Santa Clara, CA: The makers of the controversial blood pressure medication, Benicar, have agreed a $300 million settlement potentially ending multi-district litigation (MDL) that claims the drug caused gastrointestinal injuries. Forest Laboratories Inc., and Daiichi Sankyo Inc., and about 2,300 plaintiffs in the MDL reached the agreement earlier this week. 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.
According to the terms of the Benicar settlement, 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.