No. 25-257

Wells Pharma of Houston, L.L.C. v. Zyla Life Sciences, L.L.C.

Lower Court: Fifth Circuit
Docketed: 2025-09-04
Status: Pending
Type: Paid
CVSGAmici (3)Response RequestedResponse WaivedRelisted (2)
Tags: consumer-protection drug-marketing fdca-preemption outsourcing-facilities premarket-approval state-law-claims
Key Terms:
Antitrust JusticiabilityDoctri
Latest Conference: 2026-01-09 (distributed 2 times)
Question Presented (from Petition)

Whether the FDCA preempts private state-law unfair competition and consumer protection claims premised on the marketing of compounded drugs without premarket approval.

Question Presented (AI Summary)

Whether the FDCA preempts private state-law unfair competition and consumer protection claims premised on the marketing of compounded drugs without premarket approval

Docket Entries

2026-01-12
The Solicitor General is invited to file a brief in this case expressing the views of the United States.
2025-12-03
DISTRIBUTED for Conference of 1/9/2026.
2025-11-25
Reply of petitioner Wells Pharma of Houston, L.L.C. filed.
2025-11-25
Reply of Wells Pharma of Houston, L.L.C. submitted.
2025-11-17
Brief of respondent Zyla Life Sciences, L.L.C. in opposition filed.
2025-11-17
Brief of Zyla Life Sciences, L.L.C. in opposition submitted.
2025-10-27
Brief amicus curiae of Outsourcing Facilities Association filed.
2025-10-27
Amicus brief of Outsourcing Facilities Association submitted.
2025-10-20
Motion to extend the time to file a response is granted and the time is extended to and including November 17, 2025.
2025-10-16
Motion to extend the time to file a response from October 27, 2025 to November 17, 2025, submitted to The Clerk.
2025-10-16
Motion of Zyla Life Sciences, L.L.C. for an extension of time submitted.
2025-10-06
Brief amicus curiae of Americans for Access to Compounded Medication filed.
2025-10-06
Brief amicus curiae of Americans for Access to Compounded Medications filed.
2025-10-06
Amicus brief of Americans for Access to Compounded Medications submitted.
2025-09-25
Response Requested. (Due October 27, 2025)
2025-09-17
DISTRIBUTED for Conference of 10/10/2025.
2025-09-11
Waiver of right of respondent Zyla Life Sciences, L.L.C. to respond filed.
2025-09-02
Petition for a writ of certiorari filed. (Response due October 6, 2025)

Attorneys

Americans for Access to Compounded Medications
Mark Daniel BoesenBoesen & Snow, LLC D/B/A Boesen & Snow Law, Amicus
Outsourcing Facilities Association
Andrew Michael GrossmanBaker & Hostetler LLP, Amicus
Wells Pharma of Houston, L.L.C.
Jeremy Thomas GrabillPhelps Dunbar LLP, Petitioner
Zyla Life Sciences, L.L.C.
Jeffrey S. BucholtzKing & Spalding LLP, Respondent