Under Wyeth v. Levine, 555 U.S. 555 (2009), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. § 314.70(c)(6)(iii)(A). Because the
In a ruling that is contrary to Supreme Court precedent, the district court presiding over the Zostavax MDL recently held that federal law does not preempt a state-law design-defect claim based on the manufacturer’s failure to seek FDA approval of a different, purportedly safer vaccine.
Zostavax, a shingles vaccine, received FDA approval in 2006. The
Federal law regulates medical devices differently from pharmaceuticals, and branded drugs differently from generic drugs. Whether a particular state-law tort claim is preempted often depends on whether the claim involves a medical device, a branded drug, or a generic drug. Often but not always. As today’s case illustrates, there is one implied-preemption principle that applies
We’ll get to the recent Second Circuit decision, Ignacuinos v. Boehringer Ingelheim Pharms., Inc., — F.4th —-, 2021 WL 3438355 (2d Cir. 2021), in due course, but first some background.
One of our top ten decisions in 2018 was Gustavsen v. Alcon Labs., Inc., 903 F.3d 1 (1st Cir. 2018), an important implied-preemption
This blog has discussed Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), and its progeny on multiple occasions. We provided a quick take when Albrecht was issued; discussed the decision’s possible ramifications here and here; expressed consternation at certain parts of the decision; reported here and here on how