On Wednesday, the Court of Appeals for the First Circuit upheld a $21 million verdict awarded to a woman who suffered grievous injuries as a result of taking a generic pain medication prescribed by her doctor. In its appeal to the First Circuit, the generic drug manufacturer, Mutual Pharmaceutical Company, argued that the design defect claims were preempted by the Hatch-Waxman Amendments to the Federal, Drug, and Cosmestic Act (“FDCA”) under the Supreme Court’s 2011 decision PLIVA v. Mensing.
In its opinion rejecting that argument, the First Circuit noted that the Supreme Court’s reasoning in Wyeth v. Levine (2009) -- in which the Court held that failure-to-warn claims against a brand name drug manufacturer were not preempted by the FDCA -- applies equally to design defect claims. The First Circuit acknowledged that PLIVA carved an exception out of Wyeth for failure-to-warn claims against generic drug manufacturers, but the First Circuit declined to apply that exception to the plaintiff’s design defect claims. The court concluded that while a generic drug manufacturer could not choose to alter the chemical composition of the drug under the FDCA, it could simply decide not to make the drug at all due to the risks involved. Therefore, PLIVA – in which the Supreme Court found that the generic drug manufacturer could not change FDA-approved labels of its own accord and thus could not be held liable under state law for failing to change warning labels -- was not controlling.
The First Circuit concluded that the Supreme Court “adopted a general no-preemption rule in Wyeth and … it is up to the Supreme Court to decide whether PLIVA’s exception is to be enlarged to include design defect claims.” Noting the existence of a circuit split and the widespread use of generic drugs, the First Circuit suggested that the Supreme Court needs to resolve this issue.
The First Circuit’s opinion underscores that, through its opinions in Wyeth and PLIVA, the Supreme Court has created an inconsistent and unfair legal regime in which a plaintiff’s ability to recover for injuries depends in large part on whether she was given the generic or brand name version of a drug. In response to this injustice, Sen. Leahy (D-VT) recently introduced legislation that would amend the FDCA to allow generic drug manufacturers to change their labeling to warn consumers of newly discovered risks. AFJ and several of its member organizations submitted a letter in support of the legislation. This issue is of particular importance since generics account for more than 75% of drugs prescribed in the United States.