A man who allegedly suffered colitis and sprue-like enteropathy after taking Benicar HCT has filed a lawsuit against the drug’s manufacturers.

Plaintiff William M. of Illinois alleges he began using Benicar HCT sometime in 2011. Later, he says, he started suffering several different gastrointestinal symptoms, severe enough to require medical treatment at his own expense.

William alleges these symptoms were side effects of Benicar HCT. He is seeking a judgment against defendants Daiichi Sankyo, Forest Laboratories, and their related companies to cover compensatory damages, punitive damages, and costs of litigation.

Litigation Over Benicar HCT

This Benicar lawsuit is one of over 1,100 similar claims brought together in a federal court in New Jersey. These claims have been consolidated into a multidistrict litigation, or MDL, in the interest of coordinating pretrial procedures and setting up the first group of cases that will go to trial.

Generally, the plaintiffs in this MDL allege that Benicar HCT and other products containing the drug olmesartan were responsible for a pattern of severe gastrointestinal symptoms, commonly referred to as sprue-like enteropathy, the main symptoms of which include chronic and severe diarrhea with accompanying weight loss.

William’s own Benicar lawsuit alleges he suffered symptoms including diarrhea, dehydration, nausea, vomiting, colitis, and intestinal damage. Some other plaintiffs say they have been suffering 10 to 20 attacks of diarrhea per day, causing weight loss in the range of 75 to 100 pounds in some cases.

What is Benicar?

Benicar is a drug used to help control high blood pressure. Known also by its generic name olmesartan, it is sold by itself and in formulations that combine it with other drugs under the brand names Benicar HCT, Azor and Tribenzor. According to the MDL’s master long form complaint, defendant Daiichi Sankyo refers to these drugs collectively as the “Benicar Family.”

Plaintiffs often point to post-market study results that suggest a causal connection between olmesartan products and the onset of sprue-like enteropathy. They cite a case study from the University of Pittsburgh in which one patient allegedly lost 25 pounds as a result of chronic diarrhea. While some attempts at treatment failed, his symptoms began to resolve when he stopped taking olmesartan.

Plaintiffs cite another study from Columbia University Medical Center in which 16 patients with villous atrophy showed improvement of their symptoms when they stopped taking olmesartan. One patient’s symptoms resumed when he was given olmesartan again.

Despite the results of these and many other studies, plaintiffs say the defendants failed to adequately warn patients and doctors about these alleged side effects of Benicar HCT.

The plaintiffs also say that the defendants’ marketing for the Benicar Family was misleading. They say that Daiichi Sankyo and Forest Labs distributed materials that promoted these drugs as being “superior, more effective, and safer” than other comparable drugs.

But in 2006, plaintiffs say the FDA ordered the defendants to cease this campaign. The FDA allegedly determined that there was no evidence that Benicar was safer or better than comparable drugs. The agency also found that the marketing campaign failed to address certain risks associated with Benicar and minimized the risks it did address, according to the plaintiffs.

The Benicar MDL is pending under MDL No. 2606 in the U.S. District Court for the District of New Jersey. The Benicar HCT Lawsuit is Case No. 1:16-CV-00533 in the same court.