A recent Second Circuit preemption decision illustrates the importance of a clear-eyed approach to medical device preemption issues.
In Glover v. Bausch & Lomb, Inc., 6 F.4th 229 (2d Cir. 2021), the district court...more
We have written before about the Supreme Court’s impossibility preemption decision, Merck Sharpe & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (Albrecht) (here, here, here, and here), highlighting some open questions and...more
The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed... addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to...more
3/23/2020
/ Food and Drug Administration (FDA) ,
Generic Drugs ,
GlaxoSmithKline ,
Labeling ,
Merck ,
Merck Sharp & Dohme Corp. v. Albrecht ,
Pharmaceutical Industry ,
PLIVA v Mensing ,
Preemption ,
Product Labels ,
SCOTUS ,
Wyeth
For some long-awaited events, a little time and distance can add a measure of clarity. Not always – many still are processing the Game of Thrones finale, with no end in sight. But over the past few weeks pharmaceutical...more
6/25/2019
/ Agency Disapproval ,
Clear Evidence Standard ,
Failure To Warn ,
FDA Approval ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Jury Trial ,
Manufacturers ,
Merck Sharp & Dohme Corp. v. Albrecht ,
Preemption ,
Prescription Drugs ,
Question of Fact ,
Question of Law ,
Remand ,
SCOTUS ,
State Law Claims ,
Vacated ,
Warning Labels