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March 29, 2024
Health Law Weekly

U.S. Supreme Court Oral Arguments on Abortion Pill Challenge Focus on Standing

  • March 29, 2024

The U.S. Supreme Court considered March 26 the first of two abortion-related challenges on its docket involving an action looking to significantly curtail access to the abortion pill mifepristone.

The bulk of the oral arguments focused on whether the plaintiffs—several emergency room doctors and the Alliance for Hippocratic Medicine—had Article III standing to upend the Food and Drug Administration’s (FDA's) regulatory regime for the drug.

Several Justices openly questioned whether the doctors bringing the lawsuit had shown a direct harm while others seemed dubious that a nationwide injunction was needed to redress the alleged injury—i.e., forcing the physicians to perform or complete an abortion contrary to their sincerely held beliefs as part of treating women suffering from mifepristone complications.

The Court granted review of the case in December 2023 following a Fifth Circuit decision finding the FDA improperly lifted certain restrictions on mifepristone that expanded access to the drug. Food and Drug Admin. v. Alliance for Hippocratic Med., No. 23-235, and Danco Labs., L.L.C. v. Alliance for Hippocratic Medicine, No. 236 (U.S. cert. granted Dec. 13, 2023).

The FDA approved the brand-name version of mifepristone in 2000 for medical termination of pregnancy up to seven weeks. In 2016, the FDA extended the drug’s availability through ten weeks gestation among other changes. The agency further loosened restrictions on the drug in 2021, including allowing mifepristone to be delivered by mail. Mifepristone and a second drug misoprostol account for about half of abortions nationwide.

The Fifth Circuit held the FDA’s actions in 2016 and 2021 regarding the drug likely violated the Administrative Procedure Act. Alliance for Hippocratic Med. v. Food and Drug Admin., No. 23-10362 (5th Cir. Aug. 16, 2023).

Conscience Protections

U.S. Solicitor General Elizabeth B. Prelogar argued that only a small number of women experience serious complications from medication abortions requiring them to seek emergency care, and that to the extent a scenario unfolded where the specific doctors would be faced with treating them, federal conscience protections would guard against the conscience injuries they asserted.

Both Justices Bartlett and Kavanaugh picked up on this thread in their questions, asking Prelogar to confirm that a doctor could invoke federal conscience protections to refuse to complete a medication abortion. Bartlett pointedly asked about the issue in the context of the Emergency Medical Treatment and Labor Act (EMTALA), which is a question the Court will consider in the second abortion-related case that it is slated to hear this term.

“The federal government has never taken the position that EMTALA would override an individual doctor's conscience objections . . . we disclaimed that understanding of EMTALA and made clear that we understand the conscience protections to continue to apply and shield a doctor who doesn't want to provide care in violation of those protections,” Prelogar said.

Justices Thomas and Alito pressed Prelogar about who would have standing to challenge the lawfulness of the FDA’s actions. “[W]ith respect to these regulatory changes, it's hard to identify anyone who would have standing to sue, but the Court has said time and again that the fact that no one would have standing doesn't provide a basis to depart from Article III principles,” Prelogar responded.

“So your argument is that it doesn't matter if FDA flagrantly violated the law, it didn't do what it should have done, endangered the health of women, it's just too bad nobody can sue in court?” Alito continued. Prelogar noted that the FDA “takes very seriously its responsibility to ensure the safety of drugs” and conducts ongoing surveillance, making adjustments to the regulatory regime as new information warrants. Moreover, drug sponsors remain responsible and can face costly product liability actions if they don’t respond appropriately, Prelogar added.

Erin M. Hawley, representing the doctors and medical group, argued that finding the physicians' lacked standing “would allow federal agencies to conscript non-regulated parties into violating their consciences and suffering other harm without judicial recourse.” Hawley repeatedly emphasized the emergency nature of the potential complications from medication abortion creates an “intolerable” Hobson’s Choice for the doctors between “helping a woman with a life-threatening condition and violating their conscience.”

According to Hawley, the FDA approved delivery of the drug by mail based on data it admitted was "not adequate." Hawley also told the Court the FDA acknowledged that "women are even more likely to need surgical intervention and other medical care without an in-person visit."

Comstock Act

Alito and Thomas also raised the specter of the Comstock Act, an 1873 law that bans sending “lewd” materials, including those that induce abortion, through the mail. The Department of Justice has declined to enforce the 151-year-old-law but a new administration may not follow that approach.

Prelogar said the FDA did not have to consider the statute in determining the safety and efficacy of drugs under the Federal Food, Drug, and Cosmetic Act.

Jessica L. Ellsworth, arguing on behalf of Danco Laboratories, LLC, which manufactures the brand-name version of mifepristone, also faced questioning on the Comstock issue, with Justice Thomas noting the statute could apply to the company’s mailing of the product.

Ellsworth disagreed about the statute’s application, adding that the Comstock Act “has not been enforced for nearly 100 years.”

Remedy “Mismatch”

Justice Jackson raised concerns about the “mismatch” between the claimed conscience injuries and the remedy that the lawsuit was seeking—i.e., preventing access to the drugs nationwide.

Justice Jackson asked why an exemption for the doctors from having to be involved in any abortion-related procedures wasn’t enough. “[W]hy isn’t [the] plainly overbroad scope of the remedy the end of this case?” Jackson added. 

Hawley again pointed to the emergency nature of the procedures as making it difficult for the doctors to object in the moment when their services are needed. “It could be a miscarriage, it could be an ectopic pregnancy, or it could be an elective abortion.” Hawley also argued that the government has not maintained a consistent position on the application of federal conscience protections in the EMTALA context.

Justice Gorsuch echoed a similar line of questioning as Jackson, noting the recent “rash of universal injunctions” rather than more tailored relief that is typical for equitable remedies. “[T]his case 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 action,” Gorsuch commented. 

Agency Expertise

Justices Sotomayor, Kagan, and Jackson also seemed skeptical that the courts were better positioned to evaluate and make judgment calls on the scientific evidence than the FDA. “[W]hat deference, if any, do courts owe the opinion of the expert agency concerning the safety and efficacy of drugs?” Jackson asked.

Jackson also noted arguments that “the lower courts actually relied on studies that have since been found discredited and removed.”

In April, the Court will hear oral arguments in the second abortion-related action, United States v. Idaho, No. 23-727 consolidated with Moyle v. United States, No. 23-726 (U.S. cert. granted Jan. 5, 2024), raising the issue of whether EMTALA preempts an Idaho law that criminalizes most abortions.