Equitable Stays and “Irreparable Harm” Based on Unlawful-Use Profits in the Mifepristone REMS Dispute

1. Introduction

Danco Laboratories, LLC and GenBioPro, Inc.—manufacturers/distributors of mifepristone—filed emergency applications at the U.S. Supreme Court seeking to halt an order of the U.S. Court of Appeals for the Fifth Circuit. The underlying controversy centers on the FDA’s 2023 revision of the mifepristone Risk Evaluation and Mitigation Strategy (REMS), which removed an in-person dispensing requirement and thereby facilitated mail-order distribution.

Louisiana, a State that largely prohibits abortion, sued the FDA under the Administrative Procedure Act (APA), contending that removal of the in-person requirement was arbitrary, capricious, and unlawful. The District Court denied interim relief, but the Fifth Circuit entered a suspension of the 2023 REMS changes pending appeal under 5 U. S. C. §705. Danco and GenBioPro then asked the Supreme Court to stay the Fifth Circuit’s suspension so the 2023 REMS framework could remain operative while litigation continues.

The Court granted the stay in an unreasoned order. JUSTICE THOMAS and JUSTICE ALITO each dissented, offering sharply different emphases but a common conclusion: the applicants failed to justify emergency relief.

2. Summary of the Opinion

  • Disposition: The Supreme Court granted the applications for stay, staying the Fifth Circuit’s May 1, 2026 order pending further proceedings in the Fifth Circuit and any timely certiorari petition (with the stay terminating automatically upon certiorari denial, or upon this Court’s judgment if certiorari is granted).
  • JUSTICE THOMAS, dissenting: Would deny a stay because alleged harms are lost profits tied to conduct Louisiana argues is criminal under the Comstock Act (18 U. S. C. §§1461–1462(c)), and equity/public interest disfavors protecting opportunities to commit crimes.
  • JUSTICE ALITO, dissenting: Would deny a stay principally for failure to show irreparable injury. He argues the manufacturers are unlikely to be affected in the near term because FDA nonenforcement may persist, and in any event compliance burdens/uncertain sales do not satisfy the stay standard. He characterizes the broader dispute as an effort to undermine Dobbs v. Jackson Women’s Health Organization.

3. Analysis

3.1. Precedents Cited

Dobbs v. Jackson Women’s Health Organization, 597 U. S. 215 (2022)

JUSTICE ALITO frames the factual and legal stakes through Dobbs, describing the challenged distribution channels as a “scheme” to undermine States’ renewed authority to regulate abortion within their borders. Although Dobbs does not supply the stay standard, it supplies the constitutional baseline ALITO uses to characterize Louisiana’s interests and the asserted friction between state policy and cross-border medication-abortion distribution.

FDA v. Alliance for Hippocratic Medicine, 602 U. S. 367 (2024)

This decision is central to JUSTICE ALITO’s analysis of regulatory posture and remedy mechanics. He cites it for (i) background on the REMS evolution, including the FDA’s 2021 nonenforcement and 2023 formal removal of the in-person requirement, and (ii) the effect of a §705 suspension—namely that a suspension of amended REMS permits marketing under the prior regulatory framework. ALITO uses FDA v. Alliance for Hippocratic Medicine to argue that the Fifth Circuit’s action should be understood as reverting to pre-2023 requirements rather than creating unworkable regulatory limbo.

Alliance for Hippocratic 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)

JUSTICE THOMAS cites this Fifth Circuit writing for the proposition that shipping mifepristone for abortion use violates the Comstock Act (“All of this violates the Comstock Act.”). He uses it as persuasive authority to reframe applicants’ claimed economic harms as profits from illegal conduct—thus undermining irreparable harm and tipping public interest against a stay.

Hollingsworth v. Perry, 558 U. S. 183, 190 (2010) (per curiam)

JUSTICE ALITO invokes Hollingsworth for the proposition that a stay requires a showing of irreparable injury. He treats that requirement as dispositive: without irreparable harm, the Court should deny relief regardless of other stay factors.

Zedner v. United States, 547 U. S. 489, 501 (2006)

JUSTICE THOMAS relies on Zedner to anchor a public-interest proposition: reducing opportunities to commit crimes serves the public interest. He uses this to argue that granting a stay would invert the public-interest inquiry by facilitating allegedly criminal distribution.

United States v. United Liquors Corporation, 77 S. Ct. 208, 210 (1956) (Reed, J., in chambers)

JUSTICE ALITO cites this in-chambers opinion to support a narrow but consequential point in emergency equity: alleged harm consisting of inability to continue unlawful conduct does not qualify as irreparable injury warranting a stay.

Indiana State Police Pension Trust v. Chrysler LLC, 556 U. S. 960, 961 (2009) (per curiam)

This case is cited for the characterization of a stay as an exercise of equitable discretion. ALITO uses it to justify importing equitable maxims (including limits on protecting unlawful profits) into the irreparable-harm analysis.

Liu v. SEC, 591 U. S. 71, 79-80 (2020)

ALITO invokes Liu for the equitable principle that unlawfully obtained profits are to be surrendered, not protected—supporting the view that a stay should not be used to safeguard revenue streams tied to illegal activity.

Wisconsin Gas Co. v. FERC, 758 F. 2d 669, 674 (CADC 1985) (per curiam)

ALITO draws on this D.C. Circuit decision to underscore that economic loss typically is not irreparable for private parties absent an existential threat to the business. He uses it to criticize the manufacturers’ allegedly underdeveloped showing of sales harm.

Heckler v. Chaney, 470 U. S. 821 (1985)

Although not applied as a holding in this stay dispute, Heckler is deployed by ALITO to explain why compelling FDA enforcement may be difficult: nonenforcement is often “committed to agency discretion” and insulated from judicial review. This supports his practical conclusion that manufacturers face little imminent disruption because FDA may continue nonenforcement regardless of the Fifth Circuit’s order.

3.2. Legal Reasoning

(a) The Court’s unreasoned stay and what it functionally accomplishes

The Court’s order supplies no rationale, but its practical effect is clear: by staying the Fifth Circuit’s suspension, the Supreme Court leaves the 2023 REMS changes operative during the appellate process. In real-world terms, the order tends to preserve a regulatory environment compatible with mail-order dispensing during the pendency of Louisiana’s APA challenge.

(b) JUSTICE THOMAS: “Irreparable harm” cannot be grounded in facilitating alleged crimes

THOMAS reframes the stay request as an attempt to protect profits from an enterprise he deems criminal if mifepristone is shipped for abortion use. His reasoning proceeds in three linked steps:

  1. Illegality premise: Shipping abortion drugs via mail or common carriers violates the Comstock Act (18 U. S. C. §§1461, 1462(c)), especially as applied to Louisiana where abortion is banned.
  2. Irreparable harm premise: A party cannot be “irreparably harmed” in a legally cognizable way by losing the ability to profit from criminal conduct.
  3. Public interest: Under Zedner v. United States, the public interest is served by reducing opportunities to commit crimes; a stay would do the opposite.

THOMAS thus treats the stay application as failing both irreparable harm and the equitable/public-interest components traditionally considered in emergency relief.

(c) JUSTICE ALITO: failure to show imminent irreparable injury—especially given FDA nonenforcement dynamics

ALITO’s dissent is more procedural and temporally focused. He argues that the applicants do not show imminent harm because:

  • Status quo may persist regardless: The FDA declined to enforce the in-person requirement even before the 2023 REMS change, and there is “no current indication” it will resume enforcement soon. Therefore, the Fifth Circuit’s order may not practically constrain manufacturers’ distribution “for quite some time.”
  • Reapplication is available: If FDA begins enforcement abruptly, applicants could return to the Court for emergency relief then—undermining the need for immediate intervention now.
  • Compliance burdens are underdeveloped: Applicants’ alleged burdens (updating agreements, changing distribution operations) are asserted without quantified or concrete evidentiary support.
  • Lost sales are not irreparable—especially if tied to unlawful uses: Citing United States v. United Liquors Corporation and equitable principles from Liu v. SEC, ALITO argues that equity does not protect unlawful profits; and even lawful-market losses are not shown to be existential under Wisconsin Gas Co. v. FERC.

In sum, ALITO treats irreparable harm as a gatekeeping requirement; without it, the application fails.

3.3. Impact

(a) Practical impact on mifepristone access during litigation

The granted stay keeps the 2023 REMS changes effectively in place while the Fifth Circuit appeal and any certiorari petition proceed. That tends to preserve a national distribution architecture compatible with mail-order dispensing, at least until further judicial action.

(b) Federal-state conflict over abortion regulation post-Dobbs

ALITO’s dissent situates the dispute as an extension of post-Dobbs federalism conflict: States that restrict abortion versus federal regulatory choices and out-of-state actors enabling medication abortions across borders. Even without a majority opinion, the dissents highlight litigation pathways likely to recur: States challenging FDA REMS decisions under the APA, and regulated entities seeking emergency relief to preserve access models.

(c) The Comstock Act as a re-emerging litigation lever

THOMAS’s dissent underscores a potentially far-reaching legal theory: that federal criminal prohibitions on mailing or shipping abortion drugs may constrain distribution irrespective of FDA policy. While not adopted by the Court in this order, its inclusion in a Supreme Court dissent signals that Comstock-based arguments will continue to appear in emergency and merits litigation, shaping how courts assess equities and public interest.

(d) Emergency-relief doctrine: irreparable harm and “unlawful profits”

Both dissents press a restrictive view of irreparable harm where the alleged injury is lost revenue from conduct characterized as unlawful. If this framing gains traction in future merits decisions, parties seeking emergency relief in highly regulated and criminal-adjacent contexts may face intensified demands to (i) show imminent, lawful, and non-compensable harms, and (ii) separate lawful revenue impacts from contested conduct.

4. Complex Concepts Simplified

  • Stay (pending appeal/certiorari): A temporary order that pauses the effect of a lower-court ruling while further review occurs.
  • Irreparable harm: Injury that cannot be adequately repaired by later relief (often because damages are unavailable or insufficient). The dissents emphasize that ordinary, unquantified economic loss usually is not irreparable.
  • REMS (Risk Evaluation and Mitigation Strategies): Safety rules the FDA can impose on certain drugs to ensure benefits outweigh risks (here, rules governing how mifepristone may be dispensed).
  • 5 U. S. C. §705: An APA provision allowing courts to postpone the effective date of challenged agency action pending judicial review—often described as temporarily reverting to the prior regulatory regime.
  • Comstock Act (18 U. S. C. §§1461–1462(c)): Federal criminal statutes restricting the mailing/shipping of certain items, here cited for language banning shipment of drugs “for producing abortion” or “designed, adapted, or intended for producing abortion.”
  • Agency nonenforcement discretion: Under Heckler v. Chaney, decisions not to enforce may be presumptively unreviewable as committed to agency discretion—relevant to whether court orders will actually change on-the-ground behavior.
  • Equitable discretion: Emergency relief is not automatic; courts balance fairness, including whether a party seeks protection for conduct equity disfavors (e.g., profits from alleged illegality).
  • “Shield laws”: State statutes (cited here with New York examples) designed to protect in-state actors from other States’ enforcement efforts related to abortion services.

5. Conclusion

Although the Supreme Court granted the stay without explanation, the dissents map the dispute’s fault lines and the emergency-relief principles at stake. JUSTICE THOMAS would deny relief because the claimed harms are profits from conduct he regards as criminal under the Comstock Act, and the public interest favors curbing unlawful activity. JUSTICE ALITO would deny relief on narrower procedural grounds: the manufacturers failed to demonstrate imminent irreparable injury, particularly given FDA nonenforcement dynamics and the availability of later emergency applications if enforcement changes.

The decision’s immediate significance is operational: the 2023 mifepristone REMS changes remain effective while litigation proceeds. The broader significance lies in the dissents’ preview of recurring arguments in post-Dobbs litigation—especially the role of irreparable harm in emergency stays, the reappearance of Comstock Act theories, and the intensifying federal-state clash over medication abortion regulation and cross-border access.