Original FDA Warning of Increased Risk of Actos Causing Bladder Cancer
On June 15, 2011 the U.S. FDA announced that pioglitazone (active ingredient in Actos) used for long periods of time is associated with an increased risk of bladder cancer. The FDA also stated that the risk of bladder cancer should be added to the Warnings and Precautions section of the label. Over 3,000 lawsuits were filed against the drug manufacturer Takeda Pharmaceuticals and their marketing partner Eli Lilly & Co.
$9 Billion Award for Diabetes Patients Taking Actos
In April 2014, a Louisiana federal jury awarded $9 billion in punitive damages and $1.5 million in compensatory damages after finding that Takeda Pharmaceuticals and marketing partner, Eli Lilly & Co. manufactured and sold its drug, Actos, knowing about the increased risk of bladder cancer after long-term use of the drug, but hid those risks from patients and doctors.
The jury agreed with the plaintiff’s contention that the companies knew of the bladder cancer risk, but did not provide sufficient warning.
The two organizations split the awarded damages. $6 billion of the punitive award was assessed to the manufacturer (Takeda) and $3 billion to Lilly (marketing partner). This puts manufacturers on notice that they may be held liable for damages stemming from lack of a warning label – even if they weren’t responsible for designing or developing the warning labels.
The $9 billion in damages is currently listed as the seventh-largest award returned in U.S. history.
Takeda Pharmaceuticals Files Two Separate Appeals
After the announcement of the damages, the drug’s manufacturer, Takeda Pharmaceuticals, and marketing partner, Eli Lilly & Co. vowed to appeal the decision and fight for a retrial if necessary. Specifically, two appeals were filed. One of the appeal stated that the $9 billion in damages was excessive and the other appeal was a motion for retrial.
FREE Actos Case Review
If you or a loved one took Actos and suffered bladder cancer-like symptoms you could be owed substantial compensation.
The First Appeal Failed to Overturn the Verdict
The first appeal challenged the $9 billion damages award. This appeal was overturned and the original $9 billion in damages was affirmed. U.S. District Judge Rebecca Doherty said, “Plaintiffs have pointed to sufficient evidence from which the jury could have concluded that the ‘information’ about bladder cancer contained in Actos labels did not adequately warn of the increased risk of cancer.”
The Second Appeal Has Yet to be Determined
Although the first appeal failed to overturn the $9 billion verdict, there is a pending second appeal. The appeal focuses on actions taken by the judge in the original trial.
During the original trial, the Judge stated that Takeda Pharmaceuticals USA acted in bad faith when they deleted relevant emails. These actions were presented to the jury and now Takeda and Lilly claim that the judge’s actions should be used to reject the verdict.
Takeda senior vice president said, “We continue to believe that binding legal precedent requires the judge to disregard the verdict in its entirety and grant a new trial. The ruling on that motion is expected in the coming weeks.”
Although the latest ruling is good news for those who have a pending lawsuit, we strongly recommend that you speak to a lawyer to determine if you could have a claim against Eli Lilly or the drug manufacturer.