Paul Tassin  |  September 7, 2016

Category: Legal News

benicarAn alleged case of Benicar HCT colitis is the subject of a new Benicar lawsuit recently filed by a woman from Mississippi.

Plaintiff Charlotte P. says she began using Benicar HCT back in 2005.

She says that medication later caused her to develop Benicar HCT colitis and a slew of other gastrointestinal complications.

In her Benicar HCT colitis lawsuit, Charlotte lists her injuries 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 as well as medical expenses resulting from these injuries.”

MDL Claims Allege Beniar HCT Colitis, Other Complications

Charlotte has filed her Benicar HCT colitis lawsuit as part of a large-scale litigation, known as a multidistrict litigation or MDL, that is now going on in a federal court in New Jersey.

As of June 2016, the Benicar MDL contained over 1,300 individual Benicar lawsuits like Charlotte’s.

Benicar, or olmesartan, was originally approved by the FDA in 2002 as a treatment for hypertension. Benicar HCT, the product at issue in Charlotte’s claim, is a combination of olmesartan and hydrochlorothiazide, another anti-hypertension drug.

The Benicar MDL also contains claims over olmesartan-based drugs Azor and Tribenzor. Together with Benicar and Benicar HCT, these drugs are known by Daiichi Sankyo as the “Benicar Family,” according to plaintiffs in the MDL.

Claimants in the Benicar MDL allege that manufacturers Daiichi Sankyo and Forest Laboratories failed to properly warn the medical community and the general public about the fact that Benicar can cause severe gastrointestinal problems.

According to an FDA drug safety communication issued in 2013 and cited by the MDL plaintiffs, drugs in the Benicar Family have a known link to a set of complications known as sprue-like enteropathy.

Symptoms associated with this condition primarily include severe and chronic diarrhea with accompanying substantial weight loss.

According to the FDA, sprue-like enteropathy may not develop until months or years after the patient starts taking Benicar. It can be bad enough to require hospitalization.

The FDA says it found 23 cases reported to its adverse event reporting system in which patients taking olmesartan-based drugs developed symptoms like late-onset diarrhea with significant weight loss. In some cases, intestinal villous atrophy was confirmed via biopsy.

The agency says that in all 23 cases, the patients’ symptoms improved after they stopped taking olmesartan.

In May 2016, U.S. District Judge Robert B. Kugler issued a schedule for pretrial proceedings in the Benicar MDL. Discovery, depositions and hearings covering expert testimony are scheduled to be completed by March 2017.

Trials are expected to begin shortly thereafter. A group of 10 “bellwether” cases were selected out of a pool of 30 picked by Judge Kugler as the first few cases to go to trial.

Bellwether cases can be useful in multidistrict litigation to give the parties an idea of how their evidence and arguments will play out at trial. The results in bellwether cases are not binding on other claims in the MDL, but they do tend to help the parties reach settlement agreements.

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

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