Actos News

Jurors Hear Closing Arguments in First Actos Trial
Tuesday, April 16, 2013

Central Civil West Courthouse, Superior Court of California in Los AngelesAn attorney for drug maker Takeda Pharmaceutical Co. presented defense closing arguments today in the eight-week trial that has pitted Takeda against a California man who claims diabetes drug Actos caused his bladder cancer. Plaintiff Jack Cooper, whose doctors have given him only weeks to live, alleges that Takeda failed to warn him and his doctor of the bladder cancer risk associated with Actos. Due to his terminal condition, his lawsuit, one of nearly 3,000 that have been filed against Takeda, was the first to be tried.

In closing arguments yesterday, Mr. Cooper’s attorney told jurors that Takeda was aware of the bladder cancer risk as early as 2004 (Cooper began taking Actos in September 2006) but carried out a carefully executed plan, revealed in emails and other internal documents, to hide the risk in order to protect a drug that was making $1.6 billion a year.

In opposition, Takeda’s attorneys said that Actos had nothing to do with Cooper’s cancer, pointing instead to the plaintiff’s history of smoking. Mr. Cooper had been a light smoker (3 cigarettes a day) through either 1974 or 1994--there was conflicting testimony as to when he quit. “By 1974, he had smoked at least 21 years,” they said. “It doesn’t matter when he stopped. The damage was done.”  

Recent research, however, indicates that it does matter when he stopped. Smoking is a well-established risk factor for bladder cancer, but Cooper quit smoking in either 1974 or 1994, at least 12 years before he was prescribed Actos.  Two studies that were presented at the 2012 Society for Urologic Oncology meeting in Bethesda, Maryland, suggest that Cooper’s risk of bladder cancer as a result of smoking was, by 2006, the same as a non-smoker. According to Shahrokh F. Shariat, MD, assistant professor of Urology at the Weill Cornell Medical Center, “we found that if you stop smoking for over 10 years [prior to a diagnosis], your risk reverts to that of never-smokers.” Cooper had been a non-smoker for well over 10 years.  Moreover, one of Takeda’s experts (who had previously testified on behalf of tobacco manufacturers) had stated that one must smoke at least 15 cigarettes a day before a marked increase in bladder cancer is seen. Mr. Cooper’s smoking fell below that threshold.

Takeda attorneys also claimed that although studies have found an association between Actos and bladder cancer, none have established a causal connection. FDA researchers, they argued, have “not concluded that Actos increases the risk of bladder cancer.”

Ironically, cigarette companies also initially claimed that there was only an association between smoking and cancer, not a causal relationship. Moreover, the FDA published safety information on Actos in 2010 and 2011, noting that the five year results of an epidemiological study did show “an increased risk of bladder cancer … among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.”

A history of “associations” commonly precedes the establishment of causation and the scientific examination of associations reveals the degree of risk. Patients and doctors deserve to know if there is a risk of experiencing a particular side effect, and whether that risk is great or small, even if strict causation has not yet been established. When the side effect is cancer, this is even more important. It’s up to the jury now to decide whether or not Actos posed a risk to Jack Cooper and whether Takeda, in this case, met its legal obligation to warn Mr. Cooper of that risk.




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