A jury was told that Actos manufacturer, Takeda Pharmaceutical Co., hid the Type 2 diabetes drug’s risk in the first of more than 3,000 Actos injury lawsuits to go to trial.
The trial revealed that Takeda’s studies of Actos (pioglitazone) revealed 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 that $1.6 billion in yearly Actos sales.
Takeda faces more than 3,000 lawsuits that allege that Actos caused bladder cancer or other injuries in patients, court records indicate. More than 1,200 lawsuits have been consolidated before a Louisiana federal judge for pretrial information exchanges, Bloomberg News explained. The first federal case is scheduled for trial next January. This first lawsuit is among a number of similar cases collected before Judge Kenneth Freeman in Los Angeles. Other cases are also in state court in Illinois, court dockets indicate. The plaintiff in this case, a former Pacific Bell Telephone Co. cable splicer, had been taking Actos for more than two years. He was diagnosed with bladder cancer in November 2011, said Bloomberg News, and “is gravely ill,” according to the judge who put the case on an expedited basis over the plaintiff’s illness.
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. The trial has been ongoing for the past two months. 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,” according to Bloomberg News.
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.
Meanwhile, noted Bloomberg News previously, 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 regulators there.