Drager v. PLIVA USA, Inc., No. 12-1259 (4th Cir. 2014)Annotate this Case
Shirley Gross filed suit against PLIVA after her long-term use of the generic drug metoclopramide, produced by PLIVA, caused her permanent injuries. On appeal, plaintiff, as the personal representative of the estate of Gross, challenged the district court's denial of Gross's request to amend her complaint and her state common law tort claims against PLIVA for injuries sustained as a result of her use of a drug it manufactured. Federal Food, Drug, and Cosmetics Act, 21 U.S.C. 301 et seq. The court affirmed the district court's denial of leave to amend and held that none of plaintiff's claims regarding PLIVA's alleged failure to update its warnings were before the court on appeal; the court found that the complaint did not allege any violation of the federal misbranding laws or parallel state duties, and to the extent these claims were made on appeal, they were waived; and all of Gross's causes of action were preempted by the FDCA. Accordingly, the court affirmed the judgment of the district court.