Products Liability in the Pharmaceutical Industry

Abstract

This article addresses the issues relating to products liability in the pharmaceutical industry. It outlines the drug approval process and the pressures inherent in the system arising from competition from generic drugs and affordable health care organizations in the context of two infamous drug recalls: Baycol and Vioxx. Finally, the paper includes several appendices dealing with the drug approval process, the nature of product warnings, principles of federal preemption, the “learned intermediary†rule, and expected health care expenditures for 2012-

2013.

 

Keywords: Products liability, Drug approval process, Generic drugs, Affordable health care organizations, Baycol, Vioxx .