The pharmaceutical industry, a popular target for mass tort litigation, has repeatedly felt the sting of multimillion-dollar verdicts. As the recent Vioxx litigation demonstrates, one area in which the industry particularly needs to strengthen its defense position involves clinical trial protocols and implementation.

Understanding the key issues underlying these adverse verdicts for defendants, as well as developing and implementing appropriate information technology to address those issues, will facilitate standardization of clinical trial protocols and ensure a more rigorous and accurate reporting system companywide. Addressing critical issues related to the Vioxx litigation and improving clinical trial protocols and reporting will enable pharmaceutical companies to better manage risk in the pharmaceutical litigation arena.