treuman katz center for pediatric bioethics - 2008 conference is there a duty to warn regarding...

Treuman Katz Center for Pediatric Bioethics - 2008 Conference

Is there a Duty to Warn Regarding Shared Genetic Risk?

Is there a Duty to Warn Regarding Shared Genetic Risk?

The role of law, policy and literature in shaping provider obligations to family

members.

The role of law, policy and literature in shaping provider obligations to family

members.

Kate Battuello JD, MPHKate Battuello JD, MPH

Assistant Attorney GeneralOffice of the Attorney General of Washington

Seattle, WashingtonJuly 26, 2008

Assistant Attorney GeneralOffice of the Attorney General of Washington

Seattle, WashingtonJuly 26, 2008


Case ReportCase 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

• 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


Case Report, cont.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):1643-1646 (2006)

• 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):1643-1646 (2006)


OverviewOverview

• Introduction: the legal concept of duty

• Literature review: framing the debate

• Analysis: the role of the law

• Conclusions and recommendations

• Introduction: the legal concept of duty

• Literature review: framing the debate

• Analysis: the role of the law

• Conclusions and recommendations


IntroductionIntroduction

“... 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)

“... 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)


Framing the DebateFraming 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

• 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


Consensus PositionConsensus 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)

• 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)


Patients’ PerspectivesPatients’ 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)

• 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)


Patients’ ActionsPatients’ 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).

• 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).


Consensus Position: Limitations

Consensus Position: Limitations

• Adequate counseling– Provider education– Resources for genetic counseling

• Patient resistance– No contact with relatives– Desire to protect relatives– Individual autonomy

• Adequate counseling– Provider education– Resources for genetic counseling

• Patient resistance– No contact with relatives– Desire to protect relatives– Individual autonomy


Privacy Rights ….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


… are not absolute!… 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

• 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


Evolving Duty to WarnEvolving 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

• 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


Applications to Shared Family Risk

Applications to Shared Family Risk

• Pate v. Threlkel (1995)

• Safer v. Pack (1996)

• Molloy v. Meier (2004)

• Pate v. Threlkel (1995)

• Safer v. Pack (1996)

• Molloy v. Meier (2004)


Pate v. ThrelkelPate 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)

• 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)


Safer v. PackSafer 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)

• 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)


Molloy v. MeierMolloy 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)

• 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)


ConclusionsConclusions• 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

• 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


Case Report RevisitedCase 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

• 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


RecommendationsRecommendations• Refrain from extending the scope of

the duty to warn

• Focus on education and counseling

• Refrain from extending the scope of the duty to warn

• Focus on education and counseling

treuman katz center for pediatric bioethics - 2008 conference is there a duty to warn regarding...

Documents

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pediatric bioethics

treuman katz center

test results proband

sibs test

legal obligations slide

conference introduction

patient consents duty