Lawsuit Over Benicar Side Effects Moving Forward Toward Trial

A product liability lawsuit brought by a California woman who suffered chronic diarrhea and other side effects from Benicar HCT is proceeding through the federal court system, after the judge presiding over the case entered a scheduling order and protective order.

Earlier this year, a Benicar HCT lawsuit filed by Susanne Ambler and her husband was removed to the federal court system, raising allegations that Daiichi Sankyo failed to adequately warn consumers and the medical community about the risk of a condition known as sprue-like enteropathy, which has been associated with use of the popular blood pressure drug.

U.S. Magistrate Judge Barbara Major approved a joint motion for a protective order (PDF) in the case on October 2, which allow discovery to proceed between the parties, stipulating how confidential or protected information will be handled.

According to a case management order (PDF) issued in the case on September 10, all fact discovery must be completed by the parties before the end of February 2015, with all export discovery completed by June 26, 2015. Following any dispositive motions, the Court has scheduled a final pretrial conference for December 18, 2015, at which time it is expected that a trial date will be assigned for early 2016.

Benicar Lawsuits Pending Nationwide

Ambler’s complaint is one of a growing number of Benicar injury lawsuits being pursued in courts throughout the United States, involving similar allegations that the drug maker withheld important safety information about the potential link between use of the hypertension drug and the development of chronic diarrhea, weight loss, villous atrophy and other symptoms of sprue-like enteropathy.

At this time, most of the cases filed nationwide are pending at the state-court level, with only a few cases spread throughout U.S. District Courts nationwide. Therefore, no consolidated proceedings have been established in the federal court system, and Daiichi Sankyo may face several different trial schedules in various cases.

According to allegations raised by Ambler, she claims that Benicar side effects caused her to be hospitalized for extended periods of time after she began using the medication, suffering from sprue-like enteropathy, lymphocytic colitis, microscopic colitis, chronic diarrhea, weight loss, nausea, vomiting, malnutrition and dehydration.

As a result of a failure to warn, Ambler indicates that neither she nor her doctors were aware that that there may be a link between Benicar and diarrhea problems, which recent studies have suggested may begin months or even years after first use of the medication.

Benicar HCT Diarrhea Problems

Benicar HCT (olmesartan medoxomil – hydrochlorothiazide) is a blood pressure medication manufactured by Daiichi Sankyo that is part of the Benicar-family medications, which also includes Azor and Tribenzor.

Although the medication has been on the market for more than 10 years, information about the enteropathy risks associated with Benicar were not discovered by most patients and doctors until recently, following FDA warnings issued last year.

In June 2013, the FDA issued a drug safety communication, providing information to the medical community for the first time about the risk that Benicar side effects may cause sprue-like enteropathy, indicating that the agency found clear evidence of a cause and effect relationship between use of the drug and the gastrointestinal problems, which typically stop when the medication is no longer used.

Prior to the warnings, many Benicar users had been suffering from these complications for years without realizing that the problems may be caused by the medication, as symptoms may begin months or even years after the drug is first used.

In many cases, the Benicar problems have been misdiagnosed as Celiac disease or unclassified sprue, resulting in continued use of the medication, which could leave users with long-term intestinal damage.

Although the diarrhea symptoms from Benicar typically resolve when the medication is no longer used, the problems can cause permanent damage to the intestines.

Known as villous atrophy from Benicar, this involves the deterioration or decay of the villa in the intestinal tract, which may prevent the absorption of nutrients and reduce digestive capabilities. Left untreated, villous atrophy may result in dehydration, malnutrition, a weakened ability to fight off other illness and electrolyte problems.

As Benicar injury lawyers continue to review potential claims for individuals who have experienced chronic diarrhea or other complications associated with use of the medication, it is ultimately expected that Daiichi Sankyo may face hundreds of lawsuits nationwide.