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?
2019-05-23
Supplemental brief of petitioner Wendy B. Dolin filed. (Distributed)
2019-05-22
Supplemental brief of respondent GlaxoSmithKline LLC, Formerly Known as SmithKline Beecham Corp., filed. (Distributed)
2019-05-20
DISTRIBUTED for Conference of 5/23/2019.
2019-04-11
Reply of petitioner Wendy B. Dolin filed. (Distributed)
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.
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.
2018-12-19
Petition for a writ of certiorari filed. (Response due January 22, 2019)