• The Role of Clinical Trials in Mass Torts and Related Shareholder Suits

    The Role of Clinical Trials in Mass Torts and Related Shareholder Suits

    In mass tort product liability lawsuits, the key causality claim is whether and to what extent illnesses and deaths are related to exposure to the drug at issue.

    "Randomized controlled clinical trials offer an effective vehicle for establishing or debunking a causal relationship, beginning with study design up through, and including, the proper statistical analysis of the data," says Managing Principal and Chief Epidemiologist Mei Sheng Duh.

    Similar data and analyses, centering on the timing of facts leading up to a decline in a company’s stock price, are also typically required in shareholder lawsuits, such as ERISA "stock drop" and securities fraud suits. A biostatistician can opine on the reasonableness of the drug company’s statistical analyses in light of accepted statistical standards. Relating the nature and timing of disclosures by drug companies to the clinical evidence available contemporaneously is often a critical element in shareholder suits, as plaintiffs often claim delays in corporate disclosures.

    Case in Point:
    Major Pharmaceutical Mass Tort and Securities Matters

    Analysis Group was retained on behalf of the defendants in a mass tort case in which plaintiffs alleged that pain therapies caused serious adverse cardiovascular events, including death. We assisted Professor Lee-Jen Wei in conducting a meta-analysis to combine the results of the clinical trials of the drugs at issue and worked with cardiologists to develop a clinically appropriate measure of a "heart attack." We found that results varied across trials and were dose-specific: At the label dosages, we detected no elevated cardiovascular risk.

    Plaintiffs ignored the totality of evidence and sought to discard from the meta-analysis those trials in which no patient suffered a heart attack, but the judge allowed analysis of all trials. At a subsequent scientific hearing on the evidence, the judge determined that there was no statistical evidence of elevated heart attack risk with low dosage use; since 85% of the patients had taken the low dosage, most of the purported class was not considered to have been affected, and class certification was not granted.

    In two related securities-fraud class actions, we worked on behalf of a pharmaceutical manufacturer and several individuals. The first suit alleged that our client concealed pertinent clinical evidence about the cardiovascular safety of the drug that, when made public, led to a drop in the company’s stock price. The second suit alleged misrepresentation of the results from a clinical trial designed to assess specific safety aspects of a drug. The plaintiffs claimed that the company made materially false and misleading statements about the drug’s relative safety, resulting in an artificially inflated stock price. A core issue was how patients who dropped out of the clinical trial factored into the reported results and whether those results omitted key findings. Analysis Group supported Professor Daniel Scharfstein, a biostatistician and expert in evaluating missing data in clinical trials, who used existing methodologies, some of which he helped develop, to evaluate whether bias was present in the published trial data. He determined that the company’s publication of results from the first six months of the trial did not misrepresent the totality of the trial results. ■

  • Managing Principal Pierre Cremieux, Principal Almudena Arcelus, and Vice President Nikita Piankov worked with Dr. Wei on the analysis; Dr. Cremieux supported Dr. Scharfstein.