$9 Billion Verdict Against Takeda and Eli Lilly in First Actos Bladder Cancer Trial

Actos (pioglitazone) was one of the best-selling diabetes drugs in the world when internal research began linking it to bladder cancer. According to evidence presented at trial, Takeda Pharmaceutical and its U.S. marketing partner Eli Lilly knew of the elevated risk as early as 2005 but did not add a bladder cancer warning to the drug's label until June 2011. Patients went years without that information.

Terrence Allen, a hardware-store manager from Attica, New York, started taking Actos in 2006 to manage his type 2 diabetes. In January 2011 he was diagnosed with bladder cancer. He stopped the drug that April, shortly before the warning was added. Allen and his family sued both companies, arguing the diagnosis was a direct consequence of the concealment.

The Allen case was chosen as the first bellwether trial in a federal multidistrict litigation already holding thousands of similar claims. It opened in early 2014 in Lafayette, Louisiana, before U.S. District Judge Rebecca Doherty. W. Mark Lanier of the Lanier Law Firm served as lead trial counsel, joined by Paul J. Pennock of Weitz and Luxenberg and Richard J. Arsenault of Neblett Beard and Arsenault.

The trial focused heavily on what the companies knew and when. Lanier's team put before the jury internal documents showing Takeda had identified a statistically significant bladder cancer signal in its own long-term outcomes study years before any public disclosure. The jury found both companies had acted with 'wanton and reckless disregard' for patient safety. On April 8, 2014, it returned a verdict of $1.475 million in compensatory damages and $9 billion in punitive damages: $6 billion against Takeda (75 percent liable) and $3 billion against Eli Lilly (25 percent liable). The $9 billion punitive figure was the highest ever returned in a U.S. pharmaceutical products-liability case.

Judge Doherty denied the defendants' motion to overturn the award in August 2014, writing that the jury 'acted within its role and discretion.' But on October 27, 2014, applying Fifth Circuit due-process precedent that caps punitive-to-compensatory ratios, she reduced the punitive damages to $36.8 million total: $27.65 million against Takeda and $9.22 million against Eli Lilly, with compensatory damages also trimmed to $1.27 million. The ruling noted the ratio of punitive to compensatory damages could not constitutionally exceed 25 to 1 on the facts presented. Both companies signaled further appeals. Takeda ultimately settled approximately 9,000 remaining federal claims for $2.4 billion in 2015.