The U.S. Supreme Court heard arguments yesterday in the two consolidated cases challenging the U.S. Food and Drug Administration (FDA) approval of mifepristone. Throughout the questioning, the Justices focused on both the standing of the plaintiffs to bring the cases and on the suitability of the remedy sought.

The Court is expected to rule on the case in late June or early July. Although the Court has a 6-3 majority of justices appointed by Republican presidents, the questioning by the justices and the areas that they focused on seemed to indicate that any judicially-imposed limitations on both the FDA’s approval of the drug and the FDA’s current restrictions on the dispensing of mifepristone may be narrow.

At different times during the argument, both liberal and conservative Justices mixed together in the thrust of their questions in a way that could result in this case being a close decision with many different opinions or even resulting in a majority decision that would allow continued dispensation of the drug due to standing considerations.

Justices Questioned Standing

In particular, the Justices questioned whether any of the plaintiff physicians or the Alliance for Hippocratic Medicine (AHM) had particular injuries that they had undergone or would imminently undergo as a result of the FDA’s actions. During their questioning, the Justices seemed skeptical of the standing arguments advanced by AHM.

Justices Alito and Thomas, however, pushed Solicitor General Elizabeth Prelogar, who was arguing the case on behalf of the FDA, on whether anyone at all would have standing to challenge the FDA’s approval of mifepristone if the court accepted the government’s argument that the plaintiffs lack standing. Prelogar countered that a lack of any person having standing to sue doesn’t vitiate the requirement under Article III that a litigant show a cognizable injury prior to bringing suit.

Conscience Objections at Issue

One of the primary aspects of the standing arguments during the hearing was whether a physician with a conscience objection to performing an abortion would be required to assist an individual who was suffering from an adverse event as a result of taking mifepristone. Erin Hawley, arguing on behalf of AHM and the doctors, indicated that the emergency nature of care that may have to be provided to pregnant individuals meant that many physicians didn’t have the opportunity to properly assert their objections.

However, questioning from Justices Barrett and Kavanaugh explored whether the pre-existing federal conscience protections would provide physicians with sufficient cover. Prelogar indicated that hospitals already have procedures in place to provide sufficient staffing to deal with conscience objections.

Nationwide Injunction

The concept of a nationwide universal injunction, an issue which has come up many times in cases in recent years, featured prominently during the arguments. Justice Jackson, in her questioning of Hawley, asked why the objections of the plaintiffs should result in the drug being made unavailable to all physicians and pregnant individuals nationwide.

Justice Gorsuch picked up on that thread and expressed his disapproval of such methods, emphasizing that the court should provide sufficient relief to the parties before it without attempting to institute a nationwide ban on the use of the drug.

He further noted that plaintiffs are asking for a relatively new kind of relief, one that was never issued during the 12 years FDR was in office, and a kind that–even though the lower courts may have issued dozens of times recently–the Supreme Court has never granted.

Comstock Act

The one lurking issue in this case beyond the legal procedural grounds on which it will likely be decided was the existence of the Comstock Act. That nineteenth century law makes it a crime to ship any drug or device in the U.S. Mail (or in interstate commerce via common carrier) that could be used to cause an abortion.

Early on in the argument, Justice Thomas pressed Prelogar about the existence of the Comstock Act and she indicated that it didn’t apply to the FDA approval process. Additionally, as Justice Thomas later acknowledged, the federal government would have sovereign immunity from suit even if it did apply.

When Jessica Ellsworth, the attorney for the drug manufacturer Danco, took questions, Justice Thomas returned to the Comstock Act and indicated his belief that the company shipping its pills to physicians would violate the law.

Our view is that Thomas will likely write a separate opinion on Comstock, a subject that many anti-abortion commentators have focused on in recent months.  Note that Comstock liability can arguably be avoided by not using the United States Postal Service or common carriers.

Case Background

In April 2023, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a 67-page opinion ordering that the FDA’s initial approval of the drug, which was approved in 2000, should be stayed pending the court’s full review of the merits of the case. (We wrote another blog post on that case and the other pending mifepristone cases at the time).

That decision was then appealed to the U.S. Court of Appeals for the Fifth Circuit. The Fifth Circuit reversed Kacsmaryk’s order in part, leaving intact only the portion of the order that vacates the FDA’s 2016 and 2021 amendments to the mifepristone risk and evaluation mitigation strategy (REMS) program. All of the parties sought review from the Supreme Court, with the FDA and Danco seeking to have the lower court decisions overturned completely, allowing the FDA’s current approval and restrictions to remain in effect.

AHM sought to have the Fifth Circuit’s opinion reversed and to have Judge Kacsmaryk’s opinion reinstated in full, which would effectively prevent mifepristone from being sold or marketed, as it would stay the FDA’s original 2000 approval of mifepristone.

The Supreme Court, in an earlier order, stayed the effect of all of the lower court decisions pending the outcome of the Supreme Court’s review of the case.

Reed Smith will continue to track developments on the regulation of medication abortion in particular and abortion restrictions in general. If you have any questions, please reach out to the authors or to any of the health care lawyers at Reed Smith.