The FDA approved Benicar (olmesartan) in 2002 for the treatment of hypertension (high blood pressure). A member of the angiotensin receptor blocker (“ARB”) family of drugs, Benicar operates by blocking the chemicals in the body that cause the muscles around blood vessels to contract, thus promoting the blood vessel dilation critical to lowering a patient's blood pressure.
Since FDA approval, a number of patients that took Benicar reported symptoms similar to those common to celiac disease. Celiac disease is an autoimmune disorder that affects the small intestines of individuals who have a genetic predisposition to this condition. Symptoms include rapid weight loss, chronic diarrhea, electrolyte imbalance and vomiting. The only known treatment for celiac disease is a life-long elimination of gluten from a patient's diet.
In June 2012, Mayo Clinic researchers reported that between 2008 and 2010, 22 patients using Benicar had symptoms commonly attributed to celiac disease. Nevertheless, antibody blood tests conducted on these individuals were not supportive of a celiac disease diagnosis. Instead, the Mayo Clinic researchers determined that the patients had a condition that mimics celiac disease, known as sprue-like enteropathy. Patients with sprue-like enteropathy experience chronic diarrhea, weight loss and intestinal villous atrophy. Further, soon after the discontinuance of Benicar use, the Mayo Clinic reported that each of the effected patient’s sprue-like enteropathy symptoms disappeared.
Thereafter, in October 2012, researchers at the American College of Gastroenterologists noted another 40 cases of sprue-like empathy symptoms in patients that had consumed Benicar.
The FDA reviewed the studies conducted by the Mayo Clinic and the American College of Gastroenterologists, as well as investigated 23 reports of Benicar sprue-like enteropathy side effects documented in the agency's Adverse Event Reporting System. As a result, on July 3, 2013, the FDA mandated that manufacturers of Benicar and similar drugs containing olmesartan updated warning labels to reflect the risk of sprue-like enteropathy. To date, Benicar is the only drug in the ARB family that has been linked to sprue-like enteropathy.
The plaintiffs who filed cases consolidated in this litigation allege that Benicar was unreasonably dangerous and negligently designed and developed, and that the defendants failed to provide adequate warning of the risks associated with the drug. The plaintiffs further alleged that the FDA found enteropathy could take months or years to manifest after starting Benicar therapy. They claim studies concerning Benicar’s side effects were “submitted on a delayed basis to the FDA.” Lastly, the plaintiffs’ contend that some of the Benicar marketing materials were misleading because the company made unsubstantiated claims about the medication’s effectiveness.