Resolution of Futility by Due Process: Early Experience with the Texas Advance Directives Act

S.H. was a 91-year-old female intensive care unit patient with postcardiopulmonary 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 they 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 the 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. 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 K 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 (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-all 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 featuresincluding a new living will, new medical power of attorney, new definitions for both terminal and irreversible illness, and other significant changesis 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 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. Table 1. Rules for Resolving Futility Cases under the Texas Advance Directives Act, 1999 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 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 implementat