In 2023, the Supreme Court paused a district court ruling that would have undone the Food and Drug Administration’s approval of mifepristone (also known as RU-486), a drug used alongside misoprostol to terminate pregnancies. The U.S. Court of Appeals for the Fifth Circuit had partially paused the district court’s decision, leaving in place provisions that would restrict the drug’s availability. A year later the case returned to the Supreme Court, but the matter was unanimously dismissed due to a lack of Article III standing in FDA v. Alliance for Hippocratic Medicine.
Litigation over the FDA’s regulation of mifepristone has continued, and the drug’s manufacturers are once again returning 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 rule permitting mifepristone to be prescribed without an in-person medical visit (i.e., via telemedicine). Finding that Louisiana was strongly likely to prevail on its standing arguments (unlike the AHM case) and that the FDA’s decision to formally authorize telemedicine prescribing was arbitrary and capricious, the Fifth Circuit issued a stay of the rule under Section 705 of the APA.
There are several notable elements to the Fifth Circuit’s order. One is the panel’s adoption of Louisiana’s aggressively argued theory of standing. Louisiana contends it has been injured by the FDA’s order because the availability of telemedicine prescriptions makes it simpler for individuals to skirt Louisiana’s abortion laws (a sovereign injury) and that such prescriptions, fulfilled by mail, lead to medical complications in Louisiana that the state must cover (a financial injury). Both claims appear superficially plausible, yet they pose difficulties under current law.
States can indeed suffer sovereign injuries, such as when federal law preempts a state rule. But nothing of that sort is occurring here. Instead, Louisiana argues that because the FDA permits telemedicine-based mifepristone prescriptions and because those prescriptions can be fulfilled by mail, the regulatory change makes it too easy to bypass Louisiana’s law. I understand the argument, but it seems unlikely under United States v. Texas (an 8-1 decision). The theory would also seem to invite broader standing claims by states. Under this reasoning, California could have standing to sue Texas or the federal government for inadequate gun or pseudoephedrine regulation if others might exploit looser rules to commit improper acts within California.
The financial injury appears to be a more traditional Article III injury, but as stated it seems rather speculative. Louisiana points to two cases where women were treated for complications after obtaining mifepristone from outside the state, with the state bearing the costs. The financial harm is cognizable, certainly, but it is not clear that Louisiana has shown how this harm derives from the FDA’s actions. For standing it is insufficient to identify the harm; the harm must be traceable to the specific challenged action. Here, Louisiana must plausibly allege that these types of complications would not have occurred but for the FDA’s 2023 regulatory change—that these women (and others in their position) would not have obtained mifepristone and experienced the resulting complications without the telemedicine access the FDA approved in 2023—and it is not clear that Louisiana has convincingly made that claim.
The standing analysis is not the sole issue with Louisiana v. FDA. The Fifth Circuit’s order also leaned heavily on some of the now-vacated opinions in the AHM litigation. This is unfortunate, given that those opinions were incomplete in areas beyond standing. As I noted at the end of this post, portions of the Fifth Circuit’s analysis misapplied the relevant administrative-law standards—and I remain quite confident the Supreme Court would have reached the same conclusion had it not dismissed the case on standing. Since the prior decision was vacated for lack of jurisdiction, its conclusions were not binding on the Louisiana panel here, so it is particularly regrettable that they were adopted without further analysis.
By issuing a Section 705 stay of the FDA’s 2023 regulation, the Fifth Circuit’s ruling blocks telemedicine-based prescribing of mifepristone nationwide. While I am not a fan of nationwide injunctions, and I am among the relatively few who reject universal vacatur under the APA, I think this case aligns with the Supreme Court’s Trump v. CASA decision in that it represents a situation where universal relief may be necessary to redress the injuries alleged. If, as Louisiana asserts, its injuries stem from the FDA’s regulation enabling violations of Louisiana law through actions taken in other states, there is no adequate remedy without nationwide relief. So although I personally question the propriety of a stay here, there is a logical basis for its nationwide scope.
On Saturday, mifepristone’s manufacturers—Danco Laboratories (brand-name) and GenBioPro (generic)—each filed applications with the Court seeking interim relief from the Fifth Circuit’s order. Although submitted under extreme time pressure, together they present a compelling case.
Will the justices act on these petitions? I suspect they will, in one form or another (and many critics of the Supreme Court’s “shadow docket” are hoping they will). Not only is the Fifth Circuit’s stay significant in that it blocks a federal regulation nationwide, but the order also creates a circuit split with the Ninth Circuit on the threshold standing issue.
One wrinkle is that we do not yet know the federal government’s position. While the FDA opposed the Fifth Circuit’s stay and is subject to it, and has not rescinded or dissented from the 2023 rule change, it has not (as of this writing) filed any document with the Court. Given the importance of irreparable harm considerations to interim docket decisions, the Solicitor General’s choice 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.
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