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Takeda Faces Wrongful Death Claims in Actos Cancer Lawsuit

The estates of three people who died after taking Actos, a prescription medication for the treatment of type 2 diabetes, have sued Takeda Pharmaceuticals. Seven others are suing for “loss of consortium” as part of the same case. The plaintiffs allege that Actos increases the risk of bladder cancer, and that Takeda concealed their knowledge of this risk from consumers. The Actos cancer lawsuit was filed in the U.S. District Court for the Western District of Louisiana on July 15, 2013.

The lawsuit alleges that Takeda knew there was an increased risk for patients who took Actos for more than 12 months, but failed to inform the public. Unaware of the risk, the deceased parties had been treated with Actos for a number of years, believing it to be safe. One North Dakota woman had been taking the drug for 12 years before succumbing to bladder cancer in August 2011.

A number of plaintiffs suffered heart problems in addition to bladder cancer. Takeda is accused of failing to disclose the risk of Actos heart failure.

The Actos lawsuit has been added to the multidistrict litigation proceedings against Takeda (MDL 2299). The MDL was established in December 2011, and is being overseen by the Honorable Rebecca F. Doherty.

Actos is Takeda’s branded version of pioglitazone, an oral medicine that controls blood sugar levels in diabetic patients. Since launching in 1999, Actos has been responsible for a significant percentage of Takeda’s income, generating nearly $5 billion for the firm in 2009-2010. The following year, Actos pulled in 27% of the company’s revenue.

Canadian research cited in Actos cancer lawsuit

Takeda had reportedly established a link between Actos and bladder cancer as early as 2004, but  failed to inform regulators for seven years. Internal email messages were presented as evidence that the company was complicit in failing to update their labeling, even after the FDA demanded them to.

According to court documents, Takeda’s research department ignored or downplayed their knowledge of the risk of bladder cancer, and deliberately misled the FDA. In a report published in the British Medical Journal, Canadian researchers analyzed the records of more than 115,000 patients who took Actos for two or more years. The results showed 137 cases of bladder cancer above the average number of diagnoses.

In June 2011, a Health Canada Press Release indicated that in light of studies suggesting an increased risk of bladder cancer, the group was undertaking a review of the drug’s status.

In another study conducted over 10 years, the risk of developing bladder cancer was shown to be 30% greater in patients who took the drug for more than a year. Patients who took Actos for more than two years had more than a 50% increased risk.

Actos heart failure

Before the drug reached the market, Takeda allegedly ran clinical trials that proved a definitive link between Actos and heart failure. In 2007, Takeda was ordered by the FDA to add a black-box warning to the labeling, stating that Actos can cause or exacerbate heart failure.

Following the addition of the black-box warning the American College of Cardiology and the American Heart Association issued a joint recommendation that the use of Actos should be closely monitored.

The recently filed Actos cancer lawsuit is one of more than 3,000 currently pending against Takeda. The drug maker is facing litigation from all over the United States, with more than 1,200 lawsuits now awaiting trial as part of the MDL. The first federal case is scheduled to be heard in January 2014.