Medical device company pays $40.1 Million to Uncle Sam for promoting unapproved surgical prep solution

Medical device manufacturer CareFusion will pay $40.1 million to settle a False Claims Act whistleblower case for improperly promoting and marketing its surgical preparation solution Chloraprep. It also concealed kickbacks to a doctor who promoted the drug says the DOJ.

Chloraprep was promoted for the surgical prepration for use with intravenous prepration and suture care, said the Government, even though the FDA rejected Chloraprep for such uses. CareFusion allegedly also entered into agreements to make payments to Heal Care Concepts Inc. to promote Chloraprep to other healthcare providers.

The FDA has specific regulations regarding the use of medical devices and preparations and must pre-approve a product for specific use.