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Drug & Device News

By ALM Staff | Law Journal Newsletters |
June 22, 2010

FDA Certification Does Not Shield Generic Drug Maker from Suit

Generic drug manufacturers are not insulated from lawsuits by a Food and Drug Administration (FDA) approval process that certifies such drugs as the “bioequivalent” of their brand-name predecessors, a federal judge in Philadelphia has ruled. In the 29-page decision rendered in In re Budeprion XL Marketing & Sales Litigation, U.S. District Judge Berle Schiller refused to dismiss a suit brought by consumers who were previously taking Wellbutrin, a brand-name antidepressant drug, and claim they experienced side effects upon switching to generic buproprion. The suit alleges that two manufacturers ' Teva Pharmaceuticals and Impax Laboratories ' became aware of the potential problem but failed to warn the public about differences between the name-brand and generic versions of the product that affected the release rate of the active ingredient. Schiller applied the U.S. Supreme Court's recent decision in Wyeth v. Levine, and concluded that generic drug manufacturers, like manufacturers of the previously approved name-brand drugs their products mimic, also have a continuing duty to issue warnings about any new hazards that arise after approval.

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