Actos Fine Pared Down

— A U.S. district judge trims Takeda and Eli Lilly's $9 billion fine.

MedpageToday

This article is a collaboration between MedPage Today and:

Drugmakers Takeda and Eli Lilly had a $9 billion fine related to Actos pared down by more than 99%, the companies announced.

A U.S. district judge in Louisiana ordered Takeda's $6 billion fine and Lilly's $3 billion fine trimmed to $27.65 million and $9.22 million, respectively.

Takeda general counsel Kenneth Greisman said in a statement that the reduced punitive damages are a "step in the right direction," but that an award in "any amount is not justified based on the evidence presented in this trial" and that the company will appeal.

"There is no credible scientific evidence that establishes a causal link between Actos and this disease," Greisman added, with similar sentiment expressed in a press release from Eli Lilly.

Jurors in Terrence Allen et al v. Takeda Pharmaceuticals North America initially found that drug company officials failed to warn patients that the drug could raise the risk of bladder cancer.

It was the first federal case to go to trial in a consolidated group of lawsuits, and thousands of additional Actos lawsuits remain in state courts.

Actos came to the market in 1999, but the FDA issued a warning about increased risk of bladder cancer with use of the drug in 2011.

As a class, thiazolidinediones have been plagued by side effects, most notably rosiglitazone (Avandia), and an increased risk of cardiovascular complications.