San Diego-based CareFusion will pay $40.1 million to settle allegations it violated the False Claims Act by paying kickbacks and promoting its products for uses not approved by the U.S. Food and Drug Administration, according to a news release from the U.S. Department of Justice.
The settlement settles a whistleblower suite alleging that, beginning in 2008, CareFusion paid $11.6 million in kickbacks to Charles Denham, MD, who was serving as co-chair of the Safe Practices Committee at the National Quality Forum. The government contends that the purpose of those payments was to induce Dr. Denham to recommend, promote and arrange for the purchase of ChloraPrep, a product used to treat patients' skin before surgery or an injection, by healthcare providers.
ChloraPrep has been approved by the FDA for such purposes, but CareFusion allegedly promoted the product for other uses not approved by the FDA, according to the DOJ. Specifically, the government alleged between September 2009 and August 2011, CareFusion knowingly promoted the sale of ChloraPrep for uses that were not approved by the FDA. Carefusion's $40.1 million payment also settles these allegations.
Cynthia Kirk, MD, former vice president of regulatory affairs for the infection prevention business unit of CareFusion, filed the qui tam suit in 2011 in the U.S. District Court for the District of Kansas.
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