Federal judge rules generic drugs are not protected from lawsuits

posted on:
June 7, 2010

author:
JENNIFER WALKER-JOURNEY

A federal judge has ruled that makers of generic drugs are not protected from lawsuits even if the Food and Drug Administration (FDA) certifies them as the “bioequivalent” of their brand-name predecessors. U.S. District Judge Berle M. Schiller refused to dismiss a suit brought by consumers who were previously taking the brand name antidepressant Wellbutrin but claim they experienced side effects after switching to the generic version, buproprion. The lawsuit claims that Teva Pharmaceuticals and Impax Laboratories, both manufacturers of buproprion, knew of the reported side effects but failed to warn consumers of the differing release rates of the active ingredient in the generic drugs versus the brand name.

Referencing the Supreme Court’s recent decision on Wyeth v. Levine, Schiller wrote in the Teva/Impax decision that generic drug manufacturers have a duty to continuously issue warnings about any new side effects reported even after the drug has been approved. “A generic drug manufacturer is not absolved of liability because the FDA has approved its generic product,” he continued.

Buproprion isn’t the only generic drug under fire for not adequately warning consumers of potential side effects caused by subtle differences when switching from a brand name drug to its generic equivalent. In 2009, generic versions of the anti-seizure drug Keppra from numerous manufacturers were approved for marketing in the United States. Consumers who were managing their seizure disorders with Keppra quickly found that switching to the less expensive generic versions caused their seizures to return or created new conditions, such as severe headaches.

Health care professionals recommend that special care be given when patients switch from a brand-name seizure medication to a generic one, or even switching between two different generic drugs.

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