Transcript Is There a Duty to Warn Battuello

Is there a Duty to Warn Regarding
Shared Genetic Risk?
The role of law, policy and literature in
shaping provider obligations to family
members.
Kate Battuello JD, MPH
Assistant Attorney General
Office of the Attorney General of Washington
Seattle, Washington
July 26, 2008
Treuman Katz Center for Pediatric Bioethics - 2008 Conference
Case Report
• Proband: 55-year-old Caucasian
female with + family history who
seeks genetic testing, along with sibs
• Clearly stated preference to withhold
+ test results from potentially affected
relatives
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Case Report, cont.
• Proband and two sibs test + for
BRCA 1 mutation
• Sibs share test results; proband says
her results are • Proband refuses to inform daughter
(23) regarding shared risk
Loud JT, Weissman, JA, Peters, JA et. al. J. Clin. Oncology 24(10):16431646 (2006)
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Overview
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Introduction: the legal concept of duty
Literature review: framing the debate
Analysis: the role of the law
Conclusions and recommendations
Treuman Katz Center for Pediatric Bioethics - 2008 Conference
Introduction
“... The existence of a duty owed to the plaintiff by
the defendant is entirely a question of law for the
court … imposition of a legal duty reflects
society’s contemporary policies and social
requirements concerning the right of individuals
and the general public to be protected form
another’s act or conduct …”
Bradshaw v. Daniel, 854 S.W. 2d 865 (1993)
Treuman Katz Center for Pediatric Bioethics - 2008 Conference
Framing the Debate
• No duty to warn
• Privilege to warn, provided patient
consents
• Duty to warn in narrowly defined set of
circumstances
• Competing Ethical Duties
• Conflicting Legal Obligations
Treuman Katz Center for Pediatric Bioethics - 2008 Conference
Consensus Position
• Providers should counsel patients to inform
potentially affected family members
– ASHG
• Am. J. Hum. Genet. 62:747-483 (1998)
– ASCO
• J. Clin. Oncology 21:2397-2406 (2003)
– AMA
• Opinion #2.131 AMA Code of Medical Ethics: Current
Opinions
– IOM
• Assessing Genetic Risks: Implications for Health and Social
Policy (1994)
– President’s Commission (1998)
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Patients’ Perspectives
• Lehmann LS, Weeks JC, Klar N, et al
– Minority of those surveyed felt physicians have moral
duty to disclose in the absence of patient consent
• Am. J. Med. 109:705-711 (2000)
• Plantiga L, Natowicz MR, Kass NE, et al
– Less than one-third of participants agreed that providers
should inform family members without patient consent
• Am. J. Med. Genet. 119C51-59 (2003)
• Kohut K, Manno M, Gallinger, S et al
– Few participants felt that providers have a duty to warn
relatives without patient consent
• J. Med. Genet. 44:404-407 (2007)
Treuman Katz Center for Pediatric Bioethics - 2008 Conference
Patients’ Actions
• Falk MJ, Dugan B, O’Riordan M, et. al.
– 60% of surveyed medical geneticists report
patients who refused to warn an at-risk family
member
• Am. J. Med. Genet 120:374-80 (2003)
• Loud JT, Weissman NE, Peters JA, Giusti,
RM, Wilfond, BS, Burke W, Greene MH
– Case report of deliberate deceit of family
members
• J. Clin. Oncology 24(10):1643-1646 (2006).
Treuman Katz Center for Pediatric Bioethics - 2008 Conference
Consensus Position:
Limitations
• Adequate counseling
– Provider education
– Resources for genetic counseling
• Patient resistance
– No contact with relatives
– Desire to protect relatives
– Individual autonomy
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Privacy Rights ….
• Constitutional Rights
• Federal Statutes
– HIPAA
– GINA
• State Statutes
– NCSL database http://www.ncsl.org
• Common Law
– Invasion of privacy
– Breach of duty to maintain confidentiality
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… are not absolute!
• HIPAA exceptions
– Providers may disclose PHI if necessary
to prevent or lessen a serious and
imminent threat to health and safety
• 45 C.F.R. Sec. 164.512(j)
• Public Health Mandates
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Evolving Duty to Warn
• Tarasoff v. Regents of the University of California
(1976)
• Bradshaw v. Daniel (1993)
• Reisner v. Regents of the University of California
(1995)
• Criteria:
– Known or foreseeable person who is at risk
– For a serious health outcome that can be
– Avoided by disclosing or advising patient to
disclose PHI
Treuman Katz Center for Pediatric Bioethics - 2008 Conference
Applications to Shared
Family Risk
• Pate v. Threlkel (1995)
• Safer v. Pack (1996)
• Molloy v. Meier (2004)
Treuman Katz Center for Pediatric Bioethics - 2008 Conference
Pate v. Threlkel
• Existence of a duty to warn depends upon “the
prevailing standard of care…”
• Ordinarily the patient can be expected to pass on
the warning…
• “We emphasize … [any] duty will be satisfied by
warning the patient …”
661 So. 2d 278 (Fla., 1995)
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Safer v. Pack
• There is a duty to warn of avoidable risk from
genetic causes
• The duty extends to family members who share
the risk
• “We need not decide … how the duty is to be
discharged … except to require that reasonable
steps … be taken to assure that the information
reaches those likely to be affected …”
677 A.2d 1188 (NJ1996)
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Molloy v. Meier
• Duty of care regarding genetic testing and
diagnosis extends beyond the patient to biological
parents who foreseeably may be harmed by
breach of that duty
• “We … do not address whether the duty
recognized here extends beyond biological
parents who foreseeably may be harmed by a
breach of that duty …”
679 N.W. 2d 711 (2004)
Treuman Katz Center for Pediatric Bioethics - 2008 Conference
Conclusions
• The duty to warn arises in a narrow
set of circumstances
• Prevailing scientific evidence and
clinical practice shape the nature
and extent of the duty
• In almost all cases the duty will be
satisfied by warning the patient
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Case Report Revisited
• Family members other than offspring
aware of shared genetic risk
• Data regarding benefits of routine
screening and prevention options
emerging
• 23 –year-old-daughter too young to begin
mutation-related surveillance
• Proband agrees to periodic contact with
team to revisit issues around offspring
Treuman Katz Center for Pediatric Bioethics - 2008 Conference
Recommendations
• Refrain from extending the scope of
the duty to warn
• Focus on education and counseling
Treuman Katz Center for Pediatric Bioethics - 2008 Conference
Treuman Katz Center for Pediatric Bioethics - 2008 Conference