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To the Editor: In his Commentary on federal preemption of state tort claims regarding medical devices and pharmaceuticals, Mr Gostin¹ explained the critical public health issues and implicated public policy. He also remarked on the "apparently inconsistent decisions" by the US Supreme Court in Riegel v Medtronic Inc (finding suits for defective medical devices preempted) and Wyeth v Levine (no preemption for prescription drugs). From a public policy perspective, this inconsistency is even more perverse than Gostin explained.

The US Food and Drug Administration (FDA) explicitly regulates the labeling of drugs, for which the most frequent tort claim is inadequate warnings.² Thus, at the time of FDA approval there is an argument for preemption of warnings claims. By contrast, a frequent basis for alleging defectiveness of medical devices is improper design.³ Even for Class III devices, which undergo clinical testing before approval, the FDA does not review and approve the . . . [Full Text of this Article]

Michael Green, JD
greenmd@wfu.edu
Wake Forest University School of Law
Winston-Salem, North Carolina

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