Takeda named in suits over use of diabetes drug Actos

Andrea Dearden Feb. 2, 2012, 1:32am



Three Illinois couples have filed lawsuits claiming the manufacturers of a diabetes medication knew the drug caused cancer but intentionally hid that from patients.

Donald E. and Sharon Sandidge, of Alton, Phillip A. and Mickey Block, of Rinard, and John L. and Sandra Allen, of Washington, each filed complaints Jan. 18 in Madison County Circuit Court against Takeda Pharmaceuticals America Inc., Takeda Pharmaceuticals North America Inc., Takeda Pharmaceutical Company Limited and Eli Lilly and Company.

Donald Sandidge, Phillip Block and John Allen say they were each prescribed Actos for the long-term maintenance of high blood sugar. Produced joinly by Deerfield, Ill.-based Takeda and Eli Lilly, Actos was first manufactured to be used by patients in 1999. The diabetes drug received FDA approval later that year.

The three men say they took Actos every day as part of their doctors' plans to treat type-2 diabetes. They say it wasn't until they had been taking the drug for several years that they learned the blood-sugar-lowering medication increased the likelihood of developing bladder cancer.

Sandidge, Block and Allen have all been diagnosed with bladder cancer since taking Actos, according to the complaint.

The complaints cite numerous studies documenting an increased risk of bladder cancer in patients taking Actos for more than 12 months. The men, however, claim none of those studies have ever been released or published by researchers or the defendants. They contend Takeda and Eli Lilly intentionally withheld that information to avoid Actos being rejected by the FDA.

An FDA study in late 2010 allegedly found an increased risk of bladder cancer in patients using Actos. The patients say the manufacturers publicly denied the accuracy of the findings and continued to tout Actos as safe for patients.

Based on the results of that 2010 study, the FDA issued a safety announcement in June 2011 that said 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, Sandidge, Block and Allen claim Takeda Limited issued a recall on Actos in France but refused to issue the same recall in the U.S. They say the companies allowed profits to overshadow patient safety. The men claim the diabetes medication accounts for $4.8 billion -- approximately 27 percent -- of the company's revenue.

Sandidge, Block and Allen accuse the defendants of knowingly "concealing their knowledge of Actos' unreasonably dangerous risks" from patients, their doctors, other consumers and the medical community as a whole. They say they each have bladder cancer as a direct result of the companies' failure to properly share information with patients. Had those risks been disclosed, the men say they would not have taken Actos.

The three men and their wives accuse Takeda and Eli Lilly of negligence, strict liability and negligent failure to warn for allegedly hiding information about the risks posed by Actos. They say the companies were also negligent for failing to improve the medication and reduce the risk posed to patients. They say the manufacturers knew that the risks of Actos far outweighed its benefits yet continued to distribute the drug. They also accuse the defendants of breach of express warranty and violation of Illinois Consumer Protection laws.

The Sandidges, Blocks and Allens say they have endured pain and suffering, economic loss and loss of consortium as a result of the defendants' alleged negligence. The couples are each asking to be awarded more than $50,000 in actual damages along with punitive damages and court costs.

Attorneys Trent B. Miracle and John J. Foley of the Simmons firm in Alton and Paul Hanly and Jayne Conroy of New York are representing the three couples. They demand a jury trial.

Madison County Circuit Court Case Nos. 12-L-70, 12-L-71 and 12-L-72

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