MORGANTOWN – Attorney General Patrick Morrisey is celebrating a procedural victory in an ongoing lawsuit against the state filed by the maker of a generic version of an abortion drug.
The U.S. District Court on Thursday granted in part and denied in part Morrisey’s petition to dismiss the case brought by GenBioPro, the manufacturer and marketer of generic mifepristone, against the state’s 2022 Unborn Child Protection Act.
“As I have said all along,” Morrisey said in announcing the ruling, “the new Unborn Child Protection Act is constitutional. I am pleased the court saw it the way we did. While it may not sit well with manufacturers of abortion drugs, the U.S. Supreme Court has made it clear that regulating abortion is a state issue.”
Mifepristone is a progesterone blocking medication used in combination with misoprostol that can end an early pregnancy of 10 weeks or less. The court notes that the act – abbreviated UCPA throughout the ruling – expressly includes abortions performed or induced via medicine or drug.
Throughout the discussion, the court notes that in 2007 Congress authorized the FDA to re-approve previously approved drugs using a Risk Evaluation and Management Strategy (REMS). FDA made several revisions to mifepristone prescription over the following years and in 2019, in response to COVID, permitting telehealth prescriptions.
GenBioPro sued in January this year alleging that the UCPA and prior restrictions violate federal Supremacy and Commerce Clauses by limiting the sale of mifepristone in West Virginia. Morrisey and Putnam County Prosecuting Attorney Mark Sorsaia are co-defendants.
In seeking dismissal of the case, Morrisey argued that this is a “major questions” case as determined in West Virginia v EPA, requiring clear Congressional direction. District Judge Robert C. Chambers tossed that argument, saying “major questions” involves novel agency interpretations of longstanding ambiguous regulations; this case involves legitimate FDA regulation of a single drug.
Turning to potential federal supremacy over the UPCA, Chambers notes that, “The Supreme Court has made it clear that regulating abortion is a matter of health and safety upon which States may appropriately exercise their police power.”
Chambers first clarifies that GenBioPro is not regulated by the UCPA, which applies to licensed medical professionals.
Discussing whether the UCPA is Constitutional, he says, “the UCPA is a restriction on the incidence of abortion, rather than a state directive in direct conflict with the logistical REMS regulations. The Supreme Court has repeatedly indicated that similarly broad state regulations are not preempted by intricate federal regulatory systems.”
However, he says, state law restricts telehealth prescription of mifepristone. A 2023 update of the mifepristone REMS “reflects a determination by the FDA that when mifepristone is prescribed, it may be prescribed via telemedicine.”
So Chambers denied dismissal of the telehealth portion of the case but granted dismissal of the portion alleging the UCPA is unconstitutional.
Chambers then addressed GenBioPro’s assertions of federal Supremacy and Commerce clauses. The company, he says, “argues that the challenged statutes ‘violate the Clause by imposing an undue burden on interstate commerce, by regulating extraterritorially, and by functionally banning an article of commerce.’”
He knocks down GenBioPro’s arguments that the UCPA intrudes on Congressionally mandated uniform regulation, functionally bans a product for its intended use, and imperils the health and safety of pregnant West Virginians and the national market for medications.
States ban certain products within their borders without exceeding their authority he said, and the ban on mifepristone here has no effect on commerce in other states. And the issue of potential harms to pregnant West Virginians, while a matter of concern, is outside the scope of this case and relevant legal precedent.
“If West Virginia has ‘functionally banned’ mifepristone, it was well within its rights to do so,” he said.
In dismissing this portion of GenBioPro’s case, he concludes, “States enact laws pursuant to their police power to regulate public health and morality. Morality-based laws often curtail the sale of goods. The vendors of curtailed goods may lose sales opportunities. Outraged, vendors can feel the laws must somehow be unconstitutional. And yet, the Supreme Court and Courts of Appeals have repeatedly affirmed that morality-based product bans do not intrinsically offend the dormant Commerce Clause.”
Morrisey commented on the ruling, “We look forward to arguing the remaining issue of this lawsuit, and we are confident in the merits of our case.”