(CN) – A Minnesota woman can sue generic drug makers for allegedly failing to warn her that long-term use of the generic version of Reglan could lead to a severe movement disorder, the 8th Circuit ruled.
Gladys Mensing said she developed tardive dyskinesia after taking metoclopramide, the generic equivalent of Wyeth’s Reglan, for four years to treat a stomach disorder.
She sued Wyeth and handful of generic drug makers and distributors, claiming the drug labels understated the risks of tardive dyskinesia.
She lost her claims against Wyeth, because she never took the name-brand drug.
The district court also dismissed her state claims against generic drug makers Actavis Elizabeth and Pliva, saying they were preempted by federal law.
Reversing that portion of the decision, the St. Louis-based appeals court said failure-to-warn claims against generic drug makers 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.”
The three-judge panel allowed Mensing to sue the generic drug makers, but affirmed dismissal of her claims against the name-brand defendants.