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Medical Futility: Ethical, Legal, and Policy Issues
Introduction
Physicians often encounter situations in which they believe a particular treatment that they are being asked to provide may not confer any meaningful benefit to their patient. In these cases, a practitioner may decide to withdraw this treatment because he or she has judged it to be futile. However, futility is a morally and ethically freighted term, and physicians need to be knowledgeable about its definition and implications before unilaterally deciding to withdraw treatment.
The impact on the healthcare system of providing medically futile care is also uncertain. Issues of medical futility are particularly relevant to those who take care of elderly patients, who may encounter more problems associated with the end of life. Becoming more familiar with the legal and policy implications of disputes surrounding the withdrawal of care in the terminal setting may help these providers to make better-informed decisions in these settings.
Defining Medical Futility
Care that is medically futile is that which is unlikely to produce significant benefit to the patient. Unfortunately, interpreting the implications of this simple definition is difficult, because deciding what “significant benefit” means has moral and ethical implications.
Medical ethicists have therefore struggled to craft more concrete definitions of futility. Schneiderman et al1 widely cited definition states that if “in the last 100 cases a medical treatment has been useless, they [physicians] should regard that treatment as futile.”
Schneiderman and colleagues1 also distinguished between two different types of futility: quantitative and qualitative. In the case of quantitative futility, a particular treatment is capable of producing the desired result but is extremely unlikely to do so in the case at hand. One example of this would be to attempt to perform lifesaving surgery on a patient who is in extremis. On the other hand, under qualitative futility, a treatment is likely to achieve a result, but it may be “lacking in purpose.”2 For example, discontinuing HMG CoA reductase inhibitors (eg, simvastatin) for a nursing home patient with end-stage dementia could be justifiable under qualitative futility, because while the medication might improve cholesterol levels, in this particular patient achieving that goal adds little benefit to the overall care of the patient.
Independent of the definitions described above, the most important determinants of how an individual approaches the possible futility of a medical intervention may be the knowledge, values, and experiences of the individuals involved and their perceived goals of care for the patient.
Developing a consistent standard for what constitutes futile care would be valuable because the corollary of a declaration of futility is that the physician has a right to unilaterally refuse to provide a treatment. In this situation, physicians would be invoking their professional autonomy by refusing to provide a treatment that they deem to be, at the very least, useless, if not harmful. The problem with this paradigm is that families of patients may have differing views of what is useless, depending on their ethnic or religious background. For them, longevity may be a priority that has more value than quality of life.
Because quantitative futility is invoked in situations in which a treatment is extremely unlikely to achieve its stated goal, the judgment of futility would be relatively objective in those cases. For example, denying extensive abdominal surgery to a patient who is in extremis could be deemed futile by a physician without having to weigh in on whether quality or quantity of life is more important. However, when qualitative futility is involved, there might be more room for interpretation. If a physician were to deny placement of a feeding tube for a patient in a persistent vegetative state because it would not improve quality of life, then the physician would be imposing his/her own value judgment on the patient’s family, which may prioritize the preservation of life above all else.
The Role of Physician Autonomy
One of the core principles of bioethics is respect for patients’ autonomy. Somewhat contrary to this principle, some members of the medical futility movement claim that it is the physician’s exclusive right to determine the futility of treatment and decide whether treatment should be withheld or withdrawn. 3 In this sense, the movement’s proponents assert that in cases of medical futility, a physician’s professional autonomy takes precedence over that of the patient. It presumes that patients or caregivers lack the appropriate knowledge and experiences, if not the values to make an informed decision as to the futility of a medical intervention. It takes medical decision-making into a realm that many might consider excessively paternalistic.
There are certain problems associated with always asserting priority for physician autonomy in cases of presumed medical futility. First, as mentioned above, this unilateral approach prioritizing physician autonomy places the physician in conflict, rather than in collaboration, with the patient or caregiver. Another problem is that in many situations, refusing a purportedly futile treatment to a patient may hasten a patient’s death by removing his or her last chance to achieve treatment goals.
By narrowly defining futility in terms of a physician-centered perspective, providers may overlook other reasons for patients to wish to prolong their own lives. Is a patient with metastatic cancer who requests one more round of chemotherapy in the hope that he/she will have enough of a response to live a few more weeks to see a grandchild born requesting futile care? What about a patient who has a “do not resuscitate” order, but whose surrogate decision makers wish to keep the patient alive on a ventilator long enough for family members to fly in from out of town and say goodbye? Some authors contend that this power to decide on patients’ life and death should not be left in the hands of a single healthcare provider.2,4
This issue was taken up by the American Medical Association (AMA) Council on Ethical and Judicial Affairs.5 While the AMA did not provide a working definition of futility or a prescriptive solution for all situations, the AMA report does provide a detailed algorithm that attempts to facilitate conflict resolution and steps to follow. When there are “irresolvable differences,” the algorithm encourages successive and escalating steps of involving patient care representatives, involving the hospital ethics committee, an attempt to transfer care within the institution, transferring care outside of the institution, and, finally, ceasing the futile intervention if none of the preceding steps is successful.
The American Medical Directors Association (AMDA) has not directly addressed the issue of conflicts between physicians and patients related to medical futility. However, it did issue a white paper in March 2008 about the role of ethics committees in end-of-life decision-making in long-term care.6 In it, AMDA strongly encourages the use of ethics committees to help in end-of-life care, specifically mentioning their utility in situations in which there are questions about limiting or withdrawing aggressive care. Although the white paper does not specifically address disputes between patients and families about potentially futile care, these ethics committees could be useful in this regard.
Policy Issues
There is some evidence that a disproportionate amount of healthcare spending occurs near the end of life; one-quarter of Medicare outlays are in the last year of life.7 With healthcare costs skyrocketing, so-called futile care may seem to be an inviting target to slow down the growth in expenditures.
The argument that futile care adds to unnecessary costs is that the urge to “do everything” results in prolonged, expensive treatments in settings such as the intensive care unit (ICU) past the point when they would result in tangible benefits in quality of life. ICU care was estimated to cost $70 billion in 1995, out of $989 billion spent in healthcare in the United States, or 1% of the gross domestic product.8 Moreover, much of the care provided in the ICU may not be cost-effective, as measured in quality-adjusted life-years gained.9 Precise estimates of the costs of futile care in the United States are not known, but surrogate indicators such as those presented above suggest that life-sustaining treatment for very ill patients adds disproportionately to healthcare costs.
Nevertheless, it is not clear that limiting futile care would result in significant cost savings. A group of investigators calculated that if every single Medicare beneficiary who died in the year 1988 had selected an advance directive, enrolled in hospice, and chosen less aggressive interventions, it would result in a savings of 6.1% in total Medicare expenditures for that year. 10 However, this study only considered hospital savings and not the additional cost of quality palliative and/or hospice care. In addition, not all patients who complete advance directives will select hospice care or refuse life-sustaining care. Therefore, the savings enumerated above may represent an unlikely best-case scenario.
Knowing this, it is difficult to pose an argument that justifies limiting futile care based solely on the just allocation of limited medical resources. This would tend to shift the discussion from the moral, ethical, and legal arguments of what constitutes nonharmful or beneficial care and the appropriate limits of patient autonomy.
Legal Issues
The major legal issues concerning medical futility relate to physicians’ ability to unilaterally withdraw treatment when they deem it to be futile. The most important judicial decisions in this area have seen courts siding with either patients’ families or healthcare providers as to whether particular treatments should be withdrawn or instituted.
In response to the potential for conflict, the State of Texas instituted its Advance Directives Act in 1999, which will also be discussed in this section.
Court Cases
Most jurisprudence related to terminating life support has concerned autonomy, that is the rights of kin and other surrogates of patients who lack decision-making capacity to withdraw care.11 However, the only assessment of termination of medical treatment issued by the U.S. Supreme Court simply upheld a ruling by the Supreme Court of Missouri in Cruzan v Director, Missouri Department of Health that required “clear and convincing” evidence of an incompetent patient’s wishes before life-sustaining treatments may be withdrawn. 12 Even though the Court ruled in favor of the state in that case, it did enshrine “right to die” as a liberty protected by the Due Process clause of the U.S. Constitution, prompting the emergence of living wills as a medium to provide the “clear and convincing evidence” demanded by the decision in the Cruzan case. However, this case did not involve conflicts between healthcare providers and patients’ families, which are usually implicated in disputes over medical futility.
The 1988 case of In Re the Conservatorship of Helga M. Wanglie involved an 86-year-old woman who lapsed into a persistent vegetative state after a hip fracture that resulted in a series of severe medical complications, culminating in a cardiopulmonary arrest and the patient suffering severe anoxia. Before her death, she lay unconscious, with her life being sustained by a respirator and a feeding tube.11 Physicians recommended removal of life support because they deemed it to be futile care. When her husband refused to consent to withdrawal of her treatment, a Minnesota district court judge declined to name another guardian in his place.13 In this case, the court decision had more to do with the right of Ms. Wanglie’s husband to make her decisions than it did with the care team’s ability to withdraw life support.
In the 1994 Baby K case, healthcare providers and ethics committees recommended withdrawal of life-sustaining treatments for an anencephalic newborn in Virginia. Because Baby K’s brain was mostly missing, with only the parts of the brain controlling respiration and other autonomic functions present, the care team felt it was ethically inappropriate to provide treatments such as mechanical ventilation. In a controversial decision, the U.S. District Court for the Eastern District of Virginia ruled that the hospital had to provide mechanical ventilation whenever the patient needed it.14 Likely because of this aggressive care, Baby K lived to the age of 2 ½ years.
In Gilgunn v Massachusetts General Hospital, doctors were sued for negligence after they decided to withdraw mechanical ventilation and issue a “do-not-resuscitate” order for a 71-year-old patient dying of multiple organ failure, over the objection of her daughter. The suit was brought after the patient’s death, as opposed to the two cases discussed above. The jury ruled in favor of the defendants apparently based on the rationale that the treatment was futile.15
There is not a uniform theme in these three cases. In the Wanglie case, as opposed to the latter two, the decision rested on the ability of a surrogate to remain as the patient’s guardian. In the Baby K and Gilgunn cases, even though the clinical specifics were different, there were contradictory verdicts in scenarios in which there was little controversy as to the potential for a meaningful recovery for the patients involved. The main difference between the two rested in the fact that in the Gilgunn case, the case was brought post-mortem, as opposed to the Baby K case.
Because of the lack of a unified jurisprudence on medical futility and the absence of U.S. Supreme Court decisions on the subject, previous case law provides little guidance to physicians caring for terminal patients. This need has prompted the guidelines from the AMA5, as well as a novel Texas law that attempts to provide a blueprint for resolving disputes about end-of-life decisions. Both of these approaches have in common extensive efforts to promote agreement between the proxy and the care team as to what constitutes benefits and harms in any particular care withdrawal scenario before overriding the wishes of a legal proxy and withdrawing supportive care.
The Texas Advance Directives Act of 1999
Legislation passed by the Texas Legislature in 1999 provides a legally sanctioned, extrajudicial process for a healthcare facility to discontinue life-sustaining treatment against the wishes of a patient or his/her surrogate decision makers. It also established a new standard for living wills and medical powers of attorney.16 This law is noteworthy because it is the first, and thus far only, state statute to provide a detailed framework for adjudicating conflicts between patient families and healthcare providers in end-of-life cases.
A physician may initiate the process when he or she is asked to fulfill a treatment request (eg, “do everything”) that he/she feels constitutes medically futile care. The Table lists rules for resolving futility cases under this law.17 The process detailed in the Table lists an escalating series of steps by which physicians would work with the hospital ethics committee and surrogate decision makers in order to come to an agreement to withhold or withdraw therapy. At the end of the process, if the parties cannot come to an agreement, patients or surrogates may ask a judge to grant an extension. If they fail in this last measure, then the medical team may withdraw care.
It is worth noting that this law shares some similarities with the AMA guidelines on futility. They both involve escalation of steps that involve families and ethics committees. Neither details what constitutes futility; instead, they purposefully seek to resolve these conflicts on a case-by-case basis.
How has this law affected practice in Texas hospitals? One study surveyed 409 hospitals that were members of the Texas Hospital Association and found that 30% used procedures pursuant to the law to review cases, and that in 70% of cases, ethics committees agreed with the physicians’ assessments of futility.18 Another study from 2003 at Baylor University Medical Center found that overall ethics, medical futility, and right-to-die consultations all increased since enactment of the Texas law.17
Conclusions
As discussed in this article, medical futility is a morally and ethically fraught topic about which there have been conflicting opinions, not just between physicians and patients, but also among different courts. Physicians caring for a dying patient may believe that life-prolonging treatments are futile and not likely to provide a meaningful recovery; in those instances, they could be inclined to unilaterally withdraw care. But if a patient’s family values the preservation of human life above all other goals, then there is likely to be an ethical and moral standoff with the treating physician. This is the main reason why medical futility cases are rarely straightforward.
Because the ethics of futility may create recurrent conflicts between patient advocates and healthcare providers, it is important to search for guidance from the law. However, as discussed in previous sections, the jurisprudence on medical futility has offered little direction. Cases like Gilgunn and Baby K, because of their contradictory outcomes with relatively similar clinical circumstances, may prove confusing to providers who need to know when they can unilaterally refuse to provide life-sustaining treatments. Scholars of medical futility have come closer to the view that there should only be rare circumstances in which physicians should withdraw care unilaterally in end-of-life cases. This is partly because of this enduring legal ambivalence, but it is also due to the recognition that patient autonomy dictates that physicians consider patient families’ values when deciding whether to prolong life.
Due to this uncertainty, the creation of a detailed framework to resolve futility disputes that guides patient families and healthcare providers through this difficult process is the next most logical step. The AMA’s report on futility and end-of-life issues5 went a long way toward clarifying recommended action for physicians in cases involving medical futility. However, because it does not have the force of law, it has not resolved the issue of what to do when there are irreconcilable differences between patient families and providers.
This is why the Texas Advance Directives Act of 1999 is a landmark law. It not only provides a roadmap for the involved parties to resolve their conflicts about care, but it also gives authority to care providers to unilaterally withdraw care when an ethics committee and, if necessary, a judge, agrees with their decision. However, by the same token, it also allows families a forum to press their case, and a means to receive care from another healthcare provider if they disagree with the decision of the ethics committee. This may serve as a model for other states that may want to provide an explicit framework to handle difficult end-of-life cases, and in turn, lead to fewer lawsuits.
The author reports no relevant financial relationships. Dr. Eskildsen is Assistant Professor of Medicine, Division of Geriatric Medicine and Gerontology, Department of Medicine, Emory University School of Medicine, Atlanta, GA.
Acknowledgment
The author wishes to thank Jean O’Connor and Jonathan Flacker, MD, AGSF, for reviewing the manuscript.
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