Home » Defective Products » Judge’s Order Nullifies $6.5 Million Verdict in Diabetes Drug Trial

Judge’s Order Nullifies $6.5 Million Verdict in Diabetes Drug Trial

In a May 1, 2013 press release Takeda Pharmaceuticals announced that the trial court judge granted the defendant’s motion for non-suit. The ruling nullifies the April 26th jury verdict.

A Los Angeles Superior Court jury awarded $6.5 million to the plaintiff Jack Cooper in the first trial involving the diabetes drug Actos (Cooper v. Takeda Pharmaceuticals America, Inc., CGC-12-518535). The jury found Takeda Pharmaceuticals liable for the failure to warn patients that Actos could cause bladder cancer. The verdict awarded $5 million in compensatory damages to Jack Cooper and $1.5 million to his wife. As many as 3000 similar lawsuits are pending in the United States.

According to the attorney representing Cooper, the Japanese drug company was aware of possible links between Actos and bladder cancer as early as 2004. However, the company waited 7 years before reporting these findings to U.S. regulators. In 2011 Actos was removed from the market in both France and Germany after studies revealed that some patients using Actos have increased risk of developing heart problems and bladder cancer.

In 2012 the British Medical Journal reported that patients who use Actos for 2 years are twice as likely to develop bladder cancer. In the same year  the Canadian Medical Association Journal published the results of a study showing that users of Actos have a 20 percent increased risk of developing bladder cancer. Canada has since removed Actos from the list of approved medications.

A “black box” warning, the strongest of the FDA warnings, informing users that Actos is linked to congestive heart failure was added to the label in 2007. In 2011 an FDA Safety Announcement informed the public that the use of Actos for more than one year might result in “increased risk of bladder cancer”. The announcement required the drug manufacturer to add this warning to the drug label.

In response to FDA demands, Takeda launched a ten year study addressing the long term risk of bladder cancer associated with Actos. Data from the first five years of the study showed that patients taking the drug for over a year have a 40 percent higher risk of developing bladder cancer. The study was completed in 2012 and the full results should be available sometime in 2013.

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