Danco Laboratories, LLC v. Louisiana

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1 Cite as: 608 U. S. ____ (2026)
T
HOMAS, J., dissenting
SUPREME COURT OF THE UNITED STATES
No. 25A1207
DANCO LABORATORIES, LLC v. LOUISIANA, ET AL.
ON APPLICATION FOR STAY
No. 25A1208
GENBIOPRO, INC. v. LOUISIANA, ET AL.
ON APPLICATION FOR STAY
[May 14, 2026]
The applications for stay presented to JUSTICE ALITO and
by him referred to the Court are granted. The May 1, 2026
order of the United States Court of Appeals for the Fifth
Circuit, case No. 26–30203, is stayed pending disposition of
the appeal in the United States Court of Appeals for the
Fifth Circuit and disposition of a petition for a writ of certi-
orari, if such a writ is timely sought. Should certiorari be
denied, this stay shall terminate automatically. In the
event certiorari is granted, the stay shall terminate upon
the sending down of the judgment of this Court.
J
USTICE THOMAS, dissenting.
Applicants are manufacturers and distributors of mife-
pristone, a drug that is primarily designed to cause abor-
tion. They complain that the Fifth Circuit’s order would
reduce profits they derive from selling mifepristone. I
would deny their applications because they have not satis-
fied their burden for securing interim relief.
I write separately to note that, as Louisiana argued be-
low, it is a criminal offense to ship mifepristone for use in
abortions. The Comstock Act bans using “the mails” to ship

2 DANCO LABORATORIES, LLC v. LOUISIANA
T
HOMAS, J., dissenting
any “drug . . . for producing abortion.” 18 U. S. C. §1461. A
neighboring provision makes it a felony to use “any express
company or other common carrier or interactive computer
service” to ship “any drug . . . designed, adapted, or in-
tended for producing abortion.” §1462(c). Applicants
“[s]hip mifepristone . . . to certified pharmacies,” which, in
turn, must “ship mifepristone using a shipping service” to
users. FDA, Risk Evaluation and Mitigation Strategy
(REMS) Single Shared System for Mifepristone 200 MG,
pp. 3, 4 (Jan. 2023), https://www.accessdata.fda.gov/
drugsatfda_docs/rems/Mifepristone_2023_01_03_REMS_
Full.pdf (archived at https://perma.cc/T7D6-QZ5R). As rel-
evant to this case, mifepristone shipped to Louisiana, which
bans abortion, causes nearly 1,000 abortions per month.
“All of this violates the Comstock Act.” Alliance for Hippo-
cratic Medicine v. FDA, 78 F. 4th 210, 268 (CA5 2023) (Ho,
J., concurring in part and dissenting in part), rev’d on other
grounds, 602 U. S. 367 (2024).
Applicants are not entitled to a stay of an adverse court
order based on lost profits from their criminal enterprise.
They cannot, in any legally relevant sense, be irreparably
harmed by a court order that makes it more difficult for
them to commit crimes. And, whereas it would “serve the
public interest” to “reduc[e]” applicants’ “opportunity to
commit crimes,” Zedner v. United States, 547 U. S. 489, 501
(2006), a stay would have the opposite effect.
I respectfully dissent.

Cite as: 608 U. S. ____ (2026) 1

A
LITO, J., dissenting
SUPREME COURT OF THE UNITED STATES
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No. 25A1207
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DANCO LABORATORIES, LLC v. LOUISIANA, ET AL.
ON APPLICATION FOR STAY
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No. 25A1208
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GENBIOPRO, INC. v. LOUISIANA, ET AL.
ON APPLICATION FOR STAY
[May 14, 2026]
JUSTICE ALITO, dissenting.
The Court’s unreasoned order granting stays in this case
is remarkable. What is at stake is the perpetration of a
scheme to undermine our decision in Dobbs v. Jackson
Women’s Health Organization, 597 U. S. 215 (2022), which
restored the right of each State to decide how to regulate
abortions within its borders. Some States responded to
Dobbs by making it even easier to obtain an abortion than
it was before, and that is their prerogative. Other States,
including Louisiana, made abortion illegal except in narrow
circumstances. See, e.g., La. Rev. Stat. Ann. §40.1061
et seq. But Louisiana’s efforts have been thwarted by cer-
tain medical providers, private organizations, and States
that abhor laws like Louisiana’s and seek to undermine
their enforcement.
These medical providers and private organizations have
developed an operation enabling women in Louisiana and
other States that restrict abortions to place an online order
for a pill called mifepristone that induces abortion. See,
e.g., Aid Access, Get Abortion Pill Online in Louisiana–Or-
der Here, https://aidaccess.org/en/page/2934664/where-can-

2 DANCO LABORATORIES, LLC v. LOUISIANA

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LITO, J., dissenting
i-buy-the-abortion-pill-online-in-louisiana (archived at
https://perma.cc/NW2Z-M4B9). After an order is placed,
the drug is mailed to women in Louisiana. The manufac-
turers of the drug, including Danco and GenBioPro, are ob-
viously aware of what is going on yet nevertheless supply
the drug and reap profits from its felonious use in Louisi-
ana.
One might think that Louisiana could stop or impede this
out-of-state interference in its law enforcement by bringing
civil actions or criminal charges against the participants in
this scheme. But States have effectively blocked these ef-
forts by enacting so-called “shield laws,” which prevent Lou-
isiana from visiting any adverse legal consequences on the
perpetrators. See, e.g., N. Y. Exec. Law Ann. §837–x (bar-
ring state officials from cooperating with other States’ ef-
forts to take civil or criminal action relating to illegal abor-
tions); N. Y. Educ. Law Ann. §6810.1-a (exempting
mifepristone from the requirement that prescription labels
bear the prescribing medical provider’s name); see also App.
to Opposition to Applications for a Stay or Vacatur in No.
25A1207, pp. 462–463 (La. App.) (reporting that New York
Governor Kathy Hochul has refused to extradite a doctor
who allegedly prescribed and sent abortifacients into Loui-
siana). As a result, more abortions now occur each month
in Louisiana than they did before Dobbs. La. App. 519. By
one count, nearly 1,000 abortions occur there each month.
Ibid.
This scheme would not have been possible under FDA
regulations had the Federal Government not taken steps in
2021 and 2023 to facilitate mail-order abortions. Since the
FDA first approved mifepristone in 2000, the drug has been
subject to “Risk Evaluation and Mitigation Strategies”
(REMS) to ensure that its benefits outweigh its risks. See
21 U. S. C. §355–1. For two decades, REMS for mifepris-
tone required that patients meet in person with a medical
provider to administer the drug. FDA v. Alliance for

Cite as: 608 U. S. ____ (2026) 3

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LITO, J., dissenting
Hippocratic Medicine, 602 U. S. 367, 375–376 (2024). In
2021, however, the FDA adopted a policy of nonenforcement
as to the in-person-dispensing requirements. Id., at 376.
The following year, after our decision in Dobbs, the Biden
Administration announced that it would “use every lever”
it had to “ensure every American has access to . . . medica-
tion abortion that has been approved by the FDA for over
20 years,” an obvious reference to mifepristone. La. App.
244. The FDA pulled one of those levers in 2023 when it
formally eliminated the in-person-dispensing requirement
in the mifepristone REMS, removing a significant regula-
tory barrier from schemes to undermine Dobbs.
Since then, the Secretary of Health and Human Services
has admitted that the FDA gave inadequate consideration
to patient safety when it approved the 2023 REMS. La.
App. 478. Because concerns have arisen “about the safety
of mifepristone as currently administered” under the 2023
REMS, the Secretary announced that the FDA would con-
duct a study to determine whether changes to the REMS
are needed. Ibid. Nevertheless, the FDA has not yet acted,
and the 2023 REMS remain in place.
In an effort to stop ongoing schemes to subvert its abor-
tion laws, Louisiana sued the FDA under the Administra-
tive Procedure Act. Citing the Secretary’s concerns about
the 2023 REMS, the State challenges the removal of the in-
person-dispensing requirement for mifepristone as arbi-
trary, capricious, and unlawful. Id., at 4, 46–50. The Dis-
trict Court denied Louisiana’s request for interim relief, but
the Fifth Circuit suspended the 2023 changes pending ap-
peal. Louisiana v. FDA, ___ F. 4th ____ (CA5 2026); see 5
U. S. C. §705. Danco and GenBioPro then filed these stay
applications, and the FDA takes no position on this matter,
even though it concerns the question whether an important
rule that it has found to be flawed will remain in force for
some unknown period of time.

4 DANCO LABORATORIES, LLC v. LOUISIANA

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LITO, J., dissenting
I would deny the applications because, as things now
stand, the manufacturers have failed to show that they face
irreparable injury, without which this Court may not grant
a stay. Hollingsworth v. Perry, 558 U. S. 183, 190 (2010)
(per curiam). Unless the Fifth Circuit’s order spurs the
FDA into moving on its safety review, there is no indication
that the Fifth Circuit’s order will adversely affect the man-
ufacturers whatsoever in the near future. All the evidence
is to the contrary. In the two years before the 2023 REMS
changes, the FDA declined to enforce the in-person-dispens-
ing requirement, and the FDA seeks to maintain that sta-
tus quo until it completes an internal safety review of the
mifepristone REMS, which is unlikely to end this year. See
Defendants’ Memorandum in Support of Motion to Stay the
Case and in Response to Plaintiffs’ Motion for Preliminary
Relief in Louisiana v. FDA, No. 6–25–cv–1491 (WD La.),
ECF Doc. 51, pp. 4, 11–12. Indeed, there is evidence that
FDA leadership has told agency officials to delay that safety
review for at least six months. La. App. 556. So, at present,
it is most unlikely that the manufacturers would be at all
affected by the Fifth Circuit’s order for quite some time.
That could conceivably change if the Fifth Circuit’s order
were left in place and the FDA were spurred to speed up its
safety review, but our disposition of this application cannot
be predicated on the assumption that that will occur.
We must instead proceed on the basis of what is known
at present, and without any current indication that the
FDA plans to resume enforcing the in-person-dispensing re-
quirement, there is no reason to believe that the manufac-
turers could not continue their current distribution prac-
tices.
1

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1
In that event, it would be unlikely that Louisiana (or anyone else)
could force the FDA’s hand. The FDA would have a plausible argument
that its nonenforcement reflects a decision “committed to
agency

Cite as: 608 U. S. ____ (2026) 5

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LITO, J., dissenting
If the FDA were to execute an abrupt about-face and com-
mence enforcement of the in-person-dispensing require-
ment, the manufacturers could promptly reapply for stays
at that time. But even were that to happen, the manufac-
turers have not shown that they would suffer irreparable
injury. The manufacturers spent just 3 of their 80-plus
pages of applications trying to make this showing. See Ap-
plication to Stay in No. 25A1207, pp. 35–36; Application to
Stay in 25A1208, p. 35. To the extent that the manufactur-
ers address this issue at all, they refer mostly to regulatory
uncertainty that would result from a suspension of the 2023
REMS changes. Yet they fail to explain why the effect of
the Fifth Circuit’s order is not simply to restore the pre-
2023 REMS, under which the manufacturers successfully
operated for years. As we have already explained in FDA
v. Alliance for Hippocratic Medicine, 602 U. S. 367 (2024),
a §705 order suspending the FDA’s changes to REMS allows
a manufacturer to continue selling a drug subject to the pre-
vious set of regulatory requirements. 602 U. S., at 377.
2

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discretion,” 5 U. S. C. §701(a)(2), and would thus be immune from judicial
review under Heckler v. Chaney, 470 U. S. 821 (1985). In fact, the FDA
previously made this very argument about its nonenforcement of the in-
person-dispensing requirement. See Defendants’ Opposition to Plain-
tiffs’ Motion for a Preliminary Injunction in Alliance for Hippocratic
Medicine v. FDA, No. 2:22–cv–223 (ND Tex.) ECF Doc. 28, p. 20 (citing
Heckler). For these reasons, the manufacturers have not shown that
they face any imminent risk of irreparable harm.
2
In arguing to the contrary, Danco relies on an FDA declaration in the
Alliance for Hippocratic Medicine litigation. See Application to Stay in
No. 25A1207, p. 35. But that declaration does not dispute that a §705
order causes the REMS “to revert to those in place prior to” the chal-
lenged amendments. App. to Application to Stay in FDA v. Alliance for
Hippocratic Medicine, O. T. 2022, No. 22A902, p. 113a. Rather, the dec-
laration simply explains that the manufacturers would need to take ad-
ditional steps to come into compliance with the old rules. Id., at 113a–
116a.

6 DANCO LABORATORIES, LLC v. LOUISIANA

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LITO, J., dissenting
The manufacturers contend that resuming compliance
with those requirements would involve inconvenient pro-
cesses, such as updating prescriber agreements or adjust-
ing pharmacy-distribution operations. But without any ef-
fort to show the extent of these burdens, such
inconveniences are insufficient to constitute the requisite
showing of irreparable harm.
GenBioPro makes a passing reference to the possibility of
lost sales. See Application to Stay in 25A1208, p. 35. But
lost sales in States where abortifacients are generally ille-
gal are not “irreparable injuries” that can justify granting a
stay. See United States v. United Liquors Corporation, 77
S. Ct. 208, 210 (1956) (Reed, J., in chambers) (denying a
stay when the alleged irreparable injury was the defend-
ant’s inability to engage in conduct that amounted to an un-
lawful conspiracy). Our decision to grant a stay is an exer-
cise of equitable discretion, Indiana State Police Pension
Trust v. Chrysler LLC, 556 U. S. 960, 961 (2009) (per cu-
riam), and equity demands that profits from unlawful ac-
tivity be surrendered, not protected, see Liu v. SEC, 591
U. S. 71, 79–80 (2020). As for States where abortion is le-
gal, neither Danco nor GenBioPro explains why mifepris-
tone sales would dry up if the in-person-dispensing require-
ment resumed. And even if the Fifth Circuit’s order
affected sales in those States to some degree, the manufac-
turers do not establish that the lost profits would be so sig-
nificant as to constitute irreparable injury. See Wisconsin
Gas Co. v. FERC, 758 F. 2d 669, 674 (CADC 1985) (per cu-
riam) (holding that a private party must show a threat to
“the very existence of [its] business” to establish irreparable
injury).
Because the manufacturers have not shown that they
face any imminent risk of irreparable injury, the Court
must deny these applications regardless of how they fare on
the other stay factors. I therefore respectfully dissent.