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

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).

Although it is far too soon to predict the full impact of the FDA preamble, the initial judicial response and the resources being devoted on both sides of the courtroom make it clear that pre-emption arguments will play an increasingly important role in prescription drug litigation. This two-part article discusses the key legal issues ' from a defense perspective ' that are likely to shape the future debate, and provides a report on the divided case law that has emerged over the past several months.