Daiichi Sankyo Inc. and Forest Laboratories Inc. have agreed to pay $300 million to settle claims in state and federal courts that the blood pressure drug Benicar caused gastrointestinal injuries. A master settlement agreement was signed prior to a conference before U.S. District Judge Robert B. Kugler in New Jersey federal court in Camden, New Jersey.

The first lawsuits over Benicar were filed in 2014 and the cases were eventually consolidated in a multidistrict litigation (MDL) 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. The settlement will become finalized if at least 95 percent of all claimants agree, or opt in. Sankyo said the settlement fund was capped at $300 million.

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, which includes severe and chronic diarrhea, until a decade after it was introduced. The U.S. Food and Drug Administration (FDA) 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 accused the company of inadequately warning about the drug’s risks and misrepresenting its safety.

The settlement addresses about 2,300 filed collectively in state and federal court and concludes more than two years of litigation that played out before Judge Kugler and U.S. Magistrate Judge Joel Schneider in federal court and Judge Nelson C. Johnson in state court.

The suits involved Benicar and other blood pressure products containing olmesartan, including Benicar HCT, Azor and Tribenzor. The plaintiffs claimed Daiichi designed the drug in a defective manner and failed to warn users that it could cause chronic diarrhea, nausea, malnutrition, dehydration and weight loss. Forest is accused of promoting Benicar alongside Daiichi.
The Plaintiffs are represented by Mazie Slater Katz & Freeman LLC, Robins Kaplan LLP, Yale & Baumgarten LLP, Spangenberg Shibley & Liber LLP, Levin Papantonio Thomas Mitchell Rafferty & Proctor PA and Lieff Cabraser Heimann & Bernstein LLP, among others. The case is In Re: Benicar (Olmesartan) Products Liability Litigation (case number 2606) in the U.S. Judicial Panel on Multidistrict Litigation.

Source: Reuters and Law360.com

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