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 Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim. The court affirmed the dismissal of four lawsuits...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