On The Docket
On January 2, 1973, the Supreme Court of the United States (SCOTUS) ruled, in Roe v. Wade, that during approximately the first trimester of pregnancy, “the attending physician, in consultation with his patient, is free to determine, without regulation by the State, that, in his medical judgment, the patient’s pregnancy should be terminated.”
On June 24, 2022, SCOTUS ruled, in Dobbs v. Jackson Women’s Health, that “The Constitution does not prohibit the citizens of each State from regulating or prohibiting abortion.”
The Dobbs case overrules Roe, but it does not return abortion practices to pre-Roe days, because the majority of abortions currently are conducted with medication rather than through a procedure.
An emerging body of lawsuits assert challenges to medication abortion. Courts must consider whether the challengers have standing to sue. To access federal courts, the challengers cannot be mere bystanders, but instead must have a personal stake in the dispute.
Background
In 2000, FDA approved mifepristone to terminate pregnancies up to 7 weeks, with restrictions. Only physicians were allowed to prescribe mifepristone, and patients had to make three in-person visits to the prescriber. FDA required reporting of serious adverse effects to the drug sponsor, who was required to report them to FDA.
In 2011, FDA implemented a mifepristone REMS requiring in-person dispensing, prescriber certification, and documentation of patient counseling and consent.
In 2016, FDA deemed mifepristone safe to terminate pregnancies up to 10 weeks rather than 7 weeks, the dosing regimen reduced the required in-person visits to one, and non-physician prescribers were allowed to order mifepristone. Prescribers were required to report only fatal adverse effects.
In 2021, FDA relaxed mifepristone restrictions due to the COVID-19 pandemic, permanently ending the in-person dispensing requirement.
In 2023, FDA issued a new REMS that allows pharmacies to dispense mifepristone either at a physical location or by mail. Pharmacies must be specially certified to ensure compliance with safe use restrictions.
The mifepristone approval challenge
On June 13, 2024, SCOTUS ruled, in FDA v. Alliance for Hippocratic Medicine, that the plaintiffs (“several pro-life doctors and associations”) did not have standing to challenge FDA approval of mifepristone. The unanimous opinion of the Court was delivered by Justice Kavanaugh.
The opinion says, “We recognize that many citizens, including the plaintiff doctors here, have sincere concerns about and objections to others using mifepristone and obtaining abortions. But citizens and doctors do not have standing to sue simply because others are allowed to engage in certain activities—at least without the plaintiffs demonstrating how they would be injured by the government’s alleged under-regulation of others.”
The mifepristone REMS challenge
On July 24, 2024, the 9th Circuit US Court of Appeals ruled, in State of Washington v. FDA, that a coalition of seven states led by Idaho could not intervene in a lawsuit against FDA that was initiated by a different coalition of 18 states led by Washington.
The 18-state coalition challenges the mifepristone REMS as too restrictive, while the seven-state coalition challenges the mifepristone REMS as not restrictive enough. The court followed the SCOTUS ruling cited above, concluding that “none of the allegations contained in Idaho’s complaint constitute a cognizable injury-in-fact to the state’s own interests.” The court ruled that the seven-state coalition “does not have standing in this case to challenge the 2023 REMS.”
Takeaways
These legal cases, taken together, indicate that only those parties with “standing” will be allowed access to the federal courts to challenge mifepristone availability. “Bystanders” cannot legally challenge the abortion-related activities undertaken by others. Quoting the late Justice Antonin Scalia, Justice Kavanaugh noted that the Constitution requires a plaintiff to first answer a basic question: “What’s it to you?” ■