According to the testimony of a pharmacologist and toxicologist for the plaintiff, Upjohn Co. allegedly informed Takeda in 1993, during the pre-market development phase of Actos, that it was taking a pass and backing away from the continued development of Actos over concerns Upjohn had with the safety profile of pioglitazone (Actos).
Takeda’s response, according to testimony given by Randall Tackett of the University of Georgia, was to ask Upjohn to claim instead that it had doubts about Actos efficacy, rather than the safety profile.
“What this basically does, in my opinion, is remove the concern for the margin of safety and focuses on the fact that they wanted Upjohn to say that the drug didn’t work as well as they would like. That’s a big difference from saying there was a concern over the margin of safety,” Tackett testified.
“A prudent drug company should have the patients’ safety at the forefront. You shouldn’t have someone decreasing or minimizing the concern over safety.”
In previous trials, Takeda has been accused of allowing important documents to be destroyed, and has faced judicial sanctions based on that accusation.
The Actos bladder cancer lawsuit is currently hearing testimony in the Philadelphia County Court of Common Pleas. Plaintiff Frances Wisniewski, a resident of Philadelphia, had been prescribed Actos for the management of her Type 2 diabetes and had used Actos for a period of about seven years before her diagnosis of Actos bladder cancer in 2011.
She filed her Actos lawsuit a year later, claiming she was not aware of the Actos bladder cancer risk. The plaintiff also asserts in her lawsuit that Takeda was aware through clinical, premarket studies that tumors had been reported in male rats having been administered pioglitazone.
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The expert witness for the plaintiff noted, “As soon as there is any reasonable association with a particular adverse event, that would be something you’d want to have communicated to the physician or the prescriber,” Tackett said, adding that there should have been stronger warnings through label changes and correspondence with doctors and the medical community.
With Actos and bladder cancer, that didn’t happen.
The Actos lawsuit continues, with jury deliberation expected to begin the first week in October. The case is Frances Wisniewski v. Takeda Pharmaceuticals America Inc. et al., case number 120702272, in the Philadelphia County Court of Common Pleas.