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While nearly all of the lawsuits filed in recent months over chronic diarrhea from Benicar have been brought in state courts, Daiichi Sankyo recently removed a California case to the federal court system.
A complaint (PDF) was filed by Susanne Ambler and her husband, Richard, earlier this year in the Superior Court of California in San Diego, alleging that Daiichi Sankyo failed to adequately warn consumers and the medical community that chronic diarrhea, weight loss and other symptoms experienced by users of Benicar may be caused by the hypertension drug.
Ambler claims that she was hospitalized for extended periods of time after she began using Benicar HCT four years ago, suffering from sprue-like enteropathy, lymphocytic colitis, microscopic colitis, chronic diarrhea, weight loss, nausea, vomiting, malnutrition and dehydration. However, Ambler indicates that neither she nor her doctors were aware that the problems may be caused by side effects of Benicar, since the drug makers withheld important safety information.
On June 17, Daiichi Sankyo filed a notice of removal (PDF), transferring the Benicar HCT lawsuit from California state court to the U.S. District Court for the Southern District of California, claiming diversity jurisdiction since Ambler is a resident of California and the drug maker is incorporated in Delaware.
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.
Ambler’s case is one of a growing number of Benicar diarrhea lawsuits filed since the FDA issued warnings last year about the link between use of the medication and the development of sprue-like enteropathy, which can result in severe and chronic diarrhea, weight loss, colitis, and other severe gastrointestinal problems.
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 Benicar has been on the market for more than a decade, the first reports suggesting a link between the medication and sprue-like enteropathy were not published until July 2012, when independent researchers from the Mayo Clinic identified a number of cases among patients treated at clinics nationwide.
In a report published in the medical journal Mayo Clinic Proceedings, researchers outlined cases involving at least 22 patients from 17 different states who were treated for symptoms consistent with celiac disease while taking Benicar. While treatments for celiac disease were ineffective, the report found that once patients stopped taking their blood pressure medication, the symptoms usually resolved.
In July 2013, the FDA issued a drug safety communication on the issue, providing information to the medical community for the first time about the risk of sprue-like enteropathy from Benicar. The federal drug regulators indicated that they found clear evidence of a cause and effect relationship between the drug and the gastrointestinal problems, with issues often stopping when the medication was no longer used and resuming if the treatment restarts.
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.
Most of the lawsuits over Benicar are currently pending in New Jersey state court. While Daiichi Sankyo previously removed several early cases filed in New Jersey to the federal court system, those Benicar lawsuits were remanded back to state court after a U.S. District Judge found that federal jurisdiction did not apply.