224. The Return of the Mifepristone Mess
A Friday night ruling from the Fifth Circuit will have massive, nationwide effects even in states in which abortions are still generally available—unless and until the Supreme Court steps in.
Three years ago, Judge Matthew Kacsmaryk and the Fifth Circuit touched off nationwide chaos when Kacsmaryk purported to block, on a nationwide basis, the FDA’s 2000 approval of Mifepristone—and its subsequent authorization for dispensing it remotely—and the Fifth Circuit refused to stay his (profoundly flawed) ruling pending appeal. (For folks who could use the full background of the regulatory regime at issue in these cases, see my first post on the subject from 2023.)
Back then, the Supreme Court first stayed Kacsmaryk’s ruling itself, and then held on plenary review—unanimously—that the plaintiffs in that case (the “Alliance for Hippocratic Medicine”) had lacked standing.
As Yogi Berra said, it’s déjà vu all over again. Friday afternoon, a three-judge Fifth Circuit panel (Judge Duncan, joined by Judges Southwick & Engelhardt) in Louisiana v. FDA issued a “stay” under the Administrative Procedure Act of the 2021 and 2023 FDA actions that had, between them, first practically and then formally suspended the in-person dispensation requirement. In English, the Fifth Circuit effectively re-imposed a requirement that doctors prescribe Mifepristone only after having examined patients in person. And it did so, overtly, on a nationwide basis. Unless I’m missing something, that ruling—unlike Kacsmaryk’s 2023 ruling—goes into immediate effect.
So long as it remains in effect, Friday’s ruling will make Mifepristone—one of two drugs used for medication abortions, which account for more than 60% of all abortions nationwide—much harder to obtain across the country, and not just in Texas, Louisiana, and Mississippi. (Per the ACLU, “more than 1 in 4 people in the U.S. who have an abortion do so using telemedicine. Without this method of care delivery, patients using Mifepristone would be forced to travel, sometimes hundreds of miles, to a health center just to pick up a pill, a requirement that leading medical authorities agree has no safety benefit.”) It doesn’t just block the dispensation of Mifepristone through the mail; it also blocks patients from being prescribed Mifepristone through telehealth.
The panel’s ruling thumbs its nose at a quarter-century of public health data (which shows that Mifepristone is significantly safer than both Penicillin and Viagra, among other drugs no judge would issue this kind of relief against). It rests on a remarkably stilted view of the process the FDA went through before relaxing the in-person dispensation requirement. For standing, it rests on the remarkably dubious claim that Louisiana is injured because allowing Mifepristone to be dispensed remotely directly causes unlawful abortions in Louisiana—and therefore harms Louisiana, as such. (There’s also an argument about how Louisiana’s Medicaid costs will go up—which not only rests on the same problematic claims about Mifepristone being unsafe but also assumes there’s something more unsafe about Mifepristone that’s prescribed remotely versus Mifepristone that’s prescribed in-person outside of Louisiana and then brought into the state.)
And, most gallingly, the panel’s ruling pays no attention to the other side of the equities—the harm not just to Louisianans, but to people in states in which abortions are generally legal from an order reimposing an in-person dispensation requirement. (I seem to recall some discussion of whether the federal government suffers irreparable harm whenever its policies are blocked. This seems like yet another example of courts being … inconsistent … on that front.)
All of this is to say, the Fifth Circuit is Fifth Circuit-ing again. And although I don’t expect the Trump administration (the nominal defendant in this case) to seek emergency relief from the full court of appeals or the Supreme Court, the two companies that manufacture and distribute mifepristone in the United States (Danco Laboratories and GenBioPro) intervened as defendants in the district court, and will surely pursue such relief at the earliest opportunity. (Given who was on this panel, emergency relief from the full Fifth Circuit may be an uphill battle—and, almost as importantly, might take longer than going right to the Supreme Court.)
This leads to two last points, at least for now:
First, for all of the complaints about nationwide relief both before and after last year’s ruling in the CASA case, here’s the Fifth Circuit not only shrugging off those concerns, but leaning into them—by purporting to rely on the Administrative Procedure Act, rather than the district court’s equitable powers. To be sure, Judge Duncan is correct that CASA specifically distinguished APA relief. But that just leaves nationwide relief available; it does nothing to explain why nationwide relief is appropriate in this case—an omission that is compounded by the court’s refusal to account for the impact of its ruling in its (nominal) balancing of the equities.
Second, here’s yet another revealing example of why folks who are critical of much of the Supreme Court’s behavior on the emergency docket are not actually critical of the emergency docket itself. Despite how criticisms of the emergency docket are often characterized (and caricatured), no one seriously disputes that the Supreme Court should have the power to pause these kinds of lower-court rulings on an emergency basis—that is, a ruling that will have massive and immediate nationwide effects on a huge number of private citizens in a context in which it isn’t remotely clear that the ruling is the right result. The issue isn’t whether the Court should have the power to intervene; it’s how the Court does so.
Indeed, part of what made today’s ruling possible is that the Court’s April 2023 stay said nothing at all—and, thus, expressed no view on the merits of the challenge to the suspension of the in-person dispensation requirement. It’s possible, of course, that even an explanation in April 2023 would’ve rested only on the Alliance for Hippocratic Medicine’s lack of standing—and so we’d be right back where we are now. But last time, the unexplained nature of the Court’s stay left room for the Fifth Circuit to hold that there was standing even after the justices’ first intervention (which was a big part of why I was, and remain, critical of the way the Court granted that earlier stay—if not the result the Court reached). Maybe this time around, the Court will be impelled to say more than nothing—so that the message doesn’t get lost again.
Either way, it stands to reason that this emergency application will be making its way to the Supreme Court sooner, rather than later.
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I’m an old man. I remember when judges (and justices) ruled for people … not procedure.
Your analysis surfaces something most coverage misses: Louisiana is the plaintiff claiming harm, and FDA has declined to defend its own rule on the merits. That leaves the manufacturers of mifepristone — Danco and GenBioPro — as the de facto defenders of reproductive access. But they’re defending their distribution model and their revenue, not women’s rights. Those interests converge here, and as a woman, I’m glad they do. What’s troubling is how contingent that convergence is — and how much reproductive access now depends on the commercial incentives of pharmaceutical companies rather than on any government actor willing to say that access itself is worth defending.