A federal judge in Texas could issue a decision as soon as Friday that could result in an abortion medication involved in roughly half of abortions nationwide being pulled from the market, at least temporarily.
U.S. District Judge Matthew Kacsmaryk is presiding over a lawsuit filed by anti-abortion groups seeking to reverse the Food and Drug Administration’s approval of mifepristone, the first of two abortion-inducing drugs used to terminate a pregnancy through 10 weeks.
A ruling in favor of the plaintiffs could result in a nationwide injunction on mifepristone, which would affect states even where abortion remains legal.
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“The reality is we won’t know until we see his order,” said David Cohen, a law professor at Drexel University’s Kline School of Law. “His order could say that mifepristone was improperly approved and just limit it to applying in Texas or wherever he has jurisdiction. He could try to apply it nationwide and try to say that he has the authority, which many people question, to take the drug off the market nationwide. He could say something about the authority of the FDA to go back and try to reapprove it.”
Several medical associations, including the American Association of Pro-Life Obstetricians and Gynecologists and the Alliance for Hippocratic Medicine, as well as four doctors, are arguing in the lawsuit that the FDA went beyond its regulatory authority in approving mifepristone in 2000. The FDA told the Washington Examiner that it does not comment on pending litigation.
“The FDA has a basic responsibility to protect the health, the safety, and welfare of women and girls, but when it comes to chemical abortion drugs, the FDA has completely failed its duty,” said Julie Blake, senior counsel at Alliance Defending Freedom, a conservative legal group that is representing the plaintiffs. “What our doctors are doing, they’re emergency room doctors, local [medical doctors] that have been caring for women, and they’ve suffered the complications from these drugs, and they’re asking the court to order FDA to put the politics aside, follow the science and the law, and protect America’s women and girls.”
Lawyers for both sides are due to file briefs for the case by Friday, after which point Kacsmaryk could issue a decision any time, though Blake said it’s common in a case like this for the judge to hold a hearing, meaning it could be months before a final ruling is issued.
Legal experts said there is little precedent for what the plaintiffs are asking for, and the immediate effects on the availability of mifepristone would hinge on the substance of the judge’s decision.
“As far as we know, no court has ever granted the kind of relief that anti-abortion groups are seeking, and it would effectively be one hand-picked judge in Texas setting abortion and drug approval policy for the entire country,” said Lorie Chaiten, senior staff attorney with the ACLU Reproductive Freedom Project, in a statement to the Washington Examiner.
The Biden administration is likely to swiftly appeal any decision against abortion drugs. Abortion rights groups say any ruling that cuts off access to the medication would pose a threat to women’s ability to access abortion nationwide, warning that the decision could force abortion clinics to switch to surgical abortions only, likely inundating many facilities with patients.
The American College of Obstetricians and Gynecologists has said if mifepristone is unavailable, abortion providers could also switch to using only the second abortion medication in the two-dose regimen— misoprostol. The group noted, though, that the combined mifepristone-misoprostol regimens are “significantly more effective.”
Abortion advocates who have raised caution about an imminent ruling in the case, Alliance for Hippocratic Medicine v. FDA, have pointed back to Kacsmaryk’s previous sweeping injunctions over the past year relating to abortion medication for teenagers and gay and transgender rights.
Last December, Kacsmaryk made it much more difficult for Texas teenagers to access birth control without permission from parents or guardians, ruling that Title X, a federal program that gives free and confidential contraceptives to anyone regardless of age, violates parents’ rights and state federal law.
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Kacsmaryk also handed back a decision in Neese v. Becerra last November, which held that federal law prohibiting certain forms of discrimination by health providers does not protect against discrimination against gay and transgender people. He found that Title VII prevents employment discrimination against a person who identifies as gay or transgender “but not necessarily all correlated conduct,” including the use of pronouns, how a person dresses, and bathroom use.
“I think we could see a very expansive ruling that’s not based in the law. So I think the sky’s the limit for this guy,” Cohen added.
