12-14814-A
In the United States Court of Appeals for the Eleventh Circuit
UNITED STATES OF AMERICA,Plaintiff-Appellee,
v.
JOHN ANTHONY GIANOLI, III,Defendant-Appellant.
ON APPEAL FROM U.S. DISTRICT COURT FOR THE MIDDLE DISTRICT OF FLORIDA, TAMPA DIVISION,
NO. 08:11-CR-501-T-24MAP, HON. SUSAN C. BUCKLEW
BRIEF FOR AMICUS CURIAE ASSOCIATION OF AMERICAN PHYSICIANS & SURGEONS, INC., IN SUPPORT
OF DEFENDANT-APPELLANTIN SUPPORT OF REVERSAL
Andrew L. Schlafly N.J. Bar No. 04066-2003 General Counsel 939 Old Chester Rd. Far Hills, NJ 07931 Tel: (908) 719-8608Fax: (908) 934-9207 Email: [email protected] (11th Cir. Admission Pending)
Lawrence J. Joseph (Counsel of Record) D.C. Bar No. 464777 1250 Connecticut Ave. NW, Ste. 200 Washington, DC 20036 Tel: (202) 355-9452 Fax: (202) 318-2254 Email: [email protected]
Counsel for Amicus Curiae
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CERTIFICATE OF INTERESTED PERSONS AND CORPORATE DISCLOSURE STATEMENT
United States v. Gianoli, No. 12-14814-A
The undersigned counsel hereby certifies, pursuant to 11th Cir. R. 26.1-1,
that – in addition to those previously identified as having an interest in the outcome
of this case – the following additional persons have such an interest:
Association of American Physicians & Surgeons (“AAPS”), amicus curiae;
Joseph, Lawrence John, Counsel for amicus curiae AAPS; and
Schlafly, Andrew Layton, General Counsel, amicus curiae AAPS.
Pursuant to FED. R. APP. P. 26.1, amicus curiae AAPS makes the following
disclosures:
1) For non-governmental corporate parties please list all parent
corporations: None.
2) For non-governmental corporate parties please list all publicly held
companies that hold 10% or more of the party’s stock: None.
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United States v. Gianoli, No. 12-14814-A
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Dated: February 20, 2013 Respectfully submitted,
Lawrence J. Joseph D.C. Bar #464777 1250 Connecticut Ave. NW, Ste. 200 Washington, DC 20036 Tel: (202) 355-9452 Fax: (202) 318-2254 Email: [email protected]
Counsel for Amicus Curiae Association of American Physicians & Surgeons
/s/ Lawrence J. Joseph
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TABLE OF CONTENTS
Certificate of Interested Persons and Corporate Disclosure Statement ..................... 1
Table of Contents ........................................................................................................ i
Table of Citations ..................................................................................................... iii
Identity, Interest and Authority to File ...................................................................... 1
Statement of Issues ..................................................................................................... 2
Statement of the Case ................................................................................................. 3
Summary of Argument............................................................................................... 4
Argument.................................................................................................................... 5
I. It Violates Due Process to Target This “Anti-Pill-Mill” Physician With an Undercover Operation and Convict Him For Disregarding an Absurdly False Statement ..................................................... 6
A. The Sting Operation Should Not Have Targeted This Opponent of Pill Mills Whose Practice Weans Patients Off Pain Medication .............................................................................. 7
B. It Violates Due Process to Omit the Tape Recording of the Comprehensive Initial Exam, Which Included an MRI Report That Established That the Patient Was in Pain ........................................................................................................ 8
C. It Violates Due Process to Base a Prosecution on an Absurdly False Statement By the “Patient” That the Physician Correctly Recognized as False and Properly Disregarded ........................................................................................... 9
II. Dr. Gianoli Lacked A Required Mens Rea Because He Correctly Concluded that the “Patient” Was Lying About Giving Drugs to His Girlfriend for Sex and Discharged the “Patient” As Soon As He Was Clear About an Improper Use ........................ 9
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III. This Court Must Reverse Because the Prosecution Added a New Theory of Liability Outside the Indictment and Did Not Necessarily Prevail With the Jury on Either of Its Two Theories of Liability ..................................................................................................... 12
A. The Prosecution Was Required to Seek to Amend the Indictment Before It Proceeded Under a New Theory of Liability ............................................................................................... 14
B. The Prosecution Needed a Special Verdict to Demonstrate that It Prevailed Under Either Theory of Liability ............................................................................................... 15
C. The Professional-Course-of-Practice Theory Must Proceed – If At All – Under an Objective Standard Based on Florida Law .................................................................................... 15
IV. The Enhanced Sentence for Crimes Involving a Position of Trust Is Inapposite to Sting Operations ......................................................... 18
Conclusion ............................................................................................................... 20
Certificate of Compliance ........................................................................................ 21
Certificate of Service ............................................................................................... 22
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TABLE OF CITATIONS
CASES
Altria Group, Inc. v. Good, 555 U.S. 70 (2008) ................................................ 17, 18Berger v. U.S., 295 U.S. 78, 55 S.Ct. 629 (1935) ...................................................... 8 Blatchford v. Native Village of Noatak,
501 U.S. 775, 111 S.Ct. 2578 (1991) ............................................................... 16 Casey v. U.S., 276 U.S. 413, 48 S.Ct. 373 (1928) ..................................................... 9 Dorris v. Absher, 179 F.3d 420 (6th Cir. 1999)......................................................... 5Gonzales v. Raich, 545 U.S. 1, 125 S.Ct. 2195 (2005) ............................................ 17 Hampton v. U.S., 425 U.S. 484, 96 S.Ct. 1646 (1976) .............................................. 6 Kolender v. Lawson, 461 U.S. 352, 103 S.Ct. 1855 (1983) ...................................... 6 Koon v. U.S., 518 U.S. 81, 116 S.Ct. 2035 (1996) .................................................. 19
* Ladner v. Smith, 941 F.2d 356 (5th Cir. 1991) ........................................................ 15 Mason v. Allen, 605 F.3d 1114 (11th Cir. 2010) ..................................................... 14 McNabb v. U.S., 318 U.S. 332, 63 S.Ct. 608 (1943) ........................................... 6, 14 Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240 (1996) ......................... 17, 18 Morissette v. U.S., 342 U.S. 246, 72 S.Ct. 240 (1952) ............................................ 11 Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566 (2012)............................... 10 Oceanair of Florida, Inc. v. N.T.S.B., 888 F.2d 767 (11th Cir. 1989) .................... 14 Raley v. Ohio, 360 U.S. 423, 79 S.Ct. 1257 (1959) ................................................... 6 Rochin v. California, 342 U.S. 165, 72 S.Ct. 205 (1952) .......................................... 6
* Sherman v. U.S., 356 U.S. 369, 78 S.Ct. 819 (1958) ................................................. 9 Springer v. Henry, 435 F.3d 268 (3d Cir. 2006) ........................................................ 1Stenberg v. Carhart, 530 U.S. 914, 120 S.Ct. 2597 (2000) ....................................... 1Tafflin v. Levitt, 493 U.S. 455, 110 S.Ct. 792 (1990) .............................................. 16 U.S. Nat. Bank of Ore. v. Independent Ins. Agents of America, Inc.,
508 U.S. 439, 113 S.Ct. 2173 (1993) ................................................................. 5U.S. v. Fitapelli, 786 F.2d 1461 (11th Cir. 1986) .................................................... 13
* U.S. v. Ghertler, 605 F.3d 1256 (11th Cir. 2010) .................................................... 20
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* U.S. v. Herrick, 545 F.3d 53 (1st Cir. 2008) ............................................................ 15 U.S. v. Hurwitz, 459 F.3d 463 (4th Cir. 2006) ........................................................... 1U.S. v. Russell, 411 U.S. 423, 93 S.Ct. 1637 (1973) ................................................. 6 U.S. v. Rutgard, 116 F.3d 1270 (9th Cir. 1997) ........................................................ 1U.S. v. Terry, 60 F.3d 1541 (11th Cir. 1995) ..................................................... 18-19 U.S. v. Tobin, 676 F.3d 1264 (11th Cir. 2012) ........................................................ 13
* U.S. v. Twigg, 588 F.2d 373 (3d Cir. 1973) ............................................................... 7 U.S. v. Townsend, 555 F.2d 152 (7th Cir. 1977) ....................................................... 9 Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187 (2009) ..................................... 16-17
STATUTES
U.S. CONST. art. VI, cl. 2 ......................................................................................... 16 U.S. CONST. amend. V, cl. 4 .................................................................................... 14 U.S. Sentencing Guidelines, §3B1.3 .................................................................. 18-19 U.S. Sentencing Guidelines, §3B1.3, Application Notes, ¶4 .................................. 19 Federal Food, Drug, and Cosmetic Act,
21 U.S.C. §§301-399f ...................................................................................... 3 Controlled Substances Act,
21 U.S.C. §§801-904 ..............................................................................passim21 U.S.C. §802(10) .................................................................................................. 18 21 U.S.C. §830(b)(2)(A)(ii) ..................................................................................... 18 21 U.S.C. §841(a)(1) .......................................................................................... 12, 17 21 U.S.C. §841(g)(2)(B)(i) ...................................................................................... 18
RULES AND REGULATIONS
FED. R. APP. P. 29(c)(5) ............................................................................................. 1
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IDENTITY, INTEREST AND AUTHORITY TO FILE
Amicus curiae Association of American Physicians and Surgeons, Inc.
(“AAPS”), a nonprofit corporation, files this amicus brief with the consent of all
the parties.1 Founded in 1943, Amicus is an organization of physician members
located throughout the Nation, including many within the jurisdiction of this
Circuit. For 70 years, AAPS has been dedicated to defending the practice of
private, ethical medicine. AAPS has filed numerous amicus curiae briefs in
noteworthy cases like this one. See, e.g., Springer v. Henry, 435 F.3d 268, 271 (3d
Cir. 2006) (“the Association of American Physicians and Surgeons, argues that the
issue transcends the relationship between the parties and instead impacts thousands
of patients damaged as a result of hospital errors, incompetence, wrongdoing, and
cover-ups”); U.S. v. Hurwitz, 459 F.3d 463 (4th Cir. 2006) (reversing a conviction
as argued by AAPS in its amicus brief); U.S. v. Rutgard, 116 F.3d 1270 (9th Cir.
1997) (reversing many counts of conviction and vacating the sentence, as urged by
AAPS in its amicus brief). AAPS has been cited in several decisions of the U.S.
Supreme Court. See, e.g., Stenberg v. Carhart, 530 U.S. 914, 120 S.Ct. 2597
(2000) (citing an AAPS amicus brief).
1 Pursuant to FED. R. APP. P. 29(c)(5), the undersigned counsel certifies that: counsel for amicus authored this brief in whole; no counsel for a party authored this brief in any respect; and no person or entity – other than amicus, its members, and its counsel – contributed monetarily to this brief’s preparation or submission.
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The disposition of this appeal will affect the rights of AAPS members,
including many physicians who practice within the jurisdiction of this Circuit. The
precedent below sends this message to physicians: do not trust your patients or
your professional instincts. This has a tremendously harmful effect on the practice
of medicine. AAPS has members within this Circuit are affected by the ruling, and
AAPS thereby has a significant interest in filing this amicus brief.
STATEMENT OF ISSUES
1. Whether it violates due process to target an “anti-pill-mill” physician
with an undercover operation and convict him for disbelieving an absurdly false
statement.
2. Whether mens rea is satisfied when a physician rejects a statement by
a (phony) patient for being false when, in fact, it was false.
3. Whether the prosecution’s failure to seek to amend the indictment to
add an alternate theory of liability with a different standard of mens rea and the
District Court’s failure to require a special verdict to distinguish between voting to
convict under the two alternate theories of liability require reversal.
4. Whether the objective standard for assessing liability for prescriptions
not in the “usual course of professional practice” requires the use of a nationwide
standard or a standard based on the law of the state under which the physician was
practicing medicine.
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5. Whether the sentencing enhancement for violating a position of trust
applies where the underlying criminal charge includes the defendant’s status as a
physician and where an undercover officer posing as a patient did not “trust” the
physician whom the officer was seeking to entrap.
STATEMENT OF THE CASE
After a sting operation in which an undercover officer posed as a patient in
severe pain, the United States charged Dr. Gianoli with dispensing oxycodone, a
Schedule II drug under the Controlled Substances Act, 21 U.S.C. §§801-904
(“CSA”). In addition to its status as a CSA-regulated Schedule II drug, oxycodone
also is a drug regulated by the Food & Drug Administration (“FDA”) under the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§301-399f.
Dr. Gianoli is a Florida-licensed physician who devoted his practice to
weaning his patients off of their dependency on medication. Tr. June 14, 2012, at
7-8. Dr. Gianoli’s practice was the opposite of a “pill mill,” which consists of a
high volume of patients for whom “[e]verybody in the practice gets the same
medication or medications.” Tr. June 13, 2012, at 28:8-9.
The jury found Dr. Gianoli guilty on only one of five counts of prescribing
medication to an undercover agent posing as a patient. The jury hung or acquitted
Dr. Gianoli on the other four counts.
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SUMMARY OF ARGUMENT
Dr. Gianoli’s medical practice was devoted to reducing dependency by
patients on controlled substances. The practice welcomed patients who were in
pain and then attempted to wean them off of their pain prescriptions. None of the
justifications for conducting an undercover sting operation, in an attempt to catch a
physician in selling pain medication, exists here. Dr. Gianoli’s practice was the
opposite and antithesis of a “pill mill.” A conviction and 5-year-sentence for Dr.
Gianoli, based on an artful undercover “sting” operation that resulted in Dr.
Gianoli discharging the patient, transgresses important due process limits. The
decision below is a manifest injustice that requires reversal.
Context matters in medicine, as in law, and the failure by the prosecution to
provide a tape recording of the all-important initial patient encounter should have
led to a directed verdict for Dr. Gianoli below. Taking quotes out of context can
mislead a listener to an incorrect result. By failing to present a tape recording of
the initial examination to the jury, the prosecution gave the jury no context by
which to assess follow-up visits. Nothing in those subsequent visits was criminal
enough to justify five years in jail. Once Dr. Gianoli determined in the initial
examination that the patient was in substantial pain, Dr. Gianoli had a duty to treat
that pain, and he acted well within his professional judgment in discounting the
isolated statements of “sex for drugs” by the patient. Dr. Gianoli concluded that the
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patient was lying in making those statements, and in fact Dr. Gianoli was correct:
the patient was lying. Communication is largely non-verbal, but the non-verbal
aspects of those statements were not picked up by the tape recorder. What Dr.
Gianoli correctly understood to be a false statement by an undercover agent cannot
prove the mens rea necessary for a five-year imprisonment.
The conviction below should also be reversed because the prosecution added
a new theory of liability outside the indictment, which resulted in a lack of a
complete determination by the jury on either of the two prosecutorial theories.
Furthermore, the sentence should not have been enhanced for crimes involving a
position of trust when the conviction was based entirely on an undercover sting
operation.
ARGUMENT
A reviewing court can and should address “a miscarriage of justice” in a
decision below. Dorris v. Absher, 179 F.3d 420, 426 (6th Cir. 1999). In addition,
this reviewing court may extend beyond arguments raised by the parties in order to
correct an injustice. See, e.g., U.S. Nat. Bank of Ore. v. Independent Ins. Agents of
America, Inc., 508 U.S. 439, 448, 113 S.Ct. 2173, 2179 (1993) (addressing an
argument sua sponte on appeal). As explained below, this Court should reverse the
conviction and sentence of Dr. Gianoli.
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I. IT VIOLATES DUE PROCESS TO TARGET THIS “ANTI-PILL-MILL” PHYSICIAN WITH AN UNDERCOVER OPERATION AND CONVICT HIM FOR DISREGARDING AN ABSURDLY FALSE STATEMENT
Due process imposes limits on undercover sting operations and, when the
facts of this case are taken as a whole, those limits were transgressed in this case.
There are bounds on the use of “[t]he awful instruments of the criminal law.”
McNabb v. U.S., 318 U.S. 332, 343, 63 S.Ct. 608, 614 (1943). Entrapping conduct
can violate due process. Raley v. Ohio, 360 U.S. 423, 437-39, 79 S.Ct. 1257, 1265-
66 (1959). So can standardless governmental prosecutions. Kolender v. Lawson,
461 U.S. 352, 358, 103 S.Ct. 1855, 1858 (1983); see also Rochin v. California, 342
U.S. 165, 172-73, 72 S.Ct. 205, 210 (1952) (brutal conduct by government violates
due process);
While government may lie to entrap a target, there are limits to the degree of
deception that may be used. “[W]e may some day be presented with a situation in
which the conduct of law enforcement agents is so outrageous that due process
principles would absolutely bar the government from invoking judicial processes
to obtain a conviction.” U.S. v. Russell, 411 U.S. 423, 431-32, 93 S.Ct. 1637, 1642-
43 (1973). Where “[p]olice overinvolvement in crime … reach[es] a demonstrable
level of outrageousness,” then due process is implicated. Hampton v. U.S., 425
U.S. 484, 495 n.7, 96 S.Ct. 1646, 1653 n.7 (1976) (Powell, J., concurring)
Taken together, these three aspects of the prosecution go beyond what due
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process requires for a civilized society:
Target an opponent of pill mills, a small medical practice designed to wean
patients off of pain medication, for an undercover sting operation designed
to entrap pill mills;
Omit a tape recording of the comprehensive initial examination, which
included an MRI report that established that the patient was in pain; and
Base a prosecution on a tape-recorded, absurdly false statement by the
patient that the physician correctly recognized to be false and properly
disregarded.
Each of these issues is discussed below; taken together, they go beyond the limits
of due process in securing a conviction.
A. The Sting Operation Should Not Have Targeted This Opponent of Pill Mills Whose Practice Weans Patients Off Pain Medication
Where is a lack of a factual predicate for an undercover sting operation, then
a conviction cannot be properly obtained from it. See U.S. v. Twigg, 588 F.2d 373,
381 n.9 (3d Cir. 1973) (a factor in finding a violation of due process is when there
is no apparent evidence of criminal intent to justify the undercover sting
operation). Dr. Gianoli did not run a pill mill, and no one would even think he was
running a pill mill. He took patients on pain medication to get them off the drugs.
That made him an easy target for an undercover agent posing as a pain patient,
because Dr. Gianoli accepted pain patients. But someone who is an easy target for
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a sting operation is not automatically a legitimate target for a sting operation. Low
IQ people are easy targets for sting operations, but not legitimate ones, for
example, unless there is a factual predicate for the entrapment.
The sum and substance of this case is an undercover agent attempting to
elicit incriminating statements and conduct by a physician who was and is opposed
to pain medication, and tried to wean patients off the controlled substances. Any
physician who knows his patients and disregards obviously absurd statements
could be sentenced to five years in jail as Dr. Gianoli has been, under this
precedent. That is not consistent with due process.
B. It Violates Due Process to Omit the Tape Recording of the Comprehensive Initial Exam, Which Included an MRI Report That Established That the Patient Was in Pain
The most important evidence in any case like this is the initial exam that
establishes whether the patient legitimately had pain. Yet the undercover agent
either mishandled or had an equipment failure concerning that central piece of
evidence. Tr. June 12, 2012, at 101. This essential evidence for this type of case –
the all-important initial examination – was never made available to the defense.
This does not comport with due process, and an earnest responsibility for the
prosecution to seek justice and not merely another “win”. Berger v. U.S., 295 U.S.
78, 88, 55 S.Ct. 629, 633 (1935).
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C. It Violates Due Process to Base a Prosecution on an Absurdly False Statement By the “Patient” That the Physician Correctly Recognized as False and Properly Disregarded
The patently absurd drugs-for-sex-with-his-girlfriend statement used by the
undercover agent rendered the crime “the product of the creative activity of law
enforcement officials,” not of Dr. Gianoli. Sherman v. U.S., 356 U.S. 369, 373, 78
S.Ct. 819, 821 (1958). As Justice Brandeis observed, an investigator “may not
provoke or create a crime and then punish the criminal, its creature.” Casey v. U.S.,
276 U.S. 413, 423, 48 S.Ct. 373, 376 (1928) (Brandies, J., dissenting), overruled in
part on other grounds, Turner v. U.S., 396 U.S. 398, 424, 90 S.Ct. 642, 656
(1970). Yet that is what transpired here.
The background of Dr. Gianoli reinforces the unsustainable conduct in
convicting him. Courts inquire “where he sits on the continuum between naive first
offender and streetwise habitue,” and Dr. Gianoli is on the furthest end of someone
who was no more than a “naïve first offender,” casting further doubt on the entire
prosecution and conviction. U.S. v. Townsend, 555 F.2d 152, 155 n.3 (7th Cir.),
cert. denied, 434 U.S. 897, 98 S.Ct. 277 (1977).
II. DR. GIANOLI LACKED A REQUIRED MENS REA BECAUSE HE CORRECTLY CONCLUDED THAT THE “PATIENT” WAS LYING ABOUT GIVING DRUGS TO HIS GIRLFRIEND FOR SEX AND DISCHARGED THE “PATIENT” AS SOON AS HE WAS CLEAR ABOUT AN IMPROPER USE
The Supreme Court has emphasized that “we traditionally presume a mens
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rea requirement if the statute imposes a ‘severe penalty.’” Nat’l Fed’n of Indep.
Bus. v. Sebelius, 132 S. Ct. 2566, 2654 (2012). A five-year prison certainly
constitutes a “severe penalty.” Yet the basis for mens rea in the conviction below
was Dr. Gianoli’s rejection of the credibility of a statement by an undercover agent
that was, indeed, absurd and false. As a matter of law, this cannot establish mens
rea.
The conviction is based on Dr. Gianoli recognizing as false this statement by
the undercover agent (when the statement actually was false):
It’s like I said before, my girlfriend is taking most of them, she holds out on sex unless I have let her have them.
Tr. June 14, 2012, at 81:13-15. Dr. Gianoli understood this statement to be a farce,
as demonstrated by his laughter at it (which was picked up by the tape recording).
Id. at 81:15-17 (“And after he says that, the transcript indicates you were kind of
chuckling.”) It is not a crime to reject as false what is, indeed, false. And
recognizing a statement as false does not satisfy the requirement of mens rea.
If the undercover agent posing as a patient had stated that he was diverting
his medication to Batman and Robin, and Dr. Gianoli rejected that statement as
unbelievable and then prescribed the medication for the pain proven by the MRI
report and other evidence of pain, then as a matter of law Dr. Gianoli has
committed no crime. Likewise, there is no criminal intent by Dr. Gianoli in
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disbelieving a false statement by the undercover agent that said he was diverting
pain medication to his girlfriend for sex.
The conviction below rests on a thorough demonstration of pain, including
an MRI report confirming it (Tr. June 14, 2012, at 6), by an undercover agent who
pretended to be a patient. The agent does not record the comprehensive initial
exam performed by Dr. Gianoli. Instead, the undercover agent records a farcical
remark about giving his drugs to his girlfriend for sex, at which Dr. Gianoli
laughed and correctly rejected as untrue. It is not a crime – and certainly no
evidence of criminal intent – for a physician to reject a far-fetched statement by a
patient that was indeed false.
The U.S. Supreme Court has emphasized that a finding of criminal intent is
fundamental requirement:
The contention that an injury can amount to a crime only when inflicted by intention is no provincial or transient notion. It is as universal and persistent in mature systems of law as belief in freedom of the human will and a consequent ability and duty of the normal individual to choose between good and evil.
Morissette v. U.S., 342 U.S. 246, 250, 72 S.Ct. 240, 243 (1952) (emphasis added).
Lacking in proof of criminal intent, the conviction below of Dr. Gianoli should be
reversed.
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III. THIS COURT MUST REVERSE BECAUSE THE PROSECUTION ADDED A NEW THEORY OF LIABILITY OUTSIDE THE INDICTMENT AND DID NOT NECESSARILY PREVAIL WITH THE JURY ON EITHER OF ITS TWO THEORIES OF LIABILITY
As Dr. Gianoli explains in his brief, the proceedings below suffered two
inter-related and fatal defects with respect to the alternate theories of liability for
violating 21 U.S.C. §841(a)(1). First, the indictment addressed only one of those
theories of liability, but the jury was charged with both. If it wanted to proceed
under the second, alternate theory of liability, the United States needed to seek to
amend the indictment. See Gianoli Br. at 22-26. Second, given the differences
between the two theories of liability, the District Court needed to use a special
verdict to ensure that the jury unanimously convicted Dr. Gianoli under either
theory of liability. See Gianoli Br. at 26-32. Amicus AAPS fully supports both of
these two arguments against Dr. Gianoli’s conviction and adds two related
arguments here. First, these errors are not harmless errors because they deprive this
Court of the ability to know whether the jury unanimously convicted Dr. Gianoli.
Second, if the United States elects to re-try Dr. Gianoli on remand, the prosecution
should rely on Florida standards – not an imagined nationwide standard – to assess
the manner in which Dr. Gianoli practiced medicine.
By way of background, liability for violating 21 U.S.C. §841(a)(1) can rest
on one of two alternate theories when the government prosecutes a physician for
prescribing an FDA-regulated controlled substance in violation of the CSA:
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The prescription was not for a “legitimate medical purpose,” which asks
subjectively whether the physician believed the prescription was for a
legitimate purpose; or
The prescription was not made in the “usual course of professional practice,”
which the prosecution must show under an objective (and national) standard.
U.S. v. Tobin, 676 F.3d 1264, 1280 (11th Cir. 2012). As explained in the next three
sections, the prosecution was procedurally or substantively flawed in several
respects. Before addressing those flaws, however, amicus AAPS first demonstrates
that the procedural failings are not mere “harmless error.”
In an antitrust case that turned on two alternate theories of liability with only
one in the indictment, this Court pointed out that the deviation from required
procedures was not harmless error:
This is not a case in which the harmless error standard may be applied to a mere variance in the indictment. The court instructed the jury on a theory of jurisdiction which had not been charged by the grand jury. In charging the jury that they could find the defendants guilty under either or both theories the trial court materially amended the indictment and destroyed the defendants’ right to be tried only on the charges against them.
U.S. v. Fitapelli, 786 F.2d 1461, 1463-64 (11th Cir. 1986). To the extent that the
aside about harmless error raises the prospect that failure to amend an indictment
ever could qualify as harmless error, amicus AAPS respectfully submits that the
error here is about as harmful as error can be.
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At the outset, the question “[w]hether an error is harmless is a mixed
question of law and fact that [federal courts] review de novo.” Mason v. Allen, 605
F.3d 1114, 1123 (11th Cir. 2010). In the context of this case – with two alternate
theories of liability evaluated under different standards of mens rea – this Court
simply cannot know whether the jury unanimously convicted Dr. Gianoli under
either legal theory with the required mental state. Under the circumstances, the
failure to amend the indictment to add both theories and to use a special verdict
that separately contemplated both theories renders the result below indefensible.
A. The Prosecution Was Required to Seek to Amend the Indictment Before It Proceeded Under a New Theory of Liability
From a purely procedural standpoint, the Due Process Clause required the
United States to seek to amend the indictment to charge Dr. Gianoli with the
alternate “legitimate medical purpose” form of liability. See Gianoli Br. at 22-26. If
that seems like a merely procedural technicality, “[t]he history of liberty has
largely been the history of observance of procedural safeguards,” Oceanair of
Florida, Inc. v. N.T.S.B., 888 F.2d 767, 770 (11th Cir. 1989) (quoting McNabb v.
U.S., 318 U.S. 332, 347, 63 S.Ct. 608, 616 (1943)), which “protect the [public]
from arbitrary action on the part of the [government], however unintended.” Id. For
the reasons that Dr. Gianoli argues in his brief, this Court should reverse because
the United States failed to amend the indictment to include its alternate theory of
liability.
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B. The Prosecution Needed a Special Verdict to Demonstrate that It Prevailed Under Either Theory of Liability
As Dr. Gianoli explains, the District Court needed to use a special verdict in
order to ensure that the jury was unanimous on either the subjective “legitimate
medical purpose” theory of liability or the objective “usual course of professional
practice” theory of liability. See Gianoli Br. at 26-32. The fact that the jury hung
on the other counts where the jury did not outright find Dr. Gianoli not guilty
simply reinforces the unquestionable fact that no-one – not this Court, not the
District Court, and not the United States – knows whether the jury was unanimous
in finding Dr. Gianoli guilty under either theory of liability. And the two tests are
hardly two sides of the same coin, where voting for one means voting for the other.
One test is subjective, while the other is objective, which are two fundamentally
different things. U.S. v. Herrick, 545 F.3d 53, 59 (1st Cir. 2008); Ladner v. Smith,
941 F.2d 356, 360-61 (5th Cir. 1991), overruled on other grounds, U.S. v. Dixon,
509 U.S. 688, 113 S.Ct. 2849 (1993). Because the two tests simply do not even go
to the same question, the jury’s undifferentiated answer to their two separate
question does not answer whether Dr. Gianoli was guilty under either theory of
liability.
C. The Professional-Course-of-Practice Theory Must Proceed – If At All – Under an Objective Standard Based on Florida Law
As explained in the previous two sections, procedural irregularities leave this
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Court with no basis on which to affirm Dr. Gianoli’s conviction. In the event that
the United States elects to re-try this case on remand, the professional-practice
prong of liability should proceed under an objective standard but – rather than
being based on a nationwide standard – that prosecution should be based on
Florida standards because the CSA does not “clearly and manifestly” preempt the
authority of Florida to regulate the terms on which Florida-licensed physicians may
prescribe this FDA-approved drug in the course of their medical practices.
By way of background, the Supremacy Clause provides that federal law
preempts state law whenever they conflict. U.S. CONST. art. VI, cl. 2. Under the
federalist system of dual sovereignty, however, “the States entered the federal
system with their sovereignty intact,” Blatchford v. Native Village of Noatak, 501
U.S. 775, 779, 111 S.Ct. 2578, 2581 (1991), and “the States possess sovereignty
concurrent with that of the Federal Government, subject only to limitations
imposed by the Supremacy Clause.” Tafflin v. Levitt, 493 U.S. 455, 458, 110 S.Ct.
792, 795 (1990). For that reason, federal Courts interpret the laws enacted by
Congress deferentially to the states “because respect for the States as independent
sovereigns in our federal system leads [federal courts] to assume that Congress
does not cavalierly pre-empt [state law].” Wyeth v. Levine, 555 U.S. 555, 565 n.3,
129 S.Ct. 1187, 1195 n.3 (2009) (internal quotations omitted).
Thus, under the Supreme Court’s preemption analysis, all fields – and
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especially ones like medicine that have been traditionally occupied by state
government – require courts to apply a presumption against preemption. Wyeth,
555 U.S. at 565, 129 S.Ct. at 1194-95. Moreover, even if Congress had preempted
some state action, the presumption against preemption applies to determining the
scope of preemption. Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240,
2250 (1996). Thus, “[w]hen the text of an express pre-emption clause is
susceptible of more than one plausible reading, courts ordinarily accept the reading
that disfavors pre-emption.” Altria Group, Inc. v. Good, 555 U.S. 70, 77, 129 S.Ct.
538, 543 (2008) (quoting Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449, 125
S.Ct. 1788, 1801 (2005)). While the Commerce Power allows Congress to set
national rules under the CSA, see Gonzales v. Raich, 545 U.S. 1, 125 S.Ct. 2195
(2005), it is not manifestly clear that Congress intended the CSA to supplant state
law on how physicians practice medicine.2
The United States has prosecuted Dr. Gianoli for violating the generally
worded prohibitions of 21 U.S.C. §841(a)(1), which applies to his practice of
medicine because the CSA defines “dispense” to include “deliver[ing] a controlled
2 In holding that the CSA preempted state law with respect to medical uses for a Schedule I drug, the Supreme Court did not even consider what standards – national or state – apply to determining the validity of prescriptions for Schedule II drugs. Indeed, the Court expressly did not reach several issues, including the “the medical necessity defense,” and even suggested that the plaintiffs there could obtain relief by working with the Department of Justice to move marijuana to a different CSA schedule. Raich, 545 U.S. at 31, 125 S.Ct. at 2215.
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substance to an ultimate user … by … a practitioner, including the prescribing and
administering of a controlled substance.” 21 U.S.C. §802(10). Although not
expressly applicable here, the CSA elsewhere defines “valid prescription” without
reference to supplanting state standards for the practice of medicine:
The term “valid prescription” means a prescription which is issued for a legitimate medical purpose by an individual practitioner licensed by law to administer and prescribe the drugs concerned and acting in the usual course of the practitioner’s professional practice.
21 U.S.C. §830(b)(2)(A)(ii). Conversely, where the CSA intends federal interests
in prescription writing to take precedence over state law, the CSA expressly
requires registration with the Attorney General. See 21 U.S.C. §841(g)(2)(B)(i).
Here, therefore, nothing in the CSA commends an imagined nationwide standard
over the existing state standards for validly prescribing FDA-regulated drugs.
Under Medtronic and Altria Group, supra, this Court should recognize that the
CSA’s admitted preemption of state authority to allow wholesale distribution of
Schedule II drugs does not prevent interpreting the CSA’s preemptive scope
narrowly to rely on state law to determine the validity of physicians’ prescriptions.
IV. THE ENHANCED SENTENCE FOR CRIMES INVOLVING A POSITION OF TRUST IS INAPPOSITE TO STING OPERATIONS
The District Court held that Dr. Gianoli’s status as a licensed physician
triggered the sentencing enhancement for abusing a position of trust, U.S.
Sentencing Guidelines, §3B1.3, a legal issue that this Court reviews de novo. U.S.
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v. Terry, 60 F.3d 1541, 1545 (11th Cir. 1995) (“whether the defendant’s conduct
justifies the ‘abuse of trust’ enhancement is a question of law reviewed de novo”);
Koon v. U.S., 518 U.S. 81, 96, 116 S.Ct. 2035, 2046 (1996). By way of
background, Section 3B1.3 includes two prongs, one based on “abus[ing] a
position of public or private trust” and the other on “us[ing] a special skill.” U.S.
Sentencing Guidelines, §3B1.3.3 Amicus AAPS agrees with Dr. Gianoli that this
enhancement was inappropriate here, both for the double-counting argument that
he raises and for the second reason that undercover police officers do not, in fact,
“trust” the defendants whom they seek to entrap.
First, Dr. Gianoli correctly argues that the sentence for the underlying
offense already incorporates the idea of a physician acting outside his professional
obligations. See Gianoli Br. at 32-37. As Dr. Gianoli points out (id. at 34), Circuit
precedent and even the Guidelines themselves expressly provide as much: “This
adjustment may not be employed if an abuse of trust or skill is included in the
base offense level or specific offense characteristic.” U.S. Sentencing Guidelines,
§3B1.3 (emphasis added). For that reason, physicians should not fall under the
enhanced sentencing of Section 3B1.3 simply because they are physicians.
3 See id, Application Notes, ¶4 (“‘Special skill’ refers to a skill not possessed by members of the general public and usually requiring substantial education, training or licensing [such as] pilots, lawyers, doctors, accountants, chemists, and demolition experts”).
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Second, the ostensible patient – Detective Pittaluga – was actually an
undercover police officer who did not trust Dr. Gianoli. But “[a] relationship of
trust between the defendant and the victim is the sine qua non of the abuse-of-trust
enhancement.” U.S. v. Ghertler, 605 F.3d 1256, 1264 (11th Cir. 2010). For that
reason, “‘the abuse of trust enhancement applies only where the defendant has
abused discretionary authority entrusted to the defendant by the victim.’” Id.
(quoting U.S. v. Garrison, 133 F.3d 831, 839 (11th Cir. 1998) (emphasis in
Garrison)). No such abuse applied here, and the position-of-trust enhancement is
simply not available in “sting” or entrapment cases like this one.
CONCLUSION
For the foregoing reasons, the conviction below should be reversed.
Dated: February 20, 2013
Andrew L. Schlafly N.J. Bar No. 04066-2003 General Counsel 939 Old Chester Rd. Far Hills, NJ 07931 Tel: (908) 719-8608Fax: (908) 934-9207 Email: [email protected] (11th Cir. Admission Pending)
Respectfully submitted,
Lawrence J. Joseph D.C. Bar #464777 1250 Connecticut Ave. NW, Ste. 200 Washington, DC 20036 Tel: (202) 355-9452 Fax: (202) 318-2254 Email: [email protected]
Counsel for Amicus Curiae Association of American Physicians & Surgeons
/s/ Lawrence J. Joseph/s/ Andrew L. Schlafly
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CERTIFICATE OF COMPLIANCE
United States v. Gianoli, No. 12-14814-A
1. The foregoing complies with FED. R. APP. P. 32(a)(7)(B)’s type-
volume limitation because the brief contains 4,739 words excluding the parts of the
brief that FED. R. APP. P. 32(a)(7)(B)(iii) exempts.
2. The foregoing complies with FED. R. APP. P. 32(a)(5)’s type-face
requirements and FED. R. APP. P. 32(a)(6)’s type style requirements because the
brief has been prepared in a proportionally spaced type-face using Microsoft Word
2010 in Times New Roman 14-point font.
Dated: February 20, 2013 Respectfully submitted,
Lawrence J. Joseph D.C. Bar #464777 1250 Connecticut Ave. NW, Ste. 200 Washington, DC 20036 Tel: (202) 355-9452 Fax: (202) 318-2254 Email: [email protected]
Counsel for Amicus Curiae Association of American Physicians & Surgeons
/s/ Lawrence J. Joseph
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CERTIFICATE OF SERVICE
I hereby certify that on February 20, 2013, I electronically submitted the
foregoing document to the Clerk for filing and transmittal of a Notice of Electronic
Filing to the participants in this appeal who are registered CM/ECF users. I further
certify that I have mailed the foregoing document by Priority U.S. Mail, postage
prepaid, to the following participants in the case who are not registered CM/ECF
users:
James A. Muench Robert E. O’NeillKathy Peluso U.S. Attorney’s Office 400 N Tampa St Ste 3200 Tampa, FL 33602-4798
Donald C. Turner Don Turner Legal Team 1160 Grimes Bridge Rd Bldg B Roswell, GA 30075
Lawrence J. Joseph, D.C. Bar #464777 1250 Connecticut Ave, NW, Suite 200 Washington, DC 20036 Tel: (202) 355-9452 Fax: (202) 318-2254Email: [email protected]
/s/ Lawrence J. Joseph
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