports and the fact that persons using new

procedures should have been trying to keep abreast of the developments in the area so as to know

what is going on. Given the “evolving” and “experimental” nature of the UROD procedure

during the period 1995 to 1999, the different methods, procedures employed, and the potential

for mortality and morbidity, a practitioner of UROD should have had the highest level of concern

regarding the safety of his or her patients. There was a need for heightened awareness and care.

The prudent practitioner, knowing of these deaths, had to have a heightened concern to carry out

the process as safely as possible. In addition, during this latter period there were more reports

regarding the changes in stress hormone levels and the persistence of withdrawal symptoms for

as late as several weeks after the procedure. In the absence of rigorous long-term studies

regarding the safety of the UROD procedure and the risk/benefit analysis related thereto, we

have no idea scientifically of the benefits of the procedure. Gooberman has no way of knowing

the ultimate outcomes for his 2,300 patients and therefore no conclusions can be drawn regarding

15 Anesthesiology, Vol. 88, No. 5 May 1998.

- -43


the mortality rate of those who undergo Gooberman’s procedure as against the accepted death

rate of heroin addicts generally. He noted that the respondents had no idea of the mortality and

morbidity of their 2,300 patients within six, nine or twelve months after undergoing UROD. In

addition, we have inadequate knowledge of the risks involved because we have very little

information about what happens to the body in the twelve to seventy-two hours post-procedure.

Dr. David Simon has spoken at length with two of the authors of the NIDA Report,

Barbara Herman, Ph.D., and Dorynne Czechowicz, M.D., neither of who is an expert in

anesthesiology. He first learned of the report before it was published, in December 1995, when

he was calling around trying to find information about UROD for a review article he was

preparing. The authors told him that NIDA was consulted by an agency in the Israeli

government about NIDA’s view of UROD, a procedure that was then being administered in

Israel. As he understood, “NIDA had not heard of it either. NIDA scurried to do a report.”

Simon’s general criticism of the NIDA report is that the authors did not speak to anyone

who performed UROD before they published their report. His own comments to the two authors

about the procedure were ultimately ignored. As for the report itself, Simon disagrees with it. It

is “biased,” the data quoted is “in many cases, factually wrong,” and, in addition, he believes that

the authors are judging UROD by a standard to which they did not hold themselves. The

“anecdotal reports” they used were “unsubstantiated, not peer reviewed and misinterpreted to

base their conclusion and their conclusion is that everything about UROD is anecdotal.”

Simon addressed the risk/benefit issue in more specific terms. To say that there is no

known mortality risk in detoxification of uncomplicated patients is a simplistic statement. To

him, it seems that they are saying that whenever someone dies “it was a complicated case.” In

fact, death is “not uncommon.” People die “from being on methadone maintenance.” Death can

occur in unassisted withdrawal, “even in uncomplicated cases, although that’s rare.” He added

that in fact the decedents in the present case were “all complicated.” Indeed, given the fact that

withdrawal induces stress and therefore causes the heart rate to go up and the blood pressure to

increase, a person with cardiovascular disease can experience a heart attack. “It’s the stress of

withdrawal that causes the risk in complicated cases, not the stress of the method.”

- -44


Dr. Simon next addressed the report’s characterization of the death rate in anesthesia

procedures, which it states is 1 in 15,000, a figure that Simon suggested may have been accurate

at the time when Peter Cohen, a medical doctor and attorney who works for NIDA and is “long

retired” from anesthesia, actually practiced anesthesia. According to Simon, the authors of the

report called Dr. Cohen and he quoted them this figure. However, Dr. Kushins testified to a

figure of one in 250,000. Thus, Dr. Simon contended that the authors of the report have

exaggerated the risk from anesthesia, while at the same time discounting that the UROD

procedure has any benefit. Simon noted that the UROD procedure that he performed was very

similar to that performed by the respondents. He described the technology employed in his

procedure and noted that, with the use of two monitors and electrocardiogram and pulse

oximetry, as well as an end-tidal CO2 machine attached to the endotracheal tube, the risk of

dying from anesthesia has been reduced, depending on the publication that the figures are drawn

from, to 1 death in 200,000 or 1 in 250,000 to as low as 1 in 400,000. These figures stand in

stark opposition to the 1 in 15,000 figure used in the NIDA report.

On cross-examination, Dr. Simon agreed that the report actually refers to the rate of

“serious adverse events including death.” Therefore, his figures are not directly comparable to

that description. However, he would nevertheless maintain that the NIDA figure is

“misleading.”

Continuing his critique of the NIDA Report, Dr. Simon addressed its reference to what it

characterized as a “very recent report” of a life-threatening adverse event involving pulmonary

edema following anesthesia in a procedure involving the administration by i.v. of high dose

naloxone. This report was contained in a letter to the editor of the American Journal of

Psychiatry dated June 1995, known in this record as the “San” report.16 It consists of a letter

written by four doctors in Spain about a complication that they experienced with a patient who

they treated. Simon characterized this “report” as an “anecdotal finding,” published without any

peer review. No cause and effect is described. According to Simon, the authors of the NIDA

Report interpreted this case as a situation in which San administered an opiate antagonist to a

patient, who then developed pulmonary edema. The authors then determined from this that the

UROD procedure could be “dangerous.” However, the report does not stand up for this

conclusion. In the case reported, a thirty-eight-year old man with an opiate addiction was treated 16 San L. Puig M, Bulbena A, Farre M: High Risk of Ultrashort Noninvasive Opiate Detoxification. Am J Psychiatry 152:956 (1995).

- -45


in 1995. He received an oral regimen of midazolam of sixty milligrams, which Dr. Simon

characterized as “a lot.” He also received .3 milligrams of clonidine and zofran, which is an

antidiarrheal, followed by fifty milligrams of naltrexone. The patient was not intubated; instead,

all of this was administered orally. After fifteen minutes, he was given an i.v. dose of .4

milligrams of naloxone, which was expected to induce withdrawal. The patient had severe

withdrawal symptoms, including rhinorrhea, dilated pupils, gooseflesh and restlessness.

According to Simon, “this happened before their sedation kicked in that they gave the pills.” He

was sedated with very high doses by mouth, “enough to knock out a horse. That is figuratively.

It had to be absorbed to work and then they gave him i.v. narcan fifteen minutes afterwards.

That, in and of itself, is medically ridiculous.”

The doctor continued his analysis of the incident. The details are such that it is best to

quote him at length.

These symptoms of withdrawal persisted for hours. To treat this guy who is in and out of consciousness, having these bad symptoms, they start giving him i.v. midazolam, benzodiazepine. The amount of i.v. midazolam is a dose to induce general anesthesia. They didn’t know it. They were sedating him. Thirty milligrams produces general anesthesia in a seventy kilogram male. They anesthetized him. Five hours after they started all of this, they noticed that the heart rate was going down and saturation on the pulse oximeter was going down. There was a problem. They required oxygen therapy. They didn’t intubate him, which is a standard of care. They put an oxygen mask on him. At that moment he started vomiting fecaloid material, which is vomit that looks like feces. He vomited, had an unprotected airway, was anesthetized, lying there. They had a good sense to suction him and even intubated him after all the damage was done from puking. The conclusion was i.v. narcan caused pulmonary edema in this case. What really happened was the patient either had aspiration pneumonia or the patient developed laryngospasm, which the vocal cords close, which you can’t get air back and forth, an obstruction in the throat, which leads to a whole concept of negative intrathoracic pressure pulmonary edema. . . .

What we have found in the anesthesia literature, which the psychiatrists and the consults in the NIDA report clearly didn’t understand, is that one of the ways which pulmonary edema could be caused, I take a deep breath, when I do that, my rib cage goes out and I generate inside my rib cage. The negative pressure compared to the outside pressure draws air in. I’m stuck here, I

- -46


just swallowed a marble. My vocal cords are closed or I vomited and my acid from my stomach irritated the vocal cords. My protective airways closed the vocal cords. I’m panicking. I have to take a breath. I’m trying to breath. I use all my might to try to suck with a closed glottis. You create great negative pressure from the muscles of respiration. Here are the walls of the rib cage and the muscles. This is pulling out, causing negative pressure. This is one container. This negative pressure translates here, and now there’s a negative pressure in the alveolus. Guess what happens. Fluid is in there. Its called negative intrathoracic pressure pulmonary edema. That’s what happened in this case. What the doctors did to this guy is blatant malpractice. Blatant malpractice is what these people did, and that’s what caused this problem. It cannot be attributed to- -that he got narcan. He ran into problems before they gave him the narcan.

Dr. Simon also commented upon the three references listed in the index to the NIDA

Report under the heading “Side Effects.”17 Simon argued that in each of the instances discussed

in these articles in which there was an episode of respiratory distress, the distress occurred before

the patient received the opiod antagonist. The implication drawn in each case was that the

pulmonary edema was caused by or associated with the opiod antagonists. However, in Simon’s

opinion, in each case the “much more plausible explanation” was that the distress was unrelated

to the administration of the antagonist.

Simon also discussed other published materials, including a “very biased article” by Pfab,

Hirtl and Zilker; Opiate Detoxification under Anesthesia; No Apparent Benefit But Suppression

of Thyroid Hormones and Risk of Pulmonary and Renal Failure18. This 1999 article, published

after the NIDA Report, discussed alleged side effects of opiate detoxification under anesthesia.

It concluded that there was a suppression of thyroid hormones; however, according to Simon,

except for one hormone, the levels were all normal. The other levels were merely decreased, but

still lie within the normal range. This result is a normal physiological response mechanism to

stress. The “Suppression” in the title of the article really refers to a response to the stress of

opiate withdrawal, constituting secondary hypothyroidism, which is a normal response. The

article is therefore misleading.19 17 Partridge BL, Ward CF: Pulmonary edema following low-dose Naltrexone administration, Anesthesiology Vol. 65: 709-710 (1986); San L, Puig, M, Bulbena A, Farre M: High Risk of Ultrashort Noninvasive Opiate Detoxification, American Journal of Psychiatry 152: 956 (1995); Taff RH: Pulmonary edema Following naloxone administration in a patient without heart disease Anesthesiology 59: 576-577 (1983).18 Published in Clinical Toxicology, 37(1), 43-50 (1999)19 The authors concluded that there was “no obvious benefit” from opiate detoxification using anesthesia and high, repetitive doses of opiate-antagonists and that the “risks are high.” In addition, they found that, contrary to what they claimed to be the contentions of supporters of the method, withdrawal symptoms continued after 48 hours.

- -47


The witness also reviewed two additional “case reports” from Australia, each published

well before the issuance of the NIDA Report and, incidentally, before Dr. Gooberman began to

utilize UROD to treat addicts.20 He opined that the cause of the complications reported in each

case report as having been experienced by patients who received naloxone was not the use of that

drug. In the case reported in the “Wride” note, the patient had experienced facial trauma and

surgery was necessary. The patient was intubated twice and then again for a third time. The

patient then went into laryngospasm. The intubations were made easier by the use of a muscle

relaxant, succinylcholine, a “very dangerous” drug when given in repeated doses. In Simon’s

opinion, the death of this patient was the result of a phenomenon attributable to the multiple use

of the succinylcholine and the pulmonary edema was of the negative intrathoracic type and was

caused by poor airway management, not by the use of naloxone. Neither case proved anything

about the alleged relationship of the complications to the use of naloxone. There is simply no

mechanism proposed for that drug to have caused these complications. Indeed, Simon reviewed

the alleged causative effect between naloxone, nalmefene and naltrexone and “could find no

correlation between pulmonary edema and any of those antagonists.”

Simon also commented upon the “Brimacombe” note, which reports on a patient with a

gangrenous appendix, a condition which itself can cause sepsis and “all kinds of problems in

anesthesia.” The patient was reversed from anesthesia, but did not appear to be in sufficient

condition for extubation. Naloxone was administered. The tube was removed and the patient

went into laryngospasm, a not uncommon complication of anesthesia caused when the vocal

cords are “tickled” and the protective reflexes shut down and close. In his opinion, this process

caused negative intrathoracic pressure pulmonary edema, which would have occurred even if the

naloxone had not been administered.

In the second case reported by Brimacombe, a 69-year old man with a mass in his lung,

angina and ischemic cardiac disease, presented in cor pulmonale, basically pulmonary edema

caused by heart failure. He was given an opiate antagonist and still had pulmonary edema. In

Simon’s view, it is “absolutely ridiculous” to conclude that the naloxone caused the edema. The

20 The first case note, authored by Wride, Smith and Courtney, is entitled “A Fatal Case of Pulmonary Oedema in a Healthy Young Male Following Naloxone Administration.” Anesthesia and Intensive care, Vol. 17, No. 3, August 1989. The second case note, authored by Brimacombe, Archdeacon, Newell and Martin, is entitled, “Two Cases of Naloxone-Induced Pulmonary Oedema, The Possible Use of Phentolamine in Management.” It was published in Anesthesia and Intensive care, Vol. 19, No. 4, November 1991.

- -48


patient had it anyway, and there is no cause and effect between the pulmonary edema and the

opiate antagonist.

Addressing other aspects of the NIDA report, Dr. Simon argued that the authors’

criticism that UROD was not a cure for addiction showed their bias, as it most assuredly is not a

cure and there is no suggestion of a claim that it is a cure. However, detoxification is a first step

to rehabilitation, indeed, it is a “required first step. You can’t do the other parts without going

through the detoxification first.”

Another criticism voiced in the Report is that UROD is not justified due to the existence

of several other less expensive and less elaborate detoxification methods. This position fails to

take into account that Dr. Gooberman was charging $3,600 in a free-standing clinic, rather than

the cost that is charged with a hospital setting and using anesthesiologists, where in Connecticut

one hospital charges $5,300 and another $6,000. He believes that this criticism is at least

symptomatic of a “turf war” between practitioners of different approaches to addiction treatment,

psychiatrists who “make their money through the behavioral health care therapy” and medical

people “doing detoxification [who] make their money on the front part.” All of this is occurring

at a time when “money is drying up for behavioral health, especially for substance abusers.”

Simon noted that while the NIDA Report complains of the lack of any randomized,

controlled double-blind study of UROD, it would be very difficult ethically to perform any such

study. Simon conceded that he does not know how to do it. Dr. Kleber’s application for a grant

also addresses this problem, and his conclusion is the same.

In summation, Simon does not agree with the NIDA Report’s conclusion that, based upon

available information, UROD is “currently without ethical, medical, scientific or financial

justification.” He contends that the authors relied on outdated data, misrepresented the mortality

rate for alternative forms of opiate detoxification and misrepresented the risks of anesthesia. The

major risk identified was pulmonary edema, however, “they totally missed the boat” on this

subject.

The mortality rate for non-UROD detoxification is “very low.” In fact, Simon’s clinic

has never had a fatality, although there have been overdoses after detox, “because they are at a

- -49


high risk for overdose.” However, he is unaware of any systematic study regarding this question

in regards to opiate detoxification. As for UROD, no outcome study exists to demonstrate

whether it has medical efficacy. As to those patients who died who did not take any illicit drugs

post-procedure, in the absence of a well-designed study that could demonstrate scientifically that

the procedure induced greater stress than other methods of detoxification, it is not possible to

determine whether they died within this relatively short time because of anything relating to the

procedure. Further, Simon disagrees with the allegation in paragraph fourteen of the Complaint

that the alternative methods of opiate detoxification without complication have established

mortality rates of zero. This also is not accurate.

Dr. Simon does not consider that UROD, as practiced by the respondents, constitutes “a

dangerous medical procedure,” with the caveat that “every medical procedure had risks and

benefits. There are risks to the procedure. The risks are acceptable.”

Dr. Simon contended that there is a known mortality risk in opiate detoxification and the

fact of medical complications in some of the instances was unrelated to the deaths. He believes

that the withdrawal syndrome that is related to opioids carries a risk of mortality. He does not

know what the phrase “virtually no risk” means in the context in which it is used in this sentence.

However, in so-called “uncomplicated patients” the risk is “very slight.”21 The language

identifying a risk of pulmonary edema associated with naloxone has been in the PDR since at

least 1996.

Dr. Simon believed that between 1995 and 1999 there were approximately thirteen

providers of UROD in the United States. He believes that four provided the procedure on an

outpatient basis, one of which was his own practice and another was Dr. Gooberman’s. An

anesthesiologist either directly provided the procedure from start to finish or supervised and

directed a CRNA or other health care provider in probably eleven of these thirteen. The

exceptions were the respondents’ practice and that of Dr. Alan Kazan in Arizona.22

2121The sentence reads: “The withdrawal syndrome with opioids—including those that have been therapeutically administered in an opioid maintenance treatment program—can be protracted and intensely symptomatic, even if it ultimately carries virtually no risk of mortality.”22 Simon believed that there might have been another provider, Dr. Waisman, in Los Angeles. This is apparently the same Israeli physician referred to earlier as utilizing UROD to treat soldiers in Israel.

- -50


The only professional organization in the United States that has formally approved

UROD is ASAM. There is an organization in London, with a name something like

“International UROD Providers,” that provides the procedure through doctors located in London,

Hong Kong and some in the United States. The procedure is a relatively uncomplicated and

relatively benign one, with a low likelihood of morbidity or mortality.

Based on his experience, Dr. Simon opined that, while there is as yet no consensus in the

scientific community on the risk/benefit of UROD, in the case of most patients the benefits of the

procedure outweigh the risks. The deaths that occurred were, in general terms, primarily the

result of stress occurring due to the withdrawal from opiates that is precipitated by a

detoxification procedure. These decedents were patients who had preexisting, underlying

conditions which, when subjected to the stress of withdrawal, caused the patients to expire. He

cannot say whether these individuals would have died from withdrawal precipitated by any other

form of induced detoxification.

In testimony, Dr. Simon summarized the benefits of UROD thusly:

If you do a method like Dr. Kleber where you do naltrexone and clonidine while the patient is awake, what happens is as the patient receives naltrexone, they are sicker and sicker and they are consciously experiencing that. That causes psychological aversion. Here is the beauty of UROD. When the patient wakes up, they don’t feel well. Let’s make no mistake about that. They feel rotten. This is the beauty of it. Despite taking naltrexone, they continue to get better. They are more likely to take the naltrexone. There’s no aversion to it. That’s an enormous benefit. . . .

Dr. Simon testified that many addicts have “detox phobia.” This is the result of their

having attempted to detox and therefore having knowledge of the severe difficulties withdrawal

causes. They do not want to go through those again. To the extent that UROD brings into

therapy for detoxification those who would not ordinarily approach the system for treatment, it is

also a benefit. In theory, it would also have a lower rate of recidivism and a higher rate of

persons who would remain drug free. However, even if the recidivism rate were the same,

UROD is a more humane, compassionate method of detoxification.

- -51


Addressing the efficacy of UROD, Dr. Simon explained that he had made a presentation

in 1998 concerning two follow-up studies done by telephone on the first 162 patients treated by

his organization. This showed that 73% of those in the first study were opiate-free at an average

of 92 days after the procedure; 75% were opiate free 108 days out. At face value, this is a very

high success rate. In traditional detoxification, 50% relapse by three and one-half to four months

out. In addition, 54% of those detoxed engaged in an ongoing program of behavioral health care.

Simon was surprised to find that the relapse rate was the same whether the patients were

counseled or not.

Dr. David Bradway first became aware of the NIDA report in or after 1996 when Dr.

Gooberman gave it to him. He understood that it was a non-official document evaluating

UROD. He believed that its conclusion was that the risk of general anesthesia was high for some

patients when weighed against the benefit for those patients and that this conclusion was only

applicable to a certain population of patients. Both he and Gooberman felt that the report

expressed the opinion of one group of doctors who had prepared the report and neither

necessarily agreed with it.

Dr. Gooberman testified that he probably became aware of the NIDA Report in

April/May 1996 and filed a rebuttal to the document within days. The report made him “angry.”

He felt that the document was an unofficial paper, produced by a group of persons who had

never even seen UROD. The chairperson of the committee was not a physician. The report was

“unfair” and “self serving.” While he would not suggest that such consultants for the reports as

Drs. Kleber or O’Brien were themselves “shoddy,” nevertheless, he felt that the report produced

by the authors and consultants was “shoddy work,” that was based upon a couple of papers from

Europe. The research called for in the Report “had to be by them,” that is, by the authors or

consultants, who were NIDA affiliated researchers who were saying that NIDA should pay for

research. Indeed, some of the persons responsible for the report had been invited by him to

witness the procedure at his office, but they had not come. Additionally, although by the time of

its issuance Gooberman had done several hundred URODs, they did not choose to talk to him.

Gooberman explained that, as opposed to the analysis presented in the unofficial report,

UROD was at the time of its issuance and thereafter, and is today, a safe procedure if performed

by properly trained individuals. The idea that UROD is not an established or accepted method is

- -52


quite wrong, as it has been performed in Europe for about thirteen years and is “pretty well

established.” There are many physicians performing the procedure both in the United States and

overseas.

An “Alternative” Assessment of UROD: The ASAM Public Policy Statement

Dr. David Smith characterized NIDA, as “just one professional organization that had

reviewed” UROD. Another organization, the American Society of Addiction Medicine, or

“ASAM,” has also considered UROD and has taken a position regarding this detoxification

method. Smith described ASAM as an organization that is “the nation’s specialty society of

physicians that specialize in addiction,” a constituent element represented in the American

Medical Association House of Delegates.

In 1996, during Dr. Smith’s presidency of ASAM, the organization was contacted by the

New Jersey Attorney General’s Office to inquire as to its views on the legitimacy of UROD and

whether the group had a policy on the procedure. Triggered by this inquiry, the group initiated a

study by its Practice Parameters Committee. The purpose of the review was to determine

whether the procedure was “evidence based,” a term used in medicine to denote that there is

“literature that supports . . . the procedure.”

As a result of the ASAM review, David Simon, considered by those at ASAM

responsible for dealing with the issue of UROD as the “most knowledgeable” about

UROD/ROD, prepared a review article. Chris Kasser, a “well-known physician in addiction

medicine” associated with the Departments of Psychiatry and Medicine at the University of

Tennessee and a member of the ASAM Board of Directors, prepared an editorial. These were

each published in the Journal of Addictive Diseases, Vol. 16 (1) 1997.23 In his article, Dr. Simon

attempted to review some of the controversies surrounding UROD, its safety, efficacy, cost, etc.

Dr. Kasser’s editorial criticized his methodology and use of analogies, and stated that, while

there was substantial literature worldwide regarding UROD, nevertheless there were deficiencies

in the research that had been performed regarding the procedure. There had been no double-

blind, controlled, randomized test, which is the highest level of scientific testing used. There

23 Simon’s article is entitled, Rapid Opioid Detoxification Using Opioid Antagonists: History, Theory and the State of the Art, J. Addict Dis. 1997; 16(1): 103-122. Kasser’s editorial, Current and Future Prospects for Rapid Opioid Detoxification with Opioid Antagonists, is at J. Addict Dis. 1997; 16(1): 1-4.

- -53


also had not been randomized treatment outcomes studies to determine whether the claims made

with regard to the long-term outcome were valid or not. Kasser wrote

In conclusion, a body of knowledge related to opioid withdrawal management is emerging from clinical and basic research. However, we are just beginning to sort out the incredibly complex issues related to rapid opioid detoxification using opioid antagonists. It appears that there is a critical need to provide further assistance to clinicians and patients by objectively determining what is known and what is not known about potential risk and benefits of particular procedures. Dissemination of relevant evidence-based guidelines for anesthesia administration could be helpful now. There is also a need for well designed research to provide more answers and information related to these interventions. Enhanced treatment for patient with opioid dependence and other substance use disorders will only come through the collaborative efforts in scientific research and clinical addiction medicine.

Characterizing the difference between Kasser’s call for more information and research

and the somewhat similar sounding words in the unofficial NIDA Report, Dr. Smith criticized

the NIDA Report’s “jumping to the conclusion that this method is without ethical, medical,

scientific or financial justification and then call for more research. The NIDA report is like let’s

have a trial and hang them rather than talking about the research . . . .”

The ASAM Public Policy Statement on Opioid Antagonist Agent Detoxification Under

Sedation or Anesthesia (OADUSA) was finally approved in April 2000. Dr. Smith explained that

the title expresses simply another label for the procedure also known as AROD or UROD. The

Policy Statement takes a different position as to the procedure from that contained in the

unofficial NIDA Committee report. ASAM considers UROD to be one of a number of

acceptable alternatives in the treatment array, although it is not considered a comprehensive

treatment. In summing up its views, ASAM elaborates the following:

1. Treatment of addiction is a complex process that involves management of substance use, relapse potential, denial, treatment acceptance, treatment engagement, treatment retention and, when necessary, the treatment of withdrawal symptoms.

2. Any method of opioid detoxification is only a first step, and is not in itself an effective treatment of opioid addiction. ASAM

- -54


does not support the initiation of opioid detoxification interventions when these are not a part of a continuum of services that promote ongoing recovery from addiction.

3. Opioid detoxification using antagonist agents along with either oral or intravenous sedation or general anesthesia may be referred to as ‘Opioid Antagonist Agent Detoxification Under Sedation or Anesthesia’, or OADUSA.

4. OADUSA can be an appropriate withdrawal management intervention for selected patients, provided that such services are performed by adequately trained staff with access to appropriate emergency medical equipment.

5. All candidates for OADUSA should be informed about the known benefits, risks, and financial costs of the proposed procedure in comparison with the known benefits, risks, and financial costs of other treatment options available in the community. Women of childbearing age should have pregnancy tests completed prior to the initiation of OADUSA. For patients receiving opioid agonist maintenance therapy, risk of relapse to addiction with the discontinuation of maintenance treatment should be discussed.

6. The patient’s written informed consent should be obtained prior to any planned course of OADUSA.

7. Patients treated with OADUSA, especially when it employs general anesthesia, require a sufficient period of medical monitoring of their clinical status by the medical detoxification treatment team immediately subsequent to the procedure, in order to address clinical issues of craving, acute relapse risk, and accompanying agitation.

8. Although there is medical literature describing various techniques of OADUSA, more research is needed to better define its role in opioid detoxification. Further studies of outcome are needed, including both the safety and efficacy of OADUSA as compared to other opioid detoxification modalities, as well as any differential effects on the long-term rehabilitation of opioid addicts.

9. It is recognized that the methods of opioid detoxification available in a given community will evolve over time with the advancement of biomedical knowledge and treatment research, and that efficacy, safety, and cost profiles will continue to change along with the science and practice of addiction medicine.

- -55


Dr. Smith cautioned that the fact that ASAM issued its policy statement does not connote

that it was attempting to establish therein any definition of the standard of practice. In fact,

according to Dr. Smith, ASAM is very cautious regarding the establishment of a standard of

care. There may be many variables, each of which may be an acceptable procedure allowable

within the standard of practice. ASAM members were concerned that on occasion the

established standard of care can be improperly used when applied in the legal context. There is a

fear that any minor deviation from the announced standard of care may be deemed to violate the

standard, when in fact minor deviations are generally allowed. In fact, he noted that in the

medical community, there is a preference for the term “evidence based,” rather than “standard of

care.”

In Dr. Smith’s view, the NIDA study constituted just one more piece of information to be

factored into the debate regarding the legitimacy of UROD. Indeed, he noted that whereas

NIDA is more of a research-based organization, ASAM is actually a treatment-oriented group.24

In the case of a procedure such as UROD, while there may be a lack of double-blind studies,

there is nevertheless a population of addicts who need treatment and therefore the “problem is in

front of you.” Studies are very expensive and if government and drug companies won’t

undertake them, doctors “in the field” still must treat patients. There is a “yawning gap” between

clinical practice and research. This creates “friction because the research is perceived, in many

cases, as isolated from front lines of addiction treatment, which is unfortunate because research

is necessary to gather new knowledge, to improve the quality of care and also makes the research

tend to be irrelevant if it’s not translated in clinical practice.” In the doctor’s view, this

“yawning gap” may explain “differences of opinion among addiction specialists based on their

alliance with either research orientation or clinical orientation.”

Dr. Smith disagreed with the statements in Count One, paragraph 2, of the Complaint,

wherein it states that UROD/ROD is “neither a medically established or recognized addiction

procedure” and is “a relatively new, highly controversial procedure within the medical/scientific

community, which is neither approved nor recommended by a government or professional

body.” Commenting on the importance of UROD, Smith noted that the addict population is at

high risk and the addicts frequently have significant health-care problems. The fear of

withdrawal itself is such that in many cases it will dissuade patients from even considering 24 There will be more said about the treatment orientation or the research orientation of physicians and experts later in this opinion.

- -56


entering treatment. UROD provides an alternative means of withdrawal, which may assist

physicians and patients in bringing about withdrawal. In addition, the dropout rate from

treatment is a “crucial outcome for consideration in assessment of overall efficacy.” This

procedure provides a “viable option,” in that “patients understand that they will be physically

detoxified from opiates after the completion of the procedure.”

Dr. Smith also denied the allegation at paragraph sixteen, page seven, that the provision

of UROD by these physicians “demonstrates a clear and imminent danger to the public’s health,

safety and welfare.” In fact, heroin addiction is a chronic, relapsing and potentially fatal disease.

The heroin epidemic is nationwide in scope. There are a “lower percentage of people with

heroin addiction in treatment than any other chronic, relapsing and potentially fatal disease in our

country and the procedure talked about here leads to an accepted method of treatment for heroin

addiction and they are basically saying that treatment creates addiction and treatment is a threat

to public health, which I believe is an extremely inaccurate statement and is part of a nationwide

public debate that’s going on between law enforcement and treatment.”

Dr. Smith testified that, although the FDA has not approved UROD as a procedure, just

as it has not approved clonidine for use in addiction treatment, nevertheless, during the 1990’s

UROD has become an accepted method of treatment within the addiction community. However,

Dr. Smith was unable to say just when that acceptance arose. He is unsure how many

practitioners were using the procedure in one or another form between 1995 and 1999, although

he listed several of whom he was aware.

In determining the acceptability of the respondents’ practice, Dr. Smith relied extensively

upon the ASAM standards.

Dr. Gevirtz is not a member of ASAM, although generally familiar with the organization.

He is aware of its guidelines regarding UROD and its most recent policy statement. He

explained that the ASAM standards contain significant differences from the standard he uses and

recognizes. He agreed that prior to 1996 UROD was thought to be a safe and uncomplicated

procedure.

- -57


Dr. Gooberman played a role in the formulation of the ASAM Policy Statement as a

member of its Public Policy Committee. The chair of the Committee on Standards asked the

chair of the Public Policy Committee to develop standards regarding UROD. Dr. Simon was

also a member of the Committee; he and Gooberman being the only members who were familiar

with UROD. Gooberman was placed on subcommittees and the discussions went on for a

number of years. The Committee had twenty to twenty-five members and held meetings

generally attended by ten to twelve members. The policy that was developed was sent to the

Board of Directors, a group of about twenty-five to thirty members; a board of which neither

Simon nor Gooberman was a member. The Board voted and adopted the policy. The ASAM

Policy Statement addresses UROD as an alternative method of treatment.

The Deaths of Seven Patients

With this background concerning detoxification and UROD, this opinion will now turn to

the evidence regarding the demise of the seven patients treated by the respondents.

Dr. Robert Segal was covering the Medical Examiner’s position in Burlington County on

July 4, 1998. As a result, he came to perform the autopsy on Lester Kindig, a known drug abuser

whose death shortly after he had been to a clinic for detoxification was, in Segal’s

characterization, an “unexpected death under unusual circumstances.” The findings on autopsy

were essentially negative and there was no obvious cause of death. Dr. Segal was puzzled by

this and did not understand why Kindig had expired. He expected that when he received the

toxicology report it would show a straightforward drug death. However, the toxicology findings

were “confusing,” which in itself was strange as these are usually quite understandable. Thus,

the situation surrounding Kindig’s death did not make much sense to Segal.

The toxicology findings suggested that after the procedure Kindig had obtained more

illegal drugs, as methadone and free morphine were detected. Free morphine takes four hours to

disappear from the system. However, the death occurred about six hours after the procedure.

When Segal spoke to Kindig’s significant other, Ms. Klein, she advised that there was “no way”

that Kindig had taken any heroin post-procedure. She advised that Kindig was “totally wiped

out.” To Segal, she sounded “fairly convincing,” and he “tends to believe” her statements of

“the truth as she knows it to be.” He asked that she write down all that she could think of, and he

- -58


intended to try to determine if there was any other explanation for the death other than that

Kindig had ingested heroin after the procedure. He hired several persons to assist him, and then

he learned about other cases involving post-UROD deaths. He found these to be an, “ongoing

mystery that needed a solution.”

Because of the confusion presented by the toxicology, Dr. Segal consulted with other

physicians. He first approached a doctor specializing in pain management at UMDNJ Stratford

and a pharmacologist and pain expert at the Philadelphia College of Medicine. Neither was very

helpful. He then spoke to his former student, Dr. Karan. He could not understand the presence

of some of the substances discovered in the body fluids. Dr. Karan was able to “educate" him.

However, Segal is unable to say how much of her expertise provided anything more than

academic background for his own opinion.

The pathologist reviewed the records and autopsy reports for Messrs. Stavola, Beigelman,

M.J. and Kindig. He had the toxicology reports for all these except Stavola. After analysis, he

determined that, to a reasonable degree of medical certainty, the UROD procedure performed on

each of these decedents contributed to their demise. In explaining his conclusion, the doctor

noted that occasionally the cause of death of an individual is not obvious, as the causative

condition or factor only existed during the life of the patient. For instance, most of the time it is

not possible to tell if an arrhythmia killed a patient. Sometimes the medical history will allow

for a diagnosis of the cause of death. In the several cases under consideration here, a very

significant factor is that the patients each went in to the procedure “essentially healthy" and then

died relatively shortly thereafter. Each entered the procedure in “normal health,” although they

were each drug addicts. As best as he could determine none suffered from any incapacity. They

had no medical problems of consequence. Each was examined at the clinic by a doctor and was

apparently not found to have any negative condition or finding as regards the ability to undergo

the procedure. They each then had UROD performed upon them. After the procedure, they

were “no longer normal healthy” persons. Each was described to him as having been “pretty

wiped out,” unable to walk under their own power, and each had to be assisted out of the facility,

one of them having to be lifted into the car. Each went to bed and was unable to get out of bed.

Some slept most of the time. None became “better” or “well.” Each then succumbed. The

autopsy result for each was essentially negative. There was no obvious gross or microscopic

finding. Each had some toxicologic finding. There was no independent, intervening cause. In

- -59


some instances, the toxicology findings could explain the death, except that each had been given

a drug antagonist. None had suffered an identifiable overdose. The deaths were not sudden,

although he conceded that in Stavola’s case the death might be so characterized, as the decedent

got up out of bed and fell over. Beigelman was sick before he died, and the death was not

sudden; Kindig was “pretty wiped out,” went to sleep and did not wake up. This death was

“sudden,” and yet it really was not, as Kindig had been in difficulty before he went to sleep. In

Segal’s opinion, given all of these circumstances, there was no way to say that the UROD

procedure did not contribute to the deaths.

The doctor was aware of the stress levels induced by anesthesia and considered these

stress levels in reaching his conclusions. While not an anesthesiologist, he has been under

anesthesia himself, has observed persons under anesthesia, and knows in the “broadest terms”

what occurs. All of the persons with whom he has had some contact involving anesthesia,

including his own experience, recovered. Most did so quickly and well. Statistics indicate that

without any other complicating factors this is the normal result.

Dr. Segal commented upon the stomach contents found in decedents Beigelman and

Stavola. In Beigelman’s case, morphine was found, along with fentanyl and ketamine. In

Stavola’s case, free morphine was found. Segal considered how they could have exhibited these

findings. One possibility was that they had ingested drugs by mouth after the procedure. The

other possibility was that they had been given the drugs, either intravenously or via intra-

muscular injection. Circulation of the blood could then lead to secretion of the drug into the

stomach, a routine finding. Certain agents can pass by osmosis across the membrane from the

stomach to the blood and from the blood to the stomach. The latter is a quite normal occurrence.

In addition, bleeding can occur into the stomach, perhaps induced by a tube introduced into the

area. As for ketamine, while he had never seen it injected, he acknowledged, “ a few screwballs

might” do so.

The doctor also reviewed the reports and records concerning Ms. Flowers, Mr. Melendez

and G.W. Again, his opinion is that, to a reasonable degree of medical certainty, the UROD

procedure contributed to the deaths of these three individuals. Again, as with the other four

decedents, these persons, while admittedly addicts, were generally healthy, received the

treatment and died shortly thereafter. All were ill when they left the Gooberman clinic. In each

- -60


instance, Dr. Segal could determine no cause for the deaths unassociated with this illness

between the completion of the procedure and the deaths. No independent causes were

identifiable.

The autopsy report for Victor Melendez, issued by the Office of the Chief Medical

Examiner for the City of New York, listed the cause of death as “persistent nausea, diarrhea, and

vomiting, with ulcerative esophagitis, gastric ulceration and gastrointestinal hemorrhage.” This

latter is “bleeding in the gastrointestinal tract.” There is no evidence known to the doctor that

would suggest that Melendez suffered from these gastrointestinal conditions prior to the

procedure, although he could have had some gastric reflux historically. He opines that the

evidence is of a classic Mallory-Weiss syndrome, involving “a tear of the esophagus at the

junction of the stomach from persistent vomiting, which he suffered from the time he left the

clinic to the time that he was admitted to the hospital.” In this decedent’s case, this condition

could have developed within two to three days. The condition is sometimes seen in chronic

alcoholics, who do not know when to stop. The description of coffee-colored material vomited

by Melendez indicates blood. If the person had a pre-existing condition, then the use of opiates

could mask the pain associated with this condition.

Dr. Segal assumes that Melendez ingested methadone after he was discharged. However,

this does not change his opinion as to the cause of death. When Melendez left the treatment

facility, he was nauseous and vomiting the whole time. The autopsy showed that he died of

complications, predominantly nausea, diarrhea and esophagitis. These were ongoing

complications from the time of discharge until death. Thus, in Segal’s opinion, if he did ingest

methadone, it “certainly may have increased his chance of dying, but it did not kill a person who

wasn’t going to live anyway.”

Dr. Segal disagreed with the medical examiner who performed the autopsy on Mr.

Melendez. In Segal’s opinion, Melendez’s heart, which weighed 450 grams, was not a “heavy

heart” for a man who weighed 235 lbs. Nevertheless, he agreed that he did have an enlarged

heart muscle. The heart was not healthy. There was moderate to marked fibrosis, that is, scar-

type tissue. In addition, there was scarring within the arteriolars, a condition known as arteriolar

sclerosis. There were very significant degrees of blockage of arterioles. The heart pathology in

itself could be the cause for a person’s death. If a person with these conditions also had

- -61


amphetamines in the system there would certainly be a higher probability that the cause of death

was a combination of the amphetamines and the underlying heart disease. The toxicology

reports for Mr. Melendez confirmed the presence of amphetamines.

The examiner also found evidence of dead liver cells, which is not a normal finding for a

man of thirty years old. Thus, Melendez presented as a man with significant signs of alcoholic

liver disease. Despite his earlier characterization of the patients who died, he agreed that a

person with Melendez’s profile was not “an otherwise healthy person.” However, despite his

liver disease, Melendez was still able to walk into the clinic and appear healthy enough to pass a

physical examination allowing him to go through detoxification. While he had underlying

disease, he was not a “sick” person at that time. Melendez did not have cirrhosis of the liver, and

the type of liver disease that he had is not usually associated with esophageal verises, in which

veins which pass along the stomach and the esophagus may bleed due to the scarring and back

pressure in the veins of the esophagus usually associated with cirrhosis.

Lisa Flowers’ heart weighed 300 grams. Dr. Segal characterized this as a little enlarged,

a condition known as hypertrophy. A 110-pound woman normally has a heart that ranges

between 250 to 270 grams and perhaps up to 300 grams. One would look for a reason if the

weight were above 270-275 grams. There was evidence of anterior papillary muscles showing

small foci of hemorrhage near the implantation of the chordae, that is, where the valve system

attaches to the heart wall. This finding was, “not uncommon but not normal."

The toxicology report noted the presence of free morphine in Flowers’ blood. There was

also 3.84 micrograms per liter of fentanyl. Flowers died eighteen hours and twenty minutes after

discharge. Her stomach contents included 9.81 micrograms per kilo of fentanyl. A liter of blood

is equivalent to one kg. The concentration of fentanyl in the stomach was higher then in the

bloodstream. While the doctor was not aware of any biological mechanism that was an active

transport for fentanyl from the blood to the stomach, nevertheless, he would be “shocked that

there was not such a thing." As for the cause of her death, the medical examiner who performed

the autopsy first stated that it was “bilateral pneumonia, pending studies,” and later amended the

finding to “myocardial infarction following rapid detoxification.” The evidence of chronic

interstitial pneumonia is different from aspiration pneumonia, and had nothing to do with her

death.

- -62


Examining the records for Mr. Beigelman, Dr. Segal noted that the medical examiner

found cardiomegaly with biventricular dilatation. This means that the gentleman had an enlarged

heart. Both ventricles were abnormally swollen. The doctor described this condition as like a

balloon that is in enlarged, overblown, but the walls are not themselves thickened. There were

also deposits of fatty material within the heart muscle itself. The amended cause of death listed

by Dr. Ragasa, the medical examiner, was “multiple drug intake, post detoxification therapy." In

Segal’s opinion, to a reasonable degree of medical certainty death resulted from withdrawal, the

effects of the detoxification procedure and from the presence of a number of drugs in the body.

The next patient whose records were reviewed was Frank Stavola. Mr. Stavola had

hepatosplenomegaly, which means that both the liver and the spleen were enlarged. It is not

normal for these organs to be enlarged. The toxicology report for this patient lists

benzoylecgonine, a metabolite that is a product of the breakdown of cocaine. Cocaine ingestion

can cause an abnormal rhythm of the heart. Abnormal rhythms can cause pulmonary edema.

The toxicology report showed .03 milligrams per liter of free morphine in the blood, and .22

milligrams of free morphine was found in the stomach contents. This is seven times as much

free morphine as was found in the blood. Morphine can also cause pulmonary edema. The

cause of death listed for Mr. Stavola is pulmonary and cerebral edema and the amount due to

drug use (morphine, cocaine, nordazepam).

The anatomical diagnosis for decedent M.J. reveals severe acute pulmonary edema.

There are many reasons why one might have fluid in the lungs and one of these can be

irregularities in the heart. Generally, with the exception of minor changes that might be seen

microscopically in the heart muscle and indicate a ventricular dilatation, one would generally not

be able to document an irregularity of the heart at autopsy. In addition, Mr. J. had mild

myocardial hypertrophy with ventricular dilatation. An enlarged heart can lead to the organ

experiencing abnormal electrical conduction, which can set off arrhythmias, the existence of

which can also lead to pulmonary edema and can be fatal by themselves.

Dr. Segal addressed questions about the toxicology finding that Lester Kindig had

ethanol, which is alcohol, in his body. The accepted rate for the burn-off of alcohol from the

system of an average sized man such as Kindig is .015% per hour. The procedure he underwent

- -63


lasted for about four hours. He died eight hours and seventeen minutes after his discharge, a

total of twelve hours and seventeen minutes. The toxicology report showed his alcohol content

to be .03. An average sized person who presented to a doctor prior to the onset of his procedure

with enough alcohol in the system such that after approximately twelve hours of burn-off that

person still had a .03 alcohol content would have been obviously demonstrating signs of

intoxification visible to a trained physician, such as those who examined Mr. Kindig. However,

the doctor posited the possibility that the alcohol discovered was in fact formed after death and

prior to the autopsy, and was thus a “postmortem artifact.” He has seen levels as high as .10

and .12 at postmortem and fermentation can continue in the test-tube if it sits too long. However,

Segal acknowledged that this might not be the correct explanation in this case.

Mr. Stavola had a normal size heart, not a big heart. The evidence of interstitial fibrosis

indicates a minor abnormality, not one that would have caused clinical problems. His liver

showed some mild, inconsequential changes. No fentanyl was reported in his stomach, although

there is no indication that any attempt was made to look for any.

Dr. Segal took into account “the whole big picture” in attempting to explain his reasons

for concluding that the UROD procedure employed by the respondents caused or contributed to

the deaths of these patients. He agreed that the UROD procedure did not itself kill them, and

neither did the anesthesia. As for the medications employed, the fentanyl employed during the

procedure might have contributed to the deaths. However, the opiate blockers used should have

blocked all opioid-type drugs. In this connection, Segal noted that he could not explain why one

giving a patient an opiate blocker would then simultaneously provide the patient with an opiate.

There is not a lot of post-mortem experience with this fentanyl. However, it is a potent drug, and

giving it, “doesn’t make sense and particularly in retrospect, when the possibility of an overdose

of a combination of opiates, narcotics is playing a role, the fentanyl is certainly a potential

contributor to that.” He had seen two or three decedents in his experience, who had received

lethal doses of fentanyl from patches. However, he added that, “I’m a pathologist, not a real

doctor . . . I’m having my problems with that, but I’m not bright enough to know the answer.”

In a summary of the reasoning for his opinion, Dr. Segal stated that the patients were not

shot, were not stabbed, were not hit by a car and “were not given a massive overdose of anything

that we can identify that caused the death. There is no way for me to say that these procedures

- -64


did not contribute to the death.” He took into account that they were not hospitalized

immediately after the procedure and did not have professional caregivers tending to them. This

played a significant role in the fact that, in my opinion, certainly had these people been adequately monitored - - adequate is not even the right word - - medically monitored, the fact that they were getting into trouble may have been identified more rapidly. Appropriate medical things might have been done, and their lives might have been saved.

While the witness conceded that there could be no certainty that any one or all could have

been saved, he nevertheless said that

The chances would have been much, much better had they been in an intensive care facility, who are used to following these people and capable of providing the type of care of resuscitating, monitoring and saving lives.

The witness agreed that the several cardiac problems affecting these individuals were not

of such a character that they would have known they had them, and were not conditions that

would have been detected by ordinary diagnostic testing. These were hearts of normal size, so

that even with a transthoracic echocardiogram, which could identify the size of the heart, that

finding would not have been significant. Even the most meticulous cardiac workup “would not

show anything.” These “were not sick hearts,” which he would describe as “a heart that has

disease in it. It’s a heart that has severe coronary artery disease, old infarction, new infarction, a

lot of scar tissue, a heart that’s obviously significantly large, a heart that is in congestive failure.”

People with these conditions “normally have symptomatology.” In these patients however, the

only such symptomatology that he is aware of was one who had hypertension.

Segal added that the stress that was “obviously” a part of the UROD procedure

“contributed” to the deaths. In answering the judge’s question with the summary described

above, Segal did not refer to the stress, as “[I]t obviously was stressful and obviously

contributed. That part is so obvious, I didn’t include it.” However, he could not identify to what

degree the stress contributed to the deaths. “It didn’t cause. The problem with these is that we

don’t have a single cause. We have a whole bunch of things piling up on top of one another.”

- -65


Withdrawal is itself a stressful process and there is no question but that the whole idea of UROD

involves inducing withdrawal.

To a reasonable degree of medical certainty, none of the decedents other than Melendez

took illicit drugs after leaving the clinic. In Melendez’s case, Segal believes that if the laboratory

studies were correctly performed he must have gotten some methadone prior to hospitalization.

Melendez’ cause of death, as described by Dr. Milewski, does not implicate a live condition or a

cardiac condition. Mediastinitis, which is an infection, was involved. He died from

gastrointestinal hemorrhaging, lacerations of the stomach junction and the esophagus, caused by

vomiting resulting from the detoxification. To a reasonable degree of medical certainty, the

opioids, cocaine or benzodiazepines found contributed to the deaths, but Segal stressed that they

were not the only factors causing them. Stavola and Kindig died from the combined effects of

withdrawal, the stress of detoxification and the drugs found. The level of fentanyl discovered in

M.J. was within the lower end of that observed in dead bodies, which is not the same as in live

bodies. He also died from the combined effects of the stress of detoxification and withdrawal.

Ms. Flowers was cachectic, wasting away, emaciated. However, this was not a factor in her

death. He has “no doubt in his mind” that she died of an acute myocardial infarction caused by

the detoxification procedure. She had no coronary artery disease and only the stress and the

medications she was given. In G.W.’s case, death resulted from severe aspiration pneumonia

resulting from the aspiration of gastric fluids following UROD.

Dr. Lori Karan became involved in this matter because of a prior association with Dr.

Robert Segal, dating back to when she was a medical student at Hahnemann Medical School in

Philadelphia, where Dr. Segal taught. As previously noted, Segal had become involved in the

investigation of the deaths of Beigelman, Stavola, M.J. and Kindig. During a telephone call

about matters unrelated to these respondents, Segal told Karan that he could not explain the

cause of death of these persons and, knowing of her expertise in the addiction medicine field, he

asked her to review the records associated with the cases. Referring to UROD, he told her that

they had been treated with a “new procedure” and he wanted to find out about it. He sent Lester

Kindig’s fiancée’s letter to her, along with the consent forms, anesthesia records and toxicology

reports for the four decedents. She reviewed these and consulted informally with an

anesthesiologist and a toxicologist at UCSF.

- -66


Having reviewed the autopsy, toxicology and other medical records and applying her

expertise, including her knowledge of basic pharmacology, Dr. Karan opined that the UROD

procedure as practiced by the respondents caused or contributed to the deaths of the four patients.

Standard methods of detoxification for opiate addicts without co-morbidity (coexisting medical

conditions) have virtually no mortality attached thereto. In the subject cases, there was no

apparent intervening cause to point to as a cause for the deaths that occurred so proximately to

the procedure. However, Dr. Karan acknowledged that she and Dr. Segal “really did not know

what was going on,” as least as to the exact mechanism of these four deaths. It is not really

known what the potential causes of these deaths were. To the extent that the exact mechanism is

not known, one is left with theory and speculation as to what occurred. However, the deviations

from good medical practice could still be contributory, causally related factors in the deaths.

Further addressing her thoughts as to the possible causes of death, Dr. Karan noted that

the temporal relationship between the procedures and the deaths is very important. The

significance of that relationship becomes less distinct (a “gray area”) from three to four days out

to two weeks from the procedure. After two weeks, it is more likely that other factors

intervened.

Dr. Segal was concerned as to why free morphine was detected in the decedents’ blood.

Dr. Karan acknowledged that the presence of cocaine and morphine in the blood at autopsy

might be an important determinant as to the cause of death and, in assessing possible causes of

death, she took the presence of these substances into account. Nothing in Gooberman’s UROD

procedure put cocaine into the patients’ systems. In a living person, the presence of cocaine in

the blood means that the drug was taken within two to three days at the outside. Urine detection

could occur from three to five days after use. The half-life of a single dose of cocaine is very

short, less than two hours, and generally, the cocaine would be out of the system within five half-

lives, or two hours. The presence of the metabolite in the blood means that the drug could have

been used either before or after the UROD procedure.

Dr. Karan noted that there are different receptors (Mų, Kappa, Lambda, Sigma) and each

has subgroups. The effects of the antagonists may differ at different levels within the cell. In the

literature, it is presumed that naltrexone works primarily on the mų receptors, but our knowledge

of all of the brains’ receptors and pathways is limited. It is possible that not all of the opiate

- -67


receptors are blocked. Thus, Dr. Karan questioned whether some of the fentanyl receptors

remain unblocked by the naltrexone and, if that were the case, it is possible that this might permit

the fentanyl to effect respiration. In addition, neither the interactive effects of the drugs used in

the procedure nor the time of their impact is clearly understood. Finally, increased levels of

agonists in the blood following the administration of an antagonist have been documented in the

literature25 and this finding makes sense, as after the antagonist frees up the agonist by knocking

it off of the receptor the agonist has to go someplace. Thus, it is possible that the morphine

found in the blood could be from this “knock off” effect, although the drug would “disappear” as

the half-lives played out. This said, there is no easy explanation for the finding of ketamine in

the blood.

The doctor opined that the levels of opioids found in the blood at autopsy could possibly

have contributed to these deaths, but cautioned that we do not know the tolerance and how the

effects of the opioids were blocked. She does not believe that they were contributory factors to

the deaths if the cocaine present was not taken after the procedure.

Dr. Karan also understood from the autopsy reports that there were no “gross or

microscopic anatomic causes of death.” She could not comment upon the “normality” or

“abnormality” of the size of the patients’ hearts, although she acknowledged that cardiomegaly

was listed as a finding for Kindig, Beigelman and M.J., as was bilateral dilatation for Beigelman

and M.J. This latter finding means that both ventricles were enlarged, and she agreed that such a

finding was “not normal.” Persons with these conditions are more prone to heart irregularities,

such as ventricular defibrillations, which are arrhythmias that “kill people.” Cocaine could

precipitate such arrhythmias. She agreed that the increase in epinephrine levels circulating to a

dilated heart due to stress (cold turkey) could establish a greater likelihood of arrhythmia. She

noted that three of the four decedents suffered from serious to very serious pulmonary edema,

and as they tried to breathe harder and faster to overcome its effects, they could ultimately

smother from the effects of the extracellular fluid. However, death could also result from

respiratory depression.

Mr. Stavola had hepatosplenomegaly, a large liver and spleen, which is a pathological

finding. 25 Resnick RB, Kestenbaum RS, Washton A., Poole D: Naloxone-precipitated withdrawal: A method for rapid induction onto naltresone. Clinical Pharmacology Therapy, Vol. 21, 409-413 (1977).

- -68


Dr. Lin reviewed the toxicology reports filed in the several cases. Assuming the accuracy

of the times and dates provided and the toxicology reports, it is his opinion that to a reasonable

degree of scientific certainty it is more likely than not that in the cases of Beigelman, Flowers,

M.J., Stavola and G.W., these individuals did not use any illicit drug after they were discharged

from Dr. Gooberman’s facility. The toxicology reports reveal that either no opioid or other

lethal substances, or at most only trace amounts of such substances, were found in each of these

decedents. If they had used such drugs after they were discharged, the amount of such drug

present at the time of death should have been “much higher.”

In contrast to these four individuals, Dr. Lin agreed that Mr. Kindig could have ingested

either morphine or heroin after the discharge. It is not unusual for metabolization to occur even

after death. Cocaine can continue to metabolize, because the body temperature keeps the

enzymes working. A habitual user of cocaine will metabolize the drug faster. In addition,

decomposition can affect the findings.

Dr. Lin determined that it was more probable that Mr. Melendez used methadone after he

was discharged. The level of methadone found in Melendez falls into the average lethal range.

All others had levels below the lethal dose. Methadone is a long acting drug, and it can kill

hours after it is taken.

Dr. Lin commented that he found fentanyl in the blood “pretty often,” usually in the

stomach. Questioned about the ability to detect a drug after the passage of a number of half-

lives, the witness explained that it depended upon the dose taken. Thus, if enough is taken, given

the sensitivity of the instruments at the State lab, cocaine could be detected even after five half-

lives. He agreed that if an average healthy person took two drugs, the lethal dosage of the drugs

for that person would be reduced by the interaction of the two drugs.

Dr. Herbert Kleber reviewed the records relating to the seven mortality and two

morbidity cases. These include the hospital records, the doctors’ records and guidelines and the

generic doctor’s orders covering August 1988 to September 3, 1999, and the orders written for

patients Flowers, Hendrix and Perez. He also considered the autopsy and toxicology reports.

Dr. Kleber considered the fact that the majority of the deaths occurred within forty-eight hours

- -69


post procedure to be very significant. He explained that the State of New Jersey defines a

complication of anesthesia as anything occurring within forty-eight hours after the procedure,

and in his opinion, any complications occurring within that timeframe should be considered “a

possible complication of the anesthesia." It strains credibility to believe the patients dying within

this window died from anything unrelated to the procedure or the deficiencies related thereto.

He explained that the stress levels involved in the procedure play a part in this opinion. He

compared the UROD procedure to cardiopulmonary surgery, referencing studies regarding

epinephrine, ATCH and Cortisol.

Dr. Kleber opined that, in contrast to the position presented by Dr. Segal, these patients

were not, except for the fact of their addiction, healthy individuals. The doctor believed that

more extensive screening procedures would have kept some of these patients from undergoing

the procedure.

Dr. Kleber explained that there was a risk of pulmonary edema associated with the use of

the narcotic antagonists naloxone, which was used briefly in the Gooberman practice, and

naltrexone, which replaced naloxone. In the cases of Flowers, Perez and Hendrix, nalmephene

was used, rather than the other two antagonists. There are no published papers connecting this

drug with pulmonary edema.

The witness noted that the toxicology reports indicated significant factors. Of the seven

decedents, three had cocaine metabolites present at autopsy and two others had provided

histories of cocaine use. In Kleber’s opinion, these individuals’ use of cocaine was a major

contributory factor in their deaths. The human body does not produce measurable amounts of

the metabolites of cocaine or measurable amounts of ethanol. Therefore, if these substances are

found in the body, the individual has to have ingested them in some manner. The witness agreed

that, according to the standard textbook, Textbook of Pharmacology, by Goodman and Gilman,

the half-life of morphine is 1.9±05, or two to two and one-half hours, and of cocaine, forty to

sixty minutes. A half-life is the period that it takes before half of the substance is no longer

present in the blood. The pharmacological rule is that after five half-lives the substance is

considered absent from the system. As such, if morphine had been taken, after five hours, or the

outside limit of five half-lives of that substance, it would not be detectable by the usual means,

- -70


and similarly, cocaine would be undetectable after ten to twelve and one-half hours at the

outside.

Although he acknowledged that the data is inadequate to assure his conclusion, Kleber

opined that in some cases, indeed perhaps in all, the postoperative care provided was inadequate.

Proper care provided to these patients might have prevented the deaths of some or all of them.

Dr. Kleber believes that because of the potential for morbidity or mortality the patients should

have been kept overnight. At a minimum, they should have been kept until they were able to

ambulate on their own without assistance. They should also have been coherent and been able to

void. The amount of time necessary for each patient to reach this stage would vary, but in his

view, in the majority of cases, it would be at least four hours and would be longer for many

patients.

Based upon his review of the records, Dr. Gevirtz opined that the respondents’ UROD

procedure contributed directly to the demise of individuals. He identified deviations from the

accepted standards of anesthesia practice, both in general and as related to the UROD procedure

itself. He listed the primary differences between the manner in which he performs UROD and

the manner that Doctors Gooberman and Bradway did the procedure:

1) different devices to titrate the propofol;

2) different styles of anesthesia;

3) naloxone challenge used by him for the first cohort of patients, but not

thereafter ; never used by them;

4) he employed a lot more blood screening;

5) he had a psychologist and a psychiatrist involved in screening, each an

addictionologist, they did not use such professionals;

6) the length of stay post-procedure;

7) his use of a lot of gastric prophylaxes, used to prevent upper GI bleeding and gastric

ulceration.

While acknowledging Dr. Kleber as a world recognized addictionologist, Dr. Gevirtz

disagreed with the doctor as to the existence during the years 1995-99 of a standard of care for

the performance of UROD. Gevirtz contended that there were indeed standards for UROD

- -71


during that period, referencing the American Society of Anesthesiology (“ASA”) standards,

which he and the ASA each characterize as “minimum standards.

More specifically, Dr. Gevirtz opined that the use of the fentanyl patch was a deviation

from acceptable standards, as was the failure to employ clonidine. In addition, the manner in

which patients were discharged and the lack of skilled aftercare constituted deviations from

standards. In regard to the discharges, Gevirtz noted that there is no notation of Aldrete scores or

any indication that an Aldrete score was determined. The Aldrete score is determined from a

system used to evaluate the suitability of a patient for discharge. A patient who is not able to

stand, is unable to walk without assistance, to speak coherently and is somnolent is not ready for

discharge from an ambulatory care facility. Premature discharge of a patient can endanger the

patient, who may aspirate and may not have all of the protective mechanisms fully functioning.

Indeed, from 1995-99, the standard of care was to keep the patient slightly sedated after the

anesthesia wore off. There is a slightly increased risk of aspiration. If the blood pressure has not

returned to normal levels, the patient may have a stroke or heart attack.

Dr. Gevirtz explained that at the time that they were being discharged, Dr. Gooberman’s

patients were critically ill individuals who required critical care monitoring. The premature

discharge of those patients who died contributed to their deaths, as did the unavailability of

clonidine, as they could not tolerate vomiting. Gevirtz noted that clonidine, also known as

Catapres, is an Alpha two agonist drug that controls blood pressure and suppresses the release of

norepinephrine. When the drug is used, the catecholamine surge characteristic in detoxification

is not observed. According to Gevirtz’s June 9, 2000, report, the use of clonidine in

detoxification has been “a standard of care in ultra-rapid opiate detoxification” and has been “an

integral part of detoxification for twenty years.” In addition, the failure to provide adequate

doses of clonidine “will lead to marked elevations of catecholamines . . . which in turn may lead

to cardiac dysrhythmias, pulmonary edema as well as upper gastrointestinal ulceration.”

Dr. Gevirtz acknowledged that while clonidine is generally acknowledged to lower blood

pressure, the FDA has not approved its use for opioid detoxification. Between 1995 and 1999, in

the CITA protocol for UROD, patients were given clonidine to take home and were instructed to

use it in 0.2 milligram doses twice a day (“BID.”) However, these patients were not instructed to

take their blood pressure before each dose was ingested, despite the fact that the drug “has the

- -72


potential to have serious consequences in terms of blood pressure and cardiac effects.” Gevirtz

acknowledged that, like clonidine, benzodiazepines reduce the release of catecholamines.

However, he argued that they do so to a lesser degree than does clonidine.

Dr. Gevirtz opined that the inability of Mr. Melendez to control nausea and vomiting and

maintain hydration caused his death. A deviation from standards occurred in regard to post

procedure care standards. Melendez’s toxicology report did show amphetamines in the urine

samples, #s 8 and 9.

In addition, Gevirtz explained that Dr. Gooberman’s deviations from professional

standards directly contributed to the hospital admission of Messrs. Perez and Hendrix. Fentanyl

is an analgesic, good for control of pain. The witness explained that fentanyl identified in the

stomach contents might be explained by ulceration in the stomach and diffusion of the patch

reservoir across the skin and into the bloodstream. To a small degree, this blood-carried fentanyl

could enter the stomach, while additional amounts would be metabolized by the liver. In the

autopsy report for Marc Beigelman, there is no mention of any bleeding, only a reference to forty

milliliters (“ml”) of brownish liquid. If there was submucosal hemorrhaging due to the

endotracheal tube, the thin brownish material observed could be partially digested blood.

Dr. Kushins discussed the pre-operative assessments that the Gooberman and Bradway

patients underwent. These included a history and physical examination, but did not appear to

include any extensive pre-anesthetic testing. The patients were drug users who might well have

heart, lung, liver, kidney and other problems. These patients might be cocaine abusers, and

cocaine use itself poses anesthesia risks. Many abusers have episodes of coronary artery

vasospasm and constriction and some end up with resulting myocardial infarctions that damage

their heart, leaving the heart less able to handle the stresses of anesthetics and particularly the

stresses of opiate detoxification of this nature.

Based upon his review of the records of the patients in question in this matter, Dr.

Kushins opined that there had been significant increases recorded in blood pressure. Blood

pressure and heart rate increases followed upon the administration of the opioid antagonists.

These increases reflect a stress response caused by competitive antagonism for opioid receptors,

which results in a release of catecholamines, which are naturally occurring substances produced

- -73


in the body, including epinephrine and norepinephrine. The increase in epinephrine was not

measured with respect to these patients, but the increase has been reported in the literature at

least since 1997. The effect of the surge of epinephrine and norepinephrine is to heighten blood

pressure and heart rate, causing increased pressure in the lungs or pulmonary circulation and the

release of various hormones and increased respiratory activity. If experienced, these conditions

pose anesthesia related dangers that can cause complications, such as myocardial infarction,

stroke, heart failure and pulmonary edema. The appropriate anesthesia response would be the

initiation of drugs that counteract the effects of the catecholamines.

The doctor was unable to quantify the level of stress which patients Kindig, Flowers and

G.W. experienced. However, he could say that in each case they had experienced a greater level

of stress then they would have had they gone about their daily lives. The fact that they received

anesthesia caused their heart rate and blood pressure to increase. Stress can cause different

reactions in different people.

The doctor acknowledged that he had used epinephrine to treat asthmatic attacks and then

allergic reactions and that such use would significantly raise epinephrine levels, increasing the

heart rate and at times blood pressure.

A rapid lowering of the blood pressure can cause cardiac arrhythmia all by itself.

Kushins suspects that each of the decedents in this case had experienced a cardiac and/or

respiratory event(s). The occurrence of one of these events can lead to the occurrence of the

other. Some reports indicate that there can be delayed cardiac symptomatology resulting from

recent cocaine use. Although probably most such events occur within one hour, they may occur

after a couple of hours. Nevertheless, while most occur within this short time frame,

symptomatology can occur up to twelve to fourteen hours following use. Extended cocaine use

causes its own pathology. Kushins was not able to recall if any of the decedents had any

valvular problems. However, he did explain that Victor Melendez had some enlargement of cells

that was observable microscopically. There was some also obstruction of the smaller vessels in

the myocardium. This could be evidence of heart disease, however, while there may have been a

disease process occurring, it may not have been enough to damage the heart. The level and type

of activity for the patient would be an important factor in determining whether there was any

clinical symptomatology.

- -74


Kushins commented upon the addendum to the Monmouth County Medical Examiner’s

Post-Mortem Report issued for Frank Stavola which changed the cause of death from the initial

“pulmonary and cerebral edema due to pending further examination” to “pulmonary and cerebral

edema due to drug use (Morphine, Cocaine, Fentanyl and Nordiazepam,” (this latter believed by

Kushins to be a metabolite of diazepam). The witness explained that the death “may or may not”

have been the result of pulmonary edema caused by cardiac disturbance. Kushins noted that

opioid antagonists can cause respiratory depression and, in addition, may pose a risk of

pulmonary edema, which has been reported in the literature. 26 However, he acknowledged that

while naltrexone does cause shortness of breath and heavy breathing causes pulmonary edema,

there are no literature references to naltrexone as a cause of pulmonary edema. The 1999 edition

of the Physicians Desk Reference, p. 936, which states that naltrexone has caused shortness of

breath and heavy breathing, does not say that it has caused pulmonary edema. Despite this fact,

he still maintains that naltrexone is the same as naloxone or nalmefene, each of which has been

linked to pulmonary edema. Naltrexone is an opioid antagonist and pulmonary edema has been

shown in reports to be extensively demonstrated with the use of these drugs.

In addition to these concerns, there are other anesthesia related concerns. These include

problems with intubation of the trachea, the possibility of the patient awaking from general

anesthesia too early and the removal of the tube, all of which can cause stress.

In his written report, Dr. Kushins explained that he believed the “lack of post-procedure

care may have contributed to the deaths of . . . G.W., Mark Beigelman, Frank Stavola, M.J.,

Lester Kindig, and Lisa Flowers.” However, he testified that he did not necessarily hold that

conclusion “to a degree of medical certainty.” Similarly, when he stated at page two, paragraph

three of his report that, “[O]ne must wonder whether in isolated patients after Naltrexone or

Nalmefene precipitated withdrawal if the Naltrexone pellet did not result in an adequate blood

level of antagonist that the fentanyl might have caused an opioid overdose,” he did not mean to

2626The witness explained that pulmonary edema involves an accumulation of fluid in the alveoli, where gas exchange takes place. There are many possible causes for this condition. It is not regularly observed at autopsy, and if seen, it may not always be related to the cause of death. The use of morphine and its derivatives and/or alcohol can cause it, however, it is also used to treat the condition. He believes that the use of cocaine and/or amphetamines can cause it as well. Heart failure can cause pulmonary edema: as the heart muscle fails to pump an adequate supply of blood, the blood backs up to the pulmonary circulation and fluid is exuded out into the alveolar spaces. Airway obstruction and certain central nervous disturbances can also cause pulmonary edema. Pulmonary edema is a rare, but foreseeable risk of general anesthesia. When detected by a reasonable practitioner of reasonable prudence it can be treated. If caused by heart failure, drugs can be used; if by excessive amounts of fluid, then diuretics can be administered. The ease of diagnosis depends on circumstances and expectations. In a monitored setting, it is both detectable and treatable.

- -75


say that he had so determined “to a medical certainty.” Further, when he stated on page 1 of the

report that “Despite Dr. Gooberman’s extensive experience . . ., his procedure has resulted in at

least six post-procedure deaths,” he was making a distinction regarding post-procedure care

versus the procedure “as a whole.” His concern with the post-procedure care was with the lack

of ability of the caretakers to adequately understand and deal with issues that arose and the lack

of an ability in the post-procedure period to effectuate a “rapid rescue,” although he could not

say with certainty that any of the decedents could have been resuscitated. He explained that

despite this uncertainty, if patients were “rescued” earlier, they might have had a “better chance.”

However, he acknowledged that those who died following the procedure might nevertheless have

died in the same time frame. He further acknowledged that there was a potential that one or

more of the patients might have died even if the patient had been retained for a longer period at

the Gooberman facility and there was even a potential that a patient who underwent rapid

detoxification in a hospital setting might succumb. However, despite these several uncertainties,

he asserted that if a patient were retained, changes in his or her condition could be more readily

observed and acted upon and the situation might be salvaged. Therefore, in his opinion,

retention for monitoring for twenty-four hours was appropriate. In his opinion, as practiced by

the respondents, the UROD procedure placed these patients at risk to an unacceptable degree.

Dr. David Smith testified that in his expert opinion there is no empirical evidence to

substantiate the claim that the procedure “and/or respondents’ aftercare and treatment or the lack

or inadequacy thereafter” directly or indirectly caused or materially contributed to the deaths of

G.W., M.J., Stavola, Beigelman and Kindig.” In the case of each of the listed decedents, the

procedure was performed and the patients were discharged, with the decision to discharge made

based both upon criteria developed by Dr. Gooberman and the exercise of clinical judgment.

Each had stable vital signs and exhibited no pathological signs or symptoms other than those that

were consistent with opiate withdrawal and therefore anticipated. Prior to their discharge, they

were each required to demonstrate that they could communicate with the doctors if questions or

concerns arose. More than 2,000 patients were successfully treated and discharged to immediate

family, friends or relatives. The mortality rate was equal to or less than .03 percent. While an

ideal outcome would be that there were no deaths following the procedure, Dr. Smith concurs

with the findings of Dr. Cooper (to be discussed below) that the patients’ deaths were not caused

by the procedure and there is no evidence to support the argument that they were so caused. In

fact, in several of these cases, there is evidence suggestive of post-operative non-compliance

- -76


with written instructions; non-compliance that could be a contributing factor to the deaths.

While there is a temporal correlation existing between these individuals undergoing the

procedure and their subsequent demise, there is no proof of causation, and the suggestion that

there is such a causal relationship is the product of “very fuzzy” thinking.

Dr. Smith concluded that, to a reasonable degree of medical certainty, the causation of

the deaths of patients G.W., Stavola, M.J., Kindig, Beigelman and Melendez was unknown and

could not be proven scientifically to have been caused by the UROD procedure. Although he

emphasized that there were many unknowns about the cause of death, Smith explained that they

were not anesthetic deaths, but were all cardiac deaths. Dr. Smith noted that while implantation

of the naltrexone pellet was intended to block the physiological effects of the mų agonists, it is

possible that some of effects that are not mediated through the opiate receptor may still occur.

These effects may include the release of histamines, which could lead to a drop in blood pressure

and might cause a cardiac arrhythmia. In addition, histamine release can cause respiratory

system problems, which could affect cardiac function. Given that there were over 2,300 URODs

performed in which death did not occur shortly after the procedure, there is a “strong possibility

of another variable,” in these particular cases. That variable is noncompliance. Noncompliant

behavior of certain patients can lead to histamine related effects that might have led to their

demise.

Dr. Smith argued that medically unassisted withdrawal might prove fatal if a person had

an underlying cardiac disease. The withdrawal impacts upon pulse rate and blood pressure, and

the hypersympathetic discharge, which is adrenaline, could lead to fatal consequences.

Dr. Smith acknowledged that Dr. Cooper did a good job of summarizing the cases, but he

disagrees with Cooper’s comment that naltrexone is “most likely a significant contributing factor

in sudden death occurring during medically supervised opiate withdrawal.” (!Pick up comments

at page 123 of February 26 re: bias against doctors treating addicts).

Dr. John Cooper explained that Lisa Flowers was taken to a hospital before death and an

EKG indicated that she had suffered a myocardial infarction. The autopsy report revealed

bilateral pneumonia. The UROD procedure was not in itself causative of her demise. Indeed,

she, as well as all of the other individuals in question, “got through the procedure fine.” They

- -77


had a normal post-procedure course. There were some post-procedure signs and symptoms, and

additional signs and symptoms, prior to Flowers’ death. She exhibited mild wheezing and

muscle incoordination. He attributed the wheezing to the fact that she was an asthmatic. The

muscular incoordination is normal in this setting and not of significance. After her discharge and

prior to her death, Ms. Flowers also experienced restlessness, vomiting and diarrhea, was

extremely cold and had convulsive activity. Each of these was a normal, expected sign of

withdrawal and was not relevant to the cause of death. However, she also experienced

respiratory distress, which is not a normal and expected outcome with withdrawal. She also had

bradycardia, a slow heart rate and ECG abnormalities in the hospital that were consistent with a

myocardial infarction. These were harbingers of an undesirable outcome. The autopsy revealed

that Flowers was cachectic. She had a fentanyl patch in place, which to him meant that it had

been “left in place from the time that she left the treatment.” Cerebral edema was noted, but this

is a non-specific finding. She exhibited definite heart pathology, identified from some

hemorrhage in the heart around the papillary muscles. He believed that there “may have been

some actual ischemia in the heart.” There was also some general congestion of blood in the

organs, which in itself is non-specific in nature and yet constitutes an abnormal finding. The

microscopic analysis showed well-established acute inflammation of muscle fibers of the heart,

which he labeled as “incontrovertible evidence of infarction.”

Cooper concluded to a medical certainty that Flowers’ death was caused by an acute

myocardial infarction due to acute opiate withdrawal. Contributing factors were malnutrition,

asthma, chronic cocaine and heroin abuse. While death can be the outcome of an opiate

withdrawal, it is not an expected outcome. However, in Ms. Flower’s case, her death was an

example of a death resulting from opiate withdrawal. The death was neither caused nor

contributed to by the UROD procedures employed by the respondents.

Mark Beigelman was a heroin user and, at the time he presented for the UROD

procedure, was also a methadone addict. He came through UROD normally and was discharged

with routine signs of recovery from the procedure. Later he sweated profusely, which was to be

expected. He died eleven to twelve hours after extubation. The autopsy revealed that he had an

enlarged heart, with hypertensive type changes, dilatation of the ventricles, indicating acute heart

failure, and other nonspecific findings of generalized visceral congestion and cerebral edema.

- -78


Cooper noted that the upper limit of normal weight for a heart in a man of Beigelman’s

size would be 380 grams. In Beigelman’s case, as with other of the decedents whose deaths are

at issue, their enlarged hearts displayed concentric left ventricular hypertrophy. This is a

condition that results when the left ventricle, which is the main pump that creates systemic blood

pressure, thickens and the increased mass or heavier weight of the heart is a result of the

thickening of the wall of the left ventricle. This is generically referred to as hypertensive

cardiomyopathy. In the absence of drug use, this condition is most commonly caused by

sustained high blood pressure. Presumably, the abuse of cocaine and amphetamines causes a

stimulation of the sympathetic nervous system and raises the blood pressure. The effect is the

equivalent of high blood pressure for a non-drug user. In Beigelman’s case, he had a long

history of high blood pressure, which was coupled with a history of cocaine abuse. To a medical

certainty, his death was caused by a cardiac dysrhythmia, or abnormal heart rhythm, resulting

from hypertensive cardiomyopathy. The UROD procedure did not have any role in his demise.

Referring to Dr. Segal’s report, Dr. Cooper stated that Segal’s opinion as to the cause of

Beigelman’s death was not “completely non-legitimate,” as one cannot be completely dogmatic

about characterizing a 400 gram heart as enlarged. This gentleman was 185 pounds, and to the

extent that the major textbooks place the upper level of normalcy at 380 grams, Cooper would

disagree that a 400-gram size was within the range of normalcy. However, the point is

debatable. Segal’s report does not “give us any clues as to how” he reached his conclusion as to

the cause of death.

Cooper opined that there is no causative relationship of the UROD procedure and the

death of G.W. This is especially so due to the passage of three and one-half days before his

demise. G.W. died three and one-half days after discharge. He suffered from some mitral valve

abnormality that affected the flow of blood in the heart between the left and right ventricles.

This condition can lead to fatal arrhythmias. In addition, he had a very severe, very ferocious

and widely distributed pneumonia, an acute pneumonitis in both lungs, and this killed him. The

pneumonia was aspiratory in origin. Aspiration pneumonia, in which gastric contents are

introduced into the lungs with bacterial and chemical consequences thereto, usually develops

within twelve hours of aspiration and can cause death within twenty-four to thirty-six hours,

although Cooper conceded that in perhaps 10% of the cases it might take three to four days. The

pneumonia can be detected by a physician listening to a patient’s chest within a few hours of the

- -79


onset of the condition. Thus, if it is not detected by a competent physician listening to the chest,

then that “could only mean that the patient has not aspirated yet or it hasn’t been long enough to

develop physical findings.” Aspiration pneumonia is a possible complication with any anesthetic

procedure, however, if the decedent had gotten the pneumonia as a complication of the procedure

itself, it would have developed much sooner and symptoms of its development would have been

observed.

M.J. also passed through the UROD procedure and had the normally anticipated

symptoms of withdrawal. He then suffered from respiratory distress, an unexpected event. He

died some thirteen to fourteen hours after extubation. The autopsy showed nonspecific findings,

such as pulmonary edema and generalized visceral congestion. However, he also had mild left

concentric, left ventricular hypertrophy and dilatation of the ventricles, indicating acute heart

failure. His heart weighed 400 grams, higher than the normal outer limit of 380 grams. The

dilatation means that the left and right ventricles are large in diameter, a condition that “goes

along with an acute failure of the heart.” Before cardiac arrest, he would suffer an abnormal

rhythm and the heart would not pump efficiently. The blood would back up in the heart. The

size of the heart ventricles “is a reliable indicator of what the heart was doing before death.”

Pulmonary edema can result from many different causes and there is no pattern to its appearance.

It often is associated with circumstances in which people “die somewhat slowly,” and “most of

them have it.” It is often noted and classically is associated with drug overdoses, “but the reason

why is because people are laying there with a prolonged period of respiratory depression and

sluggish heart function for a period of time, long enough for these changes to set in.” The slow

nature of the death is the cause of the edema, not the heroin overdose as such.

Dr. Cooper commented upon the pathologist’s determination that M.J. died from fluid

overload due to rapid opiate detoxification with naltrexone implant due to acute and chronic drug

abuse. He responded that

The idea that this is somehow a fluid overload is - - frankly, it’s ludicrous because he was - - the reason is you can get fluid overloaded in a setting where you’re under anesthesia and you have an I.V. in you, that’s true, but then to walk out and be okay, respiratory-wise and be okay for some hours and then on top of that to be really keeping anything down, you’re throwing up, you’re sweating profusely and in effect doing all the things that a

- -80


person can do to become dehydrated and die some twelve hours later and then attribute that to fluid overload, it’s absurd.

Dr. Segal’s report advised that he believed that the pathologist who autopsied M.J. wrote

a “well-written cause and manner of death and I agree completely.” Dr. Cooper commented

upon this assessment.

As we talked about, I think that his opinion is completely in opposition to the facts as we understand them . . . You cannot justify a conclusion of fluid overload in this setting. So, I don’t understand why anybody would, with forensic pathology experience, would agree with a conclusion like that.

Cooper asserted that Segal was relying upon the interpretation of the examining

pathologist and, “when you’re analyzing a body of autopsy reports, it may be worthwhile to look

and see what the original examining pathologist thought, but it’s much more instructive to look

at the actual facts that they recorded, look at the descriptions of the individual organs.” Cooper

argued that, in reviewing the pathologist’s report for M.J., Segal was basically concurring with

his own assessment in the Kindig case and did not take into account the significance of the

naltrexone block. He “completely brushed past” “the abnormalities in the hearts of these

people.”

Finally, we have - - the concern that he goes case by case stating conclusions, but in each case he declines to explain what his thought processes are in arriving at that conclusion and I think that if you’re offering an expert opinion, it’s not enough just to say that is my opinion. At some point you need to be willing to explain how you arrived at it.

Nothing in Dr. Segal’s testimony in this hearing has changed Dr. Cooper’s critical assessment of

his report. As for the cause of death, in his opinion, to a reasonable degree of medical certainty,

M.J. died as a result of a cardiac dysrhythmia due to hypertensive cardiomyopathy. The UROD

procedure played no role in causing or contributing to the death.

Lester Kindig had a history of high blood pressure, heroin and methadone use. He also

emerged from UROD with normal withdrawal symptoms and never demonstrated other than

- -81


typical symptoms. He was not closely observed by his caretaker. He died within ten to twelve

hours of extubation. His heart weighed 460 grams, indicative of a substantial hypertensive

cardiomyopathy. Dr. Cooper characterized Dr. Segal’s stated cause of death, an adverse reaction

to drugs and ROD, as “unfounded,” claiming that it failed to take into account the findings at

autopsy and the history and failed to fit the facts. Instead, Cooper found that the cause of death

was cardiac dysrhythmia resulting from hypertensive heart pathology. Opiate withdrawal was a

contributing factor; however, the procedure he underwent was not a contributing factor.

Cooper labeled the autopsy performed on Kindig, in which Segal participated, as “not

adequate.” The shortcomings included a missing clinical history and nothing is stated regarding

the circumstances of the death. Segal’s report does not indicate that he considered, at least to

any degree of completeness, the clinical history, or that he understood UROD. “Even more

importantly,” it did not appear that he was aware that Kindig was a fifty year old with chronic

hypertension. The report did not seem to suggest that much attention was paid to the “actual

clinical circumstances of death.” There is no mention of the enlarged heart, even though its 460-

gram weight is plainly stated, and this is a “very significant finding.” Dr. Segal apparently did

not recognize this as abnormal, so it was not included in the pathologic diagnosis. In addition,

this condition ties in with the hypertension. The report should both recognize the abnormality

and why it exists. As for the stated cause of death, it “just appears there,” but the report does not

explain, “how in the world he came to such a conclusion based on the autopsy findings or based

on clinical history.” In Cooper’s opinion, Segal was “possibly confused and possibly did not

have time to look into it or think about it, but, again, I have the advantage of hindsight and being

able to look at several different cases and when he did this case, presumably it was his first

exposure to the whole business of cardiac dysrhythmia in the court (sic) of opiate withdrawal.”

In his opinion, Segal reached a “convenient conclusion.” After all, the gentlemen had recently

undergone UROD and was now dead and “presumably he didn’t recognize the heart pathology

so he just made the convenient conclusion that since its - - since it seemed to be temporally

related to the procedure it must be the cause.”

Cooper noted that the Kindig autopsy report did not contain any reference to any

microscopic examinations. Such analysis is “absolutely” required in a so-called “mysterious”

death, one that is “medically related,” as opposed to a “violent death,” and its absence indicates a

breach of the standard of practice for pathologists. He added, “I don’t want to paint it with too

- -82


broad of a sweep, but if you have an enlarged heart in a death which seems confusing to you,

then I think the standard of practice would most definitely include sections of the heart and

presumably the other organs while you’re at it.”

Cooper next discussed Frank Stavola. Mr. Stavola did well during the procedure and did

not exhibit any significant symptoms before his discharge. He was closely watched. He suffered

a sudden collapse after getting out of bed some nine to ten hours after extubation. The autopsy

revealed nonspecific findings, pulmonary and cerebral edema and generalized visceral

congestion, as well as myocardial fibrosis, the later typical of several different things and a

finding often seen in persons with coronary artery disease.

Cooper believes that due to Stavola’s ongoing cocaine use, his heart was rendered more

susceptible to abnormal rhythms. He disagrees with the pathologist’s report, which assessed the

cause of death as “pulmonary and cerebral edema due to drug use; morphine, cocaine, fentanyl

and nordiazepam.” The edemas suggest that he did not die precisely when he collapsed.

However, the facts do not support a finding that the death was the result of a drug overdose. The

presence of the opiate receptor block would prevent an overdose with an opiate type drug. The

“sudden collapse” fits with a cardiac arrhythmia. It is true that he had cocaine metabolites in his

blood, and thus cocaine is surely a factor. However, the very presence of the cocaine metabolites

is indicative of a cardiac arrhythmia, which Cooper characterized as the “mechanism of death in

cocaine deaths.” His recent use of cocaine, within twenty-four hours of presenting for the

procedure by Cooper’s definition, in conjunction with his ongoing heart problems and cardiac

arrhythmia associated with withdrawal, are the contributing factors to the gentlemen’s demise.

The witness argued that Dr. Segal’s conclusion that death was due to adverse reaction to

drugs does not fit the facts. Cooper related that the implanted naltrexone pellet, “would kind to

tend to preclude that this is a drug death and in the paragraph directly above he mentions

myocardial fibrosis.” In addition, Segal stated that he had not yet seen the toxicology report.

Thus, although Segal did not have all of the facts, he did recognize the heart pathology. The

facts simply did not fit Segal’s proffered conclusion.

Victor Melendez had hypertensive cardiomyopathy, a sign of cardiac pathology. His

heart was in the 450-460 gram range and had quite a bit of fibrous tissue in the heart muscle. He

- -83


fit into the group that might be expected to die from this particular cardiac abnormality while

going through opiate withdrawal, regardless of how that process was initiated. He actually died

of intractable vomiting, which at some point resulted in a tear in the esophagus. He had an

inflammation of the mediastinum. These are serious conditions and carry a very high fatality

rate. His temperature was 104.3, which suggests that sepsis, an infection and bacteria throughout

the bloodstream, may have resulted from the esophageal tear and mediastinitis. While the

postmortem blood cultures were negative, this does not necessarily mean that he was not septic,

as false-negative post-mortem cultures do occur. Nevertheless, it is also true that Melendez had

an alcoholic liver pathology, that is, a liver with fatty infiltration and necrosis of liver cells and

the beginning of fibrosis. From these findings, Cooper can glean that Melendez was a heavy

alcohol user. He also experienced seizures at times and one could have occurred during the

withdrawal, that is, he could have suffered from delirium tremens, which does produce high

fever and seizures.

Cooper opined that one can never be sure exactly why Mr. Melendez died, but to a

reasonable degree of medical certainty he did not die as the result of undergoing UROD, which

procedure had no connection with these two possible causes of death.

Cooper disagreed with the proposition that people do not die from opiate withdrawal,

calling this idea a “myth.” For instance, people will go “cold turkey,” an excruciating procedure

in which, commonly, a “valiant attempt” ends in the person not being able to get through the

withdrawal and giving up and getting a fix, which kills them. “We see that over and over.” It is

not listed on the death certificate as a death due to withdrawal, but instead as due to heroin

overdose. However, it is “really withdrawal related because if they didn’t try to withdraw, they

wouldn’t have died.” In this case, we see patients who died as a result of causes, “fairly

representative of the kinds of death we see in opiate withdrawal through any method. They’ll

have heart attacks. They’ll have arrhythmias because of their cocaine damaged hearts or they’ll -

- I’ve seen cases where they have had hemorrhagic stroke because their blood pressure goes up.”

Along with these causes, there frequently is aspiration pneumonia, or other forms of pneumonia,

resulting from the patient’s resistance being weakened due to going through the procedure. In

addition, there can be the esophageal tear and mediastinitis, and finally, the large amount of

epinephrine in the system can cause people to have bleeds in their heads and stroke to death.

- -84


The thirty-five year old woman who Dr. Cooper autopsied following her death after

undergoing UROD/ROD in Phoenix, Arizona, had an enlarged heart and had used cocaine

recently, as indicated by the presence of benzoylecgonine in her system. He believes that she

also had some myocardial fibrosis. She died around twelve hours after extubation. Cooper

opined that she definitely died of a cardiac arrhythmia while under direct medical care. At the

time Cooper was suspicious of the UROD procedure and felt that it was not “sound medicine.”

Dr. Kasen, the physician who performed that UROD, provided him with articles, and after

reviewing the hospital records, he determined that the death had not resulted from the procedure.

Instead, he determined that she had ventricular dysrhythmia due to cardiac hypertrophy, with

contributing factors being cocaine abuse and opiate detoxification, a term he was using

interchangeably with “withdrawal.” The patient was under medical observation, so that the

occurrence of the arrhythmia was clearly shown by the medical records. She had a grossly

abnormal heart and a microscopically abnormal heart, both enlarged and with an excess of

fibrous tissue. The mechanism for the occurrence of the arrhythmia would be the presence of

elevated levels of catecholamines, epinephrine (adrenalin) and norepinephrine (noradrenaline),

resulting from the withdrawal. These substances would sensitize the heart to abnormal rhythms,

rhythms well known to occur more likely when the heart is enlarged, even without the presence

of elevated levels of these catecholamines.

The witness agreed with the statement, “It’s fair to say that without regard to the method

of opiate withdrawal, the fact of opiate - - without regard to how it was done, would suggest that

opiate withdrawal played a part in their demise in relationship to the preexisting condition.” In

addition, he opined that “. . . I can see that these people and probably more would have died if

they had gone through opiate withdrawal through other methods. They would have just as surely

died or failed to withdraw. So it cannot be attributed to the procedure because we’re passed that

and its - - the cause of the death is the heart problem, opiate withdrawal. Saying nothing about

what procedure is involved, opiate withdrawal is a precipitating factor.”

Turning to his analysis of the morbidity cases, Dr. Cooper explained Mr. Hendrix

represents a complication of the UROD procedure. He evidently aspirated enough gastric

contents during the procedure and before discharge that he developed aspiration pneumonia

within a day or so, although the records do not contain any reference to such aspiration. The

situation was handled appropriately. Aspiration is a foreseeable complication of any anesthetic

- -85


procedure and is listed in the respondent’s consent forms. Aspiration of stomach contents can

occur during heroin use, however, it is unlikely that Hendrix would have experienced aspiration

pneumonia that very week had he not had the procedure that placed him into withdrawal. Thus,

there is a link, but not a causal link, between the use of anesthesia in the UROD procedure and

the death. As for Mr. Perez, this case fits the same pattern, respiratory distress, and in his case, a

heart attack within twenty-four hours.

On cross-examination, the witness explained that the statement in his report that the

UROD procedure had “no appreciable role” in the mortalities and morbidities that he examined

meant the same as “no causative role.” This means that if any causative relationship does exist it

does so to such a minimal extent as to be undetectable to anyone. As for post-discharge

ingestion of any drugs as a factor, when he first started to look into these deaths he considered

that possibility, indeed it was a “leading theory.” However, he did not find any evidence of such

use. Likewise, the fentanyl patch did not contribute to the deaths.

Dr. Cooper commented upon the stress levels inherent in the withdrawal process. He

noted that introduction of anesthesia mitigates the stress of withdrawal, here during the crucial

first three to four hours of that process. He denied that the anesthesia would heighten stress, and

commented, “logic dictates that it would be helpful.”

Dr. Cooper commented on the “ITU Record” for Lisa Flowers, Volume II, 0030. He had

reviewed this document “very superficially.” This is as close a document to an anesthesia record

as he found. He did not pay particular attention to the drugs administered in each individual

case, other than to look to see if they were relevant to the cause of death. He did not have any

concern that there was any synergistic effect with the combinations of drugs employed. He knew

that naltrexone, if used as an opiate blocker, would raise the level of catecholamines and thus

raise blood pressure and heart rate and make the patient more susceptible to arrhythmia. The rise

in epinephrine is “part and parcel” of the opiate withdrawal scenario.

Cooper agreed that hypotension is associated with fentanyl. This condition can

contribute to or cause dysrhythmia.

Dr. Cooper stated in his report,

- -86


Naltrexone administration is a cardinal feature of this particular therapeutic plan, and it has elsewhere been established that opiate receptor blockade - in the presence of opiate receptor agonists - leads to elevation of circulating levels of catecholamines. In my opinion, naltrexone is most likely a significant contributing factor in sudden death occurring during medically supervised opiate withdrawal.

Deputy Attorney General Harper asked Dr. Cooper to explain why this statement does

not mean that, in Mr. Stavola’s case, in which Cooper concluded that death was undoubtedly

connected to the increase in epinephrine levels, that UROD did not have a causal connection to

his demise. The witness explained that the use of naltrexone is “completely nonspecific,” “not

unique to this procedure” and merely a “common denominator,” in that it is a method used to put

patients into opiate withdrawal. He believes that all of five deceased Gooberman patients whose

cases he reviewed, as well as the lady in Phoenix, died as the result of cardiac arrhythmias

caused by excessive catecholamines acting upon heart tissue previously damaged by cocaine

abuse and, in addition, the situations were exacerbated by low serum potassium, a condition

known as hypokalemia. He would not rule out some contribution by naltrexone. He also

testified that there was currently no study or literature to support any conclusion that the

insertion of a naltrexone pellet could cause a new “burst” of catecholamine levels. Again,

“logic” dictates against such a conclusion.

Dr. David Simon testified that G.W. died as the result of aspiration pneumonia, which is

admittedly a potential complication of any anesthetic event. However, Mr. W. died some three

and a half days after undergoing UROD and his vomiting, and the resultant aspiration and

pneumonia was not caused by the anesthesia, but from a problem commonly associated with

substance abusers and alcoholics. The general time frame for looking at an anesthetic

complication is forty-eight hours. If the problem occurs after that time, it is not something

having to do with anesthesia.

Frank Stavola’s death was neither caused by nor contributed to by either UROD or

aftercare. Based upon the information identified by the pathologist, there was physical evidence

of cirrhosis of the liver, indicative of alcohol abuse. Stavola had cardiac fibrosis that could be

secondary to the alcohol abuse. He may have had a cardiomyopathy, an enlargement of the heart

- -87


muscle that also could be due to alcohol abuse. He also may have abused benzodiazepine, as he

had the metabolite of that drug in his system. He was undergoing the stresses related to

withdrawal from opiates, and superimposed thereon may have been undergoing alcohol or

benzodiazepine withdrawal. Withdrawal from either of these is well accepted to be life

threatening in and of itself. A high body temperature, such as 104.5 degrees, is a symptom of

alcohol or benzodiazepine withdrawal.

Commenting on Dr. Karan’s opinion regarding the relationship of fentanyl to the death of

Mr. Stavola, Simon declared that the only relationship that he saw was temporal, as this patient

did not die of a drug overdose, but instead of a heart arrhythmia occurring in association with

physiological stress related to opiate withdrawal. If one were to die of a drug overdose

associated with opiates, one would suffer respiratory depression, but that condition did not occur

here. Also, in Simon’s professional opinion, the pharmacokinetics of fentanyl, that is, the

manner in which it works, and the dosage involved, added to the fact that he had received three

opiate antagonists, are circumstances which indicate that, the patient could not have overdosed

on fentanyl or on any opiate. Indeed, he had a tolerance for opiates, and given the time that the

antagonists were in the bloodstream compared to the amount of opiate that he could have

reasonably had in his system, it simply is not pharmacologically possible that he died of an

opiate overdose.

As for Mark Beigelman, this patient “unequivocally” had biventricular dilatation of the

heart, in itself a very significant cardiac pathology, even if it were not associated with

cardiomegaly. Again, he did not die of a drug overdose, and therefore the fentanyl had no

relationship to the death. The respondents could not reasonably have concluded before the

procedure that he suffered from this disease. The death was therefore not predictable. He went

home and experienced the stress of withdrawal which, given his diseased heart, led to his demise.

This is a logical, if not probable, cause of death.

Simon noted that a pathologist would have to draw any conclusions as to the influence of

fatty infiltration of the heart muscle that could lead to short-circuiting and arrhythmia. The

witness acknowledged that he did not identify dysrhythmia due to cardiac myopathy as the cause

of death, but he is not a pathologist. 27 27 Originally, Dr. Simon attempted to offer a differential diagnosis that Beigelman used morphine after the procedure, perhaps because he felt sick, and this could have triggered a histamine release that could drop his blood

- -88


Dr. Simon’s differential diagnosis in the case of M.J. is that he possibly died as the result

of the stress of withdrawal from benzodiazepine. Simon is convinced to a degree of medical

certainty that UROD neither caused nor contributed to the death. The doctor noted that in his

practice of UROD the “only complication that I have seen.” has been seizure. He believes that in

those instances where seizure has occurred the patient was experiencing a benzodiazepine or

barbiturate withdrawal, superimposed on the opiate withdrawal. M.J. was an admitted abuser of

Xanax, a short-acting benzodiazepine, and his experience fits the description of seizures. While

acknowledging that he is not a pathologist, Simon believes that while the drug was not found at

autopsy, , the presence of the drug would be dependent upon its half-life, and with a short-acting

drug such as Xanax the drug rapidly goes away. In his opinion, when M.J. stopped taking it for

forty-eight hours, he experienced seizures due to withdrawal from the benzodiazepine. Indeed,

he recalls that cocaine was found in the blood, and as cocaine lowers the threshold for seizures, it

makes them more likely to occur.

Lester Kindig also may have died as the result of a benzodiazepine withdrawal or a

histamine release superimposed on the opiate withdrawal. His history reported that he took

Valium and restoril, each a benzodiazepine. Metabolites of Valium, or diazepam, were

discovered in his blood on toxicologic examination. No better explanation of the reason for

Kindig’s death is apparent.

While Simon cannot state to a reasonable degree of medical certainty what exact process

caused the demise of Lisa Flowers, he can say that, to a reasonable degree of medical certainty,

the UROD procedure neither caused nor contributed to her death. The pathologist stated that a

myocardial infarction occurred. It is noteworthy that she had bilateral consolidation of the lungs,

and this suggests that she may have had an aspiration pneumonitis or pneumonia. She also had

metabolites of benzodiazepine in her blood, although she did not have any benzodiazepine itself.

She also had received sandostatin at home, and might have had an idiosyncratic drug reaction

thereto. This drug can cause a decrease in the heart rate. Simon cannot say whether Ms. Flowers

should have had a less “invasive” form of detoxification, but he has no problem with the use of

pressure and bring on an arrhythmia, even though an opiate blocker would prevent the morphine from working. He suggested that perhaps a loved one had supplied the drug. However, later in his testimony, Dr. Simon advised that in presenting this alternative theory he had confused Beigelman with Kindig, and that it was Kindig who might have taken the morphine, not Beigelman.

- -89


UROD to detoxify newly addicted persons; indeed, these are the safest patients upon which to

perform the procedure.

Without the hospital records regarding Victor Melendez,28 Dr. Simon cannot formulate an

opinion as to the actual cause of death. However, the extended time between discharge and

death is a significant factor in the doctor’s analysis that the UROD procedure did not cause or

contribute to his demise. The stress of opiate withdrawal was a key factor, associated with

underlying medical pathology. Melendez had a high methadone concentration in his blood. The

autopsy report states that on admission to the hospital Melendez had a fever of 104.3 degrees,

which “definitely” could be a sign of withdrawal from alcohol or benzodiazepine. In addition,

the autopsy found disseminated intravascular coagulation, which means that the blood clotting

mechanism had gone awry, and Melendez was hemorrhaging “from everywhere.” This can

signify that he suffered a seizure, which can bring on such a condition. In addition, seizures can

bring on the persistent tachycardia, hypertension and episodic bradycardia/electromechanical

disassociation and ventricular dysrhythmias that are noted on the autopsy report. Evidence of

end-stage alcoholic liver disease is also noted, suggesting that alcohol withdrawal is more likely

than withdrawal from benzodiazepine. The evidence of interstitial fibrosis, which is only

identifiable on microscopic examination, and of other evidences of small vessel disease, indicate

that Melendez had small blood vessels coming off the major coronary arteries that were almost

totally occluded. These findings are “very abnormal” for a thirty year old man and therefore are

very significant. The condition of the liver is a classic indication of a person who had

chronically abused that organ.

In Simon’s opinion, Mr. Melendez was a person who, because of the conditions affecting

him, could not withstand the stresses of withdrawal, such as the hormonal increase. His heart

“couldn’t withstand that stress.” The alcohol withdrawal would be the more significant event, as

it “most likely was responsible for the seizures.”

Samuel Perez was found to have an ejection fraction of 20%.29 A normal ejection

fraction might be 50 to 60%. Thus, Perez had a very low fraction, one that Simon characterized 28 The parties stipulated that all attempts to obtain Mr. Melendez’ hospital records from Montefiore Hospital in New York were unsuccessful and there is no mention in any expert reports about his case that suggests that those records were examined by any of the experts. 29 An “ejection fraction” refers to the ability of the person’s heart to contract and expel blood out through one of the chambers. The “fraction” is the percentage of the blood that is in the chamber when the heart is relaxed and then contracts, and after the contraction, some of the blood remains in the chamber.

- -90


as indicating very significant heart disease. The care provided to Perez by the respondents met

the standard of care. Transfer of the patient to the hospital was appropriate.

Simon opined that the respondents did not violate the standard of care in Christopher

Hendrix’s case. He appears to have experienced an aspiration pneumonitis. This is a known

complication associated with substance abusers and anesthesia. Again, with reference to his own

experience described above, there is also evidence in this case of benzodiazepine intake and

alcohol abuse, and the description of Hendrix’ shaking is consistent with the possibility of

withdrawal from these substances. Further, the hospital notes reflect that he was caught self-

administering Xanax, and as a result, he was asked to leave the hospital. This instance of self-

administration bolsters Simon’s opinion that Hendrix was a regular user of benzodiazepine and

as such, he would go so far as to hold the opinion to a reasonable degree of medical certainty that

Hendrix was “most likely” undergoing withdrawal from the benzodiazepine, which may have

precipitated the aspiration.

Critical Care Nurse Jennifer Richards testified that she was on call and received more

than one telephone call from Anthony Reggio, who in his first call at about 1:00 or 2:00 p.m.

advised her that Lisa Flowers, trying to make herself feel better, had “done twenty bags” of

heroin. Richards told him to tell Lisa to stop, that the heroin would not make her feel better. He

also instructed Anthony that if Lisa experienced trouble breathing he should call 911. Ms.

Richards then spoke to Dr. Gooberman, but she does not believe that she made any note about

this call from Anthony and cannot recall why she did not, although it was probably because she

was so busy. Richards believed that a majority of UROD patients tried to use heroin after the

procedure, indeed many told her that they had. She did not chart such information.

Dr. Bunyad Haider reviewed the records of decedents Stavola, Kindig, M.J., Beigelman,

Melendez and Flowers and Dr. Cooper’s report. His concentration was on the cardiovascular

aspects and their relationship to the adverse outcomes. He considered any cardiac abnormalities,

whether these existed before death, and the causal relationship, if any, of the abnormalities to the

death of the patients.

Dr. Haider divided the six decedents into two groups: Group A consisted of Beigelman,

Stavola and M.J. In his opinion, based upon the autopsies of these individuals, they did not have

- -91


any preexisting clinical, functional or structural cardiac abnormalities. Group B consisted of

Kindig, Melendez and Flowers, each of whom had such abnormalities, mostly of a structural

nature, although he could not ascertain whether and to what extent these abnormalities may have

caused clinical/functional impairments.

Mark Beigelman’s heart weighed 400 grams. Opining that the normal range for a male

was between 325 ±75 grams, Haider classified a heart of this size as in the upper range of

normalcy. He had cardiac thickening of the left ventricular wall. This finding appears in persons

who have hypertension and are subject to cardiac disease. If the left ventricle’s muscle is

thickened beyond normal limits it is considered abnormal, and indeed, he characterized the

importance that that muscle remain in the range of normalcy as “very critical.” The average

range is 0.8 to 1.5 centimeters. Beigelman’s measured at 1.5, the upper range of normal.

Stavola’s 350-gram heart had a ventricular wall thickness of 1.4 centimeters. M.J.’s heart

weighed 400 grams, but there is no finding as to the thickness of the ventricular wall. In

Haider’s opinion, none of these three decedents had cardiomegaly/hypertrophy. In addition, he

opined that in the case of these three, there was no relationship between any preexisting cardiac

disease and their eventual deaths.

Haider disagreed with Dr. Cooper, who claimed that M.J. had hypertensive

cardiomyopathy. He also disagreed with Cooper’s opinion that Group A member Beigelman had

this condition. In Haider’s opinion, M.J. did not have either cardiomegaly or hypertensive

cardiomyopathy.

As for Mr. Stavola, while Cooper concluded that his death resulted from cardiac

dysrhythmia due to opiate withdrawal, Haider, while agreeing that “obviously” the adverse

outcome resulted from the withdrawal, disputed that preexisting cardiac disease was related to

Stavola’s demise. He did agree that a person who had no underlying structural, functional, or

clinical cardiac disease and who went through opiate withdrawal could experience a cardiac

dysrhythmia even without the presence of such preexisting cardiac conditions. Therefore, in

Stavola’s case, even though Haider was unable to detect any cardiac disease, it was nevertheless

possible that he did have a cardiac dysrhythmia.

- -92


Turning to Group B, Mr. Kindig did have an enlarged heart of 460 grams and

cardiomegaly. An overweight heart is considered a diseased heart. The condition is usually the

result of sustained high blood pressure and, indeed, Kindig had a history of hypertension. As for

Dr. Cooper’s conclusion that he died of a cardiac dysrhythmia due to hypertensive

cardiomyopathy, Haider characterized this opinion as “speculative.”

The range of normalcy for a female’s heart is 275±75 grams.30 The most striking finding

in regard to Ms. Flower’s heart was a contraction band necrosis and evidence of acute

inflammatory process. This was a damaged heart muscle. The inflammatory process means that

there are cells in the heart muscle that result from some acute process in the heart and this

occurred in the absence of any obstruction or narrowing of the coronary arteries. There was

evidence of damage to the myocardial cells, or acute myocardial infarction, despite the absence

of such blockage, which usually is the cause of most heart attacks. Some areas of hemorrhaging

were present as well, which is consistent with an acute injury to the heart muscle. Otherwise,

there was no evidence of any other significant cardiac abnormalities or disease is this twenty

year old. Dr. Haider agreed that she died of an acute myocardial infarction due to opiate

withdrawal, as Dr. Cooper had stated in his report. The withdrawal “clearly played a role in the

eventual outcome.” The other findings about her condition indicate that she might have

eventually suffered such an infarction anyway.

Victor Melendez’s heart weighed 450 grams. The left ventricular wall thickness was 1.8

centimeters. Each measurement was beyond normal limits. In addition to the left ventricular

hypertrophy, he also had some interstitial and perivascular fibrosis and some occluded small

vessels. Melendez did not have a history of hypertension and there are many other causes for

these cardiac abnormalities. He did not report any history of alcohol intake to the respondents.

A good internist would order an EKG for a thirty-year-old patient prior to most procedures,

although he could not speak to what a general practitioner might do. He opined that where a

patient was being placed under general anesthesia, it “makes no sense not to do an EKG.”

Haider explained that hearts that exhibit these abnormalities are at high risk for

arrhythmias. However,

30 The doctor accepted this statement as reported in Hurst, The Heart, at page 59. Dr. Haider referred to the text as the “Bible” in cardiology.

- -93


. . . based on the fact that none of these patients had any functional impairment based on the clinical evaluation, I don’t think that that was the primary cause of these patients’ deaths. Although, I must emphasize, that the presence of cardiomegaly does place anyone at somewhat of a high risk for arrhythmias but not the sole cause of adverse outcome that these patients suffered within a few hours of this procedure because, again, this cardiomegaly is preexistent for sometime, although there was no clinical history of any symptoms related to the fact that they had evidence of functional impairment; meaning, symptoms related to the heart disease. So a cardiac finding by itself would not be enough--sufficient to establish a causal relationship between this heart, which is abnormal, and the arrhythmias and the deaths.

In his report, Dr. Haider opined that the deaths under review were temporally related and

attributable to the UROD procedure and were potentially preventable complications that could

have been detected early and managed in a controlled hospital setting. In his testimony, the

doctor carefully defined a procedure related mortality as one in which the complications are

temporally related to the procedure. “After the patient walks into the doctor’s office and after

the procedure, died within hours. So, that we call procedure related, if it is within the

meaningful period after the procedure.” However, there is no connotation of causation in this

term. The six deaths he examined were procedure related, and this is so not only because of the

temporal relationship, but also because, in addition to the obvious temporal relationship, the

decedents “suffered respiratory and cardiac depression following the procedures, which, in my

opinion, I put down here, related to the multiple drug effects.”

Elaborating on this last point during cross-examination, the witness noted that naloxone,

naltrexone and ketamine, the later an anesthetic drug, all have a known cardio-depressant impact.

These drugs, and the effects they produce, when combined with the effects of withdrawal,

especially the hormonal surge, caused the “initial insult which eventually led to arrhythmia.”

Haider could not ascribe a degree of importance to the part played by each drug or effect;

however, in combination they did contribute to the adverse impact. In regard to the anesthetic

drugs, “general anesthesia itself poses a degree of stress which you would not have in patients

that are being treated without general anesthesia.” Just by itself, this stress results in a release of

catecholamines.

- -94


Dr. Haider opined that the deaths of the Group A patients were caused by or contributed

to by the UROD procedure. He does not believe that, absent their undergoing the UROD

procedure, these people would have died when they did. The procedure was performed under

general anesthesia and is then associated with opiate withdrawal. The withdrawal then continued

after the patient emerged from the anesthesia. The withdrawal symptoms are caused by multiple

factors.

That is partly because of the drug effect, blunted hypoxic drive, patient after anesthesia not able--to able to respond to low oxygen. In addition, there is the catecholamine surge and “also the effects of multiple drugs in the system which is a result of the anesthetic agents that the patients were exposed to and plus the drugs that the patients were addicted to in the past. Multiaspects of this can cause significant depression of the cardiac and respiratory function, which some of these patients exhibited.

These breathing problems could lead to hypoxemia, which is low oxygen in the blood,

which may not have been detected or managed, and could then lead to a further depression of the

cardiopulmonary system and eventually arrhythmia and death. These factors, added to the

preexisting heart diseases by the UROD procedure, enhance the risk of fatal arrhythmias. “One

can postulate that these factors are responsible for determining the arrhythmias in these patients.”

He noted that the problems he identified, the hypoxemia, cardiopulmonary depression and

arrhythmias, could have been detected and managed in the post-procedure period.

The same answer applies to the Group B patients. Their structural abnormalities placed

them at high risk for adverse events such as arrhythmias. The abnormalities exhibited by the

Group B patients were medically detectable during the period of 1995-99. A 12-lead EKG could

have detected them. However, he conceded that some patients with cardiomegaly cannot be

diagnosed by this device.31 An echocardiogram, which is more sophisticated, could detect these

also.

The UROD procedure poses special risks to patients with cardiac related conditions.

Cocaine can cause spasm of the coronary artery and produce myocardial infarction, or ischemia,

a decreased blood flow to the heart muscle without infarction, and can also cause cardiac

arrhythmia. Heroin can cause problems that lead to pulmonary edema and cardiac abnormalities. 31 Where the patient is very obese or has lung disease.

- -95


Together, these drugs can lead to cardio-depressive effects, which can lead to arrhythmias and

death. A physician possessing average skill and competence should have known of these risks

and the need for heightened care and caution. In the pre-screening, a physician of such average

competence should have identified those prospective patients with high, moderate or low risk

and a risk/benefit ratio must then have been applied to determine whether what one intended to

do to the patient would “harm the patient or get the patient better.” The “key to the entire

situation” is the pre-procedure assessment.

Appropriate post-procedure monitoring requires close monitoring of the heart, lungs and

brain function. This allows detection of early warning signs, which can then be assessed and

managed. “So, failure to detect those early warnings of – associated with those - - in these

situations can result in adverse outcome because it is then related to - - it progresses to a more

downward course, and the stage comes where it’s irreversible.”

Dr. Haider agreed that cardiac catheterizations are very invasive procedures. These

“routine” procedures have a mortality rate of .001% and the patient is generally discharged the

same day. A complication of bleeding from the site can occur, but the rate of such complications

is “extremely low.” Patients are retained for about six hours.

Haider acknowledged that Mark Beigelman had cocaine metabolites in his system at

autopsy. Nevertheless, he opined that it did not appear that the amount found reflected a large

dose of the drug. While cocaine could in and of itself cause ischemia and arrhythmia and is toxic

to the heart, he believed that these outcomes were usually the result of “unusually large doses”

and generally such cocaine-induced arrhythmias occur shortly after use of a large dose. He

disagreed with Dr. Ragasa’s assessment in the autopsy report that Beigelman had cardiomegaly

and that his 400-gram heart was large. He noted that while Beigelman weighed only 170

pounds, he was 6 feet tall. He also disputed that there was actually any biventricular dilatation.

While the autopsy report mentions it, there is “no data to support that,” as no dimensions are

provided and the doctor “eyeball[ed] it.” The heart will dilate terminally, “depending on how far

resuscitated the patient, CPR, so on, the heart sometimes arrests in a state of dilatation.” It is

therefore a non-specific finding and a person who in life did not have biventricular dilation could

have, in death, a heart that is dilated. There is no way to tell post-mortem whether the decedent

- -96


had the condition while alive. However, in life the condition could be detected by

echocardiogram.

Dr. Haider summed up his position regarding the factors that caused these deaths thusly:

Again, as I mentioned before, it’s a combination of factors. Anesthesia played a role clearly and drugs on board and the response of the body to withdrawal as manifested by, as I mentioned before, the release of catecholamines in a person who had just gone through withdrawal and had significant degree of respiratory and CNS alteration. So, that combination certainly together are very important, and that’s what I’m trying to allude to and that is the phase post anesthesia before discharge.

. . .

Before discharge that needs to be monitored and after discharge, clearly, these aspects of individual patients became worse clearly and which got into a state that there was a downhill course and the patient died.

Dr. Katz prepared a report after reviewing the autopsy reports and at least two opinions

from experts, as well as articles, including his own, published in the New England Journal of

Medicine, titled “Cardiovascular Complications of Cocaine Use.” He has treated persons

addicted to opiate drugs, also about a hundred cocaine addicts, and a couple of hundred heroin

addicts, in addition to alcohol dependent persons. These persons are often multi-addicted. In

addition, he understands that many of the respondents’ patients were polysubstance abusers.

Dr. Katz explained the long-term effects of heroin abuse on the cardiac system and the

growing body of knowledge about the electrophysiology affecting the heart. Among the impacts

of heroin use over the long term can be fibrosis, which is the development of scarring on the

myocardium. Whenever there is scarring, there is a potential for malignant arrhythmias to occur

and, while the bigger the scar the more likely it is that such arrhythmias will occur, there can be

arrhythmias even when there is minuscule scarring.32

The doctor commented that M.J. was an intravenous heroin user who also used cocaine.

He had a stroke in 1996, purportedly caused by “bad drugs.” The physical and history workup 32 The doctor referred to a patient, a physician, who had an arrhythmia despite scarring that was “as small as you can get.”

- -97


was adequate and up to the standard of care in medicine. The cause of death is listed as

hypertensive cardiomyopathy. There was no evidence of coronary artery disease. There were

signs of flattening of the trabeculae, that is, “like bands of muscle that line both ventricles.” To

Katz, this is a sign that the heart had sustained some damage. The reasons for such damage are

myriad, but it could possibly be the result of hypertension, although the doctor did not have

enough data to so conclude. The condition could also result from drug use, bacteria, or virus.

The complications that can result from these findings commonly include arrhythmia, which

results from pressure that develops and backs up throughout the left atrium down into the lungs

to the right side of the heart.

Lester Kindig had a history of hypertension, but was not on any medication for that

condition. He had undergone a rapid detoxification in London in 1996. His heart weight was

high. His death was labeled a hypertensive cardiomyopathy, but Katz finds the evidence of that

“vague.” Kindig would have been more prone to cardiac arrhythmia.

Lisa Flowers had a contraction band. The micro hemorrhaging that was discovered is

seen in cases of cocaine and heroin abusers, but adrenalin response can also cause it.

Contraction band irregularities could easily cause electrical problems and arrhythmias.

Mark Beigelman had a heart weighing in at the upper limits of normal. He also had heart

chamber dilatation and thickening of the heart muscle walls. Generally, the cause of this

condition is unknown, although it can be caused by high blood pressure, toxins or the narrowing

of the aortic valve. In such cases where the muscles do not work synchronously, the heart has to

work harder and this can cause thickening. Under stress, these cardiac problems could lead to

arrhythmia.

Dr. Katz found it is hard to come up with a cardiac related cause of death for Frank

Stavola, other than one caused by the impact of norepinephrine.

Dr. Katz could not rule out the impact of the withdrawal process as a factor affecting

these patients. However, he “certainly think(s) most of these changes appear to be chronic

flattening of the trabecula, the glistening, thickness doesn’t occur overnight. It occurs over a

period of time.” He could not rule out the possibility that the UROD procedure played some role

- -98


in the abnormalities found, yet he could not pinpoint what drug used in UROD caused the

abnormalities, or what about the procedure did so. Reviewing the drugs used in UROD, he

identified propofol and fentanyl as drugs used in cardioversions; these are drugs that are fairly

safe even for persons with cardiac problems. Any drug can have a side effect, but these have

been found to be “probably safer than other groups of drugs” that surgeons and anesthesiologists

could have used. Ketamine and versed, which is a “fancy form of valium,” are also used by

cardiac surgeons and anesthesiologists.

The cardiac abnormalities that were found in these decedents would “probably not” be

detectable from a history and physical examination. They also would not likely produce any

information on a history and physical that would indicate the need for additional studies. An

echocardiogram might show thickening, an EKG or echocardiogram “possibly” would disclose

an enlarged, overweight heart. Had these abnormalities been revealed in some manner they

should not have led to a decision not to do the UROD, unless they were “very severe.” More

heart damage would result if the procedure was not performed and the prospective recipient

continued to use toxic drugs.

Left ventricular hypertrophy is mild if the thickness of the wall is in the range of 1.5,

even at 1.8. Such readings “wouldn’t . . . terribly upset” the witness. Except for Ms. Flowers,

Katz saw nothing about any of the other decedents’ conditions that would suggest that, absent the

UROD procedure being performed upon them, they had anything other than a normal risk of

death due to their cardiac conditions. None presented any indication of congestive heart failure,

and the damage to the hearts indicated by the flattening is cardiologically insignificant, although

there might be “all kinds of rhythm problems.” However, he agreed, “we can only assume that

perhaps there was an arrhythmia as opposed to a total cessation of the heart.”

The abnormalities exhibited at autopsy by Stavola, Kindig and M.J., while perhaps

indicative of some significant issues, were nevertheless not such as to suggest that they would

have died from these cardiac issues at the times that they in fact expired. In Flowers’ case,

something acute is clearly indicated by the autopsy findings, and it is likely that that acute

occurrence happened within the twenty-four hours before death, in fact, his “educated guess”

would be that it happened within the last six to twelve hours. While the probability is that she

- -99


too would not have died when she did absent the UROD, it is “more probable” that she would

have than it is that the other decedents would have died when they did.33

Dr. Katz disagrees with Dr. Cooper’s opinion that M.J. died of hypertensive

cardiomyopathy. As for Beigelman, he does not totally disagree with Cooper’s assertion that he

too died of hypertensive cardiomyopathy. Katz testified that Beigelman might have had some

evidence of that condition, although in his written report he denied that he saw any such

evidence. In fact, he had some mild dilatation of both ventricles and might have had a mild form

of hypertensive cardiomyopathy, as well as the right ventricular dilatation. He acknowledged

that he was “waffling on the cause. I’m not sure that he did or did not have it.” In his

laboratory, a 1.7-centimeter reading for wall thickness would be referred to as hypertensive. He

could not give a direct linkup between this mild hypertensive myopathy and death, given that

“anybody who goes through a withdrawal long-term without medications or short-term has a

possibility of dying.” The witness found it “difficult to discern whether or not hypertensive

cardiomyopathy was present” in Kindig’s case.

In Stavola’s case, Katz would “have to say that cardiac dysrhythmia” was the cause of

death, although there were no findings at autopsy or otherwise to indicate that such a

dysrhythmia occurred. In the withdrawal setting, with the adrenalin rush that occurs, a person

with any damage to the heart muscle is at higher risk than is the average withdrawal patient. He

added, “but the average withdrawal patient certainly doesn’t have a zero mortality.” This

determination is not based upon any objective medical fact in Stavola’s history, but on the

doctor’s analysis of surrounding factors and his best medical judgment.

Dr. Katz acknowledged that in all of the cases, except Ms. Flowers, the pathologists

involved in the autopsy did not assign the cause of death as cardiac related. However, he offered

that these were patients who came in with abnormal myocardials and, while he cannot give a yes

or no answer as to whether the patient class served by the respondents were such that it was

foreseeable that they would present with such abnormalities, he suspects that they would,

although he was not sure of the percentage. He also would think that it would and should be

foreseeable that in a class of polysubstance abusers there would be cardiac problems. In

addition, he agreed that any of the drugs involved in the procedure, including the anesthetic 33 Dr. Katz has seen about fifteen to twenty persons of about twenty years of age who have had heart attacks; two of these were cocaine abusers who may have suffered vasospasms.

- -100


drugs, “have a certain propensity to aggravate arrhythmia,” by which, according to his testimony,

he means a “minor” “inclination of tendency.” Finally, he agreed that in the cases of Beigelman,

Stavola, Kindig and Flowers, each was found to have in their system at autopsy drugs such as

morphine, methadone, cocaine, or heroin that can pose a cardiac risk.

Pulmonary edema can occur from drugs such as heroin, although this is not a cardiac

pulmonary edema, but one caused when the oxygen level falls and the carbon dioxide level rises,

causing a “vicious cycle.” It can happen in one to two hours, or even as much as twenty-four

hours, after use. After that time it is not common, but he could not rule out such a later

occurrence of the condition. If one underwent UROD, heroin used shortly after the procedure

should be blocked by the naltrexone, if that drug in fact is blocking all of the receptor sites.

However, heroin toxicity might occur and not be fully blocked.

Dr. David Bradway noted that, based upon the information available to them regarding

the seven decedents, the only link that he and Gooberman could find was the temporal link. The

occurrence of seven deaths during four years and out of 2,356 procedures was clearly a lower

rate of deaths than the expected mortality rate for heroin users of between 2 and 5% a year.

After each death, the doctors discussed the case, and where available, reviewed the toxicology

reports, which were often only available to them four, six or eight weeks after the death. As for

patients in general, nurses made follow-up telephone calls to them every day for the first week,

every other day the second week, then biweekly, monthly or every six months. Given the

expected rate of mortality for this population of addicts, the respondents concluded that it was

possible that these seven deaths could “just have happened, or in other words, could have

occurred randomly.” There was no link to anesthesia, as the propofol was out of the patients’

systems within one hour. The literature was not helpful in attempting to understand the causes of

the deaths.

Dr. Lance Gooberman testified that he performed the UROD on G.W. Mr. W. was one

of the “early” cases treated by Gooberman. Mr. W. had an objection to the “photo” section on

the Consent Form and it was redacted in accordance with his wishes. A caretaker who identified

herself to Gooberman as Mr. W.’s “mate” was present.

- -101


Gooberman confirmed that neither on the written consent form nor in the oral review

thereof was death mentioned as a possible risk, as at that time in 1995, Gooberman did not think

of death as a possibility, nor did anyone else with whom he had spoken about the procedure.

G.W. “woke up slow” and was “very lethargic.” 34 He experienced some post-procedure

vomiting with blood therein, but, given the use of tubing, this was expected. While medications

were given for the vomiting, it did not abate as quickly as the doctor had hoped. As Gooberman

was “a little more guarded back then,” he requested that the caretaker take W. to a hotel room

and he paid for the stay. It happened that this procedure was performed on the weekend that Dr.

Colin Brewer was visiting from London and Brewer and Gooberman both went to the motel to

see W. W. was not very animated, was “just laying there,” and, according to his caretaker, was

still vomiting, although Gooberman did not see this occurring. His lungs were clear and the

doctor determined that W. was “responsive,” “arousable, but he wasn’t real participatory.” The

patient was given two injections to decrease the vomiting.

Gooberman thinks that he later returned by himself to check on W. He found W.

essentially unchanged, and, according to his note prepared on October 17, 1995, W. was resting

comfortably. The lungs were still clear.

The next morning Dr. Brewer and a member of Gooberman’s staff stopped by and this

time found W. “somewhat improved.” Gooberman then saw W. later that day and he was more

responsive. He appeared to be more alive, “coming out of it.” Further telephone conversations

with the caretaker indicated that he had begun to take fluids and was able to keep them down.

He last saw W. at the hotel on a Sunday morning at 7:00 a.m., forty-eight hours after W. had

arrived for his UROD. He was communicative and was taking fluids, his lungs were clear, and

he was lethargic. When he then spoke to the caretaker on Sunday afternoon she reported that

they were checking out to return to Pottstown, Pennsylvania. She reported that he was doing

better, occasionally breathing rapidly (a breathing pattern sometimes seen with naltrexone).

There was no evidence of fever and as far as he can recall, no indication that he was continuing

to vomit.

34 Parenthetically, this was also the weekend when “Joe,” the patient in the video played at hearing, was treated. He and G.W. were treated at about the same time and, in recalling W.’s “lethargic” state, Gooberman noted, “He did not wake up like Joe.”

- -102


Following many attempts to make further contact with the caretaker or W., on October 16

a staff person was told by the caretaker that W. had died and that the office should not call

anymore. Gooberman was stunned and called back. He was told that W. had died of a cardiac

arrest and had also developed pneumonia. The reason for death reported by W.’s caretaker did

not make sense to Gooberman, and he reported the possibility that someone who had had

undergone UROD had died to the Board of Medical Examiners and provided the Board with the

chart. The cause of death listed for W. is acute necrotizing pneumonia, an inflammatory

bacterial infection that destroyed lung tissue. Depending on the stage, symptoms of this illness

would be primarily a cough, shortness of breath and fever. The time in which this condition

would develop would depend in part on the ability of the patient to fight off the infection and it is

hard to estimate how long it would take pneumonia to develop. When he examined W. at the

motel, Gooberman had specifically been concerned about the possibility of aspiration

pneumonia, but he had discovered no signs of an infection and heard no “rales,” which is a

characteristic sound that could signal fluid in the small airways. However, in the early stages the

infection might not be detectable. The doctor drew a distinction between “chemical” aspirative

pneumonia, which he said was more likely if the aspirated material was vomitus, and “bacterial”

aspirative pneumonia, more likely caused by saliva and bacteria contained normally within the

mouth that get down into the lungs.

Reviewing the drugs listed in the toxicological report, Gooberman noted that he did not

prescribe any benzodiazepines for W., and yet diazepam (valium), nordazepam (a product of the

breakdown of valium) and Temazepam (Restoril) were found in his system. These are all

sedative type drugs and could affect W.’s ability to wake up and could exacerbate his lethargy,

situations which could make aspiration pneumonia a more likely occurrence. It appears that W.

took these drugs either before or after UROD. There are several possibilities regarding the

development of this aspiration pneumonia, which ultimately caused the death some thirty-six

hours after he last saw Mr. W:

(1) W. was somewhat dehydrated. He came in for UROD without having eaten or drank enough. He was hydrated during the procedure, but he then was nauseous and vomited, leaving him dry, a condition in which it is harder to hear lung consolidation or rales. It is possible that an x-ray would not have shown any problem, as it is always heard before it is seen on an x-ray. Thus, when he

- -103


examined W., he might have missed the pneumonia due to the dryness;

(2) the pneumonia was not there when he examined W. It was a virulent strain that developed after he last saw the patient;

(3) despite the fact that he was looking for signs of pneumonia, Dr. Gooberman simply missed the signs. Indeed, this also means that Dr. Brewer, who was also looking for it and listened to W.’s lungs, missed the signs as well.

Dr. Gooberman also treated Frank Stavola. Stavola had “been through the wars,” that is,

he admitted to a fifteen bag a day heroin habit and, while he did not tell Gooberman during their

meeting, he told the staff during his initial interview that he had used cocaine. Gooberman

learned of his death later that night. A CRNA was making follow-up telephone calls from

Gooberman’s house where there was a staff Christmas party taking place and he told the doctor

that the paramedics had gone to the motel because Stavola had gotten up and collapsed. On

March 13, Gooberman received a verbal report of the toxicological report. It showed the

presence of cocaine metabolites and Gooberman believes that Stavola probably tried to make

himself feel better by using cocaine. He also had some interstitial fibrosis. This heart disease is

not unusual in people who use cocaine. The stress of withdrawal could have caused an

arrhythmia, especially if there was any degree of cardiomyopathy.

Gooberman believes that Stavola was one of a group of 515 patients who were given a

fentanyl challenge before they left the office to make sure that the naltrexone pellet was working.

Due to the information available to him after Stavola’s death and during 1997, Gooberman

believed that his death had resulted from cocaine use.

Mr. Beigelman’s UROD was performed by Dr. Bradway, but Gooberman went over the

caretaker instructions with his parents, assisted by another patient or a caretaker who happened

to be there and spoke Russian. The doctor felt satisfied that they could adequately take care of

their son.

A call from Garden State Hospital later advised Gooberman of Beigelman’s demise. It

seemed that he had died a “sudden death,” as at the hospital his mother said to Gooberman that

her son had “just started gurgling.” He later learned that there was evidence of cocaine in the

- -104


system and he believed that this death, like Stavola’s, was attributable to cocaine use. With the

information he later learned of, the possibility of an arrhythmia must be acknowledged, with the

stress of withdrawal potentially impacting on abnormalities indicative of heart disease.

According to Dr. Ragasa, Beigelman had an enlarged heart.35 Ordinary and prudent medical

examinations and the history and physical did not give any indication of this problem.

Additional testing would probably not have led to the discovery of this problem. Even an

echocardiogram might not appreciate the existence of an enlargement in a heart of 400 grams.

Dilatation was not that gross as to be picked up either, even by echocardiogram. Further, as his

cardiac consultant group told him, these conditions are not in and of themselves necessarily

contraindications for UROD. No reasonable person would do a cardiac catheterization or test

pulmonary artery pressure as a pre-screening device, as these carry their own additional risks.

Neither the standard of care with regard to addiction medicine nor for the performance of UROD

required that these additional tests be performed. Indeed, the stresses would be the same for

other forms of detoxification and withdrawal brought about thereby, and in the case of UROD,

by the time the patients had emerged from anesthesia they had been through the worst stresses of

the withdrawal.

Beigelman’s death, understood to be the second cocaine-related death, caused

Gooberman to enact procedures to try and limit cocaine use, by telling patients up front, when

they first called and again when they came in for and were instructed about the procedure, that it

was very important that they not use cocaine. However, he did not employ the dipstick test when

it became available because he believed that it was an unreliable indicator of recent cocaine use.

Prospective patients were also turned away if they had used cocaine before the procedure,

despite the fact that its half-life is such that pre-procedure use really was not a contra-indicator

for UROD.

Dr. Bradway performed UROD on M.J. The records concerning his death confirm

hypertrophy (400-gram heart) and ventricular dilatation. Gooberman believes that the death

resulted from cardiomyopathy and the stress of withdrawal on this heart. M.J. was a past abuser

of cocaine and had experienced a previous CVA. There was no evidence of fluid overload.

Indeed, to the contrary, he had to be turned upside down to fill his blood vessels when he arrived

and his lungs were dry, without rales. He received only about 1,500 cc’s of fluid and this was

35 During testimony, Gooberman identified a man’s heart of less than 350 grams as “normal.”

- -105


perhaps a bit low for him. He went to the bathroom twice. All this points to the absence of such

an overload. The family never suggested any shortness of breath.

Lester Kindig’s death was indicative of hypertensive cardiomyopathy, an enlarged heart

of 460 grams going through the stresses of withdrawal. He had alcohol in his blood, but

Gooberman had not provided him with any. Based upon computations, it does not appear likely

that the bottle of beer Kindig drank before the procedure (as per his caretaker) would have

resulted in the blood alcohol reading found, as had he had enough before to lead to that result it

would have been noticeable to Dr. Bradway and to the doctor or nurse who did the pre-procedure

interview. Gooberman also noted that benzodiazepines were found in his system, which again

had not been provided by Bradway, and there is a possibility that he took benzodiazepines after

the procedure. The report that Kindig was found “the way that he left that night . . . his hands

folded on his chest on top of the covers that was pulled over him” after supposedly “nobody

checked on him” was suspicious. In Gooberman’s experience, after having observed “literally

hundreds or thousands of patients go through withdrawal and none of them lay still . . . My

experience is they never have covers on top of them. They kick them off because they are

kicking the habit. They kick the covers off and more often than not, they don’t even have a sheet

on the mattress because they toss and turn so much that it comes off.”

Based on these factors, Dr. Gooberman concluded to a reasonable degree of medical

certainty that Kindig died from an arrhythmia caused by withdrawal stresses and a very large

heart.

The respondent opined that, to a reasonable degree of medical certainty, the cause of Lisa

Flowers’ death was an arrhythmia that occurred in a person undergoing withdrawal and the

accompanying stresses; a person with cardiomyopathy and also possibly a person who used

cocaine post-procedure. Gooberman characterized Flowers’ 300-gram heart as “large,” due to

her small stature, at 5’3, 105 pounds. The toxicology report shows the presence in her system of

free morphine. Gooberman testified that Anthony Reggio, Flower’s caretaker, told Jennifer

Richards, a nurse on his staff, that he had told Flowers that she should not have used “about

twenty bags” of heroin post-procedure. He argued that the presence of the morphine suggested

post-procedure, as opposed to pre-procedure, use of heroin, as in all probability heroin taken pre-

procedure would have metabolized. He posited, as “just a possibility,” that, while the naltrexone

- -106


would have blocked the effect of the heroin, she may have also taken some cocaine, which

metabolized and therefore was not found in the system, but which may have caused a myocardial

infarction. Evidence that she did use cocaine (although not necessarily post-procedure) is that at

twenty years of age she had myocardial fibrosis, which is not a normal finding for someone her

age, except that it does occur in cocaine abusers.

In Gooberman’s opinion, Victor Melendez was a man in the terminal stages of addiction,

an “old guy inside,” with a 450-gram heart and small vessel disease, for which not much can be

done and which is both frequent in diabetics and hard to determine pre-mortem. He also had

multiple ulcers in his stomach; a hemorrhage at the top of the esophagus extended 2/3’s of the

way down to the junction and, upon microscopic analysis of the liver, marked fatty infiltration

that the doctor felt suggested an alcoholic liver of hepatitis C.

The doctor explained that the standard of care is to perform an EKG for a patient over the

age of forty, and not to do so for a person of thirty years of age. It is possible that an

echocardiogram might have shown the enlargement of the heart, but even if it had, this is not

necessarily indicative of a low ventricular output, or ejection fraction, and even such a low

output “would still be only a relative contraindication.” In Gooberman’s opinion, to a reasonable

degree of medical certainty, Melendez was septic when he died and had “quite a bit wrong with

him,” making it hard to “tease out everything that was going on.” However, he had

cardiomyopathy and some degree of withdrawal and this could have precipitated an arrhythmia.

Additional Issues

While the cause(s) of death for the various decedents are a central concern in this case,

another set of issues, admittedly in many ways directly related to possible reasons why patients

did not survive, address the question of whether the respondents, in their practice of UROD,

deviated from the standard of care applicable to their activities. It is important to note that the

experts who addressed these issues did not necessarily agree on what standards were applicable

to UROD. In fact, some suggested that there was no standard of care for the procedure, or at

least was not at the time that the two respondents were providing the procedure. It also is posited

that Dr. Gooberman, as the person either performing or responsible for such a large percentage

of the URODs, was by his own activities establishing, many of the standards. It seems that the

- -107


experts did acknowledge that at the very least, any standards for UROD were evolving over the

period 1995-99, and indeed, to the extent that any future UROD practice occurs, they continue to

evolve. In its particulars, the “standards” issue touches on many of the Complaint’s allegations

of improper and negligent conduct and therefore speaks to such issues as the intake and

screening procedure, the drugs used in UROD, the discharge criteria and practice, aftercare and

post-UROD rehabilitation.

Standard of Care

Dr. Karan testified that that there is a large amount of experience existing in the field of

addiction treatment medicine and a fairly standard set of medical procedures is applicable,

although at the present time there is some notion concerning changes in some of the techniques,

such as the use of methadone and buprenorphine. As for UROD, there are no standards of care

as of yet for ROD or UROD procedures as such, but the absence of a complete set of standards

for ROD “doesn’t mean complete anarchy” exists. There are clearly recognized standards of

care for good medical care and, therefore, there are at least minimum standards that are

applicable to the ROD procedure. Further, as information on this procedure has developed over

the past five or more years, ASAM has developed some standards. Such standards as now exist

are not more restrictive than they were five years ago. Yet, at the same time, as far as the

definition of acceptable standards of care is concerned, it is true that at present ROD is

something of a “moving target,” so that, for instance, while she firmly believes that the absence

of a supervising anesthesiologist is a violation of what the standard should be, the standard is

evolving and changing.

Taking her thoughts on this standards issue into account, Dr. Karan concluded that as

practiced by the respondents, the detoxification element of the UROD procedure deviates from

accepted standards of practice and the standards for the detoxification of opioid dependents.

Dr. Kleber acknowledged that as of 1995 UROD was a “very experimental procedure

with no one set of standards." Different antagonists were used as well as different anesthetics.

There were controversies regarding whether the procedure should be performed under full

anesthesia, or only under sedation. No published standards existed before 1995. Indeed, this

lack of published mandatory standards continued in 1996. The standards were “evolving.”

- -108


Dr. Gevirtz published a case study in the Journal of Addictive Diseases regarding some

123 UROD procedures that he and another physician performed. He acknowledged that UROD

is an evolving procedure; nevertheless, he insisted that there are standards of care applicable to

it. The standards he utilized were taken from the American Society of Anesthesiology (“ASA”).

These standards did not actually address UROD as such, but did address the anesthesia elements

of the procedure.

Dr. Smith first learned of UROD in the early 1990’s. Dr. Gooberman, who Dr. Smith

characterized as an important member of ASAM, would make presentations about the procedure.

In addiction medicine, Dr. Herbert Kleber was doing “more experimental” work at Yale. The

process was evolving.

As a practitioner of addiction medicine, Dr. Smith was interested in ways to treat the

disease. Detoxification is not treatment of the disease. However, Dr. Smith had been looking at

naltrexone as a possible drug of interest in the treatment of opiate addiction since the 1970’s. In

considering the possibility of implantation of this drug in opiate users, the question that had to be

answered was, why do it? However, while there were questions to be answered, nevertheless, he

characterized the implantation of naltrexone as a treatment modality.

At the request of former counsel for Dr. Gooberman, the witness prepared a report in

which he reviewed the series of allegations made in the Attorney General’s Complaint. In

connection with the analysis of their practice and its conformity to such standards of care, Dr.

Smith cautioned against judging the respondents based upon a standard of care that did not exist

when they were treating patients. Instead, as the ASAM Policy Statement No. 9 notes, they must

be judged “based upon the science and practice of addiction medicine relevant at the time.” The

ASAM Statement emphasizes that the methods of opioid detoxification that are available in a

given community will evolve over time as biomedical knowledge and treatment research

advances.

Addressing the charge in subparagraph two of the Complaint that, in their practice of

UROD, the respondents have “regularly deviated from accepted standards of medical care which

exist in the medical practices of addiction treatment and anesthesiology,” Dr. David Simon

- -109


explained that while there are central issues of standard of care in this case, “people are talking

about different standards.” He identified four standards of care. The first is that expected in

addiction medicine. The second is that relating to addiction psychiatry, that is, that which would

be expected by Board certified psychiatrists with a specialty Board in addiction psychiatry. The

third standard of care is that for anesthesia, subdivided into that applicable in the operating room

and that applicable in other settings. Finally, there is a fourth standard, that being the standard

applicable in UROD. As to the latter, it is Simon’s position that in the time frame 1995-99 there

was no standard for UROD. There were not many practitioners using the procedure, they were

using different protocols, and in some cases, these protocols were protected as proprietary

information. “Different practitioners were using different methods and most of the practitioners,

for whatever reasons, be they altruistic or selfish, most of them were secretive about what they

were doing.” Indeed, Dr. Gooberman was pioneering the procedure in the United States; he was

setting the standard. There was no previous standard against which he could be judged. Dr.

Gevirtz worked for CITA, an organization which kept its work secret, and therefore, “[H]ow

would we know what the standard was that he used?”

In Dr. Simon’s opinion, Dr. Kleber is really speaking to standards applicable for

addiction psychiatry, and it is not fair to hold these non-psychiatrists to those standards. Neither

of the respondents is a psychiatrist and therefore the standards for addiction psychiatry are not

applicable to them. Addiction psychiatry is only one area of practice dedicated to treating

addicts, and persons such as Simon and the respondents are addiction medicine specialists, not

addiction psychiatrists. Simon does not believe that the respondents deviated from the standards

applicable to addiction specialists. Even as of the time of his testimony, Simon argued that there

is no definitive UROD standard of care; it is evolving. As for anesthesia, the anesthesia

standards applicable to a particular operating room setting are not directly applicable to UROD

procedures conducted in an outpatient setting. However, in his view, there is no deviation from

the ASA standards in the Gooberman/Bradway practice, except perhaps regarding the standard

for monitoring every five minutes, where the respondents apparently monitored every fifteen

minutes (more about this later in this opinion). However, the witness argued that the machinery

used during the procedure can be set to established parameters automatically and can monitor

and sound alarms, recycling on a five, ten or fifteen minute cycle. Thus, it would be acceptable

to set the monitors to meet the continuous monitoring standards.

- -110


Reflecting on Count Two, paragraph 2.I, subparagraph j., which alleges that the

respondents failed “to provide safe and effective procedures and personnel to ensure safe and

effective patient recovery and continuation of appropriate addiction treatment,” Simon testified

that, in his opinion, based upon his knowledge of how drug addicts are treated in communities

across the country, there was no deviation, “from what was done in the many hospitals and

treatment programs.” Further, having reviewed “some of the expert testimony” presented in this

hearing, he opined that

what the experts speak to of the standard, in my opinion, is the gold standard, platinum standard but not the minimally required standard that’s out there. You can get a 2 ½ million dollar grant, spend all that money buys, you can deliver a maximum level standard of care. It’s not reasonably expected of a practitioner in private practice to be able to deliver that same level of standard of care. . . On some of the issues, certainly not all, Dr. Gooberman might not have met the gold standard, but he met the acceptable standard, the standard that’s out there in practice. . . Dr. Gooberman’s practice did not, in any way, deviate from the standard that’s practiced in treating addicted individuals throughout the country in many, many programs.

Dr. Bradway explained that the NIDA report did not lead to any specific changes in Dr.

Gooberman’s protocols. Nevertheless, the two were always seeking to improve the procedure

and give the patients the “best care possible,” and, to the extent that it was appropriate, changes

in the protocols were made to meet individual circumstances. In addition, some general changes

were made in the protocol over the three years. The formulation of the naltrexone pellet

changed, the antagonist utilized changed, the pharmacological regime changed and screening

criteria were changed so that more stress testing and pulmonary function testing was done in the

wake of deaths that were unexplained to the doctors, at least in terms of any objective data to

understand why exactly the deaths had occurred. Because they had some toxicology reports that

implicated cocaine, over time they excluded patients who had taken cocaine within twenty-four

hours of the procedure, and the number of persons denied the procedure increased as the doctors

became more cognizant of heavier users and cross-dependencies. Thus, the doctors’ standard of

care evolved with the implementation of new policies and procedures. As for cocaine use,

Bradway did use the dipstick on occasion when his clinical judgment led him to believe it

- -111


necessary.36 His clinical determination was based in part on his knowledge of addictions and

experience with the addict population.

Discussing the standard of care applicable to the UROD procedures and associated care

he rendered, Dr. Gooberman stated that the standard did not really change over the years 1994

through 1997, as the “basics were still the basics.” There were “nuances in terms of the

practitioners throughout the world and what they thought would be preferential and that was

changing and, I guess, it’s still changing.” He was active in bringing people together to discuss

the issues in a public forum and he reviewed the literature and attended forums. In addition, “I

exposed what I did to scrutiny by my peers at every opportunity.”

Pre-Procedure

Dr. Karan found further deviations from accepted standards of care in regard to a lack of

proper assessment of the patients before UROD and in the medication and follow-up provided.

As for the assessments, a much fuller assessment than that which Drs. Gooberman and Bradway

required was appropriate. The assessment was needed to determine both the indications for and

any contraindications against the use of UROD for the particular patient. In a “regular”

detoxification, a very detailed history of the patient’s addiction is obtained, including the type of

drugs used, the frequency and level of use and the method of administration. A urine drug

screen, a physical assessment, including breath sounds, a breathalyzer examination, a history as

to any delirium, seizures, infectious diseases, underlying medical problems, is also obtained, so

that the physician knows what he or she is dealing with. If done properly, this detailed

assessment takes an hour without any laboratory work, at least a half-hour to an hour and a half

depending on complications. The standard of care for assessing an addicted individual

oftentimes requires a urinalysis. These details are not evident in the records of the respondent

doctors.

While Dr. Karan stated that the failure to obtain a knowledge of the length of drug use

and the possible use of multiple drugs were not, as such, deviations from the standard of care,

nevertheless, her review of records did not reveal that there was enough information obtained

regarding co-morbidity, that is, the use of other drugs. There was an insufficient medical history

36 He recalled that the standard testing for cocaine and other abused drugs became available in 1998 or 1999.

- -112


obtained and a lack of appropriate diagnostic radiology. There is no evidence of any cardiac

workup, which she described as standard practice prior to surgery and the administration of

anesthesia.

The witness commented that, given that the patient’s came for the treatment on one day

and often from a distance, there was a great deal invested in making sure that the entire

assessment and treatment occurred that day.

Dr. Kleber was involved in the formulation of the anesthesia protocol for the Columbia

study, but has not supervised anesthesia use for the past five years. Therefore, the protocol was

prepared with the assistance of a Board Certified anesthesiologist who is an assistant professor of

anesthesia at Columbia. Physical examinations of the study participants are conducted by others.

Cardiologists are used to review EKGs. Internists and anesthesiologists then determine whether

a participant can continue in the study.

Dr. Kleber testified that a doctor must screen potential patients to determine their

suitability for a particular procedure, given the status of the patient and the risks and benefits of

the possible treatment. The exclusion criteria utilized by the respondents did not exclude persons

who had abused cocaine; this in spite of the fact that there is a known relationship between

cocaine use and heart damage and the fact that the stress involved in certain procedures could

lead to a bad outcome if cocaine were in the system. The presence of cocaine in the body during

a UROD procedure may heighten risks. Cocaine is known to sensitize the heart. As UROD is

known to lead to large increases in certain internal hormones and neurotransmitters, such as

cortisol, ACTH and epinephrine, cocaine use should have been considered. Indeed, as Kleber

pointed out, at the September 1999 hearing Dr. Gooberman acknowledged that he believed that

some of the deceased patients had used cocaine after the procedure, yet he did not test before the

procedure despite the warning provided by these deaths. Addicts are desperate people who often

lie and testing is needed to determine is they have in fact used recently, that is, within twelve to

twenty-four hours. In addition, although the consent form does state that cocaine use after the

procedure may kill the patient, evidence that, even after the warning given on the telephone in

initial contact calls, the patient used cocaine increases the risk that the patient will be non-

compliant with this direction after the procedure. The screening procedures did not test for

cocaine use immediately prior to carrying out the UROD procedure. A dipstick test was

- -113


available and only took a few moments to administer. It produces a result that would indicate

whether cocaine was ingested within twenty-four hours of the test. In addition, the history taken

from the patient can also assist in this task. As far as Kleber could determine from the material,

the doctors did not assess the length of use of drugs of abuse by potential UROD patients. In his

opinion, if the length of use was shorter, then less risky detoxification procedures should have

been employed.

The screening did not appear to consider benzodiazepine use in assessing the suitability

of the patient, nor did the exclusion criteria appear to exclude alcohol dependence, which

increased the risks due to possible delirium tremens. The presence or dependency upon other

drugs could complicate withdrawal. As a result, there is a need to know if a potential patient is

dependent upon alcohol and/or sedatives. Dr. Kleber opined that a breathalyzer test was an

appropriate and necessary screening tool.37

Another exclusion criteria is pregnancy, yet the respondents did not do a pregnancy test.

Guidelines adopted by ASAM in 2000 specify that pregnancy testing be done. This testing is

particularly important, as some heroin addicts are well known to experience irregular

menstruation or have stopped menstruating without being pregnant. Additionally, naltrexone is

not approved for use during pregnancy.

A patient affected by serious cardiac problems should also be excluded. Some of these

conditions cannot be detected by means of physical examinations, history and EKG. Once

deaths had occurred following UROD treatment, there was a particular need to screen those with

cardiac changes.

Dr, Gervirtz discussed the protocol that he put into place in 1996. The basic outlines

were those established by CITA in Europe. Prior to undergoing the procedure, a detailed consent

form was used, which was reviewed line-by-line, page-by-page. No candidates received the

procedure on the same day they first came to the site. The candidates had a face-to-face

interview with a Board certified psychologist, who reviewed both medical and addiction history.

Each then had a history and a physical examination for the anesthesia. A Board certified

37 Although the doctor noted in his September 10, 1999, report that dependence on alcohol or benzodiazepines was not listed as an exclusion criteria or even cautioned against in the screening procedure, nevertheless, none of the patients who died exhibited any symptoms of delirium tremens.

- -114


psychiatrist also saw the candidates, in order to determine if they were suitable. Each candidate

had a SMA 7 and SMA 22 test, electrolytes were checked, and a chest x-ray and EKG were

performed. A urine dipstick test was performed on intake and again on the morning of the

detoxification. Not all of the candidates were accepted for the procedure; some being

disqualified due to medical status, based upon findings relating to cardiac, liver or pulmonary

status. Pre-anesthesia assessment standards of the ASA were fulfilled. If the candidate was a

chronic cocaine user, a more elaborate cardiac evaluation was performed. Most of the candidates

for UROD are multi-abusers, that is, they use more than one illicit drug, and “speedballs,” a

combination of cocaine and heroin, are commonly used.

Gevirtz agreed that it is conceivable that testing for cocaine use will present a false

reading. Therefore, it is conceivable that a UROD procedure could be performed on a client who

had in fact used cocaine recently and should not have undergone the procedure.

Dr. Kushins testified that the standard of care requires that appropriate evaluation of

myocardial function occur and the witness opined that in the period from 1995 to 1999 trans-

thoracic echocardiograms were readily available to assist in this function. These provide an

excellent non-invasive method for examining the condition of the heart. This equipment is

sophisticated and expensive and is part of a hospital-based practice.

Dr. Kushins emphasized that in his opinion, if a patient admitted to cocaine abuse within

a recent period of time, the standard of care applicable in 1995 through 1999 required that the

physician order an echocardiogram prior to allowing the patient to undergo UROD. The doctor

defined “cocaine abusers” as persons abusing cocaine and admitting that they are abusing

cocaine. Such abusers are persons who had used cocaine on repeated occasions, not once in their

lifetime. Those who repeatedly use cocaine should have an echocardiogram. Indeed, if a patient

has used cocaine with any regularity, then the patient should have a trans-thoracic

echocardiogram, which is usually read by a cardiologist in the hospital. Such examinations are

not 100 percent accurate regarding underlying cardiac pathology and can miss these pathological

signs. Such additional tests as a trans-esophageal echocardiogram and a thallium stress test offer

a small additional yield of information and are not routinely required.

- -115


The doctor acknowledged that a doctor generally has to take at face value what a patient

says during a pre-anesthesia interview. If the patient denies using illicit drugs, then the doctor

must accept that statement. The doctor also acknowledged that the standard of care is that

persons under age of forty with no known history and without any significant medical problems

receive surgery without first having an electrocardiogram. Kushins explained that for a patient

under thirty-five years of age without any symptomatology, there would be no indication for an

EKG or an echocardiogram during a workup prior to anesthesiology.

Dr. Kushins observed that if Lisa Flowers, who suffered from asthma, had experienced

recent exacerbations of her asthmatic condition, then, in the case of elective surgery such as

UROD, the patient should have been advised to wait at least one to two weeks and then return if

she had normal symptomatology, confirmed by examination. He also noted that Ms. Flowers

had been wheezing before the procedure and in such an instance, the procedure should have been

deferred for a week or two until the wheezing cleared up. While some people do experience

these symptoms on an almost continual base, in Ms. Flowers’ case, she had a recent respiratory

infection. Persons with such conditions are at risk if they use heroin, as the drug has respiratory

effects of a negative nature. Thus, it is beneficial for such a person to stop using heroin.

Dr. Smith disagreed strongly with the charge that the respondents had failed to establish

“inclusion and exclusion criteria for those patients undergoing the procedure.” While “precise

research criteria for inclusion or exclusion” were not employed, Dr. Gooberman “was not bound

to a research standard.” Regarding this issue, Smith noted that the “ ‘very broad evidence’ is that

the group who are in treatment do better than those who are not,” and, in the words of the

California Society of Addiction Medicine, there are “many doors to addiction-based treatment

and none of them are bad.” In treating his patients, Dr. Gooberman responded to the selection of

his approach by persons who had, in many instances, either rejected or failed at other approaches

to treatment. “The goal of the addiction medicine doctor is to get the patient in treatment.

There’s not one set of treatment, nor is there one set path of treatment.”

Dr. Simon did not recall that he had seen any written document containing the inclusion

and exclusion criteria applied by the respondents to determine which candidates for UROD were

acceptable. However, it was clear to him that patients were appropriately evaluated and

judgments made as to their acceptability for undergoing the procedure. An individual medical

- -116


judgment as to the acceptability or lack of acceptability for inclusion in a treatment program is

perfectly within the standard of care in the addiction community.

Addressing the criticism that the respondents failed to distinguish between those

candidates for whom an alternative form of detoxification was appropriate, Dr. Simon opined

that the respondents did not breach any standard of care. However, he also noted that UROD is

itself an alternative form of treatment for seriously addicted persons who, in the great majority of

cases, have already attempted detoxification and/or treatment by other means, such as “cold

turkey,” hospitalization, methadone maintenance, etc. Simon had difficulty with the concept that

it was inappropriate to detoxify somebody in need of detoxification, by whatever method. If a

patient were not a good candidate for UROD, it is not clear to Simon that the patient would be a

good candidate for any alternative method of detoxification.

Dr. Simon rejected the allegation in Count Two, Paragraph 2. II, subparagraph c, that the

respondents failed “to adequately pre-operatively assess patients” cardiac, respiratory, hepatic

and renal systems to determine their ability to tolerate the exceptional stresses of the

UROD/ROD procedure.” Disagreeing in part with the characterization of the stresses involved

in UROD as being “exceptional” in comparison to those he said were encountered in some other

surgical procedures, he also defended the assessment forms and interview and intake forms

utilized by the respondents as “very similar [to those] that are in many surgery centers,” although

he did not believe that the “higher standard” for “typical surgery center[s]” was the standard to

which the respondents should be held. 38 Additionally, the Complaint seems to assume the need

for renal and hepatic assessments, when a review of the ASA standards for laboratory testing for

anesthesia finds that the standards do not contain such a requirement. In his opinion, the

respondents provided for an adequate physical examination prior to a surgical/anesthetic

procedure conducted in an ambulatory surgery setting. The respondents’ procedure met the

standard of care.

Discussing the screening mechanisms that he employed at Nutmeg between 1996 and

1999, the witness testified that, as recommended by colleagues in the addiction medicine field,

he used a urine test. He utilized this test, not as a prescreening device, but as an aide in aftercare, 38 Dr. Simon referenced a monograph, Cardiopulmonary Bypass: Current Concepts and Controversies, edited by Tinker (D-84), to illustrate the “significantly higher” levels of stress involved in that procedure. Further, citing the Textbook of Medical Physiology, by Guyton, he noted the effect of “mental” stress, which can raise the level of stress hormones, such as cortisol, up to twenty fold.

- -117


so that he could determine what drugs a patient was using. This was especially so with a multi-

addicted person, so that Simon could write prescriptions for appropriate medications. He wanted

to be able to exclude causes of symptoms other than opiate withdrawal. In his view, this was

“good medicine.” In addition, he used this information as a part of an outcome data analysis.

Blood tests were done on a case-by-case basis. This was good medicine, as well as a part of his

market and business strategy, impressing other providers.

Men over forty years old were given a twelve-lead EKG, as were those about whom he

had any clinical suspicion of some medical concern. No echocardiograms were performed, but

“less than ten” candidates for UROD were referred out for clearance, a step that he characterized

as a form of defensive medicine. The ASA standard for general surgery requires that men over

forty undergo a twelve-lead EKG before the surgical procedure. In the present matter, the

records do not indicate that the respondents did such testing, but when queried as to whether this

constituted a violation of the standard of care, Simon questioned whether the added

complications of a surgical procedure, as opposed to UROD, were such that the ASA standard

was inapplicable to UROD. He performed the twelve-leads because it was the standard and also

good medicine, but he was “very, very conservative and I wanted to cover all bases. I wanted to

dot all the I’s, cross all the T’s. So, in that respect I followed all the guidelines that I could.” He

never excluded anyone over forty from UROD based upon a twelve-lead test.

Dr. Simon commented that the standard of care applicable in anesthesia, addiction

medicine and the practice of the UROD procedure does not require the administration of an

echocardiogram prior to the administration of UROD. “If you ask a patient, by history, if he has

a heart problem or not and the patient says no and your exam of him doesn’t lead you to believe

that he has a significant heart problem, there’s unequivocally no reason to get an

echocardiogram.” If the patient has used cocaine, there is still no such standard in effect. Dr.

Simon “quite strongly disagrees” with Dr. Kushins “absurd” opinion that if a person used

cocaine twice in a year it was then necessary for the patient to undergo an echocardiogram in

order to comply with the standard of care. It is simply not reasonable that someone who used

cocaine twice in a calendar year would exhibit any significant cardiac pathology that would

warrant an echocardiogram or that would show up on one. The age of the patient and the degree

of any cocaine use are factors that a physician must take in to account in making judgments as to

- -118


the tests to order in specific cases. However, “I don’t believe that the heart disease caused by

cocaine is the type that will be revealed by a cardiac echogram.”

Simon advised that he had used dipsticks for testing for cocaine. He “supposed” that the

general wisdom was to use them, however, while he would defer to Dr. Karan’s opinion, in

prescreening 162 patients in his clinic, 20 percent were found to use other drugs and no

correlation was found with relapse rates. As for the opinion expressed by some practitioners of

UROD that they recommend that the procedure not be performed on someone who uses cocaine,

he “respectfully disagrees, based on my data, which shows that we had a positive cocaine in the

urine and it has made no difference. We have done it safely and effectively. . . To me it doesn’t

make sense, when I think about the pharmacology involved, to discriminate against cocaine. We

can’t do anesthesia with cocaine, but we can do it with a tricyclic antidepressant. That probably

doesn’t make pharmacological sense.” Simon argued that this reluctance to perform this

detoxification procedure on persons who use cocaine is another manifestation of the bias against

drug abusers that he has encountered in the field. This bias arises from social values, something

like the feeling that these drug abusers are not from the “better” class of persons, although in his

practice he treats lawyers, doctors, executives, etc. The bias carries over to addiction treatment

specialists, in that there seems to be a bias against drug addicts vis a vis those who need

psychiatric treatment or pain management for other reasons.39

The doctor did not believe that it was appropriate for patients to come to the UROD

procedure, “comfortable.” If a patient where to ask over the telephone, “how should I come,”

“we would always try to hedge . . . because we never wanted to recommend somebody to use an

illegal substance . . . it was inappropriate . . . .” However, while this was a valid medico/legal

concern, the witness added that “[F]rom a medical standpoint, I didn’t have a problem with a

patient coming in with opiates.”

Mr. Maziarski could not say what the standard of care was regarding the testing of

patients for cocaine use prior to a UROD procedure, although he knew that the CRNAs did not

test patients pre-operatively. He would not test unless the protocol established for the procedure

required such testing, and he knew of nothing special about this patient population that would

require such pre-assessment.39 Dr. Smith also addressed issues of bias regarding the treatment of drug addicts and of doctors who treat such persons.

- -119


In his report, Dr. Katz stated that he “would have liked to have seen an electrocardiogram

and echocardiogram performed, full history and physical including blood work for the

procedure” and “would also liked to have seen this done in the hospital.” During his testimony,

he clarified that he was referring to a twelve-lead EKG. Because of his training and practice as a

cardiologist, he likes to have as much information as possible before he makes a diagnosis. As a

cardiologist, he feels the electrocardiogram is a “crucial part of the examination.” Again, he

further clarified his written thoughts, specifying that if he could do the history and physical and

felt that there was a need, in a cardiologic sense, for an EKG or thereafter for other tests he

would want these performed. “In other words, if a patient had some signs that I didn’t like or

some symptoms that I wanted to pursue then I would have pursued them.” In the years 1995-99,

medical prudence for a physician about to perform UROD might have required the physician to

contemplate these four elements, yet he could not say that he was “clear that all of them are

critical in making the decision as to whether or not to do the procedure.” However, he agreed

that, as the EKG does provide the practitioner with the “best available information upon which

clinical judgment can be made,” and, “to the extent that there is an established and recognized

test or diagnostic procedures that provides information that’s necessary to the clinical judgment,

the failure to do that test ‘might be’ something of an impropriety, if not actually a deviation of

standard of practice.”

Dr. Katz agreed with counsel for Dr. Bradway that no test, be it electro or echo-

cardiogram or stress test, is 100% determinative of whether the patient has heart disease. Tests

such as stress tests and procedures such as cardiac catheterization carry risks, even the risk of

death. However, weighed against their benefits, the EKG and the blood test carry either no risk

or a very small one. A physician must rely upon personal judgment, and in that realm, personal

contact with the patient is “crucial” in making decisions. The more cases one does, the more

knowledgeable one becomes. Yet there are misses, and “if you don’t miss anything, you haven’t

done anything.”

Not all drug abusers have clinical heart disease. Dr. Katz would not give stress tests or

an echocardiogram to all abusers. There is no deviation from the standard of care in not doing

these tests. Yet, he acknowledged that his standard as a cardiologist is to perform an EKG, and

said, “its prudence in the evaluation of any patient,” or, at least, “most.” With the population that

- -120


the respondents were treating between 1995 and 1999, as a cardiologist Katz would have

preferred to have seen an EKG performed. However, while he did not have any idea as to the

standard of treatment to be provided by an addiction treatment specialist providing UROD

during the years 1995-99, he noted that during those years increased suspicions as to the

relationship between the abuse of heroin, cocaine and alcohol and diseases of the heart

developed into an understanding that there is a definite relationship between these toxins and

heart damage. He believes that an individual practicing in the addiction treatment field during

that period “should have known” the state of medical knowledge as to this relationship. This

should have created a greater sense of caution as to patients and UROD. The UROD procedure

had certain already recognized consequences, such as the heightened stress of general anesthesia,

with its risk of morbidity and mortality, and withdrawal, with its accompanying adrenalin rush

that effects a patient even when anesthetized, but more so when that patient is withdrawing from

opiates.

Katz opined that if there was no specific standard of care in existence for addictionology,

then the exercise of reasonable medical prudence in evaluating and diagnosing the patient

population that the respondents were treating would have required, at a minimum, the

performance of a twelve-lead EKG. Depending upon the results of the EKG, other tests might

then be required. An EKG might possibly show cardiomegaly and has a 50/50 chance of

revealing hypertrophy, particularly of the left ventricle, although it might miss the condition on

the right side. This finding would show that there was some cardiac disease and lead to

questions about what exactly was causing the condition. An echocardiogram would be “better”

for detecting cardiomegaly, although “not perfect” at doing so. An echo might show a heart of

450/460 grams. A basic blood test, blood counts with differentials and chemistries, might not

reveal cardiac problems, but could detect anemia, elevated white blood counts and infections.

Dr. Bradway explained that the interview process involved screening the prospective

patient. When he first started to perform URODs, the general office practice was to obtain a

series of tests that were a part of the screening process. These tests included a complete blood

count (“CBC”) with differential, hepatitis profile, pregnancy screen for a female of fertile age,

HIV screen, urine analysis and TB skin test. In describing the office practice, Bradway did say

that these tests were “recommended,” which he clarified to mean that tests could be waived at

the doctor’s discretion, but were generally required, and if a patient had not had the tests done, it

- -121


“was up to the physician to exempt them from it. . . but as a general rule, they were required - - a

recommended - - I don’t know how to phrase this exactly.” After about one year, Gooberman

decided to discontinue the battery of blood tests, because the experience of several hundred

UROD procedures indicated that it made no difference whatsoever to the outcomes whether

these were performed or not.

Bradway conservatively estimates that in his first year he performed 100 URODs. He

performed the histories and physicals himself. Information gathered in a telephone interview

constituted a part of this history. He felt comfortable having the prescreening tests done, as the

procedure was still relatively new to him. On several occasions, he put off a UROD because the

tests had not been done. He frequently called for a stress test or for an echocardiogram,

however, with the population they were treating, which averaged thirty-four years of age, it was

not routine to order an EKG or stress test unless the physician was presented with symptoms. If

someone had asthma, a chest x-ray was ordered.

Dr. Bradway personally performed over 1,000 URODs by the time he disassociated with

Gooberman in 1999 when the consent order was entered. He also did 150 more when

Gooberman was also present. In one in ten, or perhaps one in twenty, cases he declined to do the

procedure pending additional medical clearance. Many of the patients had come in from out of

town; however, if there were “any hint of a medical problem” he would not do the UROD. He

had some accommodation from other doctors as to getting pulmonary or cardiac tests and exams

performed. About 50-100 patients were declined altogether, although some of those who were

declined were later detoxified by UROD or by other methods. Gooberman also turned down

patients in Bradway’s presence, as when there was a left axis deviation detected by cardiogram,

and for a variety of other medical reasons.

Dr. Bradway recalled that in the early stages of his work with Dr. Gooberman, no screen

for cocaine use was performed; indeed, Bradway does not think that at that time any commercial

test was available. Later, the screening process evolved, partly in response to the fatalities, and a

dipstick urine analysis was used for some patients. These were chosen based on Bradway’s

clinical judgment, his knowledge of addictions and of the population of people, “in sum total my

experience in using—in—in understanding their problems.”

- -122


By December 1996, 671 URODs had been performed by the two doctors. This was the

point at which Frank Stavola died. Bradway noted that over the period 1996-99 he cancelled

patients who he determined were on excessive doses of a drug. These decisions resulted from an

exercise of clinical judgment. Over time, he became more conservative as to the level of a

prospective patient’s methadone addiction and whether he would not do the procedure. For the

most part, the people who came to the clinic were persons using heavier doses of illicit drugs,

and he considered the information that he obtained as to drug use and the amount thereof as a

factor in his screening process. However, the decision was a clinical one and was not made on

any strict numbers approach, that is, that a particular milligram usage in a given period was an

automatic disqualifier. When the deaths of patients occurred he and Gooberman had information

about the causes of deaths that was “severely . . . constrained.”

Dr. Gooberman testified that the primary inclusion criteria for UROD were a history of

opiate dependency and previous attempts to overcome dependency. Exclusion criteria included

pregnancy, and at first any history of cardiac problems, although later on he required that such

potential patients consult with a cardiology group. Gooberman specifically recalled that he

discussed with the prospective patients whether they had any history of arrhythmias. “If there

was any history whatsoever we would freely ask for a consultation.” There also was a Board

Certified pulmonary consultant available for consultation. There were psychiatric illnesses that

might negate doing the procedure. In addition to these criteria, the physicians’ own clinical

judgment was used “in terms of who you wanted to do and who you didn’t want to do.” The

personnel who answered the telephones did a lot of screening regarding these issues. Further, if

the caretaker was not deemed adequate, the procedure was not done, unless some other

arrangements was established, such as paying for a caretaker.

Pre-procedure use of cocaine was not at first an exclusion factor. However, after the

deaths of Stavola and Beigelman, each of whom had a history of using speedballs (heroin and

cocaine together) and, in Stavola’s case, a pathologist’s oral report that he had used cocaine,

Gooberman added warnings about cocaine use to the consent form and the telephone personnel

were advised to tell prospective patients of the risk. This precaution was not based upon “hard

evidence” that cocaine use had caused these deaths, but it “seemed like the most likely

possibility based on the evidence that I had.” Gooberman recalled that dipsticks were used

“early on,” but they “weren’t very good early on” and they check for benzoylecgonine, not

- -123


cocaine. Cocaine lasts for only an hour, but the benzoylecgonine could last in the system and

produce a positive reading two days later. Such a positive reading would not have been helpful.

He was not sure that cocaine use before the UROD made a difference and patients were being

monitored during the UROD. “In reality, it would not have made a difference if they had used

that morning because we were equipped to handle a problem if it developed.”

Dr. Karan addressed the allegation contained in Count Two, paragraph 2 I. k. of the

Complaint, which charges that the respondents created and implemented “what was an

experimental procedure without adequate disclosure of the experimental nature to patients and

without obtaining their informed consent.” She contended that the respondents failed to fully

disclose to the patients that the UROD procedure was investigational in nature. This is a very

new procedure, the guidelines for which indicate that it was “patent pending.” The patients were

not told just how new it was. This is a “definite” deviation from the standard of care.

Dr. Kleber testified that the purpose of the consent form is to provide the patient with

some informed means of understanding what he/she is about to undergo. Serious risks must be

spelled out. Kleber agreed with Karan that the consent forms did not reveal to potential patients

that UROD was experimental and that drugs were being used for “off label” purposes.

Additionally, the consent forms did not list death as a possible risk. Since, by the time of Lisa

Flowers death in July 1999, the doctors knew of six to seven deaths that had occurred among the

patients who had undergone their UROD procedure, it was incumbent that they list death as a

risk and thereby give their prospective patients the ability to make an informed judgment as to

the procedure and its implications.

Another deviation existed concerning the waiver of confidentiality and privacy contained

in the consent form. The form provided that the patient agreed to “be photographed, videotaped

or otherwise recorded before, during and after treatment,” and that the resulting material was the

property of Lance L. Gooberman, M.D., P.C. and could be used “as deemed appropriate for

scientific and/or educational purposes. In addition, the consent encompassed permitting

Gooberman, P.C. to use the patient’s appearance for use on television or radio “in any and all

manner and media throughout the world in perpetuity.” It further allowed the use of any

recording “in connection with any publicity and institutional promotion campaigns, . . . but not

as an endorsement of any product or service.” It purported to release Gooberman, P.C. and those

- -124


associated with it from any claims of invasion of privacy, defamation, or other causes of action

“arising out of production, distribution, broadcast or exhibition . . . .”

Dr. Kleber explained that there are specific federal confidentiality guidelines that are

frequently stamped on such forms or otherwise spelled out, and in the addiction community the

use of a waiver such as the respondents included constituted a deviation from standards.

Dr. Smith asserted that the allegation regarding a failure to disclose the “experimental” or

“investigational” nature of the procedure must be based on inaccuracies. In his view, UROD is

not, and was not in 1995-99, experimental, but is and was instead an established procedure. An

“experimental” procedure has a “very specific meaning,” in science and medicine. It has a

protocol, informed consent and methodology, and the technique for statistical evaluation. In

connection with the process undertaken by the respondents, the use of the term “experimental

procedure,” constitutes a “misuse of the term. He contrasted the situation existing in his own

clinic, where clonidine is used for opiate detoxification. Literature exists to support the

treatment and there is a collection of case studies. Despite the existence of these elements, such

a body of support does not rise to the level of a study and his use of the drug would still be

considered “unapproved use, but not experimental.” In contrast, his clinic also has a NIDA

grant, involving a randomized comparison of the use in detoxification of buprenorphine versus

clonidine, which is the “conventional therapy.” In this comparison, there exists a protocol and a

Human Risk Committee. This is an “experimental” procedure.

Further explaining his definition, Smith stated that the use of a drug such as clonidine,

which is approved for treating hypertension, for an unapproved use, is not an experiment, even in

the absence of randomized, double-blind studies with respect to that unapproved use. In the case

of UROD, all of the drugs used are approved for a medical use. Therefore, the fact that the

UROD procedure uses approved drugs takes the procedure out of the experimental realm.

Dr. Simon explained that the consent form employed in 1996-97 was used at a time when

UROD was viewed as an extremely safe procedure. Death was not thought to be a risk factor

greater than in any other surgical procedure utilizing anesthesia. Methadone maintenance

involves more deaths by number than does UROD, and yet, as far as Simon is aware, the consent

forms used for that maintenance do not mention death. If the lack of reference to death as a risk

- -125


accompanying the administration of methadone is representative of the standard of care in

addiction medicine, the lack of reference in the respondents’ consent form to death as a possible

risk was not a violation of the standard of care.

Simon agreed that insistence on a waiver of patient confidentiality in the informed

consent form would constitute a violation of the standard of care. However, Simon recalled that

he had seen a consent form completed by one of the patients whose cases are here under review

in which the waiver was crossed out. This indicated that such a choice was available to the

patients and therefore no violation of the standard occurred.

Mr. Ragone was sometimes present in the doctors’ office or the examination room when

patients were given the consent forms to sign. Typically, the procedure was explained to them,

including a discussion of risks and the need for follow-up treatment. Patients generally asked

questions. Sometimes Ragone went over the form with the patient and then the doctor spoke to

the patient.

Dr. Bradway testified that after deaths occurred, changes were made in the consent form

and patients were advised orally that people had died and death was a possibility. Some people

actually walked out when told this. After the third death occurred, Bradway, by then aware that

cocaine metabolites or cocaine had been discovered in the blood of two decedents, began to tell

prospective patients about deaths having occurred, but he did not say that the procedure was “in

any way” related to the deaths, that it would cause death, or that there was any direct link to

fatality from the procedure. He only related that the ingestion of other drugs was related to the

deaths and compliance with the instructions regarding medications given to the patients was

necessary. It was Bradway’s practice as a physician to “always” go over the consent form,

especially if the procedure needed a consent form. Such verbal discussion of the form is rarely

documented.

Dr. Gooberman related that the consent form and the caretaker form were drafted by an

attorney, who was a former member of the New Jersey Board of Medical Examiners. These

were each reviewed in the office before the procedure was started, and patients “heard what they

wanted to hear.” He would go through each of the listed conditions that the patient might

experience after completing the procedure, that is, post-extubation. Included in this discussion

- -126


was the abnormal breathing that frequently occurred, which was either fast and/or slow breathing

that might be caused by naltrexone. In addition, he would advise the patients about what could

happen if they reverted to opiate use, as if they used the same dose as they had used before

having UROD they could very easily die from an overdose. Likewise, he advised that a couple

of people had died and that it was thought that they had used cocaine and that it had caused them

to expire and therefore any subsequent use of cocaine was “a problem.” They were told that if

they felt the need to use opiates they could come back for another pellet. They were also told

about the duragesic patch and that if it came off they should just stick it back on.

Peri-Operative Concerns

In addition to her concerns about screening and pre-procedure diagnostic testing, Dr.

Karan related her concerns about deviations from the standard of care in regard to practices

occurring peri-operatively. One of these is in regard to the drug clonidine, or Catapres, which as

previously related, is used by the medical community, including practitioners of ROD, to

substantially reduce withdrawal symptoms. Dr. Karan described these symptoms as including

anxiety, agitation and piloerection, or “gooseflesh.” Karan used clonidine in her own practice,

which did not include the provision of ROD. Clonidine is an FDA-approved drug, but it is not

approved for use in detoxification.

In a letter dated January 9, 2000, Dr. Gevirtz stated that “Clonidine has been an integral

part of detoxification for 20 years and its use is a standard of care in” UROD. “Failure to utilize

it during detoxification is a clear deviation from the standard of care, which may result in

tachycardia, hypertension, nausea and vomiting.” Gevirtz testified that while the standards that

he first employed for peri-operative aspects of UROD were originally provided by CITA,

modifications were made in the drugs employed. The procedure lasted from four to six hours.

Among the several drugs employed during the procedure, Gevirtz felt that clonidine was

particularly important because of its anti-hypertensive quality and because it suppresses

norepinephrine. The UROD procedure is very stressful for the patient, especially if clonidine is

not used or if there is “not enough on board.” A study by Kleinman demonstrated that there is “a

very dramatic increase” of catecholamines during withdrawal, which is “very dangerous during

anesthesia” and this can dramatically increase blood pressure, a very dangerous reaction that can

trigger arrhythmias and hypertensive crisis.

- -127


Dr. Gevirtz acknowledged that clonidine has the potential for causing serious blood

pressure and cardiac effects. He opined that benzodiazepines, which are sometimes used in place

of clonidine, do not accomplish the suppression of catecholamines to the same level as clonidine

does. Dr. Gooberman’s protocol identified Atropine as the drug to be utilized if it became

necessary to reverse the paralytic condition induced during the intubation stage. Atropine is used

in conjunction with neostigmine or prostigmin and is used if the patient’s heart rate slows down.

If clonidine has been used during the early stage of the procedure, it may be necessary to

administer a higher dose of atropine to achieve the desired effect, although the clonidine does not

prevent the atropine from working.

Dr. Simon, who utilized clonidine to minimize the effects of withdrawal symptoms, was

not prepared to say that providing UROD without clonidine did not constitute the practice of

good medicine. Simon noted that Dr. Gooberman, who had “vast” experience, may have found

that fentanyl worked as well as clonidine did.

In his testimony, Dr. Gooberman at first explained that while he used clonidine for every

patient, over time he changed the point at which he administered it, due to some difficulty with a

patient’s blood pressure which caused him to consider possible drug interactions. He discussed

the issue with Dr. Michael N. D’Ambra, Associate Professor of Anesthesia at Harvard Medical

School and Director of the Cardiac Anesthesia Group at Massachusetts General Hospital, who

confirmed Gooberman’s suspicions about the possibility of such interaction.40 As a result,

Gooberman decided to change the point at which he administered clonidine.41 However, in later

testimony, Gooberman corrected these statements, as after reviewing his records he realized that,

while he employed clonidine “every day” as he uses clonidine in other forms of detoxification,

he realized that he did not use clonidine in every UROD case. He had utilized this drug in the

first half of the UROD cases and then phased it out as a regular medication, as he felt that there

were better drugs to use to achieve the purpose. Gooberman argued that the absence of clonidine

40 In a letter dated August 30, 1999, addressed to Dr. Gooberman’s former counsel, Dr. D’Ambra writes that he is personally aware of Dr. Kleber’s protocol at Columbia University “in which he will compare opiate antagonist reversal of opiate dependence in Clonidine-sedated patients and patients under general anesthesia, also to be given clonidine. We halted the use of Clonidine at MGH after the second patient because of its dangerous cardiovascular side effects.”41 The interaction that was problematic was between clonidine and atropine, which drug was administered to increase the pulse and maintain blood pressure at a time when neostigmine is used to reverse the effect of paralytic agents administered earlier in the procedure. This interaction was explored with Dr. Gevirtz during his cross-examination.

- -128


did not constitute a violation of the standard of care, as there are a variety of methods used

within the standard. The decision as to which drugs to use is a clinical decision that is made

based upon the training and experience of the clinician. Different clinicians used different drugs,

and based on his experiences he understood that “a lot of practitioners of” ROD do not use

clonidine. As an example, he noted that clonidine is not used by Massachusetts General

Hospital, and they do not use it due to the experience that he had discussed with Dr. D’Ambra.

Count Two, paragraphs I.i. and II.d., each contain an allegation that the respondents’ use

of the fentanyl transdermal patch constituted an investigational or experimental risk and that the

patients were exposed to this risk without appropriate patient consultation and informed consent.

Dr. Karan characterized the respondents’ use of the fentanyl patch as a clear deviation from the

standard of care. The use of this patch did not make sense medically, as the employment of

fentanyl, an opiate agonist, seemed contrary to the goal of the UROD procedure, which was to

knock opiates off the receptors by use of opioid antagonists. As she understood, Dr. Gooberman

had explained that the fentanyl was used to modify withdrawal symptomatology and make the

patient more comfortable, but the witness believed that this was medically “inconsistent.” There

was nothing in the medical literature supporting the safety and efficacy of the procedure.

Dr. Kleber also identified the use of the fentanyl transdermal patch as a deviation from

the standard of care. Fentanyl is an ultra short-acting analgesic, up to now utilized in operative

procedures. The purpose of the UROD procedure was to rid the patient’s system of opiates, not

to put opiates such as fentanyl into the system. In addition, if the theory of UROD and

antagonist block therapy is correct, then the fentanyl should not be effective. The use of fentanyl

carries risks of overdose and/or respiratory depression.

Dr. Gevirtz noted that fentanyl is not used in his UROD procedure, as it is a narcotic

agonist and contraindicated for one being detoxed under consent. Dr. Kushins was likewise

troubled about the use of the fentanyl patch. The patients received opioid antagonists, and there

was no surgical intervention that would require an analgesic such as fentanyl. There seemed to

be no indication for the use of fentanyl, which is normally used for relief of pain or to decrease

the doses of other anesthetic drugs given during a general anesthetic procedure. Ketamine is an

excellent analgesic and there is no indication of a need for a second analgesic. In addition, if the

- -129


purpose of providing the patients with all of the antagonists was to induce withdrawal, there

seemed to be no logical reason to administer an opioid such as fentanyl during this procedure.

Dr. Kushins has never administered fentanyl by a transdermal medium.

Dr. Simon has reviewed the literature on the uses of transdermal patches and is convinced

that whether or not the fentanyl patch is an efficacious treatment mechanism, it played no part in

the deaths of the patients. He argued that it was pharmacologically impossible for the decedents

to have suffered from a fentanyl overdose. Use of the patch does not breach any standard of

care. Indeed, their use may have some potential advantages. The use of a patch avoids a

concern, noted by Dr. Kleber, that a subcutaneous implant might dissolve or release more than

the intended amount of drugs. Additionally, as an antagonist of naltrexone, fentanyl may be

protective against the possibility of a naltrexone drug burst. While Dr. Simon does not himself

use the patch in his practice, he concluded that based upon his “vast experience,” Dr. Gooberman

may have concluded that use of fentanyl was more efficacious than use of clonidine to treat

residual withdrawal symptoms, a conclusion that Simon characterized as “reasonable.” As

providers of UROD tend to closely guard their protocols, Simon could not be sure if any others

use fentanyl.

Dr. Gooberman explained that the theory behind his employment of the fentanyl patch

was based upon the research of Dr. Jed Rose, who, working at the Duke University Nicotine

Research Center, examined the nicotine antagonist patch. He spoke to Dr. Rose and read his

papers. Rose believed that when someone goes through withdrawal from nicotine, some of the

withdrawal symptoms are not blocked by the antagonist mecamylamine, and therefore if you

gave both the antagonist and the agonist together, the nicotine and the mecamylamine, the patient

would not get the effects of the nicotine, but at the same time will not necessarily feel as bad.

Rose’s studies had shown that it was easier to get people off nicotine this way. This theory

coincided with what some of Gooberman’s patients were telling him, that they were experiencing

muscle aches and pains after UROD and that, as a result, “a lot of them did heroin and they said

the heroin made them feel better, helped them through it.” Since he would not encourage his

patients to use heroin, Gooberman perceived that a steadily delivered low dose of the agonist

fentanyl infused through the skin might help and “certainly couldn’t hurt.” The patients had

naltrexone on board via the pellet, which would block any respiratory depression, and therefore

- -130


he believed that the low dose of fentanyl provided via the patch to persons used to high doses

was “worth a try.” Even if the naltrexone did not work, the dose of fentanyl was not dangerous.

Count Two, paragraph 2. I.a. alleges that the respondents’ use of the naltrexone pellet,

without knowledge as to the duration of its action and how much heroin and other opiates it

would block on a daily basis, constituted a deviation from standards. Dr. Karan testified to her

doubts about the naltrexone implant. The formulation was not approved by the FDA. While

naltrexone is approved for certain routes of administration, there was no pre-trial data and a lack

of a research background for this method of administration.

Dr. Kleber also has concerns regarding the use of naltrexone, given what he described as

its link to pulmonary edema. There is a concern that when a patient receives this drug, there may

be an “ immediate burst” release that may cause pulmonary edema. According to Kleber, the

study that he has been conducting at Columbia regarding an injectable form of naltrexone has

demonstrated that until a “steady state” is reached, which can last for three to five weeks, “you

get a rapid burst of naltrexone released into the bloodstream.” While he himself did not know if

this were also the case with Gooberman’s pellet, he questioned whether Dr. Gooberman knew if

the implantation of the naltrexone pellet had a similar potential effect. As in the immediate

postoperative period, breathing is often irregular and the heart may be under strain, if the system

then becomes flooded with a narcotic antagonist that has been associated with pulmonary edema,

such as naltrexone, there is a danger of potential morbidity and mortality. In addition, he could

not recall seeing any reports or documentation regarding the duration of the possible blockading

effect of the pellet over a period of one to three weeks. However, as one of the normally

expected consequences of a withdrawal precipitated by UROD is abnormal breathing, giving the

patient a substance (in the pellet) that could worsen such breathing abnormalities and that has

been shown to cause pulmonary edema and that has not yet been adequately tested is troubling.

Dr. Smith commented that characterizing the respondents’ practice as at “substantial

variance” from the standard of care presupposes such a conflict. This is particularly troublesome

in an area that involves an evolving standard, and one is therefore required to evaluate the

outcome which, “in Dr. Gooberman’s procedures I felt were very positive because he was

emphasizing the implanting of the naltrexone pellet.” In fact, this aspect of the procedure may

represent an improvement in treatment procedure. The biggest issue involved with regard to

- -131


addicts’ early relapse is noncompliance with the recommended treatment. The theory of the

implant is the same as that represented by the issuance of oral naltrexone to patients, but it may

be an improvement because the oral medication has to be taken once a day and many addicts did

not comply with that dosing regimen.

The fact that naltrexone injection is not approved by the FDA does not mean its use

constitutes a violation of the standard of care. Indeed, clonidine is also used in addiction

medicine, but its use has not been approved by the FDA for the detoxification of addicts either.

Manufacturers do not want to “taint” their products by associating them with this field.

Additionally, many treatment modalities are not accepted by “mainstream medicine.” In more

conventional forms of detoxification, it is necessary to wait for from seven to ten days before

administering naltrexone. This is necessary in order to assure that there is no residual

dependence, because if the drug is administered early it can precipitate withdrawal. A narcan

challenge can be used to test for any residual dependence.

Smith noted that the use of naltrexone on a long-term basis has been advocated by Dr.

Charles O’Brien, who authored a chapter in Dr. Kleber’s textbook. Dr. O’Brien is one of the

world’s leading experts on the drug and a consultant to the study being undertaken on developing

Naltrel, a long-acting form of naltrexone.

Queried on cross-examination as to the relationship between naltrexone, nalmefene and

naloxone and pulmonary edema, Dr. Simon agreed that there is a relationship, however, in his

opinion there is not a “cause and effect.” The Physician’s Desk Reference (“PDR”) reflects

reports of adverse incidents of pulmonary edema with the administration of naloxone. However,

Simon commented that the PDR is nothing more that a

compilation of information submitted by individual drug companies for doctors and in many cases, the drug companies take a very conservative approach for medical/legal reasons so that they don’t get sued for liability and they are very apt to mention small degrees of actions. . . the statement in that book is derived from the same inaccurate data and footnotes that draw the wrong conclusions that I spoke of yesterday. . . [The doctor is referring to his comments on the NIDA report, the San report and other articles, reported above] This is a typical example of garbage in; garbage out.

- -132


Dr. Gooberman related that naloxone is a short-acting opiate antagonist. It was used by

Dr. Loimer when he started to employ UROD. Gooberman utilized the drug and then added

naltrexone at the end. Naloxone is used all over the world in emergency rooms and by

paramedics to combat a heroin overdose. However, there were rumors that naloxone might be

associated with pulmonary edema and therefore Gooberman switched to the more expensive

nalmefene, which was used in later URODs, sometimes in conjunction with naloxone.

Discussions with Dr. Simon and a Dr. Gonzales, both anesthesiologists, and a search of the

literature led Gooberman to understand that the consensus was that the edema was not caused by

the naloxone, so he went back to using it, while all the time he was also employing naltrexone.

Several studies indicate that naltrexone, while not itself a very long lasting drug, is, however, an

effective drug to use in opiate addiction treatment. As it breaks down in the system, its

metabolite of 6 beta naltrexol is long lasting. The UROD procedure provides a means to make

naltrexone an effective tool, as without the rapid procedure the need to wait to initiate the drug’s

use for seven to ten days after withdrawal is a substantial drawback to the successful utilization

of the drug.

The next problem that had to be overcome was that of patient noncompliance, for patients

would not take the daily pills required for oral administration. What was needed then was to

provide a means of keeping patients on naltrexone after they emerged from the withdrawal.

Administration by means of depo-naltrexone, an off-label pellet preparation of the drug,

provided the means to accomplish this end, using a drug already approved for opiate

detoxification.

The FDA has not evaluated the safety and efficacy of the naltrexone pellet, however,

Gooberman insisted that the agency had approved what they were doing “under certain

regulations regarding compounding and that we were free to do that for as long as we wanted, to

the degree that we wanted.” In support of Gooberman’s position, Dr. Simon stated that it is not a

breach of the standard of care in medicine for a physician to compound a drug and use it for off-

label use.

Specifically addressing the allegations of the Complaint concerning the naltrexone pellet,

Gooberman denied that he did not know, “by objective data, the duration of action of the

- -133


antagonist provided . . . and how much heroin or other opiates are blocked on a daily basis.”

While he argued that the standard of care does not require that he know these answers by

objective data, nevertheless, he did know from both objective and subjective data. His office

conducted a study in approximately 1996 of post-implant effectiveness, using a fentanyl

challenge to determine if the implant was providing the necessary level of drug to block the

effects of the fentanyl. A fentanyl challenge is a so-called “provocative testing” mechanism that

is used to determine whether the treatment is adequate. Fentanyl is administered to see if the

naltrexone is blocking its effects, which, if the drug is indeed working, results in the fentanyl

having virtually no effect on the patient. Blood samples were collected. It was determined that

the duration varies from patient to patient, as is frequently the case with medications, but while

the number of days ranged from twenty-one to seventy after implantation, in general the testing

demonstrated that the pellets worked for about thirty-five days. Gooberman has seen the pellet

be effective for as long as two, even three months, after implantation. Additionally, the office

surveyed patients who had received oral naltrexone following UROD, and patients who received

the pellet after Gooberman began using it, and determined that with the pellet, almost 100% of

the recipients reported that they had not resumed using heroin after thirty days following the

implant. This was an increase from about 66% reporting such success after thirty days following

receipt of oral naltrexone. (D-59).42

A series of charges are made that relate to the alleged impact of the UROD procedure

upon the physiology of the patients and concerns, arising at least in part from this issue, of the

manner in which drugs are used in the procedure and the qualifications of the physician and staff

who provide the procedure. Count One, paragraph 7 of the Complaint contends that the UROD

“procedure, because of the combined effects of the anesthetic agents and the antagonist and other

drugs, produces a high level of physiological stress upon patients. Count Two, paragraph 2 II. b.

asserts that the respondents deviated from standards because UROD involved “the administration

of anesthetic agents so as to produce unconsciousness during a highly stressful period without

appropriate knowledge of the effects of said drugs and their interactions with other drugs

administered.” Count Two, paragraph 2. II. e. alleges a deviation from standards resulting from

42 Interesting observations regarding the role of naltrexone are contained in an article (P-46) by Hoffman, Berkowitz, McDonald and Hass, Ultra-Rapid Opioid Detoxification Increases Spontaneous Ventilation, Journal of Clinical Anesthesia 10:372-376 (1998), which reports, in light of “interest in the success of the detoxification procedure to treat opioid addiction,” that UROD achieved 100% opioid detoxification and that the improvement noted in long-term relapse rates in a national treatment outcome study (Treatment Outcome Prospective Study) of 2,280 patients treated in conventional detoxification programs versus 113 patients treated with UROD “may be related to long-term compliance with Naltrexone in the after-care program. Thus, “Naltrexone compliance in the after-care program may improve abstinence.” Id. at 375.

- -134


“the simultaneous provision of a procedure which is the medical equivalent of general anesthesia

in an outpatient setting for as many as six patients through CRNAs and critical care nurses

subject to overarching medical supervision by a non anesthesiologist and without the presence of

a critical care physician.”

Dr. Lawrence Kushins noted that the respondent’s UROD procedure induced heightened

levels of stress for the patients, who manifested increases in blood pressure and heart rate after

the administration of the opiate antagonists. The medical literature and research studies have

shown that there are measured increases in catecholamine and epinephrine and norepinephrine in

patients undergoing ROD, but these levels have not been measured in the respondents’ patients.

These substances, which are naturally produced in the body, have differing effects at receptor

sites within the body and affect circulation, respiration, hormone secretion and other functions.

Within an anesthetic procedure, epinephrine and norepinephrine can cause increased blood

pressure, heart rate, and the pressure within the pulmonary or lung circulation and can affect

respiratory frequency. Patients who experience these changes may have complications from

heart failure, myocardial infarction, stroke, or from pulmonary edema. Monitoring of the

patient’s vital signs and other indications is thus vital. Following the procedure itself,

monitoring must continue during the recovery period from general anesthesia.

In addition to these stresses, additional stress can occur as a result of the induction of

general anesthesia and intubation of the trachea. Emergence from general anesthesia can

likewise be stressful, as can the removal of the endotracheal tube.

Dr. Kushins compared the stress level of UROD as against that of a non-UROD

procedure from the point of view of anesthesia administration. The difference is that in UROD,

the patient is exposed not only to the normal stresses of anesthesia procedures, but, in addition,

to the major surge of catecholamines. He concluded that the level of risk of danger in the UROD

procedure is “significant” in comparison to anesthesia administered for some non-UROD

surgical procedure. There are other such procedures that cause less stress, a comparable level of

stress or even greater levels of stress. However, the doctor conceded that in such examples of

what he believed to be low stress procedures, such as partial mastectomies and arthroscopy of the

knee, the catecholamine levels have not been measured.

- -135


Dr. Kushins acknowledged that a person undergoing unaided withdrawal from heroin

definitely undergoes a stressful event. The anesthetics used in the Gooberman procedure,

propofol, ketamine and midazolam, do not cause nausea or vomiting, and it can be presumed that

any nausea or vomiting or diarrhea mentioned in the orders or the instructions from Dr.

Gooberman would be precipitated by the withdrawal.

Dr. David Smith characterized the predicate allegation concerning the alleged “high level

of physiological stress,” as “meaningless in itself.” Addiction produces high levels of stress, as

does any form of opiate withdrawal. In Dr. Smith’s opinion, UROD produces stresses that are

consistent with or even less stressful than do other forms of detoxification. In fact, the doctor

argued that the high-level physiological stress involved was produced not by the procedure itself,

but by opiate withdrawal.

Dr. Simon also disagreed with this allegation. He believed that the person who wrote this

does not understand the physiology. Contrary to the paragraph’s implications, Simon posited

that, in fact, “anesthesia is a treatment to lessen the physiological stress.” Opiate withdrawal

causes the stress, not the anesthesia, which instead “treats the stress.” The increase in hormonal

levels that does occur is normal and does not reach dangerous levels. Simon noted that the

discussion of stress and of increases in epinephrine and norepinephrine must be placed in

context. According to Guyton, Textbook of Physiology, mental stress and anxiety can cause a

twenty-fold increase in such stress hormones as cortisol. Further, Simon referred to the article

by Keinbaum, et al., which addressed the “profound increase in epinephrine” (measured at thirty-

fold) resulting from opioid receptor blockade in barbiturate-induced anesthesia for acute

detoxification.” The doctor argued that the levels of epinephrine and norepinephrine identified

in this article are “nowhere that approached during open heart surgery.” Further, while the

increase in cardiac output of 74 percent may sound high, in fact it is not when compared with the

increase in cardiac output attained by running around the block, which he said was 500 percent.

Further, the catecholamine levels reached during UROD peak during the first couple of hours

while the patient is monitored in an Intensive Care Unit. The levels then return to normal. If a

heart attack were going to occur due to the increased hormonal levels, it would be anticipated

that it would occur during these early hours. It is an indication of how safe the procedure is that

- -136


these heart attacks have not happened. Indeed, the articles demonstrate that the responses are

“normal physiologic responses.” 43

Once again, Dr. Simon disagreed that the respondents administered “anesthetic agents to

produce unconsciousness during a highly stressful period without appropriate knowledge of the

effects of said drugs and their interactions with the other drugs administered.” Contrary to this

assertion, Simon contended that there is no evidence that they did not understand the drugs that

they employed. The misleading element of this allegation is that, again contrary to its assertion,

the use of anesthesia actually decreases stress. Based upon his review of the charts, the vital

signs remained in the acceptable ranges and the course of the patients’ experience under

anesthesia was “uneventful and I didn’t see anything that happened during the procedure that

was causative of any detrimental effect to a patient . . . . I can only conclude that he knew what

he was doing.” In addition, from his own interaction with Gooberman, he believed that the

doctor had adequate knowledge to perform the procedure, which was a “very simple procedure”

from an anesthetic point of view. Simon offered that Gooberman is the most experienced

physician in the country performing UROD, and the fact that the number of deaths is seven out

of over 2,300 procedures, “tells me the man must know what he’s doing.”

Mr. Maziarski, who has published a paper on hypotension and histamine release,

commented on the release of histamine that can occur when opiates, or other substances such as

muscle relaxants or blood products, are introduced into the body. There is no way to tell in

advance how significant this histamine release will be in any one individual; sometimes people

do not experience it at all, other persons do. It can be severe, even leading to anaphylactic shock

and severe hypotension, arrhythmias and tachycardias. To the witness’ knowledge, propofol,

midazolam, naltrexone, nalmefene and naloxone are not drugs that cause histamine release. In

fact, none of the drugs that Gooberman and Bradway utilized in the UROD process would

ordinarily cause a histamine release, unless the patient had an allergy to the drug.43 The witness also reviewed the article “Ultrarapid opioid detoxification: effects on cardiopulmonary physiology, stress hormones and clinical outcomes,by Eman, D’Ambra, et al., published in Drug and Alcohol Dependence 61 (2001) 163-172. In this article the authors, associated with Harvard Medical School and Massachusetts General Hospital, reviewed data concerning UROD, referred to in the article as URD, performed on seven patients. The authors, who credit Dr. Gooberman for assistance in the design of the anesthesia protocol employed, report that while hemodynamic and respiratory functions did not change significantly during the anesthesia phase of URD, plasma ACTH and cortisol levels did increase “robustly.” The authors state that reports such as that by San in 1995, Seoane in 1997 and Pfab in 1999 “underscore the evolving awareness that URD is far from being a benign procedure and that any patient entering URD is being subjected to a potentially iatrogenic risk. While they conclude that “URD may have a role in the armamentarium of treatments for opioid dependence,” p. 171, the authors also state, “In accordance with other investigators (Kienbaum . . . 1998) we suggest therefore that because of potential respiratory complications, URD and acute post-anesthesia monitoring should be handled by experienced M.D. anesthesiologists.” Id. at 170.

- -137


Picking up on the theme of stress as a significant element in UROD, Dr. Kleber

expressed his opinion that the procedure causes such severe stress that significantly effects the

patient’s hormone levels and carries with it such risks of mortality and morbidity that it should

only be carried out by a trained anesthesiologist. In his understanding, the overwhelming

majority of UROD practitioners are anesthesiologists. His opinion on this point is premised

upon his understanding that involvement of anesthesiologists was in fact the standard in the field

and that the articles he had read and the physicians with whom he had discussed the procedure

supported this view.

Dr. Gevirtz testified that, in the years 1996-99, there were an average of seven sites in the

U.S. and Puerto Rico in which UROD was performed. Most of these had more than one

anesthesiologist performing procedures. Gevirtz trained personnel at four of these sites. The

only location where an anesthesiologist did not perform the UROD procedures was Dr.

Gooberman’s facility. In Gevirtz’ opinion, in general, a critical care trained physician or

anesthesiologist is required to perform a UROD procedure. However, Gevirtz acknowledged

that Gooberman could legally administer anesthetics. The use of a nurse-anesthetist is permitted

in other outpatient procedures, although such use conflicts with the ASAM standard. Thus, the

use by Gooberman of a nurse-anesthetist is “an issue.”44

Dr. Kushins cited the fact that multiple patients were anesthetized by nurse anesthetists

who were not supervised by an anesthesiologist or physician and who were not directly

monitoring all the patients simultaneously. This nurse anesthetist would intubate a patient and

then move on to the next patient and at the appropriate time extubate the tracheal tube. Dr.

Kushins nevertheless acknowledged that during the period 1995 to 1999 there was no law that

required that a nurse anesthetist had to be supervised by an anesthesiologist in an office setting.

He also understood that critical care nurses were present and that they were responsible for

monitoring the patient. Monitoring of the patient's condition is a component part of the

anesthesia procedure and is vital to the well being of the patient.

Dr. Kushins’ opinion is that UROD should not be performed as an outpatient procedure.

He also contends that it is “prudent” for an anesthesiologist to administer the procedure. He does

44 He denied any knowledge of a movement in New Jersey to curtail the use of CRNA’s in ROD procedures.

- -138


not believe that having a CRNA administer the anesthetic is ideal, but if that is to occur than at

least an anesthesiologist should be supervising. However, and significantly, in contrast to what

Dr. Kleber presented as a basis for his testimony on the subject, Dr. Kushins acknowledged that

the standard of care does not automatically require that an anesthesiologist be involved. In his

opinion, the standard of care is that in rural areas it is acceptable for a CRNA to be supervised by

any other type of doctor; however, in other settings the standard would be for an anesthesiologist

to supervise. Thus the definition of the applicable standard of care may depend upon the

characteristics or factors taken into account, i.e., the ideal standard; the standard that

accommodates economic realities; the location where the standard is being applied. He

cautioned that the failure to meet this standard is not per se malpractice, and if the procedure is

properly conducted, there is no malpractice.

Kushins explained that the issue of what requirements government may impose on the

relationship of CRNAs and anesthesiologists is a matter of debate and controversy at the Federal

level. Currently, all states except New Hampshire require that “a doctor” supervise the work of

CRNAs. Kushins described the issue as in a “tremendous state of flux.” Regulations that were

proposed by the Board of Medical Examiners in New Jersey in 1998 for office surgery have been

challenged and are not at this time in force.

Dr. Simon did not agree that there was any violation of the standard of care regarding the

provision of multiple UROD procedures presided over by a non-anesthesiologist. Considering

the ASA standards, which are applicable to surgery in an operating room and therefore speak to a

standard higher than that that he believes is applicable to Gooberman and Bradway in their

provision of UROD, Simon noted that their activities did not breach those standards. When he

observed the facility, it was adequately staffed and the records that he has reviewed “appeared to

meet the standard. The documentation seemed appropriate.” He was aware that a UROD

provider in Miami Beach’s Mt. Sinai Hospital, Dr. Harold Whittles, who is an anesthesiologist

working under the direction of Dr. Gevirtz and affiliated with CITA, “routinely anesthetized four

patients at a time.”

Dr. Simon commented on the role played by anesthesiologists in UROD. As opposed to

their more usual role as “invited guests” in other surgical procedures, in UROD the

anesthesiologist could be “the whole show. ” Attempts to limit the use of CRNAs have been

- -139


made; indeed, he referred to a “chronic battle” over who should administer anesthesia.45 During

cross-examination, Simon testified that he had first thought of becoming involved in UROD in

1995. When he first encountered Dr. Gooberman in April 1996 at an ASAM convention, he

believed that Gooberman was a “quack.” This impression arose because of Simon’s own

background as an anesthesiologist. However, at that time Simon knew “nothing” about the

UROD procedure. He came to Gooberman’s office to view the procedure. Simon performed his

first UROD in November 1996.

Dr. Simon also believes that the competition for available dollars in the health care field

makes persons practicing in one field, such as psychiatry, “hesitant to refer patients out of their

treatment system because if they do there will be repercussions.” The persons “who have been

running the show or have been very influential in the substance abuse community have been

psychiatrists and internists.” Now along comes UROD, a procedure that requires a level of care

that “the other doctors don’t feel comfortable administering.” While by no means the only factor

in the bias against UROD and its practitioners, or at least certain of them, it is nevertheless a

factor. In addition, Simon commented on the motivation of some of the practitioners in the

UROD field to “knock out” other practitioners. Simon related that he had spoken a couple of

years ago to David Yerushalmey, then the CEO of CITA at a time that it was owned by a prior

group. At that time, UROD was a procedure that was viewed by some doctors as “kind of out

there.” It was necessary to get referrals from doctors, counselors, etc., and these people had to

feel “comfortable that this is a legitimate treatment . . . .” Yerushalmey told Simon that “a

distinct goal of his was to put Dr. Gooberman out of business . . . ,” as Gooberman was seen as a

major competitor of CITA. Dr. Oppenheim and Dr. Gevirtz were both associated with CITA at

that time. Dr. Oppenheim later on expressed a similar objective to Simon, around April 2000.

Mr. Maziarski noted that there has always been some tension between anesthesiologists

and nurse anesthetists, who are competitors, and that some anesthesiologists will not work with

CRNAs. When a CRNA is working, a physician must be present. Although some hospitals may

require that that physician be an anesthesiologist, the standard of care does not require it.

Maziarski opined that there is no deviation from the standard of care in an outpatient

setting for a CRNA to administer the drugs used in UROD, including ketamine and midazolam 45 He noted that this battle has even reached the Presidential level, as then-President Clinton had issued HCFA regulations permitting nurse anesthetists practice just before he left office.

- -140


rather than for an anesthesiologist to do so. Nurse anesthetists are trained to provide general

anesthesia and resuscitate patients and to provide a resource to the attending physician. The

CRNA is expected to be able to advise the doctor on what the drugs will do to the patients, and

there is no difference in the standard of care applicable to an anesthesiologist and to a CRNA.

The CRNA must be able to prepare and implement an anesthesia plan for the patient and the

procedure, and manage the airway and pulmonary status. New Jersey’s regulations governing

the practice of CRNAs require that they practice to the standards of the American Nurses

Association (“ANA”).

Count Two, paragraph 2, II. f. alleges that the respondents failed to provide adequately

for the management of possible anesthesia emergencies such as difficult airways. Addressing

this issue, Dr. Kushins noted that if there was difficulty in administering anesthesia there were

various types of equipment available that could be used to intervene. The doctor acknowledged

that in the cases he reviewed such difficulties did not appear to have occurred. There was also

no clear provision made for dealing with difficult airways and no obvious plan to handle

situations that could arise where there might be an inability to intubate or ventilate a patient.

Some patients present with a difficult anatomy, causing problems with intubating the patient.

The standard of care requires that appropriate equipment, including a number of different

devices, be present at the facility and that there be a plan to manage such difficulties. The doctor

explained that in order to be able to manage any difficult airway, it is necessary that the facility

have at least a half-dozen pieces of equipment on hand, including a laryngeal mask, combitubes,

a cricothyrotomy kit, and depending upon the skill of the persons doing the intubation, perhaps

three different kinds of very advanced laryngoscopes. Dr. Kushins did not recall that

Gooberman had any of these types of equipment, however, he did not recall if he asked about

each one specifically.

Dr. Simon explained that problems could arise due to anatomical peculiarities that

prevent the insertion of a tube in the trachea. Normally a facemask can be used in such

circumstances and this allows the patient to breath adequately. However, in a situation that he

labeled as the “dreaded can’t intubate, can’t ventilate scenario,” the tongue falls back in the

throat, or for other reasons air cannot be moved and the patient cannot breath. This must be

fixed quickly or the result can be serious trouble for the patient. A relatively new device, the

laryngeal mask airway, or LMA, provides a means of ventilating the patient in such emergencies.

- -141


The recommendation now is that if anesthesia is to be given, an LMA should be present.

Gooberman had such a device. In addition, when Gooberman was asked about this type of

problem during another hearing, he responded that if he could not intubate the patient, he would

abort the procedure. Simon has visited the Gooberman clinic and observed the equipment

utilized. He characterized the equipment as “appropriate.”

Mr. Maziarski visited the Gooberman clinic the day prior to his testimony. He reviewed

the methods, instrumentation and staffing, and reviewed the charts of seven of the patients at

issue in this case. He is familiar with UROD from his reading of medical literature, but has

never participated in the procedure. He issued an expert report, D-59, which addressed the first

four of the cases, the others having been reviewed later. The medical equipment and furnishings

that he observed were substantial in scope and the facility very well equipped. In addition, he

was advised that the equipment he saw was present at the time that he wrote his report.

Mr. Ragone was familiar with the equipment maintained on site and nothing that he

needed to properly monitor the patients during the UROD was missing. David Monzo, a CRNA

for six years who worked for Gooberman for about three years and was involved in between

eight hundred and one thousand procedures, testified that the Gooberman facility was “better

equipped” than a ITU for airway equipment, with all sizes and types of blades. Monzo never

encountered an airway problem.

Addressing Count 2, II. a., which alleges that ketamine, midazolam and propofol were

administered in doses that were not related to the patient’s weight as well as titrated to the

patient’s response to the drugs,” Dr. Kushins expressed concern that patients were given drugs in

accordance with “standing orders.” According to the monitoring or flow sheets, these drugs

were not administered according to the patient’s weight. The ITU sheets and flow sheets for

these patients indicated that the same doses had been provided regardless of the size of the

patient. This constituted a significant and important deviation from the standard of care. In

addition, markings on some of the flow sheets indicated that the dose of medicine provided to the

patient was not consistent with the orders of Dr. Gooberman. According to the witness,

anesthetic drugs and muscle relaxants are given to a patient based on weight, a certain number of

milligrams or micrograms by body weight. They are also administered according to the patient's

- -142


responses to those doses, which are observed by the anesthesiologist or the nurse anesthetist,

who may then determine to provide additional doses as needed.

Dr. Simon commented on this allegation of a deviation from the standard of care for

anesthesiology. The doctor argued that the statement in subparagraph a. was “misleading.”

There are guidelines in anesthesia that provide for “a very large latitude in dosing.” These are

usually expressed in terms of a range of medication per weight of the patient, such as with

propofol, where the guideline might be dosed at 2.5 to 3.5 milligrams per kilogram of the

patient’s weight. However, in the witness’s opinion, it is more prudent to titrate the dosage to

the patient’s response. This is in part due to factors such as the inherent genetic differences

between patients and the age of the patient.

In summarizing his review of the patient’s charts in this case, Simon opined that in every

case the vital signs were in the normally expected range for someone going through

detoxification. “Indeed, the blood pressure is probably lower and better maintained than it would

be if they were awake.” He observed no deviation from standards in the manner in which

dosages of these drugs were administered.

Mr. Maziarski opined that there were no violations of standards in the protocol utilized

by the respondents regarding the dosing of patients during UROD. Dr. Gooberman had a

protocol that was based upon his research and experience. The patients were given a stick

(syringe) of drugs and propofol mixtures were given to the patient based upon the patient’s

response. Anesthesia is an inexact science. Students are taught that drugs are administered in

doses of so many milligrams per kilogram of weight, but in practice the witness does not do

these calculations because he knows from experience what a man or woman of a particular

weight requires. In addition, even if the calculation is used, particular conditions affecting the

patient may require that he or she be given less or more of the anesthetic for it to be effective. In

general, dosing starts in the middle of the range of the likely need of the patient and then one

titrates to response. Not every individual patient is treated in the same manner.

Questioned about the dosage of the induction agent diprivan (propofol) administered to

persons of significantly different sizes (a 5’3”, 150 pound woman and a 5’10”, 240 pound man),

Maziarski stated that it was necessary to know the nature of the patients before he could

- -143


determine whether any deviation from standards occurred if they received the same level and

amount of diprivan. While a standard baseline is appropriate for use, after that is used it is then

necessary to titrate to the need of the individual.

Mr. Maziarski noted that once patients were stabilized following intubation and the

passage of an appropriate amount of time, their continued monitoring by a critical care nurse was

appropriate, with extubation later carried out by the CRNA or the physician.

Dr. Bradway explained that from intubation through extubation, the attending physician

supervised the CRNA and staff. The CRNA, who was stationed at the head of the bed, usually

intubated and extubated. Bradway rarely performed the intubation and did not extubate the

patient. He induced the anesthesia, using syringes of propofol and ketamine. The doctor was on

one side of the gurney and another CRNA was stationed on the other side of the gurney, handing

medications to the doctor. Sometimes the nurse did inject the medications.

Bradway further explained that the doctor decided the amount of anesthesia to be given.

There were standard quantities, based on body weight and surface area, measured in milligrams

per kilogram. However, clinical judgment was involved, as more or even less of the drug(s)

might be used within the therapeutic window. Naltrexone and other opioid antagonists were

generally injected and the dosage was generally not determined by body weight. Usually one

dose was given, and for withdrawal, the therapeutic range and latitude of efficacy were wide.

The standard protocol drawn up by Dr. Gooberman determined the amounts of the antagonists to

use. What was given was more or less determined by the posted standing orders, but the

determination also involved clinical judgment and observation by experienced doctors. If more

than the measured amount was needed, a little more was added. The standing orders were “good

estimates,” however, the clinical decision as to how much was necessary was almost an

“intuitive thing” and was not a difficult decision. The decision as to whether to administer any

other drugs was always made by Bradway, although the actual administration was performed by

the CRNA.

Dr. Gooberman explained that he developed the anesthesia protocol based upon his

experiences at Cooper Hospital, including consultations with that hospital’s chief of

anesthesiology, critical care nurses and residents. Gooberman explained that there is a range of

- -144


drugs that are given based upon the patient’s weight and then further adjustments are made,

based upon the patient’s response to the medications. Over time, the anesthesia plan was

modified, based upon conversations with other practitioners and information garnered from the

literature.

Count Three of the Complaint alleges that the records maintained by the respondents

failed to record all of the anesthetic agents administered, the amounts thereof and the route and

timing of administration. Dr. Kushins noted that when he reviewed Mr. Melendez's chart he

could not tell when naltrexone was administered. Further, the standing orders did not indicate

the timing for administration, only a sequence. Intubation of the patient and administration of

anesthesia each cause stress and the blood pressure, heart rate and heart rhythm all increase

within minutes of these events. Dr. Kushins also noted that records created during the anesthetic

procedure did not indicate appropriate monitoring, or at least did not record that monitoring of

vital signs was occurring every five minutes. Instead, the records indicate that after the first

three sets of vital signs were taken, monitoring was recorded only every fifteen minutes, in

violation of the standard of care, which required the monitoring and recording of vital signs

every five minutes during general anesthesia. The records themselves appeared, "somewhat

different from the usual records that anesthesiologists or nurse anesthetist keep in hospital or

ambulatory surgical centers." As an example, the doctor discussed propofol, which is also

known by the brand name diprivan. The manner, or route, by which diprivan was administered,

was not clearly recorded and the doctor therefore had to assume that it was administered

intravenously, although it was not specifically recorded in that fashion.

Referring specifically to the records for Lisa Flowers, Volume IV, page 169, Dr. Kushins

opined that they demonstrated these deviations. During the first half hour of the procedure, the

vital signs were recorded every five minutes and then every fifteen minutes thereafter. The

record shows that propofol was administered, as was aminophylline and vecuronium, the latter a

muscle relaxant. The anesthesia records do not show whether opioid antagonists were

administered and do not show the initial drugs given to anesthetize the patient, which would

generally be ketamine, propofol and the initial muscle relaxant. Other flow charts maintained for

other patients similarly do not show this information. It is therefore difficult to infer that doses

were given and when they were administered, and it is impossible to tell which drugs were

initially administered.

- -145


Dr. Simon argued that the respondents are properly held to the standards of care

applicable to addiction medicine, but there are no standards per se for UROD. Except perhaps

for the five-minute monitoring requirement, they did meet the applicable ASA standards as well,

although as non-anesthesiologists, he does not think that they apply to them. As for the

monitoring standard, he believes that the standard for such monitoring in the UROD context may

be evolving to a fifteen- minute requirement. As for records of anesthesia administered, a non-

anesthesiologist administering anesthesia must keep a record, but he does not believe that the

standard of record keeping for an non-anesthesiologist is the same as that applicable to an

anesthesiologist, where the ASA standards are very specific about what must be included in the

record. There is no written document that purports to set the standard for non-anesthesiologists

performing anesthesiology. A proper anesthesia record would include the drugs administered,

how much was given and by what route of administration, although if there is only one route

possible it is not necessarily the standard to show this and, perhaps, it is not even required to

show the route even where there are possible choices in the method of administration. From the

records, one could also determine when the drugs were administered, although in practice one

could not always tell to the minute when that occurred. He conceded that the respondents’

record keeping were at times “sloppy,” however; he did not think there was a violation of

standards to which the doctors should be held.

Dr. Simon also reviewed the anesthesia record maintained for Lisa Flowers. This ITU

record does not meet the typical format utilized by a Board Certified anesthesiologist practicing

in accordance with the ASA guidelines. However, the form exceeds the records that a dentist

would use in an anesthesia procedure. Nevertheless, upon examination Simon agreed that this

document is “sloppy,” because it does not note the drugs that were administered, other than

diprivan, aminophylline and oxygen. The narcotic protagonists are not listed. If considered in

conjunction with the Standing Orders, it might be clear which drugs were given, however, under

the ASA standards a Standing Order is not part of the anesthesia record. Nevertheless, while he

is not sure what standards apply, the Orders do exist and they list the medications and doses

given. While Simon characterized the records as not “optimal,” and while they make for “very

sloppy record keeping,” he believes the ITU records and the Orders should be evaluated in toto.

This said, Simon agreed that he was assuming from the existence of the Order that the drugs

- -146


were actually administered to Flowers in the course of her UROD, an assumption that “probably

I should not make.”

Frank Maziarski testified that the standards of care governing CRNAs require that an

appropriate record be maintained of the drugs administered, the amount given, the route of

administration and the time administered. The anesthetist only records what he or she gives. If

any other person administers a drug, that person should record the information. Considering the

records for Lisa Flowers, Maziarski saw the bronchodilator aminophylline recorded, as well as

propofol and vecuronium. Other than these, no other drugs are listed. Referring to the orders

written by Dr. Bradway for Flowers, there is no recording on the anesthesia records of the

administration of fentanyl via a patch, or of the induction agents octreotide or glycopyrrolate, or

of ketamine or midazolam or of naloxone, nalmefene or naltrexone. This failure to record the

information regarding these drugs is a deviation from standards, indeed in this particular example

a “certainly obvious” omission. It is axiomatic that there must be a recordation of everything

that is induced. If a CRNA knew that drugs were administered and that there was no recording

of that fact, the CRNA had a duty to tell the person who administered the drugs to record them.

Failure to do so and to follow up and make sure that it took place would be a violation of the

standard of care.

Similar omissions appeared in other patients’ records. For example, in Kindig’s records,

the major anesthetic drugs are not shown, nor are the opioid antagonists. While this record is “a

little more complete,” there are still major omissions. Again, neither the antagonists nor some of

the induction agents recorded are in the record for M.J. Other serious deficiencies are found in

the Perez, Melendez and Stavola charts. The Beigelman record is quite different, with a host of

listed agents. While there is some omission of information as to when some of the listed drugs

were given, overall this is a more appropriate record.46

Maziarski acknowledged that he had noticed that the omissions were present in the record

when he reviewed it, but he did not note this deviation in his written report, as he thought that the

protocol was being used as “a check list.” He did not advise counsel for the respondents about

46 Ronald Kumar, Associate Vice President of Pennsylvania Hospital and a CRNA who worked at the Gooberman facility during the years 1994-98, also testified that the records did fail to record medications that were administered. He noted that despite these omissions, the procedures were “pretty much standardized,” and the omission of a drug did not mean that it had not actually been given to the patient.

- -147


his knowledge of these deviations prior to his testimony, terming his failure to do so “an

omission.”

Maziarski agreed that the records do not contain an “anesthesia plan,” which he described

as a plan formulated after assessment of the patient as to how the anesthetist intends to conduct

the anesthesia. A CRNA is both competent and expected to prepare such a plan if he or she is

involved in a procedure. The “plan” might simply be a note, such as “general anesthesia with

sedation,” or “local with sedation.” While such notations are not shown on the records, the plan

would be the same in every case, following the protocol. While the records should ideally have

the plan noted, there may be “slippage.”

Reviewing the standards for monitoring vital signs, Maziarski testified that during a

surgical procedure they are to be monitored every five minutes from beginning to end. However,

there are two parts to this procedure: that part where the nurse anesthetist is involved with the

critical portion of UROD and that part where the patient has been stabilized and is passed on to

the critical care nurse. The critical care nurse takes blood pressure and pulse readings every

fifteen minutes or even longer. Maziarski viewed the critical first portion as lasting fifteen,

twenty or thirty minutes. There was no problem with the longer time period between readings

during the second phase of the procedure up to extubation. Monitoring every fifteen minutes

after extubation has occurred is okay, as long as the patients have been determined to have

recovered their reflexes, secretions and saliva and are breathing normally. The written standards

for monitoring require the five-minute interval monitoring as long as the patient is anesthetized

in the operating room, and then the culture of the institution involved determines how they will

carry out maintenance of the patient in the I.C.U., where the policy might allow for monitoring

on a reduced schedule. New Jersey regulations governing the induction and procedures for

general anesthesia administered by a CRNA in a private outpatient setting under the supervision

of a doctor or a physician’s assistant would supersede any other standards. Monitoring of the

patient between intubation and extubation was done by the CRNAs and other critical care nurses.

Once the patient was stabilized and the antagonist was administered the patient was in

withdrawal. All of the monitoring equipment was alarmed according to established parameters

and if an alarm sounded it was called to his attention. He recalled that there was one critical care

nurse assigned to one or two patients.

- -148


Gooberman identified forms used to chart medications and vital signs, forms which

evolved over the time he performed UROD. The CRNAs brought to him a “busy” document

(Volume II, page 175) that they were commonly used to, which contained superfluous

information. The form was eventually changed. Dr. D’Ambra recommended using a form used

in the Post-Anesthesia Unit at Massachusetts General, a setting that Gooberman saw as “more

analogous” to his own setting. D’Ambra suggested fifteen-minute intervals for recording signs

during the intubation and extubation periods and then a different period during the time the

patient was under I.C.U. type care “although the extubation is still under I.C.U. type care.” A

new form was designed that Gooberman named the “Intensive Treatment Unit,” a name

reflecting the British designation for an I.C.U. His re-designed record was intended to more

closely reflect the I.C.U. records with which Gooberman was familiar. In doing so he deleted

superfluous information and also

unfortunately I left out one of the things I added to this form and . . . in doing the new form, I thought I added it, but I missed it . . . where we would list the induction medications. When I modified this form, the one on Page 175, I added a box to be checked when the induction medications were given to note the time and to note what the induction medications were. When I developed a new form, for some reason, I failed to add that box and not noticing that, when we did the procedures we assumed that the nurses were checking that box and it wasn’t there.

Gooberman explained that it had been his practice that charting was left to the nurses

“and I had not provided them with an area in which to chart that and their assumption was that I

would chart what I gave. However, I can determine when those drugs were given based upon the

rest of the ITU record.” There is no question that the induction drugs were given, basically

within the first five minutes of the procedure,” but he acknowledged that the failure to provide

for and assure the proper charting of the induction medications was his “mistake.”

Post-Procedure Issues

Count Two, Paragraph 2. II. f., charges that the respondents deviated from the standard of

care by permitting patients to be discharged prematurely after they underwent UROD. This

- -149


charge is significantly related to additional issues regarding the reasons for the demise of the

patients.

Dr. Kleber advised that N.J.A.C. 13:35-4A.7 regulates discharge of patients by a

physician who administers or supervises the administration of anesthesia in an office setting.

Subsection (g) provides that such physician “shall ensure” that, prior to discharge,

1) a practitioner is present on the premises until the patient is discharged; 2) the patient is given a written and verbal instructions for follow-up care and advice regarding complications;

3) before the patient leaves the office, he/she is evaluated by the physician and the physician reviews and signs the post-anesthesia record; and

4) the patient is discharged “only into the company of a responsible individual.”

The witness’ concern regarding the manner in which patients were discharged by the

respondents arose from what he read in accounts provided by the caretakers of patients who

claimed that at the time of discharge the patients were unable to walk, had to be totally

supported, were barely coherent and/or were confused. Kleber explained that if a patient were

drifting in and out of sleep, this fact could affect the determination as to whether to discharge the

patient. A patient who exhibited these characteristics would be in danger of falling, of aspirating

and might have trouble sustaining adequate respiration. Where, as in the case of the

respondents’ practice, discharge is to the outside world as opposed to an intensive care unit, the

patient could be at risk for serious complications. This is particularly so where discharge is into

the company of caretakers who are not adequately trained regarding what constitutes abnormal,

as opposed to normal, breathing. The instructions provided to the caretakers about the possibility

of the patient experiencing abnormal breathing patterns were “totally inadequate.” They set the

caretaker up for trouble, as they could not be expected to understand from these instructions how

to distinguish between abnormal and normal breathing, and to understand those breathing

changes that will normalize and those that will not. Thus, Dr. Kleber advocated that in order to

comply with the regulation’s requirement that a patient be discharged into the care of a

“responsible person,” that person must of necessity be someone who has seen a number of

- -150


persons with breathing difficulties and can identify deviations from normally expected patterns,

someone such as a practical nurse, a nurses’ aide, or some such trained individual.

Dr. Gevirtz testified that in his opinion premature discharge of patients played a role in

the deaths of these patients. “They are critically ill patients. They need to be monitored in a

critical care setting, and discharging them to a hotel room is not a critical care setting.”

Gevirtz explained the modified CITA protocol that he put in place for the case series of

123 patients treated at Pascack Valley Hospital and elsewhere between August 1996 and

December 1996. This protocol was drafted to fulfill the standards of the ASA. Gevirtz

explained that after about six hours the anesthesia had worn off. If a patient was retained

overnight, some sedation was maintained and the patient was monitored on telemetry in the

intensive care-type setting until the next day. The median stay was thirty hours. Patients were

not discharged if they still were experiencing nausea and, if vomiting, they were not released.

Patients were not discharged in eight hours simply because they can ambulate. Upon discharge a

whole litany of medications were perscribed to protect the stomach, to control diarrhea, to

control abdominal cramps and back pain, nausea and vomiting. However, nausea should not

persist for days.

Gevirtz discussed the use of a scoring system that he deemed essential for the proper

determination of a patient’s suitability for discharge. The Aldrete scoring system, (P-57), is, in

Gevirtz’ estimation, “the standard.” This system, in the 1995 version published in the New York

State Society of Anesthesiology’s Sphere Magazine, is used in ambulatory surgery centers and

outpatient settings. In his review of the respondent’s records regarding the several patients

whose cases are under review, he saw no notations regarding the Aldrete score. Patients

appeared to have been discharged prematurely, “not having fully recovered from the anesthetic

and from the detoxification procedure.” Using the Aldrete system, Gevirtz opined that a patient

who is discharged while somnolent would score a one or a zero on the score. Under the

procedure he followed, a patient could not be discharged until he or she scored a two, that is,

until they were awake. A patient who is unable to stand without assistance, unable to walk

without assistance, unable to speak coherently and is somnolent cannot be properly discharged

from an ambulatory facility, as that patient may have an impaired airway and is at risk of death if

they vomit when not fully awake and aspirate the vomitus. If their blood pressure is “not all the

- -151


way back,” they may suffer a stroke or heart attack “or something of that ill-being.” “You have

to meet the scores to discharge people safely.” Referring to the possibility of vomiting after

discharge, the witness explained that if an inadequate amount of clonidine was given and if the

patient has not yet fully recovered from the anesthesia, the patient may not be able to tolerate

vomiting and protect the airway fully. “[I]f you don’t quantitate with the Aldrete scoring system

you don’t know whether they can do that.” While there may be another scale used for such

determinations, Gevirtz is unfamiliar with any such scale.

Dr. Kushins also determined that deviations from the standard of care occurred when

patients were discharged despite not yet being sufficiently recovered to warrant their release

from the clinic. The discharge procedures utilized were not in accordance with appropriate

standards for patients who have undergone an ambulatory procedure in which they have been

anesthetized. The respondents’ patients were not appropriately monitored before discharge and

should have been kept at the facility for a longer time, until they were more awake and stable.

Patients were discharged while continuing withdrawal and were not ready to be discharged to a

family member.

In Dr. Kushins’ opinion, if the patient has been discharged from a licensed health-care

facility and has been awake and stable for more than twenty-four hours it is all right to discharge

the person to his family. Acknowledging that the determination as to suitability for discharge is

ultimately a clinical judgment made by a physician, he nevertheless argued that for a patient to

be ready for discharge from recovery it is necessary that the patient be awake, relatively free of

pain, able to follow commands and oriented, and have a stable blood pressure and heart rate

within approximately twenty percent of the patient’s baseline. In addition, although some delete

consideration of color due to its less than objective nature, those who use it feel that the patient

should have appropriate skin color that is pink, not dusky or cyanotic, thus indicating a good sign

of oxygenation. Finally, they should be moving all four extremities on command. The patient

should be awake, coherent, not be experiencing protracted nausea or vomiting and should be able

to take fluids, stand and walk unassisted, and be able to call for help if necessary and should have

someone with them after they go home.

Dr. Kushins also referenced the Aldrete score, which he said was used to evaluate a

patient's suitability for discharge from a recovery room or a post-anesthesia care unit. The

- -152


Aldrete score is used to allow nurses and anesthesiologists to assess a patient's readiness for

discharge from the recovery room or post recovery. Among the issues considered are the ability

of the patient to move his or her extremities, skin color, blood pressure, heart rate, state of

awareness, and respiration. Although the ability of a patient to urinate is not a factor considered

in the Aldrete score, depending upon the nature of the procedure to which the patient has been

subjected, the ability to void may be a proper criteria respecting dischargeability. As for the

patient's ability to walk, this capacity must be assessed in terms of how the patient was able to

walk, that is, did the patient walk independently or with someone standing next to them for

safety. If the patient could not stand up and could not do so by him or her self, then the doctor

did not believe that this was an appropriate criterion for discharge. According to the witness, if a

patient is unable to satisfy the Aldrete score the patient should not be released to go home.

The witness said that the same standards could be applied in either a hospital or

ambulatory surgery setting, or even in an office-based practice. However, the doctor was

unaware whether there were any standards applicable to office-based surgery in New Jersey prior

to 1998.

Based upon his review of the seven patients, Kushins concluded that they had not been

appropriately discharged from the Gooberman facility. The patients were somnolent, too sleepy

and therefore unable to summon help if necessary. They were incapable of independent motor

activity and were at risk for a variety of complications due to their somnolent state. These

complications could include obstruction of the airway, which could result in aspiration. The

patient also might suffer from respiratory depression. If a patient was somnolent, unable to walk

without assistance and was not able to pass an Aldrete, in either its original or expanded version,

then the patient was not suitable for discharge.

Commenting upon notes found in the Lisa Flowers chart, Dr. Kushins stated that

evidence of a positive hand grip and positive head lift, as well as spontaneous ventilation,

seemed like criteria to consider for extubation of the trachea, but these are not really criteria

related to discharge. Extubation of the patient by a CRNA in the presence of the supervising

physician is appropriate. Evidence such as is found in the Beigelman chart, that a patient

ambulated with assistance, does indicate signs of recovery, but the question in his how much

assistance the patient needed to walk. If the patient has to be dragged around, then the patient is

- -153


not ready for discharge. However, if someone simply has to stand next to the patient for safety

reasons, then the patient may well be sufficiently ambulatory to be discharged. Kushins related

that he recalled seeing a caregiver’s report about a patient being “dragged” around the recovery

room and this comment “stuck with him.” He believed that there were reports about patients

being dragged, but the nurses’ notes do not reflect such activity. In addition, Dr. Gooberman did

not say anything about patients having to be dragged.

The doctor criticized the lack of information on the Kindig chart, which did not show

oxygen saturation on room air nor did it indicate vital signs, which should be measured before

discharge. There was not enough information on the chart to allow him to determine if Mr.

Kindig should have been discharged when he was. The doctor based his opinion on whether the

patients were dischargeable or whether they were conscious enough to go home or go to their

hotel.

Dr. Kushins also expressed concern that if the caretaker did not fill all of the variety of

prescriptions provided before arriving at the motel or other location where the patient was going

to begin recovery, the caretaker might have to leave the patient alone in order to go out and fill

additional prescriptions that might be needed. According to the protocol, the caretaker was to

remain with the patient for forty-eight hours and therefore, if the caretaker had to leave the

patient for this purpose, the caretaker would not comply with the protocol. In addition,

caretakers were expected to possibly administer injected medications to patients without specific

training, and nurses employed by the doctors were called upon to make diagnoses of changing

situations over the telephone and then instruct non-licensed, inexperienced caretakers on what to

do to treat the patient.

In conclusion, Dr. Kushins testified that in his opinion, patients were inadequately

assessed before discharge. However, in the absence of sufficient information, he could not say

whether they were in actuality discharged prematurely.

Dr. David Smith was asked to comment specifically as to the acceptability within the

standard of care of the discharge of a patient fifteen minutes after the completion of a four to six

hour UROD procedure. In response, he commented, “it’s a non-question,” because, regardless of

the procedure involved, “the trained physician makes a judgment,” that is, a clinical judgment

- -154


based upon the circumstances with regard to the individual patient. Clinical judgment

“dominates in standard of practice.” Assessing the Lisa Flowers case, Dr. Smith agreed that as

of the time of discharge, the only written note relating to the suitability of the patient for

discharge is a nurse’s note. In his opinion, the discharge of this patient at the time when she was

allowed to leave the facility was appropriate.

Smith did not see any deviation from standards arising from the lack of any indication

that the respondents employed the Aldrete System in determining suitability for discharge. His

understanding of Gooberman’s discharge criteria, as determined by his discussions with the

doctor, is that the patient must be stable, the catheter removed, vital signs stable, and the

caregiver informed of the necessary information. In Smith’s opinion, using analogy, if a patient

were unable to stand and/or walk without assistance, unable to speak coherently and was

somnolent, the patient could still be dischargeable, subject to clinical judgment. However, if the

patient were comatose, unable to ambulate at all, unable to sit up, and might aspirate vomitus,

they would not be dischargeable. Ability to void is an essential characteristic for one to be

dischargeable.

Smith was questioned as to whether the simultaneous existence of four factors at the time

of discharge of the deceased individuals would not link the procedure causally to their deaths.

These factors were identified by the deputy attorney general as follows: they were unable to

walk, to stand without assistance, to speak coherently and were somnolent. He replied that even

assuming all of these individual conditions to be present, they would not be “a medical fact that

would be appropriate to link the procedure and causation.” Neither would the additional fact that

within twenty-four hours of discharge two patients were required to go to the emergency room,

each exhibiting respiratory distress and each having to be intubated and placed on ventilators for

approximately one week before being discharged. Smith explained that for the linkage to be

made, the patients would “have to be dead on the table.”

Dr. Simon identified the issues of concern in general anesthesia regarding the suitability

of a patient for discharge as whether the patient was cognizant, is able to answer questions

appropriately, exhibits stable vital signs, has stable oxygenation and respiration and can ambulate

without much assistance. There are standards published by the American Society of

- -155


Anesthesiologists (“ASA”) in 1998.47 However, criteria for UROD patients may not be the same

as for other patients, and aspects of the ASA standards are not applicable to the UROD

procedure as practiced in Gooberman’s freestanding clinic. UROD patients are physically weak

and do not feel well. They do not look “healthy” and to some degree may appear to be

“debilitated.” There is “something going on in that center of the brain that affects muscular

coordination.”48 In addition, these people are emotional and are very needy people. “They look

different and act differently.” As a result, the standards that generally apply for discharge from

anesthesia do not automatically apply for discharging patients from UROD. Simon opined that

in the UROD setting, if the vital signs are stable, the patient is coherent, can walk while assisted,

can talk and communicate, if the airway is protected and if there is hand strength, then the patient

can be discharged. On the other hand, although he did not recall any such cases, if a patient was

somnolent, the patient probably would not be dischargeable. However, in some instances of

somnolence, depending upon the degree, discharge might even be acceptable.

Dr. Simon had heard of the Aldrete score, but he has never used it at any time during his

training or practice. The Aldrete score is not mentioned in the ASA standards and it does not

constitute the standard of care. Ultimately, the question of suitability for discharge is a

clinician’s decision. In his own practice, Dr. Simon made a decision regarding discharge after

“eyeballing” each patient, even those whose procedures he did not personally perform. While he

never discharged anyone within fifteen minutes of extubation, there were, perhaps, five patients

who were allowed to leave thirty minutes after extubation, and there were some “quick

recoveries.”

Based upon his review of the respondents’ UROD procedures, Mr. Maziarski did not find

that they failed to provide a safe procedure. The nurse anesthetist was in the recovery area with

the patients, as was a critical care nurse. Standards existed for determining the suitability of

patients for discharge; such as head lift capability, muscle tone, consciousness, ability to

maintain the airway and hand squeeze. The Aldrete Score is used as an evaluative device in

many instances, but there are other protocols and there is no violation of the standards of care if a

facility employs its own procedure, so long as it considers the necessary elements. The failure to

utilize the Aldrete is not a deviation from the standard of care. Ultimately, the determination to

47 According to the witness, these standards are probably more stringent than those that were in existence in the 1995-99 period.48 This area is thought to be the nucleus accumbens, which Simon said is thought to be related to muscle strength.

- -156


discharge is left to the sound discretion of the doctor in charge, and a nurse can utilize the

applicable protocol and decide if discharge is appropriate. In Gooberman’s practice, the critical

care nurse/CRNA and the doctor determined if discharge was appropriate.

Maziarski’s review of the charts of six of the patients revealed expected variances in the

vital signs of the patients, but no significant hypotension. Prior to discharge, the patients were

stabilized and were able to walk, talk and breathe appropriately, as well as urinate. CRNAs

came to the facility with the knowledge and training to perform the safe and proper

administration of anesthesia and management of the anesthesia patients. The ratio of nurses to

patients met the proper standards for critical care. The CRNAs stayed at the facility until the last

patient left. There were no deviations regarding the post discharge procedures and protocols. As

far as the standards of anesthesia care were concerned, the UROD procedure was safe. He

concluded that to a reasonable degree of nursing and medical certainty, it did not deviate from

standards of care for anesthesia care.

The files that Maziarski examined do not include discharge notes prepared by the nurse

anesthetist. A discharge note is required for the discharge of a patient, and should include

information about the time of extubation, respirations, vital signs and the condition of the patient

and that the patient is able to maintain his or her airway. The determination to allow the patient

to be discharged is a function of another person other than the CRNA. A patient who cannot

stand without assistance is not stable enough for discharge, nor is a patient who cannot walk

without assistance or who is incoherent. If the patient can walk and talk but is somnolent,

discharge is allowable, but not if the patient drifts in and out of consciousness. Mr. Maziarski

concluded that, as he understood it, the discharge protocol in use by the respondents was

adequate. The patient had to be able to hold a dialogue, understand, walk without assistance for

a distance of about 300 feet, urinate, not exhibit nausea and be able to hold down fluid. CRNA

and ANA standards require that there be a discharge protocol, but they do not require that it be

the Aldrete formulation.

The Lisa Flowers file does not contain a suitable discharge note. The note therein is

“minimal.” There is nothing recorded thereon as to vital signs, nothing about color of the

patient, nothing about whether she was talking. The note does state that the patient ambulated,

urinated twice, and was taken to the door in a wheelchair. Discharge fifteen minutes after

- -157


extubation following a three-hour procedure is “rare,” but if the patient meets the discharge

criteria, it is allowable. However, the witness acknowledged that in his thirty-five years of

experience he had never seen this happen or heard of it from someone else.

Frank Ragone was given guidelines as to what to expect of patients when they emerged

from the anesthetic. He was taught how to assess their condition, including their strength and

mental status. They would be positioned sitting on the side of the bed, dangling their feet and

raising their arms. They would be told to push against his hands, and would be assisted in

walking as needed. An assessment was made as to the patient’s level of consciousness and

ability to ambulate. The patient was helped to the bathroom. If the patient was ready, he or she

was then taken out to see the caretaker, or if not yet ready, was taken back to a bed and Ragone

would go out and speak to the caretaker.

Dr. Simon also disputed the accuracy of the allegation in paragraph thirteen that the

aftercare and treatment or lack thereof either directly or indirectly caused or contributed to the

deaths and/or morbidities at issue in this case. As for persons undergoing detoxification, Simon

sees no problem with discharge to caretakers, giving them prescriptions for medications and

instructions as to their use. In Canada, detoxification is routinely done on an outpatient basis. It

is also routine for nurses to call the night of the detoxification and the next day to check on the

patient. Further, there is no breach of the standard of care if a nurse is permitted to prescribe

medications pursuant to a protocol established by the doctor. If there is any deviation in the

symptoms identified by the patient or the caretaker then the nurse is required to speak to the

doctor. This is a very standard procedure and indeed, it is a part of the licensing requirement for

nurses to understand the need to call a doctor. In the present case, it appears to Simon that the

staff followed the orders and the practice regimen.

Nurse Jennifer Richards commenting upon the discharge phase, noting that when patients

awoke they generally lay for about one hour. However, some wanted to go to the bathroom

immediately. Some vomited after the procedure. A critical care nurse would assess the patient

and determine if they appeared to be ready for discharge, and then a doctor would look at the

patient and decide if discharge should occur. In making her assessment, Richards would

consider whether the patient was able to talk to her, would assess the pulse oximetry and blood

pressure and would determine that the patient was not experiencing any distressful breathing.

- -158


Although she did not consider the ability to stand up by oneself as criteria for discharge, the

patient did have to be able to walk around the hallways twice, sometimes needing assistance to

do so. Patients uniformly commented that they “felt like shit.”

Ms. Richards viewed herself as a patient advocate. When she was employed at Kennedy

Hospital, she sometimes found herself arguing with physicians when the doctor determined that a

patient could be discharged and she, in her professional opinion, did not believe that the patient

was actually ready for discharge. In her professional opinion, none of the patients she assessed

at the Gooberman clinic was discharged prematurely.

Questioned as to whether a somnolent patient who could not walk without assistance,

could not speak coherently and was unable to stand without assistance, was nevertheless

dischargeable, Richards opined that one in such a condition was not “dischargeable from

anywhere,” and insisted that she never observed any patient discharged from the clinic with all

four of these characteristics. Although she noted that there had been discussions in the office

about the efficacy of having patients go home before they started to hurt, she insisted, “it didn’t

have anything to do with being somnolent.” She considered that state in which a patient should

be when discharged from UROD to be the same as if they were to be discharged from same day

surgery.

Ms. Richards had heard of the Aldrete score, but she could not say what it was. She was

not aware of any criteria employed for determining dischargeability in a hospital setting based

upon a requirement that a patient be able to walk some specific number of feet.

Ms, Richards recalled that she learned of visits to emergency rooms by post-UROD

patients. Queried as to such visits occurring within three days after the procedure, she recalled

that she would get calls from emergency rooms about patients who wanted the pellet removed

and the emergency room physician would call to find out “what’s going on, what’s this incision.”

She “guessed” that she had received about twenty such calls. Some people who went to the

emergency room were sick with diarrhea and/or vomiting. Three or four had excessive vomiting

and were given I.V. fluids and sent home. None of the twenty or so patients she received calls

about were admitted to the hospital. She believed that 95% of them went to have the pellet

removed.

- -159


Paula Chalphin, R.N., a registered nurse for sixteen years, who worked for Gooberman

and is now a nurse recruiter, confirmed that prior to a patient’s discharge a doctor would assess

the patient to determine if he or she was ready to go. She too was “vaguely familiar” with the

Aldrete score, but she never employed it nor was she ever required to use it. Each institution had

its own standards for discharge. These were similar to those employed by Gooberman and

Bradway.

David Monzo, a CRNA who worked for Dr. Gooberman for three years beginning in

1996 and was involved in between 800-1,000 UROD procedures, recalled that after Lisa

Flowers’ procedure was completed, she practically extubated herself and “jumped out of bed” to

the bathroom. She was definitely not somnolent, and “she could probably have carried him on

her own.” She was very agitated and was “trying to make time with the patient in the next bed.”

No one had ever seen a patient act quite this way and he would term her as having an “unusual”

recovery.

Rosemary Capelli, R.N., teaches nurses how and what to assess in order to determine if a

patient is ready for discharge. The parties stipulated that Ms. Capelli’s testimony regarding

discharge issues was of a general character and was not intended to address the specific

morbidity and mortality cases under scrutiny in this case. According to Ms. Capelli, it is

absolutely appropriate for nurses to make the decision as to the suitability of a patient for

discharge, although typically a doctor sees the patient before discharge actually occurs and the

doctor always makes the actual determination to discharge. The nurse will take the last set of

vital signs and observations prior to the doctor’s review. Ms. Capelli is not familiar with the

Aldrete scores, although she knew of the Glasgow Loma score, another scoring system that can

be used for discharge determinations, although it is not typically employed. What is typical in

practice is for the nurse to employ his or her observational skills. The patient must be awake,

alert enough to respond to another person and, although not as important as these criteria, should

be oriented as to person, place and time. The nurse can decide whether to employ a more

specific score system or whether there is a need for the doctor to see the patient again before

discharge.

- -160


Ms. Capelli opined that if certain characteristics are typical and expected of patients who

have undergone a particular type of procedure, such as somnolence, an inability to stand or walk

without assistance or incoherence, then discharge with those characteristics present could be

permitted.

Commenting on the discharge procedures for patients, Dr. Katz noted that while everyone

should be monitored for an hour or so, if they were up and around, walking and talking and

coherent and there were no significant arrhythmias, then discharge to home would be okay; in

fact, he added that, “we do it everyday. Unfortunately today we send people home the same day

for all kinds of crazy surgeries.” As for the outpatient, non-hospital setting, the doctor explained

that while he was “very comfortable with an inpatient setting” and his prejudice is to keep

overnight if I can,” given insurance issues, often that cannot be done.

Dr. Bradway testified that determinations to discharge a patient were based on the

standard of care, which he described as being based upon the clinical judgment of the doctor in

charge. While the doctor could not recall if there were any written discharge standards, he

described his actual procedure. Cardiovascular stability, including heart rate, blood pressure,

oxygenation as registered by pulse oximetry and ventilation, were all considered. The Aldrete

score was not used per se, as it contained factors not pertinent to the UROD procedure, being

more attuned to the release of patients from emergent anesthesia to a recovery room and not for

discharge from an outpatient facility.

Dr. Bradway emphasized that it is important to recognize that persons who had just

undergone UROD were in withdrawal, were weak, looked sick, did not appear stable, sometimes

were curled in the fetal position, had hair that on occasion might be standing on end and they

also might be twitching. People are often not used to seeing persons in this condition. In

addition, these patients also exhibit many symptoms for secondary gain, but this is where a

trained clinician can determine how the patient is actually doing. In fact, Bradway suggested

that nearly all of the caretakers for the over 2,300 patients treated with UROD would assert

similar concerns about the appearance and condition of their patient as did the testifying

caretakers of the mortality and morbidity patients. As a part of determining the suitability of the

patient for discharge, the patient had to demonstrate that he or she could ambulate at least 300

feet around the perimeter of the premises. The doctor would look at the coherence demonstrated

- -161


by the patient, the ability to walk, with or without assistance, and the ability to void at least once.

The patient could not be experiencing refractory vomiting and diarrhea, or be unable to respond

to appropriate questions.

Dr. Bradway acknowledged that he did not create or sign a discharge note or a post-

anesthesia note for patients Melendez, Beigelman, Flowers, M.J. or Kindig. In fact, “it was not

our custom” to write such a note, not part of the protocol. He believed that nurses would record

the vital signs and information in the record. He did identify notes regarding the ambulatory

status at time of discharge placed in the notes of M.J. and Victor Melendez.

Dr. Gooberman commented that generally patients were uncomfortable when they first

awoke after undergoing UROD. They suffered from nausea and less often from vomiting,

yawned a lot and stretched, twitched and exhibited spastic movements, and were often weak.

Sometimes for a while, they were autistic in appearance, or they grunted or even exhibited signs

of Tourette’s type activity. Some, such as the gentlemen shown in the video played at hearing,

were far more comfortable when they emerged.

Gooberman had never heard of the Aldrete score before it was mentioned at the

September 1999 Board proceeding. Not all of its criteria were applicable to the UROD

procedure performed outpatient. For instance, the vital signs were affected by the fact that the

patient was still in withdrawal. Additionally, there was some advantage to the fact that the

patient was not necessarily “fully” awake. The withdrawal sometimes caused patients to

experience low back and leg pain. Most were nauseated and therefore were not “encouraged” to

drink. Most voided in the bed or went to the bathroom. He did not compute any scores. He

explained that in determining the criteria for discharge he felt that if a patient could walk with

assistance for 300 feet, or even 150 feet at a time, such would demonstrate a certain sufficient

amount of strength, respiration, and maintenance of blood pressure to allow discharge. The

physiological parameters that such activity required one to exceed were of the sort that one

would ordinarily have to demonstrate following a surgery performed with anesthesia. Many

doctors, including anesthesiologists, came to the clinic and saw what he was doing in respect to

discharge. What he did was “just basic common knowledge and common standard of care and

what I had always done as a physician and seen what other physicians do in terms of making a

clinical judgment.”

- -162


We had patients that before that they fully got up, were fully monitored with respect to their blood pressure. It was charted, their pulse oximetry and it was charted, their pulse and it was charted. They were obviously moving if they were walking . . . They were talking or a lot of times just groaning but they were communicative. Most of the times they weren’t most happily communicative, but they were communicating. These are all basic knowledge for a physician.

Gooberman’s discharge determinations were not made in a manner that was specific to

UROD, but based upon his treatment of patients for years, including in ICUs and discharging

them from hospitals.

He commented on the testimony of persons who said that they had observed patients

dragged around prior to their being discharged. To a limited extent, this characterization is true.

Patients often “flopped” when they were in view of other people. This is a “secondary gain”

mechanism, one that this group of patients was particularly prone to use. In addition, this group

did seem to have some difficulty getting their legs under them. Heroin addicts often have a

certain ambivalence as to whether they want to be helped. They come in for treatment, they get

up to walk to the office, but they “cannot get there” and walk back. Some, as a means of

canceling the scheduled UROD, even lied that they used cocaine the night before. As a group,

they are more prone to lying than is the general population.

Some of the charts indicate that a handgrip was assessed. Some CRNAs used a nerve

stimulator to see how much movement there was after the use of paralytic agents. These were

largely matters of style rather than substance. Other factors looked at were whether the patients

were sneezing, which required the use of a lot of muscle, whether they were moving their head,

their color, respiration, and EKG results. They were also taken to the bathroom, which, while

not a specific discharge criterion, was nevertheless done. Each patient was “absolutely”

examined by a physician before release. Lisa Flowers’ discharge fifteen minutes after extubation

was “not unusual,” as a lot of the patients were able to leave in a shorter period of time.49 In fact,

after Flowers died, he reviewed the charts of the other patients who had UROD the same day as

she did and discovered that two others were also discharged within fifteen minutes of extubation.

49 Gooberman cited one patient, a very well-known rock musician, who, in less than fifteen minutes, “was in the elevator and I had to run after him . . . I couldn’t keep him there.”

- -163


Mr. Maziarski agreed that there was a dearth of discharge notes in the patient records that

he examined. Drs. Gooberman and Bradway acknowledged that they had not included

discharge, or post-anesthesia, notes in the records of patients. Gooberman acknowledged that he

became aware of pending Board regulations regarding record requirements, including the need

for intra-procedure records of drugs administered, and he contended that he had instructed his

then attorney to work with the staff to assure that the requirements were complied with. His

testimony is less than clear as to whether he was actually personally aware of the requirement for

a discharge summary, but again, he wanted the attorney and staff to be sure that the facility

functioned in conformity with the rules. Nevertheless, Dr. Bradway candidly conceded that

while a physician such as himself would evaluate a patient for discharge,

it was not our custom to write a note of discharge. I don’t believe it was part of the protocol. So, I never did it. It doesn’t mean that I didn’t do it. Of course, I did it. My concern is with the patient and I know you can never write enough for patients- -For lawyers and things but the fact is I rather - - my attention was to the patient, not to making a large number of notes available for looking at afterwards.

Count Two, paragraph 2. I.h. alleges a deviation from standards based upon “the

establishment of an aftercare, post-discharge protocol which contemplates non-physicians

prescribing or dispensing multiple medications in response to patient complaints without prior

consultation with a physician.” Additionally, Count Two, paragraph 2. II. i. similarly charges a

deviation because of the “establishment of a protocol and practice which contemplates non

physicians, namely critical care nurses, receiving telephone calls from care givers and deciding

whether additional, or different, medications should be prescribed based on presented

symptomatology without prior physician consultation.” Addressing these charges, Dr. Kleber

commented about the “laundry list” of medications listed on the orders, with, for instance, five

medications listed for sleep, two for anxiety and other such multiple listings for various listed

symptomatology. Apparently, the nurse was to choose the appropriate medication from the list,

but Kleber did not see anything in writing that appeared to guide or direct the nurse as to which

of the listed medications to choose in any given situation. This constitutes a deviation from

- -164


accepted standards. If a doctor is not to personally prescribe, then there must be very clear

instructions as to when and what to prescribe.

Dr. Smith testified that there is no violation of the standard of care involved in having

nurses prescribe medications pursuant to standing orders or protocols. Indeed, he related that

practicing in California, he has a nurse practitioner working under him and has a protocol in the

pharmacy and the nurse practitioner can prescribe. While unfamiliar with the law in New Jersey,

he explained that practice by protocol is part of the health care and treatment team approach.

Likewise, Mr. Maziarski opined that there was no deviation from the standard of care in

the use of medication orders and the determination by nurses utilizing those orders of the

medications to use. This procedure is done in the ICU, with the decision as to which medication

to utilize based upon the symptomatology exhibited by patients. The doctor prepares the

protocols and the medical staff approves them.

Gooberman identified post-discharge orders (Vol. IV, 169-170a) prepared for specific

patients. These were not a protocol. There had been previous versions of these “Standing

Orders.” At first, they were posted at the nurses’ station and reviewed in in-service training;

later they were written out and incorporated in individual orders. In 1995, he might have been

doing these himself. Later, as he brought Dr. Bradway on board, he formalized the orders,

however, he is not sure when that occurred. The orders were administered by the RNs, who were

free to choose the medications from the list based upon the symptoms and the in-service training

they received. All of the nurses had worked in critical care units. No written directions were

prepared to explain these orders.

The doctor explained that in-service discussions were conducted about the twenty-six

PRN drugs listed on the Orders. If a patient complained about a symptom, the nurses had a

group of medicines to use for the particular symptom. Often these had more of a placebo effect

than a real one, as the medications were frequently not very helpful, but the patient at least felt

that something was being done for them. They would feel better after the passage of some time.

Gooberman insisted that the use of a list of medications for nurse guidance was a typical hospital

routine.

- -165


A series of allegations address the alleged deviations from the standards of care in regard

to the determination by the respondents not to require or provide for an overnight stay for their

patients in a carefully monitored, supervised medical setting. Count Two, paragraph 2. I.g.

criticizes “the failure to adequately provide for patient aftercare with appropriately trained health

care personnel.” Count Two, paragraph 2. I.k. both criticizes “the failure to provide safe and

effective procedures and personnel to ensure safe and effective patient recovery” and expands

this to include “the continuation of appropriate addiction treatment.” Count Two, paragraph 2.

II.g. speaks of a failure to provide “safe and adequate patient care post discharge through

adequately trained health care professionals and appropriate safeguards.” Finally, Count Two,

paragraph 2. II.j. alleges that the respondents’ failed “to provide safe and adequate post discharge

procedures and personnel to ensure safe and effective patient recovery from anesthesia and

detoxification procedures.”

Discussing the provision of UROD on an outpatient basis, Dr. Kleber stated that he knew

of no other provider of UROD besides the respondents doing the procedure on an outpatient

basis, although he agreed that there might be others. In his understanding, everyone else

providing UROD does so with the patient staying overnight following the procedure. Indeed,

although the process was evolving, he understood that in 1998-99 there was more of a move to

in-patient treatment. However, he could not say whether this was the standard of care.

Dr. Gevirtz identified the issue of overnight retention as one of the several significant

differences in his approach to UROD from that of Dr. Gooberman. He retained patients for an

absolute minimum of twenty-four hours and believed that the mean stay was thirty hours.

Dr. Smith disagreed that the respondents’ failure to provide for patient retention

overnight constituted a violation of the standards of care, nor did he agree that they had violated

standards by failing to “adequately provide for patient aftercare with appropriately trained health

care personnel.” He likened UROD to other “similar anesthetic procedures,” such as liposuction,

where it is an accepted practice for that procedure to be performed on an outpatient basis with

the outpatient released to a caregiver. Noting the cost factors involved in retaining patients

overnight, he contended that this critique implicates significant “health-care system” issues. If

the patient was required to stay overnight, the cost would increase by two to three times and

there is serious doubt as to whether insurance companies would pay for such overnight stays.

- -166


This same comment also addresses the previously discussed allegations that criticize the

“establishment of an aftercare, post-discharge protocol which contemplates non physicians

prescribing or dispensing multiple medication in response to patient complaints without prior

consultation with physicians.” As in the case of liposuction, medicines are dispensed and

instructions are given to the caregivers and, in the doctor’s view, the standard of care in the field

of addiction medicine for this method is the release of patients to caregivers. The practice is

accepted not only in this particular instance, but also in medicine in general.

Smith recalled that during 1995-99 he reviewed Dr. Simon’s protocol, as well as those

used by Dr. Kazen in Arizona and Dr. Colin Brewer in London, England. Dr. Kazen is not an

anesthesiologist. These protocols contributed to his general fund of knowledge in preparing his

opinion regarding the Gooberman/Bradway practices. He was unable to recall how long Dr.

Kazen retained his patient’s after the completion of the procedure, and was aware that both Drs.

Simon and Brewer kept patients overnight.

Smith further disagreed with the Complaint’s statement that the UROD procedure was

not provided, except in limited locations where its provision is “under conditions believed to be

at substantial variance from those under which respondents provide the procedure, including but

not limited to direction by an anesthesiologist, patient retention overnight and immediate

availability of critical care physicians.” In his opinion, what the Complaint refers to as

“substantial variance,” and which it converts into allegations of violations of the standards of

care, he would call “minor variation with the framework of accepted standards of practice.”

According to the AMA, a physician can use clinical judgment as long as it’s evidence-

based. . . .” Therefore “any variation should not be considered a violation of the standard of

practice….” While he cautioned as to the reluctance of ASAM to be seen as setting the

standards of care, Dr. Smith noted that in the course of formulating ASAM’s policy statement on

UROD, there was extensive discussion on the issue of whether patients should be retained

overnight. Cost factors, trends in medicine and “analogous” procedures such as liposuction were

considered. There were advocates for requiring overnight retention, although he could not

specifically recall who advocated this position. The policy statement ultimately incorporated an

accommodation between the two viewpoints. (There also was considerable discussion regarding

whether the policy should advocate the need for anesthesiologists to perform the procedure or

- -167


whether to allow that other physicians could do so. While not specifically stated in the policy,

there was a clear interest in assuring that a physician was in control). The perhaps three or four

anesthesiologists he spoke to advised that the longer that a patient can spend in the hospital the

better the safety. However, they added that a stay “is not necessary and the trend is towards the

outpatient and that’s where the liposuction example came up.” Thus, release without overnight

retention was “not ideal but acceptable.” Smith was himself surprised to learn how much

surgery was being performed in an outpatient setting.

Dr. Smith did not consider the retention of patients overnight for monitoring purposes to

be a “major difference” in procedure vis a vis the respondents’ practice of not retaining the

patients overnight. In his opinion, the standard of care contemplates both approaches. Indeed,

while he said, “there’s no standard at that level,” he conceded that his methodology might be

flawed, that is, as Dr. Kasser argues, relative to scientific validity, analogy thinking, such as the

analogy to liposuction, “does not rise to the highest level of scientific thinking.” Nevertheless,

while there are no studies on this issue, that does not mean that one position or another is not

true, it merely means that there are no studies. In determining whether Gooberman’s approach

violated the standard of care, Smith, knowing that there were no scientific studies to evaluate

whether the retention or the outpatient approach was better, concluded that he did not violate the

standard of care. In making this assessment, Smith was not guided by what other practitioners

did, given the many scientific and other variables affecting the choice, such as cost and

insurance, and the lack of studies as to what was the better approach. In fact, to the extent that

he relied upon the analogy to liposuction and other procedures that are routinely performed

outpatient, and as he was informed about these by anesthesiologists and surgeons at UCSF with

whom he consulted, the advice was that there would have to be proof, that is, scientific studies,

to justify the higher costs necessitated by hospitalization.

Dr. Cooper testified that the UROD procedure was a “very, very valuable treatment

modality” that needed to be the subject of “ongoing studies associated with ongoing therapy.”

(He also suggested that heightened screening for patients might be appropriate, a suggestion that

“should be considered as a possibility of people who are better qualified to consider it than I

am.”) He also would advise further study regarding overnight stays with telemetry and serum

potassium monitoring. The witness affirmed that there is no way to have predicted at what point

in time a post-UROD patient might suffer a fatal arrhythmia. “Once you have a cocaine

- -168


damaged heart you can go at any time.” If the withdrawal process were reversed “in time,” the

arrhythmia might be prevented. One would have to remove the opiate block and administer

opiates. In addition to reversing the withdrawal procedure, it is also possible that in the case of

these cardiac dysrhythmias, they could have been effectively treated by immediate

hospitalization and emergency intervention. “It may be possible, and that’s why I think it needs

further study.” In addition, the doctor acknowledged that if an individual had been retained

under telemetry, the dysrhythmias would have been discovered and perhaps that would have

made a difference, although the witness pointed out that in the case in Phoenix where the woman

was at least hospitalized, (although he was unsure if she was in an ICU) it did not. Given the

assumption that Dr. Gooberman’s clinic was the equivalent of a ICU, it is fair to assume that had

the patients been retained that the abnormal rhythms would have been discovered and that

medical intervention by a qualified medical person would have been available and that if

necessary immediate transfer to a hospital for specialized assistance would have occurred. Thus,

with those assumptions, that logic would suggest that the failure to have the retention in place

provides a link to the causation of the deaths. However, the doctor could not say how much

better the patient’s chances of survival would have been in such circumstances, as further studies

would be required and the exact type of arrhythmias involved would have to be known. He

denied that there was a linkage between the “constricted period of time (the limited post-

discharge period of retention at the clinic) and the deaths here, . . .”

Acknowledging, “hindsight is always 20/20,” Dr. Simon argued that in the area of patient

aftercare, what was predictable and expected had been appropriately provided for. It is clearly

the established practice in the United States to routinely discharge post-anesthesia/surgical

patients to lay persons. In addiction medicine, persons go through withdrawal and “are in

psychosocial support with lay people. That’s the foundation of AA and NA.” The discharge of a

UROD patient to a non-medically trained person is not a breach of the standard of care, either in

the case of a patient who has undergone general anesthesia or UROD.

Dr. Simon described the routine model in the United States as that described in an article

published in the quarterly edition of “Problems in Anesthesia,” Volume II, No. 1, a well-

respected authoritative journal that, although not peer reviewed, is nevertheless “analogous to a

textbook.” It describes an appropriate caretaker as “a responsible person,” defined as someone

who is physically and intelligibly capable of taking care of the patient at home,” a person who, in

- -169


Simon’s word, “must be relied upon to care for the patient, to be aware of problems should they

occur and to access help if necessary.” Simon contended that this authoritative article points out

that the standard of care does allow the discharge of a patient who has undergone surgery with

anesthesia to the care of a layperson. Indeed, while in past years the length of the surgery was

considered a factor that would prohibit such discharge, that factor is no longer considered a

negating factor. In the case of persons who undergo plastic surgery, patients who have

experienced from four to six hours of anesthesia and four to six hours of surgery are released to

laypersons.

Simon is not aware of any instance in which the respondents breached the standard of

care by discharging patients to non-medically trained individuals. In addition, there was

“probably not” any instance in which any patient was prematurely discharged. Further, it is his

opinion that none of the morbidities or mortalities were related to premature discharge in any

context relating to anesthesia. In this context, Simon disputed that one could suggest that had

these patients been hospitalized for the UROD procedure, they would not have died. Patients

who have been observed in hospitals have in fact expired. While there is a reasonable general

assumption in medicine that the more care the better, it is nothing more than that, “a general

assumption,” but one cannot jump to that conclusion with a certainty.

Dr. Simon expressed concern about an aspect of the Victor Melendez case, in which Dr.

Bradway performed the UROD. He thinks that there may have been “miscommunication” of

information associated with the visit to the motel by Mike Bortnicker, who reported to the

practice that Melendez was “stable.” Simon did not know the causes of the miscommunication;

he thinks that Melendez could have been treated and his outcome could have been improved. He

is uncertain whether this miscommunication rose to the level of a violation of the standard of

care, but it is nevertheless a concern. He was “troubled” that the patient, who was vomiting, was

not given an I.V. and evaluated in person by a physician or even by a registered nurse.

Dr. Simon provided such knowledge as he had on other providers of the UROD

procedure in the United States, including his organization, Intensive Narcotic Detoxification

Centers of America (“INDCA”), and his Connecticut practice, Nutmeg, which managed patients

at Milford Hospital in Milford, Connecticut and in Winchester, Tennessee, San Leandro,

California and Seattle, where the procedure was administered on an outpatient basis, outside a

- -170


hospital setting. Some of the hospitals his organization contracts with treat the procedure as

“somewhat an ambulatory procedure with a twenty-three-hour observation period.” Others call

it “in patient administration.”

The patients treated by Dr. Simon at his Nutmeg facility were “strongly encouraged” to

stay overnight after the procedure in a non-skilled respite area, consisting of three rooms run by a

not-for-profit foundation separate from INDCA and his practice. Eighty to ninety percent of

them did stay. He considered the patients “street-ready” after the procedure and, rather than

going to a motel, as many of the respondents’ clients did, his simply went across the hall to the

respite area. Patients who were in this area were not always monitored, although volunteer

EMTs did monitor patients at first and blood pressures were eventually taken overnight. In fact,

the State of Connecticut would not allow him to medically monitor them overnight. Those who

stayed overnight were then readmitted to the practice the next morning, reevaluated and then

discharged if appropriate. Commenting on the reasons for the overnight stays and monitoring,

Simon said that while he was not sure that he made a judgment that such overnight stays were

medically necessary, at the time he was aware of Gooberman’s case and wanted to stay out of

trouble. In addition, he was a competitor of Gooberman’s and he saw this “overnight stay” as a

marketing tool.

The witness does not presently directly provide the UROD procedure, having entered into

licensing agreements, or as he called them, “cooperative service agreements,” with three

providers.50 His company, INDCA, of which he is the sole owner and chief executive manager,

contracts with anesthesiologists to perform the procedure in hospitals, although he was hazy as to

whether the language of the agreements restricts licensing to only those providers who will do

the UROD in a hospital setting. His intent was that the procedure be performed in a hospital.

One reason for this choice is that the providers are not experienced in UROD and his

organization trains the providers and staff. In addition, in the current climate surrounding

UROD, which is partially the result of this case, it is best from a marketing and public relations

standpoint not to do the work outside of a hospital. When the company is comfortable with the

skill and experience level of the providers, it leaves them on their own.

50 Simon holds several patents for the use of pharmaceutical agents. He did not acquire any of these from Gooberman.

- -171


Dr. Bradway testified that during the summer of 1999 the two respondents discussed the

possibility of retaining their patients overnight or for a longer period. They would then have

nurses monitor them. They did not reach a conclusion as to what was the appropriate thing to do.

He also stated that the issue “may have been discussed periodically” from 1996, after each of the

deaths, although not in the same degree for each and depending on the information they had

available to them. They wondered whether it would have made a difference if the patient had

been kept overnight and observed or placed in a cardiac unit in a hospital. “We’re always second

guessing ourselves and trying to determine other factors that are involved. I think we’re our own

worse critics in that regard, and I think we’re always soul searching for answers.”

Dr. Gooberman acknowledged that dozens of UROD recipients went to the emergency

room sometime after receiving the procedure. However, he did not concede that these people

had to go to the ER, only that they went. He testified that he was aware that some people went to

the ER because they wanted the naltrexone pellet removed. He was not sure how many of those

who presented themselves to the ER following UROD had been hospitalized, although he

personally placed three or four patients in the hospital himself. When he characterized the

number of persons who went to the hospital before the Medical Practitioner Review Board, he

used the phrase “dozens,” to contrast with “hundreds,” however, the figure stated was a general

one, as he did not count the number of calls he had received over the years about persons being

hospitalized.51

51 The actual exchange was as follows: “DR. ROKOSZ: What about hospitalizations within 72 hours of rapid opiate detox treatment?DR. GOOBERMAN: Hospitalizations are more common. We, of course, mentioned the ones that we had hospitalized from the center. Patients do frequently go into emergency rooms in the first couple days to try to have their pellets removed. Caretakers certainly do take people to the emergency room and for a variety of reasons; sometimes they are just dumping them.DR. ROKOSZ: How many were admitted to the hospital, though?DR. GOOBERMAN: I don’t know the number; but there are patients that are admitted. Usually the admission is because most of them occurred in the beginning, when the emergency rooms were not aware of what was going on. And now, realizing what’s going on, they might give them some fluids and sent them out again.DR. ROKOSZ: How many approximately do you think it would be? Are we talking about dozens? Are we talking about a couple?DR. GOOBERMAN: I think we are talking about dozens.DR. ROKOSZ: Do you know if any of those were intensive care unit admissions?DR. GOOBERMAN: Yes, they were intensive car unit admissions. If the ER doctor calls me and we have a patient that’s flopping around and having muscle problems, I usually would recommend at this point just reintubate them, put them in the unit; they will be okay in the morning. What happens is when they get to the emergency room, the first thing they do, because they are flopping around, is they tie them down. Once they tie them down, they get combative because they can’t stand to be restrained. Or they will give them sedatives, which can sometimes also make them combative. If they don’t do anything and just let them relax, they will get better. It’s just a matter of waiting, but it’s not a pretty thing to watch. And it’s somewhat disturbing to an emergency room, so I say, if you have to do something, protect their airway, put them on a drip; and they will be okay in the morning.”

[Transcript of investigative inquiry of 9/2/99, pages 240-242.]

- -172


As noted previously, Count Two, 2.I.j., alleges that the respondents violated standards of

care in that they failed “to provide safe and effective procedures and personnel to ensure safe and

effective patient recovery and continuation of appropriate addiction treatment.” Count Two,

2.I.b. asserts that the respondents violated standards of practice by failing to “affirmatively

arrange for post-detoxification counseling as an essential component for rehabilitation.”

Witnesses discussed the topic from the standpoint of UROD as a detoxification process and the

need for ongoing recovery efforts thereafter.

UROD is not Dr. Smith’s detoxification method of choice. Narcotics addicts have a very

high relapse rate: 25% in the first three months, 50% in the first six months and 80% will get to

one to five years. He prefers to use medication as a carrot to get people to attend twelve-step

meetings. Smith does not see UROD as easily transitioning into the psychosocial treatment

mode, which he described as the treatment model that “works the best, which is the integration of

pharmacotherapy and recovery.” In Gooberman’s procedure, abstinence is being induced

pharmacologically with the use of the implanted naltrexone pellet. Despite his personal

preference, the doctor is familiar with Dr. Gooberman’s protocols, which he found contained a

“strong orientation” and “major commitment on the psychosocial in participation of a twelve-

step program.” The twelve-step group does better in the long-term than those not in a twelve-

step program.

He noted that the standards for office-based treatment are evolving. While Dr. Smith has

a recovery group and counseling available in his own clinic, “if you want to mobilize the main-

stream of medicine in an office-based setting, then you have to refer and “Dr. Gooberman is very

strongly oriented to twelve-step recovery, refers to twelve-step recovery, and in fact, he has even

taken some of his patients to twelve-step recovery.” Again, Dr. Smith criticized the charge

contained in Count Two, 2.I.d., which alleges that the respondents failed to distinguish between

patients for whom alternative forms of detoxification would be appropriate. Individuals who

were seeking UROD are people who have tried and failed at other methods of treatment. Dr.

Gooberman is well schooled in the broader issues of addiction medicine and has a strong twelve-

step orientation. His use of the naltrexone implant as a narcotic agonist, leading to abstinence

and recovery, particularly impressed Smith.

- -173


Dr. Simon opined that it is a perfectly acceptable approach to post-detoxification

rehabilitation to encourage participation in a twelve-step recovery program and even to arrange

for an appointment with a counselor. Due to the confidentiality inherent in such programs, there

is no acceptable procedure for affirmatively confirming whether a patient has attended such

programs, other than through the patient him/herself.52 He recalled that he had seen

documentation and, in addition, from his general knowledge of Gooberman’s practice, he knew

that the respondents did affirmatively recommend participation in such programs to their UROD

patients.

Dr. Gooberman identified the standard of care in the addiction medicine field to require

that patients be referred to twelve-step programs, and his patients were referred to psychiatrists

and those from outside the South Jersey area to ASAM certified physicians. In addition, patients

were sometimes actually taken to meetings.

Discussion and Analysis

Authority of the Board

Pursuant to authority granted by the Legislature in The Uniform Enforcement Act

(“UEA”), N.J.S.A. 45:1-14 et seq., the State Board of Medical Examiners may

. . . suspend or revoke any . . . license issued by the board upon proof that the . . . holder of such . . . license

. . .

c. Has engaged in gross negligence, gross malpractice or gross incompetence which damaged or endangered the life, health, welfare, safety or property of any person;

d. Has engaged in repeated acts of negligence, malpractice or incompetence;

e. Has engaged in professional or occupational misconduct as may be determined by the board;

. . . 52 The Attorney General stipulated that twelve-step recovery programs are a recognized form of addiction treatment.

- -174


h. Has violated or failed to comply with the provisions of any act or regulation administered by the board;

Violations of professional standards and/or regulations adopted by the Board and

applicable to the licensee(s) must be established by a fair preponderance of the credible

evidence. In re Polk, 90 N.J. 550, 560 (1982). The Attorney General of New Jersey is

designated by law to serve as the complainant in cases in which sanctions against a licensee’s

privilege to practice medicine are sought.

A State Board licensing proceeding addresses concerns that go beyond the issues and

concerns relevant in a civil malpractice case. In contrast to litigation conducted through the civil

tort system, the State Board, as the administrative body charged by the Legislature to regulate the

practice of medicine, is concerned not only with the remediation of specific wrongs done to

individuals in the past by physicians who engaged in malpractice, but is also charged with the

overall supervision of the profession. The concomitant obligation therefore rests on the Board to

protect the public from those who are unable or unwilling to practice in accordance with the

interests of public health and safety. It therefore must both deter and punish those “who risk the

health and lives of patients through gross malpractice. Polk, supra., at 565; In re Suspension of

De Marco, 83 N.J. 25, 30 (1980). As such, while the evidence necessary to establish tort liability

in a civil malpractice case must necessarily establish that the physician’s conduct not only

violated the degree of care, knowledge and skill ordinarily possessed by and exercised in similar

situations by the average member of the profession practicing in the field and that the physician’s

failure to have and use such skill and care resulted in the patient suffering damage, Schueler v.

Strelinger, 43 N.J. 330, 344-45 (1964), in a Board proceeding, the Board can consider the

demonstrated failure to comply with standards of care, knowledge and skill and the competence

or incompetence of the physician, even where demonstrated deviating conduct has not been

proven to have damaged a patient.

Medicine is not an exact science. The law recognizes that the physician is not a

guarantor of a satisfactory or successful outcome to treatment that he or she renders. “The fact

that a good result may occur with poor treatment, and that good treatment will not necessarily

prevent a poor result must be recognized.” Id. at 344. However, as Schueler, supra, notes, the

law imposes standards to which a practitioner must adhere, standards intended to insure that the

- -175


care and treatment rendered to a patient meets a level of professionalism. However, Schueler

also recognizes that there is often not only one, specific means of conduct by which a physician

can practice in his field without straying beyond the accepted limits. Thus, as has been

repeatedly pointed out here in connection with the practice of addiction medicine and the

provision of treatment to addicted individuals,

A physician must be allowed a wide range in the reasonable exercise of judgment. He is not guilty of malpractice so long as he employs such judgment, and that judgment does not represent a departure from the requirements of accepted medical practice, or does not result in failure to do something accepted medical practice obligates him to do, or in the doing of something, he should not do measured by the standard above stated. Id.

As noted, the Board of Medical Examiners can sanction a physician who has engaged in

“gross” negligence and “gross” malpractice. In re Kerlin, 151N.J.Super.179 (App. Div. 1977)

discussed the definition of these terms.

It is obvious that the terms “neglect” and “malpractice,” standing alone, import a deviation from normal standards of conduct. “Gross neglect” or “gross malpractice” suggest conduct beyond such wrongful action - - how far beyond has been left to the judgment of the Board, subject, of course, to judicial review.

See also In re Jascalevitch License Revocation, 182 N.J. Super. 455, 467 (App. Div. 1982).

In addition, the Board can sanction for “professional incompetence,” a term which the

court in Kerlin, supra, defined as “any inability to conform with proper standards of professional

conduct, . . . .”

Standard of Care

The record substantiates the fact that during the period from 1995 through 1999 UROD

was a relatively new procedure. The record developed here identifies a very limited number of

practitioners in this country, with some others also performing UROD in other parts of the world.

Additionally, the record demonstrates that during those years, there was no clearly recognized

single standard of care for the practice of UROD qua UROD. However, while that may have

- -176


been the case, as Dr. Karan wisely noted, the lack of any single, identifiable UROD standard

does not mean that the practice of UROD was left to “complete anarchy,” to a state of chaos.

UROD was, and remains, a medical procedure used by medical practitioners to treat medical

conditions. These practitioners are charged by their oath, their code of conduct and ethics, and

their status as licensees granted the privilege to act as physicians, to practice “good medicine” in

the best interest for their patients. Further, the UROD procedure, as a means of detoxifying

addicts through a process involving anesthesia, necessarily implicates for those providing it, that

they do so in accordance with the applicable elements of those standards that govern the practice

of both addiction medicine and anesthesiology. To the extent that the practice is carried out in an

outpatient setting, such standards as apply to that type of practice are also applicable. Thus,

while during the period 1995-99, there was not as such a standard of care for UROD, the several

elements of medicine and medical practice that are involved in the provision of this procedure

dictate that a practitioner providing UROD do so to the level of the average member of the

profession practicing in those fields, that is, the average practitioner of both addictionology and

of anesthesiology.

Of course, the specific standards to which the UROD provider is held may depend upon

the applicability of specific practices and standards existing within those areas of practice as they

reasonably apply to the needs and demands of the UROD process. Aspects of anesthesia

procedure and practice may have to be understood in the context of the actual processes involved

in UROD. But, suffice it to say, while the evolutionary process has, and no doubt will, continue

to define the exact parameters of acceptable UROD practice, the fact that in the mid-to-late 90s

the procedure was such a new method does not mean that those who practiced it were free to do

as they pleased and were not answerable to any standards. As for Dr. Gooberman’s

acknowledged significant role as perhaps the most prolific practitioner of the procedure in that

period, it is entirely possible that someone in his role could have established the standard of care

by which the community of UROD providers would be judged. However, for that to occur, his

practices would have to be both accepted by the general community of practitioners of UROD

and, even more importantly, be in accord with the aforementioned “good practice of medicine”

and the reasonably applicable provisions of the practice of both addiction medicine and

anesthesiology. That he and Dr. Bradway were not anesthesiologists is a point of real concern to

the complainant, but, even if the record demonstrates that the provision of UROD by and under

the supervision of a non-anesthesiologist physician is not a per se violation of the standards of

- -177


care properly applied to UROD, they nevertheless, and then especially so, must have conducted

the anesthesia component of UROD in accordance with an understanding of the anesthesia-

related concerns inherent in the use of anesthesia in any procedure and, more particularly, in

connection with the use thereof on persons addicted to opiates and possibly other drugs. They

must then have utilized acceptable uses and practices necessary to assure that the recipients of

UROD received the level of skill and care that would serve to both protect them and deliver to

them the benefits of UROD at the least possible reasonable risk to their health and safety. They

also had to assure the utilization by others under their authority of these practices.

Applying this understanding about the standard of care to which these practitioners were

reasonably held during the years 1995-99 allows an examination of the many specific claims that

they violated those standards, and ultimately, the question of why the seven decedents died and

whether these respondents have any professional liability for those deaths. However, before

reviewing these issues, the foundational question posed by the Complaint as to whether UROD

was an acceptable medical procedure at the time it was practiced by the respondents from 1995-

99, must be considered. Was UROD “beyond the pale,” a procedure of such dubious worth that

in the years in question its performance constituted a per se violation of standards, or,

alternatively, was its performance allowable, at least so long as it was provided in accordance

with appropriately applied standards of care determined in line with the preceding discussion?

The Unofficial NIDA Report

The Attorney General initially filed his complaint on October 1, 1999. The Complaint

asserts that UROD is not an “accepted” procedure. Instead, it asserts that it is, at best, an

“experimental procedure,” the worth of which can and must be assessed only after appropriate

rigorous testing and evaluation. Indeed, the Complaint cites the unofficial 1996 NIDA report

and asserts the lack of “medical, ethical, moral, and financial justification” for the procedure.

This quotation of this highly condemnatory phrase from this document is a seeming indictment

of UROD that serves as an opening theme to the Attorney General’s condemnation of the

respondents’ practices. Yet, while the Complaint goes on at length about these specific issues,

the opening volley seemingly amounts to an independent allegation of improper practice,

separate and apart from the specifics of charges that in their practice of UROD, Doctors

Gooberman and Bradway engaged in specific violations of standards of care and caused or

- -178


contributed to deaths and morbidities. The concept that UROD was, and perhaps still is, a highly

suspect, or even a morally bankrupt procedure, or, at least that until it is subjected to rigorous

scientific analysis and testing it cannot be practiced by any physician, whether an

anesthesiologist or not, without that practitioner violating the dictates of good, ethical practice, is

a stinging assertion that regardless of the care with which the respondents may have acted, they

were nevertheless utilizing a procedure that they should not have even undertaken. 53

It is evident that addiction to heroin and other opiate drugs is a veritable plague. To the

extent that any responsible physician or scientist can develop a safe, reliable, and, given the

dictates of medical need and financial realities, relatively inexpensive means of assisting those

caught in the vice of such addiction, such doctor or scientist can perform a major, indeed, even

an heroic act for the betterment of his or her fellow humans. To a significant extent, the question

posed here is whether the respondents have attempted to do that or have instead simply acted

irresponsibly and outside the limits of professionalism. This question must be considered with

the recognition of the limitations of medicine in general and of UROD in particular.

In its best light, UROD is offered by these respondents as an effective means of

detoxification and as a means of entrée, an opening to abstinence for potential recovering

addicts. It is neither a cure for addiction nor a guarantee of successful abstinence. However,

whatever UROD’s promise may be, it may be that here the respondents, acting for either good or

possibly tainted motivations, have offered to unsuspecting, at risk persons only a procedure of

dubious worth, a serious peril to those who so desperately need both an assist and a hope.

The circumstances of the preparation of the NIDA Report have been the subject of some

discussion and, frankly, some speculation, in this hearing. As the Report was written some six

years ago, an assessment today of the strong language used in the Report at that time to deny the

worth of UROD must be performed with an awareness of the developments since that time. In

considering the status of UROD in 2002, if the evidence now supports the efficacy and safety of

the procedure, practiced either in its “abstract” form, or, for the purposes of this case, as

53 The Attorney General has argued during the hearing and as recently as in his response to the October 2002 motion to reopen the record that the Complaint does not target UROD per se, but only the manner in which the respondents practiced UROD. I respect the Attorney General’s offer that the issue of UROD’s ethical, moral, financial and medical worth is not at issue, but the tenor and character of the evidence presented, as well as the specific element in the NIDA Report, have significantly raised the question as to whether, at least during the 1995-99 period, a practitioner could utilize any form of UROD in his practice. Perhaps the real thrust of the argument is that only someone performing “serious research” could do so, but in resolving the issues in this case, I have decided that it is best to meet head on the questions, and the implications, posed by the Report and the testimony.

- -179


practiced by the respondents, it matters little what NIDA’s unofficial report concluded in 1996.

Of course, it also does not matter if the NIDA Report’s more sweeping conclusions are found to

be unsupportable on this record if the record nevertheless establishes that the respondents’

practice of that otherwise “acceptable” procedure was tainted by impropriety, negligence and

malpractice. Yet, it seems apparent that at its foundation, the Complaint posits the idea that

these respondents used an inappropriate means of treatment, and while the specific manner in

which they provided UROD may yet be found herein to be deficient, it is also necessary to

consider the foundational question of whether any practice of UROD by these doctors between

1995 and 1999 could have been appropriate. Indeed, the Attorney General posits that the real

interest in the NIDA Report is that it should have served as a warning and a notice to the

respondents at the time that they should not have been providing UROD.

Although the UROD concept is apparently not entirely new, the modern development of

ROD, or UROD, has largely taken place during the 1990’s. It seeks to answer a difficult

challenge in the initial phase of removing opiate addicts from the grasp of addiction. As the

record amply reflects, the initial phases of withdrawal are quite difficult, extremely unpleasant

and, to many who attempt to withdraw, too much of a hurdle to overcome. Dr. Loimer and the

others who have followed him, including quite prominently Dr. Gooberman, have sought,

through the development of the rapid detoxification approach, to overcome this initial high

hurdle by allowing the patient to “experience” the initial phase of withdrawal while anesthetized.

Perhaps it might be better to say that they offer the patient the opportunity to withdraw while not

“experiencing” the harshest elements of withdrawal. In its conception, this approach is clearly a

very humane means of encouraging those seeking to stop opiate use to enter the long, never

ending battle of the recovering addict.

Whatever may have been the cause for NIDA to get involved in informally considering

UROD in 1996, one fact is clear. This report, while prepared at the behest of the appropriate

authorities within NIDA, was never officially published. It is therefore “informal,” and while

this does not mean that the worth of its judgments are necessarily any less, nevertheless, at least

as far as this record reveals, it has not been formally adopted as the official position of the

prestigious National Institute. It is therefore best seen as an early assessment by the writers of a

rather new procedure. It is somewhat disturbing that in putting together this assessment, the

authors did not seem to feel it worth their effort to speak to practitioners of the procedure, most

- -180


especially to Dr. Gooberman, then certainly one of the most involved practitioners of UROD,

indeed, perhaps the most involved. In determining what impact the NIDA Report has in this

case, that is, what does it mean in assessing the performance of these two licensees, it is also

important to note that the authors of the Report were not called to testify. The Report, its

statements and conclusions, have been supported and attacked, but the authors have not appeared

(at the behest of whichever party) to be examined and cross-examined as to how and why they

drew the conclusions that they did.

There can be no denying that at the time of the Report, and for all of the time after its

issuance during which the respondents practiced UROD, there was no comprehensive, double-

blind study of the procedure and its effects and effectiveness. Indeed, the Report calls for such

an evaluation.

The Report states that there is a risk of death from UROD and that, apparently opposed to

that risk, there is no known mortality risk “in uncomplicated cases” of opiate detoxification. It is

not exactly clear what the authors mean by “uncomplicated” cases, but the proposition expressed

in both the Report and by experts for the Attorney General that opiate detoxification does not

carry the risk of death is probably an overstatement of the actual situation. The reason for this is

that credibly testified to by Dr. Simon. Some deaths that occur to persons addicted to opiates

may appear to have been the result of heart attacks, yet the deceased may have suffered that

attack while detoxifying and the death may not have been reported as related to detoxification.

Further, as well explained in this record, the persons who died temporally close to undergoing

UROD were decidedly not “uncomplicated” patients. Many, if not all, had an underlying cardiac

disease, condition or defect. Those who underwent the process as performed by the respondents

and did not die may or may not have been “complicated” or “compromised” in similar fashion,

yet of those over 2,300 patients, none died in such a temporal frame as to cause the complainant

to include them in this complaint. In addition, to the extent that a morbidity event could turn into

a mortality event, the record here is largely barren as to the actual reasons for the alleged

“dozens” of hospital visits and/or admissions of recipients of these practitioners’ UROD

services. Thus, the record does not allow us to determine whether any of these visits (many of

which were purportedly requests of the patients for the removal of the naltrexone pellet for

reasons not spread on this record and therefore only determinable by rank speculation) are

instructive regarding the impact of the procedure on others, possibly “uncomplicated.” Given

- -181


the record here, and the uncertainties and strongly differing views of highly competent

professionals, including pathologists, regarding the cause of these deaths of persons who had

UROD, it is certainly probable that some deaths, of an unknown number or percentage, not

attributed to opiate withdrawal and its effects, did indeed result from those non-UROD

withdrawal processes. In addition, we cannot tell whether the authors of the Report would

consider the cases of the decedents herein “uncomplicated,” and apparently, they would agree

that there have been deaths in “complicated” opiate withdrawal.

The authors of the Report suggest that death from UROD could occur from “inadvertent

overdose” of the anesthetic agent or from aspiration of emesis during naloxone-precipitated

withdrawal. Either could no doubt occur, but assuming competent management of the process

and the patient, the likelihood of such events occurring and leading to death is surely very

limited. The record demonstrates quite clearly that aspiration of vomitus by persons addicted to

opiates is a concern and does occur, and that is true even without it being related to a UROD

procedure. Indeed, the respondents were very aware of this, and they listed aspiration

pneumonia as a potential risk in their consent forms. To suggest that there might possibly be a

risk from an “inadvertent” overdose of anesthesia is to state the obvious, and that risk is not

limited to this particular anesthesia procedure, but presumably to all to some extent.

The authors make a risk/benefit assessment and conclude that the benefit that UROD may

offer to a small group of persons “very high risk” in nature and who would refuse longer

detoxification procedures is outweighed, at least pending further rigorous study, by the risk

posed of cardiovascular complications including cardiac arrest and pulmonary edema, citing the

San letter. Several of the expert witnesses have addressed the importance of UROD as a tool in

the armamentarium of addictionologists and other practitioners seeking to help an often

desperate and in many instances endangered patient population. It does seem that the very

possibility of a procedure that allows those addicted to opiates a chance at an easier early stage

of detoxification and withdrawal offers a great benefit, and the risks identified, and especially the

limited and anecdotal nature of the support for those risks, fail to present a very convincing

argument that even in 1996, UROD was so “without ethical, medical, scientific or financial

justification as a clinical detoxification treatment . . . .” On the other hand, the lack of any

rigorous studies of its efficiency, safety and benefits was, and is, troubling. To the extent that the

unofficial 1996 NIDA Report identifies the need for study and raises some concerns that needed

- -182


to be considered and analyzed, it certainly served a purpose. However, to the extent that the

Report’s rather strongly negative, even condemnatory, summation served to spark a licensing

body, acting in its investigatory capacity, to cite the Report as a foundational broadside at

practitioners, I believe that that body, and in the first instance this judge, must push aside any

serious reliance on what the authors of the report concluded and must instead concentrate the

assessment of these licensees’ actions on the evidence produced relating directly to their practice,

the patients they treated and the expert and lay evidence directly relevant to the circumstances of

this practice, these decedents and patients.

At the same time, it is of course important to recall that while in 1996 the unofficial

NIDA Report represented the only identified statement regarding UROD by a governmental or

professional organization, since that time ASAM, a group directly involved in the battle against

addiction, has spoken. Its recognition of UROD as an “appropriate withdrawal management

intervention for selected patients,” presented within the context of its call for appropriately

trained staff and emergency equipment and the other conditions and qualifications incorporated

in its nine point elaboration, constitutes a statement of “acceptance” of the procedure that

recognizes the need for significant caution and control, yet also concludes that it is an allowable

“first step” process, useful for initiation of ongoing recovery in a “continuum of services.”

Of course, both the NIDA Report and Chris Kasser’s 1997 editorial recognize that UROD

had not then been the subject of a double-blind, controlled, randomized study. Ideally, it would

no doubt be more acceptable scientifically and, from a public policy view, perhaps more

comforting, if such a study had occurred before Dr. Gooberman and others started to undertake

any significant provision of UROD. However, even Dr. Kleber appears to accept the difficulty

in designing and implementing such a test in this particular context.

In summary, the unofficial NIDA Report raises issues and concerns, but I CONCLUDE

that the focus of this case cannot, and should not, be heavily influenced by that 1996 Report’s

broad attack on UROD’s alleged lack of “medical, ethical, moral and financial” justification. It

is far better to concentrate upon the details of what the respondents did, or did not, do.

- -183


Specific Charges

Moving on to the Complaint’s assertions about the means and manner of practice

employed by the respondents in their provision of UROD, both the Complaint and the evidence

adduced at hearing suggest that the Attorney General’s allegations of wrongdoing relate to three

distinct, and yet of course highly integrated, aspects of that practice. First, the Complaint

condemns actions and practices, or in some cases the lack of proper action, regarding the period

of time starting with the first contact of a prospective recipient of UROD through the time when

that person was taken into the operating area, the so-called “pre-operative” phase. This includes

the initial information provided to prospects and the screening given, or in some instances, not

given to these candidates to determine their fitness for UROD, or their lack thereof. Second, the

Complaint questions the specific use of drugs and combinations thereof employed by the

respondents to anesthetize the patients, induce withdrawal and manage them during the period

prior to extubation. In addition, also in dispute is the nature and responsibilities assigned to the

members of the team providing UROD, the doctors themselves, the CRNAs and critical care

nurses, and the equipment available to these professionals. Further, the Complaint alleges that

the process and decision making regarding the fitness for and the timing of discharge from the

facility was flawed, and this includes the fundamental question as to the possible need for

overnight retention. This second group of issues falls within the perioperative phase, the last

issue of which leads into the third aspect of the Complaint, that is, the procedures and

arrangements for post-operative, post-procedure care and monitoring and the impact of the

decision not to retain patients overnight in a monitored facility. Finally, in some sense overlying

these aspects, is the question of whether the doctors made the proper efforts to consider

alternative means for patients to detox and whether they made the appropriate provisions to at

least attempt to help the UROD patients move beyond detoxification to twelve-step or other

means of supporting and strengthening their continued recovery efforts.

One “issue” that surfaced during the hearing is the “definition” of the UROD procedure,

or better yet, what part of the events from the time that persons first contacted the respondents’

office until the time that an individual either moved on in life or, in the case of the patients

focused upon herein, either expired or were hospitalized, is properly deemed as part of the

UROD. In other words, is there some part of this continuum that lies outside of the UROD

process? This is important to the extent that the allegation made here is that persons died

- -184


because either UROD caused or UROD contributed to their demise. It is clear that the

“perioperative” of the UROD procedure began with intubation and lasted through extubation.

There is also no question that the intake procedures, post-extubation period until proper

discharge and some period thereafter also must be considered connected to the procedure itself.

Any death occurring therein must be looked at carefully to see if something about the way

persons were “allowed in” to the procedure and/or how they were treated after extubation is

relevant to the reasons for their death. The evidence may show that the actions of the physicians

and staff during the intubation-extubation, perioperative period, including the use of the drugs

involved, did not involve any element of negligence, and that the theory and practice of the

“technical” procedure itself was without fault. Nevertheless, the evidence may demonstrate that

the pre-procedure “intake and screening” of candidates was flawed, thus leading to the exposure

of inappropriately selected persons to what for most candidates was an otherwise safe and

efficient process. Additionally, or possibly alternatively, the evidence may show that the post-

extubation care was seriously flawed. Problems with this care may include both the process

leading to discharge, the decision not to retain patients overnight, or other aftercare issues, such

as the nature of caretakers and the instructions given to them. Thus, it is possible that the

evidence in this case might vindicate UROD per se, but condemn one or both practitioners for

other aspects of their conduct vis a vis the decedents.

Turning to specific allegations of deviation from the standard of care to which the

respondents are properly held, approximately 2,350 persons underwent UROD under the

direction and control of either, or in some cases, both respondents. Each of these patients had to

make a difficult decision to do so. It is certainly reasonable to conclude that each one knew that

by undergoing UROD they would undergo withdrawal from the opiate drug(s) to which they

were addicted. However, a series of charges are made against the respondents, alleging that in

regard to several aspects of their practice they failed to adequately advise their prospective

patients of risks involved in UROD and/or of the investigational or experimental nature of the

procedure itself or of aspects thereof.

The law requires that a prospective recipient of medical treatment receive sufficient

information about the proposed course of treatment to enable that patient to make an “informed

consent” to the treatment. In 1999, the Supreme Court of New Jersey addressed the requirement

thusly:

- -185


. . . New Jersey has long since abandoned the objectively-prudent-patient rule, recognizing the informed role of the patient in health care decisions (auth. omitted). Accordingly, a patient must be informed of material risks, which exist “when a reasonable patient, in what the physician knows or should know to be the patient’s position, would be ‘likely to attach significance to the risk or cluster of risks’ in deciding whether to forego the proposed therapy or to submit to it. [Perez v. Wyeth Laboratories, 161 N.J. 1, 20-21.]

The Court continued, with words that, while stated in a case involving a somewhat

different context concerning the mass marking of the contraceptive implant Norplant, are

nevertheless applicable here, as the record reflects the marketing efforts of Dr. Gooberman to

publicize the availability of his UROD treatment through billboards and mass-media

presentations and appearances.

When a patient is the target of direct marketing, one would think, at a minimum, that the law would require that the patient not be misinformed about the product. It is one thing not to inform a patient about the potential side effects of a product; it is another thing to misinform the patient by deliberately withholding potential side effects while marketing the product as an efficacious solution to a serious health problem. Id.

In Gilmartin v. Weinreb, 324 N.J. Super. 367 (App. Div. 1999), the court wrote that “the

physician must only disclose the ‘risks associated with the proposed treatment’ and ‘dangers

associated with . . . [the] proposed course of treatment.” He is “ ‘not responsible for failing to

disclose a risk’ which is ‘not inherent in the procedure’ and a physician ‘need not discuss a risk

of the improper performance of an appropriate procedure.’” Gilmartin, supra, at 375, quoting

Calabrese v. Trenton State College, 162 N.J. Super. 145, 156-57 (App. Div. 1978), aff’d, 82 N.J.

321 (1980) and 61 Am.Jur.2d Physicians, Surgeons, and Other Healers § 191 (1981). In the

case of a medical procedure, a “‘risk inherent in the medical procedure performed’ means that

the ‘risk is one which exists in and is inseparable from the procedure itself.’” Gilmartin, supra,

at 376, quoting Jones v. Papp, 782 S.W.2d 236, 240 (Tex. App. 1989).

Count I, paragraph 2. I. e., charges that the respondents failed to “clearly and

appropriately identify death as a risk factor in the informed consent form signed by patients.” In

- -186


his proposed findings of fact, the Attorney General presents the “cumulative” assertion that no

warning was provided “despite knowledge of at least six patient deaths.” Of course, in

considering this charge, it must be recalled that despite the Attorney General’s “cumulative”

assertion, the issue must be examined by placing it in context.

At the start of Dr. Gooberman’s UROD practice in 1994, there had been no deaths

identified as being causally related to UROD. In fact, the evidence from witnesses such as Drs.

Kleber and Simon is that at that time UROD was considered a safe procedure. It is important to

remember that Dr. Kleber was the source for the assertion in the NIDA Report that death was not

a risk in uncomplicated heroin withdrawal. Dr. Smith agreed that the mortality rate from non-

UROD detoxification was “very low,” but added that the high risk of overdose following

detoxification had lead to some deaths. Thus, given these understandings within the profession,

it would seem from this evidence that at the start there would have been no duty to warn of a risk

of death. The death of G.W, the first known death of a Gooberman/Bradway UROD patient

occurring in a temporal relationship to the decedent’s UROD procedure, occurred on September

29, 1995. The second, of Frank Stavola, occurred over one year later on December 23, 1996, by

which date, according to Dr. Bradway, the respondents had already performed 671 procedures.

It has been the consistent position of the respondents that they did not then, and, in fact, do not

now, believe that these deaths and the deaths of the other five patients were in any way casually

related to UROD. Thus, early on in the period from 1994 through September 1995 and even

perhaps through December 1996, based upon their understanding and assessment of the situation

and of their experience in performing UROD many hundreds of times, the doctors saw no reason

to begin to advise their prospective patients that death was a specific or inherent risk of UROD.

The primary source for the allegation of a deviation incorporated in this charge came in

testimony presented by Dr. Kleber. He actually did not state his charge in such a temporally

unlimited manner as the complaint does. Kleber commented that to his knowledge, by the time

of the last death in July 1999, the respondents had not warned their patients that there was a

possibility of death resulting from undergoing UROD. He specifically said, “Since - - at that

time the physicians knew of at least six deaths or seven deaths. I believe it was incumbent upon

them to warn . . . .” He did not pinpoint at what point in time, or after how many of the deaths

had occurred, this responsibility to warn their patients came to rest upon the respondents.

- -187


Importantly, the evidence adduced at this hearing from all the experts affirms that death,

which did not occur to any of these patients “on the table,” also did not occur directly from the

anesthesia or directly from the inducing drugs, although perhaps the combination did have an

adverse impact. During the years 1995-99, the respondents could not see any linkage of the

deaths to the anesthesia used, and they thought that given the small number of deaths and the

known death rate for heroin addicts generally, that these passings might have been unfortunate,

yet “random,” occurrences, not the result of something inherent in UROD. Further, to the extent

that they had some reason to believe that the death of Stavola resulted from post-procedure

intake of cocaine, which drug was found in his system, they might also have determined that the

cocaine, and not UROD itself, was the likely contributing factor to death. Even the third death,

that of Marc Beigelman in March 1997, involved evidence of cocaine metabolites found in his

system. This again suggested possible use of cocaine post-procedure, and the respondents again

may have believed that UROD was not the culprit, but that instead post-procedure usage of

cocaine posed a threat to the well being of UROD recipients. Once they saw the possibility that

post-UROD cocaine use might be fatal, they did advise potential recipients that death could

occur if cocaine were used after UROD. Indeed, as Dr. Bradway testified credibly, after each

death he and Gooberman reviewed the facts to the extent they knew them and over time made

some changes in their procedures and protocols.

The Attorney General points to the NIDA Report, noting that the Report discusses the

death reported by San and arguing that it should have served as an early warning to the providers

that there might be a risk of death associated with UROD. However, it is not clear that an

anecdotal report of a single death that might have been causally related is enough to trigger the

need to warn patients, particularly when a practitioner who was even then perhaps the most

experienced provider of the procedure in the world did not find any basis for concluding that

death was actually a risk.

It should be further noted that while there is a responsibility to warn patients of possible

inherent risks and side effects from a procedure, in the case of these patients, given their histories

of addiction and their attempts at other methods of detoxifications and treatment and their likely

desperation, there can be no certainty whatsoever that the disclosure of a possible, even of a

remote, risk of death from UROD would have dissuaded them from undergoing the procedure.

Indeed, although Dr. Bradway did testify that some people walked out when told that people had

- -188


died following UROD, there is probably not much likelihood that it would have dissuaded them.

This is especially so when, even based upon an approach to the proofs in this case most favorable

to the complainant, that inherent risk would most likely occur if the patients suffered from

conditions that might not be detectable pre-procedure. “A patient must be informed of material

risks, which exist ‘when a reasonable patient, in what the physician knows or should know to be

the patients’ position, would be ‘likely to attach significance to the risk or cluster of risks in

deciding whether to forego the proposed therapy or to submit to it’” Perez v. Wyeth

Laboratories, supra., at 20-21. In the case of most, if not all, of the seven decedents and the two

morbidities, I am persuaded that the great likelihood is that each would have gone through with

the UROD procedure even if death had been a listed possible risk.

If the deaths of these patients were for the most part the result of the stress of withdrawal

upon their systems, which were in some cases undetectably compromised, it may be that these

persons died as a result of a risk that is inherent in any withdrawal process, including, and maybe

even more so, UROD. A sufficiently damaged or compromised cardiac system may be a time

bomb that the stress of withdrawal will ignite in certain persons. If the underlying cardiac

problems are not reasonably detectable pre-operatively, that is, by use of equipment and testing

during the screening process that is appropriately used given the specific circumstances of the

patient and the application of the physician’s clinical judgment, then there is a risk inherent in

the induction of withdrawal that certain patients will experience serious, even fatal, cardiac-

related incidents. While the discussion of the findings and conclusions as to the causes of death

of the patients will follow, to the extent that these deaths may have shown that deaths can occur

after UROD even in the absence of patient non-compliance because it induces withdrawal and

because some persons’ systems cannot manage the stress, then it would seem that the law would

require that the patients be advised in advance that there is a risk that they could die or otherwise

experience serious morbidity, even if they appear to the physician to be medically able to

undergo UROD after having undergone reasonable screening procedures. However, in the

context of this series of deaths ,which posed such a mystery to even such an experienced expert

pathologist as Dr. Segal, and which are the subject of such controversy amongst experts as is

reflected in this record, I cannot find that the respondents were at fault for not listing death as a

specific risk.

- -189


Based upon the totality of the evidence, I am persuaded that the respondents did not act

improperly when they did not list death as a possible risk, as they had no reason to believe that it

was a risk inherent in the procedure. Therefore, the charge is DISMISSED.

In Count Two, paragraph 2 I. k. the Attorney General charges that the respondents

deviated from professional standards when they failed to disclose to prospective patients that

UROD was “effectively” an “experimental procedure” and to obtain their informed consent to

undergoing such an “experiment.” Count Two, Paragraph 2. I. i., alleges a further deviation

arising from “the use of fentanyl transdermal patches which were not established as either a

necessary or appropriate drug within the UROD/ROD procedure provided by the respondents

which accordingly introduced an experimental risk into said procedure without appropriate

patient consultation and informed consent.” Finally, Count Two, paragraph 2 II. d. charges

that “the administration of fentanyl” by the respondents was provided “in a fashion such that the

procedure was rendered investigational or experimental in nature without appropriate patient

disclosure and consent.”

Interestingly, none of the parties has addressed these alleged violations to any degree in

their written submissions. Whether this is an indication that one or more parties see this as a

weak point in their case is unclear, nevertheless, despite this seeming disinterest in arguing the

point, it having been raised, it must perforce be resolved.

Each of the alleged deviations from the purported standard of care that centers upon the

use of the fentanyl patch is framed in regard to the issue of notice and informed consent, and is

posited upon the concept that as employed by the respondents, the fentanyl patch constituted an

experimental usage. In the sense that these claims are expressed, there is no suggestion that the

use of the drug did any actual harm to anyone, and presumably, even if the complainant agreed

that it did not (which is not to imply that the complainant so agrees), the charge would still lie,

based as it is on the nature and status or classification of the usage, rather than its result. In the

record, Dr. Segal posited that while theoretically the antagonist naltrexone, on board the patient

through the implant, should have blocked any, or at least any significant, effect of the opiate

fentanyl, nevertheless perhaps the fentanyl “may have contributed” to the deaths, and there are

some “mysterious” findings of fentanyl within the blood or the stomach of some decedents and

speculation as to how that substance could have reached the stomach. Ultimately, considering

- -190


the evidence adduced on this point, I FIND that the evidence does not support a conclusion to a

reasonable degree of medical certainty that fentanyl did cause or contribute to any of the deaths.

This said, whether fentanyl should have been used as it was provided, via a patch medium,

whether such use deviates from accepted professional standards or is simply a “difference” in

methodology without pejorative impact or implication, are matters that need not be resolved in

order to determine the outcome regarding the stated charge that the respondents violated

applicable standards because they did not disclose that their use of fentanyl was experimental.

Thus, as with the overall charge as to UROD itself, these fentanyl issues will be addressed as

questions of “consent” and “experiment.”

The consent forms utilized by the respondents did not state that the UROD procedure was

experimental. They did state that the procedure of opiate withdrawal under general anesthesia

“is a procedure first developed in Vienna in 1989,” perhaps a fair indication that the procedure

was rather “new” and had no long history behind it. The consent form also addresses the

implantation of the naltrexone pellet. As this implantation was a part of the

Gooberman/Bradway approach to UROD, it presumably is also part of the allegation of deviance

from standards governing consent that its use was also not labeled “experimental.” The form

noted that naltrexone was a medically accepted drug for the treatment of drug addiction and that

the implantation method was a medically accepted method of administering many drugs, adding

“however, implanting naltrexone under the skin is a new way to deliver naltrexone” and

“Naltrexone has not been approved by the Food and Drug Administration (FDA) for use in

pellets.” It also cautioned that while oral administration of naltrexone had no side effects, “[I]t is

possible . . . that implanting the Naltrexone will result in new side effects.”

As previously described, Dr. Kleber testified that “recognized addiction experts”

generally agreed that, until the research identified in the NIDA Report was done to “carefully

delineate risks and benefit,” the procedure “should still be considered an experimental

procedure.” Dr. Karan characterized the failure to advise prospective recipients of this as a

“definite” deviation from standards. However, Dr. Smith, an addictionologist who does not

practice UROD, emphatically denied that UROD was experimental. He pointing out the “very

specific meaning” attached to that term within medicine and the undisputed fact that the UROD

procedures performed by the respondents were not a part of any established study of UROD,

were not conducted in a university or research center setting, were not the subject of a research

- -191


protocol, were not conducted pursuant to a grant issued for the purpose of conducting a study of

the procedure, and were not being performed by the respondents as a part of a planned study of

the procedure for publication. Additionally, the medications used were all approved by FDA,

although their use in some instances was off-label. He specifically noted that if an approved

medicine were used for a non-approved use, the usage was not “experimental,” even in the

absence of a randomized, double-blind study.

Dr. Simon, who, of course, was a practitioner of UROD and still has a significant

monetary interest in the procedure, testified that the procedure was “recognized” before ASAM’s

policy statement, however he also said that there were “recognized” procedures that are

nevertheless “experimental.”

Dr. Gooberman attempted to address this question, as, when speaking about the fentanyl

patch, he related, “there was no experiment going on. Experimenting is done for the sake of

knowledge. What I was doing was taking care of patients and trying to relieve their suffering.”

While I do not suggest that he is necessarily correct, Gooberman’s comment may reflect some

distinction, at least in his mind, between the academic study of a medicine or procedure and the

day-to-day work performed “in the trenches” by non-academic practitioners seeking to find new

means of treatment for the patients they see and attempt to treat every day. This dichotomy is

also seen in some of the cases and articles discussed below.

Interestingly, when Dr. Kleber was questioned by Deputy Attorney General Harper about

his attachment of the “experimental” label to the procedure, he said that he “believe(d) that the

procedure is still experimental.” However, while that statement of seeming uncertainty may

have referred to the status of UROD at the time of his testimony in 2001, rather than in the

period 1995-99, when Kleber spoke further, he said

If the doctors who performed it say it’s not experimental - - they don’t put it in their consent form. So, the question is who decides whether something is experimental or accepted and that may be a legal question rather than a medical one. (Emphasis supplied).

- -192


Kleber then posited his understanding that if he was performing a procedure or using a

drug for an indication not approved (later defined by Kleber as meaning not approved by the

FDA, or in other words, “off label”) - -that may be the most relevant thing here. . .”

If I’m using Sipramine, an antidepressant, to treat cocaine use and it’s not an approved use of the Sipramine, I need to inform my patients that this is not an approved use, this is an experimental use and it’s my understanding that if I don’t that there’s been numerous malpractice cases where judgments were rendered because a physician had not informed the patient that the use of this drug was not accepted. I am more aware of that than I am of procedures.

Dr. Smith noted that all of the drugs used in UROD are approved by the FDA, although,

as with clonidine, not specifically approved for use in detoxification. Thus, UROD involves off-

label usage. Seeming to disagree with Dr. Kleber’s characterization, Smith stated that the fact

that drugs are used for other than their FDA-approved uses does not make an experiment out of

such usage, at least in the technical terminology applicable to medical experimentation.

Dr. Smith refers to the technical meaning of an “experiment,” and makes some valid

points regarding the lack of a “research” context for Gooberman’s work. At the same time, it

may be said that if a procedure is used by a doctor that has not been attempted before, or has had

only limited use, and the drugs used therein are used for a purpose not yet approved by FDA, and

they are used in a manner and for a purpose intended to reach a goal that it has not yet

demonstrated that such usage and procedure can both effectively and safely achieve, then there is

certainly a measure of “experimentation” or “investigation” involved, albeit not perhaps the

formal “experiment” or “research” of which Dr. Smith speaks. It is also true that at the time that

Dr. Gooberman first began to use UROD it was a “new,” “cutting edge” process with a limited

and evolving history. At least for some period, if not for the whole time during which they

provided the procedure, the respondents really had a limited basis for predicting if it would lead

to better long-term outcomes for addicts (more on this later). As will be seen from the discussion

below, I believe that Dr. Smith’s comments more properly address what constitutes “research”

than what constitutes “experimental.” Thus, as Smith suggests, the question is how to define an

“experimental procedure.”

- -193


One court has described the responsibility of a health care provider to advise a patient

that a procedure or treatment that the provider is offering to the patient is experimental.

With experimental procedures the “most frequent risks and hazards” will remain unknown until the procedure has been established. If the health care provider has a duty to inform of known risks for established procedures, common sense and the purposes of the statute equally require that the health care provider inform the patient of any uncertainty regarding the risks associated with experimental procedures. This includes the experimental nature of the procedure and the known or projected most likely risks. . . . The underlying tort principles of rationality that require informing before operating clearly demand more information when the proposed procedure is new and untested. [Estrada v. Jaques, 321 S.E.2d 240, 254 (N.C. Ct. of App. 1984)]

The controversy over how or what to define as “experimental” in the field of medicine is

not new. Indeed, in Pilot v. State Health Benefits Commission, 95 N.J.A.R.2d (TYP) 226 (1995),

a decision on remand issued in a case involving a dispute over coverage by the State Health

Benefits Program for the drug Sabril, used for controlling intractable temporal lobe epilepsy in

Europe and legally imported into the United States, but not yet approved by the FDA for use in

this country, I noted a report issued in July 1990 by the Health Insurance Association of America

(“HIAA”) entitled “MEDICAL PRACTICE ASSESSMENT REPORT Coverage for

Unapproved Drugs: A Framework for Decision Making. In that report, the authors, who were

concerned about “the dissatisfaction among providers and patients regarding reimbursement

policies for drugs that are still in varying stages of clinical investigation,” wrote in their

Executive Summary that, “key issues” requiring resolution included “especially the conflict that

exists in medical practice over the designations “experimental,” “investigational” and “generally

accepted medical practice.” Pilot, supra at 227.

The issue of what constitutes an “experimental” use in medicine has been the subject of

some discussion in both case law and medical literature. In a leading case, Rush v. Parham 625

F.2d 1150 (5th Cir. 1980), the Fifth Circuit Court of Appeals, in a case in which it determined

that the Georgia State Department of Medical Assistance should have been allowed at trial to

show that it had a ban against paying for experimental treatment because such treatment is not

“medically necessary,” and that transsexual surgery was experimental, discussed in footnote 11

at page 1,156 what it deemed at that time to be “the clearest articulation of the considerations

- -194


that go into determining whether a particular service is experimental . . . .” This discussion was

found in a letter, entitled Enclosure #2 to Intermediary Letters Nos. 77-4 & 77-5, (1976 Transfer

Binder) Medicare and Medicaid Guide (CCH) P 28, 152 (1976), which was at that time used by

Medicare to explain to its clients and providers why a service was ineligible for reimbursement.

In making such a decision (whether to provide payment for a particular service) a basic consideration is whether the service has come to be generally accepted by the professional medical community as an effective and proven treatment for the condition for which it is being used. If it is, Medicare may make payment. On the other hand, if the service or treatment is not yet generally accepted, is rarely used, novel or relatively unknown, then authoritative evidence must be obtained that it is safe and effective before Medicaid may make payment.

Other courts have cited this excerpt in discussing the “experimental” question. These

discussions clearly establish that a procedure “generally accepted by the professional community

as an effective and proven treatment for the condition which it is being used,” is not

“experimental.” In this case, the more relevant issue is whether a procedure, not yet accorded

such wide acceptance, nevertheless may, be classified as not “experimental.” Recognizing that

there are new and “as a result, relatively unknown,” procedures, the Eighth Circuit Court of

Appeals said in Weaver v. Reagen, 886 F.2d 194, 198-99 (8th Cir. 1989), that in the absence of

general acceptance, one must turn to “authoritative evidence [ ] that attests to a procedure’s

safety and effectiveness” in order to demonstrate that the procedure is not experimental. This

approach is also followed in Peterson o/b/o Peterson v. Utah Dept. of Health, Div. of Health

Care Financing, 969 P.2d 1, 6 (Utah Ct. App. 1998).

Research has not identified case law that has addressed the issue of exactly what

constitutes such “authoritative evidence” in the context of “rarely used, novel or relatively

unknown” procedures. In a law review article published in 1995, Melody L. Harness, What is

Experimental Medical Treatment? A Legislative Definition is Needed, 44 Clev. St. L. Rev. 67,

95-96 (1995), (hereinafter “Harness”) the author writes that, in the insurance context in which so

many issues regarding the status of a procedure or the use of a medication come up,

there is no consensus definition of experimental treatment. Policies often define experimental treatment as treatment not commonly and customarily recognized by the medical community,

- -195


treatment connected with medical or other research, or treatment that has no proven medical value. Frequently, however, policies do not specify the information the insurer will consider in determining whether the treatment is commonly and customarily recognized by the medical community, is connected with medical or other research, or has no proven medical value.

The author suggests a definition for when a drug, device or medical treatment is

“experimental” and, in addition, addresses what constitutes the type of proof that she terms as

“reliable evidence,” useful for establishing the “experimental” status of the procedure. Her first

category, not relevant to the respondents’ UROD practice (although perhaps to Dr. Kleber’s

grant) involves those drugs, devices or procedures that are the subject of on-going phase I, II or

III clinical trials. Her second category seems more relevant to UROD during the period 1995-99

and to the respondents’ activities:

(2) If Reliable Evidence shows that the consensus of opinion among experts regarding the drug, device or medical treatment or procedure is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis.

Reliable Evidence means published reports and articles in the authoritative medical and scientific literature; the written protocols used by the treating facility or the protocol(s) of another facility studying substantially the same drug, device or medical treatment; or the written informed consent used by the treating facility or by another facility studying substantially the same drug, device or medical treatment or procedure.

In New Jersey, the Appellate Division considered the issue of what “experimental” meant

in Murray v. State Health Benefits Commission, 337 N.J. Super 435 (App. Div. 2001). Murray

was a state college employee seeking reimbursement from the State Health Benefits Plan for

colonic hydrotherapy. Murray asserted that the treatment was “thought to be safe and effective

by complementary or alternative physicians.” As part of his initial decision rendered in the

contested case hearing before the OAL, Administrative Law Judge R. Jackson Dwyer determined

that colonic hydrotherapy was not considered safe and effective within the “appropriate

specialty” of gastroenterology, but he determined that the procedure could not be considered

experimental or investigational under the applicable State Plan definition. On review, the State

Health Benefits Commission reversed Judge Dwyer on this latter point, concluding that the

- -196


procedure was experimental and therefore not “medically necessary,” a required condition for

reimbursement. The Commission determined that, while there did

not appear to be any ongoing clinical trials or research studies, the procedure is nevertheless investigational or experimental. Colonic hydrotherapy is prescribed only by a few doctors practicing integrative or alternative medicine. Since it is not deemed safe and effective by the appropriate specialty, it follows that the procedure needs further evaluation before it would be accepted as appropriate treatment. [Murray, supra, at 442.]

In addressing the case on appeal, the Appellate Division, in an opinion written by Judge

Steven Lefelt, J.A.D., noted that the litigation before it was “a poor vehicle” for determining

whether such a non-traditional, alternative treatment should be reimbursable “like treatments that

are prescribed by traditional doctors.” Id. at 39. While the appellate panel applied long-

recognized standards of appellate review which greatly limited its role in reaching the merits of

the dispute and upheld the Commission’s decision, Judge Lefelt nevertheless addressed the

court’s concerns about the Commission’s approach to dealing with the determination of the

“experimental” or “non-experimental” nature of procedures such as that for which Mr. Murray

sought reimbursement. Judge Lefelt noted that the Commission, in addition to looking at

“published reports in authoritative medical literature and governmental regulations, publications

and evaluations,” could also consider “prevailing medical opinion that regards a particular

treatment as experimental.” He further commented upon the Commission’s evaluation that

“traditional gastroenterologists constituted the ‘appropriate specialty of the United States medical

profession’” to which the Commission would look in assessing the “experimental” or

“investigational” nature of the procedure. Id. at 445.

New alternative medical treatments should not be excluded from coverage without careful consideration. ‘Insurer inclusion of alternative and complementary therapies is likely to expand as therapies gain acceptance and credibility, and gain support by data showing that such treatments can contribute to health so as to minimize insurer’s overall costs.” See Michael H. Cohen, Holistic Health Care: Including Alternative and Complementary Medicine in Insurance and Regulatory Schemes, 28 Ariz.L.Rev. 83, 156 (1996). . . . As more and more doctors become familiar with alternative practices, we can anticipate the availability and increasing utilization of unstudied alternative treatments.

- -197


[Kathleen M. Boozang, Western Medicine Opens the Door to Alternative Medicine, 24 Am.J.L. & Med. 185, 186-187 (1998).]

To some degree, the Commission’s approach relating to colonic hydrotherapy could be applied to any future alternative treatment that is not generally recognized or prescribed by traditional doctors. We urge the Commission not to do so routinely. Let us try to explain our concerns. In essence, the Commission has stated that because few to no traditional doctors prescribe this treatment, then the alternative practices must be experimental or investigational. And, therefore, under this rationale, the converse is true, that a treatment will be non-experimental only when traditional doctors begin prescribing or become supportive of the treatment. “Organized medicine, since its inception, has fought to maintain a firm grip on the philosophy of health care generally, as well as on the specific treatments patients should have available to them.” [Id. at 186.]

When other alternative treatments are presented for reimbursement, we hope that the Commission will determine with an open mind which “appropriate specialty” should be searched for “prevailing opinion.” Assuming there are no ongoing or planned trials or tests, the Commission should carefully consider whether the “appropriate specialty” should be alternative licensed medical practitioners of the proposed treatment rather than whatever traditional medical specialty may be related to the treatment. [Murray, 337 N.J.Super. 435, 445-446.]

An interesting and very recent analysis of the issues relating to consent and

“experimental” activity, that also touches on the issue of academic “research” vis a vis the every

day practice of clinical medicine addressed by Dr. Gooberman and the formal definition of

research and experimentation addressed by Dr. Smith, is found in Anchef v. Hartford Hospital,

799 A.2d 1067 (Supreme Ct. Conn. 2002). In this case, a medical malpractice action was

brought against Hartford Hospital and physicians. The defendant’s successfully defended the

suit at trial. On appeal, the principal issue dealt with whether the trial court had properly

excluded the report of a federal commission regarding the protection of human subjects of

biomedical and behavioral research, entitled, “The Belmont Report: Ethical Principles and

Guidelines for the Protection of Human Subjects of Research.” The plaintiff claimed that he had

been injured as a result of an improperly administered program involving a drug known as

gentamicin, a drug known to be nephrotoxic and ototoxic. 54 He claimed that the hospital had

54 That is, toxic to the kidneys (nephrotoxic) and ears (ototoxic).

- -198


failed to inform him that he was a participant in a clinical trial or procedure and had failed to

inform him of the experimental nature of his course of treatment with the drug. The hospital did

not dispute that it had not informed the plaintiff that he was a part of a program that constituted

medical research and did not ask him for informed consent to being a subject of a program of

medical research. In fact, the hospital “vigorously” contended that the program did not

constitute research. It argued that its use of the drug to treat the patient’s suspected enterococcal

osteomyelitis, a potentially life-threatening form of bone infection, was instead “the

implementation of a program or practice of medical therapy, which, in turn, was aimed, not at

validating an untested theory or hypothesis, but at using the available literature, including prior

research and clinical data, for the improvement of patient care and safety.” Significantly, the

issue of whether or not the use of the drug by the hospital constituted medical research or the

implementation of a therapeutic program for patient care and safety was litigated as a question of

fact.

The plaintiff produced evidence that in 1993 Hartford Hospital was the only hospital in

the country that provided a level dose of seven milligrams per kilogram of body weight

(7mg/kg), a dosage not previously tested on humans. The conventional dosage approved by the

FDA was three mg/kg. The hospital had itself described the seven-mg/kg dosage and the one

daily injection by which it was delivered as “radical.” In addition, the hospital utilized a

“protocol,” which meant that if a doctor failed to prescribe the dosage at seven mg/kg as called

for in the protocol, the hospital’s pharmacist would change the dosage automatically. The

hospital had stated in publications to the medical community how its Gentamicin program was a

“radical change from standard . . . administration schedules” and that their program was

different from most other hospital-based programs, involving “a radical change in both the

conventional dosing and administration of the” drug. Data was collected on each patient at the

hospital apart from the patient’s medical record and the doctors at the hospital who were

responsible for enacting the program lectured to the medical community on the findings of the

program. The plaintiff’s expert witness, a physician, identified four reasons for his conclusion

that the Gentamicin program constituted research:

(1) it was “a systematic application to many patients of a given regime, rather than individualization for the patient and the infection”;

- -199


(2) it involved “the systematic collection of data”;

(3) the data was collected “not in the [patient’s medical] chart, but in a research office”; and

(4) the purpose of the program “was to be able to publish [its results] in the medical literature and in newsletters for the hospital staff . . . .”

The hospital countered that the program did not constitute medical research. The doctors

in the hospital’s department of infectious diseases, pharmacy and therapeutics committee,

antibiotic subcommittee and medical executive committee approved the Gentamicin program

before its enactment by the hospital. Their approval was based upon “voluminous data and

known principles of pharmacokinetics and was found by the committees to embody sound policy

for the well-being of the patients and not to constitute medical research. In addition, the program

had been “widely studied for many years before it was implemented,” and was not implemented

to test the drug’s safety. The program was not a clinical trial, there were no control groups or

randomization or double-blinding. The primary consideration behind the program was the

“efficacy of outcome and patient safety.”

The hospital’s expert witness concluded that the hospital’s Gentamicin program was not

research, as the hospital had implemented, “a program rather than a research protocol,” and had

“reviewed all the literature that was available at the time, what had been done in the laboratory,

what had been [done] in animals, [and] the published information on clinical trials [and] research

trials that had been done in Europe and were starting to be done in the United States.” One of

the trials had “indicated that the program was ‘ready for patient use.’ ”

One of the experts, a doctor who was responsible for the implementation of the program

at the hospital, defined the Gentamicin program as “an aspect of clinical practice,” which he

defined as

Understanding . . . what work was done in the past and how this will affect the patients, especially their outcome in the treatment of diseases, and . . . adopting what was done by others and applying that to the care of patients. That’s what clinical practice basically is. This differs from research in that if you have a question that you can’t find an answer to in the literature of sufficient magnitude that you want to find out what the answer to the question is, then

- -200


you have to in a systematic, organized way investigate that issue and find out the answer to the question. They’re two completely separate things.

The Connecticut Supreme Court ultimately did not rule on the issue of whether the

Gentamicin program constituted research. It reserved that determination for the jury. It upheld

the exclusion of the Belmont Report, because the trial court found that it was more prejudicial

than probative, in part due to references to war crimes and the Nuremberg Code. The Court

noted that on the probative side, the Belmont Report contained a definition of research and an

explanation of the line between practice and research. That discussion is perhaps worth

consideration in this case. The Report acknowledged

the distinction between research and practice is blurred partly because both often occur together (as in research designed to evaluate a therapy) and partly because notable departures from standard practice are often called ‘experimental’ when the terms ‘experimental’ and ‘research’ are not carefully defined. . . . For the most part, the term ‘practice’ refers to interventions designed solely to enhance the well being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventative treatment or therapy to particular individuals. By contrast, the term ‘research’ designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalized knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is ‘experimental,’ in the sense of new, untested or different, does not automatically place it in the category of research. Radically new procedures of this description should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective. . . .

Another insight on the status of “new” treatments and whether they are necessarily

“experimental” is discussed in Miller v. Whitburn, 10 F.3d 1315 (7th Cir. 1993), where the court

noted that

- -201


Clearly, the best indicator that a procedure is experimental is its rejection by the professional medical community as an unproven treatment. The quoted passage [from Rush v. Parham, supra.] suggests, however, that different definitions of “experimental” may be necessary depending on the notoriety of the treatment under review. Indeed, certain procedures may be so new and, as a result, relatively unknown, that the medical community may not yet have formed an opinion as to their efficacy. [ ] We agree with the court in Rush that such procedures are not per se experimental. If “authoritative evidence” exists that attests to a procedure’s safety and effectiveness, it is not “experimental.

The above discussion highlights the quagmire that exists regarding the terminology used

to classify the status of medical procedures and other uses of medically related items such as

drugs and the considerations that are involved in attempting to identify the proper category.

While much about this process is cloudy, I FIND that the evidence here is at least clear that the

respondents were not conducting any formalized “research” program involving UROD. There

was no randomization, no double-blinding, no comparative study, no grant, and no oversight

committee, none of the attributes of academic research. Instead, the respondents were clearly

conducting a “practice,” and were utilizing UROD for the express purpose of treating individuals

and attempt to enhance their well-being. The procedure was used to treat with the intention of

providing the individuals with a significant, indeed, a crucial first step on the long road to

continuing abstinence.

At the same time, I FIND that while during the years 1995-99, there were a small number

of practitioners of UROD, the acceptance of UROD amongst the wider world of medicine during

those years and more particularly of addiction medicine, has not been demonstrated. Further, I

FIND that there is controversy amongst the several experts called to testify in this hearing as to

whether it was, at least at that time, properly deemed “experimental.” In the period 1995-99, the

procedure was still quite new and relatively rare, apparently practiced by a limited group of

physicians at various localities in the United States, Europe, the Middle East and perhaps

elsewhere. There is no evidence that up to the time of the 1999 issuance of the ASAM Policy

Statement any governmental or medical professional group had placed its stamp of acceptance

on the procedure. Additionally, as the NIDA Report detailed, there was no evidence of any

randomized, double-blind study, any phase I, II, or III clinical trails or other academic studies

going on at the time. Thus, according to the categories set up by Harness, supra, if the “reliable

evidence” shows a consensus of opinion among experts that the procedure needs further study or

- -202


clinical trials to determine its safety, efficacy or efficiency, as well as perhaps the maximum

tolerances for the dosages of medication used in UROD, the procedure is experimental.

Similarly, according to the Miller court, the question is whether “authoritative evidence” affirms

the procedure’s safety and efficacy. In the absence of the studies and research analysis, the issue

of the existence of such “authoritative” and “reliable” evidence rests mostly upon the opinion of

experts.

The ultimate determination of whether UROD was “experimental” during these years is

made more difficult by the fact that over that time the experience of the respondents in utilizing

the procedure went from the very limited experience that Gooberman had in the hospital setting

to the experience garnered over hundreds and hundreds and then again hundreds more

procedures. It may be that when he first began to offer UROD that Gooberman should have

advised his patients that there were no studies of UROD’s safety and efficacy, that the outcome

vis a vis other forms of detoxification was as yet unclear, and that there was an “experimental”

aspect to the procedure. Later on, when his own experience and follow up indicated that the

procedure was safely applied to hundreds of patients and that the procedure did detoxify and

with implantation of the pellet offered a thirty to sixty day period during which opiates were

blocked, it may have then been appropriate and ethical for Gooberman to stop using the

“experimental” tag. In this vein, an important question that must be asked is at what point a

procedure that properly fits within the category of an “experimental procedure” no longer must

be considered experimental. This question must arise because, while the evidence in this case

does suggest that in 1995-99 there were experts who viewed UROD as experimental, Dr.

Gooberman, who was generally conceded to be not only an expert, perhaps even the expert, on

UROD, but also with his associate its most active practitioner, was actively performing the

procedure hundreds and hundreds of times, with occasional refinements but in essentially the

same manner each time. If the purpose of UROD was that it serve as a means of providing

accelerated detoxification via the placement of the patient under anesthesia, the induction of

withdrawal by means of the introduction of opiate antagonists, followed by extubation and then

discharge to continue withdrawal and, hopefully, to continue abstinence, then it would appear

that their UROD procedure was overwhelmingly successful. In this instance, the success or

failure of a patient to continue to abstain cannot properly be considered a measure of the success

or failure of the procedure, for UROD could only promise or reasonably be expected to detoxify

the patient and give him or her a “fighting” chance to advance ahead in time as a recovering

- -203


addict, rather than as an active one. The question is then, if a physician/expert in a new or

relatively new and rarely tried procedure tries out that procedure, repeats it over and over and

over, hundreds of times, and finds it to be successful and then continues to employ it, can the

procedure move from the “experimental” category, despite the lack of generalized acceptance

within the appropriately defined medical community, Murray, supra, or even the consensus of

opinion among experts that more study is needed?

In M.K. v. Division of Medical Assistance and Health Services, 1992 WL 280789 (N.J.

Adm.), Judge Tolomeo quotes at length from an article entitled, “Transsexual Healing: Medicaid

Funding of Sex Reassignment Surgery (1991)

When a new medical treatment is introduced, it must be considered experimental because its safety and efficiency are unknown. As experience with the treatment is documented, its risks, side effects, and success rate are detailed. At this point, the medical community decides whether the benefits of the treatment outweigh the risks (taking into account alternative treatments and the natural course of the disease untreated). If the medical community continues to offer the treatment, it can no longer be considered experimental. Subsequent research in the field is directed toward increasing the success rate by developing a method of identifying prospectively those applicants for treatment who will likely have a negative outcome and/or those who may respond to an alternative treatment. Continuing advances in this area of investigation does not, however, mean that the treatment continues to be experimental; rather, it represents the continuing refinement of an established treatment. . . .

As the above discussion of what constitutes an “experimental procedure” amply

demonstrates, the courts, commentators and medical profession have all struggled with defining

the proper classifications and have recognized the confusion surrounding this medical and legal

issue. In determining whether the respondents violated their ethical and professional standards, I

am persuaded that at least in the early stages of Dr. Gooberman’s practice of UROD, there was

an experimental aspect to his use of the procedure. In the mid-90’s UROD was still a very new

and largely unaccepted procedure, which did not have much of a literature and did not have any,

or at least any significant, research to support its efficacy and safety. While his consent form did

mention that the procedure had only originated in Vienna in 1989, he did not choose to advise his

potential patients that it was not only very new, but largely untested. Although I believe that

- -204


there may well have been a point in time during the period 1995-99 when Gooberman, and

therefore, Bradway’s experience with the procedure had become such that there was no longer a

need to advise candidates for UROD that the procedure was experimental, I CONCLUDE that,

at least for the first few hundred procedures, the consent form should have advised the prospects

that the procedure they were agreeing to have was just that, “experimental,” new and not yet

significantly tested, Estrada, supra. It is probably true that this would not have deterred many;

indeed, very few of the desperate persons who sought Gooberman’s help would likely have

declined to undergo UROD even had they been so informed. However, at least when dealing

with the major aspects of a new and largely untested procedure, a physician has an obligation to

provide full disclosure to a patient as to the risks and benefits of that procedure and that

obligation cannot be avoided because ultimately the information may not make a difference to

the patient. Thus, I am constrained to CONCLUDE that Dr. Gooberman did violate

professional obligations and standards on each of these occasions. Given the uncertain nature of

the point in time when Gooberman’s experience was such as to permit him to ethically dispense

with the experimental label, I decline to conclude that Dr. Bradway acted in violation of these

requirements.

Turning to the use of fentanyl patches, Dr. Gooberman explained his rationale for

utilizing this opiate drug and the delivery mechanism he employed. He believed that it might

serve to modify some of the unpleasant effects of withdrawal, while being provided at so low a

dose as to pose no risk to the patient. While the record contains expert criticisms of the basic

theory and some speculative and unproven concern that fentanyl could perhaps have played a

role in the demise of patients, in this specific context neither the record nor common sense

supports a finding that Gooberman’s patients were at all likely to have considered information

about the fentanyl and the patch as a material factor that might have dissuaded them from

proceeding with the UROD procedure. Further, there is no significant evidence that Gooberman

should have foreseen any risk in using the drug as he did. He cited literature and experiments

with the patch modality for the delivery of therapeutic drugs and appears to have had a

reasonable medical basis for what he did. While it may be that his use did constitute an

experiment, a first attempt to see if the patch method could help ameliorate some discomfort for

his patients, nevertheless, I fail to see that it is reasonable to condemn him for a violation of the

consent requirements. The charges are therefore DISMISSED.

- -205


Count Two, paragraph 2. I. f. charges, “the creation and implementation of a complete

waiver of patient confidentiality including, but not limited to, an acknowledgement of the right in

Dr. Gooberman to publicize medical data and treatment provided to the patient within the public

media. Said waiver, when viewed in relation to Dr. Gooberman’s media (billboard) advertising

stating the procedure offered is confidential, is both a deviation from accepted practice standards

and a deceptive and misleading practice.” Even Dr. Simon has acknowledged that the inclusion

in the consent form of a waiver of confidentiality was a deviation from standards. The fact that

there is evidence in the record that at least one, patient crossed out the waiver is insufficient to

eliminate any violation of the standard by the respondents. If the standard does not allow for

such a waiver, than the possibility that an alert and sufficiently offended patient or advising

caretaker accompanying the patient might see fit to object and to even physically eliminate the

waiver by crossing it out is not a defense to a finding of a violation. This is especially so given

that there was at least some evidence that at the time that patients arrived for their treatment and

received the standard preliminary information they were occasionally already under the influence

of drugs, and in addition, the patients and their caretakers were often quite desperate and looking

to the respondent(s) for some last measure of hope. It was, and remains, the responsibility of the

provider to assure that his practice is conducted in accordance with the proper legal and ethical

standards, and it is most assuredly not the responsibility of the patients to do so.

I CONCLUDE that the inclusion of a waiver of confidentiality in the consent form

constituted a violation of the standards to which these professionals are properly held.

Obviously, there were multiple instances of this violation being repeated in connection with over

two thousand patients.

Count Two, paragraph 2. I. c., charges that the respondents failed “to properly establish

inclusion and exclusion criteria for patients undergoing” UROD. Count Two, paragraph 2. II.

c. charges that the respondents failed to “adequately preoperatively assess patients cardiac,

respiratory, hepatic, and renal systems to determine their ability to tolerate the exceptional

stresses of the UROD/ROD procedure.” In analyzing these charges, it must first be remembered

that the procedure was offered as a means of detoxification for persons addicted to the use of

opiates, persons who, in many, if not in most, cases were long-term users who had tried other

means of detoxification and were not successful in achieving a “permanent” end to their opiate

use, but had reverted to active use. Clearly, each of the persons who sought to obtain UROD

- -206


from the respondents and who fit this profile was a potentially appropriate recipient. Dr. Smith

noted that it is generally believed that those who are treated do better than those who are not and

Dr. Simon expressed his concern about the need to treat people and his discomfort with the

notion of not detoxifying someone in need of detoxification. However, granting that a procedure

that theoretically offered some hope of a less difficult withdrawal and a new start on the path to

abstinence would ideally be available to all addicts, the issue of criteria for “inclusion,” that is,

who is a suitable candidate for UROD, and “exclusion,” that is, who is not, implicates such

issues as prior cocaine use/abuse, pre-existing cardiac or other serious health problems, the

truthfulness of potential patients about their experiences and the need, if any, for screening

patients for the existence of evidence of existing serious medical conditions, pregnancy or recent

use of cocaine. While the need to obtain treatment by those addicted to opiates is clearly a

pressing concern, exposure of an individual with medical or other conditions or activities that

contra-indicate the use of UROD as the means of treatment is not, one presumes, in the best

interests of even such a desperate person, at least unless it could be shown, as Dr. Simon

wondered, that the prospective UROD recipient would be in at least as much potential peril from

other forms of detoxification as he or she would be from UROD. However, as the evidence

shows, not all of the experts agree as to what exactly are the appropriate exclusion criteria.

While pregnancy is accepted by all as an exclusionary condition, there is significant dispute as to

whether subjecting cocaine users to UROD is a violation of the appropriate standards and, as to

at least some cardiac issues, there is much dispute as to whether reasonable means of pre-

screening patients for the existence of such conditions would be likely to reveal their existence.

Further, as several witnesses stressed, there is an overriding “clinical judgment” factor that

cannot be overlooked or denigrated. With at least some of the factors favoring exclusion, the

reasonable and studied judgment of the clinician experienced in the procedure may properly lead

to an appropriate conclusion to go ahead despite the risks posed by the existence of the

exclusionary factor.

I FIND that in general the expert evidence supports the conclusion, on the one hand, that

there is no standard of care that requires that patients under the age of forty be given a twelve-

lead EKG before surgery if they have no known history or significant medical problems. On the

other hand, those over the age of forty should be given such an EKG. Further, there is no

standard generally requiring an echocardiogram for these patients. Dr. Kushins acknowledged

that the standards do not require such testing prior to the application of anesthesia to a patient

- -207


under forty. The respondents testified that they did not universally employ twelve-lead EKGs, or

EKGs generally, in pre-screening patients, except where there was some indication that caused

them to specially require one, which might be done as part of a consultation with their cardiac

consultants.

The testimony of Dr. Katz was particularly interesting. Katz explained that as a

cardiologist he wanted to have as much information as possible and felt that an

electrocardiogram was a “crucial part of the examination.” However, he clarified that, as a

cardiologist, he would want these tests performed when he saw signs or symptoms that he did

not like and that he “wanted to pursue.” He hedged on whether the lack of an EKG was a

deviation from standards, although suggesting that it was perhaps “something of an impropriety.”

He also stressed that the physician must use “personal judgment.” Significantly, while given the

nature of the patient population for UROD in 1995-99, he would have preferred to see an EKG,

he did not know what the standard of care was for this in addictionology at that time. In

summary, despite what I think can fairly be characterized as a good bit of “hedging,” he did

conclude that the physician who was “reasonably prudent” would have required at least a

minimum of a twelve-lead EKG.

Dr. Katz’s testimony is significant, and not only because his testimony, while presented

as a witness for the respondents, may be read as somewhat adverse to their position and interest.

It demonstrates perhaps the difference in approach of a self-described, “very cautious”

cardiologist and a non-cardiologist toward testing, and perhaps it is true that Dr. Katz has, in

assessing this issue, the benefit of hindsight that the respondents did not have in 1995-99. Yet,

as he emphasized, the nature of the patients these physicians were treating cannot be overlooked.

Given the makeup of this patient population and the good chance of multi-drug abuse and

cocaine abuse by the respondents’ prospective patients, it may not have been too much to ask or

to expect of the respondents that they routinely employ twelve-lead EKG’s. However, to say

that Dr. Katz’s comments as to the desirability of such “universal” testing regardless of the age

of the patient represents the state of the practice in addictionology or anesthesiology during the

1995-99 period, during the acknowledged evolution of standards applicable to UROD, is, I

suspect, to give it too much weight. Hindsight is a valuable assist to those seeking to determine

mistakes after the fact; however, it is not available in time to those who are later subject to

criticism. Additionally, what someone may find preferable, or what one may do in order to be

- -208


extra-cautious or conservative, is not always what one is required to do in order to meet the

generally accepted standard of care within the profession. Based upon the record adduced here, I

FIND that there was no applicable standard of care for either anesthesiology or addictionology in

1995-99 that required that prospective UROD patients be given a twelve-lead EKG as a routine

pre-screen if they were under forty years of age and did not present any other evidence of cardiac

disease. However, for patients over forty years of age who were to undergo a procedure with the

components involved in UROD, the standard required that patients receive an EKG during pre-

screening. As the respondents did not routinely require this, and as the records do not reveal that

any such testing was performed for patients Kindig, who was 50, M.J., who was 44, Stavola,

who was 43 and G.W., who was 40, I CONCLUDE that they breached the standard of care

when they did not insist on an EKG.

Most of the expert witnesses discussed in some detail the problems and challenges

presented by the fact that a percentage of the opiate addicted individuals seeking UROD were

also cocaine users/abusers and often used other drugs or alcohol. In criticizing the respondents’

inclusion/exclusion criteria (or lack thereof), Drs. Kleber, Karan, Gevirtz and Kushins each

commented on the need to establish co-morbidity, cocaine use, etc. This led to additional

criticisms concerning the lack of use of cocaine dipsticks and/or trans-thoracic echocardiograms,

the later specifically due to concerns that cocaine usage could have caused cardiac problems. Of

course, all agree that the primary source of information as to a patient’s past or present drug

usage is the patient him/herself. Yet, such information from persons who are often severely

addicted to illegal drugs is not necessarily reliable. The need for the use of screening devices

such as the dipstick, and the reliability of such devices, was a point of some disagreement.

Of course, the cocaine testing/screening issue must also consider the history of the first

temporally related deaths that occurred to Gooberman and Bradway’s UROD recipients.

Gooberman explained that he used dipsticks early on, but he stopped using them when he found

that they were unreliable. After they learned of the first deaths, and given their suspicions that

these resulted from post-procedure use of cocaine, they started to strongly warn prospective

patients about the serious danger arising from such post-procedure use and the risk that death

could occur if their warning were not heeded. The fact that they started to see the danger of such

activity and the devastating results that could occur to a post-UROD patient might well have

- -209


served as a warning to them, a warning that at a minimum required that they be sure to institute,

or re-institute, some measures to screen for cocaine users.

The record does support the concern that significant cocaine use may lead to cardiac

problems, and, given the stresses inherent in withdrawal, if not in UROD itself, the existence of

underlying cardiac conditions is therefore a matter of concern. Dr. Gevirtz testified that under

the CITA protocol a dipstick test was performed both on intake and again on the morning of the

procedure. Dr. Simon posited that there was not necessarily a good case for denying UROD to

all those who did use cocaine, as he apparently believed that such an attitude was both

pharmacologically unsupportable and reflective of a bias against drug users on the part of some

practitioners. However, Simon acknowledged that he did use dipsticks, and he “supposed” that

this was the “general wisdom” and deferred to Dr. Karan’s opinion. She said that requiring a

urine test was “good medical practice,” which she assumed was the standard of care.

It is not clear that the medical evidence supports a conclusion that if a patient used

cocaine prior to the UROD, even shortly before, that such use would necessarily have a negative

impact on the patient during or even shortly after the procedure was concluded. The half-life of

the drug is sufficiently short that if used before UROD, cocaine is not likely to still be in the

system as cocaine. However, benzoylecgonine might remain for a longer time. The real

problem about cocaine appears to be, first, the possible impact on the patient’s heart resulting

from significant prior involvement with the drug (although exactly how much or how often such

use must have been to impact the heart is not clear) and, second, use after UROD. To the extent

that knowledge of previous use might lead to an understanding that a patient might have a

compromised cardiac system, even despite the inability to easily detect such by such tests as

EKG or echocardiogram, or that a patient might be more likely to ignore warnings about post-

UROD use, such information might be “helpful” to the practitioner and ultimately beneficial to

the patient. Yet, Simon and Gooberman both said that even with such knowledge, previous use,

at least prior to twenty-four hours before procedure, was not an appropriate exclusionary factor.

It is not entirely clear from this record that it should be, but at the same time, the evidence does

appear to establish that there existed at some time during the 1995-99 period both dipsticks for

testing for cocaine and a practice among practitioners of the procedure to make use of such in the

screening procedure. The question then is whether the respondents’ decision not to use them

- -210


regularly is a violation of the standard of care, or alternatively, simply an acceptable variation in

practice that does not rise to the level of a violation of standards.

Patients who presented themselves for UROD were generally addicted users of opiates.

Continuation of their “habit” presented them with significant dangers. If they were to stop using

opiates altogether, some process of withdrawal inevitably had to occur. If a multi-abuser had a

compromised cardiac system, it is certainly possible that a prudent practitioner of addiction

medicine in general and UROD in particular might advise that some other means of withdrawal

other than UROD was preferable for that patient. The practitioner’s clinical judgment would be

an important factor, even a determining one, in advising the patient. Of course, to the extent that

the practitioner realized that one with a compromised cardiac system might still be subject to the

stresses of withdrawal post-procedure and might therefore be at risk for arrhythmia or other such

complications even despite the ability to successfully manage the patient perioperatively, the

knowledge that one was a cocaine abuser would no doubt play a significant factor in the

application of such clinical judgment.

Practitioners in the addiction treatment field during the years 1995 through 1999 with the

experience of a Dr. Gooberman certainly were aware of the potentially damaging effects of

cocaine on the cardiac system. While ultimately the decision as to whether to include/exclude a

prospective UROD patient who has used/abused cocaine rests upon the clinical judgment of such

a practitioner, it is not unreasonable that he arm himself with reasonably available information

before making final decisions. The generally accepted practice was for UROD providers to

utilize the dipsticks once they became available. As acknowledged in the record, they were not

by any means a perfect solution to the need or desire to “know” whether someone had a cocaine

history, but they did offer a useful tool and practitioners of UROD such that Gevirtz and other

CITA providers under its protocol, and Simon, used the dipsticks. I FIND that such use was the

“standard.” The respondents’ decision to abandon the use of such pre-screening testing deviated

from the standard practice.

Perioperative Issues

Count Two, Paragraph II. f. alleges that the respondents failed “to provide adequately

for the management of possible anesthesia emergencies such as difficult airways.” The chief

- -211


support for the charge came from Dr. Kushins, but while he explained the need for certain

equipment, he did not recall if he had ever ask about specific pieces of equipment. His testimony

on this allegation was general and vague in nature. Other evidence regarding this charge was

limited. Dr. Simon and Mr. Maziarski each attested that, based upon their visits to the

Gooberman facility and the information available to them, the appropriate equipment to allow

proper management of difficult airways was present on site during the years in question. I

CONCLUDE that the complainant has failed to establish this charge by a preponderance of the

credible evidence.

Additional charges are made concerning other aspects of the operative procedure.

Particularly significant in the context of the complainant’s overarching contention that the

decedents’ deaths were caused by or contributed to by UROD is the conclusion stated in Count

One, paragraph 7, that UROD, “because of the combined effects of the anesthetic agents and

the antagonist and other drugs, produces a high level of physiological stress upon patients.” This

purported “high level of physiological stress” is then a foundational fact in Count Two,

Paragraph II. b., which alleges deviations from applicable anesthesiology standards resulting

from

[t]he administration of anesthetic agents so as to produce unconsciousness during a highly stressful period without appropriate knowledge of the effects of said drugs and their interactions with other drugs administered.

The conclusion asserted in the first of these allegations regarding the level of stress to

which patients were subjected during UROD is very much related to the question, addressed

extensively by the expert witnesses, of whether that stress played a predominate role in causing

the demise of patients whose systems simply could not handle that level of stress and suffered

fatal arrhythmias as a result. However, as the second charge is worded, the claimed violation of

standards is not dependent on whether the stress led to anyone’s demise. Instead, its thrust

appears to be that the respondents’ employed anesthetic agents in a process that caused certain

physiologically significant biological responses and consequences when they did not really have

the knowledge to understand what was going to occur as a result of their administration of the

anesthetics, particularly when these were to be used in conjunction with other drugs. This

second charge necessarily ties in with the assertions of some of the complainant’s experts, such

- -212


as Dr. Kleber, who opined that because of the stresses that arise from anesthesia-induced

withdrawal, UROD must be performed by an anesthesiologist. While the Complaint does not

specifically charge the respondents with violating their professional responsibilities because

they, as non-anesthesiologists, undertook to provide this anesthesia based procedure,

nevertheless that allegation has been made at trial and therefore appears to be asserted by the

complainant as an additional failure on the part of the respondents to comply with their

professional responsibilities. The closest to a definitive allegation of this purported violation of

professional standards is contained in Count Two, paragraph 2. II. e., where the complaint

objects to the respondents’ practice of “the simultaneous provision of a procedure which is the

medical equivalent of general anesthesia in an outpatient setting for as many as six patients

through CRNAs and critical care nurses subject to overarching medical supervision by a non

anesthesiologist and without the presence of a critical care physician” as a deviation from

accepted medical practices for addiction medicine and anesthesiology. This allegation seems to

mix the issue of multiple procedures with the absence of an anesthesiologist and/or a critical care

physician.

What is interesting about the charge that these respondents employed a procedure that

allowed the use of anesthetic drugs, antagonists and other drugs and did not possess the

“appropriate knowledge of the effects of such drugs and their interactions. . .” is that the charge

very specifically alleges a violation of standards in the administration of anesthetic drugs, yet it

is not clear whether the allegation is based solely on the alleged experimental nature of UROD,

or, perhaps alternatively, on the fact that these practitioners were not anesthesiologists. The

Complaint seems to contend, and surely at least some of the complainant’s experts allege, that

the respondents should not have been performing UROD, even if other physicians who are

anesthesiologists might properly perform it. If the issue is the experimental nature of UROD,

then, in a larger sense, it may be true that, given the lack of formal study and research in the area,

those performing the procedure, at least in its early days, were “operating” in, if not the dark,

then at least in the twilight, at least as to these questions regarding the effects and impacts of the

induction of withdrawal via administration of antagonists to anesthetized patients. However, if

the basis of the allegation is instead the fact that the respondents were not anesthesiologists, then,

despite the claims that their involvement in UROD violated standards, and while a reasonable

preference for the involvement of anesthesiologists has been shown in the record and even

- -213


though the actual participating physicians at most sites have been shown to be anesthesiologists,

the claim that their involvement deviated from established standards has not been sustained.

Again, considering the first possible reading of the charge, I am readily convinced by the

evidence that the UROD procedure does cause a significant level of physiological stress, and that

the catecholamine surge is substantial. I am also convinced that, at least to some degree, that

stress is dampened or ameliorated by the use of anesthesia. On this record, it is impossible to

conclude by a preponderance of the credible expert evidence that the administration of the

anesthetic drugs and the production of unconsciousness in these patients was itself a significant

cause or contributing factor to their deaths or morbidities. In addition, while the withdrawal

induced in the patients as the result of the introduction of antagonists and the resultant surge of

catecholamines to physiologically significant levels may have played its part in their demise,

there appears to be little, if any, evidence that the respondents did not appreciate the effects of

the anesthetic drugs and their interactions. They knew that the purpose of the anesthesia and the

state of unconsciousness it induced was, in significant part, to reduce the stress that would

impact the patient if he or she were induced into withdrawal while awake or only slightly

sedated. On the record, they had no significant reason in the period 1995-99 to be concerned that

the administration of anesthetic drugs themselves, or the use of these drugs in combination with

antagonist drugs, was a danger to their patients. If they failed to appreciate anything it was the

impact of the induction of withdrawal by means of the introduction of antagonists and the

“critical” level of stress that the withdrawal might cause for some limited number of their

patients. The theory of UROD, that patients could better tolerate withdrawal in its earliest stages

by “experiencing” that withdrawal while anesthetized, may have been “correct.” The question is

whether, in practice, the impact of a sudden thrusting of the patient into withdrawal proved too

much for some limited number of patients to manage. This question will be addressed below.

Dr. Segal candidly testified that the anesthesia drugs did not kill any of the patients.

However, several experts for the complainant, citing studies and reports and their own

understandings, related that the level of physiological stress during the UROD process was very

significant. They pinpointed the significant increase in catecholamine release during UROD and

the possible impact that such may have on patients physiological response as of the greatest

concern to them. This testimony was countered by respondents’ witness Simon, who insisted

vigorously that the whole purpose and consequence of using anesthesia is to reduce stress. He

- -214


denied that there was anything untoward about placing persons under anesthesia prior to

inducing withdrawal: indeed, he claimed that to the extent that withdrawal was stressful, the

anesthesia would act as a counter, reducing the level of stress. In addition, he argued that the

catecholamine levels found were not all that extraordinary when compared to other activities that

also lead to an increase of significant size.

I CONCLUDE that whatever may have been the impact of the antagonists and the

catecholamine surges upon patients and however that may have impacted upon their deaths and

serious medical consequences, the administration of anesthesia drugs was not a factor in what

killed these persons. The respondents have not been proven to have committed a violation of

standards in their administration of anesthesia.

While Dr. Kleber, himself a psychiatrist and not an anesthesiologist, claimed that the

stresses resulting in UROD were such as to require that only an anesthesiologist carry it out, Dr.

Kushins, who is an anesthesiologist, quite candidly admitted that a qualified CRNA, such as

those employed by the respondent, could legitimately provide the anesthesia services necessary

for UROD. While he believed that an anesthesiologist should supervise the CRNA, at least in

urban and suburban areas, as opposed to the lesser level of supervision that would be acceptable

in at least some rural areas, he nevertheless acknowledged that even if a non-anesthesiologist

physician did supervise the CRNA in non-rural settings, it was not per se malpractice. While Dr.

D’Ambra expressed in his letter to Gooberman’s prior counsel that he and Gooberman had

disagreed “as to the role of CRNA vs. Anesthesiologist,” he nowhere suggests that any per se

malpractice existed because Gooberman had chosen to use CRNAs rather than anesthesiologists

in his procedure.

The issue of the relationship between anesthesiologists and CRNAs, and between

anesthesiologists and non-anesthesiologist doctors, was a topic given some attention by the

defense experts. Questions of economic competition and perhaps professional jealousy evidently

are alive and well in this area, purportedly impacting all the way to the very highest levels of

activity within the Federal government. Mr. Maziarski convincingly presented the qualifications

and skills possessed by appropriately trained and certified CRNAs. The preponderance of the

credible evidence leads me to CONCLUDE that there is no violation per se in CRNAs

providing anesthesia services during a UROD procedure, and also no professional misconduct,

- -215


negligence or malpractice per se if a competent non-anesthesiologist supervises a competent

CRNA who does so. To the extent that Count Two, Paragraph 2, II. e. addresses the “non-

anesthesiologist” issue, that charge is DISMISSED. However, still to be considered is the

question of whether the process itself causes such levels of stress that provision of it by these

doctors, even with competent assistance from certified CRNAs, placed their patients in danger

and therefore constituted professional misconduct.

Drs. Karan and Gevirtz described the failure to employ clonidine as a violation of the

standard of care. It is not clear exactly where in the Complaint this alleged deviation is charged,

if at all, but it may fairly fall within the allegations of Count Two, paragraph 2. I. j. and 2. II.

j., each of which addresses, in part, alleged failure of the respondents to “provide safe and

effective procedures . . . to ensure safe and effective patient recovery . . .” and “safe and adequate

post discharge procedures . . . to ensure safe and effective patient recovery from anesthesia and

detoxification procedures.”

Dr. Simon, who utilized the drug in his UROD procedure, nevertheless would not

characterize the failure to use it as a violation, deferring to Dr. Gooberman’s expertise and

assuming that Gooberman was satisfied that other drugs could adequately address the symptoms

for which he and others used clonidine. For his part, Gooberman defended his choice to change

from his early use of clonidine in every case to the use of other drugs, at least for the most part.

It is clear enough from this record that the majority of practitioners of UROD use

clonidine to combat the effects caused by withdrawal. However, as Dr. Gooberman correctly

stated, the “standard” of practice does not necessarily require that one and only one drug be

chosen for a task if there are other drugs that will provide a similar, if perhaps not identical,

effect. While Dr. Gevirtz argued that alternatives such as benzodiazepines simply do not work

as well as clonidine, Dr. Gooberman’s credible statements about his contacts with Dr. D’Ambra

regarding the concern that clonidine carries certain risks if interacting with atropine, risks that

were acknowledged by Dr. Gevirtz, and Dr. D’Ambra’s written confirmation regarding

Massachusetts General’s discontinuance of the use of clonidine in UROD, are sufficient to

support the conclusion that Gooberman’s determination had some legitimate basis in science and

in practice. As such, without at this time considering the possibility that in the individual cases

under consideration the lack of clonidine may have played a role in the death or serious

- -216


morbidity of a specific patient, I CONCLUDE that there was no per se deviation from and

violation of the applicable standards of practice.

Count Two, Paragraph 2. I. a. alleges that the respondents deviated from the accepted

standards of addiction medicine by

The implantation of a Naltrexone pellet without knowing by objective data the duration of action of the antagonist provided under the circumstances and how much heroin or other opiates are blocked on a daily basis.

While this charge is specifically directed at the alleged lack of “objective data” regarding

duration of effect and the extent to which the amount of antagonist provided will effectively

block what amount of opiate, the concern of complainant’s experts was more broadly stated in

their testimony. They spoke of the possibility of a “burst effect” of the pellet and the possibility

that the drug might cause pulmonary edema.

Initially, both Dr. Smith and Dr. Gooberman well explained the theory behind the use of

a naltrexone pellet, the desire to find a way to overcome the problem of patient non-compliance

and provide a long-lasting block to opiates that did not require that the patient be responsible for

taking a medication on a daily or perhaps weekly basis, and also avoid some of the discomfort

involved in the deep intramuscular (i.m.) injection used by others such as Dr. Kleber. Dr. Smith,

a highly respected and qualified expert in the addiction medicine field, felt that the use of the

pellet was perhaps a most important improvement in treatment method. Indeed, as noted in

footnote 53 at page 249, the authors of the article cited therein report the apparent positive

impact of naltrexone on long-term relapse rates, and presumably, if the pellet does indeed allow

for more easily tolerated long-term dosing of naltrexone, that might have a significant impact on

the prospects for long-term abstinence for those treated with the pellet.

Of course, it is true that the pelletized means of providing the drug was innovative, was

something new that did not have a history of use upon which Dr. Gooberman could draw to

support his usage of the pellet. Additionally, given this, the use of a naltrexone pellet clearly was

not a standard in addiction medicine before he began using it. Naltrexone is an FDA-approved

drug, but it was not approved as an implant in 1995-99. This fact does not alone condemn the

- -217


user, as indeed the evidence shows that clonidine is likewise not approved for use in the manner

it is employed by the several highly expert physicians utilizing it in connection with

detoxification procedures.

Dr. Gooberman also insisted that through his own follow-up study he had observed that

the pellet lasted as long as two months in some patients, but that as with many other drugs, the

duration of action varied. Thus, contrary to the allegation, he insisted that he did have some

knowledge of the duration of action, albeit not from some outside study or other “objective”

source. He further insisted that there was no requirement in the standard of care that he

“objectively” know such information. In fact, no source has been cited for the idea that a

physician must have such “objective” sources of support for the use of a procedure, as opposed

to other information that may support the use.

The complainant’s experts’ attack on the use of the naltrexone pellet is based largely on

the concern about “burst” and pulmonary edema. Dr. Kleber speculated about the possibility of

burst based upon some experience with the injectable form of naltrexone, however, he could not

pinpoint any evidence that that concern was actually transferable to the pellet and there is no

other evidence in the record that a “burst” effect is a real concern regarding this medium of

delivery. Presumably, unless “burst” occurs, the limited release of the encapsulated naltrexone

over a period of many days and even a few months is not what concerns Dr. Kleber in respect to

the possibility of pulmonary edema occurring. If, absent “burst,” naltrexone is in fact associated

with that condition, an idea that Dr. Simon vigorously challenged, Dr. Kleber never said so.

It is true that “objective” “outside” academic or manufacturer’s research studies and trials

on this method of providing this lawful drug to patients have not occurred. There is apparently

nothing illegal about doing what Dr. Gooberman decided to do, in a good faith effort to assist his

patients in the difficult task of avoiding opiates after completion of withdrawal. His evidence as

to the findings regarding durational effect in a sampling of his patients is unchallenged. On the

record, I cannot fault his use of the naltrexone pellet based on the lack of such “objective” data.

As for the “threat” of pulmonary edema resulting from a rapid early release of the naltrexone

from the pellet in a patient already prone to breathing difficulties and cardiac concerns, as the

findings regarding the deaths of the seven patients do not support pulmonary edema as the cause

of their deaths, and as the record does not show that condition to have been a problem in other

- -218


patients among the many, many recipients of the pellet, and in the absence of more than

speculative concern on Dr. Kleber’s part, I CONCLUDE that the respondent’s use of the pellet

in the UROD procedure did not constitute any breach of professional standards. The charge is

DISMISSED.

Count Two, paragraph 2. II. a. charges that the respondents violated the standards of

care applicable for anesthesiology because they administered “ketamine, midazolam and

propofol in a manner in which doses were not related to the patient’s weight as well as titrated to

the patient’s response to the drugs.” The evidence on this issue is not substantial and, indeed,

little attention has been paid to it in the briefs. Dr. Kushins insisted on the need to provide the

drugs in a manner that, at least initially, took into account the differing weights of the patients.

The defense witnesses acknowledged that, at least in concept, this dosage to weight relationship

was appropriate. However, as Mr. Maziarski explained and as Drs. Bradway and Gooberman

supported, the need to account for the individual patient’s response to the drug, to use clinical

judgment to assess whether the specific patient required more of the drug for it to have the

desired effect upon the patient, was at least as important, if not ultimately the paramount clinical

concern regarding the dosage of these drugs. Dr. Kushins’ testimony also supports the need for

clinical judgment to be applied to the subject of dosing, and in the end, I cannot determine from

this record that the respondent’s practice was tainted by a deviation from the standards applicable

to anesthesiology practice regarding the determination of the amount of these induction drugs

that were delivered to their patients. Therefore, I CONCLUDE that the charge has not been

proven by a preponderance of the credible evidence and it is DISMISSED.

Count Three of the Complaint alleges that, in connection with the anesthesia records for

decedents Flowers, Kindig, M.J., Melendez, and for patients Perez and Hendrix, the respondents

failed “to prepare appropriate patient records in accordance with established standards of

anesthesia practice and as required by N.J.A.C. 13:35-6.5 (b) and N.J.A.C. 13:35-4A.7(h) (3) and

(4).” More specifically, Paragraph 2 (a) charges a failure “to state all of the anesthetic agents

administered, the amounts administered and the time of administration, and subparagraph (b)

charges that “the records of anesthesia administration prepared after June 15, 1998 failed to

contain a post-anesthesia discharge note or summary as required by N.J.A.C. 13:35-4A.7 (h).”

Finally, subparagraph (c) contends that the respondents’ “records failed to identify the opioid

antagonists Naloxone, Naltrexone or Nalmefene administered and the amounts thereof.”

- -219


In the period 1995-99, the regulations of the Board of Medical Examiners required that

(b) Licensees shall prepare contemporaneous, permanent professional treatment records. . . . All treatment records shall accurately reflect the treatment or services rendered. . . . To the extent applicable, professional treatment records shall reflect:. . . Treatment ordered, including specific dosages, quantities and strengths of medications . . .if prescribed, administered or dispensed . . . . [N.J.A.C. 13:35-6.5 (b).]

In addition, N.J.A.C. 13:35-4A.7 (h) (3) and (4) provided that

Physicians who administer or supervise the administration of monitoring of anesthesia services in an office shall ensure that a patient record is prepared which contains the following:. . .

An intra-procedure record which includes anesthetic agents and techniques used, any changes since the inception of anesthesia in vital signs, oxygen saturation, electrocardiogram interpretation, temperature and end-tidal carbon dioxide measurements when required, as well as the volume and type of fluids administered.

A post-anesthesia note entered prior to the patient’s discharge from the office which shall include at least such post-procedure data as the patient’s vital signs and general condition, respiration, consciousness, circulation, special problems or precautions and a summary of fluids received during surgery or any complication or untoward event which occurred.

It cannot be doubted that there are legitimate concerns regarding the anesthesia records

maintained by the respondents. Besides the criticism of those records presented by Dr. Kushins,

even witnesses presented by the respondents themselves acknowledged, however grudgingly,

that the records were “sloppy,” and were not in accordance with the requirements of professional

standards, either as to the frequency of recording of the vital signs or the recording of the drugs

administered, or of the time of administration or the amounts administered. Dr. Simon, while

expressing some concern that the respondents not be held to a standard of surgeons or

anesthesiologists in an operating room and indicating that the existence of written orders

regarding the drugs administered during UROD could supply important information as to drugs

- -220


utilized and dosages thereof, acknowledged that he should not be assuming anything about

matters not properly recorded. Mr. Maziarski also agreed that deviations from the standard for

recording information in an anesthesia record existed, although he completely failed to note this

in his report or to acknowledge it in his direct examination. Dr. Gooberman acknowledged that,

as he reformulated charts, he had failed to provide for and assure proper charting of the drugs

given to the patient during the procedure.

I FIND and CONCLUDE, based on the records entered in evidence in this case and the

testimony of the experts, including the important admissions made by Dr. Simon, Mr. Maziarski

and even Dr. Gooberman, that the anesthesia records maintained by the respondents for patients

Flowers, Kindig, Melendez, Stavola, M.J., Perez and, to a lesser extent, Beigelman, were not

adequate to meet professional standards, failed to relate the full range of drugs administered to

the patients during the UROD procedure, and violated N.J.A.C. 13:35-4A.7 (h) (3). Therefore, I

CONCLUDE that the complainant has proven the violations charged in Count Three,

paragraphs (a) and (c). Further, I CONCLUDE that the respondents did not comply with the

requirements of N.J.A.C. 13:35-4A.7 (h) (4) and did not prepare required post-anesthesia

discharge notes as deemed necessary by the Board’s adoption of this regulation.

Post-Operative Issues

A primary aspect of the Complaint and a focus of so much understandably emotional

testimony is the allegation at Count Two, paragraph 2. II. h., that the respondents allowed the

“premature discharge of patients.” This claim, that patients were allowed to leave the treatment

facility before they were suitably ready for release, necessarily ties in with the several variously

worded charges contained at Count Two, paragraph 2. I. g., “the failure to adequately provide

for patient aftercare with appropriately trained health care personnel;” Count Two, paragraph

2. I. j., “the failure to provide safe and effective procedures and personnel to ensure safe and

effective patient recovery and continuation of appropriate addiction treatment; Count Two,

paragraph 2. II. g., “the failure to provide safe and adequate patient care post discharge through

adequately trained health care professionals and appropriate safeguards;” and Count Two,

paragraph 2. II. j., “the failure to provide safe and adequate post discharge procedures and

personnel to ensure safe and effective patient recovery from anesthesia and detoxification

procedures.” While not directly stated, the issues raised in these several charges implicate the

- -221


decision made by Dr. Gooberman, and also carried out by Dr. Bradway, that the routine practice

and protocol for UROD patients under their care would be for them to be discharged from the

treatment facility without either being encouraged or required to any stay overnight in any

monitored and/or supervised special location. Ultimately, while these several charges require

independent consideration apart from the concerns regarding the reasons for the deaths and

morbidities and the contributive role of UROD thereto, it is also true that the complainant

believes that the combination of premature discharge, discharge to inadequate caretakers,

inadequate safeguards and inadequate supervision and monitoring was a significant factor in, or

fostered the conditions that led to, the demise or serious illness of patients whose cases are under

review in this hearing.

Drs. Gooberman and Bradway each testified as to the discussions they had and the

reasons why they chose to not require an overnight stay in a monitored and closely supervised

setting. They apparently concluded that the recipients of UROD could leave their facility in

much the same manner as do others who undergo outpatient treatments, including various forms

of outpatient surgery, and that this could be done safely and in a manner that allowed them to

provide UROD at considerably less cost than they would have been required to charge had they

maintained the patients overnight. I FIND Dr. Gooberman’s explanation of his motivations to be

highly credible and there is no doubt in my mind that the ability to provide UROD at a cost that

was more readily manageable for a broader spectrum of opiate addicted persons was an

important factor for Dr. Gooberman and that Dr. Bradway agreed with this goal. Given the life

experience of these physicians and their genuine understanding and empathy with this patient

population, their goal was no doubt both understandable and, at least in theory, a good thought.

Whether in practice it was a legitimate, supportable and wise choice, or instead was a foolish,

risky and, indeed, perhaps a fatal choice for some is a question that is at the core of much in

dispute here. Had the doctors chosen to require an overnight stay, the issues as to the suitability

for discharge of these patients within a matter of minutes or hours of extubation would not be

issues. However, given the choice that was actually made, the patients were not retained, and

thus whether they were actually released too shortly after extubation is a serious matter of

contention. Further, it is readily understood that the decision not to retain also may have

foreclosed the possibility that some patients’ conditions, manifested during their overnight stay,

might have alerted the doctors that they were not yet ready to be removed from the direct care

and supervision of trained professionals, even if that meant hospitalization. Indeed, as will be

- -222


detailed below, in the case of patients Stavola, Beigelman, Kindig, M.J., Flowers, Perez and

Hendrix, an overnight stay would have encompassed the time frame within which they expired

or became seriously ill, although, of course, no one can be certain that had they stayed overnight,

they would have experienced a crisis during that stay, would have been saved or, despite the best

efforts by medical professionals to save them, would have nevertheless expired. As the experts

conceded, such is pure speculation, although the fact that certainty as to outcome is impossible

does not mean the decision not to retain cannot be assessed.

N.J.A.C. 13:35-4A-7 established regulatory standards for “physicians administering or

supervising the administration of anesthesia services in an office,” including standards for

discharge from the office. Subsection (g) provides that “physicians who administer or supervise

the administration of anesthesia services in an office shall ensure the following prior to discharge

That at least one practitioner shall remain on the premises until the patient is discharged to home or transferred to a special overnight stay area;That the patient shall be given written and verbal instructions for follow-up care and advice concerning complications;

That before the patient leaves the office or is transferred to the special overnight stay area, the physician shall evaluate the patient and shall review and sign the post-anesthesia record; and

That the patient shall be discharged only into the company of a responsible individual.

The respondents contend that they never discharged any patients prematurely. However,

the testimony of caretakers to whom the mortality and morbidity patients were released

presented a set of observations and descriptions of the perceived conditions that they believed

strongly indicated that their charges were by no means ready for discharge and were, in fact, in

no condition to be released from the treatment facility into the care of non-professional

caretakers who were expected to take the patients to hotels, motels or family homes, without any

stay in a “special overnight stay area” or other area where they would be watched, monitored or

otherwise professionally supervised. While this testimony may possibly establish that patients

were discharged too quickly and might lead to a conclusion that some delay in discharge for a

period of additional minutes or hours would have sufficed to allow the patient to recover

- -223


sufficiently to meet discharge standards and be released to the care of a caretaker, it also clearly

implicates the decision that patients would not be routinely retained overnight before discharge.

In assessing the respondents’ practices, the experts for the complainant were forced to

rely in part on the anecdotal information contained in statements made by caretakers. These

persons were without question caring persons with a particular love for, interest in and concern

about the patients released to their supervision. However, it is true that they were not

professionally trained medical personnel and were no doubt neither entirely objective about what

they observed nor professionally trained to evaluate whether discharge was appropriate. That a

patient may not “look” well, may not appear “healthy,” may seem “unstable,” to a non-physician

is not necessarily the proper criteria to decide that discharge was premature. That said, their

insights and input regarding the patients’ apparent conditions at the time of discharge are

extremely important and, despite their lack of training, not to be denigrated. They demand that

the charged professionals demonstrate that discharge determinations were made with proper

consideration of and respect for the proper standards.

In evaluating the propriety of the discharges, experts such as Dr. Kleber took into account

not only the described inability of patients at the time of discharge to walk without being

“dragged,” to speak coherently, to keep awake and alert, to demonstrate clarity of thought. They

also considered to whom these persons were being discharged; that is, they contended that

release to the caretakers involved in these cases of patients exhibiting these kinds of behaviors

and conditions and continuing to experience withdrawal did not amount to discharge to the

“responsible person,” required by above quoted regulation.

In determining whether a person was in fact ready for discharge, Dr. Gevirtz argued that

the use of the Aldrete scoring system was “the standard.” Yet, he acknowledged that there might

be other such scales in use, and therefore it is not clear that only the Aldrete Scoring System can

be used by a responsible practitioner to determine dischargeability. Indeed, while Dr. Kushins

also relied upon the Aldrete and urged its use, both Mr. Maziarski and Ms. Capelli, who despite

not being physicians nevertheless have significant background and training, related that there are

in fact other such systems or evaluative tools for discharge determinations. On this record, I

FIND that the Aldrete System is not the only evaluative system or tool that can be used to

evaluate readiness for discharge. However, it is abundantly clear that some criteria must be used.

- -224


A practitioner must be able to examine among several important criteria and then, applying the

clinical judgment essential to the practice of good medicine, determine if the time is ripe to let

the patient depart in the care of the “responsible person,” or alternatively, to keep the patient for

some additional time. The Aldrete and similar systems provide the doctor with such criteria,

with markers to consider and assess before making this vital decision. If the practitioner does

evaluate the important characteristics and apply his/her professional judgment, then the lack of

specific utilization of any one particular “system” is not a violation of the standard of care.

In determining the proper standards to apply regarding discharge from an out-patient

UROD procedure, it would be appropriate for a physician to consider the general criteria for

discharge from an out-patient, anesthesia-related procedure and decide, given the nature of the

procedure involved and its anticipated aftermath, whether any modifications in the standard

criteria were appropriate. That is, there might be something about the particular procedure, the

persons receiving it, or what they were going to experience after leaving the facility that might

suggest that the normal concerns and criteria be modified, perhaps with the deletion or

adjustment of some criteria, or even with the addition of some criteria. In the case of UROD, the

known and expected result of UROD was to place the recipient into withdrawal. Even in the

beginning of the Gooberman UROD practice, and certainly as time went on, it was known that

withdrawal and its symptoms did not entirely cease upon extubation or even at the time of

discharge, but continued on for some period, measured in many hours and some days. Unlike

some outpatient, office-based procedures in which anesthesia is utilized, this particular procedure

started up a significant systemic response that was ongoing. While some such procedures do

carry with them some ongoing bodily responses and effects after discharge, it seems safe to

assume that ongoing withdrawal from opiates carried with it more of a likelihood of “significant”

post-discharge events than many other procedures. Thus, a practitioner contemplating discharge

after UROD had to take into account these potentials.

The respondents testified that, despite not computing scores with Aldrete or a similar

scoring system, they nevertheless utilized appropriate criteria and that, while the appearance of

post-UROD opiate addicted persons may well have been discomforting to their caretakers,

nevertheless, even in the case of Ms. Flower’s discharge fifteen minutes after extubation, each

patient met the reasonable and appropriate discharge criteria utilized by the clinic. Walking 300

- -225


feet with or without assistance, being able to communicate even if reluctant to do so, sufficiently

oxygenated and with stable vital signs, these were the primary criteria used by Gooberman.

Based upon the testimony and the expert opinion’s, I FIND that the respondents and

those they supervised did have an adequate understanding of the proper criteria for determining

whether to discharge their patients. They knew that the ability to communicate, to ambulate,

even if with assistance, to maintain stable signs and the absence of significant vomiting or

nausea, were key elements. Thus, I FIND that they had in place, albeit not in written form, the

appropriate knowledge necessary for them to properly assess their patients’ suitability for

discharge. Whether they did so for the individuals specifically at issue herein and, importantly,

whether they should have even been assessing these, or any, patients for discharge so relatively

soon after extubation, as opposed to doing so only after an overnight stay, are still questions to

be determined.

The resolution of issues concerning the propriety of the decisions to discharge these

patients and of the decision made concerning any requirement for overnight retention are in

many ways related to the question of why these patients died and of whether the doctors’

procedures were directly or indirectly either the cause or a significant contributing factor in the

deaths. Therefore, it is necessary to determine, to the extent that this record and the state of the

scientific and lay evidence permits, the reason for the deaths and the apparent relationship, if

any, of the fact that these patients were not retained, but were instead discharged at varying

intervals following extubation.

Count I, paragraph 13 of the Fourth Amended Complaint presents the overarching

contention that each of the seven deaths was causally connected to UROD as practiced by these

doctors, claiming that, “[E]ach of the . . . . deaths was either directly or indirectly caused by the

UROD/ROD procedure . . . and/or respondents’ aftercare and treatment or the lack or

inadequacy thereof.” Paragraph 16 then claims that the respondents’ conduct in “providing a

dangerous medical procedure and the improper and inadequate follow-up medical care incidental

thereto” constituted the gross and repeated malpractice, negligence and incompetence that must

be proven in order to sustain disciplinary action. Thus, in order to sustain discipline on this

charge, the complainant must have met its burden of proving a causal connection between

something either done by the respondent(s) or not done and the fact of the death, and also must

- -226


prove that some action or inaction on the part of the respondent(s) was negligent. If the

respondents provided a safe procedure and performed it in accordance with the appropriate

standards of conduct, no negligence occurred and no fault lies. If negligence is proven, then and

only then must the determination be made as to whether the level and quality of the negligent

act(s) and incompetent practice is sufficient to permit the Board to exercise its statutory authority

and sanction the physicians.

To determine whether the complainant has proven the causal connection between UROD

and the respondents’ practice thereof and the deaths of these patients, it is necessary to first

determine what medical condition, illness or disease caused them to die. In order to resolve

these most serious charges, it is necessary to both determine the actual physical mechanism of

death, that is, did they die because they suffered an arrhythmia, an infection, did they choke to

death or die of an overdose of a toxic drug, etc., and then to determine if anything about either

the actions or inactions of the respondents was either directly or indirectly responsible for the

development and existence of that condition or illness that caused the death(s). If the causal

linkage has not been proven for any of the decedents, then at least as to the claim that the

respondents were responsible for the deaths, the complainant’s case will fail.

There are certain findings and conclusions regarding the circumstances of the deaths of

the seven decedents that are clear and undisputed. The facts demonstrate that none of these

persons died “on the table,” that is, none expired during the period from initial exposure to

anesthesia and intubation through extubation. Additionally, none died for at least six and one-

half hours after being discharged from the Gooberman facility. Each of the decedents had

undergone UROD, thus each was, without question, placed into withdrawal from opiates, an

outcome which both they and the physician administering UROD anticipated and which was the

very purpose of the procedure. Further, after their discharge, whether or not it occurred

prematurely, they continued to experience withdrawal for some time. Given the timing of their

demise after discharge, which ranged up to seventy-one and one-half hours, it is clear that each

was still undergoing at least some aspects of withdrawal, or at least the consequences of having

been in withdrawal, when they expired. As the intended goal of the UROD procedure was to

induce withdrawal, to that extent it must be said that the procedure worked as expected by both

physicians and patients.

- -227


The primary investigator involved in the initial stages of consideration as to the reasons

for the demise of a group of patients of Drs. Gooberman and Bradway who had undergone

UROD was Dr. Segal. While he professed that after he first became involved in the Kindig

matter he found the death “mysterious” and could not understand why the gentlemen had died

and even turned to Dr. Karan for assistance and support in his quest to understand the cause,

eventually Segal settled on a theory of causality that directly targeted UROD as a substantial

causal factor. He summed up his theory thusly: the decedents who came to the Gooberman

facility were, despite their addictions, in “normal health.” After undergoing UROD, they

emerged as “no longer normal healthy persons,” but instead as persons who were wiped out, who

did not get better and who eventually died. He perceived no other intervening cause(s) that

might explain the deaths. In view of the described pattern of events, he could not conclude

anything other than that the deaths were clearly contributed to by the UROD procedure.

If, as several of the experts posited, the deaths of most, or even all, of the patients

resulted from the stresses and strains of the withdrawal process impacting upon persons who,

despite Dr. Segal’s assessment that they were “normal healthy persons,” were, in fact, not nearly

as “healthy” as he suggested, but were instead persons whose cardiac systems were compromised

in one or another way, then, as Segal concluded, it is indeed true that the UROD process, as the

means by which they were placed into withdrawal, did, without any doubt, play a role in their

demise. A causal connection, a linkage of cause and effect, may be said to exist if by placing a

patient through UROD, the physician caused that patient to enter withdrawal and the stresses and

strains inherent in that withdrawal led to the patient experiencing a physiological effect that

caused the patient to die. In other words, in the time and place in which these decedents died the

likelihood is substantial that they would not have died at that very time, but for the fact that they

underwent UROD and thereby entered into withdrawal with its accompanying stresses. This

said, it is also within the realm of reasonable possibility that, had they somehow entered into

withdrawal at that very time by means other than UROD, they might very well have succumbed.

However, by itself, this causal link is not necessarily pejorative, either to UROD as a mode of

treatment or to the respondents as practitioners thereof. All of the more than 2,300 persons who

underwent UROD were similarly placed into withdrawal and all but seven survived the process

and, with some limited exceptions, did so without any significant medical complications. The

question then is: did the persons who died do so because they could not survive the stresses of

withdrawal under any circumstances, or instead, did something peculiarly involved in the UROD

- -228


process as practiced by the respondent physicians, whether it be the inducing and/or anesthesia

drugs used therein or the swiftness or impact of rapid withdrawal, cause these persons to

experience a withdrawal that involved a level of stress that proved fatal to them? Additionally,

or perhaps alternatively, did some aspect of the arrangements for aftercare place these persons,

some of whom were perhaps particularly vulnerable to the stresses of withdrawal due to

conditions not readily or reasonably ascertainable pre-procedure, in circumstances that were

inadequately geared to protect them during the early stages of their continuing post-extubation

withdrawal?

After considering all of the evidence, I FIND that it is apparent that G. W. died from

aspirative pneumonia, a known hazard for heroin addicts and a known risk of UROD that was

included in the warnings that were a part of the consent process. This conclusion is in accord

with the view of the medical examiner, and of those expert witnesses who presented a conclusion

as to his cause of death.

Interestingly, other than Dr. Segal’s general assessment, outlined above, and Dr. Karan’s

general identification of the temporal relationship as “very important,” the complainant’s

witnesses largely refrained from any specific identification of W’s cause of death or, a

conclusion that the provider’s conduct caused or contributed to the death. Importantly, Dr.

Kushins, while suggesting that a lack of proper post-procedure care could have played a role,

nevertheless acknowledged quite candidly that he could not say to a reasonable degree of

medical certainty that the death of G.W. was caused by or contributed to by UROD.

In assessing this question, the most difficult question is whether Dr. Gooberman should

have been alerted to the onset of pneumonia. Mr. W. died sixty-eight and one-half hours after

discharge. Dr. Cooper noted that aspirative pneumonia is usually detectable by a physician

within a few hours of its onset. The evidence is that Dr. Gooberman visited W. at the motel on

several occasions before he and Ms. B. returned home. On these visits Gooberman, and also

apparently Dr. Brewer, examined W.’s lungs and, according to Gooberman, they were clear. He

claimed that he was specifically concerned about the possibility of aspirative pneumonia.

If, as Dr. Gooberman stated, he and his experienced British colleague did not detect

either rales or other signs of pneumonia, then it is very possible that it had not yet begun at the

- -229


time of these visits. Gooberman last saw W. thirty-six hours before his death. According to Dr.

Cooper, aspirative pneumonia can start as little as twelve hours after aspiration and then cause

death within twenty-four to thirty-six hours. It is therefore quite possible that at the time of this

last visit, the aspiration that led to the pneumonia had not yet occurred, or, quite possibly, the

event had occurred so close in time to the last visit that Gooberman could not yet have detected

it.

In my opinion, it is not likely that Gooberman simply missed the signs of concern. It is

also quite likely, indeed far more likely than not, that during the earlier visits there was nothing

suspicious or indicative of aspiration pneumonia for he and Dr. Brewer to detect. Given the

length of time before W. died, the chances that he aspirated during the UROD, or at least that

any aspiration that may have occurred at that time resulted in the pneumonia is, at best,

extremely slim. It is also very doubtful that the onset of aspirative pneumonia would have been

detected had he been retained overnight in an ICU setting. In his case, he was examined several

times after discharge by physicians, and in the absence of any significant evidence that they were

negligent in their exams, the difference in outcome had he been retained as opposed to his being

examined at the motel cannot be identified. Vomiting was not an unforeseen prospect and, in

fact, the danger of aspiration pneumonia was identified in the consent form. If the aspirative

event occurred after W. left the motel, it is certainly possible that the onset of pneumonia might

have been detected by a physician or nurse at a hospital, but as Ms. B. candidly admitted, her

partner chose to reject her advice and refused to be taken to a hospital. Perhaps that choice

blocked identification in time of the start of a deadly process, but that question cannot be

answered.

I CONCLUDE that, while W. died because he aspirated vomitus and developed

pneumonia, there is no evidence to support a conclusion that either the UROD procedure or the

actions, or lack of action, by Dr. Gooberman, substantially caused or contributed to the death of

Mr. W. The complainant has failed to produce sufficient evidence to support such a close

connection, other than, as noted, the evident fact that UROD purposely induced withdrawal and,

as understood and disclosed, vomiting was a possible result of withdrawal. The connection

between the induction of withdrawal initiated through UROD, the vomiting and aspiration and

the pneumonia, ultimately leading to death, while a connection in fact, is not a connection that

supports a claim of negligence and of professional and legal responsibility. Further, based upon

- -230


the evaluation of evidence regarding the causes of death of the patient and the issue of overnight

retention, I CONCLUDE that the lack of overnight retention did not cause or contribute to the

death of Mr. G.W.

The medical examiner ultimately concluded that Frank Stavola died of “pulmonary and

cerebral edema due to drug use” listing several drugs, including morphine, cocaine, fentanyl and

nordiazepam. Aside from repeating his general comments regarding his assessment of the

relationship of UROD to the deaths of the several decedents, Dr. Segal agreed that Frank

Stavola’s death might be deemed “sudden.” He acknowledged that the benzoylecgonine found

in the toxicologic screen could cause an arrhythmia by itself. He agreed that Stavola did not die

as the result of the UROD procedure itself or from the anesthesia. Instead, he attributes the death

to the combined effects of withdrawal, stress and the drugs found in his system.

While several experts (Kushins, Segal) questioned the use of fentanyl in Gooberman’s

version of UROD and posited that it could have been a contributor to the deaths of some patients,

I FIND that the necessary evidence to support a conclusion to that effect is clearly lacking. The

other experts called by the Attorney General were not able to identify specific evidence to tie Mr.

Stavola’s death to UROD. Neither Dr. Karan, who only referred to the temporal tie, Dr. Lin, Dr.

Kleber or Dr. Gevirtz had any specific information to offer regarding Stavola’s death. Dr.

Kushins’ opinion concurs with the arrhythmia theory, although he could not be sure if there was

an underlying cardiac disturbance. Dr. Cooper noted that the heart of a cocaine abuser was more

susceptible to arrhythmias; indeed, he saw it as the “mechanism of death” in the death of cocaine

users. In addition, he too understood that the increased catecholamines resulting from

withdrawal here acted upon a damaged heart, one that was already susceptible to arrhythmias.

Even Dr. Haider, while finding no evidence in Stavola of pre-existing cardiac abnormalities and

classifying the death as “procedure related,” agreed that one could reasonably postulate that a

catecholamine surge was involved.

I FIND that the most medically reasonable conclusion as to the cause of Frank Stavola’s

death is that he succumbed to the effects of a cardiac dysrhythmia. The cause of this

dysrhythmia was most likely the stress of withdrawal, however, based on the available evidence,

I FIND that at some point not very removed from his UROD, Stavola took cocaine. It is also

possible that the cocaine caused or contributed substantially to the occurrence of the arrhythmia.

- -231


Dr. Haider pointed out that if a patient suffers an arrhythmia in a hospital setting, that

condition can be immediately addressed, although that does not guarantee a successful outcome.

To the extent that a patient was retained overnight and the arrhythmia struck during that time,

overnight retention might result in the patient surviving. Stavola died six hours and thirty-seven

minutes after discharge. In his case, it cannot be denied that overnight retention might have led

to a different result for him.

It must be added that overnight retention might also serve to prevent or at least

substantially reduce the likelihood of a patient taking cocaine or another drug in contravention of

the warning against such post-UROD usage. While the preventative or retardant effect of an

overnight stay would not have any impact once the patient was discharged the next day,

nevertheless, in the first critical hours following extubation, while the impact of the induced

opiate withdrawal continued to impact upon the patient, retention may serve a prophylactic

purpose.

Aside from those considerations, given that the death post-discharge of Frank Stavola

was the result of an arrhythmia, the question remains whether some aspect of UROD either

caused or enhanced the surge of catecholamines, such that the procedure exposed patients to

greater risk of arrhythmia, and if it did, whether that fact properly results in a conclusion that the

respondents’ actions are legally chargeable. Indeed, as with the next decedent, Mr. Beigelman,

whom Haider classified with Stavola (and M.J.) in Group A, (those whom he determined did not

have structural or functional cardiac abnormalities), it is this very point that is at the heart of

Haider’s identification of UROD as the causal or contributing factor in their deaths.

Mark Beigelman died nine hours and forty minutes after discharge; again well within the

time parameter for overnight retention. Dr. Ragasa concluded that he died from the effects of

multiple drug intake, post detoxification. His heart weighed 400 grams, which both Ragasa and

Dr. Segal classified as “enlarged,” although evidence from other experts placed a heart of this

size at the upper reaches of normalcy. In addition, the experts disputed whether he actually had

biventricular dilatation. Complainant’s expert Segal and defense experts Cooper and Simon

asserted that he did; complainant’s cardiologist Haider disputed this conclusion, arguing that the

- -232


data necessary to support the conclusion was lacking. Dr. Katz, the respondent’s cardiac expert,

was unsure, by his own description “waffling” on the issue.

The consensus of the experts suggests that this decedent had a heart that was on the

borderline of both “heaviness” and dilatation. It was a heart in the body of a heroin and cocaine

abuser (cocaine metabolites were present at autopsy, indicating recent use, whether before or

after UROD). Once again, UROD induced withdrawal and the concomitant hormonal surges.

These impacted upon this drug user’s “borderline” heart. The possibility, indeed, given the

stresses of withdrawal, the likelihood of arrhythmia as the cause of death is significant. Based on

the preponderance of the credible evidence I FIND that Beigelman died due to an arrhythmia. It

is unclear whether post-UROD cocaine use was a factor.

Mr. Beigelman was taken to a motel after his discharge. He eventually vomited

something described by his mother as a “very dark” substance. Whether the appearance of this

substance was indicative of something more than the usually expected vomit is not clear.

However, it is clear that from the time of his discharge until the time he died at the motel, no

professional medical person saw Beigelman. If he had been retained for an overnight stay, a

professionally trained person could have assessed his condition, and, if the nature of the vomitus

was such as to require any intervention, to have accomplished the same or to have arranged

transfer to a hospital. Without retention, this was not possible, or, at least, it would have required

that a professional visit the motel to assess the patient’s condition. Such a visit did not occur

here.

M.J. died sometime before 8:30 a.m. on April 17, 1998, at most eighteen hours after his

discharge. Again, his heart weighed 400 grams, at least on the high end of normalcy, if not

somewhat beyond that upper limit. I FIND that the most reasonable cause of death would

appear to be an arrhythmia, although what brought that event about is a matter of some

conjecture. Dr. Haider posits that the combination of anesthesia drugs and those used to induce

withdrawal causes a depression in both pulmonary and cardiac function that could lead to an

arrhythmia. Dr. Cooper takes note of the respiratory distress suffered by this patient, which he

identifies as an “unexpected event.” Mr. J. had a stroke in 1996. Dr. Katz argues that there is

some evidence that the heart was damaged, either by hypertension or drug use. He agrees with

Haider that M.J. did not suffer from hypertensive cardiomegaly, as Dr. Cooper believed, but

- -233


disagrees about the alleged impact of the induction drugs as creating a dangerous risk of

cardiopulmonary depression.

The credible evidence is that after Mr. J. arrived at home at about 3:30, he vomited at

about 4 p.m. and then, after being medicated with clonidine, he started to experience projectile

vomiting. He then received sandostatin injections. All of this occurred without the patient being

seen, monitored or assessed by a medical professional. When Dr. Bradway called at 10:15 p.m.

and heard what was occurring he replied that all was “under control.” An attempt to medicate

orally as per his direction in that phone call resulted in immediate vomiting. When J. shortly

thereafter appeared to be in difficulty, a call placed to Bradway was at first unsuccessful in

reaching him. He did respond to a second call, but death occurred shortly thereafter.

It is obvious that had Mr. J. been retained overnight, he would have been seen by a

medically trained professional and, if deemed appropriate, measures could have perhaps been

taken of a different, or possibly of a more effective, manner than did in fact occur. That J. would

have survived is conjecture, but the chances of survival might well have increased. The

arrhythmia that ultimately killed him might have been detected and managed.

Once again, in Lester Kindig’s case, I FIND that the evidence points most directly at an

arrhythmia as the cause of death. In Kindig’s case, the experts agree that his 460-gram heart was

well beyond the range of normalcy, and even Dr. Haider agrees that this was a diseased heart in a

person with a history of hypertension. While he thinks that Dr. Cooper’s theory of the

dysrhythmia resulting from hypertensive cardiomegaly is speculative and again posits his own

cardiopulmonary depressant concept, the outcome of whatever process occurred caused an

arrhythmia that resulted in the patient’s death.

Kindig died some eight hours and seventeen minutes after discharge, which was itself just

over two hours after extubation. He too thus died within the period of overnight retention, had it

been in place. While nothing happened at the motel after he arrived there that leaps out as a sign

that retention would have afforded immediate attention or assessment to a manifest problem,

nevertheless, once again, the arrhythmia might have been detected by monitoring and might have

been managed successfully.

- -234


Assigning an exact cause for the death of Victor Melendez is difficult. By any definition,

he was not a healthy person, a fact that in itself reflects upon Dr. Segal’s “general theory.” His

heart was diseased, he had liver disease, and he had a history of hypertension. I FIND that the

stress of withdrawal was, without question, a major factor in his demise. Dr. Haider cited the

“surge” factor, as well as the possibility of hypoxemia; Dr. Simon also believes that he could not

stand the stresses. In addition, as Drs. Segal and Cooper generally agree, there is ample evidence

and reasonable medical certainty that the esophageal tearing and mediastinitis was at least an

additional, if not the primary, factor in the death. Added to all of this is the possibility that he

either took or was given methadone, although whether he did so before or after the procedure

and whether he received it at the hospital is a subject of dispute. When all is considered, I FIND

that the preponderance of the credible evidence is that arrhythmia was a strong prospect for one

with this patient’s problems and that it, as well as mediastinitis, certainly played a very important

role in killing Mr. Melendez.

Mr. Melendez did not die until seventy-one hours and thirty minutes after discharge, and

about seventy-three hours and thirty minutes following extubation. Certainly, had he been

retained overnight and his course had not been different, he would not have died while being

retained and monitored or observed. However, while it is therefore much more difficult to say

that the failure to retain him lessened his chances of survival or contributed to his death, it must

be noted that when the Melendez family was at the motel the first night, he vomited regularly

and eventually appeared to throw up blood. Mike Bortnicker came to the scene that evening and

said that all was okay. It is a fact that Bortnicker, while having received some training from the

doctors, was nevertheless not a trained physician or nurse. It is at least possible that the nature of

Melendez’s symptoms during that first night would have alerted someone with medical training

monitoring him in retention that his distress was not what was considered “normal,” although, of

course, this is not certain.

The cause of Lisa Flowers’ demise, some eighteen hours and twenty-three minutes after

discharge and eighteen hours, twenty-eight minutes after extubation, is not disputed. Based upon

the clear evidence, I FIND that she suffered an acute myocardial infarction. Dr. Cooper

concluded that the infarction was the result of acute opiate withdrawal, yet it was not caused or

contributed to by UROD. In essence, he concluded that, having been placed into withdrawal via

UROD, her system, with a heart that was at least a bit large and showed some abnormal signs,

- -235


could not stand up to the demands of withdrawal, which included some expected withdrawal

related stresses. Indeed, Dr. Haider largely agreed with Dr. Cooper’s assessment, and added that

an infarction might well have occurred regardless of whether Flowers underwent UROD,

although not necessarily at the time when it actually occurred. Whatever its exact cause, Ms.

Flowers’ infarction occurred early enough in the morning. Had she been retained, she would

presumably still have been at the retention site when she suffered the attack. Again, she might

have been saved, or she might have succumbed anyway.

It is apparent from the above that the possibility exists that, had the respondents retained

their UROD patients overnight, five of the seven who died during the likely period of retention

might have been saved, or at least might have had a better chance of survival. However, while

this prospect may well result in a natural feeling of discomfort, concerning the respondents’

decision regarding the issue of retention versus non-retention of patients, it is still necessary to

determine if a requirement for overnight retention of patients actually constituted an accepted

standard in UROD practice in the years 1995-99, or for that matter, whether there was in those

years any standard regarding this issue with which the respondents had to comply in order to

conduct their practice safely and ethically. In examining this issue, it must be remembered that

while a very small number of non-retained patients died after receiving UROD, well over 2,300

recipients, or about 99.7% of those treated, did not55. Thus, despite the pressing concern as to the

fate of the five, it is nevertheless true that the vast majority of the non-retained patients were, at

least as far as this record reveals, not harmed by their discharge-without-retention, and there is

also really no way to determine whether, despite their non-retention, many of them were placed

in any actual danger.

The evidence indicates that while the respondents made a decision not to retain their

patients overnight, within the still quite limited community of UROD providers active during the

years 1995-99, the choice generally, if not unanimously, was to provide for some form of

overnight patient retention. Dr. Gevirtz retained patients as a standard procedure. Dr. Simon,

while quite deferential to Dr. Gooberman’s vast experience in UROD, acknowledged that when

he was providing UROD in his practice, he too made overnight accommodations available. His

patients were “strongly encouraged” to remain overnight in these facilities, where, while they

55 If the death rate is calculated based upon the idea that only these five patients out of 2,350 died when not retained overnight (as retention is unlikely to have been a meaningful factor in regards to the other two decedents), the survival rate increases slightly to 99.8%.

- -236


were not always “medically” monitored, they were nevertheless monitored by volunteer EMTs

and had their blood pressure checked. Significantly, they also were seen by a professional the

next morning before they were discharged. While Simon tried to present this process as, in part,

a marketing tool, and suggested that it was influenced by the pending disciplinary proceedings

against Dr. Gooberman, and while Simon also presented himself as acting conservatively,

nevertheless, the fact remains that his choice was to retain. As he put it, while the statement is

only based upon a “general assumption,” nevertheless, in medicine the belief is “the more care

the better.”

The issue of overnight retention cannot be entirely separated from the costs associated

with such retention, the need for beds, support staff, and the like. The cost of health care, and in

particular of providing this perhaps promising detoxification procedure to the greatest number of

addicts at the lowest reasonable cost, was a significant factor in the thinking of the respondents.

Additionally, it was a key consideration mentioned by Dr. Simon and by Dr. Smith, who detailed

the controversy attending ASAM’s decision as to whether to include a requirement for overnight

retention in its 1999 Policy Statement. As Smith saw it, ASAM eventually decided that it

wanted to make it clear that ultimately the physician must remain in control of the treatment plan

for individual patients. ASAM’s Policy Statement ultimately provided that a patient who had

been anesthetized had to be provided with a “sufficient period of medical monitoring of their

clinical status by the medical detoxification treatment team immediately subsequent to the

procedure, in order to address clinical issues of craving, acute relapse risk, and accompanying

agitation.” It thus made no specific recommendation as to the need for any overnight stay, and at

the same time, acknowledged the dynamic and evolutionary stage in which the procedure stood,

which presumably might mean that experience would demonstrate the degree to which such

post-procedure monitoring might, or might not, need to be extended to an overnight stay.

I CONCLUDE that the evidence supports a finding that during the period 1995-99

overnight retention was certainly the manner of practice in the field of UROD. While the record

may not be sufficiently complete to assure that the only practitioners of UROD who did not

provide for such retention were these two respondents, as far as is revealed here, they do appear

to be, if not the only ones, then at least just about the sole providers so practicing at that time. If

the standard of professionalism to which these practitioners are held is then that which was

practiced and accepted as the norm by the average practitioners in the field, then it may be said

- -237


that the standard of care was to provide overnight retention. However, it must be remembered

that during 1995-99 this was a rather new procedure, with a very limited number of practitioners,

and the years in question may well be considered as a formative period during which the means

and methods of practice in this area were developing and evolving. Simply because most

practiced in a certain manner does not mean that every variation from that method was a

violation of a standard of care such that the alteration, adjustment, or difference in approach

constituted a chargeable violation of professional standards. Instead, a different, perhaps an

innovative manner or method, may also be medically and, perhaps more to the point, legally

acceptable, as even the medical/legal concept of the standard of care contemplates that not

everyone must necessarily practice the exact same way, following each and every step in a rigid,

lockstep pattern. Schueler v. Strelinger, supra, at 344.345. The question then is, whether the

evidence supports a conclusion that a variation from what most practitioners do is still within the

realm of acceptable practice, or, to the contrary, whether, the record supports a determination

that the undue level of risk and possible harm that the different approach subjects patients to is so

outside the reasonable range of acceptability that the different approach constitutes not only a

deviation from, but also a violation of, the acceptable standard of care to which a practitioner is

rightly held.

In considering whether the respondents’ approach to the issue of overnight retention

constituted an allowable difference from the accepted practices of others, it is not inappropriate

to state that, at least in the early stages of Gooberman’s UROD practice, the very “newness” of

UROD itself and even more so the manner in which the respondents performed the procedure

called for the utmost caution in their decisions as to how to proceed. Thus, in making a choice as

to whether to retain or not to retain at the onset of his UROD practice, Dr. Gooberman might

well have been wiser to retain patients and evaluate the effects of the procedure within the first

day, and then, if after analyzing the course of a reasonable number of patients he was satisfied

that their progress was predictable and safe and could be well-managed by non-professional

caretakers, to have then dispensed with any general requirement for retention. This would have

then allowed him to achieve the goal of providing the procedure at lower cost, while at the same

time assuring that the choice of non-retention was a safe one. This said, on the whole, looking at

the matter after nearly 2,350 procedures have occurred, it is difficult to conclude that the general

decision not to retain patients overnight after UROD was a professionally unacceptable decision

that violated the standard of care of good medicine, even though it did differ from the practices

- -238


of other UROD providers. This general statement does not mean that there was not always a

requirement that the doctors carefully evaluate the condition of each individual both immediately

after extubation and then during the post-extubation period at the clinic, most importantly, at the

time when a decision as to whether to allow the patient to leave the clinic was made. Thus, if a

patient exhibited sufficient characteristics to indicate the existence of a medically unacceptable

risk in releasing that patient to a non-medically qualified caregiver, the responsibility of the

respondents was surely to either retain that patient overnight, or, having made no provision for

such overnight stays and the needed monitoring at their clinic, to have assured that the patient

was hospitalized. With that all-important caveat, in general the experience of the

Gooberman/Bradway team was that patients who were not retained did not suffer any significant

post-discharge problems that suggest that their retention overnight would have had any

appreciable impact on their progress. Of course, for at least the five identified above, it may be

that an overnight stay would have proven life-saving, although of that we can never really be

certain and such a conclusion is at best conjecture. However, it must also be acknowledged that

an overnight stay would not likely have meant anything for the other two decedents, unless

perhaps they had been retained a second night.

I FIND on this record that the complainant has not established by a preponderance of the

credible evidence that the inclusion of an overnight stay in a professionally supervised and/or

monitored setting was a mandatory element of the acceptable professional practice of UROD

during the years 1995-99, and that these respondents violated the acceptable standards of practice

and of care by not requiring such. In a field as new as UROD was, in a time of evolution when

the parameters of acceptable practice were not clearly established, practitioners had to have some

freedom to choose between possible courses of action. Here, starting out in a procedure

acknowledged by even now critical experts to have then been seen as involving the provision of

a rather benign process, and then having gathered a set of experiences that were the largest

amongst those practicing the procedure, the respondents had little evidence to support a need to

change what they were doing. Two of the first three deaths appeared to be either caused or

significantly influenced by non-compliance with instructions against post-UROD cocaine use.

During these early years of Gooberman’s, and later also Bradway’s UROD practice, the vast,

overwhelming number of non-retained patients did not succumb, or, as this record has it, need

hospitalization for actual problems related to withdrawal or, even more directly, to the UROD

- -239


procedure itself. The deaths of several persons were, as the record shows, “mysterious,” and yet

could be seen as coming within a range of expected deaths of opiate abusers.

Based upon these considerations and the totality of the evidence, I CONCLUDE that,

while certainly the more cautious thing to do would have been to retain patients overnight, as Dr.

Simon did, the complainant has not proven by a preponderance of the credible evidence that the

respondents engaged in malpractice, negligence or misconduct and certainly not in gross

malpractice, misconduct or negligence in the overall decision not to retain patients overnight. To

the extent that the several charges in the Complaint attack the respondents’ conduct regarding the

provision of post-discharge care, and to the extent that the lack of retention was seen as an

element in their purported sanctionable conduct, that aspect of the charges is DISMISSED.

Since the respondents were not professionally negligent in not retaining the cohort of

patients overnight, the issue then devolves to whether they did prematurely discharge any of the

several patients who died or had serious post-discharge events requiring hospitalization. To the

extent that it is known from this record, it appears that the decedents were discharged between

approximately fifteen minutes and at most about three hours after extubation occurred. While

the testimony of the caretakers paints a picture of unresponsive, somnolent, weak, sick, nauseous

persons thrust out of the respondents’ facility, and while I do not for the moment doubt the

genuineness of their characterizations, given the nature of the withdrawal experience, the

emergence from anesthesia, the generally weakened condition that a person having spent hours

in an anesthetized condition would likely be in and the nature of the patients themselves, I cannot

conclude on this record that the respondents inappropriately allowed them to depart the facility.

They did not act either carelessly, negligently, without consideration for the condition of their

patients or without some sense of a professional and moral commitment to them. I have no

doubt that, as the caretakers said, their charges were often not very responsive to communication,

as they no doubt felt quite unwell and were naturally very tired, but at the same time I do not

believe that they were incapable of communication when the need truly arose. It was no doubt

quite disheartening and difficult for the caretakers to see their loved ones and friends in such a

state. However, while the testimonies do evoke both considerable and quite understandable

sympathy, on the record as a whole, and given the findings made above that the respondents well

understood the appropriate discharge criteria even though they did not use the Aldrete scoring

- -240


system, I CONCLUDE that they did not prematurely discharge these patients. The charge is

DISMISSED.

Count Two, paragraph 2. I. b. claims the existence of a deviation from standards

because of an alleged “failure to affirmatively arrange for post-detoxification counseling as an

essential component of rehabilitation.” The evidence in support of this charge is not convincing.

While it is certainly clear that UROD is, by itself, in no sense a sufficient step to provide an

addict with the necessary support and assistance to achieve rehabilitation, nevertheless, I FIND

from the evidence spread on this record that Drs. Gooberman and Bradway have taken

reasonable steps to try to assist and encourage their UROD patients to attend twelve-step

programs after they complete withdrawal. As noted, it is not possible for them to assure that

their patients will continue in such efforts and in such programs, but several of the witnesses who

had some knowledge of the respondents and their program were quite confident that the

respondents did in fact seek to encourage such participation. While Dr. Smith expressed his

reservations as to the efficacy of the transition from UROD and naltrexone to psychosocial

methods of supporting rehabilitation, the issue here is not the ultimate success of the

rehabilitation efforts but, instead, the efforts of the respondents to at least reasonably encourage

and facilitate the entry into rehabilitation. I am satisfied that they have made a good faith

attempt to do so. I CONCLUDE that the complainant has failed to prove this charge by a

preponderance of the credible evidence and it is therefore DISMISSED.

Count Two, paragraph 2. I. h. and 2. II. i charge that the doctors breached standards of

care in regard to the aftercare, post-procedure protocol that provided a listing of medications for

nurses to prescribe based upon symptomatology described by patients and/or caretakers. Dr.

Kleber cited this as a problem without identifying any source for his conclusion other than his

own assessment. Competent witnesses for the respondents explained that contrary to Kleber’s

view, there was no violation of standards. The determination as to which of several medications

should be prescribed in a given circumstance was made by trained, certified medical personnel

acting based not only on the described symptoms, but also upon in-service training and their own

professional training and standards. The evidence does not suggest that the doctors were not

available for consultation where the trained professional was uncertain about which medication

to order. To the extent that the complainant claims that there was a violation of standards here,

- -241


the proof of such is far short of that necessary to establish the deviation. Therefore, these

charges of professional misconduct are DISMISSED.

SUMMARY

This case has presented a number of difficult issues that require consideration of the

proper role and limits of innovation and the weighing of risks and benefits of a potentially

beneficial procedure. Two physicians whose prior life experiences have included serious

difficulties with addiction have sought to apply their understandings of this terrible affliction and

of emerging treatment possibilities to the treatment of others who need help. In doing so, Drs.

Gooberman and Bradway have in some instances pushed the envelope. Dr. Gooberman, as the

physician who initiated the UROD practice and taught it to Bradway, and as the overall operator

of the treatment facility, no doubt bears the primary responsibility for the practice. However, Dr.

Bradway is, of course, responsible for the professional decisions he made and actions he took, or

failed to take.

I agree with Judge Lefelt’s thought, expressed in Murray v. State Health Benefits

Commission, supra, that litigation is indeed a “poor vehicle” for determining whether alternative,

innovative, non-traditional forms of medical treatment are medically sound. The litigation forum

is perhaps better suited to the more traditional determination of whether practitioners have

violated existing, well-understood and accepted standards of care then to a resolution of whether

a controversial new form of treatment is medically acceptable. In medicine, evolving

understandings of the workings of medicines, physiology and other aspects of science will often

alter the perceptions and even the well-accepted understandings of what works, what does not

work, what helps and what harms. What is acceptable practice today may be found to be

unacceptable next week, next year. Indeed, as this decision has been in preparation, new

information has emerged on such issues as replacement hormone therapy that may shake the

practice of medicine in regard to issues of women’s health. This is but one example of how

evolutionary medical science can be. Further, as this decision was all but completed, a new

report of a randomized study comparing forms of treatment was published and offered in

evidence by motion to reopen. No doubt other such studies will appear.56 Nevertheless, even in 56 The report, McGregor, Ali, et. al “A comparison of antagonist-precipitated withdrawal under anesthesia to standard inpatient withdrawal as a precursor to maintenance naltrexone treatment in heroin users: outcomes at 6 and 12 months, Drug and Alcohol Dependence 68 5-14 (2002), reports on a comparison between one-day precipitated withdrawal using naloxone under anesthesia and “current inpatient withdrawal treatment using

- -242


regard to as new a method of practice as UROD, still in its infancy despite its growth and

acceptance by such organizations as ASAM, it is essential that the State, through the Board of

Medical Examiners, exercise oversight over the medical profession to assure, as much as it can

within the limitations of knowledge available at any given time, that the public is protected from

dangerous medical practice, while at the same time, being cautious to avoid applying too

stringent a control on innovation. Here, the extensive record developed leads to some

conclusions that favor the work of the respondents and some that do find their work deficient

when measured against appropriate standards.

I CONCLUDE that, as practiced by the respondents, UROD cannot be said to be a per se

inappropriate or especially dangerous procedure. Nevertheless, as with many other medical

procedures involving anesthesia and other medical procedures, some limited number of persons

will unfortunately die during or shortly after the procedure, despite its relative safety and the

performance of the procedure in a responsible manner. No doubt, not every decision a physician

makes as to method of practice during the early stages of the practice of a new, alternative

medical procedure will be either the most conservative or the most successful. Nevertheless, I

CONCLUDE that in this case the respondents acted in good faith and, except for the limited

exceptions noted, within the ambit of acceptable medical standards of care for both addiction

medicine and anesthesiology, as well as the new and evolving method they chose to offer to a

population highly in need of assistance. While there is sufficient evidence to persuasively

establish a number of violations of professional and regulatory standards, I CONCLUDE that,

on the whole, the practice of UROD by each doctor did not involve substantial negligence,

malpractice or professional misconduct, or gross negligence, malpractice or misconduct.

Clonidine plus symptomatic medication.” The study was randomized. It serves to point to the interesting possibilities offered by naltrexone as a treatment modality, but also highlights the limitations of that drug and the interest in the development of a slow release depot formulation of naltrexone. This study, published four years after the last of the respondent’s URODs, certainly demonstrates that others involved in the treatment of opiate addicts see the potential advantages of a method of long term delivery of naltrexone that may help to increase the chances of longer term participation in post-withdrawal therapy. The study also does point to some short-term advantage of the precipitated withdrawal for retention in naltrexone treatment. Of course, the naltrexone treatment in the study started post-UROD and the interest in slow release depot formulations is not stated as being sought for peri-operative application, indeed, the authors report that naltrexone was not induced until withdrawal was completed, “in order to avoid severe reactions to naltrexone . . .” The study also recognizes that there have been reports of risks associated with antagonist-precipitated withdrawal, and the study did involve participants who were in some cases discharged from the hospital on the same day they received UROD. The study had other similarities and differences to the Gooberman procedure, such as the use of clonidine for all patients. On the whole, the report serves to highlight issues already addressed in this case and reviewed in this opinion. It serves neither to validate nor reject precipitated withdrawal under anesthesia, and as such, is not in any way dispositive of any of the issues in this case.

- -243


I CONCLUDE that the complainant has proven both a temporal link and a causal

relationship between UROD and the events that resulted in the deaths of some patients and the

serious non-fatal consequences that required the hospitalization of two patients. However, the

complainant has failed to prove by a preponderance of the credible evidence that the

respondents’ conduct in providing UROD, or their alleged failure to act in certain ways, was

substantially responsible for the deaths. I CONCLUDE that these deaths occurred either

because some of the patients, acting in defiance of warnings, used cocaine after the UROD and

suffered fatal arrhythmias, or, in other cases, simply could not withstand the stresses of

withdrawal and suffered fatal arrhythmias, or died of aspirative pneumonia that occurred not as a

result of any improper conduct by the respondents. Thus, intervening events may well have

occurred in the Stavola and Beigelman cases. I further CONCLUDE that while the stress of

withdrawal did prove too much for a very limited number of compromised patients, the

complainant has not proven by a preponderance of the credible evidence that UROD as practiced

by Drs. Gooberman and Bradway involved the use of a combination of drugs that exposed

patients to any undue risk of harm so long as they were properly managed during the procedure

and were appropriately discharged and, as necessary, provided with follow up support during the

ongoing withdrawal process.

Based upon the discussions above, I CONCLUDE that the complainant has established

by a preponderance of the credible evidence that the respondents’ practice of UROD has failed to

meet several requirements of the standard of good medicine. Additionally, they have violated

certain specific requirements of the regulatory code. More specifically, even though dipstick

screening was available, the respondents’ failed to continue to screen patients for cocaine use.

They improperly sought to have patients waive their rights to confidentiality as a part of the

consent form. Dr. Gooberman failed for some indeterminate period to properly advise

prospective patients that UROD was an experimental procedure, so as to properly advise them

before they gave informed consent to being treated. They failed to prepare adequate records of

both anesthesia and antagonist administration, as well as post-anesthesia discharge notes, as

required after June 15, 1998.

- -244


Penalty

N.J.S.A. 45:1-21 permits the Board of Medical Examiners to revoke or suspend any

license issued by it to a physician if the preponderance of the credible evidence establishes the

physician has engaged in acts or practices that involve gross negligence, gross malpractice or

gross incompetence, or repeated acts of negligence, malpractice or incompetence, or actions that

constitute professional misconduct or are in violation of any act or regulation administered by the

Board. In addition to such penalty or as an alternative, N.J.S.A. 45:1-22 provides that any person

who violates any provision of an act or regulation administered by a professional board may

receive a letter of warning, reprimand, or censure, may be assessed civil penalties and may be

ordered to cease and desist from future violations or take affirmative corrective action with

regard to any act or practice found unlawful. N.J.S.A. 45:1-25 provides that any person who

violates any provision of an act or regulation administered by the Board shall, in addition to any

other sanctions provided, be liable to a civil penalty of not more than $2,500.00 for a first offense

and not more than $5,000.00 for a second and each subsequent offense. Each separate transaction

shall constitute a separate offense, but “a second or subsequent offense shall not be deemed to

exist unless an administrative or court order was entered in a prior, separate and independent

proceeding.” In addition, in any action that is brought pursuant to the statute, the Board “may

order the payment of costs for the use of the State.”

I CONCLUDE that there is no basis for the imposition of the ultimate sanction of

revocation of either physician’s medical license. The extremely serious allegations regarding the

employment of a purportedly unethical and medically unwarranted procedure and the charge that

these respondents’ grossly negligent and/or repeatedly negligent and/or incompetent practices

and misconduct caused or contributed to the deaths of seven persons and the serious illness of

“dozens” of persons have not been proven by the requisite standard of proof. The suggestions

and implications that they were simply grinding out ethically tainted UROD procedures and then

were not seeking to reasonably assist their patients post-procedure in the attempt to stay abstinent

have been demonstrated to be incorrect charges.

Despite the failure of the complainant to prove the most serious charges, clearly several

violations have been established. There are obvious failures in regard to the records produced

and a failure to comply with medical record requirements. The respondents were each

- -245


responsible, as professionals and as supervisors, to assure that they and those under their

authority properly recorded the events required to allow a complete and understandable record of

the treatment rendered. It is vitally important that the records of a patient’s treatment, including

and perhaps especially so those relating to surgical and anesthetic procedures, clearly indicate the

drugs utilized, the method of administration, the dosage and the timing of such administration.

While there is apparently no firmly established formulation for the records that identify these

matters, the doctors were responsible to see that these matters were properly recorded. The

failure to do so, while not shown here to have contributed to or to have disguised any negligence,

nevertheless is a serious failure. Each respondent shall pay a civil penalty of $2,500 for this

violation.

The attempt to publicize the procedure through the possible use of patients’ identities,

even if for wholly positive reasons to alert the public that UROD was available (and no doubt

also to bolster Dr. Gooberman’s, and later also Dr. Bradway’s practice), may have gotten in the

way of the doctors’ responsibility to properly protect the confidentiality of their patients. The

patients should never have been placed in the position of having to affirmatively opt out of

possible future use of their experience, and perhaps their identity, at a time when they were quite

likely not at their sharpest and no doubt under some emotional and physical strain. Again, this

violation has not been shown to have had any affect upon patient care. Each physician shall pay

a civil penalty of $1,500 for this offense.

While the record does not allow for a definitive determination, I strongly believe that Dr.

Gooberman’s failure to advise the early patients of the “experimental” nature of UROD did not

actually lead to anyone undergoing the procedure who would not have otherwise done so.

Further, at some time during the four years and over 2,000 procedures, the need to refer to it as

an experiment ended. Nevertheless, given the importance of fair and open dealings with patients

and prospective patients, Dr. Gooberman shall pay a civil penalty of $2,500 for this offense.

Violations regarding EKGs for patients over forty and even for not continuing the use of

dipsticks to screen for cocaine use are important failures. On this record, it is impossible to

determine with any degree of probability that any particular patient was harmed by the failure to

perform these tests; however, the failure may have increased the risk to which individuals were

subjected. As such, each respondent shall be liable for a civil penalty of $2,500 for failure to use

- -246


dipsticks and $2,500.00 for failure to perform EKG’s on patients over the age of 40 as a routine

pre-screening device.

While in the overall scope of the charges, the charges that were sustained are limited,

nevertheless, they occurred multiple times and denote a less than completely careful approach to

the serious work involved. Based upon the findings and conclusions and in view of the violations

of good medical practice and appropriate standards of care, I CONCLUDE that each respondent

shall be suspended from practice for a period of six months. In addition, Dr. Gooberman shall

pay a total of $11,500.00 in civil penalties. As the record of this case demonstrates that Dr.

Bradway was previously sanctioned by the Board for serious violations of its rules and

regulations, an additional penalty of $5,000.00 is imposed. Dr. Bradway shall pay a total of

$14,000 in civil penalties. In addition to these sanctions, each respondent must enroll and

successfully complete class(es) or course(s) designated by the Board that address issues of

informed consent, patient confidentiality, screening procedures for anesthesia procedures and

record keeping requirements. Further, upon the completion of their suspensions, each physician

shall be placed on administrative probation for a period of two years, during which they may be

subject to review of their record keeping, and should they resume UROD or any other anesthesia

based procedures, their pre-procedure screening protocols.

Each physician will be equally responsible for the payment of costs of investigation.

However, the bulk of the most serious charges have not been sustained. Without doubt, these

charges constituted the greatly substantial elements that were the subject of the Board’s

investigation and were the driving forces behind a very long and highly complex trial. I

CONCLUDE that it would be manifestly unfair and inequitable for the respondents to have to

pay all of the Board’s costs. Instead, the respondents shall pay one-third of the Board’s costs and

attorneys fees. It is SO ORDERED. Counsel for the Board shall file affidavits with the Board

regarding costs and fees and the Board will presumably make a final order regarding the

allocation of costs.

I hereby FILE my initial decision with the BOARD OF MEDICAL EXAMINERS for

consideration.

- -247


This recommended decision may be adopted, modified or rejected by the BOARD OF

MEDICAL EXAMINERS, which by law is authorized to make a final decision in this matter.

If the Board of Medical Examiners does not adopt, modify or reject this decision within forty-

five (45) days and unless such time limit is otherwise extended, this recommended decision shall

become a final decision in accordance with N.J.S.A. 52:14B-10.

Within thirteen (13) days from the date on which this recommended decision was mailed

to the parties, any party may file written exceptions with the EXECUTIVE DIRECTOR OF

THE BOARD OF MEDICAL EXAMINERS, 140 East Front Street, 2nd Floor, Trenton,

New Jersey 08608, marked "Attention: Exceptions." A copy of any exceptions must be sent to

the judge and to the other parties.

DATE JEFF S. MASIN, ACTING CHIEF ALJ

Receipt Acknowledged:

DATE BOARD OF MEDICAL EXAMINERS

Mailed To Parties:

DATE OFFICE OF ADMINISTRATIVE LAWmjm

- -248


EXHIBIT LIST

(Bolded exhibits are in evidence)

JOINT EXHIBITS

J-1 StipulationJ-1 Amended as of 3/20/01

FOR THE COMPLAINANT:

P-1 Consent For Treatment, M.J., contained at Volume 2, Pages 76-79 P-2 Towne Pharmacy Description of Clonidine, Sandostatin Syringe & TrazodoneP-3 Prescription bottle labeled Trazodone (Beigelman)P-4 Prescription bottle labeled Clonodine (Beigelman)P-5 Prescription bottle labeled Sandostatin Syringe (Beigelman)P-6 Towne Pharmacy bills for Beigelman prescriptions-4 pagesP-7 Prescription bottle labeled Baclofen 50 mg (Melendez)P-8 Prescription bottle labeled Baclofen 10 mg (Melendez)P-9 Prescription bottle labeled Trazodone 50 mg (Melendez)P-10 Prescription package labeled Sandostatin SyringesP-11 Dr. Gooberman’s records concerning Lisa Flowers, Volume II, pages 3-46P-12 Hospital records for Lisa Flowers, Volume II, pages 47A-1 to 47A-70P-13 Doctor’s records for Les Kindig, Volume II, pages 48-73P-14 EMS chart for Lester Kindig- Volume II, pages 72-73 P-15 Doctor’s records for M.J.- Volume II, pages 74-101 P-16 Doctor’s records for Mark Beigelman- Volume II, pages 107-129 P-17 Doctor’s records Frank Stavola- Volume II, pages 130-161 P-18 Doctor’s records for Samuel Perez – Volume II, pages 186-210 P-19 Hospital Records for Samuel Perez- Volume II, pages 211-375 P-20 Doctor’s records for Christopher Hendrix- Volume II, pages 376-408 P-21 Hospital records for Christopher Hendrix- Volume II, pages 409-595 P-22 Doctor’s records for Victor Melendez- Volume II, pages 596-633 P-23 Doctor’s records for G.W.-Volume II, pages 162-185P-24 Orders and Guidelines- Volume IV, pages 169-262 P-25 Death Certificate for M.J.-Volume II, page101P-26 Death Certificate for Victor Melendez-Volume II, page 632P-27 Death Certificate for Lester Kindig-Volume IV, Pages 88-89P-28 Post Mortem Examination Report for Mark Beigelman-Volume I, pages 47-51P-29 Post Mortem Examination Report for Frank Stavola-Volume I, pages 53-58P-30 Post Mortem Report for Lester Curtis Kindig-Volume I, pages 60-64P-31 Post Mortem Report for M.J.-Volume I, pages 66-69P-32 Autopsy Report for Lisa Flowers-Volume I, page 72-77P-33 Autopsy Report for G.W.-Volume I, pages 85-89P-34 Autopsy Report for Victor Melendez-Volume I, pages 111A-119P-35 Toxicology Report for Mark Beigelman-Volume I, Pages 100-105P-36 Toxicology Report for Frank Stavola-Volume I, Pages 94-95P-37 Toxicology Report for Lester Kindig-Volume I, pages 106-108P-38 Toxicology Report for M.J.-Volume I, pages 96-99

- -249


P-39 Toxicology report for Lisa Flowers-Volume I, Pages 78-83P-40 Toxicology Report for G. W.-Volume I, pages 109-111P-41 Toxicology Report for Victor Melendez-Volume I, pages 122-126P-42 Death Certificate for G.W.-Volume I, page 84P-43 Excluded (Book Cover and Table of Contents)P-44 Curriculum Vitae for Dr. Herbert Kleber Volume I, pages 145-166P-45 “Opiate Detoxification Under Anesthesia: No Apparent Benefit but Suppression

of Thyroid Hormones and Risk of Pulmonary and Renal Failure, Clinical Technology, (1999), contained in Volume 4, pages 135-142

P-46 Ultra-Rapid Opiod Detoxification Increases Spontaneous Ventilation, Journal of Clinical Anesthesia 10:372-376 (1998), contained at Volume 4, pages 154-158

P-47 Profound Increase in Epinephrine Concentration in Plasma and Cardiovascular Stimulation after μ-Opioid Receptor Blockade in Opiod-addicted Patients during Barbiturate-induced Anesthesia for Acute Detoxification, Anesthesiology, Vol. 88, No. 5, May 1998, Volume 4, Pages 159-166

P-48 NIDA Scientific Report of Ultra Rapid Detoxification with Anesthesia (UROD): Opinion of the Consultants and Criteria Relating to Evaluating the Safety and Efficacy of UROD, Unofficial Report, Volume 4, pages 123-134.

P-49 Journal of the American Medical Association (JAMA) articleP-50 Not In Evidence-Three Methods of Opiod Detoxification in a Primary Care

Setting, Annals of Internal Medicine 127:526-530 (1997), Volume 4, pages 143-147

P-51 Dr. Lawrence G. Kushin’s report, September 7, 1999, Volume 1, pages 33-36P-52 Curriculum Vitae of Lori D. Karan, M.D., Volume I, pages 127-144P-53 Letter dated September 28, 1999 from Lori D. Karan, M.D. to Douglas J.

Harper, Volume 1, pages 13-14P-54 Letter dated September 27, 1999 from Lori D. Karan, M.D. to Douglas J.

Harper, Volume 1, pages 15-16P-55 Ultra-Rapid Opioid Detoxification An Analysis of 4 Cases of Mortality, Lori D.

Karan, M.D., F.A.C.P., Volume 1, pages 0017-0032P-56 Curriculum Vitae of Dr. Gevirtz, Volume I, pages 181-191P-57 Aldrete Scoring SystemP-58 NOT IN EVIDENCEP-59 Curriculum Vitae for Dr. Lawrence Kushins, Volume I, pages 167-177P-60 ChartP-61 Curriculum Vitae for Reng-lang Lin, Ph.D.P-62 Report of Dr. Lin dated May 30, 2000P-63 Letter from Jan Klein dated October 18, 1998P-64 Prescription written on Dr. Gooberman’s pad for seven testsP-65 Sketch of Dr. Gooberman’s office suite in 1996P-66a Letter from Michael N. D’Ambra, M.D. to Alma Saravia, Esq., dated August

30, 1999P-66b Letter to KoskiP-67 Depo-Naltrexone-an Adjunct to Opiate Abstinence after Detoxification,

Unpublished article by Drs. Gooberman, Bradway and BartterP-68 Transcript-In The Matter of State Board of Medical Examiners In Re: Lance

Gooberman, M.D.-October 20, 1995P-69 Report of Dr. David Smith with attachments

- -250


P-70 Letter dated 5/2/00 from Herbert D. Kleber, M.D. to Douglas J. Harper, Esq.P-71 Letter dated May 14, 1997 from Alan I. Leschner, Ph.D., to Dr. Colin BrewerP-72 Response to NIDA Report, revised January 1997P-73 Report of Dr. Kleber, dated September 10, 1999P-74 Report of Dr. Gevirtz dated June 9, 2000P-75 Report of Dr. Segal, dated May 12, 1999, Volume I, pages 1-12 P-76 Records for D. Floyd (admission limited to establishing knowledge)P-76a Chart (part of D-59)P-77 Chart-Aspirative PneumoniaP-78 ChartP-79 Letter dated March 16, 1999 from Cynthia G. McCormick, M.D. to Lance L.

Gooberman, M.D.P-80 a & b Excerpts for 1996 Physician’s Desk Reference (PDR)P-81 a, b & c Excerpts from 1997 PDRP-82 a, b & c Excerpts from 1999 PDRP-83 Letter dated 12/3/00P-84 David L. Simon, M.D., Rapid Opioid Detoxification Using Opioid Antagonists:

History, Theory and the State of the Art, Journal of Addictive Diseases, Vol. 16(1) 103-122 (1997)

P-85 Brochure issued by Nutmeg Intensive Rehabilitation Centers © 2000 INDCAP-86 Editorial: Chris Kasser, M.D., Current and Future Prospects for Rapid Opioid

Detoxification with Opioid Antagonists, Journal of Addictive Diseases, Vol 16(1) 1-4 (1997)

P-87 Elman, D’Ambra, et al., Ultrarapid opioid detoxification: effects on cardiopulmonary physiology, stress hormones and clinical outcomes, Drug and Alcohol Dependence 61 163-172 (2001)

P-88 Letter dated January 24, 2001 from David R. Black, Esq., to John Sitzler, Esq.P-89 Letter dated April 25, 2000 from David L. Simon, M.D. to Herbert Kleber,

M.D.P-90 Curriculum Vitae of Bunyard Haider, M.D.P-91 Medical Report, dated May 9, 2001 issued by Bunyard Haider, M.D.P-92 Letter dated April 6, 2001 from Douglas J. Harper, D.A.G. to Bunyard Haider, .

M.D.P-93 Additional Report, dated October 28, 1999, issued by Reng-lang Lin, Ph.D.P-94 Letter dated May 11, 2001from Frank Vocci, Ph.D., to John Farmer, Jr.,

Attorney General

FOR THE RESPONDENTS:

D-1 Intake Form for M.J., completed 4/11/98, at Volume 2, page 0075D-2 Unsigned statement regarding M.J. marked “Privileged Information; Personal

and Confidential, at Volume 2, pages 0102-0105D-3 Medical History for M.J., dated 4/10/98, Volume 2, 0080D-4 Consent for Treatment re: Frank Stavola, dated December 23, 1996, Volume 2,

0139-0141D-5 Consent for Treatment re: Lester Kindig, dated September 2, 1998, Volume 2,

0050-0053

- -251


D-6 EMS Patient Chart for Lester Kindig, Volume 2, 0072D-7 U.S. Detox, Inc. ITU Record re: Lester Kindig, Volume 2, 0065D-8 Letter dated October 19, 1998 from Jan Klein (Kindig) to Dr. Seigal, Volume 2,

pages 0067-0071D-9 Medical History of Mark BeigelmanD-10 Consent for Treatment for Christopher Hendrix, dated July 13, 1999, Volume 2,

0401D-11 Untitled document regarding Christopher Hendrix, Volume 2, 0383D-12 Medical History of Christopher Hendrix, dated July 6, 1999, Volume 2, page

0381D-13 Medical History of Samuel Perez, Jr., dated June 9, 1999, Volume 2, page 0195-

0196D-14 Consent for Treatment for Victor Melendez, dated May 26, 1999, Volume 2,

pages 0599-0602D-15 Rapid Opioid Detoxification During General Anesthesia, A Review of 20

Patients, Anesthesiology, vol. 91, No. 6 (Dec. 1999)D-16 Echocardiography for Assessing Cardiac Risk in Patients Having Noncardiac

Surgery, Educational Reviews, Inc. 1996 D-17 Nurse’s Notes re: Lisa Flowers, Volume 2, 0033D-18 Notes made by Dr. Karan after toxicology consult D-19 Blood Toxicology Chart following Dr. Karan’s report, version number 1 with

two entries below the chartD-20 Echocardiography for Assessing Cardiac Risk in Patients having Noncardiac

Surgery, Annals of Internal Medicine, Volume 125, No. 6, pages 433-441D-21 Report of Dr. SmithD-22 Summary of Preoperative Test Recommendations, Underwood-Memorial

Hospital Medical-Dental StaffD-23 Drawing showing effects of drug over timeD-24 Drawing of cellular effectsD-25 American Society of Addiction Medicine Public Policy Statement on Opioid

Antagonist Agent Detoxification Under Sedation or Anesthesia (OADUSA)D-26 Page 233 of American Psychiatric Press textbook of Substance Abuse

TreatmentD-27 Goodman and Gilman, Pharmacological Basis of Therapeutics, page 1732D-28 Goodman and Gilman, Pharmacological Basis of Therapeutics, page 1762D-29 (In evidence as P-73) Report of Dr. GevirtzD-30 Letter from Dr. Kleber to Mr. Harper, May 2, 2000D-31 PhotoD-32 PhotoD-33 PhotoD-34 Memorandum dated August 5, 1998 from Deputy Executive Director Charles A.

Janousek to Executive Director Judith I GleasonD-35 Face Sheet-D-36 Letter to the Editor of Anesthesiology, dated November 2000D-37 Dr. Kleber’s grant proposalD-38 PatentD-39 Philadelphia Magazine article, January 2000D-40 E-mail to Dr. GoobermanD-41 E-mail

- -252


D-42 Filing with Securities and Exchange Commission by Ultramed International, Inc.

D-43 Not in evidenceD-44 Pulse regarding rule concerning Nurse-AnesthetistsD-45 Letter from Douglas Harper, D.A.G. to Dr. LinD-46 Consent form for Lester KindigD-47 (also P-66a) Letter from Michael N. D’Ambra, M.D. to Alma

Saravia, Esq., dated August 30, 1999D-48 Physician notes regarding Victor Melendez-Supplemental Case InformationD-49 Preliminary Report regarding Lisa FlowersD-50 Curriculum Vitae of Dr. David E. SmithD-51 Dr. Smith’s reportD-52 Chart depicting “Withdrawal” (Intensity and Duration) via UROD procedureD-53 Letter from Richard Millstein, Deputy Director, NIDA, to Richard Walling,

Office of International Health, DHSS D-54 Letter from Dr. Colin Brewer to Barbara H. Herman, PhD., Director, Opiod

Medications Programs, NIDA, dated May 9, 1996D-55 Letter from Dr. Kleber to Dr. BrewerD-56 Curriculum Vitae of Frank T. Maziarski,, CRNA. M.S.D-57 Report of Frank T. Maziarski, M.S., dated May 31, 2000D-58 LAMD-59 Photo AlbumD-60 Video Cassette of Gooberman UROD procedureD-61 Letter from Alan I. Leshner to Dr. Colin Brewer, date stamped “RECEIVED 21

May 1997”D-62 Professional Services Agreement, Administrative Office of the Courts and US

DetoxD-63 Curriculum Vitae of John T. Cooper, Jr., M.D.D-64 Report of Dr. CooperD-65 Autopsy Report regarding decedent K.K-S. D-66 Letter from Charles A. Janousek to Alma Saravia, Esq., dated 2/11/97D-67 Statement by Gibbs, Esq.D-67A Depo-Naltrexone-An Adjunct to Opiate Abstinence after Detoxification”

Gooberman, Bradway & BartterD-68 Curriculum Vitae of David L. Simon, M.D.D-69 Report of Dr. Simon, dated June 15, 2000D-70 Supplemental Report of Dr. Simon, dated July 23, 2000D-71 Paper regarding 162 patients treated by Dr. Simon presented at 1998 ASAM

ConferenceD-72 DiagramD-73 Diagram-Normal/Dependent/After Opioid AntagonistsD-74 EXCLUDED-tape of Simon procedureD-75 Leshner, “Managing Heroin Addiction: A Look at the Options,” Behavioral

Health Management, January/February 1998

- -253


D-76 San , Puig, Bulbena & Farre, “High Risk of Ultrashort Noninvasive Opiate Detoxification,” Letter to the Editor of American Journal of Psychiatry Volume 152(6) (June 1995)

D-77 Drawing illustrating Negative Intra-thoracic Pressure Pulmonary EdemaD-78 First page of article by Wride, Smith and Courtney, A Fatal Case of Pulmonary

Oedema in a Healthy Young Male Following Naloxone Administration,Anaesthesia and Intensive Care, Vol. 17 (3) 374 (August, 1989)

D-79 Brimacombe, Archdeacon, Newell and Martin, Two Cases of Naloxone-Induced Pulmonary Oedema-The Possible Use of Phentolamine in Management,Anaethesia and Intensive Care, Vol. 19 (4), (November, 1991)

D-80 American Society of Anesthesiologists (“ASA”) standards for discharge from PAC-U (to another unit)

D-81 Problems in Anesthesia, Outpatient Anesthesia, Vol. 2(1) 13-16 Jan-March 1988

D-82 Chart identifying four standards of careD-83 Page 750-Substance Abuse-A Comprehensive Textbook, 3rd edition, pages 433,

749, 750, 790, 792D-84 Monograph-- Cardiopulmonary Bypass: Current Concepts and Controversies

(Tinker, editor)D-85 ASA Guidelines for Office-Based Anesthesia (Approved, October 13, 1999)D-85A ASA Statement on Routine Preoperative Laboratory and Diagnostic Screening,

approved, October 14, 1987 and last amended October 13, 1993D-85B ASA Statement on Qualifications of Anesthesia Providers in the Office-Based

Setting, approved October 13, 1999D-85C ASA Guidelines for Ambulatory Anesthesia and Surgery, Approved October

11, 1973 and last amended October 21, 1998 D-85D ASA Statement regarding Documentation of Anesthesia Care, approved,

October 13, 1988, approved October 12, 1988D-85E ASA Basic Standards for Pre-anesthesia Care, approved October 14, 1987D-85F ASA Guidelines for Non-operating Room Anesthetizing LocationsD-86 Department of Health and Human Services Food and Drug Administration

form: Consent to Treatment with an Approved Narcotic Drug D-87 Point/Counterpoint: Should rapid opiate detox be performed by

nonanesthesiologists, Physician’s Weekly, Vol. XV, No. 14 (April 13, 1998) D-88 Note: Methadone-related deaths in New Zealand, published in New Zealand

Medical Journal, page 303 (1999)D-89 Bentley AJ, Busuttil A, Deaths Among Drug Abusers in South-east Scotland

(1989-1994, Med. Sci. Law Vol. 36 (3) 231-236D-90 Zanis & Woody, Brief Communication: One-year mortality rates following

methadone treatment discharge, Drug and Alcohol Dependence 52 257-260 (1998)

D-91 Zador & Sunjic, Death in methadone maintenance treatment in New South Wales, Australia 1990-95, Addiction 95(1) 77-84 (2000)

D-92 Cooper, Seymour, Cassidy & Oliver, A Study of Methadone in Fatalities in the Strathclyde Region 1991-1996, pages 233-241

D-93 Steentoft, et al., Fatal poisonings in young drug addicts in the Nordic countries: a comparison between 1984-85 and 1991, Forensic Science International 78 29-37 (1996)

- -254


D-94 Payte, Opioid Maintenance Pharmacotherapy (OMP), presented at ASAM’s Review Course in Addiction Medicine, October 22-24, 1998

D-95 Not in evidenceD-96 Not in EvidenceD-97 Not in EvidenceD-98 Letter and Report from Rosemary Capelli, MA, RN, June 14, 2000D-99 Curriculum Vitae, Rosemary Capelli RN, MAD-100 Not in evidenceD-101 Not in evidenceD-102 Not in evidenceD-103 Not in evidenceD-104 Not in evidenceD-105 Not in evidenceD-106 Not in evidenceD-107 Curriculum Vitae of Robert I. Katz, M.D.D-108 Not in evidenceD-109 Not in evidenceD-110 Not in evidenceD-111 PictureD-112 PictureD-113 PictureD-114 McGregor, Ali, et. al, A comparison of antagonist-precipitated withdrawal

under anesthesia to standard inpatient withdrawal as a precursor to maintenance naltrexone treatment in heroin users: outcomes at 6 and 12 months, Drug and Alcohol Dependence 68 5-14 (2002)

- -255

Documents

Shell - Lance Gooberman€¦ · Web viewoffice of administrative law. initial decision. oal dkt. no. bds 10905-99s. agency dkt. no. --david samson, attorney general of new jersey,