Jack Cooper, a retired communications worker, states that at age sixty-four – prior to being prescribed the diabetic drug Actos – he was in good health and looking forward to many more years with his wife of nearly fifty years and his grandchildren.
Today, at age sixty-nine, he expects to be dead within the year – from bladder cancer allegedly caused by the drug he took over the course of four years. According to court documents, Takeda sales representatives met with Cooper's personal physician twice a month over an eight-year period beginning in 1999. He was literally wined and dined; these sales executives treated Cooper's doctor to deluxe meals in upscale restaurants.
It was all part of a highly aggressive marketing campaign that the company started early on and continued with even after concerns about the drug's possible connection with bladder cancer surfaced in 2003. Attorneys for Takeda continue to insist that the company's former flagship product does not cause bladder cancer. However, the plaintiff's attorney has informed the court that Takeda carried out a “secret survey” of doctors to find out if they would continue to prescribe the drug if the package contained the cancer warning. When the responses indicated that such a warning would take a huge bite out of its multi-billion dollar sales, Takeda instructed its salespeople not to mention it.
In the meantime, Actos caught the attention of the U.S. Food and Drug Administration (FDA) after a similar drug from a Danish pharmaceutical company, ragaglitazar, was shown to cause cancer in laboratory rats. For nine years, Takeda resisted all attempts by the FDA to get them to place a stronger warning on the package. According to the plaintiff's lawyer, company executives deliberately ignored any information in their database that might connect Actos with incidences of bladder cancer. (In fact, according to one plaintiff's attorney, Actos had the same effect on lab rats as did ragaglitazar – and Takeda was aware of this before applying for FDA approval in 1999.)
Attorneys for the defense continue to insist that their client's product have nothing to do with Cooper's bladder cancer, suggesting that it has more to do with his age and history as a smoker. Though Cooper was able to overcome his nicotine habit many years ago, the defense claims that the “damage was already done.”
Did a doctor make that determination? If so, how? When a patient develops cancer, it is usually quite difficult diagnose a specific cause – and if Cooper was a smoker, would not the cancer have shown up in his respiratory system first as is usually (though admittedly, not always) the case?
Currently, Takeda admits that one patient in a thousand may run a risk of developing bladder cancer from the use of its product – but insists this is “insignificant.”
If so, why did the FDA finally force the company to issue a warning? And why was the product pulled from pharmacy shelves in Germany and France?
Beyond Cooper's case (currently expedited because of his medical condition), there are some 3000 additional cases pending against the Japanese pharmaceutical giant.
Feely, Jeff and Margarate Cronin-Fisk. “Takeda Worried About Actos’s Cancer Link, Filing Shows.” Bloomberg Newsweek, 15 February 2013.
Heller, Matthew. “Takeda Failed To Warn Of Actos Cancer Risk, Jury Hears.” Law360.com, 28 February 2013.
Malik, Shazid MD. “Trial: Takeda Didn’t Warn of Actos Cancer Risk.” Dallas-Fort Worth Legal Examiner, 28 February 2013.
Pearson, Sophia and Jeff Feely. “Takeda Didn’t Warn of Actos Cancer Risk, Lawyer Says.” Bloomberg, 28 February 2013.