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Stem Cells, Building Blocks for Tissue Engineering

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

    • 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
    • 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 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
    • 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
    • Annual Suicide Rates for Males and Females Aged 10 to 19 Years, U.S., 1996 - 2005
      .
      Copyright restrictions may apply.
    • 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