The "FDA approval defense": penetrating the protective shield.

Pharmaceutical manufacturers decry the purported burdens imposed by Federal regulation when it suits their proprietary interests, yet they sing a wholly different tune when defending product liability suits. As product liability defendants, they unabashedly seek the protective womb of Food and Drug Administration (FDA) regulation, arguing that agency approval of their drug and its labeling precludes their product from being regarded as defective or their conduct characterized as tortious. Several states have recognized FDA approval as a defense in product liability actions for certain purposes. Most notably, a number of states exempt pharmaceutical manufacturers from liability for punitive damages arising from use of any drug approved by FDA [1]. A similar exemption has been incorporated in a number of Federal tort reform bills that have been introduced over the past several years in Congress [2]. Most courts have rejected pharmaceutical manufacturers' argument that compliance with FDA regulatory requirements preempts a finding of liability for negligence, defective design, and inadequate warnings under state tort law. FDA regulation of prescription drugs is "generally viewed as setting minimum standards, both as to design and warning" [3]. Compliance with FDA regulatory requirements is not dispositive on the design and warning issues if it were reasonable to have done more [4]. Even where courts have rejected Federal preemption as a defense to a pharmaceutical product liability suit, a drug company defendant will not hesitate to urge deference to the purportedly pre-eminent expertise and knowledge of FDA [5], the agency that previously determined that the drug's benefits outweighed its risks and justified its marketing and approved the warnings, precautions, contraindications, and other safety-related information contained in the drug's labeling [6]. Pharma-