Plaintiff Frances Wisniewski alleged in her Actos bladder cancer lawsuit (Frances Wisniewski v. Takeda Pharmaceuticals America Inc. et al., Case No. 120702272, in the Philadelphia County Court of Common Pleas) that seven years on Actos for treatment and management of her Type 2 diabetes cost her all hope of future optimum health after tumors were found in her bladder. She blames Actos side effects for her woes, and filed suit in the Philadelphia County Court of Common Pleas in July 2012.
The trial got underway September 8. Takeda is expected to appeal.
Actos grew into a billion-dollar drug, partly due to problems associated with a competing Type 2 diabetes drug. Doctors switched their patients from Avandia, manufactured by GlaxoSmithKline (GSK), due to a better safety profile for Actos and heart failure.
While Actos congestive heart failure remains a risk associated with Actos (pioglitazone), that risk is thought to be lower than that associated with Avandia, which several years ago was hammered for having an allegedly high risk for cardiovascular issues.
Actos liver problems are also a possibility. So is Actos macular edema. But there was no mention of Actos and bladder cancer until 2011, when various studies prompted the US Food and Drug Administration (FDA) to slap a new warning on the prescribing label for Actos with regard to the possibility for Actos bladder cancer when pioglitazone was used for more than one year.
FDA warning for Actos bladder cancer came too late for plaintiff
That was in August 2011. By that time, plaintiff Wisniewski had been using Actos for seven years - six years beyond the limit. Her doctor, according to court records, took Wisniewski off Actos and switched her to another Type 2 diabetes drug soon after the updated warning was released, but by then it was too late.
Wisniewski’s Actos lawyer notes that four of the six Actos cases that have gone to trial across the US found in favor of the plaintiff. And even though more than one of those plaintiff victories was reversed on appeal, plaintiff attorneys continue to point to the recent $6 billion verdict against Takeda this past April as part of a multidistrict litigation in Louisiana. In that case, plaintiffs alleged that Takeda and marketing partner Eli Lilly & Co. concealed risks for Actos bladder cancer from consumers and the health care industry.
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The defendant, in a statement, said that Takeda “respectfully” disagreed with the verdict, and that the company intended to challenge the outcome. “We have empathy for Ms. Wisniewski,” said Takeda senior vice president and general counsel Kenneth Greisman, “but we believe we presented sufficient evidence to show that her condition was not caused by Actos.”
The Philadelphia jurists awarded Wisniewski a total of $2,050,000 in damages after about five hours of deliberation. The majority of the jury - eight of nine jurists - found for the plaintiff.