According to court documents, as of November 15, 2015 there were 1,079 federal lawsuits consolidated before US District Judge Robert B. Kugler in MDL 2606. The lawsuits allege patients who used Benicar (known generically as olmesartan medoxomil) developed sprue-like enteropathy, a serious gastrointestinal condition. Sprue-like enteropathy is marked by severe diarrhea and weight loss. Plaintiffs allege Daiichi Sankyo failed to adequately warn patients about the risks associated with Benicar. In addition to the federal lawsuits, Daiichi Sankyo also faces lawsuits filed in state court.
In 2013, the US Food and Drug Administration (FDA) issued a warning that there was a “clear link” between Benicar and sprue-like enteropthy. The agency made its announcement after receiving 23 reports of the condition in patients who took the medication.
Benicar is an angiotensin II receptor blocker, used to treat high blood pressure. Sprue-like enteropathy can reportedly develop anytime from a few months to years after the start of Benicar therapy.
Earlier in 2015, Daiichi Sankyo agreed to pay $39 million to settle allegations from the US Department of Justice that the company violated the False Claims Act. The Department of Justice alleged Daiichi Sankyo paid kickbacks to physicians to encourage them to prescribe medications, including Azor and Benicar. Specifically, Daiichi Sankyo allegedly paid physicians speaker fees for the company’s Physician Organization and Discussion programs (PODs) from January 1, 2005 through March 31, 2011.
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Having settled the allegations against it concerning the False Claims Act and now facing federal and state lawsuits alleging failure to warn about the risks of Benicar, Daiichi Sankyo might be looking forward to saying good-bye to 2015.
The Department of Justice’s lawsuit was U.S. ex rel. Fragoules v. Daiichi Sankyo, Inc., Civil Action No. 10-10420.