In the first of more than 3,000 Actos injury lawsuits to go to trial, the jury was told that Actos maker, Takeda Pharmaceutical Co., should award the plaintiff $5 million in damages as well as an additional $300,000 in medical expenses.
The plaintiff, a 79-year-old California man, alleges that the Type 2 diabetes drug, Actos (pioglitazone), cause his terminal bladder cancer, said Law360. The trial is part of a mass tort litigation against Takeda. The plaintiff’s attorneys told that jury that their client’s life expectancy was reduced, he would never live to see his grandchildren grow up, and his marriage of more than 50 years would end prematurely. The plaintiff was diagnosed with bladder cancer in December 2011 after taking Actos for more than five years, said Law360. Because of the gravity of the man’s illness, the judge put the case on an expedited basis.
For its part, Takeda’s attorneys allege that it was the plaintiff’s prior cigarette smoking that placed him in a high risk for bladder cancer and not Actos, said Law360. Meanwhile, the jury was told earlier this week that Takeda hid the Type 2 diabetes drug’s risk. In fact, the trial revealed that Takeda’s studies of Actos showed bladder cancer links as far back as 2004; however, the drug maker did not advise United States regulators for seven years, said Bloomberg News. Takeda is Asia’s largest drug maker and, according to the plaintiff’s attorney, Takeda hid this news to protect its more than $1.6 billion in yearly Actos sales.
The plaintiff’s side produced a number of internal Takeda emails revealing that the drug maker’s executives were urging their peers to push the U.S. Food and Drug Administration (FDA) against demanding increased Actos label warnings, said Bloomberg News. In one email, Takeda executive, Kiyoshi Kitazawa wrote, “Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally.”
The FDA updated the Actos label in 2011 to include a warning that use of Actos for more than one year was associated with an increased risk of bladder cancer. That warning was based on an ongoing 10-year study being conducted by Kaiser Permanente; however, other studies continue to support this association. Last May, the British Medical Journal (BMJ) published a study that found that patients who took Actos for two years were twice as likely to develop bladder cancer. Another study, published last summer in the Canadian Medical Association Journal, found that Actos use was linked to a 22 percent increased likelihood of developing bladder cancer.
As we’ve written, in this first Actos lawsuit, prior witness testimony indicated that Takeda put money before patient safety when it came to Actos. Thousands have come forward who believe they’ve either contracted bladder cancer or been unknowingly put at risk for this life-threatening disease because Takeda hid evidence that revealed its popular drug was linked to this dangerous side effect.
Bloomberg News previously noted that, in 2011, FDA officials discovered that a review of a Takeda-sponsored study revealed some Actos users were at an increased risk of developing not just bladder cancer, but heart problems, as well, Takeda pulled Actos from the German and French market that year in response to regulator demands there.