Cornell Law Review Volume 93 Issue 5

Great and Lesser Powers of Tort Reform: The Primary Jurisdiction Doctrine and State-Law Claims Concerning FDA-Approved Products

As the federal agency tasked with ensuring drug safety, the Food and Drug Administration (FDA) is the single most important regulator in the pharmaceutical field. Currently, a vigorous debate exists over whether it should be the only regulator. Critics of the tort system see products liability suits as an additional, pernicious source of regulation. They argue that juries should not be allowed to second-guess the FDA’s drug-safety determinations, and they contend that the risk of tort liability deters useful pharmaceutical innovations. The current FDA agrees. Although the FDA, under past administrations, saw itself as setting only a floor for drug safety—such that, for example, state tort law could permissibly impose additional requirements on a drug manufacturer—the current FDA views itself as setting both a floor and a ceiling. Defenders of the tort system, however, point out that many risks become apparent only after a drug has been widely used for some time; in contrast to the rigorous scrutiny of pre-marketing review, the FDA’s “post-marketing surveillance” program—the means by which the FDA monitors a drug’s safety after its approval—is woefully inadequate. The tort system, they contend, gives plaintiffs’ lawyers an incentive to collect and analyze drug safety data in their search for valid tort claims, and the tort discovery process can bring to light new evidence concerning a drug’s risks.


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