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Brand-name drugmakers can’t be sued over generics: W.Va. high court

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Brand-name drugmakers can’t be sued over generics: W.Va. high court

The West Virginia Supreme Court held in a divided ruling Friday that brand-name manufacturers cannot be held liable for alleged injuries caused by their generic equivalents.

The 3-2 ruling by the court in Kimmy McNair and Larry McNair v. Johnson & Johnson et al. contradicts other state court rulings, including a recent ruling by Massachusetts’ highest court, which held brand-name prescription drug manufacturers can be held liable for reckless failure to warn a user of the drug’s generic equivalent. 

The McNairs had filed suit in state court alleging that Ms. McNair had developed acute respiratory distress after ingesting the generic drug levofloxacin, which was originally trademarked and sold by a unit of New Brunswick, New Jersey-based Johnson & Johnson Services Inc. The J&J unit removed the litigation to federal court.

The U.S. District Court in Charleston, West Virginia, agreed with the pharmaceutical firm that under West Virginia law, a manufacturer cannot be held liable for a drug it did not manufacture or distribute.

On appeal, the 4th U.S. Circuit Court of Appeals in Richmond, Virginia, asked the state supreme court to consider the issue.

“Requiring the defendant in a products liability case to be either the manufacturer or the seller of the product is the majority rule in this country,” said the majority opinion.

“Where the brand manufacturer neither manufactured nor sold the generic drug, it cannot impliedly represent that the generic drug is free of defects,” it said.

“Thus, while our law states that manufacturers are subject to the duty to warn about the risks of their products, the generic drug in this case is not a product of the brand manufacturer. Consequently, brand manufacturers cannot be held strictly liable for failure to warn of another manufacturer’s product.

The dissenting opinion in the case, by Chief Justice Margaret Workman, which cites the Massachusetts ruling, states: “This is, at its very essence, a reasonably straightforward failure to warn and negligence case.

“Although the facts are unique, the concepts certainly are not unfamiliar to the jurisprudence of this state. We have long held inviolate the rights of the citizens of this state to be protected from negligence of manufacturers.”

 

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