Update (9:20 a.m. on April 13)
In a late ruling on April 12, a panel of three judges on the U.S. Court of Appeals for the Fifth Circuit ruled that “it appears that the statute of limitations bars plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000,” but said that the actions taken by the FDA since 2016 are able to be challenged, including:
- Approving mifepristone for use up to 10 weeks into a pregnancy;
- Lifting an in-person dispensing requirement;
- Allowing the drug to be sent through the mail.
According to reports on MyHighPlains.com, both the plaintiffs and the defendants could now appeal this ruling to the Supreme Court.
AMARILLO, Texas (KAMR/KCIT) — After filing its notice for appeal on Friday, the United States Department of Justice is asking for the U.S. Court of Appeals for the Fifth Circuit to extend the mifepristone-related stay after a Friday ruling by U.S. District Judge Matthew J. Kacsmaryk, the judge in the United States District Court for the Northern District of Texas Amarillo Division.
According to documents obtained by MyHighPlains.com, the Department of Justice is asking for the U.S. Court of Appeals to “enter an administrative stay or grant a stay pending appeal by 12 p.m. on (Thursday), to enable the government to seek relief in the Supreme Court if necessary.”
Danco Laboratories, the company that creates mifepristone and became a part of this lawsuit in mid-January, also filed a “Motion to Stay Pending Appeal,” asking the appeals court for an administrative stay or a stay pending appeal on that same timeline. However, if the court denies the emergency or administrative stay, Danco is requesting an additional 14-day stay “to allow Danco the opportunity to seek emergency relief from the Supreme Court.”
This comes after Friday’s ruling by Kacsmaryk which stayed the FDA’s approval of mifepristone. Kacsmaryk ruled that the order will be in effect on Friday, giving the federal government the time to seek an appeal, according to previous reports by MyHighPlains.com.
In a statement from the DOJ on Friday, Attorney General Merrick B. Garland said:
“The Justice Department strongly disagrees with the decision of the District Court for the Northern District of Texas in Alliance for Hippocratic Medicine v. FDA and will be appealing the court’s decision and seeking a stay pending appeal. Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective. The Department will continue to defend the FDA’s decision.”
The Alliance for Hippocratic Medicine filed a lawsuit in Amarillo Federal Court in late 2022 against the U.S. FDA, challenging the group’s approval of mifepristone back in 2000. Friday’s ruling was in response to a more than four-hour preliminary injunction hearing back in March.
According to the documents, the Department of Justice issued an “emergency motion under circuit rule 27.3 for a stay pending appeal.” According to the Federal Rules of Appellate Procedure, parties can file emergency motions in cases other than capital cases “unless there is an emergency sufficient to justify disruption of the normal appellate process.”
“Rather than preserving the status quo, as preliminary relief is meant to do, the district court upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety,” the appeal reads. “The district court took this extraordinary step despite the fact that plaintiffs did not seek relief for many years after mifepristone’s original approval, waited nearly a year after the most recent FDA actions they seek to challenge and then asked the court to defer any relief until after a final resolution of the case.”
In the documents, they stressed that the plaintiffs in the case “lack standing” to challenge the administration’s approval of mifepristone, a drug that they say the plaintiffs “neither take nor prescribe.”
The appeal claims that the plaintiffs only speculate that other doctors will prescribe mifepristone, which will cause those doctors’ patients to experience “exceedingly rare serious adverse events” which will then cause the practices of doctors who oppose mifepristone and abortion to be overburdened. Officials claim that the allegations of possible future injury are not sufficient, stating that the speculative claims depend on other factors.
The appeal also goes through other factors raised by Kacsmaryk in his order, including the timeliness of the claims, the involvement of Subpart H and the involvement of the Comstock Act.
The DOJ continues to stress that the plaintiffs’ claims regarding the FDA’s approval of mifepristone are not timely, with each FDA claim having a six-year statute of limitations. This is despite Kacsmaryk’s order that states the statute of limitations process was restarted multiple times, including when the FDA denied the plaintiffs’ second mifepristone-related petition in 2021, which centered around the 2016 changes and in-person dispensing of the drug.
“FDA did not reopen the approval (of mifepristone) when it denied plaintiffs’ second petition in 2021,” the documents read. “An agency does not ‘trigger the reopening doctrine’ when it denies a petition and ‘respond[s] to assertions in the petition… To the contrary, when an agency refuses to rescind a prior decision, judicial review is strictly ‘limited to the ‘narrow issues as defined by the denial of the petition’ and does not reach ‘the agency’s original action.”’
The DOJ claims that Kacsmaryk misunderstood the authority of the FDA to use Subpart H to approve the drug. While the drug’s distribution can be restricted through Subpart H, the drug’s approval is based on the statutory authority of the administration.
Officials said that even if Subpart H was “properly invoked” in the order, pregnancy can be a serious medical condition in some women. According to previous reports by MyHighPlains.com, drugs under Subpart H, are drugs that treat “serious or life-threatening injuries” which provide “meaningful therapeutic benefits over existing treatments.”
In regards to the Comstock Act, officials said that the act was misinterpreted by Kacsmaryk’s order, stating that the statute originally prohibited selling drugs causing unlawful abortions in federal territories, as well as mailing and importing those drugs. Officials always stressed that the U.S. Postal Service interpreted all the restrictions as limited to articles used unlawfully.
“At most, the text is ambiguous,” the documents read. “The statute does not specify whether it applies to drugs for ‘any’ or only ‘unlawful’ abortion. Various provisions used ‘abortion’ and ‘unlawful abortion’ interchangeably. And the reference to ‘indecent or immoral’ uses suggests it does not target legitimate medical uses. Thus, at a minimum, the Act does not speak ‘clearly’ enough to have ‘significantly changed the federal-state balance’ by applying to drugs used lawfully.”
Ultimately, the court’s order, in the DOJ’s opinion, will “irreparably harm patients, healthcare systems and businesses.” They also stressed that in some cases, mifepristone is used for non-abortion purposes, including managing miscarriages. Officials compared this harm while challenging that the plaintiffs will not suffer any irreparable harm, based on speculation, allegations and hypothetical scenarios.
In the “Motion to Stay Pending Appeal” from Danco Laboratories, they said that Kacsmaryk’s order was “one-sided” and never mentions “the millions of women who have benefitted from the availability of medication abortion or the harms and injunction would wreak on Danco, a one-product company.”
“The decision below is an extreme outlier,” the company’s motion reads. “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.”
Danco stressed that the defendants will likely prevail on appeal of Kacsmaryk’s order, citing similar arguments brought forward by the DOJ, including that the plaintiffs lack standing, the challenges are time-barred and that the public interest favors a stay. Since Danco is a one-product company, they also stressed that the company faces “substantial, certain and unrecoverable harm.”
According to reports by the Associated Press, Kacsmaryk’s ruling, along with a recent ruling in Washington Federal Court, increase the likelihood the dispute ultimately reaches the Supreme Court one way or another, with far-reaching implications for access to abortion nationwide as well as the authority of the entire FDA.