International Association of Defense Counsel, Defense Counsel Journal, July 2008
29 Pages Posted: 31 Jul 2007 Last revised: 2 Jun 2013
Date Written: March 16, 2008
Though many believe that the tort system incents manufacturers to promote and manufacture their products safely, the Vioxx litigation proves that, in fact, the tort system functions as a disincentive against manufacturer transparency, scientific curiosity, and public safety. This Article examines the differences between Merck's liability for the pain reliever Vioxx and Pfizer's liability for its competing pain reliever, Celebrex. It concludes that the reason for Merck's increased product liability arises from its diligent efforts to protect the public. When Merck published studies examining Vioxx's cardiovascular safety, Merck provided plaintiffs with a wealth of data. By voluntarily withdrawing Vioxx, Merck alerted lawyers and potential plaintiffs to Vioxx's potential for harm. This Article examines several solutions to these perverse incentives, including FDA preemption at the state and federal level, the pending FDA Revitalization Act and FACT Act, Wagner's Burden-Shifting Proposal, and two market-based solutions. The Article concludes with its own market-based solution, which encourages the rapid release of study data and attempts to mitigate the red flag effect that occurs when a manufacturer voluntarily withdraws a potentially dangerous product.
Keywords: tort, Vioxx, Celebrex, cardiovascular, FDA preemption, market-based, Merck, Pfizer, incentive, transparency, defense, pharmaceutical, FDA, FDA Revitalization Act, FDARA, Fair Access to Clinical Trials Act, FACT Act, wagner, burden-shifting, cahoy
JEL Classification: K13, K41
Suggested Citation: Suggested Citation
Wolsing, Jennifer M., The Vioxx Litigation: Disincentivizing Patient Safety Through Misdirected Tort Rules (March 16, 2008). International Association of Defense Counsel, Defense Counsel Journal, July 2008. Available at SSRN: https://ssrn.com/abstract=1004144