To increase the availability, safety, and effectiveness of medical products and, thus, promote public health, medical product manufactur-ers must invest in the research and development of medical products. Unfortunately, the threat of tort liability discourages medical product manufacturers from doing so. This note attempts to resolve this dilemma. The author begins by briefly providing some background on the relevant medical and pharmaceutical approval processes. After examining the li-ability protections currently available—preemption of state tort claims, the regulatory compliance defense, and damage caps—the author con-cludes that these protections are, on the whole, beneficial. However, the author also acknowledges a critical shortcoming associated with the im-plementation of these tort liability protections—reduced manufacturer in-centive to perform adequate post-approval surveillance and testing. To address this shortcoming, the author proposes federal legislation combin-ing preemption, the regulatory compliance defense, and a nontraditional variation of damage cap to encourage investment in research and devel-opment while simultaneously maintaining manufacturers’ incentives to perform adequate post-approval surveillance and testing.
The full text of this Note is available to download as a PDF.