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The Supreme Court seemed likely to preserve access to the widely used abortion pill mifepristone (Mifeprex), in the court’s first abortion case since it overturned Roe v. Wade 2 years ago.
During oral arguments on Tuesday, justices appeared skeptical of the plaintiffs’ case for a lawsuit that questions whether the FDA overlooked safety concerns when it eased restrictions on access to mifepristone, which is now used in nearly two-thirds of abortions in the U.S.
One of the main obstacles for the plaintiffs — a group of anti-abortion doctors — is to demonstrate that they have “standing”; in other words, in order to have a legal right to sue they must demonstrate that they’ve been harmed by FDA’s actions.
If the court were to decide the plaintiffs had no standing, current access to mifepristone would remain in replace, namely prescriptions would not require an in-person visit with a physician, could be distributed by mail, and could be dispensed up to the gestational age of 10 weeks.
On that point, Justice Ketanji Brown Jackson zeroed in on what she saw as a “significant mismatch” between the injury claimed by the plaintiffs and the remedy being pursued.
The injury that’s alleged is a “conscience-induced injury,” Jackson said, referring to physicians who oppose abortion having to treat patients who have complications after using the drug. “So, the obvious common-sense remedy would be to provide them with an exemption that they don’t have to participate in this procedure,” she added, noting that federal law already allows for such exemptions.
But the plaintiffs go even further, Jackson said. “They’re saying because (they) object to having to be forced to participate in this procedure, (they’re) seeking an order preventing anyone from having access to these drugs at all.”
Solicitor General Elizabeth Prelogar, who represents the government in the case, agreed, noting that there is a “profound mismatch” given the existence of a “specifically tailor-made guard against the risk of that injury occurring.”
Justice Elena Kagan also questioned the plaintiffs’ standing, describing it as “very probabilistic.” She summarized the opening statement of Erin Morrow Hawley, the attorney representing one of the plaintiffs, the Alliance for Hippocratic Medicine, in this way: A lot of women take mifepristone, a fraction of those women will have adverse events, and a fraction of those will go to the emergency department.
Because the Alliance represents a lot of doctors, Kagan said, “there’s some probability or likelihood that one of (the) doctors who has a conscience objection is going to come face-to-face with one of these women who has an adverse event.”
And Kagan too stressed that to have standing, a person needs to have been harmed.
Kagan asked about the “imminent injury” that physicians might endure, and Hawley referred to Christina Francis, MD, who in legal documents described having to complete an abortion, specifically a dilation and curettage.
Asked whether Francis had the opportunity to object, Hawley said that in these life-threatening situations, having to “scrub out” and find another doctor is a difficult choice to make, particularly if a woman is hemorrhaging.
But Kagan noted that “most hospitals have … routines in place to ensure the doctors … are allowed to do this … in advance … and are allowed to do it at the moment.”
While the court did not entertain in-depth discussions of the FDA’s 2000 approval of mifepristone, Jackson raised the issue of “deference” — the principle that courts typically defer to agencies that have the expertise and competence to assess a subject; for example, public health.
Jackson asked Prelogar whether she had “concerns about judges parsing medical and scientific studies.”
Prelogar indicated that she did, pointing out that “you have a district court that, among other things, relied on one study that was an analysis of anonymous blog posts.” She noted that other studies used as the basis for earlier decisions in this case have since been retracted “for lack of scientific rigor, and for misleading presentations of data.”
“Those sorts of errors can infect judicial analyses precisely because judges are not … experts in statistics. They are not experts in the methodology used for scientific studies, for clinical trials,” Prelogar said. The FDA itself has “many hundreds of pages of analysis” in the administrative record to explain what the scientific data showed with regard to mifepristone’s safety and efficacy.
“Courts are just not in a position to parse through and second guess that data,” she argued.
Part of a two-drug combination with misoprostol, mifepristone is the most commonly used medication for abortion. While misoprostol alone is safe and effective, it is not as effective as the two-drug regimen.
The plaintiffs initially sought to revoke mifepristone’s full approval, and in April 2023, Judge Matthew Kacsmaryk, a Trump-appointed federal judge, suspended the approval.
But later that month that ruling was in part overturned. The three-judge panel for the Fifth Circuit Court of Appeals in New Orleans determined that the statute of limitations barred the plaintiff from challenging the drug’s approval, but held that the Alliance for Hippocratic Medicine could still challenge the FDA’s loosening of some of the drug’s original restrictions.
Going back to the original restrictions would require anyone seeking the drug to have an in-person visit with a physician, roll back the gestational limits from 10 weeks to 7 weeks, and ban mifepristone distribution by mail, which the FDA allowed starting in 2021. The decision would also return the labeling of generic mifepristone — which accounts for two-thirds of the available supply of the drug — to a time that predates its approval.
However, the Supreme Court preserved access to mifepristone, at least temporarily, by granting an “emergency stay,” stopping these restrictions from taking effect.
