HUNTINGTON – The manufacturer of the nation’s only generic abortion pill has filed a federal appeal in its case fighting West Virginia’s abortion ban.
The appeal was filed November 9, just three days after U.S. District Judge Robert C. “Chuck” Chambers had entered a final dismissal order in the case GenBioPro had filed regarding its generic mifepristone abortion pill. Chambers’ order dismissed the final count in GenBioPro’s challenge to West Virginia medication abortion ban and restrictions.
The company’s notice of appeal asks the U.S. Fourth Circuit Court of Appeals to take the case.
Morrisey
The company appeals Chambers’ dismissal of its challenge that the state’s Unborn Child Protection Act is preempted because it conflicts with the U.S. Food and Drug Administration decision to approve and regulate mifepristone for medication abortion. The challenge also asserts that this law and some state telehealth laws are unconstitutional.
Chambers said the U.S. Supreme Court’s Dobbs decision makes it clear the regulation of abortion falls on the states, and that West Virginia was regulating health care, not the company itself, in the Unborn Child Protection Act.
“GenBioPro is committed to delivering on our belief that everyone has a right to access evidence-based health care and safe and effective medicines, and that includes medical abortion,” GenBioPro CEO Evan Masingill said in a press release. “In affirmation of that commitment, we are taking the necessary next step in our ongoing efforts to make mifepristone accessible to all by appealing the decision in our case in West Virginia.”
An attorney representing the company said the appeal is the next step in “our fight to protect access to medication abortion.”
“West Virginia’s decision to step in where Congress has granted FDA the authority to regulate mifepristone is unlawful and could undermine not only access to medication, but the country’s entire drug regulation system,” said Skye Perryman, President and CEO of Democracy Forward, who is also serving as counsel for the company. “What’s more, decades of science support mifepristone’s safety and efficacy and it is unacceptable that people living in West Virginia who need this basic health care are being forced to travel out of state or forgo care altogether.
“We look forward to continuing to represent GenBioPro in the further stages of this case.”
The appeal also comes less than a month after the company filed an amicus brief with the U.S. Supreme Court asking it to review the Fifth Circuit Court of Appeal’s August ruling that would compel the U.S. Food and Drug Administration to reinstate its conditions on mifepristone that existed before 2016.
That brief, which outlines what the company calls “severe” real-world consequences of the Fifth Circuit’s decision, highlights the impact on GenBioPro and the larger healthcare community if the Fifth Circuit’s decision is allowed to take effect.
In the West Virginia federal court case, state Attorney General Patrick Morrisey’s office won an earlier partial dismissal in August when Chambers ruled West Virginia’s Unborn Child Protection Act was not preempted by federal law and dismissed all other claims except the preemption attack on the telehealth provisions.
Morrisey said his office is ready for the challenge.
“As we did in federal district court, we stand ready to defend West Virginia law to the fullest,” Morrisey said in a press release. “There’s no doubt in my mind the new Unborn Child Protection Act is not preempted by federal law and that all of these statutes are constitutional.
“This issue is very near and dear to my heart. I stand firm in the belief that it is our duty to protect innocent life. I will always stand for the most vulnerable of our society and the sanctity of life.”
GenBioPro had asked the court to render the state’s pro-life laws unconstitutional, claiming Congress gave the Food and Drug Administration the power to mandate nationwide access to chemical abortions — preempting West Virginia’s laws.
Chambers rejected most of those arguments in August, saying the state is free to pass and enforce such laws. The only part of the state’s near-total protection for life that the court found still could be challenged is the law ensuring women see a physician in person before receiving chemical abortion drugs. West Virginia had amended its law to prohibit telehealth practitioners from “prescribing or dispensing an abortifacient.”
In its federal lawsuit filed February 1, GenBioPro said West Virginia’s new abortion law violates several laws and that the state cannot enforce a ban of a U.S. Food and Drug Administration-approved drug. It asked the court to find the state’s abortion law unconstitutional.
But Morrisey’s office said mifepristone is not banned under the law, which is also called the Unborn Child Protection Act. Morrisey’s office says the pill can be used in cases where legal abortion can take place in compliance with state law. The act prohibits abortions except in cases of rape or incest or to protect the life of the mother.
When used with another drug called misoprostol, mifepristone accounted for almost half of all abortions in the United States in 2020. The FDA also has relaxed restrictions on the medication. During the COVID-19 pandemic, it allowed patients to receive the pill by mail. And this month, the FDA approved retail pharmacy dispensing of the drug with a certificate.
West Virginia’s law bans most abortions. There are exceptions for rape and incest victims as well as in cases of life-threatening medical emergencies and nonviable pregnancies.
GenBioPro has held an FDA approval for generic mifepristone since 2019 and currently makes up a majority of the market for mifepristone in the United States. After the FDA allowed certified pharmacies to dispense mifepristone earlier this year, GenBioPro recently made available updated information about accessing mifepristone, including pharmacies that it had certified.
GenBioPro is being represented by Anthony Majestro and Christina Smith of Powell & Majestro in Charleston as well as by David C. Frederick, Ariela M. Migdal, Eliana Margo Pfeffer and Mary Charlotte Y. Carroll of Kellogg Hansen Todd Figel & Frederick in Washington, John P. Elwood, Daphne O’Connor and Robert J. Katerberg of Arnold & Porter Kaye Scholer in Washington and by Skye L. Perryman and Kristen Miller of Democracy Forward Foundation in Washington. The AG’s office is being represented by Chief Deputy AG Douglas P. Huffington II and Deputy AG Curtis R.A. Capehart as well as Denise M. Harle and Erin M. Hawley of Alliance Defending Freedom. Putnam County Prosecuting Attorney Kristina Raynes, who also was named as a defendant in the suit after former Prosecutor Mark Sorsaia became the state Secretary of Homeland Security, is being represented by Assistant Putnam County Prosecuting Attorney Jennifer Scragg Karr.
U.S. District Court for the Southern District of West Virginia case number 3:23-cv-00058
