Louisiana, FDA face court hearing in lawsuit over chemical abortion safety measures

The lives of thousands of unborn children could be at stake in a district court hearing next week, according to a new court filing in Louisiana’s lawsuit against the Food and Drug Administration.

“The public interest here cuts in favor of women’s health and thousands of unborn Louisiana children,” states a new memo from Alliance Defending Freedom, which represents Louisiana Attorney General Liz Murrill and plaintiff Rosalie Markezich.

Markezich lost her baby after her boyfriend allegedly forced her to take abortion pills he received in the mail, which the lawsuit argues was enabled by FDA rules relaxed under the Biden administration.

The state of Louisiana filed the lawsuit in October over what it alleges is the unlawful dysregulation of the shipment of mifepristone – the first of two pills in a chemical abortion – into the pro-life state.

In 2023, the FDA abolished the required in-person doctor’s appointment for the prescription of mifepristone, effectively allowing the drug to be shipped to any state.

“What we’ve seen is weaponization under the Biden administration,” ADF senior counsel Erik Baptist told The Lion, citing the overturning of Roe v. Wade in 2022, which allowed pro-life states to restrict or ban abortion. “They knew the Dobbs decision was coming down, and they acted ahead of schedule and also immediately after that decision, but they were trying to undermine and nullify those pro-life states and gut the Dobbs decision.

“So, the states of Louisiana, Mississippi and Texas cannot meaningfully and effectively implement their pro-life laws when the states of California, New York allow their prescribers to brazenly send those drugs across state lines.”

Since the Dobbs decision, the number of 18–24-year-olds who have ordered mifepristone by mail has increased nearly 66%, according to a recent study. In states with stricter bans on abortion, this number has increased by more than 300%. The FDA under the Trump administration has admitted the actions of the FDA under Biden were unlawful and has promised to conduct a review of mifepristone’s safety and regulations.

“They’re sharing the same legal concerns and the same safety concerns that we have raised in our case,” Baptist said. “That’s notable. So, we were happy that the FDA is not defending what the Biden administration did…”

While Louisiana’s case proceeds, the state is seeking preliminary relief and asking the FDA to reinstate its guidelines prior to the 2023 changes, which includes requiring an in-person doctor’s visit for the prescription of mifepristone.

“It would prevent those out of state prescribers, in particular in California, New York – where they’re refusing to extradite these law-breaking doctors who have sent these drugs illegally into the state of Louisiana and other states,” Baptist said. “So, it would affect prescribers in all states. But in those states where abortion and abortion drugs are allowed, women will still be able to access them.” 

However, the FDA is asking the court to stay the case while it conducts its review, claiming reinstating prior safety protocols first would be “disruptive” to its ongoing review of mifepristone, according to a memo filed late last month.

Baptist maintains both the study and the case can proceed without hindering one another.

“The court can reinstate common sense safeguards,” Baptist previously told The Lion. “At the same time, the FDA can continue its purported years-long study on the safety of mifepristone.”

Baptist said the FDA has not acknowledged the clear economic and physical harms mailing mifepristone imposes on Louisiana and its residents. The state reports upwards of 1,000 shipments of mifepristone illegally enter the state every month, according to most recent data.

“And every day that the current [rules are] in place, there’s an irreparable harm occurring. Irreparable means you can’t recover those costs,” he said. “Whether it’s economic or unborn babies’ lives, you can’t undo those harms.”

The U.S. Supreme Court recognizes even one dollar as sufficient proof of harm, and Louisiana has paid at least $90,000 for two reported emergency room visits and medical expenses from mifepristone complications, Baptist said.

“The state is more than happy to save babies lives and treat women,” he said. “So we’re not complaining about the fact that they’re paying out of pocket, except for the fact that these emergency situations should not be occurring in the state, but for the Biden FDA allowance of the mail order regime that permits out of state providers to send these drugs unlawfully to the state.”

Additionally, the FDA’s promised study shows no sign of advancement, with no evidence that the agency has even requested the data to begin the study, which typically lasts more than a year, Baptist explained. Even if the FDA upholds its promise to prioritize the study, the earliest results and consequential new regulations of mifepristone would not be implemented for at least another 18 months, the ADF memo says.

The hearing is scheduled Feb. 24 in Lafayette, Louisiana.

“Put another way, FDA’s stay request asks this Court to ignore at least 18,000 illegal abortions, 18,000 unborn lives, at least 720 emergency room visits, and tens of thousands of dollars in unrecoverable costs from now – just in Louisiana,” the memo states.

The FDA also did not address the lawsuit’s argument regarding the Comstock Act, which prohibits the distribution of abortion materials through the mail or online services.

“Through the Comstock Act, Congress prohibited the use of the mail or ‘any express company or other common carrier or interactive computer service’ for ‘any drug, medicine, article, or thing designed, adapted, or intended for producing abortion.’ And FDA cannot authorize conduct that violates federal law,” ADF’s first memo explains.

Despite this law, the current shipment of mifepristone into all 50 states and the subsequent shield-law protections for physicians who mail these drugs illegally is harming not only Louisiana but numerous other pro-life states.

“Indeed, this case presents one of the most egregious – and most stark – examples of ‘federal interference with the enforcement of state law,’ coupled with the obvious economic harms that would flow from such interference,” the memo states.

A coalition of 21 states filed an amicus brief Friday, marking their alignment with Louisiana and demand for the re-establishment of an in-doctor visit. An alliance of 60 representatives also submitted a brief to express their support for Louisiana.

“As delegated by Congress, the FDA’s job is to ensure drug safety, not to encourage the risky use of drugs just to further former President Biden’s pro-abortion agenda,” the representatives state in their brief. “Exceeding its mandate is illegal and also harmful, both to the separation of powers and to women taking mifepristone.”

States, representatives and pro-life organizations have submitted a total of 60 amici briefs to support Louisiana in the upcoming hearing Tuesday.

“I thank Attorney General Murrill for defending women and babies in Louisiana and across the country. Chemical abortion drugs kill innocent children and put mothers’ lives at risk,” Sen. Bill Cassidy, chairman of the Senate Health, Education, Labor, and Pensions Committee, said. “Safeguards protecting against coercion, such as the in-person dispensing requirement, must be reinstated immediately.”