Abstract
Liability for injuries caused by defective drugs generally is premised on the failure of manufacturers to warn physicians of the risks associated with the product. 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. Traditionally, courts have taken the position that FDA regulation of prescription drugs imposes only minimum standards. 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.
How to Cite
48 Ariz. L. Rev. 67 (2006)
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