On September 25, 2019, the United States Court of Appeals for the Eleventh Circuit affirmed a lower court’s decision to deny a motion for a preliminary injunction to stay the implementation of the new policy for allocating donated livers to transplant candidates in the United States. Callahan v. United States Department of Health & Human Services,No. 19-11876, 2019 WL 4668052 (11th Cir. 2019). The plaintiffs behind the motion, which include liver-transplant candidates and several prominent hospital systems, contend that the new policy is substantively flawed and that HHS failed to follow legally required procedures in adopting it. The Eleventh Circuit found that the plaintiffs’ procedural challenge did not merit a preliminary injunction but sent the case back to the district court to consider whether the substantive challenges warrant injunctive relief. The new policy remains stayed pending that determination.
The current policy for allocating donated livers, which stands to be replaced if the plaintiffs are unsuccessful, was adopted in 2013 by the Organ Procurement and Transplant Network (OPTN)—a private nonprofit entity, appointed by HHS, that is responsible for coordinating the nation’s organ transplant system.
Under the current policy, donated livers are first offered to patients who reside in the same “Region”—11 groups of states—or “Donation Service Area” (DSA)—geographic areas within Regions—where the liver was acquired. Proponents of this system claim that prioritizing candidates within the same Region or DSA enables better communication between the entities that collect the organs and those that perform the transplants. But critics of this system argue that because it relies on territories, donated livers often end up traveling greater distances to less-acute patients.
In December of last year, the OPTN adopted a new methodology for allocating donated livers called the Acuity Circles model. Under this system, organs will be distributed to patients within a 150 to 500-mile radius of the donor hospital, without regard for Regions or DSAs. The OPTN found that the Acuity Circles model would result in “lower waitlist mortality rate[s]” and “more equity in access.” But critics say this new policy will require many more organs to be transported by air to reach their intended recipients, which will purportedly increase the likelihood that the organs will be discarded as unusable.
The Acuity Circles model was originally slated to take effect on May 1, 2019. Before that could happen, the plaintiffs sued HHS and OPTN to challenge the new policy. The complaint alleged that before the Acuity Circles model can take effect, HHS is required by its regulations to refer the model to the Advisory Committee on Organ Transplantation and to publish the model in the Federal Register for public comment. See 42 C.F.R. § 121.4(b). On the substance, the plaintiffs contend that the Acuity Circles model will not promote an efficient management of organs.
Before the district court, the plaintiffs filed a motion for a preliminary injunction to stay the implementation of the Acuity Circles model pending the outcome of their suit. The district court denied the motion because it found that the plaintiffs do not have a substantial likelihood of success on the merits—a perquisite to preliminary injunctive relief. Specifically, the court deferred to HHS’ position that its regulation at § 121.4(b) did not require the agency to refer the Acuity Circles model to the Advisory Committee on Organ Transplantation or publish the model in the Federal Register. However, in deciding the motion, the district court did not consider the merits of the plaintiffs’ challenge that the Acuity Circles model is substantively flawed. The plaintiffs appealed the district court’s decision and requested a temporary restraining order pending the outcome of their appeal, which was granted.
On review, the Eleventh Circuit agreed that the plaintiffs’ procedural challenge does not have a substantial likelihood of success on the merits. The court found that § 121.4(b), by its terms, does not apply to policies like the Acuity Circles model. However, the Eleventh Circuit remanded the case back to the district court to decide whether the plaintiffs’ substantive challenge could support preliminary injunctive relief.
A copy of the Eleventh Circuit’s decision is available here.
