No. 22-1180

Shire U.S., Inc., et al. v. Mark Blackburn

Lower Court: Eleventh Circuit
Docketed: 2023-06-07
Status: Denied
Type: Paid
Amici (1) Experienced Counsel
Tags: drug-labeling fda-preapproval FDA-regulations federal-preemption pliva-v-mensing preemption prescription-drugs state-law-claim state-law-claims unilateral-change unilateral-label-changes
Latest Conference: 2023-09-26
Question Presented (from Petition)

Whether a state-law claim is preempted if it places a duty on a drug manufacturer to unilaterally change FDA-approved language that appears in the Highlights section of a drug label.

Question Presented (AI Summary)

Whether a state-law claim is preempted if it places a duty on a drug manufacturer to unilaterally change FDA-approved language that appears in the Highlights section of a drug label

Docket Entries

2023-10-02
Petition DENIED.
2023-07-26
DISTRIBUTED for Conference of 9/26/2023.
2023-07-26
Reply of petitioners Shire US Inc., et al. filed. (Distributed)
Main DocumentCertificate of Word CountProof of ServiceMain DocumentCertificate of Word CountProof of Service
2023-07-12
Brief of respondent Mark Blackburn in opposition filed.
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2023-07-07
Brief amicus curiae of Pharmaceutical Research Manufacturers of America filed.
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2023-06-23
Motion to extend the time to file a response is granted and the time is extended to and including August 7, 2023.
2023-06-22
Motion to extend the time to file a response from July 7, 2023 to August 7, 2023, submitted to The Clerk.
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2023-06-02
Petition for a writ of certiorari filed. (Response due July 7, 2023)
PetitionAppendixCertificate of Word CountProof of ServicePetitionAppendixCertificate of Word CountProof of Service
2023-04-25
Application (22A846) granted by Justice Thomas extending the time to file until June 4, 2023.
2023-04-18
Application (22A846) to extend further the time from May 5, 2023 to June 4, 2023, submitted to Justice Thomas.
Written RequestProof of ServiceWritten RequestProof of Service
2023-03-29
Application (22A846) granted by Justice Thomas extending the time to file until May 5, 2023.
2023-03-21
Application (22A846) to extend the time to file a petition for a writ of certiorari from April 5, 2023 to May 5, 2023, submitted to Justice Thomas.
Main DocumentLower Court Orders/OpinionsProof of ServiceMain DocumentLower Court Orders/OpinionsProof of Service

Attorneys

Mark Blackburn
Allison M. Zieve — Public Citizen Litigation Group, Respondent
Pharmaceutical Research Manufacturers of America
Michael Xavier Imbroscio — Covington and Burling LLP, Amicus
Shire US Inc., et al.
Erin E. Murphy — Clement & Murphy, PLLC, Petitioner