Cornerstone Research was retained by a pharmaceutical company facing securities litigation after it withdrew a drug from the market because of safety concerns.
A pharmaceutical company faced securities litigation after it withdrew a drug from the market because of safety concerns. Plaintiffs claimed that the company knew the drug was unsafe based on its clinical trial data long before it withdrew the drug. Counsel for the company retained Cornerstone Research and a biostatistician to assess these claims.
The biostatistics expert concluded that the company’s analyses of its clinical trial data and interpretation of the results were appropriate and reasonable.
The biostatistics expert reviewed the company’s analysis of its clinical trial data and the clinical trial protocols. He showed that the analysis was consistent with those protocols, including the adjudication of adverse events, the timing of data unblinding, and the meta-analysis of data across multiple trials to assess safety risks. He also concluded that the measurement of adverse events was appropriate given the hypothesized nature of the safety risks. In contrast, the conclusions of the plaintiffs’ expert relied upon analyses and safety events that were not pre-specified and assumed access to data prior to the data’s unblinding.