In the consolidated cases U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine, the Supreme Court wrestles with an Article III standing issue and whether the Fifth Circuit was correct in rolling back decisions by the U.S. Food and Drug Administration (FDA) related to the availability of abortion medications.

Petitioners are the FDA and a manufacturer of an abortion medication. Respondents are doctors and associations who are against the use and prescription of the medication for various reasons. At issue are two FDA decisions in 2016 and 2021 generally expanding the medication’s approval labeling and conditions of use. In 2022, the Alliance sued, challenging those decisions. The district court concluded that the plaintiffs had standing to bring the claims, and it stayed the FDA’s decisions. The FDA and the manufacturer appealed, and the Fifth Circuit affirmed the district court’s preliminary injunction of the FDA’s 2016 and 2021 decisions.

In their Supreme Court briefs, the FDA and the manufacturer argue that the plaintiffs lack Article III standing to challenge the FDA decisions and that the Fifth Circuit erred in affirming the preliminary injunction because the record shows that the FDA’s decisions were not “arbitrary and capricious.” In response, the plaintiffs argue that they have standing because they are doctors treating patients experiencing abortion-drug complications, making them complicit in the process. They also argue that the Fifth Circuit correctly determined that the FDA failed to engage in reasoned decision-making because it allegedly disregarded certain adverse data.

During oral argument, the Justices mainly focused on standing. Chief Justice Roberts and Justice Thomas questioned who would have standing to challenge the FDA’s decisions and whether some substantial number of incidents was required before the plaintiffs could have standing. Justice Alito questioned whether the FDA’s argument meant that nobody had standing to challenge its decisions and also questioned what kind of harm was required before a person has standing in this type of case. Justice Barrett and Justice Jackson questioned whether the FDA’s decisions implicated conscience protections for doctors (allowing doctors to refuse to provide medical service due to a doctor’s moral beliefs). Justice Gorsuch questioned whether the FDA’s argument could be squared with offended-observer standing under the Establishment Clause.

The case was argued on March 26, 2024. A decision is expected later in the term. Stay tuned for Dykema’s client alert discussing the Court’s forthcoming opinion.

For more information, please contact Chantel Febus, James Azadian, Cory Webster, Christopher Sakauye, Monika Harris, Puja Valera, A. Joseph Duffy, IV., or Heming Xu.