Benicar (olmesartan) is a popular and highly effective drug for the treatment of high blood pressure (hypertension), a condition that affects a large cross section of the US population. Benicar side effects include sprue-like enteropathy, a debilitating condition characterized by weight loss, chronic diarrhea and gastro-abdominal pain that has landed many plaintiffs in hospital.
Sprue-like enteropathy can take years to develop, and can appear without warning. There are currently some 1900 cases currently centralized in New Jersey (In Re: Benicar (Olmesartan) Products Liability Litigation, Case No. 1:15-md-02606).
Plaintiff Alan Williamson filed his Benicar defective products lawsuit in July, as essentially a medical malpractice action. The original defendant, Benicar manufacturer Daiichi Sankyo, was joined following the initial filing by Dr. Srinivasa Kothapalli, with the plaintiff claiming he had received treatment from Dr. Kothapalli.
However, Judge Kugler refused to remand the Benicar illness and weight loss lawsuit back to state court in Texas based, in part on his observation that Kothapalli had treated the plaintiff only once, in 2011, administering a stress test to Williamson. The judge also found that Kothapalli had never prescribed a drug of any kind to the plaintiff, let alone Benicar.
“Consequently, plaintiffs’ claim in the state action of medical liability against Dr. Kothapalli for prescribing Benicar is wholly insubstantial and completely lacking in colorable basis,” the judge said in his decision. The medical malpractice claim against Dr. Kothapalli also failed on an expired window of opportunity according to the Texas Medical Liability Act, which observes a statute of limitation of two years.
The plaintiff, Judge Kugler found, did not file his action until three years following the expiry of that statute.
There were more problems with the Benicar lawsuit. In reviewing the testimony and documents provided by defendant Daiichi Sankyo, Judge Kugler noted that materials failed to clearly show whether, or not olmesartan (Benicar) caused the injuries alleged to have been suffered by the plaintiff.
It is not known if the plaintiff will appeal.
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The Benicar defective products complaint noted that some 1.9 million patients received a prescription for Benicar, or a similar drug for the treatment of hypertension in 2012 alone. Of those, however, olmesartan appears to be the only blood pressure medication to trigger sprue-like enteropathy.
For its part the US Food and Drug Administration (FDA) mandated a label change for Benicar and olmesartan in 2013 following the identification of 23 serious cases of late-onset diarrhea reported to the FDA. The FDA remained unequivocal in its position, noting at the time “clear evidence” of an association to sprue-like enteropathy. Prior to 2013, plaintiffs assert there was little, to no mention of the potential for sprue-like enteropathy on the product labels.