Judge Slashes $9 Billion Award Vs Eli Lilly, Takeda Pharmaceutical Co. Ltd. In Actos Lawsuit By 99 Percent

October 28, 2014

By Riley McDermid, BioSpace.com Breaking News Staff

A judge in Louisiana has reduced a $9 billion awarded by a jury to patients who developed bladder cancer while using a drug from Takeda Pharmaceutical and Eli Lilly & Co to $35.8 Monday, but blasted both companies for deliberately ignoring and concealing evidence that the drug, Actos, was dangerous.

Takeda will now be required to pay $27.6 million and Eli Lilly is on the hook for $9.2, a 75/25 percent allocation.

U.S. District Judge Rebecca Doherty also denied a request from the companies for a new trial, writing that the evidence during the trial showed that the companies "disregarded, denied, obfuscated and concealed" for more than a decade that Actos would elevate the risk of developing bladder cancer.

The case was originally brought by a patient, Terrence Allen, who used Actos from 2004 to 2011 and was diagnosed with bladder cancer in January 2011. His suit alleged, and the jury agreed, that Takeda was aware of the cancer risk, but withheld the information from consumers and the healthcare industry.

In 2011, the U.S. Food and Drug Administration warned consumers that Actos could be associated with an elevated risk of bladder cancer if patients used it for more than a year.

Allen’s compensatory damages had been reduced by mutual agreement earlier to $1.27 million from $1.475 million.

Actos (pioglitazone) is a prescription medicine used with diet and exercise to improve blood sugar control in adults with type 2 diabetes. It was rolled out by Takeda in 1999 but promoted by both Lilly and Takeda from 1999 to 2006 and analysts have projected it brought in more than $16 billion in sales in the last 15 years.

The brief was the first federal case to go to trial in a consolidated group of lawsuits—and its $9 billion award one of the largest ever handed down. Though the new award is significantly smaller, Doherty said that the new damages were still "large enough to accomplish the jury's clear aim: to send a message to the defendants that their wrongdoing must stop."

In her ruling, the judge also pressed courts hearing cases of this kind to provide stronger guidance in helping juries understand if the burden of proof for "seriously reprehensible behavior" had been sufficiently met, and to help them tailor their damage awards accordingly.

For their parts, neither company agreed with the judge’s ruling, and quickly issued statements outlining why they found any sum of punitive damages to be deeply unfair.

"While we have empathy for the plaintiff, we believe the evidence did not support his claims," said Lilly's general counsel, Mike Harrington, who vowed the firm would continue to fight the verdict.

For Takeda, establishing that it admits no wrongdoing will be crucial in the more than 8,000 American lawsuits it still faces for possibly mishandling Actos.

"We view the substantially reduced punitive damage award as a step in the right direction, but we believe a damage award of any amount is not justified based on the evidence presented in this trial and we will appeal," said Kenneth Greisman, senior vice president and general counsel, Takeda Pharmaceuticals U.S.A., Inc., in a statement.

So far, judges have sided with Takeda in five out of six of the first Actos cases brought to trial.