1. Malpractice, Clinical Practice Guidelines and Expert Witnesses: A Case Report Richard L. Elliott, MD, PhD, FAPA Professor and Director Medical Ethics and Professionalism Mercer University School of Medicine Adjunct Professor Mercer University School of Law

2. Case Report: Initial Contact Phone call from US Attorney’s office Teenager prescribed Prozac for depression Found hanging three weeks later Allegation: Failure to warn parents about suicidality Response: Ask about identities of others involved in case, need for report Review records

3. 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

4. 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 Should life, health and malpractice insurance be linked? Incentivize good health insurance Telling patients about errors Reducing risk Rule #1 – Communication

5. Rule #1 We are doctors – (not lawyers, mostly) – Think clinically – Let information about risk management inform you, but do not become overly defensive

6. What is malpractice? A civil, not criminal, legal issue – No conviction or imprisonment – Based on preponderance of evidence 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

7. Legal claim in our case Malpractice – Failure to warn patient/parents of increased risk of suicide associated with Prozac – Failure to monitor patient closely

8. What is malpractice? The Four Ds: – Dereliction of – Duty – Directly causing – Damages

9. 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?

10. Malpractice and the Four Ds Dereliction of Duty Directly causing Damages

11. Was there a duty of care? Was there a doctor-patient relationship? Duty of care established by location, advice, treatment, billing, advertising Jessica was a patient, records were kept, patient assessed, medication prescribed, insurance billed

12. Malpractice and the Four Ds Dereliction of Duty Directly causing Damages

13. Was there a dereliction of duty? Dereliction means breach of standard of care It is negligent to fail to meet the standard of care

14. Standard of Care “degree of skill and care which under similar conditions and like surrounding circumstances is ordinarily employed by the medical profession generally”

15. 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

16. 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

17. Role of the Expert Witness May offer OPINION on standard of care, i.e., to establish presence or absence of negligence Should have access to all available information on which to base opinion Paid for time, not opinion Must not be paid contingent on outcome

18. Negligence and Claims Harvard Study cited in Studdert – 2% negligent injuries resulted in claims – 17% claims resulted from medical negligence IOM – 72.6% of adverse events NOT due to negligence – >90% errors do not lead to action – 30-40% malpractice claims without negligence

19. Negligence in our case Plaintiffs claimed several acts of negligence Failure to inform patient and mother about Prozacs association with “suicidality” Failure to monitor patient for “suicidality”

20. 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 the patient and mother, but did not document this

21. 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."

22. What is “suicidality?” No deaths in 22 studies reviewed by FDA including over 4400 patients Is ther an increase in suicide attempts among patients taking an SSRI?Placebo overdoses less likely to be reported than drug overdoses Confusion among panel members

23. 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”

24. 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 – After FDA warning, 31.9% saw patients more frequently, only 7.5% saw weekly

25. Malpractice and the Four Ds Dereliction of Duty Directly causing Damages

26. Hanging leading to anoxic brain injury and ultimately death Financial costs of care Loss of lifetime earnings Non-economic damages

27. Predictor of Payment Harvard New York data – Key predictor of payment for malpractice claim was degree of plaintiff disability, not degree of negligence

28. Who gets the damage award? 60% goes for “administrative costs” – Attorney’s fees – Expert witnesses – Filing fees – And so forth

29. Georgia’s Cap on non-Economic Damages Overturned by Georgia Supreme Court 2010

30. Malpractice and the Four Ds Dereliction of Duty Directly causing Damages

31. Did Prozac directly cause Jessica’s death? Does Prozac cause suicide? – General causation – Specific to the case Were there intervening causes? – “But for” test

32. 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% – 2010 9/574 (1.6%) adolescent suicides exposed to SSRIs – Yet 4% adolescents take antidepressants (CDC 2011) Increasing rates of prescription associated with decreasing rates of suicide – 33% decline in suicides in 1990s while SSRI use was increasing – Compare county/state SSRI use and suicide rates show increasing prescription rates associated with lower suicide rates

35. Does Prozac cause suicide in adolescents? No credible evidence that, in general, Prozac causes suicide (as opposed to “suicidality”) in adolescents

36. 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 with boyfriend February 18 – Hanging minutes after phone call – ER documented mother told them breakup was cause of hanging

37. Case weaknesses for defense Poor documentation – Single word “depressed” Black box warning from FDA 2004 Young girl – Sympathy factor

38. Case strengths for defense 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?

39. Red Herrings Jessica described as “Goth”

40. Outcome of Legal Case Judgment in favor of plaintiff

41. 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

42. Special Article Malpractice Risk According to Physician Specialty Anupam B. Jena, M.D., Ph.D., Seth Seabury, Ph.D., Darius Lakdawalla, Ph.D., and Amitabh Chandra, Ph.D. N Engl J Med Volume 365(7):629-636 August 18, 2011

43. Study Overview In this analysis of data from a national liability insurer, 7.4% of physicians faced a malpractice claim each year, although 78% of claims did not result in payments to claimants. The authors estimate that 75 to 99% of physicians will face a malpractice claim by the age of 65.

44. Proportion of Physicians Facing a Malpractice Claim Annually, According to Specialty. Jena AB et al. N Engl J Med 2011;365:629-636

45. Amount of Malpractice Payments, According to Specialty. Jena AB et al. N Engl J Med 2011;365:629-636

46. Is there a malpractice crisis? Rates of paid claims have been declining

47. Date of download: 11/4/2014 Copyright © 2014 American Medical Association. All rights reserved. From: The Medical Liability Climate and Prospects for Reform JAMA. Published online October 30, 2014. doi:10.1001/jama.2014.10705 Rates of Paid Medical Malpractice Claims Against Doctors of Medicine and Doctors of Osteopathy, 1994-2013Authors’ analysis of National Practitioner Data Bank data. Because data on the number of physicians for 2013 are not yet available, the 2013 data shown are extrapolated from 2012. Figure Legend:

48. Is there a malpractice crisis? Rates of paid claims have been declining Compensation per paid claim has been steady

49. Date of download: 11/4/2014 Copyright © 2014 American Medical Association. All rights reserved. From: The Medical Liability Climate and Prospects for Reform JAMA. Published online October 30, 2014. doi:10.1001/jama.2014.10705 Indemnity Amounts in Paid Claims Against Doctors of Medicine and Doctors of Osteopathy, 1994-2013 a Based on National Practitioner Data Bank data. a Based on analysis of 263 099 reported payments. All monetary values are shown in 2013 dollars. Figure Legend:

50. Is there a malpractice crisis? Rates of paid claims have been declining Compensation per paid claim has been steady Malpractice insurance rates steady

51. Date of download: 11/4/2014 Copyright © 2014 American Medical Association. All rights reserved. From: The Medical Liability Climate and Prospects for Reform JAMA. Published online October 30, 2014. doi:10.1001/jama.2014.10705 Liability Insurance Rates Charged to General Surgeons, Internal Medicine Physicians, and Obstetrician-Gynecologists in 5 Locations, 2004-2013Medical Liability Monitor Annual Rate Survey data. Rates shown are in 2013 dollars and indicate those charged by the dominant insurer in the local market. Dashed line between 2009 and 2010 in California indicates the shift from Los Angeles and Orange counties (2004-2009) to Los Angeles, Orange, Kern, and Ventura counties (2010-2013). Blue segment on each y-axis corresponds to the range $0 to $50 000. Figure Legend:

52. Intent of malpractice system Deterrence Compensation Punishment

53. Does malpractice system work? Little evidence it deters negligence Contributes to defensive medicine – Increased costs, more adverse events associated with medically unecessary interventions Punishes one individual, but most adverse events are system issues Compensation – 60% for administrative Is the system getting worse?

54. 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

55. Alternatives to current system Caps on non-economic damages Strict liability Enterprise liability Dispute resolution, mediation, arbitration – Health care courts Truth telling and “sorry laws”

56. 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

57. 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.

58. 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 career321

59. 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.24

60. 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.

61. 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