Transcript Taking Difficult Futility Cases Public Ruth Mickelsen et al

Michael Rubin, MD, MA
No relevant disclosures
I am not a lawyer and this presentation does
not constitute legal advice
78 y/o white male with advanced dementia
(oriented to name only), hypertension, and
atrial fibrillation (on Coumadin) falls at home
and sustains a massive traumatic subdural and
subarachnoid hemorrhage
Guilt laden daughter who patient lives with
demands surgical evacuation, which occurs
Two weeks later patient exhibits corneal reflex,
asymmetric pupils, and extensor posturing
Patient may not benefit from continued life
sustaining treatment (LST)
Family continues to suffer but cannot fully
mourn
Resource utilization
Effects our daily medical practice
Taxpayers and insurance premium payers absorb
the cost
We have a duty to improve health and respect
human dignity (beneficence/nonmaleficience)
“Refusing to let people do things to you is one
thing, but demanding that people do things for
you is quite another. Patients may well have
some positive moral or legal rights to health
care, but such rights cannot be unlimited.”
“Some have argued that the futility label is just
a vehicle for slipping health care rationing into
the health care system under the radar, without
the public’s consent”
Mary Ann Baily. Futility, autonomy, and cost in end of life care.
Journal of law, medicine, and ethics. Summer 2011.
A modern debate, popularized in late ‘80’s to
90’s
Physiologic futility
Imminent demise futility
Quantitative futility
Qualitative futility
Physiologic futility: a treatment unable to
achieve its intended medical purpose
Removal of 2/3 of a patient’s brain to excise an
invasive gliobastoma
CPR 1 hour after asystole without return of a
spontaneous rhythm
Not defined by statute, but well accepted in case
law as well as by ethical consensus
Imminent demise futility – nihilist spiral and self
fulfilling prophesies
Quantitative futility – only a 1% chance of recovery to a
functional state (1)
Hard to prove this standard – a review of papers from
1980 - 2008 looking at outcomes in critical ill found
only 28% of papers (n=92) met this definition (2)
APACHE Score
Qualitative futility – a life not worth living
Commonly criticized as an application of physicians
values on patient
(1) Schneiderman et al. Medical futility: its meaning and ethical implications. Ann
Intern Med. 1990;112(12):949–54.
(2) Gabby et al. The empirical basis for determinations of medical futility. Gen
intern Med 25 (10): 1083-9.
Historical foundations
Despite Enlightenment influences on American
culture, physicians largely directed direction of
patient care through 60’s and 70’s
Move from paternalism to emphasis on patient
autonomy
1979 study from Case Western Reserve
University Hospital queried 36 house officers
and 32 nurses and majority of value laden
decisions attributed to physicians
Youngner S, Jackson DL, Allen M. Staff attitudes towards the care of the critically ill
in the medical intensive care unit. Crit Care Med 1979;7(2):35.
Civil rights movement and Vietnam Era
introduced distrust of authority
Tuskegee, Willowbrook State School, Brooklyn
Jewish Chronic Disease Cancer Study, Henrietta
Lacks
Nuremberg Code (1947), Declaration of Helsinki
(1964), National Commission/Belmont Report
(1979)
Debate about balancing autonomy and beneficence
Beauchamp and Childress, Principles of Bioethics
(1979), now in its seventh edition
Many misinterpreted other principles as subordinate to
autonomy
Robert Veatch
Advocates elevating autonomy further
Argues in Patient, Heal Thyself, that physicians are medical experts and
not philosophers or members of the clergy and therefore should not be
part of medical deicsion making
Edmond Pellegrino
Argues for balance in For the patient’s good: The restoration of
beneficence in medical ethics.
“If the physician made no effort to assess the patient’s competency, or
to dissuade a competent but noncompliant or obtuse patient from an
ill-conceived decision, then the patient’s autonomy would block the
care the physician should have for his patient. It could result in actual
harm to the patient”
Not considered controversial
Acceptable to not offer an intervention because
of lack of physiologic feasibility, likewise,
patients can refuse invasive procedures
Legal protection comes from practicing within
standard of care
Consistent with hospital policy
May still be a role for an ethics consult
Discontinuing ventilation or fluid and nutrition
are not covered by physiologic futility claim
Karen Ann Quinlan (1970-1980’s)
21 y/o drug and alcohol overdose with hypoxic/ischemic
brain injury leaving her in a persistent vegetative state
Parents wished to discontinue ventilator against hospital
wishes
New Jersey Supreme court ruled in favor of parents in 1976
withdrawing ventilator, lived until 1985
Right for a patient or surrogate (substituted judgment) to
limit care based on US Constitutional right to privacy
Emphasized that courts could not adjudicate every case of
end of life conflict, recommended resolution locally by
ethics committee
In re Quinlan, 755 A2A 647 (NJ), cert denied, 429 70 NJ 10, 355 A2d 647 (1976)
Nancy Cruzan (1980-1990)
MVA victim in coma
Parent’s wished to remove tube feeding
US Supreme Court decision permitted removal of
artificial nutrition and fluid (a step beyond Quinlan)
Also allowed state to set standard for level of
evidence of patient’s preferences
In Missouri the requirement is a “clear and
convincing evidence”
Cruzan v Director, Missouri Department of Health. 497 U.S. 261 (1990)
Bartling v Superior Court, 163 Cal. App. Ed 190,
209 Cal. Rptr. 220 (1984): Patient can
discontinue ventilator despite doctor or hospital
resistance
Bouvia v Superior Court, 179 Cal. App. 3d 1127,
225 Cal. Rptr. 297 (1986): Patient can refuse
fluid and nutrition
Barber v Superior Court, 147 Cal. App. 3d 1006 (Cal.
App. 1983): Physicians unilaterally removed fluid and
nutrition from a comatose patient – homicide charges
overturned by superior court
Gilgunn v Massachusetts General Hospital, No: 92–
4820 (Mass. Super. Ct. Civ. Action Suffolk So. April 22,
1995): Physicians and hospital removed LST from a 71
y/o with anoxic brain injury; jury awards no damages
Luce J. End of Life Care What do American Courts Say. Crit Care Med 2001 vol 29 .
In the matter of Baby K. 16F. 3d 590 (4th Cir.
1994):
Anencephalic baby, mother wished to keep baby alive and
support with vent against wishes of physicians based on
religious convictions
Physicians argued standard of medical care
Attempted ex ante claim
District Court of Virginia ruled that EMTALA required
stabilization and support of child
Explicitly stated that the courts would not rule on moral or
ethical debate
No state authorization for discontinuing LST
against surrogates wishes or when no surrogate
available
Question becomes if a surrogate will contest
with a law suit
Luce J. End of Life Care What do American Courts Say. Crit Care Med 2001 vol 29 .
American Thoracic Society Bioethics Task Force
(1991) position statement in favor of limiting
LST if meaningful return to consciousness not
likely
Society of Critical Care Medicine (1999) defines
futility by its physiologic definition
AMA (1999) recommends developing a futility
case review that involves due process
John M Luce. A history of resolving conflicts over end of life care in the
intensive care units in the United States. Crit Care med 2010 Vol 8
Hospital refused permission to withhold “futile”
treatment if patient’s condition deteriorates”
Clare Dyer BMJ 2012; 345: e8404
Judge was wrong to insist doctors should give
“burdensome” treatment to minimally
conscious patient, court rules BMJ 2013; 346:
f1455
56 y/o homeless man with SAH Acom with hydrocephalus and a
GCS 5
Neurosurgeon and neurologist estimate a 80-90% chance of
patient being in a persistent vegetative state
Family believes patient “is a fighter”
Care is continued for 3 weeks without clinical improvement
Counselor at local homeless shelter reports that patient often
spoke of not wanting aggressive interventions when his time
came
Also found to have fungating duodenal ulcer obstructing gastric
outlet likely cancer
Care of an Unresponsive Patient with a Poor Prognosis
Arthur Slutsky and Leonard Hudson N eng J med 360;5 Jan 2009
Patient’s brother and mother desire comfort
care measures but son disagrees
What would you do next?
Continue aggressive care and pursue an ethics
consult: 30%
Make patient DNR and transfer to LTAC on
ventilator: 17%
Withdraw life sustaining therapy: 53%
Act unilaterally against family wishes
Acquiesce to family without any further
attempts to resolve conflict
Call administration and risk management
Call ethics and/or palliative care
Pursue an alternative surrogate or transfer care
“Why don’t you call ethics?”
Do have an interest in resource utilization
Priority is often avoidance of liability
Limited in statutes available to help physicians
in this dilemma
Best resolution to these situations is consensus
through mediation
Outside person seen as a objective observer can
be more effective
If mediation does not help, ethics can help
define the options available and identify
additional resources
Growing trend for university or hospital
supported clinical ethicists
Skilled at end of life decision making, by
supporting patient and family they will often
allow resolution of family disagreements
I often advise their involvement, resource
management
Additionally should be considered anytime
symptoms of pain, nausea, insomnia,
depression are affecting patient decision
making
Respectful of primary team’s opinion on
direction of care
In cases where disagreements have led to
distrust and anger not amenable to
ethics/palliative care resolution, reasonable to
pursuing transfer
Patients/surrogates might view this as
abandonment, but by this point they may have
already likely decided that you are not looking
out for their interests
An inability to find an accepting physician at
another facility might influence surrogates to
move towards acceptance of futility
Albert Barnes, dementia, VP shunt for NPH without
improvement, dialysis dependent, frequent
hospitalizations for pneumonia requiring ventilation
When he had capacity (1993), appointed his second
wife Lana Barnes his power of attorney and his
advanced directive indicated a desire to forgo LST if he
had irreversible mental disability
Before becoming ill, changed POA to his son James
(1994), but never informed him
The Barnes Case: Taking Difficult Futility Cases Public
Ruth Mickelsen et al Jorunal of Law, Medicine & Ethics Spring 2013
Mr. Barnes became ill, second wife Lana demanded
treatment previous diagnosis of Lyme disease, believed
patient was being mistreated
Hospital administration and risk management, ethics,
and physicians agreed on futility but Lana threatened
legal action via her attorney
Hospital filled an Ex Parte Petition for Emergency
Guardianship
The Barnes Case: Taking Difficult Futility Cases Public
Ruth Mickelsen et al Jorunal of Law, Medicine & Ethics Spring 2013
State District Court of Minnesota granted
petition and appointed “Alternate Decision
Makers, Inc” as an emergency surrogate
Later at the full hearing, lawyer who prepared
the health care directive revealed that Lana was
not the POA
Discovered that she had falsified the advanced
directive to exclude the son as the decision
maker
The Barnes Case: Taking Difficult Futility Cases Public
Ruth Mickelsen et al Jorunal of Law, Medicine & Ethics Spring 2013
Yes there are, move down to Texas or up to
Ontario
Supports action of an advance directive
Provides a process to resolve futility cases
Physician identifies a medically futile situation
Patient must be “irreversible condition”
Family given 48 hours notice of ethics committee meeting,
attempt to resolve issue
If no consensus and ethics agrees on futility, patient is given
10 days to arrange transfer to another facility
If after this period no provider is found, LST can be
discontinued against the surrogates wishes with legal
immunity
Legal Briefing: futile or non-benefical treatment
Thaddeus Mason Pope Journal of Clincial Ethics 22, no 3 fall 2011 277-96
Main criticism is that the legal immunity provided lacks a
method of appeal, violation of due process
Multiple attempts to add such provisions or mandate reporting
on the use of the process
Survey of members of the Texas Hospital Association from 1999
to 2004 found that 81% were knowledgeable of the act, 30% use
process
Reported 256 cases with 70% report ethics agree with
physicians
No Constitutional challenge yet
Others states considering similar measures (California,
Washington, Wisconsin, Maryland, New Jersey, New York)
Martin Smith. Texas hospitals experience with the Texas Advance Directives Act. Crit Care Med
2007 vol 35 no 5.
Judicial board composed of experts, medical
and ethical
Similar process but includes an appeal process
through the judiciary
Most well known case involved one year old
with progressive neurologic deterioration,
parents were able to transfer patient to Cardinal
Glennon Children’s Medical Center
Queensland, Australia has a similar model
Legal Briefing: futile or non-benefical treatment
Thaddeus Mason Pope Journal of Clincial Ethics 22, no 3 fall 2011 277-96
Society values autonomy but also recognizes the
physician’s desire to preserve human dignity
Shared decision making and the therapeutic
relationship is essential
Physiologic futility claims have solid standing if within
the standard of medical care
Ethics and palliative care can be helpful in navigating
these challenging situations
Proceeding with whatever process we see fit and
finding out if it will lead to criminal charges or financial
damages is not a reasonable approach
While the courts prefer to not interfere with these
matters, situations will arise where physicians and
surrogates simply cannot come to a consensus and
adjudication is necessary
A formalized process needs to be available to ensure
that physicians have some guidance and institutions
cannot force decisions on patients without due process