Karen Bartlett was severely injured by the prescription pain reliever Sulindac, which she took in generic form. She brought a state-law design-defect claim against the manufacturer of the drug, and a jury ruled in her favor. The company is asserting, however that her suit is barred by federal regulation of generic prescription drugs and, even further, that federal regulation preempts design-defect claims concerning brand-name prescription drugs as well. The U.S. Supreme Court granted the company’s petition for certiorari to consider the preemption question.
Filed on behalf of U.S. Senator Tom Harkin (D-IA) and Rep. Henry A. Waxman (D-CA), our amicus brief argues that the text and purpose of the federal law regulating prescription drugs, as well as more than 75 years of history in which damages suits and federal drug regulation have co-existed, show that design-defect claims are not preempted. Moreover, whether federal law should bar state-law claims is a policy decision that should not be made by the Court but instead is properly left to Congress.
In a 5-4 decision, the Court reversed the First Circuit and held that federal regulation preempts design-defect claims against manufacturers of generic drugs.