Case Info
The Benicar drug injury cases, which began in 2014, alleged the high blood pressure medication caused intestinal problems known as “sprue-like enteropathy” later called “olmesartan-associated enteropathy (OAE).” OAE induces similar symptoms to celiac disease, including gastrointestinal inflammation and pain, nausea, vomiting, chronic diarrhea, malnutrition, dehydration, villous atrophy, kidney failure, and weight loss. Some patients were hospitalized for months, and several died from their injuries.
Medications mentioned in lawsuits included Benicar and its sister-medications Benicar HCT, Azor, and Tribenzor. People who claimed they had been harmed by taking Benicar and/or its sister medications, began filing lawsuits after the U.S. Food and Drug Administration (FDA) issued a warning in July 2013 after a three-year Mayo Clinic clinical study linked olmesartan to gastrointestinal illnesses.
In March 2015, Benicar cases filed in multiple states were consolidated into multidistrict litigation (MDL 2606) in New Jersey. In August of 2017, Daiichi Sankyo agreed to set aside $300 million to settle an estimated 2,300 lawsuits filed after January 2014 with patients who had suffered injury due to Benicar.
The settlement was approved in September 2017 and the amount was later increased to $358 million after at least 97 percent, or 2,230 claimants, opted in to the settlement.
Daiichi-Sankyo Benicar Improper Marketing
Prior to the settlement, Daiichi Sankyo had been the subject of prior warnings by federal and state investigators, including the U.S. Department of Justice for illegal payments that had been made to doctors in exchange for prescribing Benicar.
In 2006, the U.S. Food and Drug Administration warned Daiichi that their marketing materials were in violation of federal regulations requiring full disclosure of risks. The FDA also warned the company to stop making claims that Benicar was superior to other medications, to discontinue using about 50 promotional items, and to issue corrective messaging. In 2015, the company was ordered to pay $40 million in fines for illegal marketing between 2005 and 2011.
Daiichi Sankyo spent nearly $1 billion to promote Benicar and Benicar HCT, boasting its effectiveness and safety for high blood pressure patients. Drug injury lawsuits claimed that patients may not have taken the medications if the company had not misled health professionals and patients.
A majority of the Benicar drug injury cases were settled in June of 2018 with all but a few claimants agreeing to the settlement. As of 2022, the few remaining Benicar lawsuits had also been resolved.