Futility Determination as a Process: Problems with Medical Sovereignty, Legal Issues and the Strengths and Weakness of the Procedural Approach
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- Stewart, C. Bioethical Inquiry (2011) 8: 155. doi:10.1007/s11673-011-9297-z
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Futility is not a purely medical concept. Its subjective nature requires a balanced procedural approach where competing views can be aired and in which disputes can be resolved with procedural fairness. Law should play an important role in this process. Pure medical models of futility are based on a false claim of medical sovereignty. Procedural approaches avoid the problems of such claims. This paper examines the arguments for and against the adoption of a procedural approach to futility determination.
KeywordsFutilityLawSusbtitute decision-makingBest interestsSubstituted judgmentSovereigntyProfessionalism
The futility debate has focused on the search for a definition for more than 20 years. While qualitative and quantitative models have been proposed, the preponderance of current authority favours a procedural approach to defining futility (Moratti 2009). Procedural approaches begin with the traditional assessment of medical and personal factors but also subject those decisions to review by clinical teams, multi-disciplinary ethics committees and, if necessary, courts (Burns and Truog 2007). Regardless of the preponderance of views, there are still many who see the process of futility determination as one that should be left solely to the medical profession because futility determination is logically prior to any exercise of patient autonomy or calculation of best interests. According to these arguments, futility is a medical concept and as such falls to be determined by the medical profession alone.
I argue against the notion of a “pure” medical concept of futility. I examine the history of attempts to define futility and outline the procedural approach, using examples from the common law world. Claims for a pure medical concept of futility are primarily based on a claim for professional sovereignty and I examine the reasons why such claims must fail. I then argue for a procedural approach to defining futility, highlighting some of the concerns and current problems with this model.
The quantitative approach, where treatments have a very poor probability of success (Schneiderman et al. 1990)
The imminent demise or lethal condition approach, whereby a treatment is considered futile when it will fail to postpone an imminent death (once again quantitative in effect) (Younger 1988)
The qualitative approach, which looks not only at physiological success but quality-of-life factors, such as comfort, wellbeing and cognition (Schneiderman et al. 1990, 950–2).
While futility is an ancient concept, the debate regarding its definition really took off in the 1990s, when it became clear that the right-to-die debate had shifted from considering situations of patients refusing treatment situations of patients or families demanding treatments the medical profession did not feel could be provided because of perceptions of patient harm (Wilkinson and Savulescu 2011). As a result, the search for an objectively defined concept of futility became a goal of medicine.
Why Do We Need to Define Futility and Who Should Define It?
Defining futility is an exercise in what I term normative closure. Normative closure exists when there are competing claims regarding what ought to be done and one party is able to close that debate by being able to claim a form of moral authority. In disputes regarding medical futility, this is illustrated by claims that “futile treatments cannot be demanded” or “futile treatments are never in the best interests of patients.” If futility is to be defined solely by the medical profession then it is not possible for others (family members, allied health, lawyers) to argue that the treatment is not futile, because they have no control over the definition. According to this logic, the medical professional should control the concept of futility because, as a profession, medicine controls the concept of treatment and healthcare.
Regardless of definitions and descriptions, determinations and judgments about the medical appropriateness of specific treatments are first and foremost medical-clinical judgments; judgments based on the medical-clinical assessment and status of the patient, and the medical-clinical information, data and known risks and harms related to the treatment’s effectiveness, ineffectiveness and burdens for the given clinical situation. As such, judgments about medical inappropriateness should be made primarily by medical and clinical professionals who have expertise related to the specific clinical situation of the patient and the specific treatment in question (Smith 2008, 241).
Nazi jurisprude Carl Schmitt defined the sovereign as “he who decides in the exception” (Schmitt 2005, 1). The medical concept of futility is based on a similar concept of sovereignty: in situations of end-of-life care, it is the medical profession who control the definition of futility and therefore control what treatments are provided to the exclusion of other claims for control.
Problems with the Claims of Professional Sovereignty over Futility Determination
Futility determinations are not purely medical judgments
The question of who defines futility is ultimately based on the normative claims of the medical profession that it is the best body to determine futility. As a profession, medicine can lay claim to a specialised body of knowledge, the sharing of common moral and ethical standards, and the ability to control its own standards (Wyatt 1998, 19). If medical futility were a technical issue of medical science, then logically it should be defined solely by the medical profession.
The problem with this argument is the assumption that futility is a technological construct solely based on medical science. It is not. Firstly, there is rarely good available data in the end-of-life setting about the effectiveness of life-sustaining treatment (Kerridge et al. 2009, 316). Gabbay et al. (2010) have found that most studies that seek to define futility are based on insufficient data that cannot provide statistical confidence. Gabbay et al. also state that futility studies lack thresholds for determination of futility and that they draw disparate conclusions based on statistically similar data (Gabbay et al. 2010). Futility data has also been criticised for being self-serving (Wilkinson 2009). Even where there is data about the effectiveness of treatment an evaluative judgment still has to be made about whether the treatment is “worth” providing. Reasonable health professionals and others can have significant disagreements about the futility of providing a treatment that has a 10%, 5 % or 0.5 % chance of success (Wilkinson and Savulescu 2011). Futility determination is therefore a product of exceedingly complex value judgments (Smith 2005, 208). The necessarily subjective and non-medical elements of futility mean that, while the medical profession can speak with some authority about futility, it cannot claim to have complete sovereignty over its definition.
The concept of professionalism is based on accountability and review
Professionalism necessarily requires some form of ingrained ethic of care, of protection for patients and the public at large (Kuhse 1997). This has been described as the “higher aim of professionalism” (Kerridge et al. 2009, 114). The key value underlying professionalism is therefore public trust (Medical Professionalism Project 2002).
The claim of control over the definition of futility relies on the legitimacy of the medical profession as a profession, but the very concept of professionalism means that decision-making should be accountable and reviewable. Like every profession, the medical profession makes mistakes. Like every profession, there will be people who engage in outlying, and sometimes outrageous, behaviour. A closed concept of futility that relies on unaccountable and unreviewable decisions cuts across the value of professionalism and undermines the medical profession’s claims to sovereignty.
Legal sovereignty overrides professional sovereignty
The third problem with a pure concept of medical futility is that it misunderstands the all-penetrating ideological function of law. While futility determinations are made in the medical field by medical professionals, they still need to be made according to legal standards. Even a pure medical concept of futility must still remain open to questions about whether the correct legal standards of decision-making have been satisfied. This in no way necessitates official legal involvement via courts and lawyers but it does mean recognising that futility determination is part of a process infused with legal issues and, in that sense, part of a legal process. Once that realisation is made it becomes clear that the best approach to defining futility is a procedural approach where the players are knowledgeable about the legal standards of decision-making, one that provides for procedural fairness and review by an independent third party (Smith 2005, 208).
Procedural Approaches to Futility
A procedural approach to futility can overcome these objections (Faunce and Stewart 2005). A procedural approach occurs when medical decision-making is based on clinical consensus, with avenues for appeal and review (Moratti 2009; Truog 2009, 966). Under a basic model of procedural futility determination the treatment team (made up primarily of doctors but also including allied health carers) may make a provisional diagnosis that active treatment has become futile according to the definitions discussed above. The decision should then be communicated to the patient and/or family, in addition to providing information to the patients/families about their rights to have the decision reviewed (Smith 2005, 207). If the patients’ families remain unhappy with that decision, they should be able to have it reviewed by an independent body like a clinical ethics committee. If the clinical ethics committee agrees with the assessment and the patient/family still disagree then appeal can be made to a legal body such as a guardianship tribunal or court. These bodies can appoint substitute decision-makers or make their own determinations (Pope 2010).
Legal Issues and the Procedural Approach
As already stated, the procedural approach must be based on sound understanding and application of the correct tests for substituted decision-making. In most common law countries (for example, England, Wales, Ireland, Australia, New Zealand) the touchstone method for substituted decision-making is the best interests test, which requires a consideration of objective medical issues as well as personal and social factors for the patient. In other jurisdictions (like many in the United States) the primary test is the substituted judgment test, where the decision-maker has to make a best estimate of what decision the patient would have made if competent (Meisel and Cerminara 2004). Many jurisdictions (for example, Queensland, New South Wales, Victoria, Western Australia, New York State) now combine elements of both tests, starting with substituted judgment but then going to best interests if there is no direct evidence of what the patient would have wanted (Willmott et al. 2010).
Further differences arise across jurisdictions as to the level of evidence required before the best interests test or substituted judgment can be satisfied. In England and Australia the test is the ordinary standard of balance of probabilities (albeit performed in a cautionary way) whereas in the United States some jurisdictions set the standard of evidence at the higher level of clear and convincing evidence.
Select cases on futility from Australia and New Zealand
Northridge v Central Sydney Area Health Service  NSWLR 1241. Clinicians had decided to withdraw active treatment from a patient who had suffered brain damage after a drug overdose. The decision was made after approximately 5 days on the basis that he was in a “chronic vegetative state” and that active treatment was futile. A no-CPR order was entered on his chart, even though his GCS rating had risen to nine, and he was responding to voice. The relatives of the patient expressed disagreement but communications had broken down. The NSW Supreme Court found that the doctors had misdiagnosed the patient’s condition, used professionally unrecognised criteria and that the decision to withdraw active treatment had been premature. Moreover the clinicians had not followed the hospitals own policies on no-CPR orders. Judicial orders were made to continue treatment and the orders required the court to be involved in future decisions about his treatment.
Re BWV  VSC 173. The Supreme Court of Victoria ordered a guardian to be appointed for the purpose of refusing artificial feeding for a 68-year-old woman with advanced Pick’s disease. The Supreme Court found that artificial feeding was medical treatment and not the reasonable provision of food and water, under the Victorian legislation. Given the feeding was medical treatment, it could be refused under the Medical Treatment Act 1988 (Vic).
Messiha v South East Health  NSWSC 1061. The Supreme Court of New South Wales upheld a decision to withdraw life-sustaining treatment from a 75-year-old man diagnosed as having suffered asystolic cardiac arrest with resultant severe hypoxic brain damage. Some days after admission the medical staff believed that continued treatment was futile as there was a complete absence of cortical activity. The family disagreed and continued to disagree after substantial efforts had been made to explain the patient’s condition and the staffs’ assessment of best interests. After10 days an independent neurologist reviewed the case and agreed with the decision to withdraw active treatment. At the time, the hospital did not have a clinical ethics committee that could be consulted. The family was then informed that the treatment would be withdrawn the following day unless they sought legal intervention. The family applied to the Supreme Court of New South Wales and a hearing took place on November 1 (4 days after the independent assessment). A decision was handed down on November 11. In that decision Howie J upheld the clinical assessment of the patient’s best interests.
Australian Capital Territory v JT  ACTSC 105. JT was a 69-year-old man who was chronically psychotic, suffering from paranoid schizophrenia characterised by religious obsessions. He habitually fasted and was resistant to being medicated. His weight had fallen to dangerous levels and he was refusing naso-gastric feeding. The authorities sought permission to withhold artificial feeding (PEG tube) from JT, as they did not believe that force-feeding JT with a PEG tube was in his best interests. It was argued that the PEG was futile, as it would not help the treatment of his psychosis. An independent assessment had not been sought. The court found that JT was incompetent and that the Territory had a duty to provide treatment that was not futile. Force-feeding was not futile in the present case as it could still preserve life. The fact that JT’s underlying psychosis would likely reassert itself did not make the treatment futile. Nor was it futile because he was resistant to feeding and force-feeding was distressing to both himself and the staff.
Inquest into the death of Mrs June Woo, Queensland Office of State Coroner, 1 June 2009 http://www.courts.qld.gov.au/Woo_findings.pdf. June Woo was an 82-year-old woman who presented to hospital with pulmonary fibrosis, terminal chronic respiratory failure, hypertension and chronic renal failure. A consensus medical decision was made that active treatment was inappropriate given her respiratory and renal condition. After numerous discussions with the family an NFR order was placed on her chart, she arrested and died. The family later claimed that Mrs Woo had been poorly treated. The coroner dismissed these claims and found that treatment was futile. In Queensland, legislation requires that consent be given by the substitute decision-maker to the withholding of life-sustaining treatments including CPR. The Coroner found that while express consent had not been given, an implied consent from the family could be determined from the facts. However the Coroner was critical of the hospital policy, which contradicted the legislation by stating that express consent was not necessary for futile treatment.
Slaveski v Austin Health  VSC 493. The Supreme Court of Victoria ultimately refused an application to injunct the threatened withdrawal of life-sustaining treatment from an elderly male patient who had a catastrophic brain stem haemorrhage, was unresponsive and ventilator-dependent. The prospect of a meaningful neurological recovery was considered to be negligible and all the health care team agreed that, should he survive, he would remain in a “locked-in” state. The relationship between family members and the treatment team had broken down. An initial informal application was brought by the patient’s son, who had no legal representation and who appeared to struggle with stating his reasons for why the court should intervene. The judge ordered a temporary injunction and organised for the hospital and other relatives of the patient to be contacted and for the Victorian Public Advocate to make inquiries. A final decision was handed down on October 22, 11 days after Mr Slaveski’s stroke. In the intervening period independent experts had assessed the patient and had agreed with the initial decision that treatment was futile. The judge stated that the court’s power was to protect the right of incompetent patients to receive treatment but not “extraordinary, excessively burdensome, intrusive or futile medical treatment, sustenance and support.” The judge said that futile treatment was at first instance a medical matter but that the court’s role was to review such an assessment when there was doubt or serious dispute.
New Zealand cases
Auckland Area Health Board v Attorney General (Re L)  1 NZLR 235. Thomas J held that withdrawal of treatment from a man in a permanently locked-in state could take place when it was no longer in the best interests of the patient as determined by “prevailing medical standards … which command general approval within the medical profession.” Thomas J encouraged referral to a clinical ethics committee in contentious cases.
Shortland v Northland Health Ltd  1 NZLR 433. A decision to withhold dialysis and a kidney transplant from a 63-year-old man was made on the basis that he had moderate dementia and was able to comply with the treatment regime. Hospital policies on assessment were followed and the decision was made by a full assessment team consisting of a nephrologist, nurse, and other allied health workers. The decision was reviewed and confirmed by independent experts but was not subjected to ethics committee review. The Court of Appeal refused to overturn the decision. The lack of ethics committee review did not render the decision unlawful, as the issue was primarily one of a clinical judgment. The law would not countenance a requirement for consent from family for the cessation of treatment. However, the appropriate course was to require “reasonable” consultation with the family.
[I]t seems to me that it would be an unusual case where the Court would act against what is unanimously held by medical experts as an appropriate treatment regime for the patient in order to preserve the life of a terminally ill patient in a deep coma where there is no real prospect of recovery to any significant degree… [I]t is simply an acceptance of the fact that the treatment of the patient where, as here, the Court is satisfied that decision as to the appropriate treatment is being made in the welfare and interest of the patient, is principally a matter for the expertise of professional medical practitioners
Problems with the Procedural Approach and the Need for Fairness
The procedure may require the provision of futile treatment in the interim
One of the obvious detriments with applying a procedural approach is that it may require the patient to be given futile treatment while the process works its way through. The cost of thorough procedure is the maintenance of the status quo (presuming that is possible). Courts will invariably order injunctions or temporary restraining orders to continue treatment prior to a final determination because the balance of convenience lies in favour of treatment, but that is obviously at the cost of the patient (should the determination result in a finding of futility). Of course the opposite is also true—interventions requiring treatment may keep the patient alive in cases where the futility determination was wrongly made (as in Northridge).
The procedural approach may result in delay
A related problem to the first is the claim that procedural determination takes too long, especially if courts become involved. This is clearly a valid concern. All efforts need to be made for a speedy resolution of futility disputes. The evidence suggests that even in cases where there is court intervention it is possible to have a resolution in days, rather than weeks or months. The response time of the Australian courts in the Messiha and Slaveski decisions is worth noting (10 days in Messiha and 8 days in Slaveski from initial application to final decision).
The procedural approach may require consent to withholding futile treatment
It has been often said that consent does not need to be sought for withholding futile treatment (Skene 2005, 228–9; Murphy 2008). This is because futility determination is logically prior to any question of patient autonomy or substituted decision-making. If a treatment is futile then it cannot ever be in the patient’s best interests. Nor could it be a treatment that the patient would have consented to (because it would not have been offered in the first place). Patients and families therefore have no right to demand futile treatments in law (see for example Shortland in Table 1) or ethics (Beauchamp and Childress 2009, 167).
The problem with a procedural approach is that it seems to conflict with the above principle and mandate consent from the substitute decision-maker to withhold futile treatment. A case that illustrates this problem is the Inquest into the death of June Woo (see Table 1). It is clear from that case that the doctors did not believe that they had to seek consent to place a no-CPR order on Mrs Woo’s chart from her family (although on the facts the Coroner found that an implied consent had been given by the family) (Parker 2010). The hospital’s own policy contradicted the legal requirements. If the Coroner had not found an implied consent presumably the withholding of CPR may have been illegal and the death of Mrs Woo may have been culpable. The decision has caused considerable alarm amongst the Queensland medical profession and there have been calls for reform because of the way that the law appears to force doctors to provide treatments that they do not believe should be provided (Parker 2010).
As Professor Parker states, the problem with this interpretation is that it ignores the fact that if a relative refuses to consent to withholding treatment, the healthcare team can challenge that decision before the Queensland guardianship authorities (Parker 2010). Any dispute that cannot be mediated automatically triggers a transfer of the substitute decision-maker powers to the Adult Guardian according to the Guardianship and Administration Act 2000 (Qld), s 42. If the futility determination is made competently and in good faith then there will be no right to force doctors to provide treatment. In that sense the Queensland regime’s approach is balanced as all the parties have a right to say what they think is in the patient’s best interests. If there is a dispute then there is a clear pathway for review, which safeguards the patient’s welfare.Perhaps the way to allay medical fears about being “forced” to provide treatment is to rebadge the requirement of consent as a requirement of consultation. In Shortland the Court of Appeal said at 443:
The appropriate course is to expect, where circumstances permit, that there will be reasonable consultation with the patient and such members of the family as are available. Indeed the patient’s wishes about who else should be consulted, if the patient is able rationally to express those wishes, should ordinarily be respected. Those responsible for the patient’s care should bear in mind the views expressed but ultimately they must decide what in clinical terms and within the resources available is best for their patient.
The procedural approach may be unfair
Some jurisdictions have adopted stringent requirements for futility determination. For example, the Texas Advance Directives Act (Texas Health and Safety Code §166.046(a)), creates a process of review of decisions where treatment is deemed “medically inappropriate.” If a physician believes a treatment is medically inappropriate but it is nonetheless being demanded by a substitute decision-maker, the doctor can ask for the treatment to be reviewed by an ethics committee. If the ethics committee agrees that the treatment is medically inappropriate the substitute decision-maker has the option of finding an alternative health care provider with 10 days. If, after the 10 days, no alternative provider can be found the doctor has the option of withdrawing treatment. The 10 days can be extended by a court order, if such a transfer is considered likely. By following this process the doctors receive civil and criminal immunity from suit (Fine 2009).
The process is illustrated by Hudson v Texas Children’s Hospital 177 SW 3d 232 (Tex Ct App 2005). Sun Hudson was 6 months old and diagnosed with thanatophoric dysplasia, a disorder that causes severe disabilities, including insufficiently developed lungs. Sun was ventilator-dependent. His treating physicians had determined that he was not going to survive and they made a decision that continued ventilation was inappropriate. The hospital ethics committee reviewed and confirmed that decision. Sun’s mother was then given 10 days to find an alternative treatment facility but she was unable to do so. She applied for court intervention (on the advice of the hospital, which paid her legal fees), but the trial court denied her application. During the course of the hearing the trial judge made comments about Sun being in “significant pain.” These comments were seized upon by Hudson as being proof that the matter had been pre-judged and she asked the judge to recuse himself. He refused. Her appeal on that matter was upheld (Hudson v Texas Children’s Hospital 2005 Tex App LEXIS 1693) but the new judge again denied the application as there was no likelihood of another facility taking on Sun’s care. Sun later died.One of the main critics of the Texan approach is Professor Truog (Truog 2007, 2009). He argues that the law is not procedurally fair because:
ethics committees lack independence because they are staffed by medical professionals who share the same values and beliefs as the treating physicians and who have close working relationships with the treating physicians;
the committee members are not independent enough from the treating physicians as they work with them and know them well; and
ethics committees exist primarily in urban hospitals so the system will be disproportionately applied to socioeconomically deprived people.
O’Callaghan takes an even stronger line and has argued the law is effectively unconstitutional because of the way that it takes over a judicial function and limits judicial review (O’Callaghan 2008). It might be argued that the Texas approach has merely created a legislative form of pure medical futility. Professor Fine has responded to these criticisms by pointing out that the Act directs the courts to what they are good at, namely examining procedure. Moreover there has been no constitutional challenge to the law in over 10 years of operation (Fine 2009).
The procedural approach may be hampered by legal problems with substitute decision-making standards
An essential component of the procedural approach is effective legal rules for substitute decision-making (Pope and Waldman 2007). If the laws do not provide for clear guidance on who can make decisions and how they should be made there is a greater likelihood of conflict arising (Stewart 2006, 2009). In the United States, Professor Pope has argued that statutes that adopted a procedural approach have been hampered by poor drafting and vague language (Pope 2007). Lawyers have no ground to complain about the indefinite nature of medical futility when the laws themselves are rife with vague propositions.
Secondly, as cases like Woo illustrate, the laws need to be understood and incorporated into practice. Good laws mean nothing if families and physicians remain ignorant of them.
The procedural approach is not perfect but, paraphrasing Professor Fine (and Winston Churchill), “it is the worst approach, except for all the others” (Fine 2009, 967). Whatever one’s view on the problems with procedural approaches to futility, it is time to end the continued claims for an exclusive form of medical sovereignty over the definition of futility. That battle has been fought and lost. It could never have been won. Futility determinations are necessarily evaluative and entail a consideration of legal standards of substitute decision-making (best interests, substituted judgment, or combined tests). Furthermore, the very concept of modern law treats the notion of an unreviewable exercise of unilateral power being deposited in the medical profession as a fantasy that could never be countenanced. Additionally the very concept of professionalism, on which medical sovereignty seems to be based, means an inevitable subjection to accountability and review.
That does not mean that the medical profession cannot speak with authority about futile treatments. The medical profession should remain an instigator of provisional views concerning futile treatment, and these views should be accorded a primary role. However, it does mean that when such decisions are made by the medical profession, they should be made according to legal standards of substitute decision-making, in an environment that is procedurally fair, and open to review. There will always be intractable disputes in this environment but if a procedural approach is adopted they will remain rare (Luce 2010). The evidence we have from Australia, New Zealand and the United States suggests that if the procedural approach is adopted courts will rarely overturn futility determinations.