Lafayette, LAJapanese drug maker Takeda Pharmaceutical Co Ltd, has been ordered to pay $6 billion in punitive damages in settlement of allegations the company concealed information regarding the risk for cancer associated with its diabetes drug Actos. Eli Lilly and Co, a co-defendant in the case, was ordered to pay $3 billion in punitive damages and $1.45 in compensatory damages by the jury in Louisiana on Monday.
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Actos (pioglitazone hydrochloride) is a member of a class of drugs known as thiazolidinediones, which have been linked to liver and cardiovascular issues. Actos side effects include increased risk of congestive heart failure (CHF), increased risk of rare but serious liver problems, an increased risk of fractures, and an increased risk for bladder cancer. A black box warning exists for Actos and heart failure, however, an Actos whistleblower lawsuit suggests a previously known but downplayed link between Actos and myocardial infarction (Actos heart attack). Actos is used to treat type 2 diabetes.
According to Lilly, 75 percent of the liability was allocated to Takeda and 25 percent to Lilly. Takeda plans to dispute the awards, stating that judgments were entered in its favor in all three previous Actos trials. This was the first federal case to be tried in a consolidated multidistrict litigation comprising more than 2,900 lawsuits.
Germany and France suspended use of the drug in 2011 due to concerns of a possible link to cancer.
The case is In Re: Actos Products Liability Litigation Case U.S. District Court, Western District Louisiana, No. 6:11-md-2299. Takeda plans to appeal the award.