During testimony at the lawsuit, Howard Greenberg, a clinical pharmacologist, said Takeda management was concerned that officials would request the company include a warning label about the risk of bladder cancer, as evidenced by e-mails from officials. Bloomberg (3/5/13) reports Greenberg testified that one e-mail, which reportedly said, “we need to manage this issue very carefully and successfully not to cause any damage for this product globally,” admitted the e-mail may not actually speak to the company’s policy on the safety of patients.
The lawsuit (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535 California Superior Court, Los Angeles) resulted in a jury award of $6.5 million for the plaintiff, but a judge set aside that award, agreeing with Takeda that the plaintiff did not prove his use of Actos caused his bladder cancer. According to Cooper’s lawsuit, he was diagnosed with bladder cancer in 2011 and had taken Actos for four years.
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While litigation about Actos works its way through the courts, GlaxoSmithKline, maker of Avandia, has reportedly agreed to pay almost $230 million to eight states to settle allegations of improperly marketing its drug. Avandia was the rival drug to Actos until its use was heavily restricted by the US Food and Drug Administration (FDA) due to concerns about heart problems linked to the drug. According to Reuters (7/24/13), GlaxoSmithKline has not admitted to any wrongdoing. States involved in the settlement include Louisiana, Kentucky and New Mexico.