As previously summarized in Dykema’s April 2024 edition, at issue are two FDA decisions from 2016 and 2021 generally expanding the approved labeling and conditions of use for mifepristone. In 2022, the Alliance for Hippocratic Medicine, a group of doctors and associations that oppose its use but do not prescribe or use the drug in treatment, sued the FDA challenging those decisions. The district court found standing to sue and stayed the FDA’s decisions. The FDA and a manufacturer of mifepristone tablets (Danco Laboratories) appealed, and the Fifth Circuit affirmed the district court’s preliminary injunction of the FDA’s 2016 and 2021 decisions.
The Supreme Court disagreed, rejecting all asserted standing arguments. The Court first rejected the argument that the doctors and medical associations had standing based on potential downstream conscience injuries to individual doctors who would be forced to prescribe or use mifepristone despite their beliefs, finding that federal regulations already protected doctors in such situations. Next, the Court rejected the theory that the plaintiffs could assert standing due to the monetary cost and increased liability risks of diverting resources and time away from some patients to treat patients with mifepristone complications, finding that such a causal link was too speculative. The Court also rejected the medical associations’ argument that it had standing because it had incurred costs opposing the FDA’s decisions, reasoning that such costs were not sufficient injury to allege standing. Finally, the Court rejected the argument that standing should be assumed because, absent the assumption, no one would have standing to sue, noting that such instances may be resolved by the political and democratic processes.
In a concurring opinion, Justice Thomas questioned the legitimacy of the Court’s associational-standing doctrine.
Takeaways
- When an agency does not require an association or its individual members to take specific action in response to a regulation, there is no standing to sue the agency, and potential downstream injuries or incurred costs are not enough to establish concrete harm required for standing.
- The Court’s decision means that mifepristone remains available for prescription and use, and the FDA’s regulatory authority to approve or regulate the drug remains intact.
For more information, please contact Chantel Febus, James Azadian, Cory Webster, Christopher Sakauye, Monika Harris, Puja Valera, or A. Joseph Duffy, IV.