Is there a Duty to Warn Regarding Shared Genetic Risk ?

1. Is there a Duty to Warn Regarding Shared Genetic Risk? Kate Battuello JD, MPH The role of law, policy and literature in shaping provider obligations to family members. Assistant Attorney General Office of the Attorney General of Washington Seattle, Washington July 26, 2008

2. 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

3. 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)

4. Overview • Introduction: the legal concept of duty • Literature review: framing the debate • Analysis: the role of the law • Conclusions and recommendations

5. 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)

6. 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

7. 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)

8. 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)

9. 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).

10. Consensus Position: Limitations • Adequate counseling • Provider education • Resources for genetic counseling • Patient resistance • No contact with relatives • Desire to protect relatives • Individual autonomy

11. 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

12. … 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

13. 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

14. Applications to Shared Family Risk • Pate v. Threlkel(1995) • Safer v. Pack (1996) • Molloy v. Meier (2004)

15. 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)

16. 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)

17. 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)

18. 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

19. 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

20. Recommendations • Refrain from extending the scope of the duty to warn • Focus on education and counseling