The bills seek to legislatively work around a recent Supreme Court ruling and, if passed, would open the door allowing consumers to file lawsuits against generic-drug manufacturers for failing to issue proper warnings on labels.
By law, a patient can sue a manufacturer of a brand-name drug, but not one that produces generics. A 2011 Supreme Court Decision, Pliva v. Mensing, sided with a generic-drug manufacturer being sued; the Court wrote that “it was impossible” for the defendant, Pliva, “to comply with both state and federal law.” Many states have laws demanding safer labels, but federal law mandates generic-drugs have the same label warnings as the brand-name it’s modeled after. As federal law stands, it is the responsibility of brand-name drug manufacturers to update warning labels, and for generics to follow.
Sen. Patrick Leahy of Vermont, who drafted the Senate version of The Patient Safety and Generic Labeling Improvement Act, said the Supreme Court ruling “creates a troubling inconsistency in the law governing prescription drugs.”
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