Assessing the Legal Claims in Alliance for Hippocratic Medicine v. FDA

There's been lots of heat, but very little light in coverage and commentary about the lawsuit seeking to revoke FDA approval of mifepristone.

Last fall, the Alliance for Hippocratic Medicine (AHM) filed a lawsuit against the U.S. Food and Drug Administration seeking to force a revocation of the FDA's approval of mifepristone, a drug that is widely prescribed to terminate pregnancies (i.e. to perform a "medication abortion").

This lawsuit has generated substantial commentary, but very little legal analysis. Articles warn that a single federal judge in Texas could ban a common abortion drug, and cast all sorts of aspersions on that judge before he has issued a single ruling in the case, but few identify, let alone discuss, the legal questions that will determine the outcome of the case. Like most legal controversies touching abortion, everyone knows what side they are supposed to be one given their views of the underlying subject matter, and few have stopped to consider what the law has to say about how this case should be resolved.

As most of the underlying legal issues in AHM v. FDA concern administrative law -- and have nothing directly to do with whether the FDA properly approved mifepristone, let alone whether abortifacient drugs should be available, I figured it was worth taking a deep dive into the case. Fortunately, Adam Unikowsky, a former Scalia clerk who is now a partner at Jenner & Block, has already done such a dive.

Unikowsky has a post on substack, "Mifepristone and the Rule of Law," analyzing AHM's claims. Here is how it begins:

In 2000, the FDA approved a drug known as mifepristone for purposes of terminating pregnancies through 49 days' gestation. The FDA concluded that mifepristone, when used in conjunction with a different drug called misoprostol, was safe and effective, and that the benefits of mifepristone exceeded the risks.

In November 2022, a group of plaintiffs, led by the Alliance for Hippocratic Medicine, filed a federal lawsuit in the Northern District of Texas seeking to overturn the FDA's approval of mifepristone and force mifepristone off the market. The plaintiffs have filed a motion for a preliminary injunction, which is currently pending in the district court.

This lawsuit has gotten considerable attention from the press. Many articles have accused the presiding district judge of being biased based on his legal advocacy before his appointment as well as second-hand descriptions of his personal views. I view these attacks as inappropriate and unfair: the judge was entitled to represent whatever clients he wished before ascending the bench, and I see no basis for believing that the judge will act in bad faith in this case or any other.

I would prefer that commentary focused on the legal merits of the lawsuit, and that will be the subject of this post. Cutting to the chase: the plaintiffs' legal theory is remarkably weak. Basic principles of administrative law, having nothing to do with abortion, squarely foreclose the plaintiffs' claims.

I will not venture a prediction on how the Northern District of Texas or the Fifth Circuit will rule. If the plaintiffs prevail in those courts, however, the Justice Department is likely to seek emergency relief from the Supreme Court. In my view, the Justice Department will likely prevail. If the subject matter of this case were anything other than abortion, the plaintiffs would have no chance of succeeding in the Supreme Court. The plaintiffs are banking on the hope that because this is a case about abortion, the Court will bend ordinary principles of administrative law. I predict it will not.

There are at least four problems with the plaintiffs' suit:

• The plaintiffs' theory of standing is irreconcilable with Supreme Court precedent.
• The statute of limitations has expired on plaintiffs' challenge to the FDA's approval of mifepristone. The plaintiffs claim that the FDA "constructively reopened" that approval in 2016, thus restarting the statute of limitations, but that's clearly wrong.
• The plaintiffs did not exhaust their claims, even though a regulation explicitly required them to do so.
• Although the plaintiffs claim that the FDA's actions are contrary to the Food, Drug, and Cosmetic Act (FDCA), the plaintiffs have failed to identify any particular provision of the FDCA that the FDA has actually violated.

The full post is here, and I recommend it because it is quite thorough.

I largely agree with Unikowsky's assessment of the legal merits of AHM's claims. Without making any predictions about how the case will turn out, I think it fairly clear that the plaintiffs have severe jurisdictional hurdles to overcome under existing law, and that they have failed to make their case on these questions. Like so many policy-oriented lawsuits, administrative law should control the outcome.

Unikowsky devotes substantial space to the threshold issue of standing and makes a powerful argument that the plaintiffs' allege precisely the sort of speculative injuries the Court held were insufficient in Clapper v. Amnesty International. He argues that to allow this case to go forward would, in effect, allow groups of doctors to challenge any agency decision that could conceivably result in an increase in injuries among an identifiable group of people. These objections are well-taken, and are not meaningfully addressed by AHM. Asserting that "Plaintiffs have standing six ways from Sunday," as AHM does in its reply brief, is not much of an argument. I would add that some of AHM's standing arguments are quite similar to those made by CREW in seeking to raise emoluments clause claims against then-President Trump, and I do not mean the comparison as a complement.

Standing is a serious obstacle to AHM's lawsuit, but it is hardly the only one. Another problem for AHM is making the case that a court, in 2023, should revisit a decision initially made by the FDA in 2000, and revised in 2016, when the statute has a six year statute of limitations. AHM tries to get around this with a creative and aggressive invocation of the reopener doctrine, under which (in certain limited circumstances) an agency can be said to have "reopened" a prior decision, thus allowing parties to reach back and challenge the prior decision in the context of a contemporary dispute. The problem is that the relevant caselaw on when and where this doctrine applies does not provide much support for AHM's specific claims, nor can AHM effectively appeal to the reopening doctrine's purpose of ensuring adequate opportunities for judicial review, as AHM had ample opportunity to challenge the FDA's prior actions.

It is difficult to maintain that the FDA has "reopened" a prior drug approval decision any time it considers a petition seeking a revision or modification of the rules governing a particular medication. Further, to treat all such actions as "constructively reopening" prior drug approval decisions would introduce tremendous uncertainty into the FDA's drug approval regime. Combined with AHM's expansive standing arguments, allowing AHM's claims to go forward would create open season on all manner of previously approved pharmaceuticals that one activist group or another decides to target. Fortunately, no such move is legally warranted.

The FDA determined that mifepristone is safe and effective when used as directed and has seen no reason to revisit that conclusion. AHM and its co-plaintiffs contest that view. Whether one agrees with the FDA or AHM on whether it is a good idea for mifepristone to be widely available, there is little doubt about how the underlying legal issues in AHM v. FDA should be resolved. The barriers to this suit are substantial, and AHM's attempts to surmount them are wholly unpersuasive.