No. 18-803

Wendy B. Dolin v. GlaxoSmithKline, LLC, fka SmithKline Beecham Corporation

Lower Court: Seventh Circuit
Docketed: 2018-12-21
Status: Denied
Type: Paid
Relisted (2)
Tags: clinical-trials drug-labeling drug-manufacturer fda-regulations impossibility-preemption labeling-changes preemption truthful-risks unilateral-labeling-changes unilateral-warning wyeth-v-levine
Key Terms:
FirstAmendment TradeSecret JusticiabilityDoctri
Latest Conference: 2019-05-23 (distributed 2 times)
Question Presented (from Petition)

Does federal law prevent a drug manufacturer from enhancing its label to reflect truthful risks revealed in its clinical trials when the relevant FDA regulations allow a manufacturer to make unilateral labeling changes and when the FDA encouraged the manufacturer to utilize those regulations to submit an appropriate labeling change?

Question Presented (AI Summary)

Does federal law prevent a drug manufacturer from enhancing its label to reflect truthful risks revealed in its clinical trials when the relevant FDA regulations allow a manufacturer to make unilateral labeling changes and when the FDA encouraged the manufacturer to utilize those regulations to submit an appropriate labeling change?

Docket Entries

2019-05-28
Petition DENIED.
2019-05-23
Supplemental brief of petitioner Wendy B. Dolin filed. (Distributed)
Main DocumentCertificate of Word CountProof of Service
2019-05-22
Supplemental brief of respondent GlaxoSmithKline LLC, Formerly Known as SmithKline Beecham Corp., filed. (Distributed)
Main DocumentCertificate of Word CountProof of Service
2019-05-20
DISTRIBUTED for Conference of 5/23/2019.
2019-04-11
Reply of petitioner Wendy B. Dolin filed. (Distributed)
Main DocumentCertificate of Word CountProof of Service
2019-04-10
DISTRIBUTED for Conference of 4/26/2019.
2019-03-25
Brief of respondent GlaxoSmithKline LLC, Formerly Known as SmithKline Beecham Corp., in opposition filed.
Main DocumentCertificate of Word CountProof of Service
2019-01-11
Motion to extend the time to file a response is granted and the time is extended to and including March 25, 2019.
2019-01-09
Motion to extend the time to file a response from January 22, 2019 to March 25, 2019, submitted to The Clerk.
Main Document
2018-12-19
Petition for a writ of certiorari filed. (Response due January 22, 2019)
PetitionPetitionPetitionPetition

Attorneys

GLAXOSMITHKLINE LLC, Formerly Known as SmithKline Beecham Corp.,
Lisa Schiavo Blatt — Williams & Connolly LLP, Respondent
Wendy B. Dolin
Bijan Esfandiari — Baum Hedlund Aristei & Goldman, P.C., Petitioner