Alleged Failure to Disclose Drug Safety Issues

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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 biostatistics expert to assess plaintiffs’ claims.

The expert concluded that the company’s analyses of its clinical trial data and interpretation of the results were appropriate and reasonable.

The expert reviewed the company’s analysis of its clinical trial data and showed that the analysis was consistent with its clinical trial protocols, including the adjudication of adverse events, the timing of data unblinding, and the pooling of data across multiple trials to assess safety risks. The expert 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 unblinded data prior to when unblinding occurred.

The expert supported by Cornerstone Research concluded that the company’s analyses of its clinical trial data and interpretation of the results were appropriate and reasonable and the opinions of the plaintiffs’ expert were not reliable.


For more information on this case, contact Sally Woodhouse or Carlos Brain.