In a unanimous ruling, the U.S. Supreme Court dismissed a challenge to the Food and Drug Administration’s 24-year-old approval of mifepristone, a common gynecological drug also used for medication abortion, ruling that the plaintiffs did not have legal standing to bring the suit in the first place. The ruling keeps mifepristone legal across the country — at least for now.
Under the Constitution, a plaintiff must be suffering some concrete injury to bring a federal lawsuit. In the mifepristone case — FDA v. Alliance for Hippocratic Medicine — the suit was brought by a collection of anti-abortion advocates, some of them doctors, who neither provide abortion care nor prescribe mifepristone. Nonetheless, they claimed that somehow, someday they may be forced to treat a patient suffering complications from taking mifepristone, which they said granted them the right to sue.
The Supreme Court didn’t buy it. “The plaintiffs do not prescribe or use mifepristone,” and the FDA approval doesn’t require them to do so, Justice Brett Kavanaugh wrote for the court. “Rather, the plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain.” Their desire to make the drug “less available for others does not establish standing to sue.”
The plaintiffs have long made the demonstrably false claim that mifepristone is frighteningly unsafe — indeed, research making this claim was recently retracted by its publisher. Kavanaugh’s opinion seems to acknowledge what mainstream medicine and science have said about those claims: that mifepristone is safe, and there is no evidence that the FDA’s actions have led to increased safety issues or drug complications.
Although the court made quick work of dismantling the Alliance’s claims, the future legal status of mifepristone is most certainly still in the crosshairs.
In January, the states of Missouri, Kansas, and Idaho sought to intervene in the Alliance lawsuit, arguing that they have standing to sue because of their “quasi-sovereign interest” in protecting the “health and welfare of women and girls in their states” against the dangers of mifepristone so recklessly ignored by the FDA. Their effort to join in the legal action before the Supreme Court was denied, but their efforts at intervention are still alive in the lower courts.
In statements just after the Supreme Court’s Thursday morning ruling, the attorneys general of Kansas and Missouri vowed to press their case. “We are moving forward undeterred with our litigation to protect both women and their unborn children,” Missouri Attorney General Andrew Bailey said.
And Idaho is fighting to roll back abortion access in other ways as well. Still outstanding from the Supreme Court this term is a ruling in another consequential case — Idaho v. United States — where the state is challenging long-standing federal law that requires hospitals to provide whatever emergency medical treatment is necessary to stabilize a patient, including abortion. That opinion is expected later this month.
A Cynical Endeavor
Mifepristone is the first drug in the standard two-medication abortion protocol. The FDA approved the drug in 2000 for use in early pregnancy termination. Mifepristone, which blocks the hormone progesterone (needed to maintain pregnancy) and softens the uterine lining, is taken first. The second drug, misoprostol, is taken 24 to 48 hours later and causes the uterus to contract, expelling the pregnancy. Medication abortion accounted for just 5 percent of abortions in 2001 and has since grown — particularly in the wake of the Supreme Court’s 2022 Dobbs decision — and now accounts for more than 60 percent of all abortions in the U.S. The protocol is also commonly used in miscarriage management.
Over the years, the FDA has loosened restrictions around mifepristone — including increasing the window for its use up to 10 weeks into pregnancy and doing away with a requirement that doctors dispense the drug in person (after all, there is no such requirement for dispensing misoprostol, which actually causes the abortion, and is taken later, at the time and place of the patient’s choosing). The FDA subsequently expanded access by allowing mail-order and brick-and-mortar pharmacies to dispense mifepristone to patients with a prescription in states where abortion is legal.
The anti-abortion groups at the heart of the Alliance lawsuit didn’t like any of these developments and have long claimed — devoid of any scientific backing — that mifepristone is a uniquely dangerous drug and instead of being liberalized should be banned altogether.
From the jump, the Alliance suit was a cynical, propagandistic endeavor. The Alliance is an umbrella organization made up of the American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical & Dental Association, the American College of Pediatricians, the Catholic Medical Association, and the Coptic Medical Association of North America. The members of these five well-known affinity groups have long been vocal about their anti-abortion views.
The Alliance itself, however, is new: It incorporated in Texas’s Panhandle just three months before filing its lawsuit there — an obvious ploy to draw federal Judge Matthew Kacsmaryk, a far-right darling, who is the lone judge in Amarillo tasked with hearing cases filed in the area. Kacsmaryk did not disappoint: In a raving opinion lifted from the pages of an anti-abortion talking-point glossary, he said the groups and their individual plaintiff doctors had the right to sue, and he issued a sweeping nationwide injunction that would block anyone, anywhere from using mifepristone for any reason.
The federal government appealed to the 5th U.S. Circuit Court of Appeals, which ultimately disagreed that mifepristone should be banned altogether, but did block the FDA’s more recent moves to increase its availability. In other words, the appeals court ruled that mifepristone could only be available under the most stringent of rules, rolling back the widely accepted medical standard of care. The FDA again appealed to the Supreme Court, which heard oral arguments in the case in March.
Dubious Arguments
Before the court, Erin Hawley, a lawyer with the far-right Alliance Defending Freedom, which represents the Alliance for Hippocratic Medicine, struggled to present a cogent argument for why her clients had standing to sue. The gist of it went something like this: Mifepristone is so wildly dangerous that patients suffering complications are going to be flooding medical facilities and inundating providers. Eventually one of those patients will maybe — probably? — come to a member of one of the Alliance’s organizations, forcing the doctor to participate in providing an abortion, even if only tangentially.
The organizations themselves were also directly harmed by the FDA’s approval of mifepristone, she argued, because they were forced to divert resources from their other anti-abortion priorities and to instead channel them into fighting against the FDA and commissioning studies claiming mifepristone is a deadly drug.
Hawley also leaned into the argument that the zombie law from 1873 known as the Comstock Act, which forbids the mailing of “every article or thing” that could be used for abortion, bars the freer distribution of mifepristone. Mifepristone, she noted, certainly fits in the category of banned items.
In its 9-0 opinion, the court was mum on the Comstock question. Somewhat surprisingly, Justice Clarence Thomas did not mention it in his concurring opinion either, after having referenced it during oral arguments, as did Justice Samuel Alito.
Instead, the court focused on Alliance’s standing arguments — and dismissed the case on those grounds. The organizations that make up the Alliance had not shown any concrete injury from the FDA’s approval, and it “cannot spend its way into standing simply by expending money to gather information and advocate against the defendant’s action,” Kavanaugh wrote. “An organization cannot manufacture its own standing in that way.”
The court also readily dismissed the notion that any of the individual doctors had standing to sue. Their arguments were too speculative and tenuous to hit the mark. “Because the plaintiffs do not prescribe, manufacture, sell, or advertise mifepristone or sponsor a competing drug, the plaintiffs suffer no directly monetary injuries from the FDA’s actions relaxing regulation of mifepristone,” Kavanaugh wrote. “Because the plaintiffs do not use mifepristone, they obviously can suffer no physical injuries from FDA’s actions relaxing regulation of mifepristone.”
Notably, the court’s opinion nodded to mifepristone’s safety by acknowledging that the plaintiffs presented no evidence suggesting that the FDA’s actions both increased the number of patients seeking them out for treatment and caused them to divert attention from other patients. Nor have they identified “any instances” from the past where they were sued or where their insurance costs increased because they’d treated pregnant patients “suffering mifepristone complications,” he wrote. “Nor have the plaintiffs offered any persuasive evidence or reason to believe that the future will be different.”
The case now goes back to the 5th Circuit, with a mandate to follow the high court’s ruling.
