A University of Chicago Medical Center urologist told a Los Angeles jury last week that Takeda Pharmaceuticals’ type-2 diabetes drug Actos was “the most substantial causative factor” in a California man’s development of terminal bladder cancer. The doctor’s testimony was part of the first product liability case against Takeda to go to trial over injuries allegedly caused by the blockbuster drug.
Plaintiff Jack Cooper, a 79-year-old San Diego area resident, sued Japan-based Takeda after taking Actos for a five-year period from 2006 to 2011. His lawsuit against Takeda was selected as the first of more than 3,000 similar cases to go to trial because his doctors say he has two to eight months to live.
Dr. Norm D. Smith, a University of Chicago Medical Center urologist and associate professor of surgery and urology, told the jury that Mr. Cooper’s prolonged exposure to the diabetes drug was the primary reason he became sick with cancer. The doctor said that Mr. Cooper’s ingestion of Actos amounted to about 55,000 milligrams over five years’ time.
According to Law 360, Takeda’s defense team argued that Mr. Cooper’s bladder cancer could have stemmed from his past smoking habit. Dr. Smith testified that he believed Mr. Cooper quit smoking in the 1970s and that “risk (of various smoking-related illnesses) goes down a lot with time since quitting.”
Actos (pioglitazone) is in a class of type-2 diabetes drugs known as thiazolidinediones , or TZDs, which also includes Avandia (rosiglitazone). In 2010, the U.S. Food and Drug Administration severely restricted the use of Avandia after it was linked to fatal heart attacks. The following year, the FDA issued a warning after studies found Actos heightened the risk for bladder cancer.
Actos was once the most commonly prescribed diabetes drug and one of the top selling drugs in the U.S. The drug earned Takeda $4.5 billion in sales in the fiscal year ending March 2011. Takeda’s Actos patent expired in January 2011 and the first generic forms of the drug first became available in August 2011.