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In arguments Tuesday, the U.S. Supreme Court indicated there may be a majority of justices willing to preserve access to mifepristone, a common abortion-inducing drug. This is the first major abortion case the high court has heard since it overturned Roe v. Wade in 2022.
The case was first filed in Amarillo, where conservative federal Judge Matthew Kacsmaryk sided nearly a year ago with anti-abortion groups seeking to move mifepristone off the market. Subsequently, the Supreme Court froze any changes to the drug’s legal status until it had a chance to hear the case.
The Alliance for Hippocratic Medicine, an organization of anti-abortion doctors, filed the initial lawsuit in November 2022, saying the U.S. Food and Drug Administration did not properly vet the safety of mifepristone before approving it in 2000 or loosening restrictions in 2016 and 2022. In their filings, the FDA and Danco Laboratories, which produces mifepristone, point to decades of overwhelming evidence that shows the safety and efficacy of mifepristone.
But the arguments before the nine justices Tuesday focused primarily on the question of standing, or whether the Alliance for Hippocratic Medicine has sufficiently demonstrated that its members are harmed by mifepristone remaining on the market. While justices Samuel Alito and Clarence Thomas seemed convinced by the group’s claims, the others, including some of the conservative members of the court, repeatedly questioned whether the doctors who brought the lawsuit have actually had to treat patients suffering medical complications from taking mifepristone.
The justices also questioned whether removing mifepristone from the market was really the answer to these doctors’ concerns.
“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,” said Justice Neil Gorsuch, who was appointed by President Donald Trump in 2017.
The next frontier
When the U.S. Supreme Court overturned Roe v. Wade in June 2022, Justice Samuel Alito indicated his hope that allowing states to set their own abortion laws might remove the need for the high court to weigh in on the issue time and time again.
“Far from bringing about a national settlement of the abortion issue, Roe and Casey have enflamed debate and deepened division,” Alito wrote, referring to two landmark abortion rulings from 1973 and 1992, respectively. “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”
But less than two years later, the abortion issue is once again before the nine justices. While the question in this case is less fundamental than in the 2022 case that overturned Roe, the ruling would have widespread repercussions for abortion access nationwide.
Medication abortion, in which a combination of mifepristone and misoprostol are taken to terminate a pregnancy up to 10 weeks, is the most common abortion method in the United States. It is lower risk than a surgical procedure, and while patients can take just misoprostol alone, the two-drug regimen has been shown to be more effective and lower risk.
With abortion banned or significantly restricted in more than a dozen states, access to mifepristone has become the new focal point for both sides of the abortion fight. While it is illegal to mail abortion-inducing medication in Texas, international providers and out-of-state groups are still finding ways to get the pills to the people.
Timeline of the case
This is exactly what anti-abortion groups have been fighting against, almost since mifepristone was approved back in 2000. Initially, some of these groups filed a citizen petition challenging the approval in 2002. The FDA did not respond until 2016, rejecting the petition on the same day it announced new guidelines allowing the medication to be used through 10 weeks of pregnancy, instead of the original seven.
In 2019, the FDA approved a generic version of mifepristone, and then in January, after easing some requirements during the pandemic, the agency permanently lifted the in-person dispensing requirement, allowing the medication to be prescribed through telehealth appointments, dispensed at retail pharmacies and sent through the mail.
The anti-abortion groups argue that all of this was improper, starting with the 2000 approval. Last April, Kacsmaryk agreed, issuing an opinion laced with anti-abortion rhetoric, calling abortion providers “abortionists” and describing the medical procedure as “starv[ing] the unborn human until death.”
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”
Kacsmaryk’s ruling would have revoked mifepristone’s approval and taken it off the market in the United States. But before it could go into effect, the 5th U.S. Circuit Court of Appeals intervened, allowing mifepristone to stay on the market but undoing some of the newer regulations allowing for the provision of generic mifepristone and telemedicine prescribing. That’s when the Supreme Court stepped in and said nothing would change about mifepristone’s regulations until the case was resolved.
U.S. Solicitor General Elizabeth Prelogar argued Tuesday that the case should be thrown out on the grounds that the doctors who filed the lawsuit cannot demonstrate they were harmed by the FDA’s approval of mifepristone.
“They have to identify a specific doctor who faces imminent harm, but their theories rests on a long chain of remote contingencies,” Prelogar said. “Only an exceptionally small number of women suffer the kind of serious complications that could trigger any need for emergency treatment. It's speculative that any of those women would seek care from the two specific doctors who asserted conscience injuries. And even if that happened, federal conscience protections would guard against the injury the doctors face, and there's no basis to conclude that any of that would be traceable to the incremental changes that FDA made in 2016 and 2021, as opposed to the availability of mifepristone in general.”
The Alliance for Hippocratic Medicine has filed affidavits from seven doctors, three of whom point to specific circumstances in which they were asked to treat patients who were experiencing complications from medication abortion. Several of the justices honed in on why those doctors did not claim conscience protections, which protect medical providers from performing care that violates their strongly held beliefs.
Erin Hawley, chief legal counsel for the Alliance Defending Freedom, said the doctors they represent may be faced with a fast-moving, emergency situation in which they must “choose between helping a woman with a life-threatening condition and violating their conscience,” a choice she called “intolerable.”
“The difficulty here is that, at least to me, these affidavits do read more like the ... conscience objection is strictly to actually participating in the abortion to end the life of the embryo or fetus, and I don't read either [Dr. Ingrid] Skop or [Dr. Christina] Francis to say that they ever participated in that,” said Justice Amy Coney Barrett,
Alito repeatedly challenged Prelogar’s assertion that the doctors don’t have standing to challenge FDA’s approval, asking whether anyone would have legal standing to challenge the FDA. He presented several hypothetical scenarios -- a patient harmed by a drug, a doctor forced to treat someone with complications -- and asked Prelogar whether those situations would generate legal standing under to bring a lawsuit.
“I think that with respect to these regulatory changes, it's hard to identify anyone who would have standing to sue,” Prelogar responded.
“Your argument is that it doesn't matter if FDA flagrantly violated the law, didn't do what it should have done, endangered the health of women,” Alito asked. “It's just too bad. Nobody can sue in court.”
Prelogar disagreed, and said if “a drug were actually producing safety consequences,” there would be avenues to raise those concerns, including tort litigation. Jessica Ellsworth, the attorney for Danco, noted in her response that drug companies frequently face lawsuits related to their products, including product liability suits, failure to warn suits and deceptive advertising cases.
What is “revolutionary” about this case, Ellsworth said, is that it is brought by “individuals who do not use this product, do not prescribe this product and have a conscience right not to treat anyone who has taken this product,” who want to “prevent anyone else from using it in line with FDA’s considered scientific judgment.”
In the arguments Tuesday, Justice Ketanji Brown Jackson asked Ellsworth for her thoughts on judges overturning established agency precedent.
“Judges are not ... experts in statistics,” Ellsworth said. “They are not experts in the methodology used for scientific studies for clinical trials. That is why FDA has many hundreds of pages of analysis in the record of what the scientific data showed, and courts are just not in a position to parse through and second-guess that.”
Alito and Thomas also both raised the specter of a 150-year-old zombie law, the Comstock Act, which prohibits using the U.S. postal service to mail anything related to abortion. The law remains on the books, but has not been enforced for decades. Anti-abortion groups would like to see the Comstock Act used to regulate the mailing of abortion medication, but legal experts warn it could have much wider implications, potentially halting the mailing of anything medical.
In his original ruling, Kacsmaryk found that Comstock could prevent the medications from being sent through the mail, a view the 5th Circuit upheld. Alito asked Prelogar if FDA should have considered the Comstock Act when it allowed mifepristone to be prescribed through telehealth; she said assessing legal landmines was beyond the scope of the agency’s role when considering whether restrictions on certain medications were necessary.
“FDA was not affirmatively approving mailing in violation of Comstock, even if you interpreted it that way,” Prelogar said. “We don't think it means what respondents suggest it means, but at the very least, I don't think that it was FDAs responsibility to consider that, nor could it have permissively considered that under the statute.”
The arguments were laced with criticism for Kacsmaryk’s process in deciding this case, both from the justices and lawyers defending mifepristone’s approval. Ellsworth noted that several of the studies Kacsmaryk cited have since been retracted. Gorsuch raised this case as one example in a recent “rash of universal injunctions,” in which lower judges in one state issue rulings that block a law or reverse a regulation for the entire country.
“I went back and looked and there are exactly zero universal injunctions that were issued during Franklin Delano Roosevelt's 12 years in office,” Gorsuch said. “And over the last four years or so, the number is something like 60 and maybe more than that, and they're a relatively new thing.”
Gorsuch noted that it would be unusual for the Supreme Court to issue a nationwide injunction, saying it’s a method the “lower courts kind of run with.”
The Supreme Court is expected to rule before the court’s term ends in June.
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