Takeda Face Wrongful Death Claims in Actos Injury Lawsuit

Takeda Pharmaceutcals has been sued by the estates of three people who allegedly died of bladder cancer caused by Actos, a treatment for type 2 diabetes. In the same Actos injury lawsuit, seven other people are suing the firm for concealing the risk of heart failure and other health problems brought about by Actos. The complaint, filed on July 15 in the U.S. District Court for the Western District of Louisiana, alleges Actos increases the risk of bladder cancer and heart problems, and that Takeda failed to warn the public.

According to court documents, Takeda was aware of an increased risk of bladder cancer in patients who used Actos for more than a year. All of the decedents at the center of the Actos injury lawsuit had used it for a number of years. The estate of one of the deceased women claims she had taken the drug for 12 years, completely unaware of the risk. Takeda is also accused of failing to warn the public of Actos heart failure risk.

The complaint has been added to the consolidated Actos litigation proceedings now underway against the company (MDL no. 2299). Established by the Honorable Rebecca F. Doherty in 2011, the MDL comprises more than 1,200 lawsuits. The first federal case is due to be heard in January 2014.

Actos generated billions for Takeda

Actos is Takeda’s brand name for pioglitazone, an orally administered medicine designed to control blood sugar levels in diabetics. The product launched in 1999, and has since been responsible for a significant percentage of Takeda’s revenue, generating nearly $5 billion for the firm in 2009-2010. In 2011, Actos generated 27% of Takeda’s takings.

Actos heart failure risk concealed

Prior to receiving FDA approval for Actos in 1999, Takeda allegedly conducted clinical trials proving a definitive link between the product and an increased chance of heart failure. In 2007, the FDA ordered Takeda to update its labeling to reflect the Actos heart failure risk. The black box warning stated that Actos can cause or exacerbate heart failure. After the warning was added,  the American College of Cardiology and the American Heart Association issued a joint notice that the use of Actos should be closely monitored by physicians.

Takeda purportedly knew of Actos and bladder cancer link

According to allegations in this lawsuit, Takeda had also established a link between Actos and bladder cancer in 2004, but failed to inform health regulators for another seven years. Internal emails are presented as evidence that the company was complicit in consistently failing to update their labeling – even after being ordered by the FDA to do so.

Takeda’s research and development department allegedly ignored or downplayed the  risk of bladder cancer, and deliberately misled the FDA. In a report published in the British Medical Journal, Canadian researchers looked at the medical records of more than 115,000 patients who had taken Actos for two or more years. The results showed a significant increase in the number of cases of bladder cancer in Actos patients.

The Actos injury lawsuit also points to a Health Canada Press Release issued in June 2011. The release stated that the group was undertaking a review of the drug’s status after recent research had shown a link between cancer and Actos.

In another study, the risk of developing bladder cancer was shown to be 30% greater in patients who took the drug for more than 12 months. Patients who used Actos for over two years had more than a 50% increased risk.