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Medical Devices / Commercial Operations

CareFusion Pays Out $41 Million in ChloraPrep Settlement

Jan. 15, 2014

CareFusion has paid the U.S. government and the states involved in the lawsuit approximately $41 million to settle charges of illegal sales and marketing practices related to its ChloraPrep topical skin antiseptic wipes, according to a Jan. 9 SEC filing.

The settlement resolves allegations stemming from a qui tam lawsuit filed in the U.S. District Court in Kansas, which claimed that CareFusion promoted ChloraPrep for off-label intravenous preparation and suture care between Sept. 1, 2009 and Aug. 31, 2011. The whistleblower also alleged that CareFusion’s predecessor corporation, Cardinal Health, paid kickbacks to a business called Health Care Concepts to promote off-label uses.

“We are pleased to resolve this matter and are confident we have strong practices, processes and controls in place, CareFusion Chairman and CEO Kieran Gallahue said Jan. 9. “We have made significant investments during the past several years to improve our quality and compliance systems, including our sales and marketing practices, and will continue to do so as part of our commitment to adhering to the highest standards and aligning with best global practices.”

ChloraPrep is a chlorhexidine-based solution. The FDA has cleared it only for preparing skin for surgery or injection.—Lena Freund

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