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Actos Verdict Against Drugmakers

Published on Apr 9, 2014 at 5:40 pm in Dangerous Drugs.

In a federal court in Louisiana this week, a jury found that the makers of the diabetes drug Actos concealed the cancer risks associated with the drug. In its historic verdict, the jury awarded the plaintiff – a New York man who claims his bladder cancer was caused by Actos – $1.5 million in compensatory damages.

Then came the real story – a whopping award of $9 billion in punitive damages ordered against the manufacturers. This amounted to $6 billion against Japan-based Takeda Pharmaceuticals, and $3 billion against Eli Lilly, which co-marketed the drug. This large punitive damages award will likely be reduced on appeal, but the verdict remains a major victory, and a solid finding of intentional concealment by the drug makers.

Actos is the brand name of the prescription drug pioglitazone, which is taken to treat Type 2 diabetes. The U.S. Food and Drug Administration (FDA) first approved the drug in 1999. Then, in July 2011, the FDA issued a warning that the use of Actos for more than one year “may be associated with an increased risk of bladder cancer.” This warning came from the results of an ongoing long-term study, which at the five year point, showed serious risks: users for more than a year had up to a 40% increased chance of developing the cancer. Studies in France also showed a cancer link.

While the FDA didn’t recall Actos, it released warnings to doctors for its use in patients with bladder cancer or a prior history of the cancer. Doctors were instructed to carefully weigh the benefits of Actos in treating diabetes against the potential cancer-causing risks.

In the Louisiana case, the plaintiff began taking Actos in 2006 and was diagnosed with bladder cancer in 2011. The evidence presented at trial showed experts knew that Actos had a link to bladder cancer seven years before Takeda issued any warnings about it.

Bloomberg news reports that lawyers for the plaintiff claimed in closing arguments that Takeda managers “made conscious decisions that amounted to reckless disregard” for the millions of consumers who took Actos. He also argued that the company “was more concerned about making money” than about alerting regulators and patients that side-effect reports showed some users developed cancerous tumors in their bladders.

Court filings showed that Actos has generated more than $16 billion in sales since its release in 1999. According to Bloomberg, Actos sales peaked in the year ended March 2011 at $4.5 billion; the drug accounted for 27% of Takeda’s revenue at the time. There is now a generic competitor made by Ranbaxy Laboratories.

Thomas Law Offices is currently handling cases involving individuals injured by defective and harmful drugs such as Actos.