Supreme Court Upholds Personal Injury Claims Against Drug Makers

The United States Supreme Court issued a major decision upholding the right of persons injured by badly labeled prescription drugs to sue drug manufacturers for failing to warn of the risk of injury.  In its decision in Wyeth v. Levine, No. 06-1249 (U.S. March 3, 2009), the Supreme Court held that the Food and Drug Administration's (FDA's) approval of a prescription drug's label does not "preempt," or wipe out, plaintiff's state-law claims for personal injury damages.  Wyeth, other drug makers, and their allies (including the FDA itself under the previous administration) urged the Court to issue a sweeping ruling that any time the FDA approved a prescription drug's label, people who were injured by the drug could never bring suit.  But the Supreme Court strongly rejected this argument, and held instead that:

• Congress never intended to preempt personal injury claims against drug makers;
• Congress and the FDA have long recognized that personal injury claims against drug makers further the public health and safety goals of federal law in this area; and
• the FDA's reversal in 2006 to a pro-preemption position deserves no deference by the Court because the FDA made this switch without providing any opportunity for public comment and its position was directly at odds with that of Congress.

WCB filed an amicus curiae brief in Levine urging the Supreme Court to rule as it did.  Our brief was filed on behalf of Dr. David B. Ross, former deputy director of the FDA's Office of Drug Evaluation, and Dr. Stefan P. Kruszewski, former Psychiatric Consultant for the Pennsylvania Department of Public Welfare.  Our brief addressed repeated failures by the FDA to ensure drug safety, including the high-profile examples of Ketek, Avandia, and Zyprexa, and argued that these failures proved that patients cannot rely exclusively on the FDA for drug safety.  The Court's opinion cites many studies supporting this argument.  Our brief was written by associate attorney Michael Quirk, with assistance from partners Esther Berezofsky and Mark Cuker.

The Supreme Court's opinion in Wyeth v. Levine can be accessed at http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf