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Brand-name manufacturer not liable for failing to warn patient who ingested generic form of medication

October/November 2019

The Fourth Circuit Court of Appeals recognized the West Virginia Supreme Court’s holding that West Virginia does not recognize a cause of action for failure to warn and negligent misrepresentation against a brand-name drug manufacturer when the drug the injured plaintiff ingested was produced by a generic drug manufacturer.

Kimmy McNair took the generic form of the drug levofloxacin, which is manufactured by Janssen Pharmaceuticals, Inc., and marketed under the trade name Levaquin. McNair developed acute respiratory distress syndrome after taking the generic drug. She and her husband sued Janssen Pharmaceuticals in West Virginia state court, alleging that the defendant failed to include the link between acute respiratory distress syndrome and levofloxacin in its warnings despite awareness of the connection and the fact that the defendant had exclusive control of the content of the warnings sent to the public and to health care providers. The defendant removed the case to federal district court, which granted the defendant summary judgment. The court held that under West Virginia law, a plaintiff who consumes a generic drug is precluded from suing the manufacturer that developed the original brand-name drug and warning label. The plaintiffs appealed.

The Fourth Circuit certified to the West Virginia Supreme Court of Appeals the question of whether West Virginia law permits a claim of failure to warn and negligent misrepresentation against a brand-name drug manufacturer when the drug ingested by a plaintiff was produced by a generic manufacturer. The West Virginia high court held that there is no cause of action in the state for failure to warn or negligent misrepresentation in such a scenario.

Finding the West Virginia high court’s decision dispositive, the court concluded that the district court’s grant of summary judgment for the defense had been proper.

Citation: McNair v. Johnson & Johnson, 2019 WL 3238907 (4th Cir. July 18, 2019).