Recently, medical device manufacturer CareFusion Corporation agreed to pay the government $40.1 million to resolve allegations involving illegal kickbacks and off-label promotions. As explained in the DOJ press release, CareFusion’s predecessor-in-interest allegedly paid $11.6 million in kickbacks to a Kansas physician to induce him to recommend and promote CareFusion’s ChloraPrep products. The DOJ said that the alleged kickbacks were paid to the physician while he was serving as the co-chair of the Safe Practices Committee at the National Quality Forum, a nonprofit organization that reviews, endorses, and recommends standardized healthcare performance measures and practices.
In addition to the kickback allegations, the government alleged that CareFusion knowingly promoted the sale of ChloraPrep for uses that were not approved by the FDA, some of which were not medically accepted indications. ChloraPrep products were only intended to prepare a surgical patient’s skin before an operation. However, according to the relator’s qui tam complaint, CareFusion promoted ChloraPrep to hospitals, surgery centers, and other health care providers for the “prevention of infection” and/or “reduction of infection,” and/or “reduction of microorganisms,” all without FDA approval.
This successful qui tam action was brought by the Vice President of Regulatory Affairs for CareFusion’s Infection Prevention Business Unit. She will receive a relator’s share of $3.26 million.
More information for whistleblowers is located at the Nolan Auerbach & White website.