A lawsuit seeking to sharply restrict the abortion pill mifepristone — a case the Supreme Court threw out this year — has re-emerged in a version that presents new challenges for abortion-rights supporters and the federal government’s ability to regulate abortion medication.
The revised lawsuit was filed this month by the conservative state attorneys general of three states — Missouri, Idaho and Kansas — against the Food and Drug Administration in the same federal district court in Texas as the original case. It seeks to reverse numerous regulatory changes the F.D.A. has made since 2016 that greatly expanded access to mifepristone.
It also asks for new restrictions, including to outlaw the medication for anyone under 18. And it takes aim at the fast-growing practice of prescribing abortion pills through telemedicine and mailing them to patients, including those in states with abortion bans.
In the United States, abortion pills are prescribed up to 12 weeks into pregnancy and are now used in nearly two-thirds of abortions. The typical regimen involves mifepristone, which blocks a hormone needed for pregnancy development, followed 24 to 48 hours later by misoprostol, which causes contractions like a miscarriage. Decades of research has found the pills to be overwhelmingly safe, and serious complications rare.
The original lawsuit, filed in 2022 by anti-abortion doctors and groups, was rejected in June by the Supreme Court in a unanimous ruling. The court said that the plaintiffs did not have standing to sue because they couldn’t show they had been harmed by the F.D.A.’s decisions on mifepristone. But that ruling didn’t extinguish the case’s chance of being revived.
Last year, Missouri, Idaho and Kansas petitioned to join the suit at the lower court level and were granted the status of intervenors. The states were denied permission to intervene at the Supreme Court level, but after the original plaintiffs’ claims were rejected, the states remained part of the lower court case, and this month they filed an amended complaint as plaintiffs.
“We are moving forward undeterred for the safety of women across the country,” Andrew Bailey, the attorney general of Missouri, said in a statement.
The amended complaint was filed before Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, a Trump appointee who opposes abortion access. In April 2023, Judge Kacsmaryk ruled for the original plaintiffs, issuing a sweeping preliminary injunction that effectively nullified the F.D.A.’s approval of mifepristone nearly 25 years ago.
An appeals court decision kept the F.D.A.’s approval in place, but it rolled back mifepristone regulations to their pre-2016 status. The subsequent Supreme Court decision to reject the original plaintiffs’ case meant that any revised case would have to start again from the lower courts.
The F.D.A. changes that the states want to reverse include provisions that removed the requirement that patients visit prescribers in person; the agency’s approval of generic mifepristone, now the widely used form; the ability for nurse practitioners and other health providers who are not doctors to prescribe mifepristone; and the ability for retail pharmacies, like CVS and Walgreens, to dispense the medication.
The lawsuit argues that those regulations and other F.D.A. actions allow women to obtain abortion pills despite state abortion bans or restrictions. It says this has required the states’ health systems to treat patients who visit emergency rooms for follow-up care or abortion complications, costing the states money. It also claims that the states have been harmed because “loss of fetal life and potential births” reduces the “potential population of each state.”
Since the national right to abortion was overturned in 2022, bans or restrictions stricter than the standard set by Roe v. Wade have gone into effect in 21 states. In states that support abortion rights, telemedicine abortion providers have expanded, and eight states have passed shield laws that protect doctors and other health providers who prescribe and send abortion pills to patients in states with bans or restrictions.
Shield law providers say they are now prescribing and sending abortion pills to more than 10,000 patients a month. Abortion opponents haven’t yet challenged shield laws in court, but the revised mifepristone lawsuit cites shield laws repeatedly, acting as a salvo in an escalating battle against abortion pills by mail.
“They’re trying to kind of create a way to say the F.D.A. can’t allow this, and the whole kind of shield system has to be shut down,” said Mary Ziegler, who is a law professor and abortion expert at the University of California, Davis.
David S. Cohen, who is a law professor at Drexel University and supports abortion rights, said states might have slightly more coherent claims to legal standing than the original plaintiffs, but their ability to sue in this case and claim harm from F.D.A. decisions could still face strong challenges. He said it was also legally questionable that the states had filed as plaintiffs in the same court as the original plaintiffs after the initial group was rejected.
“It is a nakedly political and judge-shopping ploy,” he said. “Missouri, Idaho and Kansas, if they really are harmed by these pills, should file in Missouri, Kansas or Idaho. But they want to be before Judge Kacsmaryk, so they are trying to piggyback on this lawsuit that had no standing in the first place, and that shouldn’t be allowed.”
An official with the attorney general’s office in one of the three states, who asked not to be identified because they were not officially authorized to discuss the matter, said decisions about where to file lawsuits often aim for courts that might be friendly, a practice called forum-shopping. The official defended the practice, saying that lawyers who don’t do it might not be acting in the best interest of their clients.
Some legal experts said it was particularly surprising that Kansas was claiming harm because abortion continues to be legal there and Kansas voters endorsed the right in a 2022 referendum.
In a statement, the state’s attorney general, Kris Kobach, cited safety concerns and said “We’re pursuing this case to protect Kansas women.”
The new filing’s differences from the original lawsuit include seeking to prohibit mifepristone for adolescents, arguing that the F.D.A. did not specifically study it in that age group. Medical experts said there’s no reason that the medication would have different effects for adolescents, who are a small proportion of those seeking abortion medication.
Another difference is the complaint’s emphasis on shield laws, which began being used last year. The states say that when the F.D.A. lifted the requirement for in-person medical visits, it set the stage for shield laws, which they claim violate their state sovereignty by allowing mifepristone to be mailed into states with abortion bans or restrictions.
“Removing the in-person dispensing protections enabled a 50-state mail-order abortion drug economy,” the complaint says.
The complaint also focuses on the Comstock Act, a rarely enforced anti-vice law from 1873 that has recently become a subject of discussion because its language says it prohibits mailing items “intended for the prevention of conception or procuring of abortion.”
The states say the F.D.A. violated the Comstock Act because the agency’s decisions have allowed pills to be mailed. A 2022 Justice Department opinion said the law should not be interpreted to criminalize most abortion pill mailing. Professor Ziegler said if courts say the Comstock Act prevents mailing abortion pills, that might lead to efforts to repeal the law altogether.
While the complaint says the states want to reverse a set of 2016 changes by the F.D.A., it nonetheless indicates that some of those changes should remain, including the agency’s decision to lower the mifepristone dose used in abortions to 200 milligrams from 600.
“They’re saying the F.D.A. didn’t have the authority to make all these changes, but don’t rewind the clock all the way — which is kind of being weird and inconsistent,” Professor Ziegler said.
Legal experts also noted that the complaint does not seek to restrict the second abortion drug, misoprostol, which can terminate pregnancy on its own. If the lawsuit succeeds, Professor Cohen said, providers could still prescribe and mail misoprostol, which is widely available and not subject to the same F.D.A. restrictions.
Legal experts on both sides of the abortion debate expect other efforts to restrict abortion pills. They said additional states or anti-abortion groups may join this case or file other lawsuits.
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