The Supreme Court on Tuesday signaled that it was likely to allow mifepristone, one of two drugs used in medication abortions, to remain widely available in the United States. During roughly 90 minutes of oral arguments, a majority of the justices appeared ready to throw out the dispute over the FDA’s expansion of access to the drug in 2016 and 2021 because the challengers in the case – several individual doctors and groups of doctors who are opposed to abortion on religious or moral grounds – do not have a legal right to sue, known as standing.
Tuesday’s argument was the first time that the justices had considered efforts to restrict abortion since their 2022 decision to eliminate the constitutional right to an abortion, in Dobbs v. Jackson Women’s Health Organization. After that ruling, 21 states either banned or significantly limited access to abortion. Medication abortions now account for more than half of all abortions performed in the United States, and a ruling in favor of the challengers in this case would restrict access to abortion even in the states where abortion is otherwise legal.
The case began in November 2022, when several individual doctors and groups made up of doctors opposed to abortion went to federal court in Texas. They challenged both the FDA’s initial approval of mifepristone in 2000 and a series of decisions by the FDA in 2016 and 2021 that expanded access to the drug – for example, allowing it to be used through the 10th week of pregnancy, authorizing health-care providers who are not physicians to prescribe it, and permitting it to be prescribed without an initial in-person visit.
The U.S. Court of Appeals for the 5th Circuit ruled that the challenge to the initial approval of the drug had come too late. But it rolled back the FDA’s 2016 and 2021 decisions that expanded access to the drug, pointing to flaws in the FDA’s decision-making process.
The FDA and Danco, which manufactures mifepristone, came to the Supreme Court last fall, asking the justices to review the 5th Circuit’s ruling. The justices agreed in December to take up the case. Meanwhile, the lower court’s ruling is on hold, so that mifepristone remains widely available until the challenge is resolved.
Most of the debate on Tuesday morning focused on whether the challengers have standing, so that the lawsuit can go forward. Representing the FDA, U.S. Solicitor General Elizabeth Prelogar told the justices that the lawsuit can only go forward if the challengers can identify a doctor who faces imminent harm as a result of the 2016 and 2021 changes. But the challengers’ standing argument, she contended, rests on a “long chain of remote contingencies”: Although they are not required to prescribe mifepristone, one of the individual challengers or the groups’ members would nonetheless have to treat women who had been prescribed mifepristone by someone else and then suffered complications, which are very rare. Particularly when federal laws provide an additional layer of protection for health-care providers who believe that providing certain kinds of treatment, such as care related to abortion, would violate their conscience, Prelogar concluded, the connection to the 2016 and 2021 changes is “too attenuated” for the challengers have a right to sue.
Some of the court’s more conservative justices were skeptical – most notably, Justice Samuel Alito, who pressed Prelogar to explain whether anyone would be able to sue to challenge the 2016 and 2021 changes. Even if the FDA acted unlawfully in making those changes, Alito said incredulously, “the American people have no remedy?”
Chief Justice John Roberts asked both Prelogar and Jessica Ellsworth, representing Danco, to identify a point at which an increase in the risks associated with mifepristone might be enough to confer standing. What percentage of adverse consequences would suffice, Roberts asked, or how many visits to the emergency room?
But several other justices seemed persuaded by Prelogar’s contention that the challengers had not alleged the kind of imminent injury required for standing, particularly when federal conscience exemptions are available for health-care providers who object to providing care relating to abortion. Justice Elena Kagan told Erin Hawley, who argued on behalf of the challengers, that her theory of standing sounded “very probabilistic.” When Hawley told Kagan that it was not, Kagan pressed her to provide an example of a health-care provider who could “meet the court’s regular standing requirements.”
Hawley pointed to a declaration by a doctor who said that she had been required to perform a procedure known as a dilation and curettage, which removes tissue from the uterus, “which she was required to perform due to a life-threatening emergency.”
But when, in response to questions, Hawley noted that the doctor had not objected to performing the procedure, Kagan observed that “most hospitals have mechanisms in place, routines in place to ensure that doctors who are allowed to do this … in advance.” But she had not seen anything in the declaration, Kagan continued, to suggest that the doctor had had to perform the procedure over her objection.
Justice Amy Coney Barrett also voiced skepticism that the conscience exemptions would not provide enough protection for health-care providers opposed to abortion. She told Hawley that she read the declaration that Hawley had cited as alleging that the physician had “performed a D&C on a woman who was suffering serious complications, but the fact that she performed a D&C does not necessarily mean that there was a living embryo or a fetus because you can have a D&C after … a miscarriage.”
“So, if that’s right,” Barrett continued, “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” of the doctors that Hawley cited “to say that they ever participated in that.”
Justice Brett Kavanaugh, who often provides the key vote on ideologically divisive cases, was relatively quiet on Tuesday, but he too focused on the scope of the conscience exemptions. “Just to confirm,” he asked Prelogar, “under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?”
“Yes,” Prelogar responded. “We think that federal conscience protections provide broad coverage here.”
Justice Ketanji Brown Jackson echoed the idea that the existence of the conscious exemptions undermined the challengers’ claim to standing. Jackson described what she characterized as a “significant mismatch” between the injury that the challengers claim and the 5th Circuit’s remedy. The challengers argue that they are injured by “being forced to participate in a medical procedure that they object to.” The “obvious common-sense remedy,” Jackson posited, in this case, “would be to provide them with an exemption,” but they already have that and are instead “seeking an order preventing anyone from having access to these drugs at all.”
Thomas was dubious about the groups’ claim to standing in their own right, known as organizational standing. The challengers contended (among other things) that the groups had been injured because they had had to divert their own resources in response to the FDA’s actions. But in a question for Hawley, Thomas asked whether that diversion wasn’t “just the cost of litigation?”
Hawley countered that the groups had been “forced to divert resources from speaking and advocating for their pro-life mission generally to explaining the dangers of the harm from abortion drugs.”
Thomas seemed unconvinced, however. “[T]hat would be anyone who is aggressive or vigilant about bringing lawsuits. Just simply by using resources to advocate their position in court, you say now, causes an injury. That seems easy to manufacture.” Seek help from a lawyer if you have suffered a birth injury.
The justices spent relatively little time on the merits of the challenge to the FDA’s actions. Alito, who along with Thomas dissented from the court’s decision last year to allow mifepristone to remain widely available while the challenge continued, was the challengers’ most vocal supporter. He asked Ellsworth whether she believed that “the FDA is infallible?” “Has the FDA,” Alito continued, “ever approved a drug and then pulled it after experience showed that it had a lot of really serious adverse consequences?” And he questioned the FDA’s decision to roll back the requirement that prescribers report complications from the drug, known as “adverse events,” that are not fatal. Wouldn’t Danco want data, he queried, about such complications?
Ellsworth responded that the FDA had “decided not to continue that reporting requirement in 2016 based on more than 15 years of a well-established safety profile when that reporting was required. There is no drug on the market today,” she stressed, “that requires the kind of reporting that the Plaintiffs are saying should be reimposed here.”
On the other end of the ideological spectrum, Jackson was more sympathetic. She asked Ellsworth whether “courts have specialized scientific knowledge with respect to pharmaceuticals.” “As a company that has pharmaceuticals,” she continued, “do you have concerns about judges parsing medical and scientific studies?”
Justice Neil Gorsuch had a different concern: the scope of the relief ordered by the 5th Circuit. Gorsuch, who has long been a critic of so-called nationwide, or universal, injunctions, emphasized that courts normally provide “a remedy sufficient to address the plaintiff’s asserted injuries and go no further.” But this case, involving a “handful of individuals” opposed to abortion, he told Hawley, “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 rule.”
In her rebuttal, Prelogar acknowledged the “profound mismatch” between the injury that the challengers are claiming and the remedy that the 5th Circuit ordered. “[W]hat the Court did to guard against that very remote risk” that a health-care provider will have to provide treatment despite the protections available to her “is enter sweeping nationwide relief that restricts access to mifepristone for every single woman in this country.” She urged the justices to reverse the 5th Circuit’s decision and send the case back to the lower courts “with instructions to dismiss to conclusively end this litigation.”
A decision in the case is expected by summer.
