The FDA Defense: Vioxx and the Argument Against Federal Preemption of State Claims for Injuries Resulting from Defective Drugs

Federal regulation of pharmaceuticals by the Food and Drug Administration raises the question whether the Agency’s authority preempts common law tort claims for injuries caused by defective drugs. The FDA once considered products liability lawsuits to be supportive of the Agency’s goal of promoting drug and medical device safety. The Agency has since reversed its position on the benefits of civil litigation, and now contends tort claims interfere with its ability to regulate the market. In January 2006, the FDA introduced a new rule encouraging courts to recognize a broad preemption doctrine that would immunize manufacturers from civil liability when the FDA previously approved a product for sale.