First Actos Plaintiff Awarded $6.5 Million

Actos attorneys at Pintas & Mullins Law Firm report that a California jury recently awarded $6.5 million to a man who sued Takeda Pharmaceutics after he developed bladder cancer. This is one of more than 3,000 similar Actos cases currently pending in the United States.

The plaintiff in this case, Jack Cooper, obtained an early trial date because of his advanced cancer. He is 79-years-old and suffering from terminal metastatic bladder cancer, which he claims he developed from Takeda’s popular anti-diabetic medication. The two-month-long is considered a bellwether trial, meaning that other courts and judges will look to this case as a precedent, to indicate future trends in litigation.

The FDA approved Actos as a treatment for type 2 diabetes in 1999, and, by 2007, it was Takeda’s best selling drug. In 2011, the FDA issued a safety warning associating Actos with an increased risk of bladder cancer. One study found that patients taking Actos for more than one year were found to have a 40% elevated risk of developing bladder cancer, and those females taking the drug were five times more likely to suffer from the cancer.

Several European regulators suspected the sale and prescribing of Actos after a study of over 150,000 diabetes patients confirmed these risks. Instead of banning the drug, the FDA decided to add new warnings and information to the drug’s label to alert patients of the risks.

Actos’ chief rival, Avandia is also currently facing litigation over allegations that it causes adverse cardiac episodes, such as heart attacks. Avandia’s manufacturer, GlaxoSmithKline, stopped promoting the drug worldwide in 2011, and it is now only prescribed to those diabetic patients who have exhausted all other treatment methods. Glaxo announced that year that it was setting aside nearly $6.5 billion to cover expenses associated with the Avandia litigation and investigations.

Like Avandia plaintiffs, those injured by Actos are alleging that Osaka, Japan-based Takeda failed to adequately warn patients and healthcare professionals about the risks of Actos to protect its profits. Damagingly, several of Takeda’s internal studies showed links to bladder cancer as early as 2004, even though the company did not alert U.S. officials until 2011 (also the year Actos sales peaked, at $4.5 billion, or 27% of Takeda’s total revenue).

This was undoubtedly because diabetes medications are a big deal in the United States, where 8.3% of the population has diabetes. Other damaging Takeda internal documents produced during the California trial included those in which executives urged each other to persuade the FDA to not include bladder cancer warnings on Actos labels. It was, ultimately, the company’s responsibility to fully disclose the drug’s risks upon introduction into U.S. markets – a responsibility it did not take seriously, at the peril of thousands of already ill patients.

Other witnesses testified that Actos executives indeed put drug sales ahead of consumer safety, proving their claims through multiple 2005 e-mails. The documents detail attempts to persuade FDA and European regulators in various levels of Takeda management. Officials stated that the worst case scenario for them would be for global regulators to mandate the addition of a bladder cancer warning on the drugs’ labeling, and they therefore had to act “carefully and successfully.”

Jack Cooper was taking Actos for four years before his bladder cancer diagnosis. He stated that he was in good shape before he began the medication, regularly walking five miles and repairing his own roof. The jury agreed with his claims, and awarded him $5 million in compensatory damages along with another $1.5 million to his wife.

Actos lawyers at Pintas & Mullins Law Firm urge anyone seriously injured by a diabetes medication – whether it be Avandia, Janumet, Januvia, Byetta, or any of the like – to get in contact with a skilled and experienced attorney as soon as possible. We are currently evaluating claims involving Actos bladder cancer, and are available to aid clients in all 50 states.

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