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Takeda loses in lawsuit claiming cancer link to Actos

Ordered to compensate woman who claims drug gave her bladder cancer

Takeda pharma buildingTakeda has been ordered to pay $2m in damages to a US woman who claimed to have been harmed by the company's diabetes drug Actos.

The verdict is the latest of six individual cases brought against Takeda regarding Actos (pioglitazone) safety that have reached trial, and could be significant as it is the second ruling to go against the Japanese pharma company.

After almost a month of deliberations, the jury found in favour of the plaintiff - 79-year-old retired accountant Frances Wisniewski - who claimed the drug caused her bladder cancer. Takeda had argued that smoking was the more likely cause.  

Thousands of other lawsuits alleging harm from Actos are waiting to go to trial, and the latest verdict comes after a Louisiana court ordered Takeda and former US co-promotion partner Eli Lilly to pay $9bn in punitive damages after concluding the companies covered up cancer risks associated with the drug.

The jury in that case also awarded compensatory damages to plaintiff Terrance Allen, who had alleged that he developed bladder cancer after taking Actos for more than five years, to the tune of nearly $1.5m.

In August Lilly and Takeda failed to overturn the punitive damages but said they would continue to fight the award in the courts. Meanwhile, in the latest case the jury determined punitive damages were not appropriate.

Takeda's general counsel Kenneth Greisman said in a statement that the company "respectfully disagrees with the verdict, and we intend to challenge this outcome", possibly via post-trial motions and an appeal.

The company published a 10-year study in August, which it said showed there was no statistically significant increased risk of bladder cancer among people who took Actos.

Both the EU and the US regulatory authorities launched safety reviews of the drug and concluded it should remain on the market with labelling amended to indicate a slight increase of bladder cancer found in an earlier five-year trial. Takeda has filed its new data to the regulators to try to get the labelling updated.

Actos was a huge commercial success for Takeda, with sales peaking at $4.5bn before losing patent protection in the US in 2012. Court documents obtained by Bloomberg suggest Actos has generated more than $16bn in sales since its US launch in 1999.

Article by
Phil Taylor

6th October 2014

From: Regulatory, Healthcare



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