The appellants sued generic drug manufacturers for injuries related to use of the drug metoclopramide. The appellants allege the generic defendants are liable for failing to convey FDA-approved information; information communicated by generic manufacturers that is consistent with the brand-name labeling does not violate the duty of sameness. Because no brand-name manufacturer sent a warning based on a 2004 label change, the generic manufacturers were not at liberty to do so. As Mensing concluded, preemption is triggered because it would be impossible for the manufacturer to comply with both the state law duty to warn and the federal law duty of sameness. The district court's grant of a motion to dismiss and its denial of a motion to alter or amend the judgment is affirmed. 5th U.S. Circuit Court of Appeals, No. 12-30319, 02-14-2013.
Morris v. Pliva Inc.
April 18, 2013