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Stem Cells, Building Blocks for Tissue Engineering

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Stem Cells, Building Blocks for Tissue Engineering Presentation Transcript

  • 1.
  • 2. 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
  • 3. PowerPoint on Abuse and Impairment on Ethics site
    Need repeat lecture for Savannah?
  • 4. 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
  • 5. 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
  • 6.
  • 7. 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
  • 8. Rule #1
    We are doctors
    (not lawyers, mostly)
    Think clinically
    Let information about risk management inform you, but do not become overly defensive
  • 9. 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
  • 10. 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
  • 11. Case Report - Legal Claim
    Malpractice
    Failure to warn patient/parents of increased risk of suicide associated with Prozac
    Failure to monitor patient closely
  • 12. What is malpractice?
    The Four Ds:
    Dereliction of
    Duty
    Directly causing
    Damage
    Know this!
  • 13. 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?
  • 14. Malpractice and the Four Ds
    Dereliction of
    Duty
    Directly causing
    Damage
  • 15. Was there a duty of care?
    Jessica was a patient, records were kept, patient assessed, medication prescribed
  • 16. 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
  • 17. Malpractice and the Four Ds
    Dereliction of
    Duty
    Directly causing
    Damage
  • 18. 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
  • 19. Was there a dereliction of duty?
    Dereliction means breach of standard of care
  • 20. Standard of Care
    “degree of skill and care which under similar conditions and like surrounding circumstances is ordinarily employed by the medical profession generally”
  • 21. What determines the Standard of Care?
    Res ipsaloquitur
    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
  • 22. 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
  • 23. 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."
  • 24. 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
  • 25. 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”
  • 26. 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
  • 27. Malpractice and the Four Ds
    Dereliction of
    Duty
    Directly causing
    Damage
  • 28. Damages
    Hanging leading to anoxic brain injury and ultimately death
    Financial costs of care
    Loss of lifetime earnings
    Non-economic damages
  • 29. Predictor of Payment
    Harvard New York data
    Key predictor of payment for malpractice claim was degree of plaintiff disability, not degree of negligence
  • 30. Georgia’s Cap on non-Economic Damages
    Overturned by Georgia Supreme Court 2010
  • 31. Malpractice and the Four Ds
    Dereliction of
    Duty
    Directly causing
    Damage
  • 32. Did Prozac directly cause Jessica’s death?
    Does Prozac cause suicide?
    General causation
    Specific to the case
    Were there intervening causes?
    “But for” test
  • 33. 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
  • 34.
  • 35.
  • 36. Does Prozac cause suicide in adolescents?
    No credible evidence that, in general, Prozac causes suicide (as opposed to “suicidality”) in adolescents
  • 37. 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
  • 38. Case Weaknesses
    Poor documentation
    Single word “depressed”
    Black box warning from FDA 2004
    Young girl
    Sympathy factor
  • 39. 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?
  • 40. Red Herrings
    Jessica described as “Goth”
  • 41. Outcome of Legal Case
    Mediation June 17, 2010
    Plaintiffs had previously rejected mediation
    No ruling as of 11/1/10
  • 42. 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
  • 43. 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
  • 44. 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
  • 45. 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
  • 46. 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
  • 47.
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  • 66.
  • 67.
  • 68. 2010 9/574 (1.6%) adolescent suicides exposed to SSRIs
  • 69. 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
  • 70.
  • 71.
  • 72. Annual Suicide Rates for Males and Females Aged 10 to 19 Years, U.S., 1996 - 2005
    .
    Copyright restrictions may apply.
  • 73.
  • 74.
  • 75. 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?
  • 76. 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
  • 77. 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.
  • 78. 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
  • 79. 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.
  • 80. 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.
  • 81. 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
  • 82. 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%
  • 83. Terminology
    Plaintiffs
    Defendants
    Bench trial
    Jury trial
    Deposition
  • 84. Why serve as an Expert Witness?
    Rule #1
    We are doctors
    Advantages
    Flexible hours, challenging environment
    Disadvantages
    Inflexible hours, hostile environment
  • 85. 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