Japan’s largest drugmaker, Takeda Pharmaceutical Co, yesterday said it has agreed to pay US$2.4 billion to thousands of patients and their families over its diabetes drug Actos, which has been linked to cancer.
Takeda faces 9,000 product liability lawsuits in the US, in which the plaintiffs say the company failed to inform them of the drug’s cancer risks.
The company said the settlement would resolve most of the lawsuits, though it does not admit liability.
The settlement is to go into effect if 95 percent of the litigants agree to the deal, and the company would pay US$2.37 billion. If the number of participants rises to 97 percent or more, Takeda will pay US$2.4 billion.
Takeda said the settlement is aimed at resolving the lawsuits more quickly and allowing the company to move on.
“Takeda’s decision to settle does not change the company’s continued commitment to Actos,” it said in a statement. “The settlement will reduce financial uncertainties for the company and provides a significant degree of assurance toward resolving a high percentage of the Actos product liability claims.”
Then Takeda can focus on developing medicines, it said.
Takeda said it would set aside US$2.7 billion against earnings in the January-to-March quarter to cover the settlement and related costs.
It would cause the company a group net loss of ¥145 billion (US$1.2 billion) for the business year ended March 31, sending it into the red for the first time since its 1949 listing.
A previous legal battle in the US District Court in western Louisiana last year turned on whether Actos, a drug used to treat type-two diabetes, caused a patient’s bladder cancer and by implication was responsible for other cases of the cancer.
In a 2011 drug safety update on Actos, the US Food and Drug Administration cited a 40 percent increase in bladder cancer risk in people who used the drug for longer than a year. It ordered the cancer risk to be added to a warning label for the medicine, sold since 1999.
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