Medication Abortion Litigation at the Supreme Court

This Feature Article is brought to you by AHLA's Life Sciences Practice Group.

June 21, 2024

Sheela Ranganathan , O'Neill Institute for National and Global Health Law, Georgetown University Law Center

Background

In 2000, FDA approved Mifepristone as one of two drugs to be used together for termination of pregnancies, medical management of miscarriage, and other evidence-based indications after determining that the drugs are safe and effective through its approval process. FDA approved the drug for use up to seven weeks of pregnancy, but also imposed certain Risk Evaluation and Mitigation Strategy (REMS)[4] restrictions which unnecessarily[5] imposed many barriers to accessing the drug.

Over time, FDA removed many of these restrictions under its authority to consider the drug’s safety and efficacy, which enabled patients to have greater access to Mifepristone. In 2016, FDA approved the drug for use up to 10 weeks of pregnancy, allowed non-physician providers like nurse practitioners to prescribe the drug, and allowed for the drug to be prescribed after one in-person visit instead of three.[6] In 2019, FDA approved a generic version of Mifepristone.[7] Finally, in 2021, FDA announced that it would relax more requirements for Mifepristone and its generic, including that it would no longer enforce the in-person visit requirement in light of COVID-19.[8]

Seeking to leverage opportunities to further restrict access to abortion care following Dobbs, the Alliance for Hippocratic Medicine (AHM) filed a lawsuit challenging FDA’s 2000 approval of Mifepristone, 2016 changes to the drug’s conditions of use, 2019 approval of the generic, and 2021 exercise of enforcement discretion.[9] At the district court, Judge Kacsmaryk issued a nationwide stay of the 2000 approval of the drug, finding FDA’s actions were arbitrary and capricious under the Administrative Procedure Act.[10] On appeal, the Fifth Circuit granted the government a stay regarding the 2000 approval of the drug but otherwise upheld the district court stay.[11] The government then requested the Supreme Court to both review the case and issue a stay of the district court order pending appeal.[12] The Supreme Court granted certiorari and stayed the entire district court order.

Supreme Court Reverses on Standing

Justice Kavanaugh wrote the opinion for a unanimous Court, finding that the doctors and associations did not have standing to bring the case. The opinion provided a comprehensive outline of Article III standing doctrine, noting that a plaintiff must have a personal stake in the dispute to ensure that courts “do not opine on legal issues in response to citizens who might “roam the country in search of governmental wrongdoing.” Though recognizing the plaintiffs had “legal, moral, ideological, and policy objections” to medication abortion, the Court ultimately held that each of their theories for standing failed, reversing the lower court decisions.

First, AHM argued that because more pregnant people might suffer from pregnancy complications as a result of improved access to medication abortion, doctors might be required to provide emergency abortion care against their conscience objections. The Court posited that under federal conscience laws, doctors would never be required to provide abortions or any other medical treatments that violated their consciences—even under emergency scenarios governed by the Emergency Medical Treatment and Labor Act (EMTALA). The Court concluded that because the federal conscience protections are so “broad and comprehensive,” AHM’s conscience objections theory failed.

Second, AHM asserted that it would suffer a variety of monetary and other injuries as a result of FDA’s actions, including that (1) treating patients with complications from Mifepristone might result in diversion of resources and time from other patients; (2) physicians may incur increased malpractice risk as a result of treating patients with such complications; and (3) physicians may face increasing insurance costs. The Court squarely rejected these arguments because “the chain of causation is simply too attenuated.” The Court noted that in the context of FDA approvals where almost all drugs come with some risk of complications and side effects, allowing this standing theory to proceed would “essentially allow any doctor or healthcare provider to challenge any FDA decision approving a new drug.”

Lastly, the Court considered AHM’s argument that the associations have organizational standing because FDA has “impaired their ability to provide services and achieve their organizational missions.” AHM argued that FDA compelled the organization to prepare studies on Mifepristone and “expend considerable time, energy and resources” on litigation, advocacy and public education. To this, the Court responded that “an organization that has not suffered a concrete injury caused by a defendant’s action cannot spend its way into standing simply by expending money to gather information and advocate against the defendant’s action.”

In addition, Justice Thomas wrote a concurrence asserting that the theory for associational standing raises constitutional concerns by “relaxing” the injury and redressability requirements under Article III. In particular, he noted, modern associational standing doctrine would allow an association to seek relief for its entire membership when just a single member has suffered an injury. Similarly, he expressed concerns that associations do not always present an injury that the court can remedy because the remedy must address the plaintiff’s injury. Justice Thomas noted that the courts have issued “universal injunctions” as a workaround to this remedy problem, and expressed criticism for such relief provided to non-parties. He concluded by noting that in the future, the Supreme Court should consider whether associational standing can be squared with Article III requirements in an appropriate case.

Takeaways

The FDA approvals for Mifepristone remain intact for now, but the case has been remanded to the district court where state attorneys general of Missouri, Kansas, and Idaho have intervened to participate in the litigation.[13] The state plaintiffs may be able to show standing under Article III—and consequently, may eventually get an opinion on the merits from the Supreme Court. Such a future holding on the merits could strike down FDA’s Mifepristone approvals.
If Justice Thomas’ concurrence on associational standing is endorsed by the Court, it may chill third party litigation by associations and organizations, which are the primary plaintiffs in many civil rights and abortion care cases. Many reproductive care cases are filed by doctors and associations attempting to protect their patients from potential repercussions such as stigma, criminal investigations, unwanted publicity, and violence. If these sorts of parties are restricted from bringing cases in federal court, many patients could lose an important channel for advocating for relief.
During oral arguments, Solicitor General Elizabeth Prelogar argued that the plaintiffs did not have standing because “federal conscience protections would guard against the injury the doctors face.” Adopting this reading of conscience protections, Justice Kavanaugh’s analysis expanded the reach of the Church Amendment,[14] allowing doctors the right not only to refuse to provide abortion or sterilization but also “the full range of medical care.” Under the opinion, physicians would be allowed to refuse to provide not just abortion but the full range of medical services to an individual who comes to a facility seeking abortion care.[15]
Though FDA’s approval of Mifepristone stands, there are many state laws that make the pill illegal or make it extremely difficult to access. For example, legislation has been passed in Louisiana and other states to reclassify medication abortion pills as dangerous controlled substances despite countless studies demonstrating that these drugs are extremely safe and have a very low risk of complications.[16] There is ongoing litigation to challenge these restrictions: in North Carolina, for example, a district judge recently struck down several restrictions that the state had imposed on the use of Mifepristone.[17] It is likely that the prevalence of these sorts of lawsuits will increase.
Because the opinion did not get into the merits, questions about whether and how the courts can override FDA’s expertise remain unanswered. This challenge to FDA, paired with the potential reversal of the Chevron Doctrine in another Supreme Court case[18] this term, could result in regulatory instability and could encourage the courts to play a heightened policymaking role in contradiction to separation of powers principles.