Abortion pill maker Danco to SCOTUS: Undo the pause on mail-order abortions

One day after the Fifth Circuit Court of Appeals ruled in favor of the State of Louisiana, temporarily pausing the mail-order distribution of abortion pills, drug manufacturer Danco Laboratories filed an emergency application before the Supreme Court.

Louisiana contended that the drug's 2023 REMS (safety regulations) are arbitrary and capricious, violate the federal Comstock Act, cause Plaintiffs’ current and future Injuries, cause sovereign harm by facilitating illegal abortions in Louisiana, and cause economic harm by directly increasing Louisiana’s Medicaid costs.

Defendants in the lawsuit include the U.S. Food and Drug Administration (FDA), Danco, and generic drug maker GenBioPro, among others.

Key Takeaways:

• Danco made an emergency appeal to the U.S. Supreme Court asking for a "stay" of the Fifth Circuit Court of Appeals' decision to temporarily pause the mail-order distribution of abortion pills due to a lawsuit filed by the State of Louisiana.

• Danco claims the State of Louisiana has no standing to sue, but the Fifth Circuit found that the State's financial loss shows injury.

• Danco's only product is Mifeprex, the brand name drug mifepristone.

The Details:

What Danco and defendants are requesting

Danco's emergency application is asking the Court to "stay the judgment of the United States Court of Appeals for the Fifth Circuit" until the case is heard by the full Circuit.

Danco added:

Alternatively, the Court should treat this application as a petition for a writ of certiorari before judgment and set this case for expedited briefing and argument before the summer recess. In addition, Danco respectfully requests an immediate administrative stay pending the Court’s consideration of this application.

Danco's application concluded:

The Court should stay the Fifth Circuit’s injunction pending the consideration and disposition of Louisiana’s appeal and Danco’s cross-appeal to the Fifth Circuit and, if the Court of Appeals alters the District Court’s judgment in any way other than to order dismissal, pending the timely filing and disposition of Danco’s petition for a writ of certiorari and any further proceedings in this Court. Alternatively, the Court should grant certiorari before judgment and set this case for expedited briefing and argument before the summer recess.

In addition, Danco respectfully requests an immediate administrative stay of the Fifth Circuit’s judgment pending the Court’s consideration of this application.

What is a writ of certiorari?

According to Cornell Law School:

Certiorari simply defined is a “writ” by which a higher court (such as an appellate court) reviews some lower court’s decision (such as a district court). 

When a party loses in a court of law,  often said party is allowed to appeal the decision to a higher court. In some instances, parties are entitled to an appeal, as a matter of right. However, sometimes a party is not able to appeal as a matter of right. In these instances, the party may only appeal by filing a writ of certiorari. If a court grants the writ of certiorari, then that court will hear that case. 

Danco challenges Louisiana's standing

SCOTUS Blog reported that "the drug companies tell the justices that... the Fifth Circuit should have applied the same analysis that the Supreme Court used in holding that the doctors and medical groups did not have standing in 2024...." and went on:

They stress that the Supreme Court “has already held that claims of downstream financial harm by doctors who provide follow-up care for treating complications after a medication abortion is too attenuated” to provide standing to sue.

Here, they say, “Louisiana’s theory—that it can base standing on having to pay those doctors if someone who received FDA-approved mifepristone through the mail seeks follow-up care to treat a complication—is a more attenuated version of the” theories that the court specifically rejected two years ago. And Louisiana’s claim that it is injured because of the disconnect between federal law and its own state law is not the kind of injury that courts can review, they said.

However, the Fifth Circuit addressed this concern, and held that Louisiana did have standing to sue:

On appeal, FDA and Danco dispute the district court’s ruling that Louisiana has standing. Specifically, they contend that by removing mifepristone’s in-person dispensing requirement, the 2023 REMS caused no injury either to Louisiana’s sovereignty or its treasury.

We disagree.

In addition the Appeals Court claimed the FDA's "2023 REMS causes 'federal interference with the enforcement of [Louisiana] law,' which gives Louisiana standing to challenge it."

Medical malpractice attorney Michael Seibel told Live Action News:

In order to have standing you need to have a concrete particularized harm that is actual or immanent and not hypothetical. Economic or monetary loss fits that definition. So, unliked AHM, where physicians had no monetary loss, the states such as Louisiana had financial loss in Medicaid and thus have standing.

This tracks with the Fifth Circuit's decision, which stated that "unlike the doctors... Louisiana provided hard evidence linking thousands of dollars in Medicaid costs to care stemming from out-of-state mifepristone." and this "alone [is] sufficient to establish Louisiana’s standing."

"In sum, on either theory Louisiana has shown it has standing to challenge the 2023 REMS," the ruling read.

However, Danco claimed that "even if Louisiana had standing, Plaintiffs have still failed to make the 'clear showing' of irreparable injury required for their 'drastic remedy.'" Danco also claims a "sweeping injunction" isn't needed because the "FDA has already committed to engaging in further review of the 2023 REMS...."

Danco: Rollback of mail-order abortions means providers must 'guess at what is allowed'

Danco called the Fifth Circuit Appeal decision "unprecedented," claiming that Louisiana's lawsuit "should have been dismissed outright," and asks SCOTUS to stay the Fifth Circuit's injunction against mail-order abortion pills "pending the final resolution of this case."

The manufacturer added:

Never before has a federal court purported to immediately enjoin a several years’ old drug approval; restrict a distribution system for that drug that manufacturers, providers, patients, and pharmacies have all been using for years; or reinstate conditions that FDA determined do not meet the mandatory statutory criteria.

Danco then claimed the appeals court's decision caused "immediate confusion and upheaval into highly time-sensitive medical decisions" and "resulting chaos for patients, providers, pharmacies," adding that the change somehow "forces Danco, FDA, certified Mifeprex providers, patients, and pharmacies all to guess at what is allowed and what is not."

It says the decision caused "a quintessential irreparable harm that underscores the need for emergency relief from this Court."

Danco argued that "Both Danco and the public would be harmed" if the revocation of mail-order abortion pills stands. It asks:

• What happens when patients arrive for scheduled appointments...to obtain Mifeprex...prescribed by a provider yesterday?

• What should a patient do if she cannot obtain an in-person appointment immediately?

• [W]hat are Danco’s obligations as Mifeprex’s sponsor?

Danco claimed it "face[d] substantial uncertainty as to what its obligations are," adding that "None of these changes can occur without FDA signing off on a new REMS."

The very question is laughable given that, as Live Action News has documented multiple times, Danco and generic manufacturer GenBioPro have not properly policed or decertified prescribers who continue to flout the FDA's REMS safety requirement. Yet Danco claims it "understands the law to require Mifeprex to have an approved REMS and to be distributed in accordance with that REMS."

Danco's profit concerns

Danco asked SCOTUS:

What can pharmacies do with the stock on their shelves? Louisiana’s complaint is about mail-order pharmacies, but does the stay prevent brick-and mortar pharmacies from dispensing drugs in-person to a patient?

What acts of distribution... could lead to civil and criminal penalties? ...

There are no answers to these questions (and many others), leaving Danco—and others—to face a “Hobson’s choice” between possible exposure “to potentially huge liability” or “suffer[ing] the injury of obeying the law during the pendency of the proceedings,” which itself is irreparable harm.

Danco accused the Fifth Circuit of "shrugg[ing] off the District Court’s concerns about judicial interference with FDA’s statutory authority to make science- and medicine-based judgments, especially while FDA’s own review is ongoing; the risks of conflicting judgments across the country; and the sweeping scope of Louisiana’s requested relief which would invalidate the 2023 REMS nationwide."

Danco, which was recently fined hundreds of thousands of dollars by the Department of Justice for a False Claims Act violation, added:

Mifeprex is Danco’s only product. Without a valid legal framework for distributing that product, Danco will lose its only source of revenue and may be unable to continue operating.

Timeline:

• October 2025: State of Louisiana v. FDA refiled in Western District of Louisiana, Lafayette Division

• December of 2025: Louisiana filed for preliminary injunctive relief.

• January 2026: Trump's FDA asked the courts to "stay judicial review" until the FDA completes its own review of the drug, which it claimed could be completed in less than a year.

• 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."

• February 24, 2026: The case was heard in federal court before U.S. District Judge David Joseph.

• April 7, 2026: A stay in the lawsuit was approved until the FDA safety review is completed.

• April 8, 2026: Louisiana appealed the 'stay' ruling (LAN).

• April 17, 2026: Louisiana filed their appeal 

• May 1, 2026: US Court of Appeals ruling favors Louisiana and pauses abortion pill dispensing by mail 

What's Next:

According to SCOTUS Blog:

The drug companies’ request goes initially to Justice Samuel Alito, who handles emergency requests from the 5th Circuit. Alito is likely to ask Louisiana to respond before acting on the companies’ request.

The Bottom Line:

There is indeed 'irreparable harm' that has been done to more than 7.5M preborn babies whose lives have been intentionally ended by the abortion pill.