FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Court Denies Lilly, Takeda’s Request to Toss $9 Billion Damage Award in Bladder Cancer Case

Sept. 8, 2014
A A

Eli Lilly and Takeda Pharmaceuticals have lost their appeal to reverse a combined jury award of $9 billion in punitive damages for hiding bladder cancer risks associated with their diabetes drug Actos, but experts say that verdict will likely be reduced.

Federal District Judge Rebecca Doherty of Louisiana rejected the drugmakers’ bid to toss out the award, claiming the companies didn’t present any new evidence to refute the evidence presented by plaintiffs at the April trial.

At that trial, the jury concluded that diabetes patient Terrence Allen had acquired bladder cancer by taking Actos (pioglitazone), and that Eli Lilly and Takeda had inadequately warned physicians of the drug’s risks. The jury also found that the companies went so far as to deliberately hide risk information from as far back as 1999, which they didn’t put on the drug’s label until 2011.

This was the first federal case to be tried in the consolidated Actos multidistrict litigation, which includes more than 2,900 claims.

In its appeal, Lilly argued that it had no authority to change the FDA-approved Actos label as it was not the NDA holder. The company also asserted that the agency would not have allowed further warnings of bladder cancer risks to be added, and that such “bad decision-making” on the part of the FDA should protect it from any liability.

But Doherty countered that any decision the FDA made had clearly been influenced by the flawed evidence presented by the two drugmakers.

Lily and Takeda also asserted that a doctor’s testimony for the plaintiffs had failed to prove specific causation. Doherty rejected this argument as well, noting the drugmakers failed to address any specific part of his testimony and completely ignored the substance of the testimony actually given.
Lilly plans to appeal the latest ruling, spokeswoman Candace Johnson said. Other courts already have cleared the companies of wrongdoing. In May, a Las Vegas jury found Takeda not to be liable for bladder cancer in two women who took Actos.

The drugmakers are unlikely to get a reversal of the latest case, but they stand a good chance of getting the punitive damages reduced, said University of Michigan business professor Erik Gordon. The Supreme Court has set a precedent against punitive damages that are out of proportion to the action committed and the damage suffered. “A verdict of $9 billion is susceptible to being seen as over the top by a circuit court of appeals,” he said.

In a separate move, Takeda released a 10-year epidemiology study of Actos that concluded there is no statistically significant increased risk of bladder cancer among patients exposed to Actos. The company has submitted those results to the FDA, the European Medicines Agency and Japan’s Pharmaceuticals and Medical Devices Agency. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.