Camden, NJA Benicar side effects lawsuit involving the manufacturers of Benicar olmesartan, identified as Daiichi Sankyo (Daiichi) and Forest Pharmaceuticals Inc. (Forest) may have ended on a motion of summary judgement put forward by the plaintiffs. However, a judge with the US District Court in New Jersey ruled that documents cited by the plaintiffs and characterized by them as an admission of guilt on the part of the defendants, failed to clearly show that Benicar was the cause of sprue-like enteropathy.
Central to the attempt for summary judgment by the plaintiffs were excerpts from a long deposition taken from Hideki Tagawa, identified as the associate manager of Daiichi’s clinical safety and pharmacovigilance unit located in Japan.
“[Tagawa] confirms that [a PowerPoint presentation he is referencing] states the cause of the death of a 70-year-old man in France was an olmesartan drug [Benicar is olmesartan],” US District Court Judge Robert B. Kugler said November 8 of this year, in New Jersey. “He is then asked to comment on an unidentified PowerPoint and on other unidentified documents, which leaves this court no point of reference from which to review independently to what Tagawa san is attesting to.”
Three years ago the US Food and Drug Administration (FDA) mandated that warning labels for olmesartan be updated to include the risk for sprue-like enteropathy (SLE), a gastrointestinal condition linked to olmesartan that causes severe and chronic diarrhea and dehydration.
That warning was based on 23 serious cases of Benicar illness and weight loss that has allegedly resulted in death. This appears to be the point made in the PowerPoint presentation to which Tagawa is referring – the death of a 70-year-old Benicar patient in France related to use of olmesartan. Serious, chronic diarrhea can have serious, negative health impacts on the elderly.
However, the judge didn’t think there was enough in Tagawa’s deposition to warrant a finding of general causation sufficient to grant the plaintiff’s motion of summary judgement. The judge also referenced an email written by Tagawa stating that reports indicated chronic diarrhea improves when patients cease use of olmesartan, in most cases.
“[Tagawa] states that what he wrote in that email is based on what defendants’ medical advisers had told him,” the judge said. “Although Tagawa san affirms that he wrote certain content relating to SLE and confirms the statements set forth in the documents before him, he clearly indicates he is not an expert able to independently attest to general causation.”
Benicar defective products lawsuits have been centralized in multidistrict litigation in New Jersey, and have so since April of last year. There are some 1,900 cases.
The MDL is In Re: Benicar (Olmesartan) Products Liability Litigation, Case No. 1:15-md-02606, in the US District Court for the District of New Jersey.
Benicar is a drug prescribed to combat high blood pressure, a particularly common condition amongst a large percentage of the American population. In 2012, some 1.9 million Americans were prescribed Benicar or a similar drug for high blood pressure. The issue is that olmesartan appears to be the only drug linked to sprue-like enteropathy.
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