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Prescription Drug Litigation Pre-emption Following the FDA Preamble: The Defense Perspective

By Eric G. Lasker

Part One of a Two-Part Series

It has now been more than 9 months since the U.S. Food and Drug Administration ('FDA') issued its new labeling rule for prescription drugs with an extensive preamble analysis of how many state tort legal claims conflict with and accordingly are pre-empted by the its regulation of such drugs. The FDA re-emphasized its position that state tort law claims threaten its ability to pursue its statutory mandate of protecting public health through balanced labeling. It thus explained that 'under existing pre-emption principles, FDA approval of labeling under the [FDCA] pre-empts conflicting or contrary State law.' 71 Fed. Reg. 3922, 3933 (Jan. 24, 2006).

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