LOUISVILLE, Ky. – Dr. Mark Heinicke, a Louisville physician, pleaded guilty to a criminal charge of treating patients with misbranded medications, announced Acting United States Attorney John E. Kuhn, Jr.
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.
The misbranded drugs were administered under Dr. Heinicke’s supervision, and he used these foreign, non-FDA approved products on Medicare recipients without informing them that they were receiving non-FDA approved products. Dr. Heinicke 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.
Dr. Heinicke pleaded guilty to a criminal information on January 27, 2015. He 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.
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).
The total restitution and fines paid by Dr. Heinicke amount to $515,408.85. Dr. Heinicke’s actions demonstrate a blatant disregard for the safety and well-being of his patients, and his punishment is a stark reminder of the consequences of such actions.
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.
The civil case was handled by Assistant United States Attorney Benjamin Schecter, with assistance from the Office of Criminal Investigations for the FDA.
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Key Facts
- State: Kentucky
- Category: Drug Trafficking|Fraud & Financial Crimes|White Collar Crime
- Source: DOJ Press Release â†â€â€
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