In a somewhat unexpected move, the federal government has asked a district court judge in Texas to dismiss a lawsuit questioning the safety of the abortion pill mifepristone.
The lawsuit has a long history. In 2022, several anti-abortion doctors argued that the Food and Drug Administration should restrict access to chemical abortions. Ultimately, the U.S. Supreme Court unanimously dismissed the case for lack of standing. Three states — Idaho, Kansas, and Missouri — revived the lawsuit, which was decided on procedural grounds, not the merits. This kept the case before U.S. District Court Judge Matthew Kacsmaryk, who previously ruled in favor of restricting access to the drug.
How Mifepristone Works
Chemical abortions currently make up about 60% of the procedures used to end pregnancies in the United States. The two-pill regimen of mifepristone and misoprostol has been FDA-approved since 2000 and carries an extremely positive safety record. Some studies suggest it's safer to use than over-the-counter acetaminophen.
Under a single, shared system risk evaluation and mitigation strategy (REMS), both the original and generic versions of mifepristone must be prescribed by a physician or nurse practitioner. In subsequent approvals, prescriptions by telehealth appointments and delivery by mail were added.
Lawsuit Sought FDA Revocation
A suit was brought by a group of doctors who claimed injury due to mifepristone. Filing as the Alliance for Hippocratic Medicine, they alleged that even though they themselves didn't prescribe abortion pills or administer abortions, they could suffer because they'd have to treat women with complications from taking mifepristone. This, they reasoned, was one of many reasons to provide just cause for blocking the prescription of the mifepristone REMS.
The suit sought a number of changes in mifepristone REMS policy, most in the form of rolling back FDA changes made in 2016 and 2021. All patients would be required to meet with their physician at least three times. Despite no data showing it to be any less safe or effective than the original, generic mifepristone would be banned. Nurse-practitioners would no longer be allowed to prescribe or administer the regimen, and sales by retail pharmacies would be halted.
They won a legal victory in 2023 before Judge Kacsmaryk of Texas. After the Fifth Circuit restored access to mifepristone but stayed certain approvals made in 2016 and 2021, SCOTUS unanimously ruled the plaintiffs lacked standing to bring the lawsuit. In order to challenge a law in federal court, the plaintiff(s) must show actual harm, not just stridently disagree with a regulation or law. SCOTUS reasoned that the doctors bringing the lawsuit suffered no concrete injury. Speculating about uncertain future possibilities of harm is not enough.
But it didn't end there. Three states were allowed to step into the existing lawsuit as intervenor plaintiffs. Doing so allowed Idaho, Missouri, and Kansas to sidestep the need to start the case over in the lower courts and kept it in Texas.
You Can't Unspoil Milk
The main reason to revive the lawsuit was to keep it in Texas, where Judge Kacsmaryk had previously held in favor of the plaintiffs. On May 5, the Justice Department asked Judge Kacsmaryk to dismiss the case. While they are free to bring legal challenges over the FDA approval of mifepristone, doing so in Texas is an improper venue, the DOJ argued.
It's quite possible that even if Judge Kacsmaryk sides with President Trump's Justice Department, the three states will bring their own claims in the proper venue, so the legal battle over the merits of the argument — whether mifepristone is safe — could continue. However, the three states may have to take the chance they'll get a judge less sympathetic to their case when bringing it in the proper venue.
Related Resources
- Abortion Laws: What's Required To Get an Abortion? (FindLaw's Reproductive Rights
- SCOTUS Unanimously Rejects Restrictions of Abortion Pill Mifepristone (FindLaw's Federal Courts)
- Article III Standing Requirements (FindLaw's U.S. Constitution)
