The History, Successes and Controversies
of the Texas “Futility” Policy

By Dr. Amir Halevy and Amy L. McGuire

Though “Medical Futility” has become a term of art referring to medical cases where the health care team believes that a particular intervention requested by a patient or a patient’s surrogate decision maker is futile, non-beneficial or medically inappropriate. These cases, which seemingly pit the health care team against a patient with a terminal or irreversible condition (or his family), engender much passion and debate and have been the source of litigation throughout the country. Texas is the only state that has adopted a detailed statutory process to deal with such difficult cases. Section 166.046 of the Texas Advance Directives Act1 answered many questions and has withstood recent legal challenge, but several uncertainties remain. This article is a brief review of the history of the Texas “futility” policy, its successes, and its controversies.

A Brief History of Medical Futility in Texas
Early cases dealing with conflicts between patients or their surrogate medical decision makers and health care professionals, including the seminal cases of Karen Ann Quinlan2 and Nancy Beth Cruzan,3 involved fact patterns in which the patients’ surrogate decision makers had to obtain judicial approval for the removal of life-sustaining medical treatments. Patient autonomy became the ethical basis for the legal rulings that competent adult patients had the right to refuse medical treatment and that the appropriate surrogate decision maker could decide on behalf of a patient lacking decision making capacity. These decisions provided a framework for resolving conflicts at one end of the spectrum, situations where the physician recommended unwanted treatment, but did nothing for the other end of the spectrum, situations where the patient or family demanded medical interventions that the physicians thought were medically inappropriate or futile. Unfortunately, by the late 1980s these hard cases were being seen with increasing frequency across the country.
In Houston, these cases included an infant born with multiple congenital abnormalities that rendered survival unprecedented. The patient developed gangrene in his extremities and his parents sequentially demanded amputations of several limbs in an attempt to “do everything.” In another case, the surrogate decision maker for a comatose woman dying of multisystem organ failure was her estranged husband. They separated because of spousal abuse, and despite many conferences recommending comfort measures and a do-not-resuscitate order, the husband demanded that the medical staff “do everything to my wife.” In both of these cases the health care professionals believed that continuing aggressive life-sustaining interventions was not in the patients’ best interests and that forcing the health care professionals to use their skills in such a way violated their professional ethics.4
These cases, plus reports of others from around the country, resulted in the creation of the Houston Citywide Taskforce on Medical Futility (Taskforce), an ad hoc group of individuals representing most major Houston hospitals.5 Many institutions were interested in pursuing policies that would allow physicians to refuse to provide futile medical treatment. However, the legal and ethical uncertainties and the confusing array of proposed definitions of futility discouraged institutions from proceeding alone. The goal of the Taskforce was to create a common policy on medical futility that was ethically and legally defensible and also sensitive to the needs of the various affected constituencies. Initially, the Taskforce unsuccessfully tried to define “futile” treatment and concluded that futility was like obscenity in that we can’t define it but we “know it when [we] see it.”6 Eventually, the Taskforce developed a process-based approach to determining medically inappropriate treatment, which in 1996 became the model for the American Medical Association’s Council on Ethical and Judicial Affairs.7 The recommended nine step approach included several procedural safeguards to ensure that the patient or appropriate surrogate decision maker would be kept fully informed throughout the process. At the core, the recommended approach reviewed all of the relevant information by either an ethics committee or some other multi-disciplinary hospital committee and made a binding decision. At the end of the process, if the review body determined that the requested intervention was medically inappropriate, the institution would not provide the requested intervention. If the review body determined that the requested intervention was appropriate, the hospital would not limit the intervention without patient or surrogate agreement.8
The ethical justification for this policy was grounded in professional integrity. Critics argued that it was an ethically indefensible violation of patient autonomy for a physician or health care institution to limit such treatment if desired by the patient or surrogate. As noted above, patient autonomy is widely recognized as grounding a prohibition on health care professionals forcing unwanted treatments on patients. Professional integrity serves as a counter balance to respect for patient autonomy and should ground a prohibition on patients and families forcing these same health care professionals to provide treatments they judge as inappropriate.

The Texas Statute
In spite of its adoption as hospital policy by most of the participating institutions and endorsement by the American Medical Association, no cases went through the entire process or reached the point where the review body made a decision. The most likely explanation is that residual legal uncertainty regarding the policy still lingered. The Texas Legislature’s passage in 1999 of the Texas Advance Directives Act, however, eliminated this legal uncertainty. Section 166.046 of the Act, subtitled “Procedure if not effectuating a directive or treatment decision,” created a process-based mechanism to allow an “ethics or medical committee” to review cases when an attending physician refuses to honor a patient’s advance directive or a treatment decision made on behalf of a patient by the appropriate surrogate. The statutory provision was adopted in part in response to the Taskforce’s policy on medical futility. A bipartisan group initially drafted the legislation and included various interested parties throughout the state.
The statute provides that, if the review committee affirms that the requested life-sustaining intervention is inappropriate, “the physician and health care facility are not obligated to provide life-sustaining treatment after the 10th day….”9 Additional provisions require the health care facility to assist in attempting the patient’s transfer to another physician or another facility and the creation of a Web site maintained by the Texas Health Care Information Council. This Web site creates a registry of “health care providers and referral groups that have volunteered their readiness to consider accepting transfer or to assist in locating a provider willing to accept transfer.”10 As of the registry’s last update on December 22, 2005, only one physician has registered. Additionally, a law firm has registered as “willing to receive requests for legal counsel from families that are going through a transfer,” and the Texas Right to Life group has registered as willing to help facilitate patient transfers. No health care facilities have registered to date.11
The statute explicitly limits the ability of the courts to intervene in such cases. The courts’ only role is the ability to grant an extension of the ten-day waiting period if the court finds, “by a preponderance of the evidence, that there is a reasonable expectation that a physician or health care facility that will honor the patient’s directive will be found if the time extension is granted.”12 There is no specific provision allowing a patient, family, or physician to appeal the decision of the hospital review committee in court.

Legal Challenges
Since the passage of the Act in 1999, a number of hospitals throughout Texas have used the futility mechanism to resolve difficult cases, and life-sustaining interventions were removed in several of these cases. The first legal challenges to the new law came from a pair of cases in the Texas Medical Center in Houston in the winter of 2004-2005.

The Case Of Sun Hudson
Sun Hudson was born in September 2004, with thanatophoric dysplasia, a rare and fatal form of neonatal dwarfism.13 Immediately after his birth, he was transferred to Texas Children’s Hospital and admitted to the neonatal intensive care unit. After the physicians firmly established the diagnosis, they explained to Sun’s mother that his condition was fatal and recommended that all life-sustaining treatment be withdrawn. Ms. Hudson insisted on continued treatment, expressing her belief that her son would live. After many failed attempts to negotiate a course of treatment that was acceptable to both Ms. Hudson and the health care team, Sun’s attending physician requested that the hospital’s Biomedical Ethics Committee review the case as an example of medically inappropriate or futile treatment. The Committee followed the steps required by section 166.046 of the Texas Advance Directives Act and affirmed that continuing to provide life-sustaining treatment to Sun Hudson would be medically inappropriate. At that point, the hospital was legally obligated to continue providing life-sustaining treatment to Sun Hudson for only 10 days, unless he was transferred to another facility. However, the hospital was concerned that Wanda Hudson, Sun’s surrogate decision maker, was not competent to make decisions. Although the Act does not require that decision makers be competent, the hospital was concerned about the ethical implications since Ms. Hudson did not fully appreciate the process; therefore the hospital decided to assist Ms. Hudson in obtaining an attorney.14 Texas Children’s Hospital continued providing life-sustaining treatment throughout the judicial process.
Wanda Hudson sued Texas Children’s Hospital in November 2004 seeking injunctive relief and monetary damages. A temporary injunction requiring Texas Children’s Hospital to continue to provide Sun with life-sustaining treatment lasted five months, until March 2005. On March 14, 2005, the probate judge hearing the case held that there was no reasonable expectation that another health care provider would agree to continue treatment if time were further extended. The ruling essentially allowed Texas Children’s Hospital to withdraw life-sustaining therapy under section 166.046 of the Texas Advance Directives Act.15 Texas Children’s Hospital withdrew life-sustaining treat-ment the next day and Sun Hudson died in his mother’s arms.

The Case Of Spiro Nikolouzos
Spiro Nikolouzos was a 68 year-old retired electrical engineer for an oil drilling company who had been an invalid since 2001, when he experienced bleeding related to a shunt in his brain. He had required tube feeding and was being cared for by his wife at home, when on February 10, 2005, the area around his feeding tube began to bleed and he was rushed to St. Luke’s Episcopal Hospital in Houston. Mr. Nikolouzos’ condition deteriorated while in the hospital and his physicians recommended that all life-sustaining treatment be withdrawn. His wife refused and, after many attempts to reach agreement, the attending physician invoked the futility policy. The hospital ethics committee determined that continued life-sustaining treatment would be medically inappropriate in Mr. Nikolouzos’ case, and his family was told that life-sustaining treatment would be discontinued after 10 days unless they could transfer him to another facility. Mrs. Nikolouzos filed suit, seeking several temporary restraining orders and an extension of the ten-day waiting period. All of her motions were denied, and it was determined by the district court judge that there was not sufficient evidence of a reasonable expectation that the family would be able to effectuate a transfer even with an extension. Mrs. Nikolouzos’ request for relief was also denied by the 14th Court of Appeals.16 Mr. Nikolouzos was ultimately transferred to a long-term care facility in San Antonio, where he lived for about three months before dying of natural causes.
In both of these cases, the courts recognized their limited authority to intervene and upheld the institution-based procedural approach adopted by the Texas legislature in 1999. The reality is that, most of the time, this type of conflict between the patient or family and the health care providers can be resolved without involving the hospital ethics or medical committee. When an agreement cannot be reached, however, the law provides a clear procedural approach for resolving the situation that seeks to balance professional integrity and patient autonomy based on the medical appropriateness of continued treatment.

Remaining Controversies
While the passage of the Act has eliminated many of the legal uncertainties regarding determinations of medical futility, several controversies remain. Aside from one of the questions raised by the Sun Hudson case of what should be done if the surrogate decision maker is incompetent, controversy revolves around the questions raised by the transfer option. Three particular issues regarding transfer require further discussion and resolution: (1) should the ten-day waiting period between the committee’s decision and the ability of the hospital to withdraw inappropriate life-sustaining therapy be lengthened or shortned; (2) the statutory list of willing transfer providers remains essentially empty; and (3) the distinction between intra- and inter-institutional transfers.
The ten-day waiting period appears to have been a legislative compromise, which balanced the desire of some parties to have a more expedited process (the original Houston Taskforce protocol had no required waiting period after the committee’s decision) and the desire by others to have a longer transfer option. It is unclear what the optimal waiting period actually is. Some would like to extend the waiting period beyond ten days in an effort to optimize the opportunity for transfer. However, given the lack of options on the transfer website and that for any given patient no transfer of care could be arranged prior to the committee’s meeting (otherwise the issue would have been moot), it appears unlikely that a longer waiting period will result in more successful transfers. In fact, some believe that even a ten-day waiting period is too long because it simply prolongs the conflict without any apparent corresponding benefit for the patient or the health care professionals.
The second issue is that the registry list of health care providers volunteering their readiness to consider accepting transfer has been a near total failure. As noted above, aside from one physician listed on the site, it is empty. Ironically, the fact that the registry is so sparse supports the underlying ethical principle of professional integrity that is the basis of the futility policy. Professional integrity must be based on more than just the personal views of an individual professional. The fact that physicians and institutions are not willing to volunteer blindly to consider accepting the responsibility for the care of a patient that another health care institution has determined to be medically inappropriate supports the argument of a professional consensus as opposed to a personal opinion.
The final issue is that the Act preserves the option of intra-institutional transfers to another physician within the facility. Both the policy created by the Houston Taskforce and the American Medical Association policy specifically excluded the option of intra-institution transfer to a physician willing to accept the patient and write the requested orders. The reasoning was that the institutional review mechanism represents the full set of professionals whose efforts would be involved and the institution whose resources must be employed. If the institutional review determines that it is medically inappropriate for the intervention to be offered, another physician’s willingness to write the orders does not change the institution’s determination of medical appropriateness. Additionally, it places the other health care professionals in the institution in the uncomfortable position of being forced to potentially violate professional integrity and provide treatment that the institution has determined to be medically inappropriate.

Conclusion
The decision to withdraw life-sustaining treatment at the end-of-life can be very emotionally difficult for some families. It is important for the health care team to communicate compassionately and honestly with family members when modern medicine has reached its limits and the provision of aggressive treatment is no longer appropriate. Conflict often arises due to a lack of effective communication, distrust in the medical profession, feelings of guilt and sadness, or hope for a miracle. Every effort should be made to resolve this conflict and negotiate a plan for patient care. When those efforts fail, physicians can turn to the Texas Advance Directives Act and its mechanism to deal with demands for medically inappropriate, or futile, treatment. This policy, however, can be adversarial, and should only be invoked as a last resort.
While the statute is not perfect and will likely be refined in future legislative sessions, section 166.046 of the Act has created a hospital-based procedural mechanism that has balanced various disparate but legitimate interests when conflict arises in end of life decision making. The process allows for a balancing of the principles of patient autonomy and professional integrity when, in those uncommon circumstances, health care professionals and patients or their surrogates are in what had been, prior to the passage of the Advance Directives Act, an irresolvable conflict regarding end of life care.

Amir Halevy, M.D. is an Associate Professor of Medicine and Medical Ethics in the Department of Medicine and the Center for Medical Ethics and Health Policy at Baylor College of Medicine, where he teaches medical students and residents. He is also a first year law student at the University of Houston Law Center. Dr. Halevy served as co-chair of the Houston Citywide Taskforce on Medical Futility, the taskforce that drafted the original futility policy described in this article.

Amy McGuire, J.D., Ph.D. is Assistant Professor of Medicine and Medical Ethics in the Center for Medical Ethics and Health Policy at Baylor College of Medicine. Her responsibilities at Baylor include teaching medical students, residents, and practicing physicians. Additionally, she serves on the Ethics Committees of Ben Taub General Hospital, St. Luke’s Episcopal Hospital, and The Methodist Hospital.

Endnotes
1. Texas Health & Safety Code Ann. §166.046. 2. In re Quinlan, 70 N.J. 10, 355 A.2d 647 (1976). 3. Cruzan v. Director, Missouri Dept. of Health 497 U.S. 261, 110 S.Ct. 2841 (1990). 4. Halevy A, Brody B. A Multi-institution Collaborative Policy on Medical Futility. JAMA. 1996:276(7): 571-4. 5. Id. 6. Jacobellis v. State of Ohio, 378 U.S. 184 7. Council of Ethical and Judicial Affairs of the American Medical Association. Policy E-2.037. “Medical Futility in End-of-life Care” 8. Halevy, supra note 4. 9. Texas Health & Safety Code Ann. §166.046. 10. http://www.dshs.state.tx.us/THCIC/Registry.shtm 11. Id. 12. Texas Health & Safety Code Ann. §166.046(g). 13. A more complete history of the case can be found in Lightfoot L. Incompetent Decisonmakers and Withdrawal of Life-Sustaining Treatment: A Case Study. Journal of Law, Medicine, and Ethics, Winter 2005, 851-5. 14. Id. 15. Id 16. Nikolouzos v. St. Luke’s Episcopal Hospital, 162 S.W.3d 678 (Tex. App.-Houston [14th Dist.], 2005).

Text is punctuated without italics.

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