U.S. Court in West Virginia Refuses to Stay Generic Drug Maker’s Challenge to Abortion Ban
- April 28, 2023
GenBioPro Inc., which manufactures the generic version of the abortion pill, mifepristone, can proceed with its lawsuit challenging West Virginia’s near-total ban on abortions, a federal court in the state ruled April 21.
The U.S. District Court for the Southern District of West Virginia refused to stay the action after a federal judge in Texas upended the Food and Drug Administration’s (FDA’s) approval of the drug. A Fifth Circuit panel only partially stayed the injunction, allowing additional restrictions on mifepristone to remain in place. The U.S. Supreme Court ultimately stepped in and stayed the entire injunction while the challenge to the abortion pill plays out.
“The Court finds it inadvisable to stay based upon a district court opinion granting a preliminary injunction, which merely forecasts that FDA approval of generic mifepristone may eventually be set aside,” the district court in West Virginia said in an order issued April 21. Decisions from the Northern District of Texas and the Fifth Circuit are not binding on the court, the opinion noted.
In addition, the court accorded “little weight” to U.S. District Court for the Northern District of Texas Judge Matthew J. Kacksmaryk’s issuance of a preliminary injunction to plaintiffs who argued the FDA’s fast-track approval of the drug ignored safety concerns and was politically motivated, see Alliance for Hippocratic Med. v. U.S. Food and Drug Admin., No. 2:22-CV-223-Z (N.D. Tex. Apr. 7, 2023), given “broad criticism” of the decision “from legal commentators.”
Oral arguments in GenBioPro’s challenge on the issue of standing were held April 24.
The FDA approved the brand-name version of mifepristone in 2000 for medical termination of pregnancy. Mifepristone, taken in combination with a second drug misoprostol, is used to end a pregnancy through ten weeks gestation. Medication abortions now account for about half of abortions nationwide.
GenBioPro filed its lawsuit January 25, arguing the state’s near-total ban on abortion enacted in the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, 142 S. Ct. 2228 (2022), has “severely constricted the market for mifepristone statewide.”
According to the complaint, federal law—the FDA’s approval of the medication with a risk evaluation and mitigation strategy—preempts West Virginia’s conflicting ban and other restrictions. The lawsuit alleges the West Virginia ban on mifepristone violates the Supremacy and Commerce Clauses of the U.S. Constitution.
GenBioPro, Inc. v. Sorsaia, No. 3:23-cv-00058 (S.D. W. Va. Apr. 21, 2023).