Takeda Pharmaceutical and Eli Lilly said they will appeal a federal jury’s verdict ordering them to pay a total $9 billion in punitive damages after finding the companies guilty of hiding the risk of cancer from patients taking their diabetes drug Actos (Pioglitazone HCl).
The jury hearing the case in U.S. District Court for Western Louisiana in Lafayette, LA, assessed $6 billion in punitive damages to Takeda, and $3 billion to Lilly, after previously ordering the companies to pay combined compensatory damages of $1.475 million to Terrence Allen of Attica, NY. In the compensatory phase, the jury assessed 75% of liability to Takeda, the rest to Eli Lilly.
Allen blamed Actos for causing his bladder cancer after taking the drug for five years, from 2006 to 2011. That year, the FDA published a drug safety update that required adding to the product label a warning of a 40% increase in the risk of bladder cancer for people who used Actos longer than a year.
The billion-dollar jury awards may end up being reduced following appeals that the companies said they will pursue.
“Takeda respectfully disagrees with the verdict and we intend to vigorously challenge this outcome through all available legal means, including possible post-trial motions and an appeal," Kenneth D. Greisman, senior vice president, general counsel, Takeda Pharmaceuticals U.S.A., said in a statement. "We have empathy for the Allens, but we believe the evidence did not support a finding that Actos caused his bladder cancer. We also believe we demonstrated that Takeda acted responsibly with regard to Actos."
Lilly issued a separate but similarly-worded statement: “While we have empathy for the plaintiff, we believe the evidence did not support his claims."
Lilly noted, additionally, that under an indemnification agreement with Takeda, “Lilly will be indemnified by Takeda for its losses and expenses with respect to the U.S. litigation and other related expenses.”
In Terrence Allen, et al. v. Takeda Pharmaceuticals North America, Inc., et al, No. 6:12-cv-00064, Allen sued Takeda, which developed Actos, and Lilly, which served as Takeda’s U.S. marketing partner for the drug from 1999 to 2006. Since then, Lilly has retained rights to sell Actos in parts of Asia and Europe, as well as in Canada and Mexico.
The case was the first within the consolidated Actos multidistrict litigation, through which more than 2,700 lawsuits by plaintiffs alleging injury due to Actos were combined into a single case for exchange of pretrial information before a single judge, U.S. District Court Judge Rebecca Doherty.
Doherty presided at the 34-day Allen trial, during which she allowed the jury to hear that Takeda lost or destroyed documents compiled by 46 current and former employees and sales representatives involved in marketing Actos: “The breadth of Takeda leadership whose files have been lost, deleted or destroyed is, in and of itself, disturbing,” Doherty wrote in a January 27 ruling rejecting Takeda efforts to quash the document-destruction claim.
The Allen trial was the fourth involving plaintiffs alleging that the companies knew the potential cancer risks of Actos but failed to give proper warning to patients and their doctors—and the first to entail punitive damages.
Juries in California and Maryland state courts ordered Takeda to pay a combined $8.2 million in damages to Actos users, but the verdicts were thrown out by judges. In a third trial in Las Vegas, jurors sided with the companies and rejected arguments by plaintiffs that Takeda and Lilly failed to warn about Actos risks.
The companies continue to face hundreds of additional lawsuits over Actos in state courts nationwide.
How confident are you that Takeda and Lilly will see the punitive damages reduced substantially on appeal?
A great deal
Not at all