A new Benicar lawsuit from a Georgia plaintiff blames the antihypertensive drug for an episode of severe gastrointestinal symptoms.

Plaintiff Rodney Z. says he developed severe gastrointestinal issues sometime after he began to use Benicar in July 2014. He complains of symptoms including diarrhea, nausea, vomiting and dehydration.

Rodney is now suing defendants Daiichi Sankyo, Forest Laboratories, and their associated companies, all of whom allegedly had a hand in the development, manufacturing, marketing or sale of Benicar.

His Benicar lawsuit is bringing claims based on theories of product liability, negligence, misrepresentation, fraudulent concealment, fraud, breach of warranty, and unjust enrichment.

Benicar Lawsuit Joins Many Others

Rodney’s Benicar lawsuit joins over 1,200 others already pending as part of a multidistrict litigation going on in a New Jersey federal court. The MDL grew out of a group of 15 Benicar lawsuits originally consolidated by the federal Judicial Panel on Multidistrict Litigation (JPML) in April 2015.

Plaintiffs in these Benicar lawsuits are raising allegations that are generally similar to Rodney’s. They say that defendants Daiichi Sankyo and Forest Laboratories designed Benicar defectively, in such a way that it would cause a set of gastrointestinal problems somewhat similar to IBS symptoms.

Plaintiffs have reported episodes of chronic diarrhea with attendant dehydration, malnutrition and weight loss. These symptoms are sometimes grouped under the name sprue-like enteropathy.

They also accuse the defendants of failing to properly warn them and their doctors that they were at risk for developing these Benicar side effects.

The Benicar MDL puts at issue a group of drugs all of which contain olmesartan, the generic ingredient in Benicar. Besides Benicar itself, the list also includes Benicar HCT, Azor, and Tribenzor.

Plaintiffs say that Daiichi Sankyo refers to this group as the “Benciar Family.” These drugs entered the U.S. market with FDA approval one at a time over a period from 2002 through 2010.

According to the FDA, about 1.9 million patients were prescribed an olmesartan-containing product through U.S. outpatient retail pharmacies in 2012.

The FDA’s Label Change

The FDA addressed the issue in 2013 with a drug safety communication that warned about the connection between Benicar and sprue-like enteropathy.

The agency cited several reports submitted to its adverse event reporting system about patients who experienced complications resembling IBS symptoms while taking Benicar or related olmesartan drugs.

The agency referred to 23 specific and serious cases found in which the patients had suffered significant weight loss and in some cases had intestinal villous atrophy confirmed by biopsy.

Some Benicar side effects were severe enough to require hospitalization. In all the cases, patients’ symptoms improved after discontinuation of the drug, the agency said.

In the same communication, the FDA announced it would add a notice about these reports to the label for Benicar.

The plaintiffs cite the FDA’s announcement as well as several clinical studies and reports as evidence that the defendants were on notice about the risk of sprue-like enteropathy.

But despite the availability of that information, the plaintiffs say, the defendants failed to adequately warn patients or doctors about those risks.

The Benicar Lawsuit is filed within In Re:  Benicar (Olmesartan) Products Liability Litigation, MDL No. 2606, U.S. District Court for the District of New Jersey, Camden Vicinage.