'Destructive of state sovereignty': Louisiana sues to block mail-order abortion pill expansion

The State of Louisiana and coerced abortion victim Rosalie Markezich have filed a motion for a preliminary injunction against the U.S. Food and Drug Administration's (FDA) enforcement of the 2023 REMS safety protocols, which removed in-person dispensing requirements for the abortion pill mifepristone (200mg).

The lawsuit contends that the 2023 REMS "unlawfully remov[ed] the in-person dispensing requirement for the sole purpose of allowing out-of-state doctors to facilitate illegal mail order abortions in pro-life states like Louisiana."

The lawsuit seeks injunctive relief for a period of for 705 days (just under two years).

Backstory:

The Alliance for Hippocratic Medicine (AHM) initially challenged the FDA's abortion pill approval as well as its expansions. However, in 2024, the U.S. Supreme Court ruled that the plaintiff doctors in AHM did not have standing to sue, and they eventually dropped their challenge.

• January 2025: Judge Matthew Kacsmaryk ruled that the states of Missouri, Kansas, and Idaho could intervene in that case and file a complaint in Amarillo, Texas.

• May 2025: Trump’s Department of Justice (DOJ) called for dismissal of the lawsuit.

• August 2025: The states of Texas and Florida first petitioned the court to intervene — and one month later (September 2025), Louisiana along with Rosalie Markezich filed a motion to do the same. Markezich claimed in her complaint that her boyfriend ordered abortion pills from a California provider and coerced her into taking the pills. Her baby died.

• August 2025: Judge Kacsmaryk denied the motions by Texas, Florida, and Louisiana and moved the venue to Missouri.

• October 2025: Alliance Defending Freedom (ADF) refiled the lawsuit in State of Louisiana v. FDA (along with Rosalie Markezich) in the Western District of Louisiana, Lafayette Division.

• December 9, 2025: A new lawsuit, State of Florida and the State of Texas v. FDA, was filed in the Northern District of Texas, Wichita Falls Division.

• December 17, 2025: Louisiana filed for preliminary injunctive relief.

Lawsuit challenges 2023 REMS

The lawsuit was filed by Alliance Defending Freedom (ADF) on behalf of the State of Louisiana and Rosalie Markezich, "a Louisiana resident whose ex-boyfriend ordered mifepristone from a California doctor, received it by mail, and coerced Rosalie to take it, ending her baby’s life."

The Plaintiffs are challenging "the 2023 REMS as unlawful under the Administrative Procedure Act (APA)" and "seek[] to vacate the 2023 REMS to restore the in-person dispensing requirement." The lawsuit states, "There is no serious question that the 2023 REMS is unlawful."

"I felt pressured to take the pills" | Rosalie's Story

The Court Document explained:

In Dobbs v. Jackson Women’s Health Organization...(2022), the Supreme Court “expressly returned the issue [of abortion] to the States.”

... States, like Louisiana, had laws on the books that sprang into effect broadly prohibiting abortion unless necessary to save the mother’s life.

President Biden knew this. So he ordered his administration to end-run Dobbs by finding every possible means to facilitate abortion in pro-life states. Relevant here, his Food and Drug Administration (FDA) carried out that directive by promulgating a Risk Evaluation and Mitigation Strategy for the abortion drug mifepristone (the 2023 REMS).

The 2023 REMS removed a longstanding in-person dispensing requirement. Why? So doctors in states like New York and California could prescribe and mail FDA approved mifepristone into pro-life states, causing abortions that otherwise would not occur. The results are sobering. Hundreds of mifepristone-induced abortions are occurring in Louisiana every month.

"To carry out this plan, organizations like AidAccess.org have blanketed the Internet with order forms for FDA-approved mifepristone... extolling the ease with which New York and California doctors may inject pills into locales from Baton Rouge to Lafayette," the Plaintiffs added.

The State of Louisiana contends that the 2023 REMS are:

• Arbitrary and capricious

• Violate the Comstock Act

• Cause Plaintiffs’ Current and Future Injuries in Fact

• Cause sovereign harm by facilitating illegal abortions in Louisiana.

• Cause pocketbook harm by directly increasing Louisiana’s Medicaid costs.

'Destructive of State Sovereignty'

The lawsuit states (emphasis added):

It is difficult to imagine a federal action that is more “destructive of state sovereignty[]”... particularly one that ends the lives of hundreds of unborn Louisiana children, like Rosalie’s, every month.

On top of that, Louisiana has suffered, and continues to suffer, a classic pocketbook injury from the 2023 REMS in the form of hundreds of thousands of dollars in increased Medicaid costs attributable to mifepristone-induced abortions that have required emergency care — costs that would not be incurred but for the 2023 REMS.

Data published by #WeCount "revealed that 800 mifepristone induced abortions per month was the minimum in Louisiana in 2025; more frequently, that monthly number was approximately 900, and nearly 1,000 in March 2025," the lawsuit added.

'Rosalie is Not Alone'

The lawsuit also states (emphasis added):

Rosalie is not alone. Consider the well-known story of Margaret Carpenter, a New York doctor who mailed mifepristone to a Louisiana woman who forced the drug on her pregnant teenage daughter... The teen faced a medical emergency alone at home, called 911, and was rushed to the hospital in an ambulance after delivering a dead fetus...

Or, consider data from the Louisiana Department of Health showing that over $92,000 in Medicaid dollars were paid for emergency room care and hospitalization resulting from just two mifepristone-induced abortions in 2025...

And these instances are just two examples of many women believed to have suffered similar adverse events requiring emergency medical care at Louisiana hospitals, paid for by Louisiana Medicaid.

"These stories are not just disturbing but entirely predictable," the State claimed.

Abortion pill harms:

According to Louisiana:

FDA’s own mifepristone label warns that roughly 1 in 25 (or 4% of) women who take mifepristone as directed will end up in the emergency room...And this was before the Biden Administration removed the requirement for an initial in-person visit—the only opportunity to screen for dangerous conditions like ectopic pregnancy, to accurately assess gestational age, to screen for coercion and trafficking, and to ensure informed consent....The label also features a black box warning that mifepristone can cause “[s]erious and sometimes fatal infections and bleeding,” and mifepristone can cause other problems warranting emergency attention.

... What’s more, there is good reason to believe that the emergency-room-visit and hospitalization rate is at least as high as 11%... and FDA’s own data demonstrates that dispensing mifepristone by mail exacerbates that rate.

... It is thus unsurprising that the flood of mifepristone into Louisiana under the 2023 REMS is directly resulting in life-threatening harm to Louisiana women and babies, as well as identifiable sovereign and monetary harms to Louisiana itself.

Preliminary Relief 'Essential'

The lawsuit noted that "a preliminary stay of the 2023 REMS has become blindingly clear in recent days" following news that a review of the abortion pill by the FDA may be delayed:

Under pressure from pro-life states and advocates, Secretary Kennedy announced on September 19, 2025, that, “through the FDA, HHS will conduct a study of the safety of the current REMS, in order to determine whether modifications are necessary.”

... Yet on December 8, 2025, it was publicly reported that FDA Commissioner Marty Makary “has told agency officials to delay [a] safety review [of mifepristone] until after the midterm elections.”

... In other words, FDA will not consider taking action on the 2023 REMS until 2027 at the earliest. And if FDA attempts to rescind or modify the 2023 REMS, the governing statutory framework imposes a timeline of nearly a year before that action could take effect.

"So absent preliminary relief in this case, Louisiana and its citizens face the prospect of unbounded and illegal mifepristone-induced abortions for at least two more years if not longer. That is untenable. Preliminary relief is essential," the State contended.

ADF Senior Counsel and Director of the Center for Life, Erik Baptist, responded:

“After the U.S. Supreme Court’s reversal of Roe v. Wade in 2022, President Biden directed his administration to pursue every possible avenue to thwart states that have chosen to protect unborn life.

The result was the FDA’s scheme to push mail-order abortion drugs throughout the country, a horrific political move that jeopardizes women’s safety, ends unborn babies' lives, and directly undermines state laws.

ADF is honored to stand with the State of Louisiana and Rosalie Markezich in seeking a preliminary injunction to protect every woman and child from this illegal abortion-drug scheme.”

Summary

"This case is hard to swallow because of its egregious facts — but it is easy to resolve on the merits and standing. As the Fifth Circuit previously directed, the proper route is to enter a preliminary stay of the 2023 REMS under 5 U.S.C. § 705 and ensure that the 'in-person dispensing requirements, and FDA’s obligation to enforce them, will continue to apply,'” the lawsuit asserts. "This case presents one of the most profoundly important issues threatening Louisiana’s sovereignty, its values, and its people."