Generic Drug Makers Can Be Liable for Harmful Drugs

The manufacturers of generic drugs can not be protected by a preemption defense in product liability suits against the generic drug manufacturer, according to the 8th District Court.
The case involved a Minnesota woman who sued the generic drug manufacturers for failure to warn her concerning dangerous side effects associated with metoclopramide, the generic version of Reglan. Both the generic and brand name drugs have been linked to a severe movement disorder, tardive dyskinesia.
Gladys Mensing developed tardive dyskinesia after taking metoclopramide for four years to treat a stomach disorder. She sued Wyeth and other generic manufacturers of metoclopramide for understating the risks associated with the drug.
The 8th District Court’s ruling allows those who’ve been injured by generic drugs to bring claims against the manufacturer of those drugs for failure to warn the public about potentially dangerous side effects. Causes of action based on a failure to warn are not preempted by the Food, Drug and Cosmetic Act.
“The regulatory framework makes clear that a generic manufacturer must take steps to warn its customers when it learns it may be marketing an unsafe drug,” Judge Diana Murphy wrote.
Federal law “does not permit generic manufacturers passively to accept the inadequacy of their drug’s label as they market and profit from it,” Murphy added. “If Mensing’s injuries resulted from their failure to take steps to warn their customers sufficiently of the risks from taking their drugs, they may be held liable.”