On April 7, 2023, only minutes apart, two federal district courts issued rulings on cases challenging the Food and Drug Administration’s regulations governing mifepristone, a key medication for women seeking an abortion. Both rulings faulted the FDA’s handling of the approval and its subsequent restrictions on the dispensing of mifepristone, but the two rulings came to very different conclusions as to what the availability of the drug should be.
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. The court then stayed its own order for seven days to allow the FDA to appeal to the U.S. Court of Appeals for the Fifth Circuit.
Just minutes later, Judge Thomas Rice of the U.S. District Court for the Eastern District of Washington issued a 31-page opinion ordering FDA and HHS not to make any changes to the availability of mifepristone under the current operative Risk Evaluation and Mitigation Strategy (REMS) program, which requires the drug to be prescribed and dispensed only by certified providers, among other requirements. Unlike Judge Kacsmaryk, whose injunction has nationwide effect, Judge Rice limited the effect of his order to only the 17 states and the District of Columbia who brought the challenge in his court. The 17 plaintiff states in this lawsuit are: Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington and the District of Columbia.
The most difficult-to-reconcile aspect of the two orders is the fact that Judge Kacsmaryk’s order is a nationwide stay of the drug’s approval, while Judge Rice’s order to maintain the status quo availability only applies to the specific plaintiffs. Notably absent from the Washington order’s applicability would be California, Massachusetts, New Jersey, New York, North Carolina, New Hampshire, and Virginia.
The FDA has appealed Judge Kacsmaryk’s order to the Fifth Circuit and is seeking an emergency stay of his order. Regardless of how that emergency stay request is adjudicated, the Fifth Circuit’s ruling will likely be immediately appealed to the U.S. Supreme Court. That appeal would take the form of an emergency appeal application to a single justice who would then refer the application to the full court for review. The current justice assigned to receive petitions from the Fifth Circuit is Justice Samuel Alito, the author of the majority decision in Dobbs.
While the FDA has not yet appealed Judge Rice’s order, on April 10, 2023 the FDA filed an expedited motion for the judge to clarify that his order requires FDA approval of mifepristone to stand unchanged, at least in the plaintiff states, despite Judge Kacsmaryk’s order. Hours later, the Plaintiff states opposed that motion to clarify and expedite.
As the deadline for Judge Kacsmaryk’s order to take effect approaches, the competing orders and the different procedural postures leave more questions than answers.
A Note on the Comstock Act
Judge Kacsmaryk’s opinion bolstered an argument that has also been made by the coalition of GOP attorneys general against retail pharmacies – that a nineteenth-century federal criminal law known as the Comstock Act prohibits the use of the U.S. Postal Service or a common carrier to distribute abortion medication.
The defendants argued that the 1870 morality law did not prohibit the shipment of mifepristone, pointing to a 2022 opinion from the U.S. Department of Justice’s Office of Legal Counsel (“OLC”).
That opinion informed the U.S. Postal Service’s General Counsel that the mailing of abortifacients to a jurisdiction that substantially restricts abortion would not be illegal if the shipper did not have the intent that the drug would be used for an unlawful purpose. The opinion reasoned that because a lawful abortion could be performed in any jurisdiction (e.g., under an exception for the life of the mother or at a federal installation), that, absent such intent, the mails could be utilized.
Judge Kacsmaryk’s opinion, however, rejects the OLC’s reasoning, pointing out that the “unlawful” intent element relied upon by OLC is not in the statute and instead was created through consensus view in caselaw. The court found the statute’s language is “plain” the consensus view is rejected in favor of the textual language: “In any case, the Comstock Act plainly forecloses mail-order abortion in the present, and Defendants have stated no present or future intention of complying with the law. Defendants cannot immunize the illegality of their actions by pointing to a small window in the past where those actions might have been legal.” Alliance for Hippocratic Medicine v. U.S. FDA, No. 2:22-cv-00223-Z, (N.D. Tex. Apr. 7, 2023) at *38.
The Comstock Act, a federal criminal law, has a five year statute of limitations. It is also a predicate to a civil or criminal RICO violation (the former which can be brought by private citizens). Now that a federal court has negatively opined on the merits of the OLC opinion, it seems harder to place reliance on it; raising the specter of a future Department of Justice prosecution based on today’s conduct. Note that Judge Rice did not address the Comstock Act in his opinion.
That said, the Comstock Act is perhaps not the significant obstacle its advocates would have you believe – as it only applies when using the U.S. Mail or a common carrier (e.g., UPS or FedEx) to ship in interstate commerce. It is not unusual, for example, for companies to have their own vehicles for local deliveries. In addition, if the federal government was so inclined, it could distribute mifepristone interstate itself (a not inconceivable prospect given previous discussions about abortion clinics on federal installations). In addition, arguably common carriers could be utilized if companies could somehow limit any shipping to hubs that cross state line – i.e., if common carrier shipments were not made interstate but only intrastate. There is at least one case that has held that Section 1462 of the Act would not implicate intrastate carriers. See, United States v. New Buffalo Amusement Corp., 600 F.2d 368 (2d Cir. 1979).
Reed Smith will continue to track the numerous expected developments related to these lawsuits and developments related to abortion laws around the country. For further information, please visit our Reproductive Health Working Group and Resource Center or reach out to the health care attorneys at Reed Smith.