NEW YORK (Reuters) - Daiichi Sankyo on Tuesday said it has agreed to pay up to $300 million to settle some 2,300 U.S. cases accusing the Japanese drugmaker of failing to warn that its blood pressure medication Benicar can cause gastrointestinal illness.
The settlement will become finalized if at least 95 percent of all claimants agree, or opt in, Daiichi Sankyo said in a statement. The company said the settlement fund was capped at $300 million.
Daiichi Sankyo said it was not admitting liability by settling and that it continues to believe that the Benicar claims were without merit.
“We believe a settlement is in the best interest of all, and will allow us to continue our focus on bringing to market innovative medicines that help people live healthy and meaningful lives,” Glenn Gormley, the group’s executive chairman, said in a statement.
The first lawsuits over Benicar were filed in 2014 and the cases were eventually consolidated in a multidistrict litigation in federal court in New Jersey.
The Tokyo-based drugmaker said the agreement would not have a material impact on its financial position, as the settlement is expected to be funded by several of the group’s insurance companies.
Representatives for plaintiffs did not immediately return a request for comment.
Shares in Daiichi Sankyo were down 0.08 percent to 2,406 yen ($21.82) at 17:30 GMT.
Plaintiffs alleged that the company’s blood pressure medication Benicar, along with its sister drugs Benicar HCT, Azor and Tribenzor, did not carry labels that warned of gastrointestinal side effects, such as sprue-like enteropathy, until a decade after it was introduced.
The U.S. Food and Drug Administration approved olmesartan medoxomil, Benicar’s active ingredient, in 2002. But when studies showed the drug to be linked to intestinal problems, the agency required Daiichi Sankyo to change its label to include the warning in 2013.
Plaintiffs, who filed their first suits in 2014, accused the company of inadequately warning about the drug’s risks and misrepresenting its safety.