Generic Drugmakers Lose Preemption Argument

A generic drug may be bioequivalent with a brand-name med and approved by the FDA, but that doesn’t mean a generic drugmaker is shielded from a product-liability lawsuit. That’s what a federal judge ruled in refusing to dismiss a lawsuit by consumers who allege two generic drugmakers failed to warn about side effects caused by differences in their versions of the Wellbutrin XL antidepressant.

In a 29-page decision, US District Judge Berle Schiller cited the US Supreme Court’s decision in Wyeth vs. Levine, which determined FDA approval does not shield drugmakers from state lawsuits, and concluded that generic drugmakers also have a duty to warn about any new side effects that may occur after the FDA has approved their medicines. Several generic drugmakers recently petitioned the US Supreme Court to review their liability .

The lawsuit alleges that Teva Pharmaceuticals and Impax Laboratories became aware of the side effect issue, but failed to warn the public about differences that affected the release rate of the active ingredient. “A generic drug manufacturer is not absolved of liability because the FDA has approved its generic product,” Schiller wrote