GenBioPro v. Raynes
In November 2023, GenBioPro filed an appeal to a judge’s August ruling in its case against West Virginia’s near-total abortion ban.
In his ruling, U.S. District Court Judge Robert Chambers dismissed some claims filed by pharmaceutical group GenBioPro in a lawsuit against the state’s attorney general Patrick Morrisey.
GenBioPro v. Raynes claimed that Morrisey violated federal law, more specifically the commerce clause of the U.S. Constitution, by prohibiting the sale of the drug in West Virginia.
“Mifepristone is a medication that is subject to a very specific set of regulations that Congress itself considered,” said Skye Perryman, president and CEO of Democracy Forward, GenBioPro’s legal counsel. “The state of West Virginia cannot and should not, under our constitution, be able to maintain a law that conflicts with that.”
The clause gives Congress broad power to regulate and restrict states from impairing interstate commerce.
“The theory is based on the Supremacy Clause of the Constitution, which unequivocally says that when federal law and state law conflict, it is the federal law, that must take precedence,” Perryman said.
However, Chambers, who presides over the southern district of West Virginia, said states have the right to regulate public health and morality by curtailing the sale of goods.
The court earlier ruled that GenBioPro had legal standing to bring a suit against the attorney general’s office on the basis of economic damages incurred by the company.
On Feb. 7, GenBioPro filed an appellate brief at the U.S. Court of Appeals for the Fourth Circuit, arguing that West Virginia’s post-Dobbs abortion ban is in direct conflict with federal law.
The brief urges the Court to reverse the District Court’s August ruling in GenBioPro v. Raynes, which dismissed GenBioPro’s challenge to West Virginia’s near-total abortion ban.
According to Morrisey’s office, in August 2023, the district court dismissed the preemption claim against the state’s Unborn Child Protection Act and the constitutional challenges entirely, but it allowed the preemption challenge to the telehealth provisions to proceed.
Morrisey said GenBioPro removed the telehealth challenge in order to proceed with an appeal.
“GenBioPro won its challenge to the telehealth ban, which it is not pursuing now at this time, but the district court ruled for the state with respect to GenBioPro’s challenge to the abortion ban,” Perryman said.
Perryman said GenBioPro believes that West Virginia’s restrictions are unconstitutional and said that is why she is taking the case on appeal to the U.S. Court of Appeals for the Fourth Circuit.
National Litigation
In the first case of its kind since the overturn of Roe v. Wade, oral arguments for and against access to the abortion pill will be heard at the U.S. Supreme Court on March 26.
The outcome of the case will determine how and when patients can access mifepristone, a pharmaceutical approved by the U.S. Food and Drug Administration in 2000.
GenBioPro manufactures a generic version of Mifepristone. The medication is used in conjunction with Misoprostol for medical abortions and can be taken at home to terminate a pregnancy.
Mifepristone is currently approved for use up to 10 weeks gestation and is often used to treat miscarriages and accounts for more than half of abortions in the U.S.
Mifepristone was first approved by the FDA in 2000 and the agency required the drug to be prescribed in person, over three visits to a doctor. Since 2016, the FDA eased restrictions, allowing patients to obtain prescriptions through telemedicine appointments, and to get the drug by mail.
The original lawsuit was brought by the anti-abortion legal organization Alliance Defending Freedom.
On April 7, 2023, U.S. District Judge Matthew Kacsmaryk imposed a nationwide ban on mifepristone, declaring that the FDA had improperly approved the drug.
At practically the same moment, U.S. District Judge Thomas O. Rice in Washington state issued a contrary ruling, in a case brought by 17 states and the District of Columbia seeking to expand the use of mifepristone. Rice declared that the current FDA rules must remain in place.
While the case was argued in lower courts, the Supreme Court put the lower court decisions on hold, allowing the abortion pill to continue on the market as it had been. That stay will remain while the court considers the case.
The Alliance for Hippocratic Medicine argues they have the authority to bring the case because the “FDA overlooked important safety risks in approving mifepristone and amending its restrictions.”
They argue the FDA depends on emergency room doctors to be a crucial component of the mifepristone regimen, as the treating physician in the event of complications.
“According to the doctors, when they treat women who are experiencing complications after taking mifepristone, they are required to perform or complete an abortion, or otherwise required to participate in a process that facilitates abortion,” the filing states. “They maintain that personally conducting those procedures violates their sincerely held moral beliefs.”
The Biden Administration responded that the Alliance for Hippocratic Medicine failed to show “any evidence of injury from the availability” of the medication.
“This Administration will continue to stand by FDA’s independent approval and regulation of mifepristone as safe and effective,” White House spokeswoman Karine Jean-Pierre said in a statement.
Dozens of groups have filed briefs with the supreme court, from both sides of the argument.
On Jan. 30, GenBioPro filed an amicus brief to SCOTUS in Alliance for Hippocratic Medicine v. Federal Drug Administration.
In the brief, GenBioPro claims: “The court never examined the clinical studies underlying and amply supporting FDA’s 2016 changes, which reported that thousands of patients had successfully and safely used mifepristone under the modified conditions.”
Perryman released the following statement:
“The Fifth Circuit’s ruling in this case undermines decades of science and access to evidence-based medication, as well as the FDA’s regulatory authority,” Perryman said. “The ruling was not based on science or facts, but rather furthered another effort waged by extremists in their attacks on women’s rights and ability to access necessary medication.”
The U.S. Supreme Court will hear oral arguments in Alliance for Hippocratic Medicine v. Federal Drug Administration on March 26, 2024.
Appalachia Health News is a project of West Virginia Public Broadcasting with support from Marshall Health.
