An Edwardsville man claims he developed bladder cancer because drug manufacturers purposefully hid the risks of his diabetes medication.
William R. Greenlee and his wife, Diana, filed a complaint Jan. 4 in Madison County Circuit Court against Takeda Pharmaceuticals America Inc., Takeda Pharmaceuticals North America Inc., Takeda Pharmaceutical Company Limited and Eli Lilly and Company.
Greenlee says he was first prescribed Actos in 2007 for long-term maintenance of high blood sugar. Produced joinly by Deerfield, Ill.-based Takeda and Eli Lilly, Actos was first manufactured for use in patients in 1999 and received FDA approval the same year.
Greenlee says he took Actos every day between 2007 and September 2011 for treatment of type-2 diabetes. He says it wasn't until late into his treatment, however, that he learned the blood-sugar-lowering medication increased his likelihood of developing bladder cancer. Greenlee was diagnosed with the disease in June 2010, according to the complaint.
Greenlee says numerous studies have documented an increased risk of bladder cancer in patients taking Actos for more than 12 months, yet he says none of those studies have ever been released or published by researchers or the defendants. He contends that Takeda and Eli Lilly intentionally withheld the information to avoid Actos being rejected by the FDA.
According to the complaint, an FDA study in late 2010 found an increased risk of bladder cancer in patients using Actos. The manufacturers, however, allegedly publicly denied the findings and continued to speak to Actos' safety.
Based on the results of that 2010 study, the FDA issued a safety announcement in June 2011 stating the "use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer." The information was immediately added to the drug's warning label.
A month after the FDA warning, Greenlee claims Takeda Limited issued a recall on Actos in France but refused to issue the same recall in the US. He contends the companies were motivated by money. Greenlee claims the diabetes medication accounts for $4.8 billion -- approximately 27 % -- of the company's revenue.
Greenlee accuses the defendants of knowlingly "concealing their knowledge of Actos' unreasonably dangerous risks" from patients, their doctors, other consumers and the medical community as a whole. He says that he has bladder cancer as a direct result of their failure to properly share the information. Had those risks been disclosed, Greenlee says he would not have used Actos.
Greenlee accuses Takeda and Eli Lilly of negligence, strict liability and negligent failure to warn for allegedly hiding information about the risks posed by Actos. He contends the companies were also negligent for failing to alter the medication to reduce the risks posed to patients. He says the manufacturers knew the risks of Actos far outweighed its benefits yet continued to distribute the drug. He also accuses the defendants of breach of express warranty and violation of Illinois Consumer Protection laws.
Greenlee and his wife say they have suffered pain and suffering, economic loss and loss of consortium as a result of the companies' alleged negligence. They are asking to be awarded more than $50,000 in actual damages along with punitive damages and court costs.
Attorneys Randy L. Gori and D. Todd Matthews, both of Edwardsville, are representing the Greenlees. They ask for a jury trial.
Madison County Circuit Court Case No. 12-L-16