NOTE: THIS MATERIAL MAY BE PROTECTED BY COPYRIGHT LAW
(TITLE 17, U.S. CODE)
PERSPECTIVE
Resolution of Futility by Due Process: Early Experience with the Texas
Advance Directives Act
Robert L. Fine, MD, and Thomas Wm. Mayo, JD
Every U.S. state has developed legal rules to address end-of-life
decision making. No law to date has effectively dealt with medical
futility—an issue that has engendered significant debate in the
medical and legal literature, many court cases, and a formal opinion from the American Medical Association's Council on Ethical
and Judicial Affairs. In 1999, Texas was the first state to adopt a
law regulating end-of-life decisions, providing a legislatively sanctioned, extrajudicial, due process mechanism for resolving medical
futility disputes and other end-of-life ethical disagreements. After
S
.H. was a 91-year-old female intensive care unit patient
with post-cardiopulmonary resuscitation anoxic encephalopathy superimposed on preexisting quadriplegia,
seizure disorder, multiple decubitus ulcers, severe ischemic
peripheral vascular disease, and congestive heart failure.
Her medical treatment included mechanical ventilator support, artificial nutrition and hydration by percutaneous endoscopic gastrostomy, intravenous antibiotics, various cardiac medications, antiseizure medications, and wound care.
She was unresponsive except for showing signs of pain and
distress. The treatment team believed that S.H. could be
kept alive for many months or more in the ICU but would
not survive outside it. The team's opinion was that treatment was "futile," and they wished to switch S.H. to palliative care and withdraw life-sustaining treatment.
Several meetings with the patient's eldest daughter,
who held medical power of attorney, failed to change her
request that the doctors "do everything" to keep her
mother alive. Two other adult children of the patient privately told the attending physicians that they agreed with
the recommendation to withdraw life-sustaining treatment,
but were unwilling to publicly disagree with their older
sibling.
Must the treatment team maintain treatments diey
judge to be medically futile?
HISTORICAL BACKGROUND
The concept of "medical futility" is present in ancient
Hippocratic writings, which suggested three major goals
for medicine: cure, relief of suffering, and "refus[al] to treat
those who are overmastered by their diseases" (1).
Throughout much of medical history, it was reasonably
easy to know when a patient was overmastered by disease.
The latter half of the 20th century, however, brought extraordinary progress in curing serious disease. With die
advent of cardiopulmonary resuscitation, death was no
longer final, and practitioner and patient alike could legitimately question what it meant to be "overmastered" by
illness.
2 years of practical experience with this law, data collected at a
large tertiary care teaching hospital strongly suggest that the law
represents a first step toward practical resolution of this controversial area of modern health care. As such, the law may be of
interest to practitioners, patients, and legislators elsewhere.
Ann Intern Med. 2003;138:743-746.
www.annals.org
For author affiliations, see end of text.
By the late 1980s and early 1990s, the medical profession formally articulated the concept of medical futility. In
1993, Lundberg suggested that physicians define medical
futility and that hospitals develop guidelines for dealing
with it (2). In response, the profession offered numerous
definitions, including the concepts of physiologic, quantitative, and qualitative futility (3, 4). Some believed that the
concept was too value-laden to be used by the medical
profession alone (5). Schuster argued that the profession
must distinguish between everything that can be done and
everything that should be done (6). Lo wrote that although
the concept could sometimes be justified, it was "fraught
with confusion, inconsistency and controversy" (7). In
2000, Helft and colleagues argued that "futile care in hospitals is still very much an issue," but then claimed that it
was a moot point because "doctors today are no more empowered to declare a treatment futile unilaterally than they
were 15 years ago" (8).
Simultaneous to the debate over futility in the medical
literature, a legal debate occurred in the courts. In the 1988
Wanglie case, physicians in Minneapolis, Minnesota, recommended that life support for a severely brain-injured
patient be stopped on the ground that it was futile (9). In
the 1994 Baby A'case, physicians and ethics committees in
Virginia argued that providing certain treatments such as
mechanical ventilation to an anencephalic newborn was
"futile," "would serve no therapeutic or palliative purpose,"
and was "medically and ethically inappropriate" (10).
These legally complex cases are discussed in detail in the
legal literature. Briefly, in both of these cases, the judicial
process determined that families should judge the appropriateness of continuing or stopping treatment that physicians or ethics committees consider medically futile. However, in the 1995 case of Gilgunn v Massachusetts General
Hospital, a court found that cardiopulmonary resuscitation
need not be provided to a patient dying with multiple
organ-system failure, even if requested by the patient's
family (11).
As the debate over medical futility progressed, some
institutions developed policies for dealing with this area
© 2003 American College of Physicians
743
PERSPECTIVE
Resolution of Futility by Due Process in Texas
Table 1. Rules for Resolving Futility Cases under the Texas
Advance Directives Act, 1999
1. The family must be given written information about hospital policy on
the ethics consultation process.
2. The family must be given 48 hours' notice and be invited to participate
in the consultation process.
3.
The ethics consultation committee must provide a written report
detailing its findings to the family.
4.
If the ethics consultation process fails to resolve the dispute, the
hospital, working with the family, must try to arrange transfer of the
patient to another physician or institution willing to give the treatment
requested by the family.
5.
If after 10 days (measured from the time the family receives-the written
summary from the ethics consultation committee) no such provider can
be found, the hospital and physician may unilaterally withhold or
withdraw therapy that has been determined to be futile.
6. The patient or surrogate may ask a state court judge to grant an
extension of time before treatment is withdrawn. This extension is to be
granted only if the judge determines that there is a reasonable
likelihood of finding a willing provider of the disputed treatment if more
time is granted.
7.
If the family does not seek an extension or the judge fails to grant one,
futile treatment may be unilaterally withdrawn by the treatment team
•with immunity from civil and criminal prosecution.
(12, 13). In 1999, the American Medical Association
(AMA) Council on Ethical and.Judicial Affairs published
guidelines on medical futility (14). Rather than offering a
"one-size-fits-aU" definition of futility, the guidelines recommended a process-based counseling approach to futility
disputes, with attempts to transfer the patient to alternate
providers if disagreements could not be resolved. At the
end of this process, if no resolution was achieved and no
transfer to a willing provider could be arranged, it would
be ethically acceptable to halt futile treatments. Having
said this, however, the council noted that "the legal ramifications of this course of action are uncertain."
It is unclear how effective such guidelines could be in
the face of legal uncertainty (15). Even when ethics committees agreed that treatment was futile, treating physicians
were generally unwilling to withdraw life-sustaining treatment in the face of any potential lawsuit from families who
disagreed. We found no reports in the medical literature
indicating the routine successful use of futility guidelines
for limiting treatments deemed futile by physicians yet still
requested by family members of the patients in question.
In 1999, Texas legislation combined three preexisting
laws regulating end-of-life treatment into a single law, the
Texas Advance Directives Act (16). An overview of the
politics of the law and its practical features—including a
new living will, new medical power of attorney, new definitions for both terminal and irreversible illness, and other
significant changes—is available in other sources (17-19).
Most important, this law establishes a legally sanctioned
extrajudicial process for resolving disputes about end-of-life
decisions. This mechanism for dispute resolution may be
TO.O.\(, Mav 7ftfl^l AnnaU nf Internal Mcrlirinpl Volume 138 -Number 9
used in response to a surrogate, living will, or medical
power of attorney request to either "do everything" or
"stop all treatment" if the physician feels ethically unable
to agree to either request. A "medical futility" conflict is a
situation in which the physician is asked to "do everything"
but feels that withdrawal of treatment is most appropriate;
a "right to die" conflict is a situation in which the physician is asked to stop all treatment but feels that it should be
maintained. This paper focuses primarily on the use of the
law in the setting of futility conflicts.
When there is a request for treatment that the physician feels is inappropriate, an ethics consultation may be
requested. If the guidelines of the statute (Table 1) are
followed, the law creates a legal safe harbor for both physicians and hospitals by granting immunity from civil and
criminal liability.
Several features of the statute are worth noting. Like
the guidelines of the AMA Council on Ethical and Judicial
Affairs, it recognizes the absence of a universal definition
for medical futility. The statute reserves that determination
for ethics committee judgment while supporting a community standard for medical futility, by stating that a health
care facility may not withdraw treatment if another facility
is willing to provide that treatment. The law provides that
some other type of "medical committee" may provide the
consultation if an ethics committee is not available. Although many on the task force that wrote the law believed
this was suboptimal, they believed that most futility cases
would occur in larger tertiary care hospitals, most of which
have ethics committees. The statute does not define the
rules by which an ethics committee must operate, other
than the following: 1) The attending physician may not
participate as a member of the committee, 2) patients and
families must be informed of their rights, 3) the timing of
the patients' and families' participation must be specified,
and 4) the patients' and families' right to receive a written
report must be established. Finally, in addition to creating
a "legal safe harbor" for resolving futility disputes, the statute creates a "moral safe harbor" by providing a largely
extrajudicial process of consultation with parties outside
the treatment team.
IMPACT OF THE LAW ON CLINICAL PRACTICE
To date, there has been no statewide study of the impact of this law. However, the Baylor University Medical
Center (BUMC) experience before and after the law took
place does provide some insight. Since 1985, BUMC has
had an active, open-access clinical ethics consultation service that handles more than 100 consultations per year.
Physicians, nurses, chaplains, social workers, patients, families, attorneys, and administrators have requested consultations.
The most common reason for consultation has been to
seek assistance with determining the appropriate intensity
of treatment for patients for whom any decision reached
www.annals.org
Resolution of Futility by Due Process in Texas
PERSPECTIVE
Table 2. The Baylor University Medical Center Ethics Consultation Experience before and after the Texas Advance Directives
Act, 1999*
Timing
General Ethics Consultations
Total
12 months before TADA, nt
24 months after TADA, rt*
Increase, %
69
188
Medical Futility Consultations
Right-To-Die Consultations
Per Month
Total
Per Month
Total
Per Month
5.6
7.8
14
47
1.2
2
5
19
0.4
0,8
67
39
100
* TADA = Texas Advance Directives Act.
t I September 1998-31 August 1999.
t 1 September 1999-31 August 2001.
might be considered a decision near the end of life. That is,
these consultations help distinguish between what can be
done and what should be done in the setting of a critical
illness in which life hangs in the balance. Most end-of-life
consultations ease the transition from a curative to a palliative model of care and occur in the absence of any particular conflict between parties. Some, however, involve
explicit conflicts that we label as "medical futility," a request for treatment that the physician feels cannot meet a
reasonable physiologic or qualitative goal, or "right to die,"
a request to withhold or withdraw life-sustaining treatment
that the physician feels is inappropriate.
Table 2 shows the overall ethics consultation experience at BUMC in the 12 months before and the 24
months after the implementation of the Texas Advance
Directives Act. Table 3 reflects the outcome of the futility
consultations at BUMC before and after the implementation of the new statute.
Of the six futility cases that were pursued throug"h the
dispute-resolution process, three families agreed to withdrawal of life-sustaining treatment within a few days of
receiving the formal written report from the ethics committee. In two cases, the patient died during the 10-day
waiting period without an alternative provider having been
found. In one case, an alternative provider was located, but
the patient died while awaiting transfer.
In the case study described at the beginning of this
article, an ethics consultation team consisting of a physician ethicist, social worker, and chaplain became involved.
After detailed review of the case and counseling with all
parties involved, they agreed with the treatment team that
further life-sustaining treatment was futile, but they could
not convince the eldest daughter of this. Although she was
clearly upset, the younger children thanked the ethics consultant for invoking the legal process. The eldest daughter
asked that there be no search for an alternative provider
and indicated that she had no desire to go to a court of law.
Three days after receipt of the formal report from the ethics committee, she agreed to withdrawal of life support and
the patient died peacefully.
In our 2-year experience at BUMC, no family member
has chosen to go to court to seek to delay or overturn the
judgment of the ethics consultation process. Some families,
even those who vigorously argued for maintenance of lifewww.annals.org
sustaining treatments, seem relieved by the process. We
have had many conversations with families who said in
essence, "If you are asking us to agree with the recommendation to remove life support from our loved one, we cannot. However, we do not wish to fight the recommendation in court, and if the law says it is OK to stop life
support, then that is what should happen."
We have also noted that this legally sanctioned process
gives physicians more comfort in confronting possible futile-treatment situations. Explicit futility consultations
have increased 67%. This suggests that a previously less
visible process has been converted into an explicit process,
which provides safeguards and accountability for decisions.
Our experience suggests that when physicians have a legally
approved process to appeal to, they are willing to use it in
an open fashion.
CONCLUSION
The experience reported in this paper comes from the
first 2 years under the law at a single institution and should
be interpreted with caution. The authors of this paper both
serve as clinical ethics consultants at large tertiary care hospitals, and both served on the task force that developed the
law. Our familiarity with the law certainly favored its effective implementation at BUMC. The experience reported may not apply to all health care institutions in
Texas, although anecdotal reports from other institutions
Tabled. Outcome of Futility Consultations before and after the
Texas Advance Directives Act, 1999*
Variable
12 Months
before TADAt
24 Months
after TADAt
Total futility consultations, n
Ethics committee agreement with futility
determination, n
Family agreement to withdraw futile
treatment, n
Time to achieve family agreement after
ethics intervention
Family refusal to withdraw treatment, n
14
47
14
43 §
12
37
Days to weeks
2
Hours to days
6
* TADA = Texas Advance Directives Act.
t 1 September 1998-31 August 1999.
* 1 September 1999-31 August 2001.
§ In 4 cases, the ethics committee did not certify futility, and so life-sustaining
treatment was maintained.
6 May 2003 Annals oflnternal Medicine Volume 138-Number 9 745
PERSPECTIVE
Resolution of Futility by Due Process in Texas
have been favorable. Many significant questions about the
law and its impact will be answered through more time and
broader experience at a variety of institutions.
We believe that the greatest significance of the law is
how it changes the nature of conversations between providers and patients' families about futile-treatment situations by providing conceptual and temporal boundaries.
The conceptual boundary is twofold. It clearly places limits
on families and surrogates who request therapies that the
profession considers futile. At the same time, it forces the
profession to think carefully about the concept, for if another physician and facility are willing to provide the "futile" treatment, then the law does not allow withdrawal of
that treatment on grounds of futility. The law also provides
temporal boundaries (12 days) for resolving disagreements
over futile treatment. Based on our early experience, other
states may want to look at the Texas law as a starting point
for possible changes in their own statutory regulations regarding end-of-life treatment decisions, particularly in the
area of medical futility.
From Baylor Health Care Sysrem and Southern Methodist University/
Dedman School of Law, Dallas, Texas.
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Robert L Fine, MD, Office of Clinical
Ethics, Baylor Health Care System, 3434 Swiss Avenue, Suite 330, Dallas, TX 75204; e-mail, robertf@baylorhealth.edu.
2. Lundberg GD. American health care system management objectives. The aura
of inevitability becomes incarnate [Editorial]. JAMA 1993:269:2554-5. [PMID:
8487424]
3. Youngner SJ. Who defines futility? JAMA. 1988;260:2094-5. [PMID:
3418875]
4. Schneiderman LJ, Jecker NS, Jonsen AR Medical futility: its meaning and
ethical implications. Ann Intern Med. 1990;! 12:949-54. [PMID: 2187394]
5. Truog RD, Brett AS, Frader J. The problem with futility. N Engl J Med.
1992;326:1560-4. [PMID: 1285741]
6. Schuster DP. Everything that should be done—not everything that can be
done [Editorial]. Am Rev Respir Dis. 1992;l45:508-9. [PMID: 1546827]
7. Lo B. Futile interventions. In: Resolving Ethical Dilemmas: A Guide for
Clinicians. Baltimore: Williams & Wilkins; 1995:73-81.
8. Helft PR, Siegler M, Lantos J. The rise and fall of the futility movement.
N Engl J Med. 2000;343:293-6. [PMID: 10911014]
9. PX-91-283 (Minn 4th Dist Ct, Hennepin Co, July 1, 1991). Reprinted in 2
BioLaw U:2161 (Aug-Sept 1991).
10. In re Baby "K," 832 F3d 590 (4th Cir), cm denied, 513 US 825 (1994).
11. Gilgunn v Massachusetts General Hospital, SUCV92-4820 (Mass Super Ct,
Suffolk Co, April 21, 1995).
12. Johnson SH, Gibbons VP, Goldner JA, Wiener RL, Eton D. Legal and
institutional policy responses to medical futility. J Health Hosp Law. 1997;30:
21-36. [PMID: 10167091]
13. Halevy A, BrodyBA. A multi-institution collaborarive policy on medical
futility. JAMA. 1996;276:571-4. [PMID: 8709410]
14. Medical futility in end-of-life care: report of the Council on Ethical and
Judicial Affairs. JAMA. 1999:281:937-41. [PMID: 10078492]
15. Basra L, Tauth J. High technology near the end of life: setting limits [Editorial]. J Am Coll Cardiol. 1996;28:1623-30. [PMID: 8917280]
16. Tex Health and Safety Code §l66.046(a) (Vernon Supp 2002). Accessed at
www.capitol.state.tx.us/statutes/he/heOOl6600.html#he025.166.046 on 17 February 2003.
Current author addresses are available at www.annals.org.
17. Fine RL. The Texas Advance Directives Act of 1999: politics and reality.
HEC Forum. 2001:13:59-81. [PMID: 11307584]
References
18. Heitman E, Gremillion V. Ethics committees under Texas law: effects of the
Texas Advance Directives Act. HEC Forum. 2001;13:82-104. [PMID:
11307585]
1. Jecker NS. Knowing when to stop: the limits of medicine. Hastings Cent Rep.
1991;21:5-8. [PMID: 1885297]
19. Fine RL, Mayo TW. Life-and-death decisions. Tex Med. 1999:95:64-8.
[PMID: 10578625]