In recent years, the health care industry has experienced an increasing number of black box warnings and drug withdrawals, heightened regulatory scrutiny, and widely publicized product liability/mass tort litigation.
Given the nature of the pharmaceutical industry in general and the underlying science of biologic products in particular, the strategies pursued by brand manufacturers may be vulnerable to a variety of legal challenges.
Patent, copyright, and trademark infringement disputes are also on the rise, as the industry’s competitive dynamics impact intellectual property issues.
From very high stakes class actions to cases involving allegations of securities or product fraud, we apply fact-based expertise to help clients achieve successful outcomes in the courtroom. In situations involving government investigations of manufacturer pricing and promotion practices, we provide economic, epidemiologic, and statistical support to counsel, often in the context of settlement discussions.
We use biostatistical and econometric techniques to develop empirical evidence based on a range of sources. We ensure that our work can withstand cross-examination in court or detailed review by government agencies.
In many litigation matters, our professionals focus on both liability and damages issues as well as the appropriateness of class certification. In product safety litigations, we complement our expertise in the economic issues involved with hands-on knowledge of the therapeutic area at issue and, often, of the drug itself.
SPOTLIGHT ON AN EXPERT
Academic affiliate Ernst Berndt of MIT has worked on health outcomes research projects involving the analysis of prescription drugs and econometric studies on pharmaceutical price growth.
Our work is frequently published in prestigious peer-reviewed journals and leading business and industry publications.