Criminal Prosecution of Sandoz, Inc.
In February 2010, Eon Labs, Inc., a subsidiary of Sandoz, Inc., paid $3.5 million to resolve FCA allegations relating to the company's drug Nitroglycerin Sustained Release (SR) capsules. In April 1999, the FDA determined that Nitroglycerin SR lacked substantial evidence of effectiveness and published a notice proposing to withdraw approval of the product. The government contended that, after the FDA notice, Nitroglycerin SR no longer was legally eligible for reimbursement by government health care programs such as Medicaid. The government further alleged that from April 1999, and continuing through September 2008, Eon submitted false quarterly reports to the government that misrepresented Nitroglycerin SR's regulatory status and failed to advise that Nitroglycerin SR no longer qualified for Medicaid coverage. As a result, the government contends, Eon knowingly caused false Medicaid claims to be submitted for Nitroglycerin SR.
Source: HHS Health Care Fraud and Abuse Control Program, Annual Report for FY 2010
This article was posted on July 15, 2012.