U.S. Department of Justice Press Release
For Immediate Release
January 29, 2015
United States Department of Justice
Western District of Kentucky
LOUISVILLE, Ky. – A Louisville physician pleaded guilty this week in U.S. District Court to a criminal charge of treating patients with misbranded medications and was sentenced to a term of one year probation and ordered to pay restitution in the amount of $176,915.55 by U.S. Magistrate Judge Colin H. Lindsay, announced Acting United States Attorney John E. Kuhn, Jr.
Dr. Mark Heinicke pleaded guilty Tuesday, January 27, 2015, to a criminal information. Dr. Heinicke admitted to purchasing Rituxan, Actemra, Remicaid, Aclasta, Prolia, and Synvisc, among others, from foreign drug distributors based in the United Kingdom, from December 1, 2010, through April 19, 2012. The drugs originated outside the United States and were never approved by the U.S. Food and Drug Administration (FDA) for introduction into the United States. These are infusion and injectable medications used to treat cancer, rheumatoid arthritis, osteoarthritis and osteoporosis. The misbranded drugs were administered under Dr. Heinicke's supervision.
This case is being prosecuted by Assistant United States Attorney Lettricea Jefferson-Webb and was investigated by the Office of Criminal Investigation for the U.S. FDA.
Further, in a separate civil agreement, Dr. Heinicke agreed to pay $338,493.30 in addition to the court ordered restitution to settle certain claims brought against him by the United States on behalf of the Office of Inspector General of the Department of Health and Human Services (OIG-HHS).
According to the civil settlement agreement, between December 1, 2010, and April 19, 2012, Dr. Heinicke purchased foreign, non-FDA approved products (Rituxan, Actemra, Remicaid, Aclasta, Prolia, and Synvisc) at a cost significantly less than FDA-approved versions. Dr. Heinicke used these foreign, non-FDA approved products on Medicare recipients and did not inform those recipients that they were receiving non-FDA approved products. Dr. Heinicke thereafter submitted or caused to be submitted false claims to Medicare, seeking payment for the products as if they were FDA-approved versions and seeking payment for the administration of these products, in violation of the False Claims Act. Medicare made payments to Dr. Heinicke based upon these claims.
The civil case was handled by Assistant United States Attorney Benjamin Schecter, with assistance from the Office of Criminal Investigations for the FDA.
The claims settled by this civil agreement are allegations only; there has been no determination of liability.