1. Treuman Katz Center for Pediatric Bioethics - 2008 Conference 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 Assistant Attorney General Office of the Attorney General of Washington Seattle, Washington July 26, 2008

2. 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 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. Treuman Katz Center for Pediatric Bioethics - 2008 Conference 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)

4. Treuman Katz Center for Pediatric Bioethics - 2008 Conference Overview 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

5. 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) “... 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. 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 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. 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) 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. Treuman Katz Center for Pediatric Bioethics - 2008 Conference 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) 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. 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). 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. 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 Adequate counseling –Provider education –Resources for genetic counseling Patient resistance –No contact with relatives –Desire to protect relatives –Individual autonomy

11. Treuman Katz Center for Pediatric Bioethics - 2008 Conference Privacy Rights …. Constitutional Rights Federal Statutes –HIPAA –GINA State Statutes –NCSL database http://www.ncsl.orghttp://www.ncsl.org Common Law –Invasion of privacy –Breach of duty to maintain confidentiality Constitutional Rights Federal Statutes –HIPAA –GINA State Statutes –NCSL database http://www.ncsl.orghttp://www.ncsl.org Common Law –Invasion of privacy –Breach of duty to maintain confidentiality

12. Treuman Katz Center for Pediatric Bioethics - 2008 Conference … 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

13. Treuman Katz Center for Pediatric Bioethics - 2008 Conference 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 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. 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) Pate v. Threlkel (1995) Safer v. Pack (1996) Molloy v. Meier (2004)

15. 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) 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. Treuman Katz Center for Pediatric Bioethics - 2008 Conference 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) 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. Treuman Katz Center for Pediatric Bioethics - 2008 Conference 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) 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. 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 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. Treuman Katz Center for Pediatric Bioethics - 2008 Conference 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 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. Treuman Katz Center for Pediatric Bioethics - 2008 Conference Recommendations 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

21. Treuman Katz Center for Pediatric Bioethics - 2008 Conference