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Malpractice, Clinical Practice Guidelines and Expert Witnesses: A Case Report
Richard L. Elliott, MD, PhD, FAPAProfessor and Director of Medical Ethics
Mercer University School of Medicine
Adjunct Professor
Mercer University School of Law
PowerPoint on Abuse and Impairment on Ethics site
Need repeat lecture for Savannah?
Case Report: Initial Contact Phone call from US Attorney’s office Teenager prescribed Prozac Found hanging Allegation: Failure to warn parents about suicidality Response: Ask about identities of others, need for
report Agreement: Review records Fee: $350/hr record review, consultation, testimony No retainer Never a contingency fee
Case Report
16 year-old girl prescribed Prozac 10 mg on January 26, 2006 for “depression”
February 18, 2006, found hanging in closet Anoxic brain injury Died May 2006 from complications Suit filed in Federal Court
– Bench trial– Daubert rules
Goals Rule #1 What is a tort?
– Why do we have a tort system?
Medical errors and negligence Malpractice
– Reasons for malpractice– Causes – Dx, Rx, informed consent, trainee issues (handoffs)….
Standards of care– Clinical Practice Guidelines– Expert witnesses
Tort reform Telling patients about errors Reducing risk Rule #1
– Communication
Rule #1
We are doctors– (not lawyers, mostly)– Think clinically– Let information about risk management
inform you, but do not become overly defensive
What is malpractice? A civil, not criminal legal issue
– No imprisonment A tort
– Breach of duty owed to another individual other than breach of contract
– Motor vehicle accidents, slander, medical malpractice, others
– Purpose: to make injured party whole and to discourage such conduct
Some tortious acts may not be malpractice and not covered by insurance – sex with patients
Nature of Legal Claim
Civil suit - tort– Decision based on preponderance of
evidence– Must have statement from expert for
plaintiff on which to base claim
Case Report - Legal Claim
Malpractice– Failure to warn patient/parents of
increased risk of suicide associated with Prozac
– Failure to monitor patient closely
What is malpractice?
The Four Ds:– Dereliction of– Duty– Directly causing– Damage
Know this!
Four Ds in Our Case
Four D’s of malpractice– Dereliction of Duty Directly causing Damage– Was there a duty?
• To properly diagnose and treat• To inform patient of risks• Informed consent in Georgia
– Was there dereliction of duty? (failure to meet standard of care)– Were there damages?
• Anoxic brain injury• Financial
– Was Prozac responsible, or were there intervening causes?• Does Prozac cause suicide?• Did Prozac cause suicide in this case?
Malpractice and the Four Ds
Dereliction of Duty Directly causing Damage
Was there a duty of care?
Jessica was a patient, records were kept, patient assessed, medication prescribed
Was there a duty to inform?
Informed consent in Georgia– General informed consent overturned 2009
Mother was a nurse– Ought she to have known the risks?– Defendant claimed to have informed, but
did not documented
Malpractice and the Four Ds
Dereliction of Duty Directly causing Damage
Negligence and Claims Harvard Study cited in Studdert
– 2% negligent injuries resulted in claims– 17% claims resulted from negligent injuries
63% settled claims involve negligence IOM
– 72.6% of adverse events NOT due to negligence
– >90% errors do not lead to action– 30-40% malpractice claims without
negligence
Was there a dereliction of duty?
Dereliction means breach of standard of care
Standard of Care
“degree of skill and care which under similar conditions and like surrounding circumstances is ordinarily employed by the medical profession generally”
What determines the Standard of Care?
Res ipsa loquitur Clinical Practice Guidelines Recommendations of consultants Testimony of expert witnesses Can expert witnesses say anything?
– The problem of “junk science” Other documents, laws, standards
– FDA warning
Daubert and Constraints on Expert Testimony
Testimony must assist trier of fact to understand evidence or determine a fact
Expert qualified by knowledge, skill, training, experience, or education
Testimony based upon sufficient facts or data Testimony is the product of reliable principles or
methods Witness has applied those principles and methods to
the facts of the case
Does the FDA establish the Standard of Care?
"Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of [Drug Name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior."
What is “suicidality?”
No deaths in 22 studies reviewed by FDA including over 4400 patients
Placebo overdoses less likely to be reported than drug overdoses
Confusion among panel members
FDA Advisory Committee on “Suicidality”
Dr. Irwin “Is there a word suicidality?” Dr. Goodman (Chair) “Every time I write it in Word it gets red
underlined.” Dr. Irwin “I am not certain anyone really knows what it is we are
saying, what we are voting on” Ms Griffith (patient representative) “It’s not in Webster’s” Dr. Irwin “I think it may lead to a kind of misrepresentation” Dr. Goodman “I am interested in what parents think when they
read “suicidality” – my guess is they are going to think “suicide”” Dr. Goodman (later) “Hopefully the public will understand what
we mean, specifically that we are not talking about completed suicide”
What was the standard of care?
Bhatia – 2008– Surveyed 1521 physicians in Nebraska– 96.8% aware of FDA warning– 76.9 prescribed antidepressants to children
and adolescents– 31.9% saw patients more frequently, only
7.5% saw weekly
Malpractice and the Four Ds
Dereliction of Duty Directly causing Damage
Damages
Hanging leading to anoxic brain injury and ultimately death
Financial costs of care Loss of lifetime earnings Non-economic damages
Predictor of Payment
Harvard New York data– Key predictor of payment for malpractice
claim was degree of plaintiff disability, not degree of negligence
Georgia’s Cap on non-Economic Damages
Overturned by Georgia Supreme Court 2010
Malpractice and the Four Ds
Dereliction of Duty Directly causing Damage
Did Prozac directly cause Jessica’s death?
Does Prozac cause suicide?– General causation– Specific to the case
Were there intervening causes?– “But for” test
Does Prozac Cause Suicide in Adolescents?
No deaths in data reported to FDA– 22 RCT, 4400 patients– RCT not helpful means of studying relationship between SSRI and
suicide• Small numbers, high risk screened out, short time
Teen suicides rarely have antidepressant in blood– Dudley et al 2010 574 adolescent suicides, SSRI present 1.6%
Australasia Psychiatry June p. 242 Declining rates of prescription associated with increasing
rates of suicide– 33% decline in suicides in 1990s while SSRI increasing– Compare county/state SSRI use and suicide rates show
increasing prescription rates associated with lower suicide rates
Does Prozac cause suicide in adolescents?
No credible evidence that, in general, Prozac causes suicide (as opposed to “suicidality”) in adolescents
Did Prozac cause Jessica to commit suicide?
Lack of general causation Intervening causes
– Medication prescribed January 26– Break-up with boyfriend February 14– 40 minute phone call February 18– Hanging minutes after phone call
Case Weaknesses
Poor documentation– Single word “depressed”
Black box warning from FDA 2004 Young girl
– Sympathy factor
Case Strengths
Lack of clear evidence for general causation Intervening causes
– Cell phone records, mother’s deposition, boy friend testimony, linking hanging to break-up with boyfriend
Mother described Jessica as depressed, and attributed hanging to break-up
Mother as nurse – to what extent should she have been aware of warning?
Red Herrings
Jessica described as “Goth”
Outcome of Legal Case
Mediation June 17, 2010– Plaintiffs had previously rejected mediation
No ruling as of 11/1/10
Clinical Recommendations
Suicide should always be considered when prescribing an antidepressant
“Warning” – don’t need to link to antidepressant, just advise to observe for worsening, including suicidal thoughts/behaviors
Follow-up
Three Pillars of Protection against suits
Communication with patient and family Consultation - Rule #1 – clinical utility
– If you disagree with consultant, resolve – no chart fights Documentation
– Not more, but more appropriate– Rule #1 – documentation should be clinically
relevant, not merely CYA– NEVER alter records– Documentation after an incident should be viewed
in light of potentially public nature
Rules for Expert Witnesses
Agree only to review a case Retainers are ethical Contingency fees are not ethical Avoid creating a doctor-patient
relationship as an expert witness Make concerns about case or your
participation known ASAP
Tort Reform I
Malpractice – 2-3% of healthcare costs Costs of malpractice insurance not tied solely
to physician risk Goals of tort reform
– Reduce costs of insurance– Reduce disincentives to practice (e.g., OB)– Reduce costs and risks of defensive
medicine
Tort Reform Proposals Cap non-economic damages Health courts
– Neutral experts, greater expertise– Evidence-Based Medicine– Analogous to workers’ compensation
Limit attorney contingency fees Losing plaintiff pays all costs Eliminate “joint and several” liability
2010 9/574 (1.6%) adolescent suicides exposed to SSRIs
Were there intervening causes?
Medication prescribed January 26 Break-up with boyfriend February 14 40 minute phone call February 18 Hanging minutes after phone call
Copyright restrictions may apply.
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Annual Suicide Rates for Males and Females Aged 10 to 19 Years, U.S., 1996 - 2005
We're would like to expose the students to information regarding malpractice, evidence-based practice, and standards of care, i.e., what legal implications are there when physicians fail to follow such standards. Perhaps a case or two?
2030 BC when the Code of Hammurabi provided that “If the doctor has treated a gentlemen with a lancet of bronze and has caused the gentleman to die, or has opened an abscess of the eye for a gentleman with a bronze lancet, and has caused the loss of the gentleman’s eye, one shall cut off his hands
In 1532, during the reign of Charles V, a law was passed that required the opinion of medical men to be taken formally in every case of violent death; this was the precursor to requiring expert testimony from a member of the profession in medical negligence claims, to establish the standard of care.
In the United States, medical malpractice suits first appeared with regularity beginning in the 1800s [3]. However, before the 1960s, legal claims for medical malpractice were rare, and had little impact on the practice of medicine [21]. Since the 1960s the frequency of medical malpractice claims has increased; and today, lawsuits filed by aggrieved patients alleging malpractice by a physician are relatively common in the United States. One survey of specialty arthroplasty surgeons reported that more than 70% of respondents had been sued at least once for medical malpractice during their career
Medical malpractice is defined as any act or omission by a physician during treatment of a patient that deviates from accepted norms of practice in the medical community and causes an injury to the patient. Medical malpractice is a specific subset of tort law that deals with professional negligence. “Tort” is the Norman word for “wrong,” and tort law is a body of law that creates and provides remedies for civil wrongs that are distinct from contractual duties or criminal wrongs [24]. “Negligence” is generally defined as conduct that falls short of a standard; the most commonly used standard in tort law is that of a so-called “reasonable person.” The reasonable person standard is a legal fiction, created so the law can have a reference standard of reasoned conduct that a person in similar circumstances would do, or not do, in order to protect another person from a foreseeable risk of harm.
In the United States, medical malpractice law is under the authority of the individual states; the framework and rules that govern it have been established through decisions of lawsuits filed in state courts. Thus, state law governing medical malpractice can vary across different jurisdictions in the United States, although the principles are similar. In addition, during the last 30 years, statutes passed by states’ legislatures have further influenced the governing principles of medical malpractice law. Thus medical malpractice law in the United States is based on common law, modified by state legislative actions that vary from state to state.
One exception to medical liability can arise in the context of those who volunteer assistance to others who are injured or ill; this exception is embodied in “Good Samaritan” laws that address bystanders’ fear of being sued or prosecuted for unintentional injury or wrongful death, In the United States, Good Samaritan laws vary from jurisdiction to jurisdiction and specify who is protected from liability and the circumstances pertaining to such protection. In general, Good Samaritan statutes do not require any person to give aid to a victim, although a handful of states, such as Vermont and Minnesota, specify a duty to provide reasonable assistance to an
Medical Liability Claim Frequency by Specialty,2007-2008 % Ever Sued
General & family practice 38.9% General internal medicine 34.0% Internal medicine sub-specialties 40.2% General surgery 69.2%Surgical sub-specialties 57.0% Pediatrics 27.3% Obstetrics/gynecology 69.2% Radiology 47.4%Psychiatry 22.2% Anesthesiology 42.4% Pathology 34.9%Emergency medicine 49.8%
Terminology
Plaintiffs Defendants Bench trial Jury trial Deposition
Why serve as an Expert Witness?
Rule #1– We are doctors
Advantages– Flexible hours, challenging environment
Disadvantages– Inflexible hours, hostile environment
What is an expert witness?
Ordinary witness can testify to first hand experiences related to facts of an event (what he/she saw, heard, etc.)
Expert witness has education, training, expertise which can help trier of fact to understand aspects of case beyond the knowledge of the average person
Expert may give opinions
