PLIVA v. Mensing and Its Implications

Abstract:     
The U.S. Supreme Court ruling in PLIVA Inc. v. Mensing will immunize generic drug manufacturers facing failure-to-warn claims from state-law liability, and may also have implications for preemption jurisprudence more generally, says attorney Brian Wolfman and co-author Dena Feldman in this BNA Insight. The authors analyze the ruling, and offer their views on the questions that PLIVA raises about the ongoing vitality of the presumption against preemption, the standard for determining ‘‘impossibility’’ preemption, and the propriety of deference to an agency’s views on preemption.

Number of Pages in PDF File: 13

Keywords: Supreme Court, PLIVA, FDA regulations, generic drugs, preemption jurisprudence, failure-to-warn claims

JEL Classification: K00, K30, K39

Accepted Paper Series