This Amici Curiae Brief is available here as an Adobe Acrobat PDF.

Summary of Argument

Prominent in arguments opposing preemption of state tort law liability for alleged inadequacies in prescription drug labeling is the argument that such liability can complement FDA regulation by improving on a regulatory scheme that fails to provide adequate deterrence against the marketing of unsafe or inadequately labeled drugs. The premise of this argument is faulty. Fundamental principles of economics and numerous studies of FDA drug regulation reveal that FDA in fact errs on the side of overregulation of prescription drugs. Product liability litigation focused solely on one side of the prescription drug public health equation leads to further distortions of the drug approval and labeling process and exacerbates FDA's inherent overly cautious approach. Preemption of state tort law where it conflicts with FDA requirements will minimize these distortions and thereby maximize public health.

FDA's incentive to overregulate is clear upon examination of the underlying forces that can skew its regulatory decisionmaking. In particular, FDA faces substantial criticism when it mistakenly approves drugs that should not have been approved ("Type I errors"), but considerably less criticism when it fails to approve drugs that should have been approved ("Type II errors"). As a result, FDA has an incentive to be overly cautious in approving new drugs, even though the failure to approve a beneficial drug can lead to more significant public health harms than mistaken approval of potentially dangerous drugs. The same FDA tendency toward over-caution (Type II errors) carries over to regulation of the drug label, where FDA has an incentive toward overwarning and undue contraindications. Such excessive warning language also has adverse public health consequences.

State tort lawsuits exacerbate the problems of FDA's overly cautious approach by imposing additional requirements on pharmaceutical companies to add new warnings or contraindications. These requirements lead to a host of distortions in drug marketing and availability that have adverse consequences for public health and wellbeing. Preemption provides an important safeguard against expected FDA Type II errors by countering the exacerbating impact of state tort lawsuits for failure to warn. . . .