Time For a Fresh Look at Strict Liability for Pharmaceuticals

Abstract

Over the ensuing 50 years from the promulgation of § 402A, products liability in general has seen a retrenchment from strict liability. The Restatement (Third) of Torts: Products Liability openly adopted negligence principles for design and warning claims, and created an entirely new provision to protect pharmaceutical manufacturers even more robust than 402A's comment k. Regarding pharmaceutical liability, the trend away from any liability at all has been remarkable. In the face of this legal history, and in spite of it, this Article proposes taking a fresh look at strict liability for pharmaceutical injuries. What has changed since the adoption of the Products Liability Restatement, which endorsed a virtual immunity from liability for pharmaceuticals? Such a suggestion is likely to be met with cries of “absolute liability” and concern for a chilling effect on innovation for much needed therapeutic treatments. There are three primary reasons this Article proposes a reassessment for strict tort liability in this context. First, the expansive federal preemption doctrine that the United States Supreme Court has fashioned in the last decade defeats almost all state tort liability for pharmaceuticals, particularly for generic pharmaceuticals which comprise over 85 percent of the prescriptions in this country. Second, both the pre-marketing approval process and the post-marketing risk assessment regulatory structures fundamentally cannot adequately identify, communicate, and reduce adverse drug events and, consequently, those events are increasing and likely to continue to do so. Third, the structure of pharmaceutical marketing, increasingly unregulated, has influenced prescribing practices in ways that compound the likelihood and severity of adverse drug events.

These trends in pharmaceutical marketing practices, coupled with the systemic limitations on information-gathering and response in the regulatory system, has created a demand for pharmaceuticals that increases the likelihood of adverse drug events with no meaningful mechanism to identify and reduce the risks presented. While the legal landscape has become barren to the use of tort liability to compensate for the inevitable risk of adverse drug effects, the medical care landscape has become more fertile for those side effects to occur. The convergence of these trends supports a reevaluation of the use of strict, non-fault liability on producers of pharmaceuticals for the harms their products cause.