Anti-Abortion Doctors Struggle to Explain Mifepristone Harms Before Supreme Court
Jordan Smith
Justice
The justices didn’t seem to buy the tenuous theory that would allow the doctors to sue the FDA over medication abortion.

The theory at the core of the lawsuit filed by the Alliance for Hippocratic Medicine and a handful of anti-abortion doctors who are challenging the Food and Drug Administration’s approval of the abortion drug mifepristone is that they have been harmed — or will be harmed — by the FDA’s actions.

The doctors are not claiming that they’ve been hurt by taking the drug or prescribing it, which none of them do. Instead, their theory goes something like this: Mifepristone is dangerous, and pregnant people who take the drug are bound to have serious complications. When they do, they’ll probably go to an emergency room, which could be in a hospital where one of the anti-abortion doctors works. As a result, the doctor could be pulled from regular patient duties to deal with the mifepristone-related emergency, forcing them to play some role in the provision of abortion and causing emotional trauma.

The claim is so tenuous that during oral arguments in the case on Tuesday, not even the anti-abortion majority of the U.S. Supreme Court seemed to buy it as a theory that would give the group standing to sue the FDA. The justices appeared disinclined to rule in a way that would narrow access to medication abortion, at least for now.

“FDA approved mifepristone based on the agency’s scientific judgment that the drug is safe and effective,” U.S. Solicitor General Elizabeth Prelogar told the court. “It’s maintained that judgment across five presidential administrations, and millions of Americans have used mifepristone to safely end their pregnancies.” The alliance “may not agree with that choice,” she continued, “but that doesn’t give them … a legal basis to upend the regulatory scheme.”

Mifepristone is the first in a two-drug protocol approved for early pregnancy termination. It blocks progesterone, a hormone needed to continue pregnancy, while the second drug, misoprostol, causes the uterus to contract, expelling the pregnancy. Mifepristone is among the most studied drugs in the country; it has been used in more than 600 published clinical trials, and at less than 1 percent, the risk of serious complications is low. Today, the two-drug regimen accounts for more than 60 percent of all abortions in the United States.

The FDA first approved mifepristone in 2000. In 2016 and 2021, the agency loosened restrictions on the drug that had long been challenged as medically unnecessary, extending its use through 10 weeks of pregnancy and lifting a requirement that it be dispensed in person.

The Alliance for Hippocratic Medicine, an umbrella organization for several groups of anti-abortion doctors, filed federal suit in Amarillo, Texas, in late 2022, challenging the FDA’s initial approval of mifepristone as reckless and the subsequent changes as hazardous. Filing the suit in Amarillo — where the group had only recently incorporated itself — offered a tactical advantage: It guaranteed that the case would be heard by Judge Matthew Kacsmaryk, a far-right Trump-appointed judge who hears all federal civil cases filed in the Texas Panhandle.

Kacsmaryk did not disappoint. In April 2023, he sided with the alliance, ruling that the FDA never should have approved mifepristone in the first place. To support his position that mifepristone was wildly unsafe, Kacsmaryk disengaged from science and instead cited an analysis of anonymous blog posts, a researcher whose work has been repeatedly called into question, and two studies sponsored by an anti-abortion organization that have since been retracted by the journal that published them.

The government appealed to the 5th U.S. Circuit Court of Appeals, which disagreed with Kacsmaryk’s conclusion regarding the 2000 approval of mifepristone but nonetheless said the FDA impermissibly loosened restrictions in 2016 and 2021.

In coming to their conclusions, both courts bought the alliance’s shaky theory of legal standing. On Tuesday, the justices on the Supreme Court seemed less convinced — even if Justice Samuel Alito was inclined to try to help his colleagues along. What if an anti-abortion doctor was the only person on duty in an emergency room when a “woman comes in with complications from having taken mifepristone … and as a result, in order to save her life, the doctor has to abort a viable fetus?” he asked the solicitor general.

If the doctor was forced into action, that could be a violation of longstanding laws that protect providers’ conscience rights, Prelogar responded, but that “situation has never come to pass.” The alliance and its doctors “haven’t identified any incident in more than 20 years that mifepristone has been available on the market that resembles that kind of hypothetical situation.”

Experts have worried that allowing legal standing on such a thin premise would lower the bar and permit nearly anyone to sue the FDA or any other agency for nearly anything they disagree with. Doctors who don’t think vaccinations are safe could sue to have their approval yanked; cardiologists could challenge a new heart medicine on the grounds that “some patients would no longer require their services,” as the FDA pointed out in a legal brief. Pharmaceutical companies have voiced concern that accepting the alliance’s premise would upend the system, encourage judges to second-guess scientists, chill drug development, and harm patients.

Even if the court were to accept that conscience rights had been violated, the doctors’ suggested remedy — making mifepristone illegal for everyone — was excessive, Justice Ketanji Brown Jackson observed. “I’m worried that there is a significant mismatch … between the claimed injury and the remedy that’s being sought.” Exempting the doctors from participating in abortion-related care seemed the logical solution, she said. Instead, “they’re saying because we object to having to be forced to participate in this procedure, we’re seeking an order preventing anyone from having access to these drugs at all.”

Erin Hawley, a lawyer with the far-right Alliance Defending Freedom, which represents the Alliance for Hippocratic Medicine, tried to push back, ignoring the fact that broad conscience objections can be raised with hospital administrators or other health care employers well before a particular situation arises. She argued that the doctors couldn’t afford to waste “precious moments scrubbing in, scrubbing out” of the ER to lodge an objection.

Justice Neil Gorsuch interrupted: There had been a “rash” of recent cases in which a lower court issued a nationwide ruling when the circumstances called for a more modest result. “This case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on … an FDA rule or any other federal government action,” he said.

If the court rejects the alliance’s theory of legal standing, the case is dead without the justices having to address the group’s baseless arguments about the dangers of mifepristone, and the drug will remain available, as it is now, under the FDA’s current regulations. The court is expected to issue a ruling later this year, likely near the end of its session, which concludes in June.

That doesn’t mean that the attacks on medication abortion will stop or that the court will stand in their way. Both Alito and Justice Clarence Thomas seemed open to discussing a revival of the Comstock Act, an 1873 law that outlawed mailing anything considered “obscene, lewd, lascivious, indecent, filthy, or vile” — which included contraception — as well as “every article or thing” that could be used for abortion.

The zombie law has been dormant for decades, but many anti-abortion activists see it as a means of enacting a de facto national medication abortion ban without having to confront mifepristone’s safety record — even if the law’s broad language would trigger the possibility that instruments and drugs used for routine gynecological procedures could also be subject to its provisions.

During oral arguments, Alito asked whether the FDA should have considered the Comstock Act before lifting the in-person dispensing requirement, which led to widespread mail order sales. No, the solicitor general responded. If the restriction wasn’t medically necessary, then the FDA was required to lift it, not consider a statute that was outside its scientific purview.

Thomas asked Hawley, the alliance lawyer, for her take on Comstock. “The Comstock Act says that drugs should not be mailed,” she said. “We think the plain text of that, your honor, is pretty clear.”
The justices didn’t seem to buy the tenuous theory that would allow the doctors to sue the FDA over medication abortion.
The theory at the core of the lawsuit filed by the Alliance for Hippocratic Medicine and a handful of anti-abortion doctors who are challenging the Food and Drug Administration’s approval of the abortion drug mifepristone is that they have been harmed — or will be harmed — by the FDA’s actions. The doctors are not claiming that they’ve been hurt by taking the drug or prescribing it, which none of them do. Instead, their theory goes something like this: Mifepristone is dangerous, and pregnant people who take the drug are bound to have serious complications. When they do, they’ll probably go to an emergency room, which could be in a hospital where one of the anti-abortion doctors works. As a result, the doctor could be pulled from regular patient duties to deal with the mifepristone-related emergency, forcing them to play some role in the provision of abortion and causing emotional trauma. The claim is so tenuous that during oral arguments in the case on Tuesday, not even the anti-abortion majority of the U.S. Supreme Court seemed to buy it as a theory that would give the group standing to sue the FDA. The justices appeared disinclined to rule in a way that would narrow access to medication abortion, at least for now. “FDA approved mifepristone based on the agency’s scientific judgment that the drug is safe and effective,” U.S. Solicitor General Elizabeth Prelogar told the court. “It’s maintained that judgment across five presidential administrations, and millions of Americans have used mifepristone to safely end their pregnancies.” The alliance “may not agree with that choice,” she continued, “but that doesn’t give them … a legal basis to upend the regulatory scheme.” Mifepristone is the first in a two-drug protocol approved for early pregnancy termination. It blocks progesterone, a hormone needed to continue pregnancy, while the second drug, misoprostol, causes the uterus to contract, expelling the pregnancy. Mifepristone is among the most studied drugs in the country; it has been used in more than 600 published clinical trials, and at less than 1 percent, the risk of serious complications is low. Today, the two-drug regimen accounts for more than 60 percent of all abortions in the United States. The FDA first approved mifepristone in 2000. In 2016 and 2021, the agency loosened restrictions on the drug that had long been challenged as medically unnecessary, extending its use through 10 weeks of pregnancy and lifting a requirement that it be dispensed in person. The Alliance for Hippocratic Medicine, an umbrella organization for several groups of anti-abortion doctors, filed federal suit in Amarillo, Texas, in late 2022, challenging the FDA’s initial approval of mifepristone as reckless and the subsequent changes as hazardous. Filing the suit in Amarillo — where the group had only recently incorporated itself — offered a tactical advantage: It guaranteed that the case would be heard by Judge Matthew Kacsmaryk, a far-right Trump-appointed judge who hears all federal civil cases filed in the Texas Panhandle. Kacsmaryk did not disappoint. In April 2023, he sided with the alliance, ruling that the FDA never should have approved mifepristone in the first place. To support his position that mifepristone was wildly unsafe, Kacsmaryk disengaged from science and instead cited an analysis of anonymous blog posts, a researcher whose work has been repeatedly called into question, and two studies sponsored by an anti-abortion organization that have since been retracted by the journal that published them. The government appealed to the 5th U.S. Circuit Court of Appeals, which disagreed with Kacsmaryk’s conclusion regarding the 2000 approval of mifepristone but nonetheless said the FDA impermissibly loosened restrictions in 2016 and 2021. In coming to their conclusions, both courts bought the alliance’s shaky theory of legal standing. On Tuesday, the justices on the Supreme Court seemed less convinced — even if Justice Samuel Alito was inclined to try to help his colleagues along. What if an anti-abortion doctor was the only person on duty in an emergency room when a “woman comes in with complications from having taken mifepristone … and as a result, in order to save her life, the doctor has to abort a viable fetus?” he asked the solicitor general. If the doctor was forced into action, that could be a violation of longstanding laws that protect providers’ conscience rights, Prelogar responded, but that “situation has never come to pass.” The alliance and its doctors “haven’t identified any incident in more than 20 years that mifepristone has been available on the market that resembles that kind of hypothetical situation.” Experts have worried that allowing legal standing on such a thin premise would lower the bar and permit nearly anyone to sue the FDA or any other agency for nearly anything they disagree with. Doctors who don’t think vaccinations are safe could sue to have their approval yanked; cardiologists could challenge a new heart medicine on the grounds that “some patients would no longer require their services,” as the FDA pointed out in a legal brief. Pharmaceutical companies have voiced concern that accepting the alliance’s premise would upend the system, encourage judges to second-guess scientists, chill drug development, and harm patients. Even if the court were to accept that conscience rights had been violated, the doctors’ suggested remedy — making mifepristone illegal for everyone — was excessive, Justice Ketanji Brown Jackson observed. “I’m worried that there is a significant mismatch … between the claimed injury and the remedy that’s being sought.” Exempting the doctors from participating in abortion-related care seemed the logical solution, she said. Instead, “they’re saying because we object to having to be forced to participate in this procedure, we’re seeking an order preventing anyone from having access to these drugs at all.” Erin Hawley, a lawyer with the far-right Alliance Defending Freedom, which represents the Alliance for Hippocratic Medicine, tried to push back, ignoring the fact that broad conscience objections can be raised with hospital administrators or other health care employers well before a particular situation arises. She argued that the doctors couldn’t afford to waste “precious moments scrubbing in, scrubbing out” of the ER to lodge an objection. Justice Neil Gorsuch interrupted: There had been a “rash” of recent cases in which a lower court issued a nationwide ruling when the circumstances called for a more modest result. “This case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on … an FDA rule or any other federal government action,” he said. If the court rejects the alliance’s theory of legal standing, the case is dead without the justices having to address the group’s baseless arguments about the dangers of mifepristone, and the drug will remain available, as it is now, under the FDA’s current regulations. The court is expected to issue a ruling later this year, likely near the end of its session, which concludes in June. That doesn’t mean that the attacks on medication abortion will stop or that the court will stand in their way. Both Alito and Justice Clarence Thomas seemed open to discussing a revival of the Comstock Act, an 1873 law that outlawed mailing anything considered “obscene, lewd, lascivious, indecent, filthy, or vile” — which included contraception — as well as “every article or thing” that could be used for abortion. The zombie law has been dormant for decades, but many anti-abortion activists see it as a means of enacting a de facto national medication abortion ban without having to confront mifepristone’s safety record — even if the law’s broad language would trigger the possibility that instruments and drugs used for routine gynecological procedures could also be subject to its provisions. During oral arguments, Alito asked whether the FDA should have considered the Comstock Act before lifting the in-person dispensing requirement, which led to widespread mail order sales. No, the solicitor general responded. If the restriction wasn’t medically necessary, then the FDA was required to lift it, not consider a statute that was outside its scientific purview. Thomas asked Hawley, the alliance lawyer, for her take on Comstock. “The Comstock Act says that drugs should not be mailed,” she said. “We think the plain text of that, your honor, is pretty clear.”