One of the first questions I ask potential clients in pharmaceutical litigation is whether they took the name brand of the drug or the generic version, as I know under the current law in most states they will only have an actionable claim if they took the name brand. This limitation originates from the U.S. Supreme Court’s ruling in Pliva v. Mensing, 131 S.Ct. 2567 (2011). Mensing provides legal protection to generic drug manufacturers when a plaintiff alleges injuries resulting from an inadequate warning label, as long as the warnings on the generic drugs mirrored the labeling of the patented version of the drug. In response to Mensing, and a related ruling in Wyeth v. Levine, 555 U.S. 555 (2009), the U.S. Food and Drug Administration (FDA) issued a rulemaking proposal to amend its drug regulations to allow generic manufacturers to supplement their warning labels to reflect newly acquired information such as adverse drug effects.

If the proposed rule is adopted, it would provide recourse to individuals who have suffered injuries caused by the use of generic drugs with inadequate warnings. The proposed rule would render Mensing moot because generic drugmakers would be permitted to update labels when risks associated with their medications become known, thereby creating a legal duty to warn of known safety risks.

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