Kelley Drye: Supreme Court Rules on Generic Drug Labeling Preemption | Practical Law

Kelley Drye: Supreme Court Rules on Generic Drug Labeling Preemption | Practical Law

This Kelley Drye & Warren LLP memorandum discusses a recent Supreme Court decision, Pliva, Inc. v. Mensing, which held that Food and Drug Administration (FDA) regulations preempt state laws requiring generic drug manufacturers to change warning labels that provide state-defined adequate warnings. The ruling protects generic drug manufacturers from state tort claims based on failure to strengthen warning labels.

Kelley Drye: Supreme Court Rules on Generic Drug Labeling Preemption

Practical Law Article 9-507-1196 (Approx. 2 pages)

Kelley Drye: Supreme Court Rules on Generic Drug Labeling Preemption

by Kelley Drye & Warren LLP
Published on 29 Jul 2011 • USA (National/Federal)
This Kelley Drye & Warren LLP memorandum discusses a recent Supreme Court decision, Pliva, Inc. v. Mensing, which held that Food and Drug Administration (FDA) regulations preempt state laws requiring generic drug manufacturers to change warning labels that provide state-defined adequate warnings. The ruling protects generic drug manufacturers from state tort claims based on failure to strengthen warning labels.