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Daiichi Sankyo Pays $39 Million to Settle False Claims Act Lawsuit

Law 360 reports that Daiichi Sankyo Inc., a Japanese pharmaceutical giant, has agreed to pay $39 million to the Massachusetts government and state Medicaid problems in order to settle a False Claims Act (FCA) lawsuit alleging that the company paid kickbacks to physicians to encourage prescriptions of the company’s cholesterol and blood pressure medications (U.S. ex rel. Fragoules v. Daiichi Sankyo, Inc., Case No. 10-cv-10420, District Court in the District of Massachusetts).

The United States Department of Justice (DOJ) announced that the government asserted that, between 2004 and 2011, the company paid physicians for promoting Azor®, Benicar®, Benicar HCT®, Welchol® and Tribenzor® under the guise of speaker fees in violation of the FCA. In the statement released by the DOJ, U.S. Attorney Carmen Ortiz from the District of Massachusetts, said, “Drug companies are prohibited from using lavish entertainment and padded speaker program payments to induce physicians to prescribe their drugs for beneficiaries of federal health care programs.” Ortiz added, “Settlements like this one show that the government will continue to pursue health care companies that use kickbacks to promote their products.”

Daiichi Sankyo is involved in other lawsuits pending in federal court involving their blood pressure medication Benicar where plaintiffs allege that the drug causes severe intestinal damage. Benicar® was approved by the U.S. Food and Drug Administration (FDA) in April 2002 for the treatment of hypertension to lower blood pressure. The FDA reports that a total of approximately 10.6 million prescriptions were dispensed in 2012, and approximately 1.9 million patients received a dispensed prescription from retail pharmacies.

In July 2013, the FDA issued a Drug Safety Communication warning that Benicar® could cause severe intestinal damage known as sprue-like enteropathy. The agency required immediate label changes to include this concern. Prior to the FDA warning, in June 2012 researchers at the Mayo Clinic in Rochester, Minnesota published a case series in Mayo Clinic Proceedings reporting their findings in response to discontinuing Benicar® in patients with unexplained severe sprue-like enteropathy. In particular, the study included 22 hospital patients who presented to the Mayo Clinic with unexplained chronic diarrhea, weight loss and enteropathy. Doctors at the Mayo Clinic discovered that all 22 patients had something in common – they were each taking Benicar® to control their blood pressure. The doctors then asked the patients to discontinue their use of Benicar®, and after discontinuing Benicar®, the researchers discovered that the patients’ symptoms of chronic diarrhea, weight loss and vomiting improved.

 

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