Last week, a federal judge in Philadelphia granted a temporary restraining order (TRO) that permitted an 11-year-old child with end-stage cystic fibrosis to be added to and prioritized on the adult waiting list for a double lung transplant. Since that order, the child received donor lungs and at the time of this writing reportedly has a positive post-operative prognosis. The situation has received substantial media attention, and some bioethicists have raised concerns about the role of judges and legislators in making medical determinations in individual cases.
At issue in this case was a policy of the Organ Procurement and Transplantation Network (OPTN), which is operated by Congress and the private organization United Network for Organ Sharing (UNOS). The policy, known colloquially as the “Under 12” policy, places children under 12 years of age on a waiting list for pediatric lung donors in order of severity and waiting time, and on adolescent and adult donor lists in order of waiting time only (effectively at the end of those lists). The pool of lungs donated from adults is more than 50 times larger than that of lungs donated from children under 12, so the chances of finding a suitable organ in a short amount of time are much higher for recipients on the adult list.
The parents of the child had asked the Secretary of the U.S. Department of Health and Human Services (HHS) to suspend the policy that prevented their child from being considered for a donation of lungs from the much larger pool of adult donors, but the Secretary declined to intervene. In refusing, the Secretary stated that medical experts should make those decisions and that she lacked the authority to intervene in a particular case. The Secretary did call for review of the policy at issue, but changes to policies can take up to two years to go into effect.
As of this writing, everything that could have gone well for the child did. The parents filed a lawsuit seeking a TRO, a preliminary injunction, and a permanent injunction to stop enforcement of the “Under 12” policy. U.S. District Judge Michael Baylson granted the TRO and set a hearing date for the preliminary injunction. Because the TRO effectively placed the child on the adult waiting list, she was matched to a lung donor and received the transplant operation. On June 10, the same day the TRO was granted and in response to a request by the Department Secretary, the OPTN Executive Committee conferenced and approved a revision to the “Under 12” policy, effectively eliminating the restriction, just as the lawsuit sought to do.
The change in policy became effective immediately but will expire on July 1, 2014, unless the full OPTN/UNOS Board of Directors decides to change the pediatric lung allocation policy on a permanent basis.
In this column, I will first discuss the arguments the parents presented against the “Under 12” policy and why the judge granted the TRO. I will explain why this decision need not alarm bioethicists or anyone else concerned with the interference of legislators and judges in medical decisions for individual patients, but it should prompt experts to review and update health policies more proactively.
Evaluating a Policy: The “Arbitrary and Capricious” Standard
Courts give substantial deference to administrative agencies to establish rules and policies. Indeed as long as an agency’s rule is reasonable—that is, not “arbitrary, capricious, or manifestly contrary to the statute [that created the agency]”—the court must defer to the agency’s interpretation of the statute.
The National Organ Transplant Act of 1984 established the Organ Procurement and Transplantation Network (OPTN) to maintain a national registry for organ matching, as well as to develop and promulgate organ transplant policies. The Act also prescribed that the OPTN be operated by a private, non-profit organization with federal oversight by the Health Resources and Services Administration (HRSA) of the HHS. This organization is the United Network for Organ Sharing (UNOS). Jointly run by a private nonprofit and a government agency, OPTN is itself a nonprofit organization and not a government agency, but its policies may become mandatory if the Secretary of HHS adopts them as mandatory.
UNOS/OPTN developed the policies that govern organ transplant procedures that were adopted as mandatory, including the policy at issue in this case. Policy 188.8.131.52 addresses lung candidates with exceptional cases. The stated purpose of the policy is to establish the function and duties of the Lung Review Board (LRB), which involves calculating the Lung Allocation Score (LAS). LAS is the measure by which a candidate recipient is prioritized for placement on the waiting list.
However, the LAS system does not apply to lung candidates who are younger than 12. Instead, these candidates are placed at the end of the adult and adolescent lists and have a separate list for under-12 donors.
In the present lawsuit, the parents of the child needing the double lung transplant brought a lawsuit challenging the “Under 12” policy. They argued that the “Under 12” policy violates the command of the National Organ Transplant Act of 1984 that the system for allocating donated organs be “equitable” and address “the unique health care needs of children.” They also posited that the policy violates a regulation promulgated by the HHS, which requires OPTN’s policies to give greatest consideration to allocating organs based on medical urgency. By not applying the LAS system to lung candidates under 12, the complaint argues, the policy fails to adequately consider on urgency, solely because of the age of the recipient.
In support of their position, the child’s doctor—an expert in pediatric pulmonology—testified that the “Under 12” policy was developed almost 9 years ago and that medical and scientific advances have made that policy obsolete as applied to children between the ages of 5 and 11 who have a disease process also found in adults. The physician testified that “children in this group can now successfully receive adult lungs (often via a surgery that reduces the size of the lung), with survival rates and long-term outcomes that are essentially the same as adults.”
For these reasons, the child’s parents argued that the policy arbitrarily discriminated against children under 12 and was contrary to the language and purpose of the National Organ Transplant Act. Because the child’s death was imminent without a transplant, and because the judge found the lawsuit was likely to succeed on the merits, he granted the emergency TRO suspending the policy.
How Unique Was This Case?
For reasons I explain below, this situation (and its current state of resolution) illustrate that the balanced system of medical experts, judges, and government do (sometimes) function well to serve the people they are intended to benefit. However, this case was exceptional in that high-level decisionmakers stepped up and acted quickly. The failure of the medical experts to review and update the policy without the prompting of legislators and a federal lawsuit should be most alarming.
First of all, the Secretary correctly declined to intervene in an individual patient’s case. There is no process for seeking an exception to the OPTN’s policy except by making a request directly to the Secretary to set aside the policy. Although the Secretary declined to issue a waiver, she asked the OPTN to review the policy. Senator Bob Casey (D-PA) wrote to OPTN also asking for immediate review of the policy. In response, the OPTN Executive Committee scheduled a meeting mere days later.
Had the Secretary waived the policy upon request, the waiver would have been perceived as granting a special exception for one individual. Indeed the child’s life is valuable, but a government official should not make a decision that ostensibly declares one person’s life as more valuable than another’s. The determination of the relative priority of organ recipient candidates should be made only by medical professionals and experts with actual knowledge of the circumstances. Instead of making that determination herself, the Secretary asked appropriate experts to conduct an immediate review of the policy and issue a recommendation.
Secondly, if a government agency’s regulation or policy is outdated to the point of being arbitrary or capricious, the federal court system is a proper forum to seek a change of policy. While agencies do update and review their regulations periodically, that process is necessarily time consuming and burdensome. Here, a periodic review of the policy might have altered the “Under 12” policy, but the lawsuit urged immediate action. The result (in this case) was a change in the policy that provided exactly what the lawsuit sought to achieve, and more. In contrast to the highly individual nature of a waiver from the Secretary, the broad policy change affected other children in the same situation. Indeed, one other child was able to benefit immediately from the changed policy instead of seeking his own individual waiver from the Secretary.
Fears that judges and legislators will substitute their own judgment for that of medical professionals as a consequence of this case are unfounded; the experts and physicians were the ones who ultimately changed the policy, and both the Secretary and the federal judge deferred to their judgment.
Hopefully this case will serve either as (1) the first of many lawsuits to challenge and change outdate health policies, or (2) the catalyst for other organizations responsible for developing nationwide health policies to proactively review and update their policies. In addition to providing at least two children with an opportunity to live, this case raises public awareness of the need for organ donors—an unequivocally positive consequence.