A couple from Florida have added their claims to the litigation over the severe gastrointestinal side effects of Benicar.

Plaintiff John C. says he started taking Benicar HCT in March 2005. He later developed severe gastrointestinal symptoms requiring “numerous hospitalizations and in-office treatments,” the Benicar lawsuit says. John attributes these symptoms to his regimen of Benicar HCT.

John’s Benicar lawsuit is one of over a thousand similar lawsuits that is part of a multidistrict litigation centralized in a federal court in New Jersey. At issue in this MDL is the link between Benicar and certain serious gastrointestinal symptoms, known as sprue-like enteropathy.

Generally, the plaintiffs in the MDL are patients who suffered from sprue-like enteropathy or similar gastrointestinal symptoms after taking Benicar or related medications.

Benicar, generic olmesartkan, is made by Daiichi Sankyo’s. It is approved by the FDA to treat high blood pressure. According to the Benicar lawsuit, the Benicar HCT that John took is part of the “Benicar Family,” a group of medications that included Benicar, Azor and Tribenzor.

All four of these medications contain the active ingredient olmesartan. Benicar HCT, Azor and Tribenzor use olmesartan in conjunction with other cardiovascular drugs.

The plaintiffs cite a Drug Safety Communication issued in July 2013 by the FDA alerting the public and the medical community to the link between Benicar and symptoms of sprue-like enteropathy.

The communication also announced a mandatory change to the labeling of Benicar that would add a notice alerting patients and physicians to this concern.

The FDA based its warning and label change on several reports received in its Adverse Event Reporting System that described instances of sprue-like enteropathy associated with Benicar or other olmesartan medications.

The federal agency noted 23 reports of serious cases of late-onset diarrhea with significant weight loss. All patients in these cases showed improvement of symptoms after discontinuing olmesartan.

Benicar Side Effects

John’s Benicar lawsuit includes a long list of the Benicar side effects he claims to have suffered. John reports having had severe and chronic diarrhea coupled with weight loss, the characteristic symptoms of sprue-like enteropathy.

With the diarrhea came malabsorption, dehydration, syncope, rectal bleeding, and low protein and lipid levels, he says. He also reports having abdominal pain, nausea, vomiting, reflux, loss of appetite.

He reports developing secondary conditions including gastritis, duodenitis, colitis, proctitis, cholelithiasis, and a gastric mucosa abnormality characterized by erythema.

John’s Benicar lawsuit also includes a claim by his wife Norma for loss of consortium. Loss of consortium is a type of claim that seeks compensation for the spouse of a harmed person, based on the harm done to the marital relationship.

Daiichi Sankyo’s handling of Benicar was also the subject of a settlement reached with the U.S. Department of Justice early in 2015. The Justice Department alleged that from 2004 to 2011 Daiichi had been paying physicians kickbacks in the form of “speaker fees” in exchange for those physicians’ prescribing medications in the Benicar Family and other Daiichi drugs.

The investigation culminated in a January 2015 settlement agreement in which Daiichi agreed to pay $39 million to resolve the allegations, without admitting to any actual liability.