Late yesterday, a district court docket in Texas issued its much-anticipated ruling in Alliance for Hippocratic Medicine v. Food and Drug Administration, a problem to the FDA’s approval of the abortion medicine mifepristone, which has been available on the market for over 20 years. As some hoped and others feared, the court docket dominated in opposition to the FDA, concluding that mifepristone shouldn’t be an accredited medicine.
By an incredible coincidence, a second district court docket, this one in Washington State, issued its own ruling in a competing mifepristone lawsuit quickly after the Texas resolution, issuing an order barring the FDA from altering the standing of mifepristone, a minimum of within the plaintiff states. (Apparently sufficient, this isn’t the one time we have seen dueling opinions on a high-profile health-law query issued on the identical day. The identical factor occurred with Halbig v. Burwell and King v. Burwell in 2014, creating a circuit split in a matter or hours. Go determine.)
I previewed a few of the arguments in every case in prior posts. Here and here I defined why the district court docket in Texas lacked jurisdiction to listen to AHM’s claims in opposition to the FDA. Amongst different issues, the plaintiffs lack standing, didn’t file inside the related statute of limitations, and didn’t exhaust their administrative choices. Nothing within the district court docket’s opinion modifications my view of those arguments. If something, it reinforces them. Amongst different issues, the court docket makes clear that the conclusion that AHM satisfies Article III standing necessities rests on outlier selections like Havens Realty (which the Supreme Courtroom could take into account overturning, or simply abandoning, subsequent time period), which progressive teams like CREW tried to make use of of their emoluments litigation.
Moreover, the opinion’s embrace of an expansive conception of equitable tolling and refusal to implement the executive exhaustion requirement relaxation on essentially the most gossamer of threads—the evaluation reads extra like what one would count on in a time-limited law-school examination than a thoughtfully thought-about judicial opinion. And the invocation of Part 705 of the Administrative Process Act to justify the bizarre treatment of issuing a keep of the FDA’s 2000 approval of mifepristone is simply too intelligent by 5. It doesn’t matter what one thinks of abortion or the supply of mifepristone, this opinion is tough to defend (and that is with out stepping into the deserves of the problem).
Because it occurs, the second resolution isn’t any higher. For causes I defined here, the plaintiff states in that case face equal jurisdictional hurdles in demonstrating standing and exhaustion, significantly insofar as they have been suing to keep up the established order (versus difficult the FDA’s present mifepristone guidelines as too restrictive). The Washington district court docket barely engages these arguments, waiving them away with conclusory statements unaccompanied by any significant evaluation. It is sufficient to make a cynical observer suppose that the opinion was rushed for launch, maybe explaining the coincidental timing. Regardless of the faults of the Texas ruling—and there are a lot of—a minimum of there’s substantive evaluation to critique. The Washington resolution is extra like a punt. Its one saving grace is that it doesn’t try to justify nationwide aid and as an alternative limits the impact of its injunction to the plaintiff states.
The place does this all depart us? The Texas resolution stayed the efficient date FDA’s 2000 approval of mifepristone—in impact suspending the approval (with a caveat that it might revoke the approval if the U.S. Courtroom of Appeals for the Fifth Circuit disapproves of the court docket’s use of APA Part 705 in one other case), however has additionally stayed the efficient date of the choice by seven days to afford the federal government time to attraction. In the meantime, the Washington resolution has enjoined the FDA from “altering the established order” regarding its regulation of mifepristone as of the FDA’s January 2023 guidelines governing prescription and distribution of the drug inside the plaintiff states. Thus, a minimum of inside these states, we would seem to have dueling injunctions (as happened with the DACA litigation), nearly guaranteeing fast motion from appellate courts, if not the Supreme Courtroom itself.
I hope to have extra to say about each of those selections shortly, time allowing.