DOJ, drugmaker ask Fifth Circuit to halt medication abortion ruling during appeals

Lawyers for Mifeprex maker call ruling "an unprecedented judicial assault." [Update: Response due Tuesday.] Also: A request for clarification in the Washington mifepristone case.

The Biden administration is asking the most conservative federal appeals court in the country not to allow a district court ruling to go into effect that purports to stay the U.S. Food and Drug Administration’s 2000 approval of mifepristone for use in medication abortions.

U.S. District Judge Matthew Kacsmaryk already put his April 7 ruling on hold for a week. On Monday, as expected, DOJ asked the U.S. Court of Appeals for the Fifth Circuit to keep that ruling on hold while it is appealed — and signaled that a U.S. Supreme Court request would follow “if necessary.”

And, while the Fifth Circuit is as conservative as it gets, Kacsmaryk’s ruling is bad enough — and has received enough criticism in the days since he released it — that even the Fifth Circuit might stop it in its tracks. (Of course, the Fifth Circuit didn’t stop Texas’s S.B. 8 vigilante six-week abortion ban and the U.S. Supreme Court allowed that law to go into effect, so nothing is for certain.)

“[N]o precedent, from any court, endorses plaintiffs’ standing, timeliness, or merits theories” in the case, DOJ lawyers argued in the filing at the Fifth Circuit. “[T]here is no basis for extraordinary nationwide relief that would upend a decades-long status quo and inflict grave harm on women, the medical system, and the public.”

Both the Biden administration and Danco Laboratories — the maker of Mifeprex — have now asked the Fifth Circuit to issue a stay of Kacsmaryk’s ruling in Alliance for Hippocratic Medicine v. FDA while the decision is appealed.

“The merits of plaintiffs’ claims are not properly before any court,” the DOJ lawyers wrote, arguing that the plaintiffs in the case lack standing and are bringing time-barred claims.

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Update, 5:50 p.m.: The Fifth Circuit has requested a response.

The response is due by the end of the day Tuesday.

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In his April 7 ruling, Kacsmaryk wrote that he views a stay of the FDA’s approval as the appropriate interim relief at the preliminary injunction stage in a case where the final judgment, if it were to be granted, would be vacating the agency action. That would mean that the 23-year-old approval of the drug for this use would not be in effect while the case proceeds. At the same time, Kacsmaryk stayed his order — yes, he stayed the stay, sorry about the law — for a week “to allow the federal government time to seek emergency relief from the United States Court of Appeals for the Fifth Circuit.”

Now, DOJ has done just that.

“The government requests that this Court enter an administrative stay or grant a stay pending appeal by noon on April 13, to enable the government to seek relief in the Supreme Court if necessary.”

In other words, the Biden administration plans to take this stay request to the Supreme Court — likely on Thursday afternoon — if the 5th Circuit doesn’t issue a stay by then.

As to standing, DOJ lawyers wrote:

Under the court’s approach, doctors would have standing to challenge FDA approval of any drug; they would likewise have standing to challenge any other federal action that might injure third parties. … Neither plaintiffs nor the district court cited any precedent for that extravagant position.

On the merits of the case brought by the Alliance for Hippocratic Medicine, DOJ highlighted how far outside of the judicial function Kacsmaryk went in his ruling.

As for Kacsmaryk’s proposed remedy, Danco Laboratories — which, as noted, also weighed in seeking a stay pending appeal — laid out the case plainly, with their lawyers from Hogan Lovells writing:

The decision below is an extreme outlier: No court has ever “stayed” or “suspended” the longstanding approval of a drug consistently found safe and effective by FDA. The court’s mandatory injunction is an unprecedented judicial assault on a careful regulatory process that has served the public for decades. It should be immediately stayed.

Also, Danco Laboratories specifically asks for additional time for Supreme Court review, if that is to be needed.

“If this Court is inclined to deny the emergency or administrative stay, Danco also requests an administrative stay of at least fourteen days to allow Danco the opportunity to seek emergency relief from the Supreme Court,” lawyers wrote.

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In addition to the two filings at the Fifth Circuit, DOJ lawyers also filed a motion for clarification in the other mifepristone case — Washington v FDA, brought by Democratic attorneys general — in which U.S. District Judge Thomas Rice ordered the FDA not to alter “the availability” of mifepristone under current rules in the Democratic-led states that brought the second lawsuit.

The motion in that case asked Rice to “clarify [the federal government’s] obligations” under Rice’s order due to the “significant tension” between the two orders should Kacsmaryk’s ruling be allowed to go into effect — a conflict noted at Law Dork on April 7. In light of the timing of Kacsmaryk’s stay of his ruling, DOJ lawyers have asked Rice for a ruling on the clarification motion by Friday.

[Update, 9:00 p.m.: The Democratic attorneys general opposed DOJ’s motion to expedite the request because, they argue, DOJ doesn’t actually say what it needs clarified: “Simply put, Defendants’ motion gives the Court little to consider and nothing to rule on.”]