Transcript Informed Choice- legal issues

Informed Choice- Do We
Need It?
Edward Goldman, J.D
UM Obstetrics and
Gynecology
March 20, 2011
Introduction
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We will discuss patient consent or
refusal of non-emergency treatment.
Legal issue: No touching unless you
have permission.
Medical issue: Forging a therapeutic
alliance with your patient.
Ethical issue: Doing the right thing.
Law and Ethics
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The legal system sets fixed rules to
guide conduct. The rules may be seen
by some as arbitrary.
The systems of ethics (and there are
various systems) seek to create a
moral framework for discussion of
important societal issues.
Various Approaches
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Consent: The Good, the Bad and the
Ugly. (Doctors arguing that consent is
an illusion)
Consent: Let’s Make a Deal.
Consent: Moving away from the
patient as passive to the patient as
participant.
Law and Ethics Revisited
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Not always the same.
In our discussion law and ethics may
overlap since obtaining patient
permission is both legally required and
the “right thing to do”.
Good process should help create trust,
rapport and alliance by showing
respect for the patient.
“Are you telling me that just
because something is against the
law, that makes it illegal?”
The Basics
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Informed Choice is a process of
information exchange with:
A competent (understands
nature/consequences of actions) uncoerced patient who understands the
procedure, its risks, benefits and
alternatives then makes a free
informed choice.
The Elements of Choice
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Nature of the procedure
Its risks and possible benefits
Alternatives to the procedure
Competent patient, engaged
professional
No coercion or duress
A full discussion and documentation.
The Professional-Client Model
A fiduciary relationship.
 1. What are the facts (prognosis)
 2. What limits exist (“I can’t prescribe a
non-FDA approved drug”)
 3. What are the options (various
treatments, research, doing nothing)
 4. What are the client’s values?
The Professional-Client Model
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5. What does the professional recommend
and why? (i.e. What are the available
options? Are there some options that are
professionally unacceptable? Ex: Violation
of the law, un-approved medical practices,
outcome unacceptable to the provider?).
6. How free is the client to make choices
(take this treatment or stay sick)?
Difficult Issues
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The next few slides will cover various
difficult cases. Note: the underlying
problems are the same for providers,
lawyers, other professionals. i.e. what
are the limits for professionals when a
party seeks professional advice and
assistance?
Informed Refusal
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Patient is told the indicated procedure,
its risks, benefits and alternatives and
patient refuses. If injury occurs can
patient claim malpractice?
Ex: Patient refuses all ultrasound then
has a life threatening bleed from an
undiagnosed placenta previa. Why
refusal? Belief that US causes autism.
Patient Chooses- Provider
Does Not Agree
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Must all patient choices be honored?
What if the choice violates your beliefs
(abortion, unconventional therapy) or
professional rules (illegal drugs).
Resolution: Parting of the ways in
extreme cases but must counsel and
be sure patient will not be abandoned
first. Query: Conscience Clause.
Rules to Avoid Abandonment
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1. Tell patient what the disagreement
is and what options you are willing to
provide. No guilt or blaming.
2. If patient disagrees then provide a
period of time to allow transfer of care.
3. Do not discontinue care if that would
result in avoidable injury. Document.
Provider-Patient Disagreement
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Ranges from minimal (listen to heart
tones with fetoscope versus ultrasonic
fetal monitor) where provider may be
willing to follow patient’s request, to
maximal ( once distress is detected
more invasive monitoring is medically
necessary) where provider is not
willing to follow the patient’s request.
The Limits of Autonomy 1
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Case: 24 yr. old recently married
patient wants an abortion for a 6 week
pregnancy. Her BP is high (157/99). A
review of her medical records shows 6
months of untreated elevated
pressures.
You offer surgical versus medical
abortion. Patient refuses surgical.
The Limits of Autonomy 2
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You fully discuss risks of stroke with
medical approach. Pat. says she
understands then says: “Now can I
have the pill?” You refuse.
Informed choice or physician’s right
(fiduciary obligation?) to refuse?
Can provider’s treatment of a medical
condition trump patient’s autonomy?
The Limits of Autonomy 3
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In the prior refusal of ultrasound with a
placenta previa example assume the
baby is born damaged.
Mother may not have a successful
legal claim because we documented
an informed refusal. Does baby have
an independent claim?
The Limits of Autonomy 4
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In the 2001 case of Nold v. Binyon, 31 P.3d
274, the Kansas Supreme Court decided a
physician has a doctor-patient relationship
with both mother and any developing fetus
she intends to carry to a healthy full term. In
Nold, the infant was born with hepatitis B,
transmitted from her infected mother. Doctor
knew mother had Hep B. Treatment is to
administer gamma globulin and a vaccine at
birth; the infant received neither and so
contracted the virus.
The Limits of Autonomy 5
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States may allow a child to sue for prenatal
injuries, but the vast majority of states do not allow
"wrongful life" actions. In a WRONGFUL LIFE
lawsuit, the child sues for failure to diagnose a
severe, disabling condition of the child before birth.
The argument is that if the doctor had informed the
child's parents of the child's condition, the mother
would have had an abortion. The child's theory is
that life with the injury or debilitating condition is
worse than no life at all. Most courts say they
cannot determine that non-existence is preferable
to diminished existence.
The Limits of Autonomy 6
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Courts support the rights of mothers to
refuse recommended C-Sections.
Courts have not granted rights to the fetus
as an independent person.
In re: AC, 1990. Appeals court judge is
reported to have asked, "Are you urging this
court to find that you can handcuff a woman
to a bed and force her to give birth?"
The Limits of Autonomy 7
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ACOG Committee on Ethics 11-2005
says “Efforts to use the legal system to
protect the fetus by constraining
pregnant women’s decision making or
punishing them erode a woman’s basic
rights to privacy and bodily integrity
and are not justified.”
Autonomy-Not a Trump Card ?
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Autonomy is a basic ethical principle as is
beneficence - doing what is best for the
patient. Which principle governs?
Autonomy means that a patient must be
included in decision making, and can refuse
the recommended treatment. Issue: Can the
provider then say that care cannot continue
under the conditions set by the patient? How
about invasive care without consent?
A Note About Ethics
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The true ethical principle is not “autonomy” but
instead is “Respect for Persons”- an idea that we
should “give weight to autonomous persons'
considered opinions and choices while refraining
from obstructing their actions unless they are
clearly detrimental to others. To show lack of
respect for an autonomous agent is to repudiate
that person's considered judgments, to deny an
individual the freedom to act on those considered
judgments, or to withhold information necessary to
make a considered judgment, when there are no
compelling reasons to do so.” Belmont Report 1979
Minors
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Minors can consent for certain things
as allowed by State law (Ex: birth
control information and pregnancy
related care)
Basic Rule: Parent/guardian consents.
Exceptions: Emancipated minor
(married, armed forces, court order),
State law, mature minor rule.
Parental Refusal 1
Minor needs treatment (blood transfusion,
cancer therapy) but parents refuse for
religious or other reasons.
1. Knowing parental refusal? Will counseling
help?
2. How medically necessary is the care?
Abuse or neglect?
3. As minor matures courts evaluate ability to
understand and assent to the proposed
treatment.
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Parental Refusal 2
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Parents do not want chemotherapy because
chance for cure is low and treatment causes
pain. Provider says doing something is
better than doing nothing.
Role for Ethics Committee?
Switch provider?
Court order? (last resort if there is a
reasonable medical chance for cure)
Parental Refusal 3
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If life or limb at risk courts will usually
order care.
What if care is “futile” but mother
demands it? In re: Baby K (Va. 1994)
where the court ordered treatment for
anencephaly. Theory: EMTALA, ADA
and mother’s choice controls.
Incompetent Patients
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If adult but never competent due to
mental status then guardian decides.
If adult but transitorily incompetent
(coma) then Durable Power of
Attorney (with named Advocate) or
Spouse or guardian decides.
Ex: Sterilization of incompetent adult.
In re: Lora Fay Wirsing (Mi. 1998)
Research and Consent
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Be sure patient understands that
research is not therapy. Problem:
Confusion between role as provider
and role as researcher.
Rules of research found in 45 CFR 46
written as a reaction to past abuses
(Tuskegee, Willowbrook) say consent
is essential but also allow for a waiver.
Stubborn Patients
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Patient needs dialysis but only wants
treatment on her schedule. How to
manage?
Behavioral contracts and consent.
Involving the legal system. Ex: Payton
v. Weaver, Calif. 1995.
Issue: Can consent really be court
mandated?
“Life is not Worth Living”
Patients
Patient wants to consent to:
 1. provider assisted suicide
 2. euthanasia
 3. withdrawal of life support
 4. treatment felt by provider to be
“futile”.
Where can/should provider (society?)
“draw the line” with patient autonomy?
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Testing for HIV
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Most States require prior written
permission and pre and post test
counseling for HIV tests
But, if there is health care worker
exposure testing can occur without
consent and even over the patient’s
express refusal.
Uniform Anatomical Gift Act
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Patient, while living, expresses intent to
donate organs upon death. Organs are
viable after death but family members refuse
to allow donation to occur.
Must patient wishes be honored? Does
patient have priority over family? What if
patient said no but family wish to donate?
Are the rules symmetrical?
Exceptions to Need for
Consent
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Emergency
Unforeseen developments in surgical
procedure (No need to wake patient up
for permission if immediate medically
necessary action is required)
Newborn Screening
Others? (consent implied from patient
conduct Ex: routine procedures)
Documenting the Decision
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Remember that the process of arriving
at a decision is a conversation.
Once a decision is made it is
documented on an “Informed Consent”
form but that form is the outcome and
not a substitute for the process of
information exchange.
Consent-Do we Need It?
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Allows clarity for who decides. (Ex:
specific rights for minors)
Allows clarity for what decisions can
be made. End of life, suicide.
Allows a defense in court for lack of
consent cases.
Shows respect and helps build a
sound provider-patient relationship
Case Study #1
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24 year old woman undergoing fertility
treatment. 12 eggs obtained and
fertilized.
She wants to have 6 embryos frozen
and 6 inserted.
Current practice, per specialty
guidelines, is to insert no more than 2
embryos.
Case Study #2
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Provider wants to enroll pregnant
woman in a phase 3 research protocol
with direct relevance to an otherwise
untreatable medical condition (in
mother? Fetus?).
How to proceed? Must both mother
and father consent?
Case Study #3
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Pregnant woman in ICU with
eclampsia. It’s day 5 and patient is
stable and ready for transfer to general
unit. Patient refuses transfer because
she believes care is better in ICU.
How to proceed? Justice issues?
Allocation of scarce resources issues?
Case Study #4
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Competent 24 year old with heavy
bleeding requesting hysterectomy.
Had not exhausted medical therapy
but is “fed up” and wants the surgery.
“Everyone else in my family had one
by age 30.”
Provider not ready to move to surgery.
Case Study #5
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Gravida 1 wants C-Section to preserve
her perineum. No medical indication
for C-Section.
Professional societies (ACOG and
NIH) says patient gets to choose.
Provider not sure this is in patient’s
best interests.
When Policies Clash
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“…the emerging norm of patient
autonomy (which) has contributed to
the erosion of the professional stature
of medicine…an emphasis on mutual
responsibility has been gradually
supplanted by an emphasis on
individual rights.” R. Alta Charo, The
Celestial Fire of Conscience, NEJM
352:24, 06-16-05
Conclusion
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Informed choice is a process of
information exchange resulting in an
informed patient who understands the
medical choices and medical chances
in the relevant medical interaction and
who can partner with you to make
“good” decisions.
Remember…
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These are emotional and difficult
situations where excellent listening
and communication skills are critical. If
you have one of these situations and
feel comfortable (“This is easy”) then
question your assumptions.
If it feels difficult you are probably on
the right track.