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Stem Cells, Building Blocks for Tissue Engineering
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Stem Cells, Building Blocks for Tissue Engineering

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  • 1. Malpractice, Clinical Practice Guidelines and Expert Witnesses: A Case Report Richard L. Elliott, MD, PhD, FAPA Professor and Director of Medical Ethics Mercer University School of Medicine Adjunct Professor Mercer University School of Law
  • 2.  PowerPoint on Abuse and Impairment on Ethics site  Need repeat lecture for Savannah?
  • 3. 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
  • 4. 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
  • 5. 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
  • 6. Rule #1  We are doctors – (not lawyers, mostly) – Think clinically – Let information about risk management inform you, but do not become overly defensive
  • 7. 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
  • 8. 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
  • 9. Case Report - Legal Claim  Malpractice – Failure to warn patient/parents of increased risk of suicide associated with Prozac – Failure to monitor patient closely
  • 10. What is malpractice?  The Four Ds: – Dereliction of – Duty – Directly causing – Damage  Know this!
  • 11. 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?
  • 12. Malpractice and the Four Ds  Dereliction of  Duty  Directly causing  Damage
  • 13. Was there a duty of care?  Jessica was a patient, records were kept, patient assessed, medication prescribed
  • 14. 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
  • 15. Malpractice and the Four Ds  Dereliction of  Duty  Directly causing  Damage
  • 16. 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
  • 17. Was there a dereliction of duty?  Dereliction means breach of standard of care
  • 18. Standard of Care  “degree of skill and care which under similar conditions and like surrounding circumstances is ordinarily employed by the medical profession generally”
  • 19. 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
  • 20. 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
  • 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  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 – 31.9% saw patients more frequently, only 7.5% saw weekly
  • 25. Malpractice and the Four Ds  Dereliction of  Duty  Directly causing  Damage
  • 26. Damages  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. Georgia’s Cap on non-Economic Damages  Overturned by Georgia Supreme Court 2010
  • 29. Malpractice and the Four Ds  Dereliction of  Duty  Directly causing  Damage
  • 30. Did Prozac directly cause Jessica’s death?  Does Prozac cause suicide? – General causation – Specific to the case  Were there intervening causes? – “But for” test
  • 31. 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
  • 32. Does Prozac cause suicide in adolescents?  No credible evidence that, in general, Prozac causes suicide (as opposed to “suicidality”) in adolescents
  • 33. 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
  • 34. Case Weaknesses  Poor documentation – Single word “depressed”  Black box warning from FDA 2004  Young girl – Sympathy factor
  • 35. 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?
  • 36. Red Herrings  Jessica described as “Goth”
  • 37. Outcome of Legal Case  Mediation June 17, 2010 – Plaintiffs had previously rejected mediation  No ruling as of 11/1/10
  • 38. 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
  • 39. 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
  • 40. 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
  • 41. 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
  • 42. 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
  • 43.  2010 9/574 (1.6%) adolescent suicides exposed to SSRIs
  • 44. 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
  • 45. Copyright restrictions may apply. . Annual Suicide Rates for Males and Females Aged 10 to 19 Years, U.S., 1996 - 2005
  • 46. 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?
  • 47. 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
  • 48. 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.
  • 49. 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
  • 50. 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.
  • 51. 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.
  • 52. 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
  • 53. 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%
  • 54. Terminology  Plaintiffs  Defendants  Bench trial  Jury trial  Deposition
  • 55. Why serve as an Expert Witness?  Rule #1 – We are doctors  Advantages – Flexible hours, challenging environment  Disadvantages – Inflexible hours, hostile environment
  • 56. 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