Late this afternoon, two federal district courts—one in Texas, one in Washington state—issued rival rulings in cases involving the FDA’s approval of the abortion drug mifepristone. My initial read is that the rulings don’t conflict and that the Texas ruling would instead render the Washington ruling irrelevant.
1. In Alliance for Hippocratic Medicine v. FDA, federal district judge Matthew Kacsmaryk issued a 76-page ruling that blocks the FDA’s approval of mifepristone. Judge Kacsmaryk has stayed his order from taking effect for seven days to allow the federal government to seek emergency relief from the Fifth Circuit.
I have only quickly skimmed Judge Kacsmaryk’s thorough opinion and offer this guide:
Plaintiff medical associations have standing, both associational (pp. 7-11) and organizational (pp. 11-13), allege injuries that are concreted and redressable (pp. 13-17), and are within the statutory zone of interests (pp. 16-18). Their claims are reviewable and are not untimely or unexhausted (pp. 18-31).
Plaintiffs are likely to succeed on their challenges to the FDA’s 2021 actions (pp. 32-39). Federal law prohibits the mailing of abortion drugs (pp. 32-38), and the FDA’s actions violate administrative law (pp. 38-39).
Plaintiffs are likely to succeed on their challenges to the FDA’s pre-2021 actions (pp. 39-60). The FDA’s 2000 approval violated Subpart H (pp. 39-48), and its pre-2021 actions were arbitrary and capricious (pp. 49-60).
Plaintiffs face a substantial threat of irreparable harm (pp. 61-63), and a preliminary injunction would serve the public interest (pp. 63-65).
An APA stay of the FDA approval is more appropriate than ordering withdrawal or suspension of the approval (pp. 65-66).
2. In Washington v. FDA, federal district judge Thomas Rice issued a 31-page ruling that preliminarily enjoins the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy … in Plaintiff States.” On a quick skim, I’m confused by the lawsuit and the ruling (what do the plaintiff states under Democratic leadership fear that Biden’s FDA might do? is there any real disagreement, or is this a sham suit?), so I will leave it to interested readers to sort out.
I will note that the jurisdictions in which the injunction applies are Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, District of Columbia, Hawaii, Maine, Maryland, Minnesota, and Pennsylvania.