Brand Name Drug Manufacturers May be Liable for Generic Drug Injuries, Alabama Supreme Court Rules

In a recent ruling, the Alabama Supreme Court ruled held that a brand-name drug manufacturer may be liable for injuries caused by a generic equivalent produced by another manufacturer, when the brand-name company made misrepresentations about the drug.

This is the first state court to rule that plaintiffs injured by generic drugs can bring misrepresentation claims against brand-name manufacturers, according to the American Association for Justice (AAJ). Danny Weeks, the Alabama plaintiff, developed tardive dyskinesia, a neurological disorder characterized by uncontrollable movements, after taking metoclopramide, the generic version of Reglan. Reglan is prescribed for chronic digestive problems. Weeks sued five drug makers that sold the brand-name and generic versions, including Wyeth Inc., one of the brand-name manufacturers. Wyeth moved to dismiss the suit, arguing that the claims are barred for “product identification” failure and because the drug makers had no duty to warn about the generic drug’s risks.

In 2011, the trial court held that the plaintiffs might be able to seek relief under Alabama law if they could prove the brand-name companies had a duty to warn. In early 2013, the state’s supreme court ruled that brand-name manufacturers may be liable for misrepresentation claims. The decision was heavily criticized and the court agreed to rehear the case, AAJ reports.

The Alabama Supreme Court relied on the intermediary doctrine, which provides that manufacturers only need to inform doctors of a drug’s risks to fulfill the duty of warning users.  But Judge Michael Bolin, writing for the majority, said it was reasonable that the plaintiff’s doctor would rely on Wyeth’s misrepresentation, because federal law requires brand-name and generic drug labels to be identical, according to AAJ. “An omission or defect in the labeling for the brand-name drug would necessarily be repeated in the generic labeling, foreseeably causing harm to a patient who ingested the generic product,” Bolin wrote.