Placing Blame for the Vioxx Debacle

Abstract

The purpose of this paper is to tell the complete story, from creation to termination to litigation, of the Merck Pharmaceutical Company drug, Vioxx. This paper will explain the type of drug Vioxx is and the way in which it was tested by researchers. It will outline the FDA drug review and approval process and briefly consider the debate between accelerated and traditional drug approval guidelines. It will then discuss the actions taken by the FDA in its review of Vioxx in 1999. It will paint a picture of the actions and negotiations which took place between Merck and the FDA after approval. Then it will discuss the decision by Merck to voluntarily withdrawal Vioxx from the market. It will then consider the ramifications of the withdrawal including the SEC and DOJ investigations, Congressional inquiry, and civil litigation. Finally, the paper will examine the pending litigation regarding Vioxx to determine the existence of themes and strategies in those cases as well as Merck’s future post litigation.