Under the terms of the civil settlement, CareFusion will pay $40.1 million to the states and the federal government. Georgia’s portion of the settlement is approximately $124,000. The settlement resolves a whistleblower lawsuit under the provisions of the federal False Claims Act and analogous state False Claims statutes.
CareFusion, a corporation spun off from Cardinal Health in 2009, allegedly promoted and marketed Chloraprep for uses that were not approved by the Food and Drug Administration, some of which were not medically accepted indications. Once the FDA approves a surgical solution such as Chloraprep as safe and effective, its manufacturer cannot market or promote it for an “off-label” use, i.e., any use not specified in the FDA-approved product label. Chloraprep was approved by the FDA for specific inpatient hospital procedures, including the preparation of a patient’s skin prior to surgery or injection, but the FDA explicitly rejected its use for intravenous preparation and suture care. The lawsuit alleges that between Sept. 1, 2009, and Aug. 31, 2011, CareFusion promoted Chloraprep for use with intravenous preparation and suture care, which went beyond the FDA-approved uses for the drug. CareFusion also allegedly made and disseminated unsubstantiated representations about the use of Chloraprep solutions.
The payments were allegedly made in order to conceal kickbacks to the physician-owner of HCC, for the purpose of promoting and inducing providers to use Chloraprep in violation of various federal and state anti-kickback statutes.