Takeda and Lilly get Actos trial reprieve
pharmafile | October 29, 2014 | News story | Sales and Marketing | Actos, Takeda, bladder cancer, diabetes, lilly
A judge has dramatically reduced the $9 billion damages bill Takeda and Lilly were set to pay over safety allegations against their drug Actos, but the companies have said that it is still not enough.
The damages relate to accusations by Louisiana bladder cancer patient Terrence Allen that Takeda withheld information on the potential link between its drug Actos (pioglitazone) and the disease, from consumers and the healthcare industry.
Saying that the original amount was larger than allowed by law, Judge Rebecca Doherty reduced the amount of money the Takeda and Actos’ co-promoter Lilly will have to pay in punitive damages by 99% to $36.8 million – which is still the maximum amount the jury could have awarded.
The judge also said that the original ruling of wrongdoing relating to concealing of risks should still stand, though, and denied the companies’ request for a new trial.
Kenneth Greisman, senior vice president and general counsel of Takeda US, says: “We view the substantially reduced punitive damage award as a step in the right direction, but we believe a damage award of any amount is not justified based on the evidence presented in this trial and we will appeal.”
Actos has generated worldwide sales of over $16 billion, but after a safety review in 2011 the FDA said that using it for more than one year could be associated with an increased risk of bladder cancer.
The drug was subsequently banned in France and Germany, although the EMA and the FDA have not pulled it from market. Both Takeda and Lilly strongly deny the accusations of safety issues with Actos, arguing that people who developed bladder cancer while using the drug did so because of other risk factors.
“Patient safety is a critical priority for Takeda,” says Greisman. “There is no credible scientific evidence that establishes a causal link between Actos and this disease.”
Mike Harrington, senior vice president and general counsel of Lilly, adds: “While we have empathy for the plaintiff, we believe the evidence did not support his claims. We will continue working vigorously to overturn the verdict.”
This is just one of over 8,000 suits Takeda is facing alleging that the company hid Actos’ risks, however, with nine having been decided so far. Takeda has won in seven of these cases, with a Pennsylvania trial being the company’s only other loss so far. That trial ended with Takeda having to pay out $2 million.
Another trial in West Virginia is currently underway.
George Underwood
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