Merit Medical Settles False Claims Act Violations for $18M
In mid-October 2020, Merit Medical Systems, Inc. (MMSI) agreed to pay $18 million to resolve allegations that the company violated the False Claims Act and Anti-Kickback Statute by paying kickbacks to physicians and hospitals to induce the use of MMSI products.
As we covered in our September 2020 issue of our sister publication, Policy & Medicine Compliance Update, this case is somewhat unique because the qui tam suit was brought by the company’s former compliance officer.
Background
Charles Wolf, MD was the Chief Compliance Officer for MMSI until October 2015. Six months after he left his role as Chief Compliance Officer, in April 2016, he filed a qui tam complaint against the company, alleging that MMSI: caused the submission of false claims for services; made misrepresentations to the Food and Drug Administration (FDA) and others; engaged in false and misleading off-label marketing of its QuadraSphere Microsphere, Embosphere, and Endotek devices, as well as its CO2 kits; and systematically violated the Federal Anti-Kickback Statute.
