Seyfarth Synopsis: In an anticipated decision, released late on Friday April 7, 2023 of the Easter weekend, Texas District Court Judge Kacsmaryk has halted the FDA’s approval of Mifepristone. While in Washington State, District Court Judge Thomas Rice granted a motion to enjoin the FDA from altering the status quo related to Mifepristone.

Mifepristone was approved by the FDA in 2000 and has been used, along with Misoprostol, to induce medication abortions ever since. More than half of the abortions in America are performed through medication (instead of surgery). We have been monitoring dueling actions filed against the FDA in Texas (asking that the FDA’s approval of Mifepristone be revoked) and in Washington (asking that the FDA remove its restrictions on the use of Mifepristone).

As a result, the outcome of these decisions would have the biggest impact on abortion rights since Dobbs overturned Roe, by potentially taking safe and effective medication abortion out of the hands of the states where the Dobbs court said it should reside.

Texas Decision

The lengthy Texas decision, released late on Friday April 7th, found the FDA rushed its approval of the drug in 2000 (a process which took 4 years) and stonewalled judicial review of its decision in the intervening years. This district court decision results in a nationwide ban on prescribing and dispensing Mifepristone.

The plaintiff in the case, the Alliance for Hippocratic Medicine incorporated itself in Amarillo, Texas shortly before filing the case in the Northern District of Texas, where Judge Kacsmaryk is the only judge. It is widely believed the plaintiffs engaged in what is known as “judge shopping” and engineered this path to secure an injunction, something Judge Kacsmaryk has bristled at.

It is expected that the FDA will appeal the decision to the Fifth Circuit within the seven-day window before the decision goes into effect.

Washington Decision

In the Washington case, plaintiffs had asked the court to affirm the FDA’s determination that Mifepristone if safe and effective, enjoin the FDA from removing the drug from the market, and remove unnecessary and burdensome restrictions added to its use in January 2023. The court found the plaintiffs had standing to bring the case and satisfied the irreparable harm standard for relief.

The court then issued a status quo preliminary injunction while the matter proceeds on the merits. As a result, the FDA is “preliminarily enjoined from altering the status or rights of the parties under the operative Mifepristone REMS Program until a determination on the merits.” However, the court declined to issue a nationwide injunction and limited the order to the “Plaintiff States”. The Plaintiff States are identified as Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania and the District of Columbia.

The dueling Federal District Court cases with opinions issued on the same day is unprecedented. Stay tuned for further developments.