News Feature | April 9, 2014

Jury Awards $9 Billion to Plaintiff In Actos Lawsuit Against Eli Lilly And Takeda

By Cyndi Root

A U.S. jury financially penalized Japanese firm Takeda and American firm Eli Lilly for hiding the cancer risks of the drug Actos (pioglitazone). The plaintiff, Terrence Allen, sued Eli Lilly and Takeda for damages relating to bladder cancer, which he alleged was caused by Actos diabetes therapy. The jury in Louisiana found that the two pharmaceutical companies "failed to adequately warn" Actos patients about bladder cancer risks. The jury also said that company personnel "acted with wanton and reckless disregard" for patient safety.                                         

The two companies expressed displeasure with the verdict and their intent to appeal the decision. Mike Harrington, SVP and General Counsel at Eli Lilly said in a press release, "While we have empathy for the plaintiff, we believe the evidence did not support his claims. Lilly disagrees with the verdict and we intend to vigorously challenge this outcome through all available legal means."

Kenneth D. Greisman, SVP and General Counsel at Takeda Pharmaceuticals U.S.A., Inc. said, “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.”

Actos

Takeda and Eli Lilly began marketing Actos in the U.S. in 1999. Eli Lilly discontinued the Actos partnership in 2006. Sales of the drug total more than $16 billionto date. In 2011, the Food and Drug Administration (FDA) issued a safety alert, warning the public that “the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.” The FDA based its warning on an ongoing, ten-year epidemiological study in animals and humans. Germany and France banned the drug after the FDA’s warning.

Actos Trial

The recent trial is one of more than 2700 lawsuits filed over Actos. The lawsuits are pending in the U.S. District Court for the Western District of Louisiana due to the need for consolidation and pre-trial motions. Previous lawsuits have had mixed results. Three were found in Takeda and Eli Lilly’s favor. Another lawsuit favored the plaintiff, but it was later thrown out by the judge.  

Jury Award

The plaintiff took Actos from 2004 to 2011 and developed bladder cancer in 2011. He claimed that Takeda investigators hid the bladder cancer risks from the public and regulatory authorities. The jury ordered the two companies to pay $9 billion in punitive damages. Takeda must pay $6 billion, and Lilly must pay $3 billion. However, because of the companies’ plans to appeal, it is hard to say when, or even if, these funds will be granted.