A lawsuit filed recently on behalf of a Mississippi woman alleges that the blood-pressure drug Benicar HCT caused her colitis and other gastrointestinal complications.
This lawsuit is part of a multidistrict litigation (MDL) in progress in federal court in New Jersey, Top Class Actions reports.
According to legal documents, the woman began taking Benicar HCT in 2005 to control her blood pressure. The lawsuit alleges that as a result of taking Benicar (olmesartan) she developed colitis and other complications. The lawsuit describes the gastrointestinal complications as “villous atrophy, sprue-like enteropathy, colitis, kidney failure, malabsorption, malnutrition, dehydration, atrophy and/or symptoms of diarrhea, vomiting, nausea, abdominal pain, and/or other related symptoms.” In addition to these injuries, the woman incurred medical expenses as a result of the drug side effects.
As of June 2016, the Benicar multidistrict litigation contained over 1,300 individual Benicar lawsuits similar to the one filed by the Mississippi woman.
Benicar (olmesartan) was approved by the Food and Drug Administration (FDA) in 2002 as a treatment for high blood pressure. Benicar HCT, the product named in the Mississippi woman’s lawsuit, is a combination of olmesartan and hydrochlorothiazide, another blood-pressure drug.
The Benicar MDL also involves the medications Azor and Tribenzor, which contain olmesartan. The drug maker Daiichi Sankyo calls these drugs the “Benicar Family,” according to legal documents in the MDL.
Plaintiffs in the Benicar MDL allege that Daiichi Sankyo and Forest Laboratories failed to properly warn the medical community and the public about the possibility that severe gastrointestinal problems could be a side effect of Benicar.
A 2013 FDA drug safety communication said drugs in the Benicar Family have a known link to gastrointestinal complications known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe and chronic diarrhea accompanied by substantial weight loss. The FDA explains that sprue-like enteropathy may not develop until months or years after the patient starts taking Benicar.
In 23 reports to the FDA adverse event reporting system involving olmesartan-based drugs, the patients say they developed symptoms like late-onset diarrhea with significant weight loss. In some cases, intestinal villous atrophy was confirmed by a biopsy. The FDA says that in all 23 cases, the patients’ symptoms improved after the patient stopped taking olmesartan.
In May 2016, U.S. District Judge Robert B. Kugler, the judge overseeing the Benicar MDL, issued a schedule for pretrial proceedings. According to the schedule, the discovery phase, depositions and hearings concerning expert testimony should be completed by March 2017, with trials expected to begin shortly thereafter.
A group of 10 bellwether cases were selected from a pool of 30 to be the first few cases to go to trial. Bellwether cases can serve a useful function in an MDL, giving the parties an idea of how their evidence and arguments will be received by jury. The outcomes of the bellwether cases can help the parties decide whether to work toward a settlement or continue to bring cases to trial.