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Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, et al.

Paid petition · United States Court of Appeals for the Fifth Circuit, No. 23-10362 · judgment August 16, 2023


Decided · June 13, 2024
Pre-decision estimate: 33% cert probability (95% interval 23%–46%)

Before the decision, about 8.1× the 4.1% base rate. The model weighted this up for a petition filed soon after the judgment below, a Fifth Circuit decision below, and counsel with five or more prior petitions here.

Questions presented

In 2000, the Food and Drug Administration (FDA) approved Danco's drug Mifeprex for termination of early pregnancy based on the agency's expert judgment that clinical data showed the drug to be safe and effective. The agency later modified certain conditions of use for mifepristone in 2016 and 2021, again relying on clinical data and the agency's expert judgment that the drug would remain safe and effective under the modified conditions of use. In 2022, associations of doctors who have never prescribed Mifeprex sued FDA, arguing that FDA's actions modifying the drug's conditions of use in 2016 and 2021 violated the Administrative Procedure Act. The questions presented are:

  1. Whether an association can demonstrate Article III standing to enjoin a government action by arguing that some unspecified member may be injured at some future time by the challenged action; and

  2. Whether the Fifth Circuit erred in upholding the preliminary injunction of FDA's 2016 and 2021 actions based on the court's review of an incomplete administrative record. Consolidated with 23-235 and a total of one hour is allotted for oral argument

Counsel of record

For petitioner
Jessica Lynn Ellsworth
Hogan Lovells US LLP

For respondent
Erin Morrow Hawley
Alliance Defending Freedom

Case

Conference history
Distributed for 1 conference

Amicus briefs
14 cert-stage

Argument & decision

Argued March 26, 2024 — Elizabeth B. Prelogar · Jessica L. Ellsworth · Erin M. Hawley. Audio and transcript

Decided June 13, 2024. Opinion by Kavanaugh.

Proceedings

  1. Aug 22 2024
    Record returned to the United States District Court for the Northern District of Texas.
  2. Jul 15 2024
    Judgment Issued.
  3. Jun 13 2024
    Judgment REVERSED and case REMANDED. Kavanaugh, J., delivered the opinion for a unanimous Court. Thomas, J., filed a concurring opinion. VIDED.
  4. Mar 26 2024
    Argued. For federal petitioners: Elizabeth B. Prelogar, Solicitor General, Department of Justice, Washington, D. C. For petitioner Danco Laboratories, L.L.C.: Jessica L. Ellsworth, Washington, D. C. For respondents: Erin M. Hawley, Washington, D. C. VIDED.
  5. Feb 14 2024
    CIRCULATED
  6. Feb 13 2024
    Public electronic record on appeal received from the United States District Court for the Northern District of Texas (one DVD) and available with the Clerk.
  7. Feb 13 2024
    Record received from the United States Court of Appeals for the Fifth Circuit. The record is electronic and is available on PACER.
  8. Feb 09 2024
    Sealed record received electronically from the United States District Court for the Northern District of Texas and available with the Clerk.
  9. Jan 31 2024
    Record requested from the United States Court of Appeals for the Fifth Circuit.
  10. Jan 29 2024
    SET FOR ARGUMENT on Tuesday, March 26, 2024. VIDED.
  11. Dec 13 2023
    Petition GRANTED. The petition for a writ of certiorari in No. 23-235 is granted. The cases are consolidated, and a total of one hour is allotted for oral argument.
  12. Dec 13 2023
    Because the Court has consolidated these cases for briefing and oral argument, future filings and activity in the cases will now be reflected on the docket of No. 23-235. Subsequent filings in these cases must therefore be submitted through the electronic filing system in No. 23-235. Each document submitted in connection with one or more of these cases must include on its cover the case number and caption for each case in which the filing is intended to be submitted. Where a filing is submitted in fewer than all of the cases, the docket entry will reflect the case number(s) in which the filing is submitted; a document filed in all of the consolidated cases will be noted as “VIDED.”
  13. Nov 21 2023
    DISTRIBUTED for Conference of 12/8/2023.
  14. Nov 21 2023
    Reply of petitioner Danco Laboratories, L.L.C. filed. (Distributed)
  15. Nov 15 2023
    Waiver of the 14-day waiting period for the distribution of the petition pursuant to Rule 15.5 filed by petitioner.
  16. Nov 09 2023
    Brief of respondents Alliance for Hippocratic Medicine, et al. in opposition filed. VIDED.
  17. Oct 12 2023
    Brief amici curiae of Over 600 State Legislators filed. VIDED.
  18. Oct 12 2023
    Brief amici curiae of American College of Obstetricians and Gynecologists, et al. filed. VIDED.
  19. Oct 12 2023
    Brief amici curiae of Food and Drug Law Scholars filed. VIDED.
  20. Oct 12 2023
    Brief amici curiae of Pharmaceutical Companies, Executives, and Investors filed. VIDED.
  21. Oct 12 2023
    Brief amici curiae of Patient and Provider Advocacy Organizations filed. VIDED.
  22. Oct 12 2023
    Brief amici curiae of National Association of Nurse Practitioners in Women's Health, et al. filed. VIDED.
  23. Oct 12 2023
    Brief amicus curiae of GenBioPro, Inc. filed. VIDED.
  24. Oct 12 2023
    Brief amici curiae of Local Governments and Local Government Leaders filed. VIDED.
  25. Oct 12 2023
    Brief amici curiae of The City of New York, et al. filed. VIDED.
  26. Oct 12 2023
    Brief amici curiae of 257 Members of Congress filed. VIDED.
  27. Oct 12 2023
    Brief amici curiae of New York, et al. filed. VIDED.
  28. Oct 12 2023
    Brief amici curiae of Doctors for America and the Reproductive Health Coalition filed. VIDED.
  29. Oct 12 2023
    Brief amicus curiae of Pharmaceutical Research and Manufacturers of America filed. VIDED.
  30. Oct 12 2023
    Brief amici curiae of Religious Coalition for Reproductive Choice, et al. filed.(10/26/23) VIDED.
  31. Oct 07 2023
    Application (23A301) to file consolidated brief in opposition in excess of word limits granted by Justice Alito. The consolidated brief in opposition may not exceed 13,500 words.
  32. Oct 02 2023
    Motion to extend the time to file a response is granted and the time is extended to and including November 9, 2023.
  33. Sep 29 2023
    Motion to extend the time to file a response from October 12, 2023 to November 9, 2023, submitted to The Clerk.
  34. Sep 29 2023
    Application (23A301) to file consolidated brief in opposition in excess of word limits, submitted to Justice Alito.
  35. Sep 08 2023
    Petition for a writ of certiorari filed. (Response due October 12, 2023)