US Supreme Court decision on challenge to mifeprostone

In 2000, the US Food and Drug Administration (‘FDA’) approved a new drug application for mifepristone tablets (marketed under the brand name Mifeprex) for use in terminating pregnancies up to seven weeks. In order to ensure that the drug would be used safely and effectively, FDA placed particular restrictions on its use and distribution. For example, only doctors could prescribe or supervise prescription of Mifeprex. In addition, patients were required to have three in-person visits with the doctor in order to receive the drug. In 2016, the FDA relaxed some of the restrictions: allowing use of the drug to terminate pregnancies up to ten weeks; allowing healthcare providers, such as nurse practitioners, to prescribe the drug; and approving an arrangement whereby one in-person visit was sufficient to receive the drug. In 2021, the FDA further relaxed the restrictions by announcing that it would no longer enforce the initial in-person visit requirement. Overall, the changes made it easier for doctors to prescribe and patients to obtain the drug. In 2022, four pro-life medical associations and several individual doctors sought a preliminary injunction that would require the FDA to either rescind approval of mifepristone or, at the very least, rescind its 2016 and 2021 regulatory actions. Prior to the hearing in the Supreme Court, the case was heard in the US District Court for the Northern District of Texas, and on appeal in the US Court of Appeals for the Fifth Circuit. The District Court accepted that the plaintiffs had the necessary standing to bring the case, that they were likely to succeed in all of their claims, and that an injunction removing the drug from the market would serve the public interest. The Appeal Court agreed that the plaintiffs had the necessary standing to bring the case. On the merits of the case, the court held that the plaintiffs were unlikely to succeed in their challenge to the FDA’s initial 2000 approval but were likely to succeed in showing that its 2016 and 2021 approvals were unlawful. The court agreed to injunctive relief that would allow the drug to continue to be marketed but only under the more stringent requirements imposed when the FDA first approved the drug in 2000. When the case came on for hearing in the Supreme Court, the issue as to whether the plaintiffs had the necessary standing to challenge the FDA’s actions regarding the regulation of mifepristone took centre stage. Giving the unanimous decision of the Court, Justice Kavanaugh referring to Article III of the US Constitution said that ‘standing’ is a ‘bedrock constitutional requirement’ that the Court had applied to all manner of important disputes’. Standing is based on the concept of ‘separation of powers’ between the three branches of government – executive, legislative and judicial. No principle is more fundamental to the judiciary’s proper role in the US system of government than ‘the constitutional limitation of federal-court jurisdiction to actual cases or controversies’. Federal courts are not an open forum for citizens ‘to press general complaints about the way in which government goes about its business’. In order to establish standing, a plaintiff must demonstrate (1) that he/she has suffered or likely will suffer an ‘injury in fact’, (2) that the injury was likely caused or will be caused by the defendant, and (3) that the injury would likely be redressed by the judicial relief sought. By requiring a plaintiff to establish an injury in fact, Article III standing screens out plaintiffs who might only have a general legal, moral, ideological, or policy objection to a particular government action. The plaintiffs in the present case were opposed elective abortion and had sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others. They themselves did not prescribe or use the drug. The FDA did not require them to do or refrain from doing anything. Recognising that their legal, moral and other concerns were insufficient in themselves to confer Article III standing to sue in a federal court, they advanced ‘several complicated causation theories’ in an effort to connect the FDA’s actions to their alleged injuries in fact. The Court ruled that none of those theories were sufficient to establish Article III standing. By way of example, the plaintiffs contended that the FDA’s relaxed regulation of mifepristone might cause downstream ‘conscience injuries’ to the individual doctors. Even assuming that the FDA’s 2016 and 2021 changes caused more pregnant women to require emergency abortions and that it was likely that some of those women would seek treatment from the plaintiff doctors, they had not established that they could be forced to participate in an abortion or provide abortion-related medical treatment contrary to their conscientious objections. Federal conscience laws definitively protect doctors from being required to perform abortions or provide other treatment that violates their consciences. Federal law also protects doctors from repercussions when they have ‘refused’ to participate in an abortion. The Court ruled that the Federal courts were not the appropriate forum for addressing the plaintiffs’ concerns about the FDA’s actions. It was open to them to present their concerns and objections to the President and the FDA in the regulatory process, or to Congress and the President in the legislative process. The Court reversed the judgment of the appeals court and remanded the case for further proceedings consistent with the Supreme Court decision. Reference: Ref 23-225 FDA v Alliance for Hippocratic Medicine (06/13/2024)