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Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University.

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Presentation on theme: "Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University."— Presentation transcript:

1 Sonia M. Suter, M.S., J.D. Assoc. Prof. of Law George Washington University

2  Consent  Informed Consent  Wrongful Birth/Life  Privacy and Confidentiality  Confidentiality Exceptions

3  Medical treatment requires patient’s consent  “Every adult human of adult years and sound mind has a right to determine what shall be done with his own body.” (Cardozo, 1914)  Ethical Underpinnings  Bodily Integrity: Right to control access to one’s physical space  Autonomy/Self-Determination Right to make decisions for and about oneself Response to paternalism

4  Battery  A claim for touching without consent or legal justification  Long common law tradition  Medical corollary  Medical treatment requires consent  Right to refuse medical treatment  “Inferred/assumed” constitutional liberty interest

5  Limited physical invasiveness  Collecting genetic sample or medical exams  Invasiveness is largely informational  Collecting information  Disseminating information

6  Common law requires consent for invasive procedures: testing, exams, etc.  State statutes require consent for  Collection of DNA samples  Genetic analysis  Retention of genetic information/samples  Uses of genetic information  Disclosure of genetic information to 3d parties

7  Not only is consent required for medical intervention/treatment  Consent must be informed

8  Autonomy and self-determination  Fosters Rational Decision Making  Encourages physicians to think carefully about medical recommendations  Moves from paternalism to shared decision making

9  Duty to inform patients about procedure Duty to “satisfy the vital informational needs of the patient” (Canterbury v. Spence, 1972)  Origins in Battery  Requires limited disclosure: proposed treatments  No physical injury necessary  Few defenses if no consent  Movement to Negligence (vast majority)  Broader range of disclosure requirements  Causation more difficult to prove  Usually must show physical injury

10  Information to disclose (2 approaches)  Professional Standard What a reasonable practitioner would disclose  Patient-based standard: Information material to reasonable patient  Typical information to disclose:  Diagnosis  Nature and purpose of treatment  Risks of treatment  Treatment alternatives  Consequences of refusal to test/treat

11  Physician liable if  Fail to disclose required information  (Reasonable) patient would’ve decided differently -- causation  AND patient suffered physical harm -- damages  Emphasis on physical risks/physical harms  Few cases regarding non-physical risks/harm

12  Not traditional risks of invasive treatment  Exceptions: reproductive testing Invasiveness, physical risks  Risks are largely psychosocial  Anxiety, altered self-image  Altered family relationships  Social/group stigmatization  Discrimination  Impact on privacy and confidentiality

13  Several state statutes require informed consent for genetic testing  Handful describe information to disclose for (presymptomatic/predictive) testing  Nature and purpose of test  Effectiveness and limitations of test  Implications of taking test  Meaning of test results  Procedure of providing test results  (no information reasonable doc wouldn’t know) -- MI  Some statutes for disclosure and retention

14  Clear ethical/legal duty to obtain consent for any genetic test, physical examination  Legal duty to disclose range of information  Diagnosis/Genetic Risk  Testing options  Nature and purpose of genetic tests  Physical risks  Consequences of not testing  What about psychosocial risks?

15  Uncertainty about degree of risk  Limited data on psychological stress, effect on family dynamics, risks of discrimination  Risks depend on numerous variables  Penetrance/expressivity/severity/nature of disease  Unclear reach of legal obligations  Statutes that mandate disclosure of “implications of genetic testing” are vague  Common law focuses on physical risks

16  Duty would be based on standard of care or materiality of information  Causation may be hard to show  Studies suggest concerns about discrimination don’t influence decisions  Exceptions: some of the psychological risks  Damages  Law is highly reluctant to allow recovery for pure emotional distress without physical harm

17  Goals of Genetic Counseling  Enable “clients to make informed independent decisions, free of coercion, by providing or illuminating the necessary facts and clarifying the alternatives and anticipated consequences.” (NSGC Code of Ethics)  Decisions based on personal values and life plans  Emphasizes informed decision making  Emphasizes independent decision making  Nondirectiveness: goes beyond IC

18  Nondirectiveness avoids prescriptiveness  At the extreme, may not answer question “what would you do?”  Extreme nondirectiveness may conflict with self-determination and informed consent  Prevents coercion regarding actual decision  But prescribes manner of decision making and  Prevents access to information patient believes would help with the decision

19  “Cousins” of Informed Consent  Claim for failure to disclose reproductive risks, which limits reproductive options  Wrongful birth:  parents sue for lost chance to avoid birth of child  Wrongful life:  child sues for lost chance to have birth prevented  Liability if  Breach of standard of care by not providing information about reproductive risks and  Lack of information prevents patients from avoiding conception or terminating pregnancy

20  Wrongful birth claims widely recognized  Fewer than 10 states prohibit these claims  Usual damages: Extraordinary costs/costs of delivery  Less typical damages Emotional distress, ordinary costs of raising the child  Wrongful life claims rarely recognized  Only 4 states: NJ, CA, WA, ME  Damages limited to extraordinary costs

21  Claim for termination based on inaccurate diagnosis of abnormality  Subject of only a handful of judicial opinions  Far less likely basis of lawsuit than wrongful birth claim

22  Failing to identify prenatal conditions can lead to wrongful birth claims  Incorrectly diagnosing a condition that leads to a termination is not likely to result in a wrongful termination claim  Best defense against wrongful birth claim is not only to offer a test, but TO test .:. Strong incentive to PUSH prenatal testing  But inconsistent with goals of genetic counseling

23  Different from (informed) consent  But based on overlapping concerns and interests of autonomy and self-determination  Privacy and confidentiality are not precisely the same, overlapping rights

24  Control over personal information  Right to be let alone  Control over one’s physical person  Protection of disclosed information (confidentiality)

25  “Cousin” of Privacy  It’s relational  Protects information disclosed in confidence  Physician must not reveal sensitive information without patient’s consent  Fiduciary obligation – relationship of trust  Longstanding medical ethical obligation  Hippocratic Oath -> Code of Medical Ethics AMA

26  Privacy is infringed by unauthorized access to information  Confidentiality infringed when person in a confidential relationship fails to protect the information

27  Good in its own right  Protects autonomy  Space to develop and maintain self/identity  Prevents us from being misunderstood  Limits shame/stigmatization/discrimination  Necessary for intimacy  Builds trust in medical care  Encourages participation in research

28  Every state safeguards medical records  Tend to protect privacy by entity  Protections depend largely on who possesses info  Few state laws are intended to be comprehensive  Lots of Variation

29  Protects individually identifiable health information, in any form, electronic or non- electronic, held or transmitted by covered entity  Individually identifiable information  relates to physical/mental health or condition  Provision of or payment of health care  Includes genetic information  Covered entities  Health plans  Health care clearinghouses  And health care providers

30  Ensures patient access to medical records  Allows review and requested amendments  Covered entities must  Provide patients with information about privacy rights  Adopt written privacy provisions  Safeguard patient records  Sets national “floor” of privacy standards

31  Most courts recognize legal duty to preserve patient confidentiality  Some base on invasion of privacy (tort)  Others distinguish where obligation of secrecy, a fiduciary duty  Additional bases for duty:  Testimonial privilege  licensing statutes  implied K  Etc.

32  Genetic information is personal/intimate  Influences physical, psychological traits  Reveals information about family members  Much of it is hidden  Potentially sensitive information  May predict susceptibility to disease  Can be misunderstood/ history of abuse  Can be basis of discrimination or stigmatization  Fear of discrimination can undermine health care and research

33  Over 30 states address the issue  Great variation  Tend to focus on information, as opposed to specific entity or use  Protect information at different stages:  From information gathering to dissemination

34  Some require personal access to one’s info  Require (written and/or informed) consent  To obtain genetic information  To retain genetic sample or information Description of information retained Potential uses and limitations  For disclosure of genetic info to 3d party Purpose for which information being requested Information to be disclosed Individuals/entities making disclosure To whom disclosure made

35  Broad definition of genetic information (GI):  Genetic information about individual and family  Genetic information shall be treated as health information as described in HIPPA  Focus is primarily on nondiscrimination  Confidentiality provision  GI must be treated as confidential  Must be kept separate from employment records as required by American with Disabilities Act

36  Confidentiality is not absolute principle  Exceptions where “necessary to protect the welfare of the individual or of the community.”  (AMA Code of Ethics)  Legal duty is not absolute  May breach without liability (discretion to warn) To protect public health/ family members Contagious diseases  Sometimes duty to breach confidentiality Duty to report communicable diseases, gunshot wounds, evidence child neglect/abuse, etc. Duty to warn identifiable 3d party of risk of psychopath

37  Legislative exceptions to privacy protections:  Diagnosis, treatment  Newborn screening  Law enforcement  Court order  Paternity testing  Anonymized research  Etc.  Exceptions to confidentiality within doctor- patient relationship?  Patient won’t disclose genetic risk to relative

38  Client has gene for late-onset condition  E.g., Huntington disease gene, inherited thyroid carcinoma  50% risk children will inherit condition  Existing condition, hidden genetic component  E.g., testicular feminization syndrome  25% risk to patient’s female cousins  Risks of prenatal abnormalities  E.g., inherited balanced translocation  50% risk sibs will have translocation

39  Different kinds of risks from usual exceptions to confidentiality  Risk to others is not created by patient  Not contagious disease, psychopath  Patient’s refusal to share information doesn’t create risk  Genetic risk already exists  Patient actions make it difficult to warn relative  BUT relative might benefit from information

40  Strong bias in favor of confidentiality  Right and responsibility of patient to determine who shall access his/her information (NSGC)  Privilege but no duty to warn relatives when  Attempts to encourage patient disclosure fail  Harm is serious, imminent, and foreseeable  The at-risk relative is identifiable  Disease is preventable  Harm of not disclosing > harm of disclosing (ASHG)  Very hard to meet all of these conditions

41  Pate v. Threlkel (1995- Florida)  Duty to daughter of patient – AD thyroid cancer Foreseeable risk and benefit of knowledge  BUT duty fulfilled by informing patient of risk  NO duty to seek out and warn relatives  Safer v. Pack (1996 – NJ App.)  Duty to daughter of patient with colon cancer Immediate family, avertable risk  Refused to decide limits of duty  Requires reasonable steps to insure info reaches those at risk  Tension: duty to warn and confidentiality

42  Many norms of genetic counseling consistent with legal obligations  Consent, Informed consent  Privacy and Confidentiality generally  Unresolved area: confidentiality concerns v. risks to uninformed relatives  Professional guidelines might conflict with legal obligations (discretion v. duty to warn)  Education, discussion with patient goes long way toward dissolving dilemma


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