Wrangle Over Changes to Liver Transplant Policy Lands Before 11th Circuit

MONTGOMERY, Ala. (CN) – An 11th Circuit panel heard arguments Thursday over a proposed policy change that would affect how patients on the liver-transplant waiting list would receive their new, life-saving organs.

(AP Photo/Molly Riley)

The plaintiffs in the case, which include four patients who are currently on the waiting list and multiple hospitals that operate liver-transplant programs, filed suit in Georgia federal court in April seeking to block the implementation of the new organ-allocation policy.

Included among the plaintiff hospitals are Emory University Hospital, Henry Ford Health System, Indiana University Health, Oregon Health & Science University, Vanderbilt University Medical Center and others.

In their original complaint, the plaintiffs accused the U.S. Department of Health and Human Services (HHS) of failing to follow “legally required procedures in developing the policy, instead choosing to defer virtually all decision-making to a private government contractor.”

The contractor in this case is the nonprofit United Network for Organ Sharing, acting as the Organ Procurement and Transplantation Network.

Along with their complaint, the plaintiffs filed a motion for a temporary restraining order, which was denied in May by U.S. District Judge Amy Totenberg.

In denying the motion, Totenberg said the regulatory language at issue was “susceptible to two interpretations, one of which, supports, at least minimally, HHS’ view as to when the formal procedures contemplated in section (b)(2) are required to be utilized.”

Arguing for the plaintiffs on appeal Thursday morning, attorney Courtney Carrell contended it was the Health and Human Services secretary’s obligation to act to ensure compliance with the law, stating it is “inappropriate to defer” and that the regulatory language is “unambiguous in plaintiff’s favor.”

In the original complaint, the plaintiffs claim the new policy was adopted in “unwarranted haste” and that the secretary’s failure to act was in violation of the Administrative Procedures Act.

“The government has a responsibility,” Carrell said on Thursday.

Countering that argument, an attorney for Trump adminstration said the plaintiffs’ position “would upset the balance … by removing the secretary’s discretion.”

An attorney for the United Network for Organ Sharing, Linda Coberly, also emphasized the secretary’s discretion and stated that “no policy has gone through the (b)(2) process.”

According to the plaintiffs’ complaint, Section (b)(2) requires the secretary to refer “significant proposed policies” to an advisory committee and to publish them in the Federal Register.

The attorneys’ competing arguments may not get very far, however, as U.S. Circuit Judge Charles Wilson consistently pushed back on the issue of whether the court has subject matter jurisdiction over the case.

Wilson specifically questioned how the court could have subject matter jurisdiction if the policy at issue does not amount to a final agency action.

After the attorney for the intervenor-defendants suggested the panel should affirm Judge Totenberg’s decision to deny injunctive relief, Wilson noted he was still “hung up” on subject matter jurisdiction.

Joining Wilson on the panel were U.S. Circuit Judge Kevin Newsom and U.S. District Judge L. Scott Coogler, sitting by designation from the Northern District of Alabama. Wilson was appointed by Bill Clinton, Newsom by Donald Trump and Coogler by George W. Bush.

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