June 13, 2024

Supreme Court Decides Food and Drug Administration v. Alliance for Hippocratic Medicine

On June 13, 2024, the U.S. Supreme Court decided Food and Drug Administration v. Alliance for Hippocratic Medicine, No. 23-235, together with Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, No. 23-236, reversing the decision below and holding that a plaintiff challenging government regulation of someone else lacks Article III standing absent a showing that third parties have reacted, or likely will react, to the government regulation in predictable ways, which in turn have or likely will injure the plaintiff.

In 2000, the federal Food and Drug Administration (FDA) approved a new drug application for mifepristone, a drug which is used for, among other things, terminating pregnancies. In 2016, in response to an application by the drug’s sponsor, Danco Laboratories, the FDA approved labeling changes and relaxed certain of the risk evaluation and management strategies applicable to the drug. In 2019, the FDA approved an application for a generic version of the drug under the same conditions. And in 2021, in connection with the COVID-19 pandemic, the FDA relaxed other risk strategies in both its original and generic forms.

In 2022, four pro-life medical associations and several individual doctors sued the FDA in the U.S. District Court for the Northern District of Texas, challenging the FDA’s initial approval of the drug, as well as its later regulatory actions, on various grounds. After Danco Laboratories intervened, the District Court found the plaintiffs had standing to raise their claims and preliminarily enjoined the sale of the drug. The Supreme Court ultimately stayed the District Court’s order during the pendency of the defendants’ appeals. In reviewing the District Court’s decision, the Fifth Circuit agreed with the District Court that the plaintiffs had standing to pursue their challenge, but disagreed that the plaintiffs were likely to succeed on their merits challenges related to the 2000 and 2019 FDA actions.

The Supreme Court granted review and unanimously reversed the Fifth Circuit’s decision below, concluding that the plaintiffs lacked standing to pursue their claims under Article III of the United States Constitution. The Court reiterated the “bedrock” requirement that “the plaintiff cannot be a mere bystander, but instead must have a ‘personal stake’ in the dispute.” Thus, to have standing to pursue claims in federal court, a party must prove that it: (1) actually has suffered, or is imminently likely to suffer, a particularized, rather than general, injury, (2) which the defendant caused or is likely to cause, and (3) which the requested relief likely will redress.

When a plaintiff challenges government regulation of someone else, as the plaintiffs in this action did, the plaintiff may not rely on speculation about future choices of independent actors to establish standing and instead must show that the government regulation resulted or will result in a “predictable chain of events” that “has caused or likely will cause injury in fact to the plaintiff.” The Court rejected the plaintiffs’ reliance on conscience injuries, which may be sufficient to establish concrete injury for purposes of standing, because the plaintiffs have not shown that the FDA’s decisions caused those injuries in light of broad protections federal law provides for conscience objections. The Court rejected the plaintiffs’ reliance on various economic injuries the plaintiffs alleged they would suffer as too speculative or attenuated to establish that the FDA’s challenged decisions caused them. And the Court rejected the medical association plaintiffs’ assertion of organizational standing, confirming that an organization may not “spend its way into standing” by creating injury through expending money to gather information and advocate.

Because the plaintiffs did not allege the kinds of injuries that the Court’s jurisprudence has identified as sufficient to demonstrate causation, the Supreme Court rejected plaintiffs’ challenge entirely. It remanded the action for further proceedings consistent with its opinion.

Justice Kavanaugh delivered the opinion for a unanimous Court. Justice Thomas concurred.

Download Opinion of the Court

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