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Following Alabama Supreme Court Ruling, Generic Drug Injuries May Lead to Lawsuits Against Brand- Name Manufacturers

Sep 8, 2014

The Alabama Supreme Court is the first state court to rule that brand-name manufacturers can be liable for generic drug injuries if information about the drug was misrepresented, the American Association for Justice (AAJ) reports. The recent ruling confirms the court’s decision from early 2013.

Danny Weeks took metoclopramide, a generic version of the drug Reglan, to treat chronic digestive problems. According to AAJ, the drug caused tardive dyskinesia, a permanent neurological disorder that causes uncontrollable movements. He and his wife sued five current and former manufacturers who produced both brand name and generic versions of the drug (Wyeth, Inc v. Weeks, 2014 WL 40585813 (Ala. Aug. 15, 2014)).

Brand-name drug companies, including Wyeth, moved to have the case dismissed. The manufacturers argued that Weeks’ allegations are product liability claims barred for “product identification” failure, and asserted that manufacturers did not have an obligation to warn about generic drugs.

The Alabama Supreme court found that brand name manufacturers are liable for generic drug injuries if the company made misrepresentations about the drug. The ruling focused on the intermediary doctrine, which says that brand name manufacturers fulfill their duty to warn consumers of drug risks by disclosing safety information to physicians. 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,”

The label on generic medications must carry the same label as the brand-name version. Therefore, “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. He also stated 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.” he stated.

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