Fifth Circuit rules for mifepristone limits, but drug remains available on current terms by SCOTUS order

The appeals court would revert to pre-2016 limits on mifepristone, but, under April's SCOTUS order, nothing changes about limits on the drug's availability.

On Wednesday afternoon, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit issued its ruling Wednesday in the high-profile challenge to the U.S. Food and Drug Administration’s approval of the abortion medication drug mifepristone and subsequent loosing on restrictions for use of the drug.

Although the appeals court would make access to the drug more restrictive, including by requiring in-person dispensing again, an earlier U.S. Supreme Court order means that the ruling does nothing to change mifepristone’s accessibility. The drug remains available on current terms.

First things first: Nothing immediately changes about the accessibility of mifepristone or the terms under which it can be used due to Wednesday’s ruling. This is due to the U.S. Supreme Court’s April order effectively halting any implementation of lower court orders in the case until the Supreme Court has a chance to review them. As such, the abortion medication drug remains available on the terms in place before the U.S. District Judge Matthew Kacsmaryk issued an order purporting to remove approval of the drug.

What happened: The extremely conservative appeals court that includes Texas, Mississippi, and Louisiana heard the appeal of that preliminary ruling from Kacsmaryk and issued its opinion Wednesday.

In a 2-1 ruling, the court held that challenges to mifepristone's initial approval and to the generic approval will likely fail, for differing reasons. On those two parts of the challenge, the court tossed out Kacsmaryk’s order, which has been widely criticized. “We vacate the component of the order that stayed the effective date of the 2000 Approval and the 2019 Generic Approval,” Judge Jennifer Walker Elrod wrote for the majority.

The court also, however, ruled that challenges to changes loosening restrictions on the use of the drug since 2016 will likely succeed. On that front, then, it affirmed Kacsmaryk’s ruling. Specifically, Elrod wrote, “We affirm the portions of the stay order regarding the 2016 Amendments and the 2021 Non-Enforcement Decision.”

The opinion, if allowed to go into effect, would mean mifepristone remains on the market, but subject to restrictions that would make access very difficult for many in a post-Roe nation. Under the Supreme Court’s order, the Fifth Circuit’s decision would go into effect either if the Supreme Court doesn’t take up the case on appeal or if it takes the case and affirms the Fifth Circuit.

Elrod, a George W. Bush appointee, was joined in the majority by Judge Cory Wilson, a Trump appointee. Judge James Ho dissented in part from the majority in order to explain that he would have affirmed Kacsmaryk’s order in full — including purporting to halt approval of mifepristone altogether.

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In depth

In the majority opinion, the court first found that the organization of doctors suing, in part, due to their opposition to abortion had associational standing to do so as to the FDA’s 2000 approval and the later loosening of restrictions. The appeals court — like Kacsmaryk below — held that the doctors’ group sufficiently showed that their members are “reasonably likely to be harmed” in the future due to the fact the some people who take mifepristone have adverse medical effects requiring follow-up medical care and some of their members are “fairly likely” to treating such people.

The Fifth Circuit did not, however, find that the challengers showed likely injury from the generic approval. As such, that claim was tossed on standing grounds and that part of Kacsmaryk’s order was vacated.

With that, the appeals court considered the initial 2000 approval and the later loosening of restrictions in 2016 and 2021.

As to the 2000 approval, the panel majority found that the challenge was untimely. As Elrod stated as to one of the challengers’ rationales for why the far-removed challenge should be allowed, “[T]he Medical Organizations and Doctors offer no reason why they could not have filed their lawsuit within the six-year limitations period.” That decision ended the appeals court’s consideration of the claim, leading it to vacate that part of Kacsmaryk’s order as well.

The challenges to the 2016 and 2021 changes loosening the restriction were timely. As such, the court actually got to the merits of those claims. When it did, the court held that the challengers were likely to succeed in their claims that the changes violated the Administrative Procedure Act.

As to the 2016 changes, Elrod wrote for the court that the FDA violated the APA because it “failed to address the cumulative effect [of the changes] at all. At a minimum, the agency needed to acknowledge the question, determine if the evidence before it adequately satisfied the concern, and explain its reasoning.” It was not clear where Elrod pulled this standard from, and I suspect that we will see significant pushback in DOJ’s further filings about this standards and the fallout effects of this.

Nonetheless, under the decision, the Fifth Circuit would affirm that part of Kacsmaryk’s order returning the use of mifepristone to include the pre-2016 restrictions.

As to the 2021 non-enforcement decision effectively allowing mifepristone to be mailed, later formalized in a subsequent policy, the Fifth Circuit first held that the later formalization does not moot the challenge. On the merits, Elrod’s decision went on to hold that the challengers would likely succeed on their claim that the decision ending the in-person dispensing requirement was “arbitrary and capricious” in violation of the APA, affirming that part of Kacsmaryk’s order as well.

In light of that decision, the majority noted, it did not consider the Comstock Act claim raised by the challengers — a claim that has gotten significant attention due to its potentially wide-reaching effects.

After considering the other injunction factors and siding with the challengers on the irreparable harm and equities factors, the court then turned to Kacsmaryk’s remedy — staying the effective date of the approvals and decisions. Elrod wrote that the appeals court concluded that was “an appropriate form of relief,” rejecting the arguments of both the FDA and Danco Laboratories, the maker of Mifeprex, for why that was not the appropriate relief.

Notably, the court also stated that “[r]emand without vacatur” — sending these decisions back to the FDA — “is likely not appropriate because ‘it is far from certain’ that FDA could cure its mistakes with further consideration.”

In his partial dissent, Ho wrote how he would go further than the panel, affirming Kacsmaryk’s order in whole. Specifically, he wrote that he would consider the 2000 approval claim to be timely and would revoke the approval of mifepristone.

“I would hold the 2000 approval unlawful,” Ho wrote in discussing the initial approval, seemingly forgetting the fact that the case was only before the court on a preliminary injunction.

He also addressed the Comstock Act claim, writing in part, “The FDA’s 2021 revisions also violate the Comstock Act,“ citing its provision that purports to criminalize mailing abortion-related drugs — a provision subject to debate not only about its continued validity but also as to what it criminalizes — and again suggesting he was writing his final, not preliminary, views on the matter.

Ho also went even further than the majority in explaining the challengers’ “conscience injury,” writing about the “aesthetic injury” that he claimed the plaintiffs face as well.

Ho is one of the most extreme judges on the nation’s furthest right appeals court, and this partial dissent makes that all the more clear. Even with two other conservative judges — Elrod and Wilson — pulling back some key pieces of Kacsmaryk’s ruling while affirming others, Ho felt it necessary to make it clear that he would affirm Kacsmaryk’s ruling in full.

The majority’s decision, meanwhile, was similar to what a different three-judge panel of the appeals court had decided on the parties’ initial request for a stay pending appeal. When the Fifth Circuit issued that ruling, only granting a partial stay, DOJ and Danco, went to the Supreme Court, which then issued the full stay — pending not only the Fifth Circuit’s resolution of the appeal, but also pending the Supreme Court’s review of any petition for certiorari that the court was aware is almost certain to follow the appeals court’s decision.

It’s that order from the Supreme Court that keeps Wednesday’s decision from the Fifth Circuit from having any immediate effect — other than starting the clock for parties to seek Supreme Court review.

While the Supreme Court is not required to take this case, assuming certiorari is sought, it is likely that it will. In addition to the importance of the case and the court’s April decision to step in, there is also the fact that both sides of this dispute are likely to seek further review and there is — if you recall — still another case brought in federal court in Washington by several Democrat-led states that remains pending and in which the district judge there issued a preliminary injunction (since clarified) that protects access in those states and clearly conflicts with the ruling issued by the Fifth Circuit on Wednesday.

This is a breaking news report. It was updated and expanded after initial publication, with the final update at 11:30 p.m. Check back at Law Dork for the latest.