Lawsuit: Louisiana suffered 'sovereign and economic harms' from FDA abortion pill changes

The State of Louisiana has filed a response in an ongoing abortion pill lawsuit to be heard by a district court this week, which challenges the Food and Drug Administration's (FDA) 2023 erosion of the drug's safety regulations.

Earlier this month, abortion pill manufacturers Danco Laboratories and GenBioPro filed to intervene in the case, 60 lawmakers filed briefs in support of Louisiana, along with AGs from 21 states.

The State contends that "although Louisiana has significantly restricted abortion, there are nearly 1,000 abortions occurring in the State every month — all through mail-order abortion."

Key Takeaways:

Louisiana contends that the drug's 2023 REMS (safety regulations) 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 economic harm by directly increasing Louisiana’s Medicaid costs.

The Details:

Louisiana calls out FDA's "puzzling attempt to shelve this case"

The legal response began by excoriating the FDA:

The Federal Defendants (collectively, “FDA”), Danco, and GenBioPro do not dispute that certified prescribers are mailing FDA-approved mifepristone into Louisiana in violation of Louisiana law and ending the lives of nearly 1,000 babies in the State each month.

They also do not dispute that FDA’s removal of the in-person dispensing requirement through the 2023 REMS is the indispensable ingredient in those unlawful abortions:

Prescribers could not lawfully (under federal law) mail mifepristone without the 2023 REMS. And FDA concedes the 2023 REMS was “informed by [a] lack of adequate consideration.”

"Perhaps because the route is so easy, FDA and the drug manufacturers try to scuttle the case on standing grounds. But that tactic does not work," Louisiana wrote in its response.

That is because they do not seriously dispute that Louisiana is suffering injuries in fact, whether they are sovereign or economic; instead, they dispute only traceability, trying to cast prescribers, pro-abortion states, and even domestic-abuse victims as the real perpetrators of Louisiana’s harms.

But, as just explained, if the Court stays the 2023 REMS, then the whole mail-order abortion scheme will fall apart—that is the best indication Louisiana has satisfied both traceability and redressability and thus has Article III standing.

Louisiana called out the "FDA’s puzzling attempt to shelve this case for a few years," asking the United States District Court to "reject that request out of hand," claiming that Louisiana is "entitled to preliminary relief."

The "FDA does not cite a single case where a court has stayed proceedings and denied preliminary relief even though the defendant (a) concedes that its conduct is unlawful and (b) would suffer no irreparable harm from the grant of preliminary relief."

Louisiana's economic loss establishes standing to sue

To establish standing, “a plaintiff must demonstrate (i) that she has suffered or likely will suffer an injury in fact, (ii) that the injury likely was caused or will be caused by the defendant, and (iii) that the injury likely would be redressed by the requested judicial relief," Louisiana wrote, adding:

Louisiana has suffered pocketbook and sovereign harms from the 2023 REMS—harms that led tragically to bodily harms for Plaintiff Rosalie.... Louisiana has suffered two types of classic pocket injuries, either or both of which assure the Court’s jurisdiction: (a) economic harms incurred while enforcing Louisiana law against violations caused by the 2023 REMS; and (b) the expenditure of Medicaid dollars to treat adverse events caused by the 2023 REMS.

"[N[either FDA nor the manufacturers dispute these expenditures. Their failure to dispute these harms alone ends the injury-in-fact analysis," the state wrote, noting (emphasis added):

We know—and neither FDA nor the manufacturers dispute—that Louisiana already has spent over $90,000 in Medicaid dollars for emergency room care and hospitalizations directly traceable to just two FDA-approved mifepristone-induced abortions.

"Louisiana’s ongoing costs are thus plainly 'certainly impending,' or at the least there is a 'substantial risk' these costs will occur," they added.

Spending time and money to hold criminals accountable

Louisiana Attorney General Liz Murrill told WGNO why she filed the lawsuit and is seeking criminal charges against those who illegally mail abortion pills into Louisiana:

"If I mailed a gun into their state - if I filed the identification number off that gun and mailed it into their state - that is the equivalent of what they're doing in our state. And I feel confident that they would want to hold me accountable if I were mailing guns to people illegally in their state.

And we want to hold people accountable for improperly mailing those pills into our state."

Louisiana wrote in its response:

Louisiana has expended substantial money, time, and resources attempting to mitigate the avowedly intended harm caused by the 2023 REMS... for example, Louisiana has indicted two out-of-state prescribers who violated Louisiana law by sending FDA-approved mifepristone into Louisiana.

The State has issued warrants for their arrest. And Governor Landry has completed the necessary paperwork and formally asked the governors of California and New York to extradite these fugitive prescribers.

To be even more precise: In just three distinct investigations alone regarding the unlawful mailing of mifepristone into Louisiana, the State has spent at least $17,604[...] Through these efforts, Louisiana is incurring costs every day to bring criminal prescribers to justice and deter others from breaking the State’s pro-life laws.

FDA 'anticipated emergency-room visits would increase'

As Louisiana pointed out, the FDA knew that removing the in-person dispensing requirement would cause "emergency-room visits [to] increase — with the baseline being a 2016 warning that roughly 1 in 25 women would end up in the emergency room."

The state added:

So, there was a “reasonable probability” and “substantial risk” that Medicaid-covered women would seek care, especially in Louisiana where half a million women are on Louisiana Medicaid...

In the end, Medicaid costs are indisputable economic harm — and they plainly reinforce Louisiana’s standing as a matter of dollars and cents.

Injury to Louisiana's sovereign interests

Louisiana noted that "States have standing to vindicate their sovereign (or quasi-sovereign) interests" and that "it is telling... that neither FDA nor the manufacturers could identify a single instance in which Louisiana has been able to enforce its criminal code to stop the onslaught of illegal abortions."

The state also argued:

It also is important to recognize that FDA and the manufacturers rest on a false premise: that so long as a State can find some other way to stop a violation of its laws, the State lacks Article III standing to sue the federal government for causing the violation in the first place. That is emphatically wrong.

The state also reiterated that the "whole point" of the Biden FDA's removal of the in-person requirement in 2023 was to "target" and "authorize a direct attack on pro-life states, and that attack, in turn, has caused natural sovereign and economic harms. There is nothing 'indirect' or coincidental about it."

Years prior, the Obama FDA removed the requirement to report non-fatal adverse events and Louisiana cited two different Fifth Circuit panels concluding that it was arbitrary and capricious for the FDA to remove what it recently acknowledged was both “minimally burdensome” and “necessary to mitigate” mifepristone’s “serious risks,” based on FAERS data that “cannot be used to calculate the incidence of an adverse event,” plus studies that were “not adequate on their own to establish the safety of … dispensing mifepristone by mail.”

The Timeline:

• 2023: President Biden's FDA further eroded the REMS to allow the drug to be dispensed through mail-order and in pharmacies.

• September 2025: The State of Louisiana along with Rosalie Markezich filed a motion to intervene in an ongoing abortion pill lawsuit. Markezich alleged 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 Matthew Kacsmaryk denied the motions by Texas, Florida, and Louisiana and moved the venue to Missouri.

• October 2025: 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.

• January 27, 2026: FDA filed a motion to stay the case.

• February 3, 2026: Danco Laboratories and GenBioPro, both manufacturers of the drug, file to intervene in the case, opposing Louisiana's request for the injunction.

• February 13, 2026: 21 states file in support of Louisiana, along with another brief from 60 lawmakers.

• February 17, 2026: Louisiana responds, accusing the FDA and the drug manufacturers of "try[ing] to scuttle the case on standing grounds."

In Conclusion:

Louisiana, which defines abortion is “impermissible,” pointed to the federal Comstock Act, which prohibits the mailing of abortion inducing drugs, and reinstated their state's “longstanding policy” to protect the “right to life of every unborn child from conception.”

The State's response claimed that because the FDA's alleged "safety study of mifepristone" wasn't expected to be final for a year, the "FDA’s review can continue apace with the in-person dispensing guardrail back in place."

The State argued that the Court should preliminarily stay the 2023 REMS and deny the FDA’s motion to stay, because:

FDA puts forth zero evidence that it has even requested or commissioned the data necessary to initiate its purported review—other than vague statements on its own website that its efforts purportedly began in late January 2026.

And this, after first promising this review over a year ago...

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.