Life Sciences Capabilities in Securities Litigation

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 withdrawing the drug.

Counsel for the company retained Cornerstone Research to support a health economist who opined on the dynamics of the pharmaceutical industry generally and the role of the at-issue drug in the company’s portfolio in particular.

The expert discussed the benefit and risk considerations leading to regulatory approval of a new drug and manufacturers’ continued efforts to discover new uses and monitor safety risks after drug approval. Additionally, the expert opined that the marketing for the at-issue drug was appropriate and expected given the large potential market and competitive threats. The expert also found that plaintiffs’ expert overstated the impact of direct-to-consumer advertising, first mover advantage, and black box warnings when assessing the drug’s sales in the “but-for” world.

Cornerstone Research was retained by a biotechnology company that faced securities litigation related to allegations that the company and its CEO made misleading statements about the results of its Phase III clinical trial for a cancer drug.

We supported an FDA expert who reviewed the relevant case documents and opined on the factors influencing the FDA’s approval of the company’s drug. The expert relied on experience with the FDA to describe the agency’s review process and how regulators would have viewed the safety and efficacy data from the clinical trials.

Cornerstone Research was retained by a pharmaceutical company that faced securities litigation alleging that the company had selectively disclosed metrics with positive results and failed to promptly disclose allegedly unfavorable results in its clinical trial, which purportedly led another company to terminate a collaboration between the two companies. We supported a health economist to assess these claims.

The expert explained that the metrics with positive results are the “gold standard” for evaluating both the clinical and commercial value of the drug. The expert further showed that the results for the remaining metrics were comparable to or better than those for other drugs in the same treatment space and for similar patient populations, and thus were not unfavorable. Finally, the expert reviewed documentary evidence and concluded that the other firm may have terminated the collaboration as a result of unexpected budget cuts and strategic portfolio evaluation, or due to a shrinking market size for the drug’s other indication that was irrelevant to the clinical trial at issue.

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 the company withdrew the drug. Counsel for the company retained Cornerstone Research to support a biostatistician to assess these claims.

The expert reviewed the company’s analysis of its clinical trial data, along with the clinical trial protocols. The expert 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. The expert also concluded that the measurement of adverse events was appropriate given the hypothesized nature of the safety risks. In contrast, plaintiffs’ expert’s conclusions relied on analyses and safety events that were not prespecified and assumed access to data prior to their unblinding. The defense expert concluded that the company’s analyses of its clinical trial data and interpretation of the results were appropriate and reasonable.

Cornerstone Research was retained by a pharmaceutical company that shareholders alleged had overestimated the commercial success of certain of its products, as well as its ability to command a price premium on those products. Plaintiffs further claimed that rebates had driven sales for these products, and these rebates were eroding the company’s profits. Finally, plaintiffs contrasted the company’s optimistic messaging regarding the products’ market prospects with the messaging of competing manufacturers, which made less favorable predictions. W supported a health economist, a pharmacy benefit manager (PBM) expert, and a physician to evaluate those claims.

The health economist explained the uncertainty involved in drug research and development, regulatory approval, and market performance, as well as associated challenges in predicting the commercial success of pharmaceutical products. The health economist further explained that several other factors affect pharmaceutical products’ market access and commercial success and that plaintiffs’ emphasis on rebates as the single determinant was misplaced. In addition, the health economist noted that other manufacturers’ predictions may have been less favorable because they had different products in their portfolios.

The PBM expert drew on academic and industry expertise to discuss the negotiation process between PBMs and drug manufacturers for formulary access and the factors that may be considered relevant to drug access.

The physician offered expert opinion regarding which characteristics of drugs in the relevant therapeutic space are important.

Cornerstone Research was retained by a pharmaceutical company facing securities litigation. The matter involved claims that the company knew but failed to disclose statements by key opinion leaders that they would not use the drug at issue because clinical trial data on the drug’s efficacy were not compelling.

We supported an FDA expert who opined on the FDA approval process for prescription drugs and the role of key opinion leaders in approval and drug uptake. The expert also opined on whether the company disclosed relevant clinical trial results prior to the FDA issuing a complete response letter and whether labeling changes prior to final approval affected the target opportunities of the drug.