The Alabama Supreme Court is the first state supreme court to rule that a brand-name drug manufacturer can be held liable for injuries caused by a generic equivalent. According to the American Association for Justice, the court ruled that brand-name companies can be sued if the injury was caused by making misrepresentations.
Metoclopradmide, the generic version of Reglan, caused Danny Weeks to develop tardive dyskinesia, AAJ reports. He and his wife sued five current and former manufacturers of brand-name and generic versions of the drug, which is used to treat chronic digestive disorders (Wyeth, Inc. v. Weeks, 2014 WL 40585813 (Ala. Aug. 15, 2014)). Brand-name drug makers, including Wyeth, attempted to have the case dismissed, arguing that they had no duty to warn about the risks of generic drugs.
The intermediary doctrine, which states that manufacturers only need to inform doctors of a drug’s risks to fulfill its duty of warning users, was the focal point in the ruling. Judge Michael Bolin, who wrote for the majority, stated that “when the warning to the prescribing health care professional is inadequate, however, the manufacturer is directly liable to the patient for damage resulting from that failure,”
Week’s physician would rely on Wyeth’s information in prescribing the generic because the law requires generic drugs to carry the same label as the brand-name version, Bolin said. “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,” he stated. Bolin, who wrote the original majority opinion, also noted that the ruling only applies to prescription drug manufacturers. “We are not turning products liability law (or tort law for that matter) on its head, nor are we creating a new tort of ‘innovator liability’ as has been suggested. Instead, we are answering a question of law involving a product that, unlike any other product on the market, has unprecedented federal regulation.”