Sonia M. Suter, M.S., J.D.
Assoc. Prof. of Law
George Washington University
 Consent
 Informed
Consent
 Wrongful
Birth/Life
 Privacy
and Confidentiality
 Confidentiality
Exceptions
 Medical

“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:


treatment requires patient’s consent
Right to control access to one’s physical space
Autonomy/Self-Determination


Right to make decisions for and about oneself
Response to paternalism
 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
 Limited

physical invasiveness
Collecting genetic sample or medical exams
 Invasiveness


is largely informational
Collecting information
Disseminating information
 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
 Not
only is consent required for medical
intervention/treatment
 Consent
must be informed
 Autonomy
 Fosters
and self-determination
Rational Decision Making
 Encourages
physicians to think carefully
about medical recommendations
 Moves
from paternalism to shared decision
making
 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
 Information

Professional Standard


What a reasonable practitioner would disclose
Patient-based standard:

Information material to reasonable patient
 Typical





to disclose (2 approaches)
information to disclose:
Diagnosis
Nature and purpose of treatment
Risks of treatment
Treatment alternatives
Consequences of refusal to test/treat
 Physician



liable if
Fail to disclose required information
(Reasonable) patient would’ve decided
differently -- causation
AND patient suffered physical harm -- damages
 Emphasis
 Few
on physical risks/physical harms
cases regarding non-physical risks/harm
 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

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
 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?
 Uncertainty

Limited data on psychological stress, effect on
family dynamics, risks of discrimination
 Risks

depend on numerous variables
Penetrance/expressivity/severity/nature of
disease
 Unclear


about degree of risk
reach of legal obligations
Statutes that mandate disclosure of “implications
of genetic testing” are vague
Common law focuses on physical risks
 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
 Goals

Enable “clients to make informed independent
decisions, free of coercion, by providing or
illuminating the necessary facts and clarifying
the alternatives and anticipated consequences.”


of Genetic Counseling
(NSGC Code of Ethics)
Decisions based on personal values and life plans
 Emphasizes
informed decision making
 Emphasizes independent decision making
 Nondirectiveness: goes beyond IC
 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

“Cousins” of Informed Consent


Wrongful birth:


parents sue for lost chance to avoid birth of child
Wrongful life:


Claim for failure to disclose reproductive risks, which
limits reproductive options
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

 Wrongful


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


birth claims widely recognized
life claims rarely recognized
Only 4 states: NJ, CA, WA, ME
Damages limited to extraordinary costs
 Claim
for termination based on inaccurate
diagnosis of abnormality
 Subject
 Far
of only a handful of judicial opinions
less likely basis of lawsuit than wrongful
birth claim

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

 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
 Control
 Right
over personal information
to be let alone
 Control
over one’s physical person
 Protection
of disclosed information
(confidentiality)
 “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
 Privacy
is infringed by unauthorized access to
information
 Confidentiality
infringed when person in a
confidential relationship fails to protect the
information
 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
 Every
 Tend
state safeguards medical records
to protect privacy by entity

Protections depend largely on who possesses info

Few state laws are intended to be comprehensive
 Lots
of Variation

Protects individually identifiable health
information, in any form, electronic or nonelectronic, 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

 Ensures

Allows review and requested amendments
 Covered



patient access to medical records
entities must
Provide patients with information about privacy
rights
Adopt written privacy provisions
Safeguard patient records
 Sets
national “floor” of privacy standards

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.
 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
 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
 Some
require personal access to one’s info
 Require


To obtain genetic information
To retain genetic sample or information



(written and/or informed) consent
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
 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

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
 Legislative







exceptions to privacy protections:
Diagnosis, treatment
Newborn screening
Law enforcement
Court order
Paternity testing
Anonymized research
Etc.
 Exceptions
to confidentiality within doctorpatient relationship?

Patient won’t disclose genetic risk to relative

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

 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
 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

 Very
(ASHG)
hard to meet all of these conditions

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

 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