The Legal Perspective

Despite the many limitations to interpreting spontaneous adverse drug reaction (ADR) reports, including making causality judgments, ADR reports play a significant role in product liability lawsuits. Product liability is a rapidly growing issue for pharmaceutical manufacturers because recent judicial decisions have taken drug liability law beyond the traditional concepts of negligence and are approaching absolute liability, partly because many cases reveal a search for the “deep pocket.” A majority of cases center on the duty to warn of side effects and, more recently, the duty to warn about unknown side effects, a trend that could have deleterious consequences on pharmaceutical manufacturers. Examples are provided by experiences with cases involving vaccine liability, which rely on two major proofs of causation: (1) temporal association, an easily understood but flawed criterion when the alleged injury is either common in occurrence, or when it does not occur in thousands to millions of those exposed to a suspect agent; (2) epidemiologic studies, which are limited, particularly in retrospective analyses, by lack of conclusive evidence of causation versus group differences. The experience in this type of product liability suggests the need for alternatives to the current tort system. At present, however, a manufacturer can help diminish liability with programs directed to the major sources of liability — physical defects of the product and failure to warn. A detailed liability prevention plan is outlined, focusing on quality control, comprehensive ADR information management, and diligent training of the sales force.