A conservative federal judge in Texas is poised to rule in a lawsuit that could disrupt abortion access across the nation — including in states with strong abortion protections such as California — by halting distribution of a key abortion pill.
“Ironically, the case is filed in Texas, but the impact will be felt entirely in states that permit abortion,” said Elisabeth Smith, an attorney who directs state policy and advocacy at the Center for Reproductive Rights.
The lawsuit, filed in November on behalf of several anti-abortion groups and doctors, alleges that the drug, mifepristone, is not safe for use in medication abortion. The complaint claims the U.S. Food and Drug Administration “chose politics over science” when it approved the drug more than two decades ago.
About 54% of abortions nationwide rely on a two-drug combination of mifepristone and misoprostol. In January, the FDA finalized a new rule that broadened access to abortion pills by allowing patients to receive medication by mail after a telemedicine appointment with a certified provider.
If the Trump-appointed judge, Matthew Kacsmaryk, rules the FDA’s approval of mifepristone was unlawful, women in the U.S. could face the most far-reaching limit on abortion access since the U.S. Supreme Court overturned Roe vs. Wade last year.
But there are a range of potential legal scenarios. The Times spoke to attorneys and abortion providers about what’s at stake in the Texas case and how they are preparing.
Is mifepristone safe?
Mifepristone, which is approved by the FDA for medical termination of pregnancy up to 10 weeks gestation, has been in use since 2000. Leading physicians’ groups, including the American College of Obstetricians and Gynecologists and the American Medical Assn., have said the drugs are “safe and effective.”
Taking mifepristone has a lower risk of complications, the medical groups noted, than removing a wisdom tooth, having a colonoscopy or taking Viagra.
“Serious side effects occur in less than 1% of patients, and major adverse events — significant infection, blood loss, or hospitalization — occur in less than 0.3% of patients,” key medical groups said in an amicus brief. “The risk of death is almost non-existent.”
What does the lawsuit allege?
Anti-abortion groups, including the relatively new umbrella Alliance for Hippocratic Medicine, argue that the FDA “exceeded its regulatory authority” in 2000 by using an accelerated review process reserved for drugs to treat serious or life-threatening illnesses when it approved use of mifepristone. It also argues the agency “never studied the safety of the drugs under the labeled conditions of use despite being required to do.”
The plaintiffs also ask the judge to withdraw misoprostol for use in abortions. But restricting that drug would be more complicated, experts say, because it was developed and approved to treat stomach ulcers. While the lawsuit asks for an injunction against the two-drug cocktail, it focuses on mifepristone.
In its legal response to the lawsuit, the FDA said it reviewed the scientific evidence thoroughly and determined that the benefits of mifepristone outweigh any risks. The agency also disputed that its approval of mifepristone was “accelerated,” noting that it came four years after the manufacturer first submitted its new drug application.
Among the plaintiffs is Texas obstetrician and gynecologist Dr. Shaun Jester, who claims that one of his patients suffered complications after traveling from Texas to New Mexico to obtain mifepristone, suffering two weeks of moderate to heavy bleeding and then developing a uterine infection. “If she had waited a few more days before receiving care from Dr. Jester, she could have been septic and died,” the lawsuit alleges.
The lawsuit asks Kacsmaryk to issue a nationwide preliminary injunction that would block access to mifepristone — not only in the states that have decided to criminalize abortion, but states that have taken steps to protect abortion access.
Who is Judge Kacsmaryk?
Former Republican President Trump nominated Kacsmaryk, 47, to serve as a United States district judge for the Northern District of Texas first in 2017 and then, after that nomination died, again in 2018. A controversial pick, his nomination was opposed by Senate Democrats as well as a coalition of civil rights groups who argued he was a “culture warrior” with a record of hostility to legalized abortion and same-sex marriage.
From 2014 to 2019, Kacsmaryk served as deputy general counsel for First Liberty Institute, a Christian conservative nonprofit group that litigates on cases involving religious freedom. He opposed same-sex marriage, writing that “the Catechism holds that ‘homosexual acts are intrinsically disordered.” He criticized the Supreme Court’s landmark 1973 Roe vs. Wade decision that recognized a woman’s constitutional right to abortion, protesting that “even the unborn child must yield to the erotic desires of liberated adults.”
Kacsmaryk, who was confirmed in 2019 in a nearly party-line Senate vote, presides alone over the judicial district’s Amarillo division. He has frequently sided with conservatives. In 2021, he halted the Biden administration’s attempt to end the so-called “Remain in Mexico” policy, a ruling that forced asylum seekers to return to Mexico while they awaited their U.S. immigration court date. Last year, he ruled that teenagers need parental consent to obtain birth control and Biden administration attempts to protect LGBT workers and transgender youth were unlawful.
How might the judge rule?
Judge Kacsmaryk could order the FDA to start the process for revoking mifepristone, a process that is likely to take months or years. But he could also interpret his powers more broadly and order the FDA to immediately revoke approval for mifepristone and remove the drug from the market.
“If we were assuming a reasonable judge, I think many people would say the worst he could do is order the FDA to start the process for revoking the drug,” said Greer Donley, an associate law professor at the University of Pittsburgh. “The problem is that no one really trusts that he’s going to follow the letter of the law.”
Even if Kacsmaryk ordered an immediate halting of the drug, Greer said, the FDA could exercise its enforcement discretion.
“The FDA is the final decision maker,” Greer said. “The courts do not enforce law. The agencies have power to decide not to enforce the law.… But just because the FDA can exercise enforcement discretion doesn’t mean it will.”
Whatever approach the FDA takes, the manufacturer of mifepristone, GenBioPro, could decide it’s unlikely that the Biden FDA would go after it, and take the risk of continuing to distribute the pill.
“But we’re at a point right now,” Greer said, “where there’s been a lot of risk aversion in the reproductive rights movement, and probably for good reason: There’s a huge appetite in the anti-abortion movement to go after anyone who’s a part of providing abortion care.”
I live in a blue state. How worried should I be?
Experts say a ruling taking the drug off the market would add pressure on overtaxed abortion providers as well as people seeking to end their pregnancies.
If mifepristone were no longer available, women would still be able to obtain an abortion, but their choice would narrow. They could take off-label misoprostol alone or obtain a surgical abortion.
Misoprostol is safe and effective, said Elizabeth Nash, a state policy analyst for the Washington, D.C.-based Guttmacher Institute, a research group that supports abortion rights. Women in numerous countries that don’t have access to mifepristone use only misoprostol for abortions, but the two-dose regimen is more effective and some patients might feel uncomfortable with taking it alone as it requires taking more medication, and there are more side effects such as vomiting and diarrhea, experts say.
If more patients opted for surgical abortions, the demand would put additional strain on many clinics already reeling from the Dobbs ruling, because procedural abortions take more time and require more staff.
Many abortion providers across the nation, including more than half in California, provide only medication. A few providers in some states — particularly those with fewer protections — might decide not to switch to the misoprostol-only regimen and stop providing abortions altogether.
“At this point, if we lose a few providers, that has a real impact on the remaining providers,” Nash said.
After the Dobbs ruling plunged many clinics across the country into a chaotic, patchwork system of access, any further limitation to abortion care would be devastating, said Smith, of the Center for Reproductive Rights.
“Because no medication abortions are happening in the states that ban abortion right now,” Smith said, “this is just going to impact people in states where abortion remains legal.”
Already, Smith noted, the plaintiffs have gone beyond their call to halt distribution of mifepristone. In a reply brief, they expanded their ask, asking the judge to limit all medication abortion across the country.
Some legal experts, however, said they doubted Kacsmaryk would go so far as to halt the distribution of misopostrol — a drug that is used not just for abortion, but for stomach ulcers, miscarriage care, and to induce labor.
“I think that that’s extremely unlikely,” Donley said: “Look, this judge, I don’t trust him at all. He might try to be extremely radical… But that would have really serious implications — not just for abortion care, but for all of reproductive healthcare. I would be pretty surprised if he went that far.”
How are abortion providers preparing?
Even in California, with its multiple protections for abortion, providers are bracing for the Texas ruling.
“I’ve heard some people describe this as more devastating than Dobbs and I don’t think that’s wrong,” said Sue Dunlap, president and chief executive of Planned Parenthood of Los Angeles. “What this Texas court has the potential to do is literally take one of the safest medications in the country off the market.”
About 50% of Planned Parenthood of L.A.’s patients choose medication abortion — a combination of mifepristone and misoprostol, Dunlap said. The other 50% opt for surgical abortion. If mifepristone were no longer distributed, Dunlap is uncertain how many patients would shift to misoprostol only.
For now, Dunlap is making sure Planned Parenthood clinics are stocked up on a three-months supply of misoprostol. She is also working to make sure her 600 employees at Planned Parenthood of Los Angeles are prepared with scripts to help patients navigate any changes in the abortion landscape.
“For a licensed practitioner to go from one moment where they’re describing and offering a mix of mifepristone-misoprostol abortion to misoprostol only, or perhaps recommending surgery, where the day before they might have offered medication abortion, it’s a complete transformation of the practice,” Dunlap said. “All of us, in one way or another, need to be able to shift and meet that moment.”
Could the ruling have impacts beyond abortion?
Some lawyers note the arguments in the abortion pill case could set a dangerous precedent for public health, allowing politicians to venture beyond abortion care and go after other types of drugs, such as birth control, HIV prevention and treatment, COVID-19 vaccines and gender-affirming care.
“Limiting the FDA discretion and limiting their authority, injecting ideology and politics into the process of drug approval is a really dangerous proposition,” Smith said. “This case goes to the heart of the Food and Drug Administration’s authority, and the discretion that they have to look at scientific and medical research, approve drugs, make determinations about what is safe.”
