Introduction
It is extraordinarily difficult to determine the appropriate course of treatment for a child with a terminal illness. One possible approach is to assess the futility of all possible treatments. But what constitutes futility? The medical community seems comfortable with saying that treatment can be medically futile in a specific context, but formulating an objective and precise definition of this concept is the topic of ongoing debate.1 This Note uses the case of Charlie Gard (Charlie) to illustrate the complexities of defining a condition or treatment as medically futile and to show that such an endeavor is itself futile.
Charlie was born on August 4, 2016 with a rare and fatal mitochondrial DNA depletion syndrome.2 Within his first few weeks of life, his parents noticed that he was unable to support his head in the same way babies of a similar age could.3 By October 2, 2016, his parents noticed that he was not gaining weight despite being fed every two to three hours.4 By October 11, 2016, Charlie was lethargic and his breathing was shallow.5 He was then admitted to Great Ormond Street Hospital for Children, where he would remain until his death.6
Eager to find a treatment for their son, Charlie’s parents wanted to transfer him to Columbia University Medical Center to be treated with an experimental nucleoside therapy designed by Dr. Hirano.7 On the other hand, Charlie’s doctors at Great Ormond Street Hospital in the United Kingdom felt that, medically, it was in Charlie’s best interest8 to be removed from life support and to die with dignity.9 Because the hospital disagreed with Charlie’s parents regarding the best course of treatment, on March 3, 2017, judicial intervention was sought in order to override their parental responsibility.10 On July 24, 2017, Charlie’s parents ended the legal battle over their son’s right to experimental and life-sustaining treatments,11 as any treatment would have been futile in improving or prolonging his quality of life.12 Charlie died shortly thereafter.13
The legal issues presented in Charlie’s case raise significant questions about a U.S. state’s role in medical decisions, family members’ interests, and the ethics of using experimental treatment.14 Specifically, this case raises two questions: (1) who is the best authority to determine, in the face of futility, whether prolonging or withdrawing life-sustaining treatment is in the best interest of a minor; and (2) whether state or physician-made decisions regarding end-of-life care and experimental treatment, which are based predominantly on medical speculation, can be enforced against a parent’s wishes.15 These questions, and Charlie’s case in general, exemplify the pitfalls and inconsistencies of defining futility broadly.
In mediating medical futility disputes,16 parents’ interests in making their children’s medical decisions must be balanced against the states’ interests in protecting minors from unnecessary or prolonged harm, as well as maintaining the integrity of the medical profession.17 Current U.S. futility statutes do not properly balance these countervailing interests because they give no guidance as to what can, or should be, characterized as medically futile.18 The guidelines set forth by the American Thoracic Society (the ATS) remedy this problem,19 and states should amend their futility statutes to reflect its recommendations.
Part I of this Note examines the disparate legal frameworks of the United States and the United Kingdom with respect to parental rights. Next, this Part analyzes an infant’s right to have access to experimental treatment for life-prolonging or life-sustaining purposes in the United States.20 Finally, this Part examines the right to withdraw life-sustaining treatment, exploring the countervailing interests of parents and states. Due to the states’ police powers under the Tenth Amendment21 to regulate the health, safety, and welfare of its inhabitants, futility statutes vary across states. Part II analyzes three distinct approaches: in “red light” states, providers cannot withdraw life-sustaining treatment without parental or surrogate consent; in “yellow light” states, providers must abide by judicial standards when withdrawing life-sustaining treatment; and in “green light” states, providers can withdraw treatment without parental or surrogate consent.22
Lastly, Part III of this Note proposes that the ATS’s procedural guidelines for assessing medical decisions in the face of futility should be adopted by all states. The lack of a uniform definition of medical futility results in subjective, value-laden interpretations and vague state policies.23 This contributes to the inherent flaws apparent in each of the three types of futility statutes in the United States. Although the states are laboratories of experimentation, the Constitution creates a floor for the fundamental right24 of child-rearing,25 and current state statutes do not meet this constitutional standard. The red and yellow light futility statutes do not afford proper balance between the interests of the state and parents, and the green light futility statutes are overly paternalistic.26 Accordingly, the guidelines dictate that the word “futile” should only be used in “rare situations in which surrogates request interventions that simply cannot accomplish their intended physiologic goal” and should otherwise be replaced with “potentially inappropriate.”27 This characterization would help remove subjective, valued judgments from the determination of futility and would allow for an effective process-based dispute resolution.28 Adopting these guidelines would thus help clarify and unify the medical goals at issue so as to best balance the interests of the parent, child, and state.
I. Background
In order to analyze what would have happened to Charlie if he had been treated in the United States, this Part explores the scope of parental and state rights with respect to medical decision-making on behalf of infant minors against the backdrop of research laws, access to experimental drugs, and withdrawal of life-sustaining treatment in the face of futility.
A. Child, Family, and State29
Parents’ liberty interests over the care of their children is one of the oldest fundamental rights recognized by the Supreme Court.30 The ability of parents to speak on behalf of their minor children is a right that is deeply rooted in U.S. tradition and common law. It has been suggested that not only is there a presumption that parents have their children’s best interests in mind when making medical decisions,31 but also that the Constitution requires states to respect those decisions.32 Balanced against that liberty interest are the states’ police powers as parens patriae33 to protect minors from harm and to ensure that health care and treatment decisions are made in the best interest of the child.34 States also have a compelling interest in protecting the integrity of the medical profession.35 States can therefore set statutory guidelines to prevent and mitigate these harms.36
In the United States, if parents have been properly informed of their child’s medical condition, treatment options, and prognosis, courts will generally defer to parental discretion in determining what is in the best interest of their child, even if it is not exactly in accord with current medical standards.37 This determination of the child’s best interest is quite ambiguous within the context of experimental treatment, as the cost-benefit analysis38 can be unknown due to inadequate testing. It has been argued that when the potential benefits of the treatment are unclear, or are outweighed by substantial possibility of harm, parents should have the right to determine which course of treatment is in the infant’s best interest.39
In comparison, in the United Kingdom, parents do not have constitutionally protected parental rights.40 Pursuant to the Children Act of 1989, parents are bestowed with parental responsibilities.41 When there is a disagreement over deciding which course of treatment is in the best interest of the child, the courts in the United Kingdom presume that the judge42 is in the best position to make that determination.43 Given that Charlie’s condition had deteriorated to the point at which his life could not have been improved by the experimental nucleoside therapy,44 the court determined that it was not in his best interest to prolong his inevitably transient life.45
B. Research Laws and the Right to Experimental Treatment
1. Research Laws
Research laws regulate the protection of human subjects in medical research.46 Internationally, these laws and regulations significantly evolved subsequent to World War II.47 In response to the Nuremberg Trials,48 the Nuremberg Code (the Code) was introduced in August of 1947.49 The Code set forth rules embodying the legal and ethical principles that must be addressed when conducting clinical research experiments on humans.50 Prior to its adoption, there were no national or international laws differentiating legal and illegal practices.51 The Code’s central principle is the concept of informed and voluntary consent.52
Thereafter, the Declaration of Helsinki (the Declaration)53 was promulgated by the World Medical Association in 1964 to address the shortcomings of the Code.54 The Declaration articulated that those unable to consent, such as children, require proxy consent in order to participate in research trials.55 Additionally, it introduced the concept of therapeutic research in comparison to nontherapeutic research.56 Of particular importance to this Note, paragraph 32 of the Declaration articulates that physicians can sometimes treat patients with experimental treatments not yet approved or licensed due to incomplete clinical research trials.57
In 2002, the Council for International Organizations of Medical Sciences (CIOMS) set forth the “International Ethical Guidelines for the Biomedical Research Involving Human Subjects.”58 CIOMS specifically promulgated these guidelines for the ethical review of emergency compassionate use of an investigational therapy.59 It notes that in some countries, physicians may undertake compassionate use of an experimental treatment60 before obtaining the approval of an ethics committee, provided that the patient requires emergency treatment and the only available treatment option is one that is still undergoing research.61
The United States has created its own research laws and regulations.62 The Belmont Report (the Report) was published in 1979, followed by the codification of Titles 21 and 45 of the Code of Federal Regulations in 1996.63 The Report summarizes ethical principles and guidelines for human research subjects.64 It found that the principle of beneficence65 supports involving children in clinical research trials, even if they are not the direct beneficiaries of the treatment.66 Additionally, within Title 21, 21 C.F.R § 50.5267 is most relevant to Charlie’s case, as the treatment proposed by Dr. Hirano had not been tested on subjects containing the mutation that Charlie inherited, but had been proven effective for those suffering from a different mutation.68 This Section sets forth guidelines for performing such research on children, elucidating that the anticipated benefits must justify the risks, and that there must be proper informed consent.69 The same guidelines are set forth by 45 C.F.R § 46.405 with respect to whether the U.S. Department of Health and Human Services can conduct or fund research that involves greater than minimal risk but presents the prospect of direct benefit to the individual subjects.70
2. The Right to Experimental Treatment
The ability to have access to experimental treatment is not a fundamental right protected by the Constitution.71 In United States v. Rutherford, the Supreme Court held that Congress can authorize the Food and Drug Administration (FDA) to create a rule that denies terminally ill patients access to drugs that are safe but whose efficacies are unproven.72 In fact, the federal district court that first heard the Rutherford case asserted that the constitutionally protected right of privacy prevented the government from denying access to an experimental drug.73 However, this constitutional argument was not addressed by the Supreme Court’s opinion on certiorari.74
Moreover, in the seminal case Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach,75 plaintiffs brought suit advocating for access to Phase 176 experimental treatment for patients who had no other medical options for life-sustaining or life-prolonging care.77 Plaintiffs argued that denial of such treatment violated the Due Process Clause under the Fifth Amendment.78 A three-judge panel of the D.C. Circuit ruled that terminally ill patients whose only treatment options were not government-approved had a constitutionally protected right to obtain access to such treatment free from government intervention.79 However, this holding was later reversed en banc.80 The en banc panel asserted there is no constitutionally protected right for terminally ill patients to be treated with drugs not yet approved by the FDA, even if there is a high probability that the patients would die before the drug is approved.81
Although access to experimental treatment is not constitutionally protected as a fundamental right, in some instances it can be protected by statute. For example, In re Baby K,82 the court held that the plain language of the Emergency Medical Treatment and Active Labor Act83 could not be ignored.84 Since there was no explicit statutory language or legislative history alluding to congressional intent to suggest otherwise, the court reasoned that physicians must provide the requested stabilizing treatment even when it exceeds the prevalent standard of medical care.85 In this case, the physicians treating the infant—who was born with a congenital condition for which there was no treatment and from which infants die shortly after birth—claimed that aggressive, life-sustaining treatment would not serve an effective therapeutic or palliative purpose.86 In their professional opinions, treating the condition would be futile.87 They thus believed there was no requirement to provide stabilizing treatment.88 However, as the statute dictates, even when a physician receives a request for treatment they believe is inappropriate89 due to their assessment of the patient’s condition as medically futile, they are required to provide such treatment even if it might exceed the general standard of care.90
The right to access experimental treatment can also be protected by federal regulations. In the United States, patients who are out of treatment options can apply to specific drug companies and the FDA to use experimental drugs outside of a clinical research setting.91 Under the FDA’s compassionate use92 exception of the Expanded Access Program,93 a patient may obtain access to pre-approved treatment if the FDA determines (1) that patient has a serious or life-threatening disease and there is no established treatment alternative; (2) the benefits justify the risks of treatment; and (3) the administration of the drug will not interfere with the completion of its clinical research trials.94 However, it appears that it is rather difficult to obtain treatment under the compassionate use exception.95 While the FDA approves about ninety-nine percent of compassionate use requests,96 drug manufacturers will often refuse to distribute the experimental medication, fearing that either the FDA could use the results of its consumption against them, or that patients who might be injured from using these unapproved drugs will sue.97
In response to the shortcomings of the FDA’s Expanded Access Program, the Goldwater Institute has encouraged the adoption of Right to Try laws among states.98 Right to Try laws allow physicians and drug companies to treat those suffering from life-threatening conditions that have no known effective treatments with non-FDA approved medications.99 The thirty-eight states that have adopted such laws have done so with “overwhelming bipartisan support and almost no opposition.”100 Recently, on May 30, 2018, the Right to Try Act became law, expanding the access to experimental drugs for those who suffer from terminal illnesses.101 Specifically, the bill promulgates uniform, national rules for distributing experimental drugs to terminally ill patients that shield pharmaceutical companies and doctors from legal liability.102 It is important to note that the bill recognizes that access to experimental drugs is within the scope of individual liberty, which is a fundamental right protected by the Constitution.103
Alternatively, under the principle of altruism, parents are justified in enrolling their children in clinical research trials even if there is a low probability that it could therapeutically benefit their children: it contributes to research that will ultimately benefit other children with similar conditions in the future.104 This participation can still be considered in the best interest of the child because, from a policy perspective, participation in non-beneficial pediatric research endorses that research study.105 Moreover, due to the unknown nature of experimental treatment, it could ultimately prove beneficial to the child.106
C. Withdrawal of Life-Sustaining Treatment in the Face of Futility
While the term futility has been defined outside the medical context,107 according to the American Medical Association (the AMA), medical futility cannot be meaningfully defined108 as its interpretation is inherently subjective.109 Because futility is framed as an inquiry of potential benefits, determining whether treatment is medically futile is contingent upon determining what is in the best interest of the patient.110
In the United States, parents have the authority to make decisions regarding the withdrawal of life-sustaining medical treatment on behalf of their minor children111 since they speak for them with respect to medical treatment decisions.112 In making such a decision, parents must use the best interest standard.113 The best interest standard encompasses a good faith determination114 and includes the following: (1) the consideration of holistic evidence assessing the patient’s physical, sensory, emotional, and cognitive functioning; (2) the amount of physical pain that can result from the condition itself, the treatment, and termination of treatment; (3) the projected life expectancy and possibility of recovery with and without the treatment; and (4) the risks, side effects, and benefits of all viable treatment options.115 If there is a fundamental difference in opinion116 between the parents, who have assessed what is in the best interest of their child, and the treating physicians, who have a duty to do no harm,117 a consultation with an ethics committee could best balance the countervailing perspectives.118
Surrogate decision-making, such as that of parents for their child, or a court for a minor, cannot be based on the subjective assessment of quality or value of life.119 Just because the minor’s prognosis is unclear or limited does not mean that treatment should automatically be withdrawn, that it is in his best interest to die, or that he cannot enjoy the rest of his life.120 Therefore, instead of characterizing a condition as futile, and having that classification influence whether life-sustaining treatment should be withdrawn, it should be assessed whether the treatment, or lack thereof, satisfies the intended medical goal.121
II. Analysis: Who Speaks for the Child?
A. What Would Have Happened to Charlie Gard in the United States
In order to determine what would have happened to Charlie in the United States, we must assess the constitutional rights at issue. In analyzing whether a right is fundamental, the judicial body is constrained by “the teachings of history, [and the] solid recognition of the basic values that underlie our society.”122 American law has historically reflected the view consistent with Western civilization that the family is a unit, with parents having broad authority over their minor children.123 The U.S. constitutional system has rejected that a child is “the mere creature of the State,” and has instead proclaimed that parents generally have the right to guide their children.124 It can be inferred that this includes a parental duty to make medical decisions that are in the best interests of their children.125 Therefore, it can be argued that there is a fundamental right for parents to decide what is in their child’s best interest when faced with difficult medical decisions related to treatment uncertainty or futility, and in these cases, decision-making should be deferred to the parents.126 It is only when parents’ refusal of treatment involves a risk of harm to the child127 that it is considered not in the child’s best interest and could constitute child abuse.128 In those situations, and those in which parents’ decisions impede the physician from fulfilling his ethical duty of not causing harm,129 the state can interfere, asserting its status as parens patriae to prevent the child from being harmed and protect the integrity of the medical profession.130
Five months after Charlie’s birth, and four months after he was diagnosed with a rare mitochondrial DNA depletion syndrome, his mother found an American doctor who was willing to offer Charlie an experimental nucleoside treatment that was successful in treating children who had a similar condition but had never been used on someone who had his exact mutation.131 Pursuant to paragraph 32 of the Declaration, a physician can, with the informed consent of the patient—or in this case, the patient’s parents as proxy—use unapproved experimental treatment when there are no other proven alternatives for treatment, and where, in the physician’s judgment, the experimental treatment has the ability to either alleviate suffering or prolong life.132 This proposition is further supported by the Belmont Report, and Titles 21 and 45 of the Code of Federal Regulations.133 Although the treatment might not be the prevailing standard of care134 and could involve a greater than minimal risk—as it has never been tested on those who presented the same mutation as Charlie had—because this could be the only way to stabilize him, and because there was a possibility for direct therapeutic benefit in his best interest, albeit slim, statutory law would protect the right to obtain such treatment.135
Accordingly, Charlie could have received access to the experimental nucleoside treatment in the United States if (1) in Dr. Hirano’s medical judgment it offered hope of saving his life or alleviating his suffering, and there was no other proven therapeutic treatment;136 (2) there was proper informed consent;137 (3) subjecting Charlie to this treatment was truly in his best interest; and (4) if either the FDA, under its Expanded Access Program, or the state, under its Right to Try Law, approved of such a request. Here, there was no alternative treatment option except withdrawal of palliative care.138 Dr. Hirano had reason to believe that the experimental nucleoside treatment could benefit Charlie, as he had prior success with treating another infant who was born with a different form of the mitochondrial depletion syndrome.139 Additionally, full informed consent is characterized by the disclosure of risks, benefits, and alternatives of a treatment, as well as the identification of experimental procedures and unknown risks.140 Therefore, when there are no other treatment options, and experimental treatment remains the only hope, parents such as Charlie’s might well have accepted and consented to the unknown risks.
Thereafter, it must be determined whether subjecting Charlie to experimental treatment would have been in his best interest or medically futile. When the only treatment option available is experimental, parents are tasked with the responsibility of weighing the unknown risks and burdens with the benefits of such a treatment.141 Using the best interest standard, Charlie’s parents would have made a good faith determination in their assessment of (1) their son’s physical, sensory, emotional, and cognitive functioning; (2) his level of pain; (3) his life expectancy with and without the treatment; and (4) the potential risks and benefits of undergoing experimental treatment as opposed to withdrawing life-sustaining measures.142
Charlie’s condition caused him progressive muscle, organ, and brain deterioration, compromising his ability to react physically, cognitively, and emotionally to external stimuli.143 Dr. Hirano’s experimental nucleoside treatment had already proved successful in treating an infant with a different form of a mitochondrial depletion syndrome, in that it prevented further deterioration and restored the ability to perform basic motor skills.144 From his parent’s perspective, there was a real possibility that Charlie could survive,145 and even though he might live a life with disabilities, it could still be a meaningful life for him. When assessing what is in best interest of a child, subjective opinions and biases regarding the “value-laden” characterization of quality of life cannot dictate the decisional outcome; a limited quality of life can nonetheless be meaningful.146 Therefore, from his parents’ perspective, it would have been in Charlie’s best interest to pursue a treatment that had shown promising effects, instead of continuing to let his brain and muscles deteriorate, which could have possibly caused him more prolonged harm and suffering.147
Thereafter, using the best interest standard, Charlie’s parents would have had to assess whether the treatment would have caused Charlie such pain that administering it and other life-sustaining measures would have been inhumane.148 Analyzing this prong in conjunction with the Child Abuse Amendments of 1984,149 when his parents initially requested experimental treatment, Charlie was not chronically and irreversibly comatose, the administration of the treatment would neither prolong dying nor be ineffective as there was evidence of its efficacy, and thus it would not have been “virtually futile” or inhumane.150 Moreover, even though the potential benefits and risks were not fully known with absolute certainty,151 the principle of altruism can justify such a treatment.152 Administering the experimental nucleoside treatment would have advanced research to help children in the future who are suffering from Charlie’s condition, and would have therefore comported with the best interest standard.153 Since it is the parents’ constitutional right154 to assess these determinations, absent unequivocal evidence this would have undoubtedly harmed Charlie such that the state could have intervened,155 Charlie’s parents would have received extreme deference, especially because the decision was regarding access to experimental treatment.156
Consequently, if both the doctor and parents approved the use of experimental treatment, it must next be analyzed whether Charlie could have obtained access to it either under the FDA’s Expanded Access Program, or under state-adopted Right to Try laws. Charlie would probably not have been successful in obtaining access under the FDA’s expanded access program because (1) authorization for distribution under the FDA’s Expanded Access Program is ultimately contingent upon pharmaceutical companies who are generally fearful of incurring legal liability from injuries that can be unknown;157 and (2) the overall process is rather slow and costly such that patients with quickly deteriorating conditions, such as Charlie, might not receive the treatment before it would become futile to pursue it.158 Therefore, he probably would have had a better chance of obtaining pre-approved experimental treatment in the states that have adopted Right to Try laws.159 Under these laws, parents have successfully been able to obtain experimental treatment for their terminally ill children.160 Thus, if Charlie had been in the United States, there would have been a good chance he could have received the experimental nucleoside treatment in a Right to Try state instead of relying on FDA approval or a serendipitous acceptance into a clinical trial.161
On April 11, 2017, the High Court judge denied the request of Charlie’s parents to allow him to have experimental treatment and ruled that life support should be withdrawn against his parents’ wishes, as his condition was deemed medically futile.162 The concept of futility is inherently subjective and, thus, influences the best interest analysis.163 The value Charlie’s parents placed on his life led them to conclude that withdrawal of life-sustaining treatment was not in Charlie’s best interest, as it could cause him pain and would not respect his personhood.164 Moreover, as a family unit, parents should be able to be with their son and treat him until the very end.165 Contrastingly, physicians value beneficence in conjunction with their duty to do no harm.166 Therefore, if continuing life-sustaining treatment would have no empirical benefit to the patient and would be ineffective in treating or improving the patient’s condition, the physician, in his professional capacity, would not be obligated to continue administering such treatment.167 In Charlie’s case, the physicians felt that they could not do anything that would improve his condition, as he had deteriorated to the point such that any life-sustaining treatment was futile and would only prolong his death.168 The conflicting values of Charlie’s parents and physicians produced different views of what was in his best interest, causing a medical futility dispute.169 In the United States, the resolutions of a futility dispute diverge as states have enacted different futility statutes that have varied deferential stances towards parental rights.170
B. Futility Statutes
This Section explores the three types of futility statutes in the United States—red light, yellow light, and green light—in order to assess what would have happened to Charlie had he been treated in those respective jurisdictions. Furthermore, an analysis of the critiques of these approaches exemplifies the problem with a broad and ambiguous definition of futility.
1. Red Light
In states that have adopted a red light approach to futility, physicians cannot withdraw or withhold life-sustaining treatment without the consent of the surrogate decision-maker.171 These substantive red light statutes dictate that in situations in which a surrogate requests life-sustaining treatment, the physician must comply even if in his professional capacity he ethically and morally objects.172 Moreover, in procedural red light states, guidelines allow for surrogates to resort to the judicial process to get temporary restraining orders and injunctions.173 In determining whether to grant such requests, judges will generally preserve the status quo of continuing life-sustaining treatment until adjudication; however, since the judicial process is slow, the patient often dies before the court can reach the merits.174 Almost by default, then, the surrogate decision maker wins.175 If Charlie was treated in a red light state,176 the physician would have had to follow to his parents’ wishes to continue administering life-sustaining treatment, even though Charlie’s condition was deteriorating, there was no possibility of recovery, and the treating physicians felt that prolonging his life, and thus his suffering, was medically and ethically inappropriate.
Although this approach takes a highly deferential stance toward the parental right to make important and personal decisions on behalf of children, one of the major critiques of it is that the elimination of physicians’ discretion of what is medically and ethically appropriate eliminates the identification of futile treatment.177 This allows for the prolongation of the patient’s suffering and leads the physician to be morally and ethically distressed, as the administration of treatment would go against his duty to do no harm.178 Moreover, this undercuts the state’s interest in protecting both the well-being of a minor child and the integrity of the medical profession: continuing life-sustaining treatment—if considered to be outside the standard of medically appropriate care—prolongs inevitable suffering and death, which would not only compromise the physicians’ integrity in their role as healers, but would also permit state intervention in its capacity as parens patriae to prevent such protracted harm.179 Therefore, this approach does not adequately balance the interests of both parties.
2. Yellow Light
Most states adopt a yellow light approach to futility disputes in which there is uncertainty surrounding the determination of whether physicians may stop treatment without the consent of the surrogate.180 These statutes neither expressly permit nor forbid physicians from unilaterally ceasing the administration of life-sustaining treatment and leave the physicians uncertain as to the legal consequences of stopping such treatment without consent.181
The California statute is a noteworthy example of the inherent ambiguity in the yellow light futility statutes.182 In California, physicians can refuse to comply with the surrogates’ requests to provide life-sustaining treatment if such requests are “medically ineffective” or “contrary to generally accepted healthcare standards.”183 These guidelines base legal immunity on a standard that is undefined due to the inherent and significant variability in medical practice.184 Accordingly, if Charlie was treated in a yellow light state, the result of his futility dispute would be uncertain, as it would depend on how the treating physician interpreted the “generally accepted healthcare standards” as applied to Charlie’s unique situation.
While yellow light futility statutes incorporate oversight and accountability into the proposed standard of care, it is so uncertain, and physicians are so fearful of litigation, that the statute is more often than not interpreted as a red light.185 Taking into account this understanding, the yellow light approach does not afford the proper constitutional balance between the parent’s fundamental right to make decisions about child-rearing and the state’s interest in protecting both children from harm and the integrity of the medical profession. It leaves physicians with essentially no rights186 and gives parents too much power to make decisions for their own personal reasons, which can ultimately worsen the harm and suffering of their child, thereby justifying state intervention.187
3. Green Light
Lastly, green light futility statutes allow clinicians to stop treatment without the consent of the surrogate decision-maker.188 These statutes, such as the Texas Advance Directives Act, set forth clear guidelines regarding legal immunity.189 Abiding by the statute’s procedures, physicians who cease life-sustaining treatment after a hospital committee agrees with their classification of treatment as futile, then wait ten days to allow the surrogate decision-maker time to find a facility who will provide the requested treatment, will be civilly, criminally, and disciplinarily immune from legal action.190
This approach most resembles that of the United Kingdom. In the United Kingdom, the courts appointed a guardian ad litem191 to represent the best interests of Charlie,192 who had to agree with the physician’s determination for the withdrawal of treatment to proceed.193 Similarly, pursuant to the green light approach, an institutional committee must agree with the physician’s determination before unilaterally withdrawing treatment.194 If a hospital committee agreed with the physician’s assessment of Charlie’s futile condition, and his parents could not, within ten days, find a facility that would provide the life-sustaining treatment they requested, the treating physicians would have the unilateral right to withdraw such treatment without the consent of his parents.195 Therefore, if Dr. Hirano could not have accepted Charlie’s case within that short timeframe, and if Charlie was treated in a state with a green light approach, such as Texas, the result would most likely have been the same as it was in the United Kingdom.
One criticism of the green light approach is that it can cause life-sustaining treatment to be incorrectly identified as futile.196 Additionally, it does not afford the opportunity to seek appellate review in front of an independent and neutral decision maker, which is a cornerstone of procedural due process,197 and which is necessary in addressing the fundamental parental rights at stake.198 Moreover, these statutes do not reduce the risk of error in withdrawing life-sustaining treatment, as they do not prevent a physician’s “corruption, bias, carelessness, and arbitrariness” from seeping into this extremely significant decision.199 Because of the value-laden characterization of medical futility, “[c]linicians and ethics committees may inappropriately determine that the burdens of treatment outweigh the benefits, because they judge the patient’s quality of life to be far lower than the [parent or surrogate decision maker] would judge it to be.”200 This allows for physicians to treat their patients in an overly paternalistic way when unilaterally deciding to cease treatment.201 Consequently, this limits parents’ decisional autonomy and substantive due process rights in making decisions that are essential to their children’s personal bodily dignity.202
III. Proposal
Decisions surrounding medical futility are ultimately centered around principles of child-rearing, a fundamental right protected under liberty and privacy of the Due Process Clause.203 Therefore, state futility statutes must properly balance parental rights and the state’s interests in determining who is in the best position to properly assess an infant’s quality of life and best interests in end-of-life treatment and care. However, the current state statutes are unable to attain this constitutional balance because the ambiguous interpretation of futility is embedded in its provisions—in these futility statutes, the states rarely define what constitutes medically futile care.204
Labeling a patient or a treatment as “medically futile” is inherently problematic because it invites subjective, value-laden judgment about quality of life or medical prognosis.205 The lack of uniformity in defining futility, therefore, often leads to overly paternalistic, physician-centered decisions206 regarding the administration, withholding, and withdrawal of treatment. Consequently, this undermines parents’ right to make autonomous decisions with respect to the bodily integrity of their children. This is illustrative of the green light approach, which gives a physician unilateral authority to withdraw life-sustaining treatment, even though there is inevitably variability—rooted in the subjectivity of ethical and medical judgment—among physicians in what constitutes appropriate care in the face of futility.207 This poses a concern of undue variability in making decisions about treatment, dissuades physicians from fully engaging in challenging conversations that often help support surrogates though this painful process, and hinders physicians from working with surrogates to achieve mutually agreeable decisions.208 A physician-centered futility statute in conjunction with an overbroad characterization of futility is problematic.209 In comparison, although the red light approach is most deferential to parental rights, as it gives the decision-making authority to the parents or surrogates, it is problematic because parents do not have a positive right to request and demand treatment that is contrary to accepted medical practices.210 The strong emotional and psychological factors that are involved in assessing end-of-life decisions may alter the parents’ perception of whether their child’s condition is truly futile and thus may dissuade them from genuinely considering a physician’s professional recommendations.211
A statute that narrowly characterizes “futile” conditions or treatments, and that provides a more workable definition, would enable a collaborative approach that would respect a proper constitutional balance between state and parental rights.212 It would also help remove the value judgment attached to futility.213 The Society of Critical Care Medicine, the AMA, and the Texas Advance Directives Act have individually published statements regarding how to manage disputes between surrogates who request interventions and physicians who believe such interventions should not be administered.214 However, their guidelines offer substantially different and conflicting definitions of “futile,”215 which further blurs this already confusing concept.216 In response to a need for clear guidance, in 2015, the ATS promulgated guidelines that are structured in such a way that narrow the ambiguity in futility and force surrogates and physicians to work collaboratively to make treatment decisions.217 The guidelines remedy the shortcomings of the current futility statutes, enabling an adequate constitutional balance.218 Its language should therefore be adopted by all states. This would respect the states’ roles as laboratories of experimentation, as it would merely clarify the central concept of the statutes while preserving the respective approaches.
The ATS recommends that “potentially inappropriate,” instead of “futile,” should be used to characterize a treatment that has a minimal chance of accomplishing the desired result of the surrogate, but for which a physician cannot ethically justify its administration.219 This is because “inappropriate” more accurately and clearly conveys that the determinations being made by the physician depends on both technical medical expertise and technical judgment rather than just value-laden determinations.220 Additionally, “potentially” suggests that these judgments are preliminary and thus require review before they can be acted upon.221 In situations in which requests for potentially inappropriate treatment remain burdensome or demanding, despite the fact that the physician has communicated222 with the surrogate about the proposed treatment plan, the ATS suggests that there should be fair, process-based dispute resolution.223
In comparison, “futile” should only be used when a medical intervention cannot accomplish the intended physiological goal, which is a rare occurrence.224 This narrow definition distinguishes cases in which the requested treatment cannot, under any circumstances, produce a benefit, from those that might be able to accomplish the desired goal.225 In the infrequent cases in which the intended psychological effect cannot be accomplished, physicians should not provide futile care because, in these situations, the state’s interest in protecting the medical profession and the welfare of children, in conjunction with the physician’s ethical obligation to do no harm, outweigh parental interests in demanding a treatment that is contrary to acceptable medical care.226 However, such determinations should not automatically defer to the physicians, and an expert consultation should assist with the conflict resolution process.227
This distinction between “potentially inappropriate” and “futile” treatment would have better allowed for a proper assessment of Charlie’s options. At the point when Charlie’s parents initially requested experimental treatment, it might have been “potentially inappropriate” because of the countervailing ethical considerations, but the constitutionally protected parental rights to determine what is in the best interest of their child would have prevailed. At the point at which it was determined that no treatment, including life-sustaining interventions, would work towards accomplishing the physiological goal of improving Charlie’s condition, it would have forced his parents to assess what in fact their goal was and whether that goal would be truly consistent with what was in his best interest. Here, keeping Charlie alive was the intended physiological goal. Therefore, even though continuing life support might ethically be “potentially inappropriate,” as it is prolonging his death, it would be consistent with the physiological goal of keeping him alive. However, since a disagreement between the parents and the treating physicians persisted regarding the administration of life support, per the ATS’s guidelines, a dispute resolution process would have taken place that would have helped balance the parents’ interests with those of the physician.228 An expert consultant would have empathetically communicated the medical reasoning behind the refusal to administer treatment and would have provided the emotional and psychological support that Charlie’s parents desperately needed during this painful time.229
A. Counterarguments
It can be argued that the state should not have authority to enter into this private and deeply personal realm of decision-making and allow physicians to act contrary to parental wishes, as this undermines decisional autonomy on issues essential to the bodily dignity of their children. However, parental rights are not absolute.230 Parental authority should be carefully examined when there is a fundamental disagreement about medical facts, prognoses, risks and benefits of a proposed treatment, and likelihood of suffering.231 State intervention is justified when (1) the parents’ decision would pose a risk of significant and preventable harm; (2) the harm is imminent, requiring immediate action to prevent it; and (3) the physician’s treatment plan is both supported by proven medical evidence and is the least intrusive alternative that would minimize harm.232 Without state intervention, parents would have free reign to make medical decisions for their children that could amount to abuse or neglect.233 That is why states, pursuant to their police powers, can, and must, be able to promulgate their own futility statutes that protect the health, safety, and welfare of minor children in end-of-life treatment and care.
Moreover, while commentators have accepted that there is no workable definition of futility, they have nevertheless proposed that more states should either adopt a green light, process-based approach,234 or a yellow light, multi-institutional ethics committee approach235 to medical futility disputes. It can be argued, therefore, that there is no need to constrict the definition of futility or attempt to define it in a more particularized manner, as the chosen dispute resolution process ensures fair procedural and substantive due process. However, the core issue in these “traffic light” futility statutes is that the word futility is used without further clarification. This inherently ambiguous, value-laden term causes an imbalance between parental rights and state interests, which becomes evident during the dispute resolution process. Therefore, in order to truly ensure fair procedural and substantive due process, the definition of futility in these statutes must be narrowed according to the guidelines of the ATS.
Conclusion
An analysis of the Charlie Gard case within the U.S. legal framework demonstrates the complexities of trying to define futility and the implications of such an ambiguous term in state statutes. Limiting the use of the term futility to describe situations in which the requested treatment would not serve the intended physiological goal better balances the interests of parents, physicians, and states. This narrow definition diminishes the degree to which subjective values and beliefs contribute to a determination of futility. Therefore, the guidelines proposed by the ATS should be adopted and implemented by all states in their current futility statutes. As laboratories of experimentation, states have the power to adopt their own respective “traffic light” statutes regarding disputes surrounding end-of-life care. The implementation of the ATS’s guidelines will preserve that power while providing a better constitutional balance to those statutes by ensuring a holistic and particularized approach and reserving the classification of futility for extremely rare scenarios. This will result in more effective and less burdensome dispute resolution proceedings for cases involving futility disputes.