Legislation May Restore Generic Drug Lawsuits For Failure to Warn

Legislation may soon go before Congress that would circumvent a Supreme Court decision that allows generic drug manufacturers to escape responsibility for failing to warn about serious and potentially life-threatening side effects associated with medications they sell. 

Senator Patrick Leahy has announced that he is preparing to introduce a bill that would require generic drug manufacturers to be responsible for making sure consumers are adequately warned about the side effects of their drugs.

The bill would get rid of current federal regulations that require generic drug labels to be exactly the same as those of the brand name drug they are copying, which was the basis for a recent Supreme Court decision that has resulted in the dismissal of many product liability lawsuits filed by individuals who were given generic versions of medications that carry unwarned of side effects.

Last year, in Pliva v. Mensing, the Supreme Court ruled 5-4 down ideological lines that FDA regulations pre-empt failure to warn lawsuits against generic drug makers. The majority of the Court determined that the requirement that the label for generic drugs match their brand-name equivalents may make it impossible for generic drug makers to comply with both federal and state law.

The decision stemmed from a Reglan lawsuit filed against the manufacturer of a generic version of the gastrointestinal medication. As a result, thousand of other cases involving side effects of generic medications have been dismissed or are at risk of being thrown out, including Accutane lawsuits, Darvocet lawsuits, Zocor lawsuits and other cases involving medications that are now available as a generic.

Even the Supreme Court justices who voted for lawsuit immunity for generic drug makers appeared to acknowledge the decision’s unjust effect for consumers, saying in the majority opinion that the public would be confused by the ruling. They indicated that congressional action could address the problem.

Sen. Leahy says that his legislation will do just that. The bill, which could come as early as this week, would allow generic drug makers to change the labels of their medications to add new warnings.