$300M Benicar MDL Settlement Reached

This is a settlement for the Benicar lawsuit.

Santa Clara, CA: A $300 million settlement has been reached between makers of the Benicar, Forest Laboratories Inc., and Daiichi Sankyo Inc., and about 2,300 plaintiffs in multi-district litigation (MDL) that claims the blood pressure drug caused gastrointestinal injuries.

The settlement addresses claims filed collectively in state and federal court. The plaintiffs alleged personal injury stemming from defective design of Benicar (known generically as olmesartan), which is also in blood pressure products Benicar HCT, Azor and Tribenzor.

The hypertension drug is used to lower high blood pressure. It is in a class of drugs known as angiotensin II receptor blockers (ARB). In 2013, the US Food and Drug Administration (FDA) issued a warning for patients stating that Benicar could cause sprue-like enteropathy, a condition that includes severe and chronic diarrhea. The agency mandated that Benicar warning labels be changed to include the condition. According to the FDA, sprue-like enteropathy has not been linked with other ARB medications.

The FDA’s action was based on adverse event reports of serious cases of late-onset diarrhea associated with Benicar use. Court documents state that an estimated 1.9 million patients received a prescription for Benicar or a similar drug in 2012 alone.

The litigation had been underway for more than two years. The plaintiffs alleged that not only did Daiichi design the drug in a defective manner but also that it failed to warn users that it could cause chronic diarrhea, nausea, malnutrition, dehydration and weight loss. Daiichi and Forest were jointly accused of promoting Benicar.

According to the terms of the agreement, the funds will be triggered when 95 percent of all eligible litigants and claimants opt in to the settlement under certain conditions. Patients who have not yet filed a claim and wish to be eligible to receive settlement funds, must have a retainer agreement in place with an attorney by August 23, lawyers told the court.

The case is In Re: Benicar (Olmesartan) Products Liability Litigation, case number 2606, in the U.S. Judicial Panel on Multidistrict Litigation.