Spring, 2004
By Anne L. Flamm, JD
The University of Texas M. D.
Anderson Cancer Center Houston, TX
For years,physicians and other clinicians, ethicists, hospital attorneys and administrators have struggled with a problem characterized as "medical futility." 1 The term typically refers to end-of-life situations in which patients or their representatives demand aggressive medical interventions that caregivers object to providing because they believe that the interventions will not benefit and may even harm patients. In such circumstances, clinicians' professional judgment and fidelity to their traditional role as healers, as well as their duties to allocate healthcare resources responsibly, weigh against providing interventions they view as medically inappropriate. The controversy derives when patients or their representatives perceive clinicians' judgments to conflict with their autonomous right to identify and pursue their healthcare goals. They may also criticize clinicians' judgments for prejudice or inaccuracy in the prognostication of medical outcome. In the absence of direction from courts or legislatures identifying the consequences of withholding or withdrawing life-sustaining treatments sought by patients, many institutions developed policies for dealing with clinical futility disputes.2,3
September 1, 1999, marked the effective date of legislation in the state of Texas that bears directly upon clinical management of patient-driven requests for medically inappropriate or futile treatment. Under the Texas Advance Directives Act (the "Act"), 4 failing to honor a patient's "healthcare or treatment decision"5 (whether that decision is communicated via a living will, by the patient's representative, or by the patient) exposes the health professional to disciplinary action by the appropriate licensing board and any other action available under state law. 6 However, the Act grants immunity from disciplinary action and criminal or civil liability to health professionals who follow a statutorily prescribed procedure for "failing to effectuate" the patient's decision.
Section 166.046 of the Act directs that an attending physician's refusal to honor a patient's treatment decision "shall be reviewed by an ethics or medical committee." 7 The patient shall be given life-sustaining treatment during the review. Other than prohibiting the attending physician from being a member of the review committee, the statute offers no additional detail about either the composition of that committee or the steps of its decision making process.
Section 166.046 also lists the patient's or representative's rights during the review process. The patient or representative must be given 48-hours notice of the meeting called to discuss the controversy, "unless the time period is waived by mutual agreement," and is entitled to attend the meeting. Per revisions completed in June 2003, notice to the patient or representative must include a written description of the review process. 8 The recent revisions also created a registry, maintained by the state healthcare information council, "listing the identity of and contact information for healthcare providers and referral groups ... that have voluntarily notified the council they may consider accepting or may assist in locating a provider willing to accept transfer of a patient" 9 under these circumstances. This registry must be provided to the patient or representative upon notice of the meeting. Finally, Section 166.046 states that the patient or representative is entitled to receive a written explanation of the decision reached during the review process.
If the review committee affirms the attending physician's judgment that the requested treatment is inappropriate, life-sustaining treatment must be provided for 10 days following the notification to the patient of the committee's decision in writing. During the 10 days, the patient may transfer to a physician who is willing to provide the controversial treatment. The patient's physician and personnel at the current facility shall make reasonable efforts to assist in arranging the patient's transfer, if transfer is possible. After the 10th day, the physician and facility "are not obligated to provide life-sustaining treatment" unless ordered to do so by a court. The statute instructs that a court may extend the 10-day period "only if the court finds, by a preponderance of the evidence, that there is a reasonable expectation that a physician or healthcare facility that will honor the patient's directive will be found if the time extension is granted."
Reflections on the Texas procedure
The reassurance against civil, criminal or disciplinary liability given to providers who follow Section 166.046 before withholding or withdrawing life-sustaining treatment is powerful, particularly when the previous ambiguity of legal consequences often prevented clinicians from fulfilling ethical obligations against providing medically inappropriate care. The promise of immunity, of course, is not guaranteed; plaintiffs can challenge a provider's adherence to Section 166.046 or more generally dispute the reasonableness of actions taken. Texas courts have yet to contribute case law addressing Section 166.046, 10 leaving institutions to forge their own policies from its relatively sparse procedural guidance. However, the existence of the legislatively-defined process shifts the "futility" controversy out of the state of impasse that existed previously.
The process offers other advantages. Requiring review of a physician's decision inherently affirms that the physician's authority is not absolute and that decisions should be without unfair bias. Mandatory notice and the opening of the review to patients and their representatives suggest the need for reviewers to consider patient values and preferences along with medical factors. The requirement of openness to patients and families also conveys to healthcare professionals the need to make decisions transparently and to communicate effectively. Finally, the 10-day grace period promotes patient choice - or at least its value - since the practical options for dying patients are likely limited. So long as one accepts that futility controversies require balancing competing interests and some compromise of values, the Act offers a pragmatic and cautious approach to resolving futility problems in the clinical setting.
So far, only one Texas medical center has published data concerning their experience with the procedural mechanism.11 Ethics consultants at Baylor University Medical Center reported generally positive experience after two years of practice with the Act, in which six cases proceeded through the statutory mechanism. In their experience, no family member challenged the hospital's process in court, and many family members expressed their endorsement once "the law" indicated life support should be stopped. They also noted that the explicitness of the process encouraged physicians' willingness to confront futility situations, promoting safeguards and accountability as decisions are reached. Fine and Mayo 11 articulately described that the legally sanctioned process advances futility problems by imposing boundaries: conceptual boundaries on parties who may believe they have authority over controversial decisions, and temporal limitations on how long a disagreement may stall action.
While my observations are anecdotal, as a clinical ethicist at M. D. Anderson, I appreciate the process itself. Futility controversies are upsetting, time-consuming and emotionally draining for clinicians and patients alike, and having procedural guidance that enables the controversy to progress is beneficial. From the perspective of institutional participants, I consider as positive the protection of physician integrity, and in cases in which withholding or withdrawal occurs, clinicians' release from feeling that they are causing pain and suffering. While some might criticize the review board's authority, the process promotes professional responsibility when the conclusion permits the death of dying patient, a burden of decision making see as more appropriately placed on the physician than on a family member in crisis.
Shadowing the advantages of the statutory review process, however, is the nature of futility controversies. The very presence of the controversy means that crucial relationships are jeopardized, good intentions are challenged, and sacred values are threatened. All involved in a futility controversy make substantial investments - of time, energy, as well as physical resources - from which the dividend is either the patient's continuation with burdensome illness and treatment, or death. Even within M. D. Anderson's limited experience,12 the emotional reactions of participants, whether staff, patients or family members, to the review board's final decisions have varied; within one family or medical team, gratitude, relief, resignation and anger often coexisted. As one might predict from the outset of a true, end-of-life dilemma, resolution cannot produce a happy ending.
Footnotes
1 I adopt the term "futility," despite its flaws, in this article for the sake of brevity.
2 Halevy A, Brody BA. A multi-institution collaborative policy on medical futility. JAMA 1996;281:937-41.
3 Schneiderman LJ, Capron AM. How can hospital futility policies contribute to establishing standards of practice? Camb Q Healthc Ethics 2000;9(4):524-31.
4 Texas Health and Safety Code, Subtitle H. Title 2, Chapter 166.
5Section 166.002(7). 2003 revisions clarify the Chapter applies to decisions on behalf of minors.
6Section 166.045.
7Unless otherwise stated, statutory quotes are from Section 166.046 of the Act.
8Section 166.052. The statute suggests a form for the explanatory information.
9Section 166.053. The registry, updated online as of February 2, 2004, contained one physician's contact information.
10 One case from the Texas Medical Center reached a hearing stage by a judge, but the case resolved clinically before the court issued any ruling. See Murphy B. Comatose man dies after battle over life support; Family cited spiritual beliefs. Houston Chronicle 23 March 2001.
11 Fine RL, Mayo TM. Resolution of futility by due process: early experience with the Texas Advance Directives Act. Ann Intern Med 2003; 138:743-6.
12 Since the legislature acted in 1999, M. D. Anderson has had only four cases reach the review process. Numerous factors contribute to the infrequency, one of which is that institutional policy guides clinicians and patients and families first to use other conflict-resolution avenues.
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Dartmouth-Hitchcock Medical Center
The opinions expressed in the journal, Lahey Clinic Medical Ethics,
belong to the individual contributors and do not represent the institutional position
of Lahey Clinic on any subject matters discussed.
