Takeda Pharmaceuticals Co. and Eli Lilly & Co. lost the battle to overturn a $9 billion punitive damage award based on claims that the companies failed to warn the public about the potential risk for developing bladder cancer when taking the diabetes medication Actos.

On Aug. 27 U.S. District Judge Rebecca Doherty ruled that the decision was based on evidence that the defendant companies failed to warn patients and healthcare providers of the cancer risk even though they were aware of the risks. The verdict is the second largest verdict in the U.S. this year, according to Bloomberg, and will likely be reduced on appeal.

According to Bloomberg, Takeda and Eli disagree with the ruling and are awaiting a ruling on a motion for a new trial.

“Lilly respectfully disagrees with the verdict and we intend to vigorously pursue all post-verdict options, including an appeal,” Candace Johnson, a Lilly spokeswoman, said in an e-mailed statement to Bloomberg. “We believe the evidence did not support claims that Actos caused his bladder cancer.”

Despite the companies’ denial of the allegations, the claims outlined in the lawsuit are similar to those being made by hundreds of other Actos users.

This was the first bellwether Actos trial. And, according to Melinda Helbock, Founder of The Law Office of Melinda J. Helbock, A.P.C., it sets the tone for future lawsuits with similar allegations.

“We are watching the Actos litigation closely and are pleased with this judgment,” said Helbock. “We will continue to pursue damages on behalf of clients who claim they developed bladder cancer as a result of taking Actos.”

Actos, a medication prescribed for adults with type 2 diabetes, has generated more than $16 billion in sales since it hit the market in 1999.