This article was updated on June 13 at 2:20 p.m.
The Supreme Court on Thursday threw out a lawsuit seeking to roll back access to mifepristone, one of the two drugs used in medication abortions. In a unanimous decision, the court ruled that the doctors and medical groups challenging the expansion of access to the drug by the Food and Drug Administration in 2016 and 2021 lack a legal right to sue, known as standing. The justices did not reach the merits of the challenge – that is, they did not rule on whether the FDA acted properly in expanding access to mifepristone.
Writing for the court, Justice Brett Kavanaugh acknowledged what he characterized as the challengers’ “sincere legal, moral, ideological, and policy objections” to elective abortion “by others” and to FDA’s 2016 and 2021 changes to the conditions on the use of the drug. But the challengers had not shown that they would be harmed by the FDA’s mifepristone policies, he explained, and under the Constitution, merely objecting to abortion and the FDA’s policies are not enough to bring a case in federal court. The proper place to voice those objections, he suggested, is in the political or regulatory arena.
Thursday’s ruling means that mifepristone will continue to remain widely available in the United States, where it is used in over 60% of abortions by health care providers. The decision, however, does not necessarily foreclose another challenge to the FDA’s actions. Three states with Republican attorneys general – Idaho, Missouri, and Kansas – joined the dispute in the lower court earlier this year.
The decision came a little less than two years after the Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization, in which the court eliminated the constitutional right to abortion. In the wake of that decision, 21 states either banned or significantly limited access to abortion.
A few months after the court’s decision in Dobbs, the challengers in this case – several individual doctors who are opposed to abortion on religious or moral grounds, as well as medical groups whose members are opposed to abortion – went to federal court in Texas. Arguing that mifepristone is unsafe and that the process that the FDA used to approve the drug was flawed, they asked U.S. District Judge Matthew Kacsmaryk to rescind both the FDA’s initial approval of the drug in 2000 and its expansion of access to the drug in 2016 and 2021.
The FDA, as well as several leading medical groups like the American College of Obstetricians and Gynecologists and the American Medical Association, pointed to extensive evidence that mifepristone is safe and effective. But citing “legitimate safety concerns,” Kacsmaryk suspended the FDA’s approval of the drug and the agency’s later changes to the conditions on the use of the drug, which included allowing the drug to be used through the 10th week of pregnancy, allowing health-care providers who are not physicians to prescribe the drug, and permitting it to be prescribed without an in-person visit.
The FDA and Danco, which manufactures mifepristone, appealed to the U.S. Court of Appeals for the 5th Circuit, which ruled that the challengers had filed their lawsuit seeking to invalidate the FDA’s initial approval of the drug too late. But it upheld the part of Kacsmaryk’s ruling that rolled back the expanded access to mifepristone.
The Supreme Court put the 5th Circuit’s ruling on hold, ensuring continued access to the drug, and in December it agreed to weigh in. On Thursday, it reversed the lower court’s ruling and sent the case back to the lower courts.
Kavanaugh began his 25-page opinion with a quote from the late Justice Antonin Scalia summarizing the core of the constitutional doctrine of standing. A plaintiff, Scalia wrote, must “first answer a basic question: What’s it to you?” Moreover, Kavanaugh continued, a plaintiff needs to show that the defendant caused the injury that she is complaining about.
Applying these rules, Kavanaugh rejected each of the “complicated causation theories” that the challengers offered to try to “connect FDA’s actions” to the injuries that the challengers were asserting. He first rebuffed the challengers’ contention that the FDA’s 2016 and 2021 decisions that expanded access to the drugs injure them because, although they are not required to prescribe mifepristone themselves, they could be required to provide emergency treatment to women who obtain the drug from other health-care providers and then suffer complications. Kavanaugh agreed that “doctors would have standing to challenge a government action that likely would cause them to provide medical treatment against their consciences” But because federal laws “definitively protect doctors from being required to” do so, Kavanaugh emphasized, the challengers cannot show that the FDA’s actions will harm them. (And indeed, Kavanaugh observed, the challengers had not pointed to any case in which a doctor who is opposed to abortion had actually been required to perform one or provide other care that would violate her conscience.)
Kavanaugh similarly rebuffed the challengers’ contention that having to treat patients who have suffered complications will injure them in other respects, such as diverting resources, increasing the likelihood that they will be sued, and potentially increasing their insurance costs. The link between the FDA’s actions and those potential injuries, Kavanaugh said, “is too speculative or otherwise attenuated to establish standing.”
And if the challengers here were allowed to sue based on this theory, Kavanaugh cautioned, it could open the door to a wide range of lawsuits challenging “almost any policy affecting public health”: Emergency-room doctors might try to challenge an increase in the speed limit on the ground that it would require them to treat more car-accident victims, while trauma surgeons might challenge the repeal of gun restrictions, Kavanaugh posited, on the ground that they might have to operate on more gunshot victims. Such an “unprecedented and limitless approach,” Kavanaugh continued, could sweep even more broadly – for example, resulting in lawsuits by teachers in states near the U.S.-Mexico border to challenge immigration policies that lead to overcrowded classrooms. “We decline to start the Federal Judiciary down that uncharted path,” Kavanaugh admonished, which would “seemingly not end until virtually every citizen had standing to challenge virtually every government action that they do not like.”
Kavanaugh also turned down the medical groups’ bid for standing on behalf of their members – a doctrine known as associational or organizational standing. Although the groups argued that the FDA had “‘impaired’ their ‘ability to provide services and achieve their organizational missions,’” because they had had to spend money to oppose the FDA’s actions – for example, by conducting their own studies on mifepristone and by drafting citizen petitions to the FDA – that they could have spent on other things, that was not, in the court’s view, enough to give the groups a legal right to sue.
Finally, Kavanaugh dismissed any suggestion that the challengers “must have standing because if these plaintiffs do not have standing, then it may be that no one would have standing to challenge FDA’s 2016 and 2021 actions. For starters,” Kavanaugh observed, “it is not clear that no one else would have standing to challenge” the FDA’s actions. But even if that were the case, he continued, the prospect that no one would otherwise have standing is not a reason to conclude that a particular set of challengers must have standing. “Rather,” Kavanaugh concluded, “some issues may be left to the political and democratic processes: The Framers of the Constitution did not ‘set up something in the nature of an Athenian democracy or a New England town meeting to oversee the conduct of the National Government by means of lawsuits in federal courts.’”
Justice Clarence Thomas filed a concurring opinion in which he urged the court to reconsider the doctrine of associational standing altogether. “Despite its continued reliance on” that doctrine, Thomas argued, the Supreme Court has “yet to explain how the doctrine comports with” the Constitution.
The case now returns to the lower courts, and the dispute over access to the drug likely is not over. In a press conference shortly after the ruling, Erin Hawley – who argued the case on behalf of the challengers – indicated that the three states that had joined the case would remain in it, and that the case “presumably will continue.”
Nancy Northrup, the president and CEO of the Center for Reproductive Rights, praised the decision but conceded that the dispute could continue even after Thursday’s ruling. She, too, noted that the three states “could still attempt to keep the case going, including taking it back up to the Supreme Court,” and she warned that access to mifepristone “is still at risk nationwide.”
The justices have not yet ruled on another pair of cases involving abortion: Moyle v. United States and Idaho v. United States, involving whether emergency rooms in Idaho can provide abortions to pregnant women in an emergency. Those cases were argued in late April; a decision could come at any time.
This post is also published on SCOTUSblog.
