Futile Care, Experimental Treatments, and the Right to Try Movement: Could the Charlie Gard Case Happen in America?

• Author: Hansen, Kaitlyn

"To postpone the withdrawal of treatment, which is otherwise accepted to be the better course for this young child, to go to America to receive treatment which has 'zero' prospect of improving his condition, would only prolong his existence in a manner which all, most sadly, agree can no longer be justified as being in his best interests." (1)

1. Introduction

   Medical ethics scholars and legal commentators were looking to England this summer, awaiting a final ruling on the Charlie Gard case. (2) On July 27, 2017, the European Court of Human Rights (ECtHR) announced it would not interfere with the United Kingdom Supreme Court's ruling denying parents of a terminally ill infant the right to travel to America for an experimental treatment. (3) In early spring, the Family Division of the High Court in London began analyzing the case, and announced on April 11, 2017, that doctors could stop providing the life-supporting treatments they had been administering to Charlie Gard--then eight months old and afflicted with terminal mitochondrial DNA depletion syndrome (MDDS). (4) Three court of appeals judges then heard and dismissed the case on May 25, 2017, discussing the irreversible brain damage already sustained by the patient, as well as his inability to breathe on his own. (5) The Gards' appeal, which was later denied by the ECtHR, sought a declaration that it was both lawful and in the best interest of their child to transport him to the United States for nucleoside therapy, an experimental treatment not likely to improve his condition. (6) The parents' efforts at the United Kingdom Supreme Court and ECtHR were ultimately unsuccessful, with judges at both levels agreeing with the lower court of appeals' decision. (7)

   Nearly four years earlier, on December 9, 2013, an American teenager, Jahi McMath, entered the Children's Hospital in Oakland, California, for a routine removal of her tonsils and adenoids. (8) The surgery was unsuccessful and resulted in excessive bleeding that led to cardiac arrest; three days later, the patient was pronounced brain dead. (9) Although the diagnosis of brain death was official, Jahi's mother claimed her daughter was still alive, and wanted to transport her to a New Jersey facility that provided a religious exemption for brain death. (10) The doctors overseeing Jahi argued that they had no duty to continue providing medical support after brain death, but were subsequently court ordered to continue providing treatment to Jahi until December 30, 2013. (11) Jahi's mother was ultimately allowed to move her daughter to the New Jersey hospital, and recent reports state that she is responding to commands to move her fingers. (12)

   In both the British and American cases discussed, the same issues emerge as to when parents' medical decisions for their children should be honored over the opinions of medical professionals or court orders. (13) The Charlie Gard case was complicated by the fact that the proposed experimental treatment was not supported by strong evidence of its potential success. (14) In fact, the doctor testifying in support of the procedure admitted there was no clear evidence the treatment had even been administered to an animal or patient with the same deficiency as Charlie Gard. (15) While some American states, like Texas, allow hospitals to overrule requests for what they see as "futile care," federal law diverges from this approach. (16) For patients arguing to try a treatment with low possibilities of a favorable outcome, the long-debated Right to Try Act recently became law. (17) The Act allows American citizens access to the same type of experimental drugs the British courts had decided against--not yet federally approved treatments, available to terminal patients, with minimal testing proving their efficacy. (18)

   This Note examines the limits of experimental medicine and treatment, particularly when minors are involved and doctors or the court system disagree with a parent's medical decision for his or her child. (19) Through the lens of the recent Charlie Gard case, the Jahi McMath matter, as well as other prominent American cases, this Note discusses parental rights and suggested limits for those rights. (20) This Note compares and contrasts the older ideas immortalized in the Texas Advanced Directive Act, and evaluates the danger of new American Right to Try legislation. (21) Using the Charlie Gard case as a model, and applying the proposed U.S. Bills and subsequently enacted Act, this Note analyzes the future of experimental treatment for terminally ill children. (22) Although the Right to Try legislation seems to drastically expand patient rights, this Note examines how healthcare decisions in line with the Texas Advance Directives Act, or with the existing process for requesting early access to experimental drugs through the Food and Drug Administration (FDA), will ensure incapacitated minor patients are not forced to undergo futile interventions. (23)

2. HISTORY

   1. The Charlie Gard Legal Battle

      Charlie Gard's parents sought an order to release their baby to them so he could be transported to the United States for experimental treatment, but were unsuccessful with their domestic and ECtHR appeals. (24) The ECtHR ultimately considered two decisions from the case's earlier proceedings--a review of the treating hospital's successful application for a declaration allowing the lawful withdrawal of artificial ventilation for the infant, and an opinion on whether it was in the infant's best interest to undergo experimental treatment in the United States. (25) The parents argued that the lower court decisions in favor of the hospital violated their child's right to life, liberty, a secure and fair trial, and privacy, in addition to interfering with their parental rights. (26)

      As the ECtHR analyzed the parents' claims, it considered domestic and international legal principles. (27) The Children Act 1989 provides that "the child's welfare shall be the court's paramount consideration," and the court has the power to make orders regarding children in specific circumstances. (28) The role of the courts in settling disputes has been announced in prior decisions:

      As a dispute has arisen between the treating doctors and the parents, and one, and now both, parties have asked the court to make a decision, it is the role and duty of the court to do so and to exercise its own independent and objective judgment.... The right and power of the court to do so only arises because the patient, in this case because he is a child, lacks the capacity to make a decision for himself. (29) The ECtHR reviewed how the domestic court applied this objective standard when reviewing the Charlie Gard case, considering whether palliative care or experimental treatments were in the minor's best interests. (30) The court held that the decisions in the lower courts were based on "extensive and high-quality expert evidence," and found that the courts did not disproportionately interfere with parental rights about medical treatment choices. (31) The ECtHR also supported the lower court's holding that the parents' desire for experimental treatment would be futile, and was not a viable option. (32)

   2. Futile Treatment Determinations and Ethical Concerns

      The ECtHR's ruling affirmed the decision that the parents' requested experimental treatment would be futile for the infant. (33) The ECtHR based its decision partly on medical testimony stating the treatment would not improve the minor's condition and could possibly cause pain or suffering. (34) The domestic appellate court who first reviewed this decision noted that examining the merits of an experimental treatment was a proper "child focused, court-led evaluation" of the baby's best interests. (35) The cultural difference in medicine can be summarized with one of the appellate court judge's commentary on testimony by an American expert, Dr. I: "Dr[.] I[,] who has not had the opportunity of examining Charlie, and who operates in what has been referred to as a slightly different culture in the United States where anything would be tried, offers the tiniest chance of some remotely possible improvement." (36) The court's decision illustrates that governments and courts must fulfill a regulatory duty to protect patients from harm caused by treatments that do not have proof of efficacy or scientific validity. (37)

      The courts weighed the miniscule chance of success against the possible suffering the treatment would cause the infant, and ultimately settled the conflict between the hospital and the parents. (38) The difficulty this case presented for many was that the court made a decision regarding the limit of the current state of medicine when the parents were not yet ready to accept that decision. (39) In both the United Kingdom and the United States, patients cannot demand nonbeneficial treatments simply because they have the money to pay. (40) Although Charlie Gard's parents raised over $1.6 million to fund the treatment, experts did not believe the treatment would benefit the infant, and courts confirmed the treatment was not a right simply because it could be funded. (41)

   3. Treatment of Minors in the United States

      Without a human rights court like the ECtHR in the United States to provide uniform guidance on the right to treatment and best interest conflicts regarding minors and their parents, the amount of deference that should be given to parental choices is frequently litigated in American courts. (42) Most similar in approach to the logic explained by the ECtHR, the pure objective test provides that treatment should be ended if the burdens of living outweigh the benefits, with no consideration given to the patient's wishes. (43)

      Complicating any decision regarding a patient's wishes is the fact that minors are generally unable to give legal consent for their own treatment and diagnosis. (44) Because of this, minors are often completely reliant on...