The Department of Justice announced that it settled part and continues to intervene in the Carefusion Qui Tam whistleblower lawsuit. CareFusion, a California-based medical technology company, develops, manufactures and sells pharmaceutical products, including products sold under the trade name ChloraPrep.
ChloraPrep has been approved by the Food and Drug Administration for the preparation of a patient’s skin prior to surgery or injection.
The CareFusion Corp. has agreed to pay the government $40.1 million to settle allegations that it violated the False Claims Act by paying kickbacks and promoting its products for uses that were not approved by the Food and Drug Administration.
The settlement resolves allegations that, under agreements entered into in 2008 by CareFusion’s predecessor,
- CareFusion paid $11.6 million in kickbacks to a doctor that served as the co-chair of the Safe Practices Committee at the National Quality Forum, a non-profit organization that reviews, endorses and recommends standardized health care performance measures and practices.
- The allegations were that the purpose of those payments was to induce the doctor to recommend, promote and arrange for the purchase of ChloraPrep by health care providers.
- This settlement also resolves allegations that CareFusion knowingly promoted the sale of ChloraPrep for uses that were not approved by the Food and Drug Administration
- some of which were not medically accepted indications
- made unsubstantiated representations about the appropriate uses of ChloraPrep.
- The settlement resolves a lawsuit filed by former vice president of regulatory affairs for the Infection Prevention Business Unit of CareFusion (the whistleblower)
- The whistleblower’s, or relator’s, share in this case is $3.26 million.
The Carefusion qui tam whistleblower lawsuit was filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private parties to sue on behalf of the government when they believe that defendants submitted false claims for government funds and to receive a share of any recovery. The False Claims Act also permits the government to intervene in such lawsuits, as it has done in this case.
For more information on Qui Tam Whistleblower lawsuits, click here.
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