Takeda Pharmaceuticals and Eli Lilly Must Pay $9 Billion in Punitive Damages in Actos Case


Company-Ordered-to-Pay-9-Billion-in-Punitive-DamagesTakeda Pharmaceuticals and Eli Lilly have been ordered to pay a combined $9 billion in punitive damages to settle the first federal lawsuit over the diabetes drug Actos, brought by a man alleging he developed bladder cancer after taking thr drug Actos.

The case  (Case No. 12-cv-00064) in U.S. District Court, Western District of Louisiana (Lafayette) is part of a multidistrict litigation (MDL No. 2299), in which the Honorable Rebecca F. Doherty is presiding. Approximately 2,700 lawsuits have been filed into the Actos MDL (MDL No. 2299).

Allegations in the lawsuit include that Takeda and Eli Lilly, which partnered for a number of years in the sale and marketing of Actos (pioglitazone), hid cancer risks tied to Actos, according to Bloomberg Businessweek. Judge Doherty ruled that jurors appropriately considered evidence that indicated Takeda and Eli Lilly officials were aware Actos was associated with bladder cancer, yet did not warn physicians and patients. The verdict, which may be reduced on appeal, is the second largest verdict this year in the U.S. “The jury acted within its role and discretion to attach whatever weight and make whatever reasonable inference it deemed appropriate when assessing the defendants’ conduct,” Doherty wrote in her decision.

In court documents, the plaintiffs Terrence and Susan Allen said that Mr. Allen took Actos for his Type 2 diabetes from 2004 through 2011; he developed bladder cancer in 2011. Mr. Allen alleges that Actos caused the cancer, that Takeda concealed risks associated with Actos from the public, and that he never would have taken Actos had he been informed of these risks.

In 2011 the Food and Drug Administration (FDA) warned that taking Actos for more than one year could substantially raise this cancer risk, and patients with bladder cancer were advised not to use the drug. These warnings came years after experts said the link became clear and 12 years after the drug arrived on the market in the U.S., Bloomberg News reported. Studies published in 2012 in the British Medical Journal and the Canadian Medical Association Journal reveal the increased likelihood of Actos users developing bladder cancer. Takeda recently halted development of TAK-875 (fasiglifam), another diabetes drug, when research linked the drug to liver damage.