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Manufacturers of Generic Pharmaceuticals Must Warn of Dangers Learned After Obtaining FDA Approval

06/09/2010

In a case of first impression for the U.S. District Court for the Eastern District of Pennsylvania (and the first for district courts within the Third Circuit), the court recently found that Food and Drug Administration (FDA) approval of a generic pharmaceutical does not necessarily protect its manufacturer and distributor from state law claims. In In re: Budeprion Marketing & Sales Litigation, the court refused to accept the defendants’ argument that FDA approval (and associated finding of bioequivalence) for a generic drug preempted state law failure to warn claims. MDL No. 2107 (E.D. Pa. May 26, 2010). In doing so, the Eastern District of Pennsylvania has joined numerous other federal courts in reading the U.S. Supreme Court case of Wyeth v. Levine, 129 S. Ct. 1187 (2009), to apply to generic as well as name brand pharmaceuticals.

As a result of the Budeprion decision and other similar federal court decisions, generic pharmaceutical manufacturers and distributors cannot rely upon the bioequivalence and drug labeling approval they received from the FDA to protect them from state law claims. In these decisions, the courts instead expect that if a generic drug’s manufacturer learns of adverse side effects or new dosage and efficacy information that should be included in the label, the manufacturer can change its label to reflect such information or otherwise inform consumers and doctors of this information, even if the name brand manufacturer of the drug has not.