Tuesday, February 26, 2013
Forbes reports that Pfizer is asking the Alabama Supreme Court to reconsider its decision holding Pfizer liable for failing to warn a consumer who took a generic version of the drug Reglan. The article points out the regulation, not litigation, may answer this one:
Meanwhile, though, the issue may be decided by the FDA. The agency recently disclosed plans to revise its regulations so that generic drugmakers can update product labeling and warn patients about risks associated with their drugs. If the FDA were to make such a change, generic drugmakers could be sued in state courts – if they become aware of evidence of serious side effects, but do not take action to update the product labeling (back story).