Flurry of briefing at the 5th Circuit, with most urging a stay in medication abortion case

DOJ: "[T]here is nothing modest about upending the decades-long status quo by blocking access nationwide to a safe and effective drug." Expect a ruling — or a SCOTUS filing — Thursday.

Lawyers for leaders of the pharmaceutical industry called the April 7 federal court order from U.S. District Judge Matthew Kacsmaryk that purports to halt mifepristone’s decades-old approval for use in medication abortion a “lawless” ruling in a court filing on Tuesday night.

Their brief was just one of a flurry of filings at the U.S. Court of Appeals for the Fifth Circuit that highlighted the extreme nature of the ruling and the widespread concern about the implications were it even allowed to go into effect, let alone stand as a proper interpretation of the law.

Kacsmaryk’s ruling is due to go into effect on April 15 if no higher court acts to stop it. That led both the Justice Department and Danco Laboratories, the maker of Mifeprex, to ask the appeals court earlier this week to put Kacsmaryk’s ruling on hold during their appeal of the ruling (or to temporarily do so while the appeals court decides whether to grant to a stay pending appeal). If nothing else, Danco also asked for a 14-day administrative stay if necessary so that it can seek a stay from the U.S. Supreme Court.

DOJ asked the Fifth Circuit for a ruling by noon Thursday. As such, expect a U.S. Supreme Court request from DOJ soon thereafter if the appeals court doesn’t issue a stay by then.

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Update: The Fifth Circuit ruled late Wednesday night:

Breaking: Fifth Circuit says mifepristone stays approved during appeal, but questions remain

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The plaintiffs, represented by the Alliance Defending Freedom, filed their opposition to all of those requests on Tuesday night, as well as a request that the appeals court dismiss the appeal altogether.

Calling Kacsmaryk’s ruling “meticulously considered,” and ignoring the extensive criticism of the ruling in the days since, the ADF lawyers argue that “it is the government’s stay request that is ‘extraordinary and unprecedented’” — quoting from DOJ’s stay request — “not the district court’s ruling.”

The plaintiffs’ filing built on Kacsmaryk’s extreme ruling — referring to the FDA’s recent decision to end the in-person dispensing requirement for mifepristone as the “FDA’s unlawful mail-order abortion regime.” They also argued that Kacsmaryk’s “order merely removes mifepristone from the mails and the market; abortion will still be available in states that permit it” — a claim that ignores both the widespread use of medication abortion in 2023 and the difficulty of obtaining surgical abortions in many areas.

Those briefs, as well as all of those from non-parties, showed how much attention now focuses on whether this ruling from a federal judge sought out in Texas is allowed to go into effect.

A brief filed by 240 congressional Democrats — 50 members of the Senate and 190 in the House — focused on an element raised in much of the briefing supporting the stay: Drug approval is the FDA’s job, not Kacsmaryk’s.

“Congress intended to—and did—vest authority in FDA to evaluate and ensure the safety and efficacy of drugs in the United States, and Amici call on this Court to give due weight to that intent,” lawyers for the members of Congress wrote.

Then there was the pharmaceutical industry brief: “Unless stayed, the district court’s lawless opinion will empower any plaintiff to grind drug approvals to a halt, disrupting patients’ access to critical medicines.”

Lawyers for the Justice Department were barely more restrained in their Wednesday reply brief. “There is no basis in science or fact for plaintiffs’ repeated claims that mifepristone is unsafe when used in the manner approved by FDA,” the DOJ lawyers wrote. “Nor is there any basis in administrative law for the district court’s unprecedented overriding of FDA’s considered scientific judgment.”

Danco’s lawyers also took on the extreme nature of the ruling — and the Alliance Defending Freedom lawyers backing the plaintiffs behind the lawsuit — writing, “Plaintiffs defend the District Court’s unprecedented decision to second-guess FDA’s longstanding approval of this drug with rhetoric, instead of precedent or legal principles.”

In addition, Former FDA officials and former DOJ officials weighed in to support DOJ’s stay request. The NAACP Legal Defense Fund supported the request as well.

Notably, the briefs opposing the stay request were few and far between — and came mainly from groups strongly opposed to abortion. Ed Whelan filed a brief focused on the Comstock Act. (More on that issue, more broadly, to come.)

While nearly all Democrats in Congress joined the brief supporting DOJ’s stay request, just more than one-quarter of congressional Republicans (69, including only 11 senators) joined a brief opposing DOJ’s stay request.

So, there are many briefs and arguments at the Fifth Circuit now, with a district court ruling due to go into effect on April 15.

What happens now?

DOJ’s statement in its reply of what Kacsmaryk did, and what the Fifth Circuit now is being asked to stop, sums up the scope of what we will be dealing with over the next few days.

“The district court purported to be acting in a restrained manner; but there is nothing modest about upending the decades-long status quo by blocking access nationwide to a safe and effective drug,” the DOJ lawyers wrote. “If allowed to take effect, the court’s order will cause irreparable harm across the country.”

So, first, there’s the question of what the Fifth Circuit will do. Then, if necessary, the U.S. Supreme Court. There is also the Washington ruling in the Democratic attorneys general suit, which bars the FDA from changing the availability of mifepristone in those states (and DOJ’s clarification request there).

And, finally, there is the question of enforcement (or nonenforcement): Whether the FDA or any Biden administration agency and various state agencies would take actions that would help to keep the drug available (or agree not to take actions that could prevent it from being available) even if Kacsmaryk’s ruling goes into effect. (A trio of law professors have been highlighting this final point throughout this year, but the effect would differ by state.)

It’s going to potentially be a quick-moving, confusing few days, but I will try my best to keep providing additional information as I know it.¹

1. This post was updated, with a few small clarifications and an expanded conclusion, with the final update at 11:45 p.m.