Mifepristone Returns to the Shadow Docket

In 2023, the Supreme Court stayed a district court order undoing the Food and Drug Administration’s approval of mifepristone (aka RU-486), a medication used (in combination with misoprostol) to terminate pregnancies. The U.S. Court of Appeals for the Fifth Circuit had partially stayed the district court’s decision, but had left portions that would have restricted mifepristone’s availability in place. One year later the case returned to the Supreme Court, only to be dismissed unanimously due to a lack of Article III standing in FDA v. Alliance for Hippocratic Medicine.

Litigation over the FDA’s regulation f mifepristone has continued, and the drug’s manufacturers are once again headed to One First Street seeking interim relief.

On Friday, in Louisiana v. FDA, a unanimous panel of the U.S. Court of Appeals for the Fifth Circuit stayed the FDA’s 2023 regulation allowing mifepristone to be prescribed without an in-person medical visit (i.e. through telemedicine). Concluding that Louisiana was strongly likely to prevail in its arguments that it had standing (unlike AHM) and that the FDA’s decision to formally allow prescribing mifepristone via telemedicine was arbitrary and capricious, the Fifth Circuit entered a stay of the rule under Section 705 of the APA.

There are quite a few notable aspects to the Fifth Circuit’s order. One is that the panel embraces Louisiana’s quite-aggressive arguments for standing. Louisiana claims to be injured by the FDA’s order because the availability of prescription-via-telemedicine makes it easier for individuals to circumvent Louisiana’s abortion laws (a sovereign injury) and (the state claims) results in medical complications in Louisiana that the state has to pay for (a financial injury). Both arguments seem superficially plausible, but are nonetheless problematic under current law.

States can undoubtedly suffer sovereign injuries, such as when federal law preempts an otherwise lawful state law. But nothing of the sort is occurring here. Rather, Louisiana is claiming that because the FDA allows individuals to get mifepristone prescriptions through telemedicine, and because such prescriptions can be fulfilled by mail, the FDA’s regulatory change makes it too easy to circumvent Louisiana’s law. I get the argument, but it seems implausible under United States v. Texas (an 8-1 decision). The argument would also seem to open the door even wider to aggressive state standing claims. Under this theory, California would have standing to sue Texas or the federal government for the inadequate regulation of guns or sudafed because other people might take advantage of less stringent regulation to commit bad acts in California.

The financial injury looks like a more traditional Article III injury, but as pled it looks awfully speculative. Louisiana points to two cases in which women were treated for complications caused by mifepristone obtained from out-of-state and the state had to foot the bill. The financial impact is a cognizable injury, to be sure, but it’s not clear to me Louisiana has explained how this is attributable to the FDA’s actions. For standing it is not enough to identify the harm. The harm must be traceable to the specific action challenged. Here that means that Louisiana has to plausibly allege that these sorts of complication would not have occurred but for the FDA’s 2023 change to the regulations governing mifepristone–that these women (and others in their position) would not have obtained mifepristone and suffered the resulting complications without the access to telemedicine the FDA authorized in 2023, and it’s not clear to me Louisiana has plausibly made that claim.

The standing analysis is not the only problem with Louisiana v. FDA. The Fifth Circuit’s order also heavily relied upon some of the since-vacated opinions in the AHM litigation. This is unfortunate, as the analysis in those opinions was wanting–and not just on standing. As I explained at the tail end of this post, portions of the Fifth Circuit’s analysis misapplied the relevant administrative law standards–and I am quite confident the Supreme Court would have found as much had it not kicked the case on standing. As the prior decision was vacated for lack of jurisdiction, its conclusions were not binding on the Louisiana panel here, so it is particularly unfortunate that they were adopted without any additional analysis.

By entering a Section 705 stay of the FDA’s 2023 regulation, the Fifth Circuit’s decision blocks the prescription of mifepristone via telemedicine nationwide. Although I do not like nationwide injunctions, and am one of the few who rejects universal vacatur under the APA, I believe this case is consistent with the Supreme Court’s Trump v. CASA decision, in that it is the sort of case in which universal relief may be necessary to redress the injuries alleged. If, as Louisiana claims, it is injured because the FDA’s regulation facilitates the violation of Louisiana law through actions taken in other states, there is no way to adequately redress Louisiana’s injuries without providing nationwide relief. So while I do not think a stay was warranted here, there is a logic to the stay’s nationwide scope.

On Saturday, mifepristone’s manufacturers–Danco Laboratories (name brand) and GenBioPrio (generic)–each filed applications with the Court seeking interim relief from the Fifth Circuit’s order. Although each of these filings was produced under tremendous time pressure, together they make a strong case.

Will the justices act on these petitions? I suspect they might, in one way or another (and that many critics of the Supreme Court’s “shadow docket” are hoping they will). Not only is the Fifth Circuit’s stay quite significant in that it blocks a federal regulation nationwide, the order creates a circuit split with the Ninth Circuit on the threshold issue of standing.

One wrinkle is that we do not yet know what the federal government’s position will be. Although the FDA opposed and is subject to the Fifth Circuit’s order, and has yet to rescind or disavow the 2023 rule change, it has not (as of this writing) filed anything with the Court. Given the importance of irreparable harm to the government tends to play in interim docket decisions, the Solicitor General’s decision whether to support the drug makers, or perhaps to support certiorari before judgment on the standing question, could be influential.

Stay tuned.

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Here are links to my posts on the prior mifepristone litigation:

• “The Next Abortion Battlegrounds,” June 22, 2022;
• “Assessing the Legal Claims in Alliance for Hippocratic Medicine v. FDA,” March 8, 2023;
• “AHM v. FDA: A Contrary View and a Rejoinder,” March 28, 2023;
• “Blue-State AGs Have A Mifepristone Lawsuit of Their Own,” March 29, 2023;
• “Two (Wrong) Mifepristone Court Rulings in One Day,” April 8, 2023;
• “The Good and Bad of the Fifth Circuit’s Abortion Pill Ruling,” April 13, 2023.
• “BREAKING: Supreme Court to Consider Fifth Circuit’s Abortion Pill Decision,” Dec. 13, 2023.
• Supreme Court Denies Red State Effort to Intervene in Mifepristone Case, Feb. 20, 2024.
• Can Emergency Room Doctors Sue the FDA for Failing to Regulate Mifepristone More Aggressively?, Mar. 26, 2024.
• Mifepristone in the Supreme Court—Comments on Oral Argument (Updated), March 26, 2024.
• Who Can Sue the FDA?, April 2, 2024.
• Unanimous Supreme Court Finds No Standing to Challenge FDA Regulation of Mifepristone (UPDATED), June 13, 2024.
• Struggling with Standing, July 30, 2024.
• Alliance for Hippocratic Medicine on Remand – Still Struggling with Standing, Sept. 17, 2024.