The multidistrict litigation over gastrointestinal symptoms associated with Benicar has added a new plaintiff from Texas.

Plaintiff Ira A. says that in 2006 he started using Benicar and Benicar HCT, both brand-name drugs that contain olmesartan. He later developed an array of gastrointestinal symptoms associated with a condition known as sprue-like enteropathy.

Ira reports suffering from chronic diarrhea, one of the trademark symptoms of sprue-like enteropathy. He also says he suffered from nausea, vomiting, abdominal pain, dehydration, and other symptoms. Ira attributes these symptoms to the olmesartan in the medications he took.

Ira seeks an award of compensatory damages and also punitive damages against defendants Daiichi Sankyo, Forest Laboratories, and their related companies.

Olmesartan and Sprue-Like Enteropathy

Olmesartan was first approved by the FDA in 2002 as a treatment for hypertension. It’s sold by itself under the brand name Benicar and in combination with other drugs under the brand names Benicar HCT, Azor, and Tribenzor.

These olmesartan drugs are associated with an increased risk of developing sprue-like enteropathy, a condition with symptoms that mimic celiac disease complications. Characteristic symptoms of sprue-like enteropathy are chronic diarrhea with weight loss.

The patient may also suffer from villous atrophy, a degradation of the tissue that lines the inside of the intestine. Villous atrophy can contribute to malabsorption and other gastrointestinal disorders. Olmesartan is the only angiotensin receptor blocker drug that has been associated with villous atrophy.

Enteropathy related to Benicar treatment may not develop until months or years after the patient starts taking the drug. The more serious cases my require hospitalization.

The FDA addressed this problem with a drug safety communication issued in July 2013. The agency had found in its own adverse event report database and in outside clinical studies that some patients came down with sprue-like enteropathy or related symptoms while taking olmesartan. These patients’ symptoms generally improved after discontinuing the drug.

The communication recommended that olmesartan be discontinued in patients who experience enteropathy symptoms with no other possible cause.

The Benicar MDL

The Benicar lawsuit Ira has filed is part of a much larger group of similar lawsuits all being processed together in a federal court in New Jersey. This multidistrict litigation, or MDL, was created by the federal Judicial Panel on Multidistrict Litigation so that these Benicar lawsuits could be processed more efficiently.

The plaintiffs in the MDL allege that Daiichi Sankyo and Forest Laboratories, the makers of drugs containing olmesartan, promoted olmesartan as being safe and effective for treatment of hypertension even though they knew or should have known that olmesartan increased the risk of developing sprue-like enteropathy. They say that the defendants failed to adequately warn physicians and patients about the risks of gastrointestinal symptoms associated with olmesartan.

The MDL also allows claims from the relatives of those who developed sprue-like enteropathy after taking olmesartan. These plaintiffs may be able to bring claims for loss of consortium, wrongful death, or survivor actions.

The Benicar MDL is pending in the U.S. District Court for the District of New Jersey under MDL No. 2606. Ira’s individual Benicar Lawsuit is Case No. 1:16-CV-00160.