Photo of Eric Alexander

Lawyers really like to be right.  This dive into the latest on reproductive rights in the context of challenges to FDA’s regulation of a prescription medication is an instance where we wish we had not been right with some of our predictions.  Back when the Dobbs decision had been leaked but not yet issued, we offered that the decision would open the door to a range of challenges to FDA-approved drugs for medical abortion and emergency contraception, along with a wide range of other regulated medical products.  Immediately after the decision came out, we did a more thorough analysis on the arguments for preemption of state actions against FDA-approved drugs for medical abortion.  The last ten months have seen a flurry of legislation, litigation, and executive and administrative actions related to medication abortion.  We will not attempt to recap that flurry; there are many resources that track it, along with other developments related to reproductive rights and reproductive health.

We cannot resist, however, addressing the case that is heading up the appellate chain the fastest.  The chain does not get higher than the Supreme Court, which has already weighed in with a temporary stay of a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.  The full cite for this mess is Alliance for Hippocratic Med. v. FDA, ___ F. Supp.3d ___, 2023 WL 2825871 (N.D. Tex. Apr. 7, 2023), stayed in part, ___ F.4th ___, 2023 WL 2913725, 2023 U.S. App. LEXIS 8898 (5th Cir. Apr. 12, 2023), temporarily stayed, FDA v. All. for Hippocratic Med., ___ S. Ct. ___, 2023 WL 2942266 (U.S. Apr. 14, 2023).  Because the appellate decisions are only on the issue of staying the district court’s decision and because there is a conflicting decision from another federal district court in Washington v. FDA, ___ F. Supp.3d ___, 2023 WL 2825861 (E.D. Wash. Apr. 7, 2023), clarified, 2023 WL 2941567 (E.D. Wash. Apr. 13, 2023), we will be seeing other appellate action soon.

If you were counting along, then you would have noticed five separate decisions in the course of one week.  A sixth issued on April 19, 2023, when the Supreme Court extended the stay by 48 hours.  We are going to focus on the Fifth Circuit’s decision assessing the likelihood that FDA and the other defendants will prevail on the merits.

The first thing to understand is that the plaintiffs in AHM (we briefly considered calling it Hippo. and drawing comparisons to the Escobar hippopotamuses causing havoc in Colombia) are individuals and private entities, so preemption is not as front and center as with more direct state action, like a legislative ban on an FDA-approved medication.  State action is lurking in plaintiff’s arguments and what they seek, but we will shelve the preemption discussion.  The Fifth Circuit certainly did not mention preemption, the Supremacy Clause, the Commerce Clause, or the dormant Commerce Clause, among a number of implicated constitutional issues.  Hell, it not even discuss Dobbs, except in a footnote referencing an obscure footnote on third-party standing.  Before we dive in, we suggest a thought exercise where the subject was a class of FDA-approved medications intended for the treatment of type 2 diabetes or obesity, for example, instead of for medical abortion.  Many of those drugs have REMS (risk evaluation and mitigation strategies) in place, have had citizen’s petitions calling for their withdrawal denied, etc.  Some individuals and private entities, or perhaps judges, might have beliefs that these conditions should not be treated, perhaps based on a religious viewpoint that they result from sinful gluttony.  There is no specific substantive due process right to medical treatment for these conditions, let alone one recognized when the Fourteenth Amendment was ratified.  Are you with us?  Even in that scenario, we cannot envision the sort of results-driven and shoddy analysis seen in the AHM decisions.  We also cannot imagine that an appellate court would use loaded language when purporting to give facts like the approved indication for the drugs.  (We will not dwell on the latter bit on disbelief, but compare the language in the AHM decisions with the terms used in the FDA documents, which are publically available.)

The district court decision in AHM “would have the practical effect of an injunction because it would remove mifepristone from the market.”  Even in the context of a veiled injunction, the bar for a stay is high, reserved for “extraordinary circumstances.”  The four factors are:

1) whether the stay applicant has made a strong showing that he is likely to succeed on the merits; (2) whether the applicant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.

As to the first factor, FDA—which we use to cover all the stay applicants—argued only standing, the six-year statute of limitations for cases against the United States, exhaustion, and that FDA did not violate the Administrative Procedures Act.

Standing in the constitutional sense is a matter of a legally cognizable injury caused by the defendant that can be redressed in the lawsuit.  The Fifth Circuit held that the individual doctors had standing because of three purported injuries due to a perceived weakening of the REMS requirements over time.  (The entities also had standing because some of their members did.)  Not due to the approval itself.  It seemed that the post-suit change to the REMS that removed the requirement of in-person dispensing of the drug was considered fully in the standing analysis, which is supposed to look to standing at the time the suit was brought.  When you put it together, the plaintiffs who wanted to invalidate the drug’s approval had standing only because the current REMS was not strict enough.  That is unusual.  The identified injuries were even more unusual in light of the lack of standing to challenge approval.  The first injury was that the doctors would have to provide emergency care for some number of women because of “unsuccessful chemical abortions.”  (Yes, emergency care for complications during unintended pregnancies and “illegal” abortions will surely be required too.)  The second injury was stress to physicians from “treating these women.”  (Even our restrained comments do not fit in a parenthetical.)  The third and most ludicrous injury was “the irreconcilable choice between performing their jobs and abiding by their consciences.”  (See above.)  The court tried to disclaim that its broad interpretation of injury to find standing had the implications it obviously had:

We do not hold that doctors necessarily have standing to raise their patients’ claims. We do not hold that doctors have constitutional standing whenever they’re called upon to do their jobs. And we do not hold that doctors have standing to challenge FDA’s actions whenever the doctor sees a patient experiencing complications from an FDA-approved drug. Rather, we hold that on the record before us applicants know that hundreds of thousands of women will-with applicants’ own statistical certainty-need emergency care on account of applicants’ actions.

Here is one of the problems, and it ties to why doctrines like preemption and primary jurisdiction—also not discussed—exist.  FDA is charged by Congress with advancing public health.  Although the AHM court acknowledged that FDA has “the responsibility to ensure that ‘new drugs’ are ‘safe and effective,’” it missed the broader context of that responsibility.  Going back to our thought exercise, there is a statistical certainty that a significant number of one million people with type 2 diabetes will suffer complications requiring emergency medical care in the absence of effective treatment.  There is also a statistical certainty that a significant number of one million people with type 2 diabetes who take any approved diabetes medication will suffer complications requiring emergency medical care due to their treatment.  The FDA’s job is to balance risks and benefits on a population basis.  Individual healthcare providers are supposed to do that for each individual patient they have, but they tend not to be very good at appreciating the overall public health calculus.  FDA did this calculus when it approved mifepristone and each type 2 diabetes drug.  It does this calculus each time it considers imposing or updating a REMS.  That is why, with very narrow exceptions, a healthcare provider or patient declaring “I disagree with FDA on XYZ” should not bestow standing or form the basis of a lawsuit.

The discussion of the statute of limitations was better, mostly because it rejected weak arguments the district court accepted in allowing a challenge to the 2000 approval of the drug in a lawsuit brought in 2022.  Subsequent actions within six years of the suit, such as rejecting citizen’s petitions or revising a REMS, did not “reopen” the original approval.  Equitable tolling also did not apply because the plaintiffs could have brought the suit earlier.  (Here, Dobbs might have been raised by the plaintiffs as opening the door to the lawsuit they brought six months after the decision was issued.)  Because of the posture, though, the challenges to the 2000 approval and other older FDA actions are not out of the case for good.

We can dispense with the exhaustion analysis because we find it, well, exhausting, albeit it short.  The APA analysis is more interesting and focused on the non-time-barred actions by FDA.  Whereas a plaintiff in an APA suit has the burden of proving that an agency’s action were arbitrary and capricious, which has a very high bar, the AHM court viewed the burden in this context to be on FDA to show that its actions were not arbitrary or capricious.  Notably absent from the discussion of applicable law was Chevron deference, including the more recent decisions in Kisor and Am. Hosp. Ass’n.  With the burden flipped and no deference, the court quickly concluded that FDA had not carried its burden.  Again, without any consideration at all of the broader health implications, the court found that FDA had not evaluated the overall impact of its 2016 REMS change and adopted an “ostrich’s-head-in-the-sand approach” to adverse event reporting in that same REMS change.  None of the other timely challenged FDA actions were discussed, including the 2019 approval of the ANDA for the currently marketed version of the drug.  Put a pin in that.

The court found no irreparable harm to FDA in invalidating 2016 and later REMS changes because “the world operated under the 2000 Approval for sixteen years, apparently without problems.”  All of those years were with Roe and its progeny as the law of the land (but not the whole world).  By contrast, the same convoluted arguments that the plaintiffs were and would be injured under 2016 and later REMS were dispositive on the third factor.  The public interest factor was something of an afterthought given the other conclusions and included a punt on the implications of the Comstock Act.  It did include, however, an acknowledgement (“credit their showing”) that compelling FDA to remove mifepristone from the market—relief the court had already concluded was likely time-barred—would entail “injury to pregnant women, to public healthcare systems, and to the sense of order that governs FDA drug approvals.”  As we have noted, these considerations were noticeably absent from the rest of the decision.

The end result is that a stay of the district court’s decision was entered as to the 2000 approval of mifepristone, but not as to “FDA’s Major REMS Changes and all subsequent actions.”  If you follow the court’s analysis, though, it seems that only the challenge to the 2016 REMS and not to “all subsequent actions,” including the ANDA approval in 2019, checked all the boxes.  The temporary stays from the Supreme Court cover the entire district court order, but that does not mean an expansion of the stay will stick.  While we certainly think the entire lawsuit is without merit, FDA’s approval of an ANDA should not be second-guessed like this and the Fifth Circuit’s failure to stay the order as to that approval is a real problem.