A multidistrict litigation (MDL) has been organized in the U.S. District Court for the District of New Jersey, Camden Vicinage over the blood pressure medication Benicar (olmesartan). As of August 2016, there were 1,718 complaints pending. Benicar is manufactured by Daiichi Sankyo.
Benicar is an angiotensin II receptor blocker (ARB) approved for the treatment of hypertension—alone or with other antihypertensive agents—to lower blood pressure. The drug is taken to reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks, according to the U.S. Food and Drug Administration (FDA). Olmesartan medoxomil is sold under as generics and under the brand names Benicar, Benicar HCT, Azor, and Tribenzor.
The plaintiffs in the Benicar MDL just filed a joint report to advise the Court that a filing of a motion for partial summary judgment on the issue of general causation, based on numerous admissions in depositions, is to be expected over Daiichi Sankyo’s alleged failure to warn about gastrointestinal risks associated with the drug. Benicar MDL plaintiffs are also seeking partial summary judgment on the issue of if Daiichi Sankyo provided adequate warnings concerning Benicar sprue-like enteropathy.
The lawsuits in the Benicar MDL similarly allege that drug makers Daiichi Sankyo and Forest Laboratories did not fully review Benicar and did not warn about the risk of developing sprue-like enteropathy and other serious side effects associated with Benicar. Allegations also include that Benicar marketing materials were deceptive.
The first Benicar bellwether trial dates are scheduled for 2017 and coordinated discovery continues. Bellwethers involve a few cases selected as representative of the larger number of MDL claims and help all parties determine possible jury reactions to witnesses and evidence. Bellwethers also help parties considering settlement agreements before the remaining MDL cases go before a jury.
There are more than 70 additional lawsuits pending at the New Jersey state level over allegations that patients treated with Benicar experienced the serious effects of sprue-like enteropathy, including chronic diarrhea and rapid weight loss.
The FDA indicated that it received 23 serious cases in its Adverse Event Reporting System (FAERS) database that included late-onset diarrhea with significant weight loss. In some cases, the very serious intestinal villous atrophy was seen on biopsy. Every patient experienced clinical improvement after discontinuing olmesartan. In 2013, the agency directed drug makers to add sprue-like enteropathy to Benicar’s warning label, advised patients to contact a healthcare professional if chronic diarrhea and severe weight-loss symptoms are experienced, and indicated that a review of FAERS showed “clear evidence of an association between olmesartan and sprue-like enteropathy.”
In 2012, Mayo Clinic researchers published 22 case reports of sprue-like enteropathy in patients treated with Benicar. Some were misdiagnosed with celiac disease, yet their symptoms did not improve with celiac disease treatment—a gluten-free diet. Patients suffered for years before doctors found that Benicar was the cause of the adverse reactions. Benicar labeling lacked warnings about sprue-like enteropathy for one decade, leaving many victims misdiagnosed with celiac disease for years. In some cases, this Benicar side effect allegedly led to permanent intestinal damage. Other Benicar side effects include chronic diarrhea, dehydration, malnutrition, nausea, and intestinal damage.