Federal judges in Texas and Washington handed down two opposing rulings on the abortion pill mifepristone on Friday, jeopardizing access to the drug and putting the US Food and Drug Administration in an impossible situation.
Matthew Kacsmaryk, a conservative federal district court judge in Texas, issued a long-awaited ruling Friday evening calling for the FDA to stay its approval of mifepristone, which has been deemed safe and legal for 23 years, while Thomas Rice, a federal court judge in Washington state, swiftly issued a directly contradictory decision.
Kacsmaryk’s order to halt mifepristone’s approval was widely expected given his conservative views and background in the Christian right, and hinges on the idea that medication abortion is not safe. That claim, though, is disputed by decades of evidence to the contrary, and in the Washington state order enjoining the FDA from making changes to mifepristone’s availability in the 17 states and Washington, DC, Rice also argued that it isn’t the role of a court to determine a drug’s safety.
As of now, medication abortion — most frequently a two-drug regimen consisting of mifepristone and misoprostol — remains legal in the US, and both drugs, mifepristone and misoprostol, are approved by the FDA. Kacsmaryk’s order would have invalidated mifepristone’s approval after a seven-day stay of the order to allow for potential emergency relief. But Rice’s ruling further complicates Kacsmaryk’s, since the FDA would be unable to fully comply with both orders at once.
“There is now directly conflicting federal court decisions on what the status of mifepristone is,” Rachel Rebouché, dean of Temple University’s Beasley School of Law told Vox in an interview. “So nothing changes for the next week, and we’ll see litigation start to move as the FDA and DOJ ask the Fifth Circuit and Supreme Court to clarify.”
Not only does the Texas ruling endanger access to medication abortion, but it also calls into question the ability of the FDA and other federal agencies to follow through with their mandates, according to several experts. Kacsmaryk’s ruling cites dubious claims about mifepristone’s supposed dangers, and experts told Vox that the fact that a court has now decided it can arbitrate scientific fact better than medical experts is unprecedented and potentially quite dangerous.
“We know medication abortion overall has a 0.5 percent of risk involved, so very low, and when we talk about the risk of associated deaths, it is 0.001 percent,” or less than one death per 100,000 medication abortions, Jennifer Lincoln, an OB-GYN and the head of Mayday.Health, an education resource that informs people about medication abortion and how to access it, told Vox. “That statistic includes deaths that are likely not related to the medication abortion itself.”
Contrary to Kacsmaryk’s order, mifepristone is extremely safe, and along with misoprostol is widely used to end abortions within the first trimester. As Vox’s Rachel M. Cohen explains:
Medication abortion — referring to the combination of both mifepristone and misoprostol — accounts for more than half of all abortions in the US, and is used typically within the first 10 to 12 weeks of a pregnancy. It’s become the most common method for ending pregnancies in the United States, partly due to its safety record, its lower cost, diminished access to in-person care, and greater opportunities for privacy.
Medication abortion is just the latest battleground in reproductive rights after the Supreme Court overturned Roe v. Wade last summer, voiding the constitutional right to an abortion. Kacsmaryk’s case has been the highest-profile attack on mifepristone, but it’s not the only one; in March, Wyoming’s governor signed a bill banning medication abortion effective July 1, though that law is being challenged in court.
Friday’s contradictory rulings are by no means the last word on medication abortion; both the Justice Department and Danco Laboratories, which manufactures mifepristone under the name Mifeprex, have filed appeals to the Fifth Circuit Court, and it’s likely the issue will end up before the Supreme Court. However, given the recent track record of both the Fifth Circuit and the Supreme Court on abortion issues, the outcome for medication abortion is far from clear.
For its part, the FDA made a statement to the Washington Post defending mifepristone and its approval for the market. “FDA stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications that FDA has determined to be safe and effective for their intended uses,” an agency spokesperson said.
The legal labyrinth around mifepristone, explained
The decisions came down rapid-fire Friday evening; Rice’s order became public just after Kacsmaryk’s, fueling confusion over the future of the drug. Kacsmaryk’s 67-page order rules on the idea that the FDA didn’t properly study the effects of medication abortion and fast-tracked its approval, siding with the plaintiffs — four anti-abortion medical groups and four anti-abortion doctors.
According to Greer Donley, an associate professor of law at the University of Pittsburgh’s Center for Bioethics and Health Law, “If the Texas order goes into effect in seven days — if there’s no appeal that changes that — the drug will become unapproved. There’s nothing for the FDA to do. The order was specifically written to avoid any action on the FDA’s part, the drug just becomes unapproved in seven days.”
That outcome is complicated by the injunction from a Washington state federal court: Rice’s decision orders that the FDA maintain the status quo for mifepristone by not blocking its availability. While Kacsmaryk’s order would apply nationally, Rice’s only applies to DC and the 17 states named as plaintiffs.
It’s unlikely, however, that the limited scope of the Washington state ruling clears the way for Kacsmaryk’s injunction in any meaningful way. According to Steve Vladeck, a law professor specializing in federal courts at the University of Texas, it’s “a distinction without a difference given what it orders the FDA to not do.”
“So there would be no way for the FDA to comply with both *if* Kacsmaryk’s ruling ever goes into effect,” Vladeck tweeted Friday evening. “Hence, #SCOTUS.”
The WA ruling is *not* nationwide (although I think that’s a distinction without a difference given what it orders the FDA to not do), but Kacsmaryk’s would be. So there would be no way for the FDA to comply with both *if* Kacsmaryk’s ruling ever goes into effect. Hence, #SCOTUS.— Steve Vladeck (@steve_vladeck) April 7, 2023
It’s possible the courts could find a way to square the circle, Donley told Vox, by issuing an “enforcement discretion notice to say, ‘Even though it’s technically illegal in seven days, barring any appeal, for a manufacturer to market mifepristone because it’s going to be unapproved, we’re not going to go after anyone who does that.’” But more likely, the contradictory orders will expedite the cases’ trip to the Supreme Court.
Vox reached out to the FDA regarding the possibility of an enforcement discretion notice but did not receive a response before publication.
Kacsmaryk stated in his order that mifepristone’s safety hadn’t been well established, even though the FDA reapproved the drug in 2016 and 2019 after its initial approval in 2000. Certain assertions in the order, including an assertion that “chemical abortions are over fifty percent more likely than surgical abortion to result in an emergency room visit within thirty days,” are used without context or are not borne out by data.
But some of the damage may already have been done — in addition to Friday’s contradictory rulings on medication abortion, restrictions in states and court challenges to those restrictions have created an atmosphere of fear and confusion that makes it difficult for providers to operate.
“People are very afraid, criminal laws are very scary, understandably, to providers,” Donley said. “So you’re seeing that chaos is really impacting and affecting abortion access.”
The Texas ruling could set an alarming precedent
Whatever the outcome of the fight over medication abortion — whether mifepristone’s approval status is decided in the Fifth Circuit or the Supreme Court — the Kacsmaryk case in particular has the potential to set some alarming precedents.
In terms of abortion access, Cohen wrote, there are still some options for people who need them:
If mifepristone is ultimately pulled from the market, people seeking abortions could still access care at in-person clinics for surgical abortions. But those procedures typically cost more money, and require more time and resources from already-strapped abortion clinics. In its legal filing opposing the Texas case, the Justice Department warned that taking mifepristone off the market would lead to delays and overcrowding at these clinics, which were already managing an influx of out-of-state patients since Roe’s overturn.
And at least one state has gone even further to protect medication abortion access: Washington has stockpiled tens of thousands of doses of mifepristone against the possibility of a decision like Kacsmaryk’s. Lincoln also told Vox that, even if Kacsmaryk’s injunction takes effect, Mayday.Health will be able to direct people toward resources that provide mifepristone, including Aid Access, a nonprofit that provides mifepristone by mail in all 50 states and internationally.
If the Fifth Circuit or the Supreme Court allow Kacsmaryk’s order to stand, however, Rebouché told Vox that it would have significant implications regarding the role of the FDA and other federal agencies and their ability to carry out their mandates.
“No matter your feelings about abortion, what’s your track record on federal power?” she said. Should the case make it to the Supreme Court, “They would have the same questions about not just the nature of abortion or the nature around the fact-finding of the safety of medication abortion, but also the role of the FDA in all of this.”
As Donley told Vox, the Kacsmaryk ruling is unprecedented — and if the Fifth Circuit or Supreme Court were to agree with its logic, it would create a precedent for the courts to not only call into question the power of federal agencies, but also for the courts to overrule matters of settled medical science which could have wide-ranging implications.
“This is uncharted territory,” Donley said.
Update, April 9, 5:06 pm: This story was originally published on April 8 and has been updated to include a new interview with Jennifer Lincoln.