In Mutual Pharmaceutical Co. v. Bartlett, No. 12-142, the Supreme Court of the United States will consider whether the Federal Food, Drug, and Cosmetic Act supersedes state-law claims against manufacturers of generic prescription drugs for design defects. CCL has filed two amicus curiae briefs in support of the injured plaintiff, Karen Bartlett, whose adverse reaction to the generic pain medication ‘sulindac’ included burns, disfigurement, and blindness.

An amicus brief written by CCL’s Andre M. Mura, and filed on behalf of the American Association for Justice, a voluntary national bar association, and Public Justice, PC, a national public interest law firm, argued that Congress did not intend to deprive persons injured by unreasonably dangerous drugs of long available compensation. Responding to the generic drug manufacturer’s argument that it was impossible for it to comply with both state tort law and federal drug-safety law, the brief explained that even a state-law prohibition against the sale of an unreasonably dangerous drug would not impose an impossibility conflict with federal law because federal law does not require drug manufacturers to sell drug products. Lastly, the brief criticized the United States’ position on preemption, which favors the generic manufacturer in this case, for failing either to acknowledge the Food and Drug Administration’s (FDA’s) shortcomings, which hamper its ability to monitor the safety and efficacy of prescription drugs, or to credit product-liability litigation for providing a critical layer of consumer protection.

CCL filed a separate amicus brief on behalf of persons injured by the prescription drug propoxyphene, which is alleged to have caused serious cardiac injuries or death to thousands, and which has now been withdrawn from the market. The brief, written by CCL’s Louis M. Bograd, argued that state-law design-defect claims are entirely consistent with and complementary to the FDA’s regulatory system. Further, the brief explained that the Supreme Court’s recent decision in Pliva, Inc.  v. Mensing, 131 S. Ct. 2567 (2011), which held that failure-to-warn claims against the manufacturers of generic prescription drugs were preempted by federal law, is not controlling here because design-defect liability differs in important ways from liability for failure to warn.

This critical preemption case is set for argument on March 19.  A decision is expected by end of the Court’s Term in June.