Malpractice, Clinical Practice Guidelines and Expert Witnesses: A Case Report Richard L. Elliott, MD, PhD, FAPA Professor and Director of Medical Ethics.

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

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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

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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