Failure To Warn- Generic Drugs
Failure to warn claims involving generic drugs took a significant hit on June 23, 2011 with the decision of Pliva, Inc. v. Mensing from the U.S. Supreme Court. In that decision, the Court diluted the Wyeth decision by concluding that manufacturers of generic drugs cannot be sued for failure to warn because such claims are preempted by federal law. In Wyeth the Court held that drug manufacturers could be sued for failure to warn in state court on the theory that the FDA approval process does not preclude drug companies from providing better warnings than what are required.
In particular under the Hatch-Waxman statute, the Court said that warning labels for generic drugs must be the same as those for brand name drugs approved by the FDA, and therefore failure to warn claims against manufacturers of generic drugs are preempted by federal law.
The decision affecting drug injury law is especially troubling in light of the fact that 75% of all prescriptions are filled with generic drugs.
The decision likewise creates an inconsistency between the generic drugs and brand name drugs in that now different standards apply to the two. The decision creates the incentive for manufacturers to push more generic drugs than brand name drugs and thereby potentially decrease their liability.
See off-label drugs for more information on that topic.See also the numerous other articles on this site dealing with drug injury and the general concept of federal preemption.