Daiichi Sankyo fined $39M for Kickbacks to Physicians

The Department of Justice and the Japanese-based drug company Daiichi Sankyo, Inc. have reached an agreement that the U.S. subsidiary of the company will pay $39 million to settle claims concerning kickbacks paid to physicians in order to illegally promote their products, including the drugs Azor, Benicar, Tribenzor, and Welchol. The lawsuit filed against the pharmaceutical company claims that it paid the doctors speaking fees, including for lavish dinners in which they spoke only to their staff, in exchange for prescribing the drugs.

The U.S. headquarters of the firm, based in New Jersey, has also pledged to implement internal reforms. The settlement was arrived at while the firm is also in the midst of legal struggles involving the high blood pressure medication Benicar. A Benicar settlement of this kind adds to the company’s legal woes at a sensitive time.

The lawsuit contended that several physicians were illegally provided with kickbacks between January 1, 2005 and March 31, 2011 through the Physician Opinion & Discussion programs (PODs) sponsored by the company.   Joyce R. Branda, Acting Assistant Attorney General Joyce R. Branda for the DOJ’s Civil Division, notes that “The Anti-Kickback Statute prohibits payments intended to influence a physician’s ordering or prescribing decisions” and that the speaking fees were clearly in violation of this statute.

Benicar settlement adds to Daiichi Sankyo’s legal entanglements

The settlement reached by Daiichi Sankyo over kickbacks to physicians adds to claims regarding the companies illegal or ethical activities where the drug Benicar in particular is concerned. A small but growing number of lawsuits has been filed regarding the drug (also known by the name Olmesartan) which entered the market in two different forms in 2002 and 2003 respectively.

Plaintiffs who have filed such lawsuits contend that the makers of the drug knew (or should have known) about the severe intestinal troubles that Benicar allegedly causes, that they provided insufficient testing to determine the safety of the drug, that they make aggressive, unsubstantiated claims about the drugs effectiveness in their marketing campaigns, and that they downplayed risks associated with the drugs in these campaigns.

Several cases have been filed in New Jersey, with some removed to the U.S. District Court in the state. In a large number of similar cases are filed, it is likely that a multidistrict litigation (MDL) will be filed there to consolidate and efficiently process the cases and to encourage a large-scale Benicar settlement for patients who have suffered the side effects of the drug.

Benicar side effects include serious intestinal problems

Plaintiffs who have filed lawsuits over Benicar content that the drug causes sprue-like enteropathy, a condition involving nausea, vomiting, chronic diarrhea, abdominal pain, weight loss and malnutrition. Many endured numerous hospital stays and sustained damage to the lining of their small intestines. For many patients, the condition was difficult to diagnose and they suffered long-term damage.

However, the Mayo Clinic and FDA have published studies that isolate the condition as a result of Benicar-use and physicians have slowly become aware of the link as well. As this link becomes better known, more plaintiffs may file Benicar lawsuits against Daiichi Sankyo.

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