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Plaintiff Seeks $10 Million in Damages in Actos Bladder Cancer Lawsuit

A New York woman who clams that she developed bladder cancer from Actos (pioglitazone) after taking the drug for five years has filed a lawsuit against Takeda Pharmaceuticals in which she seeks $10 million in damages. The lawsuit was originally filed on June 12, 2012 in the Eastern District of New York, but on July 12, 2012, it was assigned to the Actos MDL in the Western District of Louisiana.

According to the lawsuit, the plaintiff, Wanda Heavey, began taking Actos in January 2005 to treat her type II diabetes. She continued taking it as prescribed until 2010 or thereabouts. In December 2010, she was diagnosed with bladder cancer. As a result, she has suffered severe, permanent personal injuries, pain and suffering, fear and emotional distress, and the need for chemotherapy and surgery.

Takeda did not warn for Actos bladder cancer despite evidence, lawsuit claims

Heavey’s Actos attorney argues in the suit that Takeda Pharmaceuticals did not warn patients or physicians about the risk of bladder cancer from Actos despite evidence that showed the drug could cause this life-threatening condition. It wasn’t until 2011, when the FDA forced Takeda to add the warning, that the Actos label was finally updated to warn about bladder cancer.

Studies show bladder cancer risk

The lawsuit cites a 2005 study that found that Actos increased the risk of bladder cancer more than other similar medications. Despite this finding, Takeda did not add a bladder cancer warning to the Actos label.

On April 22, 2011, a study was published ahead of print in Diabetes Care, a scientific journal, which examined Actos adverse event reports made to the FDA from 2004 to 2009. After studying the data, the researchers concluded that there was a link between Actos and bladder cancer.

In June 2011, regulators in France and Germany suspended use of Actos when a French study of public insurance data found a slight increase in the risk of bladder cancer among patients using Actos. The medication was later recalled in France and Germany, but there has been no recall in the U.S.

Around the same time, the FDA published a report based on five-year interim findings of an ongoing 10-year epidemiological study that found that patients who used Actos for more than 12 months had a 40% greater risk of bladder cancer than people who had never taken the drug. On June 15, 2011, the FDA issued a safety announcement warning that the use of Actos for more than one year may be associated with an increased risk of bladder cancer. The FDA then ordered Takeda to add that warning to the Actos label.

But that warning came too late for patients like Heavey, who had already been diagnosed with bladder cancer after having taken Actos for years, believing it to be safe.

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