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Mifepristone in the Supreme Court—Comments on Oral Argument (Updated)

Live commentary on the Supreme Court oral argument in FDA v. Alliance for Hippocratic Medicine

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What follows is some live commentary on the Supreme Court's oral argument today in FDA v. AHM, the mifepristone case.

Solicitor General Elizabeth Prelogar began today's oral argument in FDA v. AHM with standing, emphasizing the plaintiffs' argument for Article III standing is based upon an attenuated chain of causation that fails to satisfy the requirements of Article III standing. This was a good start. In turning to the consequences of allowing this suit to go forward, I think it was an error to focus exclusively on the consequences for reproductive choice and women seeking to terminate pregnancies. Allowing standing in this case poses the risk of opening the door to suits against all manner of FDA decisions, such as decisions to approve vaccines (among other things). Courts have generally rejected standing in such suits. Is that really something the Court wants to change?

Asking the first question (as has become traditional), Justice Thomas wants to know, if not these plaintiffs, who could sue to challenge the FDA's approval (a question that Justice Alito picks up later). This is a good question, but there is no constitutional requirement that Article III standing must exist for someone. Put another way, there can be cases in which no one has Article III standing to challenge the federal government's failure to regulate someone else, particularly where (as here) Congress has not created a cause of action or purported to authorize such suits. Under Lujan, the standing inquiry can be eased when Congress has created a procedural right or authorized suit, but it has never done so here. As Justice Thomas notes in response, the plaintiffs may have a stronger argument relying upon some of the Court's associational standing cases (such as Havens Realty, for instance), but I doubt the Court really wants to rely upon that outlier decision. (Indeed, some of us thought the Court was poised to cut back on Havens Realty in Acheson Hotel.) 

Pressed on this point by Justice Alito, SG Prelogar effectively acknowledges that there may not be any specific individual who can sue the FDA for revising ts regulation of mifepristone. The theory the plaintiffs have pressed, she notes, does not come within miles of the requirements of Article III standing as the Court has articulated them in prior cases. Whether there is some other theory out there that might work is not a question the government has to answer.

Asked to distinguish Havens Realty by Justice Barrett, SG Prelogar notes that in Havens Realty there was direct harm to the organization, due to its contractual obligations and the like. In other words, Havens Realty was a far narrower decision than some lower courts have assumed (which is something we saw in the emoluments clause litigation). Prelogar is correct on this point. Havens Realty is not the open door for associations that some circuit courts have turned it into.

While most of the early questioning of SG Prelogar focuses on standing, Justice Alito turns to the merits. Prelogar effectively responds to AHM's claim that FDA failed to adequately consider the potential combination of regulatory changes it made. Then Justice Alito raises the Comstock Act: Should the FDA have considered the statute? No, Prelogar answers, because the Comstock Act is not in the FDA's lane. This is precisely correct. The FDA does not enforce Comstock (and Comstock was clearly unenforceable prior to the Dobbs decision). Put another way, the Department of Justice could enforce the Comstock Act in a future administration, but the FDA was not obligated to focus upon it. Moreover, the FDA relied upon an Office of Legal Counsel memorandum on the enforceability of the Comstock Act.

Justice Kagan asks SG Prelogar whether it is still true that this case marks the first time in which a federal court has second-guessed the FDA's decision to approve a product. It is. No doubt this is largely due to standing. [Note, however, some medical groups did successfully sue the FDA for failing to regulate vaping products more aggressively, which led to some of the FDA's current problems in that area.] The question here is not whether the FDA ever makes mistakes–it certainly does!–but whether these plaintiffs have standing to bring this case.

Justices Barrett, Kagan, and Kavanaugh all raise the issue of whether a doctor's conscience objection is sufficient for standing in a case like this. SG Prelogar maintains that federal law protects the legitimate conscience objections of doctors who object to performing abortions or providing abortion-inducing medications. Moreover, the FDA's loosening of the regulation of mifepristone does not implicate such conscience claims (nor does the remedy that the plaintiffs seek–regulating mifepristone more stringently–does not align with the injury claimed).

Justice Jackson asks an interesting question about whether the Court's resolution of the pending Corner Post could affect this sort of litigation. The Fifth Circuit had found that AHM's claims against the initial 2000 approval of mifepristone was too late. Might an aggressive ruling in Corner Post make such claims viable in the future? Prelogar concedes it might, but notes that the federal government might have other arguments against allowing such stale claims to proceed.

Jessica Ellsworth, Danco's lawyer is now up, and the questioning here focuses a bit more on the merits than standing. Right off the bat, she is challenged on the Comstock Act by Justice Thomas. There are interesting questions here about whether Danco is potentially liable for violating the Comstock Act by distributing mifepristone, but that is not an issue in this case.

Justice Jackson asks Ellsworth about the problems of judges reviewing expert agencies. While it's fair to note that the district court bollixed some of the technical issues below, this is not a helpful line of questioning. There is no reason the FDA should be exempt from traditional arbitrary and capricious review. and such review (done properly) does not require courts to second-guess the scientific judgments of expert agencies. Rather, it calls upon courts to make sure that agencies have engaged in reasoned decision-making.

Justice Thomas begins the questioning of AHM's attorney, Erin Hawley, about standing, focusing on whether AHM's claimed associational harm is anything more than having to spend money to challenge a government decision it does not like. Hawley's answer adopts the broad conception of Havens Realty embraced by many lower courts, and does not appear to satisfy Justice Thomas. Hawley's argument, Thomas suggests, would make standing "easy to manufacture."

Asked about conscience objections, Hawley contests whether existing conscience protections are sufficient for objecting doctors, but is not able to identify anything in any of the declarations demonstrating that doctors have been unable to raise conscience objections where called for. She does note, however, that the federal government may not have been entirely consistent in how it has applied such protections under statutes such as EMTALA. Justice Gorsuch jumps in to underline the point that insofar as conscience harms are alleged, the appropriate remedy would be to provide direct conscience protections, not to restrict the sale or marketing of a pharmaceutical nationwide. (Cue Gorsuch's oft-repeated concerns about the "rash of universal injunctions"—concerns that Hawley does not seem to want to address directly.) Hawley's argument here is, in effect, that the emergency nature of ER work makes raising conscience objections impracticable, and therefore the only relief that can remedy the harm is to limit the use of mifepristone nationwide.

Justice Kagan returns to standing, honing in on the probabilistic nature of AHM's standing claims (an issue I discussed here). Hawley attempts to parry by noting that FDA has acknowledged the possibility of adverse events or needs for doctors in emergency rooms to help ensure patient safety, but as Kagan notes, this does not solve the problem. While AHM has identified specific plaintiffs, none of their declarations show the sort of imminent injury traceable to the FDA's decision to loosen the regulation of mifepristone. Note that even if such claims could be shown, it would be difficult to show that such harms are traceable to the FDA's modification of the regulation of mifepristone, as opposed to mifepristone being available. Other justices pick up on this line of questioning, focusing on what is (and is not) in the declarations.

Justice Alito helps Hawley out by pointing out that the Court has, at times, been a bit lax in enforcing its standing (as in the census case). Hawley responds by leaning heavily into some of the probabilistic claims. She overstates what the record shows (e.g. by suggesting the findings of particular small-gauge studies show what the nationwide effects of changing the regulation of mifepristone will be). I wonder whether any of the justices caught this (or will call her on it).

Justice Kagan presses Hawley on whether any of the harms alleged can be traced to the 2016 and 2021 revisions. Hawley's response is that the revisions increased the likelihood of harm. As I discussed in this morning's post, this is precisely the sort of claim that Clapper and Summers rejected, as it is not clear how the alleged actual or imminent harms claimed by AHM can be traced to the increased quantum of risk allegedly caused by the FDA's loosening of the rules governing mifepristone.

The SG's rebuttal is quite strong and (in my view) strikes a better balance on the various arguments and issues (given the audience that is this Court) than did the tail end of her intro. It really hits standing hard, and emphasizes the systemic effects on FDA regulation more than the reproductive rights angle. This is the sign of a good advocate: Making the arguments that will appeal to the justices, not those that appeal to the administration's political constituencies.

Overall, it seems the justices are quite skeptical of standing here (as they should be).  While some might be concerned that the Court is not consistent in its approach to standing (as Justice Alito was in California v. Texas) it seems like there are likely to be five votes to dismiss this case on standing grounds–as it should.

Note that if this case is dismissed on standing, a future presidential administration would still be able to reconsider the existing regulation of mifepristone or enforce the Comstock Act. Moreover, dismissing this case on standing grounds would do little to buttress the (weak) arguments some are making that federal approval of mifepristone preempts state laws restricting or prohibiting mifepristone's use within their borders. It is also possible that standing to pursue this sort of lawsuit could be facilitated by the enactment of a citizen suit provision authorizing suits against the FDA for improperly approving or revising the regulation of prescription drugs.

Put another way, if this case is resolved on standing grounds, it will be an important standing decision, but it will resolve very little about the broader issue of abortion and the use or availability of mifepristone.

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For those interested, here are my prior blog posts about this case and the issues it raises: