Over Four Years After Being Indicted, CEO of Unlicensed Canadian Wholesaler Sentenced

According to the U.S. Food and Drug Administration’s Office of Criminal Investigations (FDA-OCI), a Canadian citizen, a principal at both TC Medical Group and SB Medical (TC Medical), received a 26-month sentence after following his admission of guilt in October 2018. Tzvi Lexier of Toronto, Ontario, pleaded guilty to conspiracy and unlicensed wholesale of prescription drugs for his role in a scheme that saw over $18 million in illegally imported misbranded drugs and devices shipped to doctors’ offices and patients throughout the United States. TC Medical did not have a wholesaler license to distribute prescription drugs in the country.

According to court documents, Lexier admitted to instructing employees to smuggle the misbranded prescription drugs and devices into the U.S. The types of medications that TC Medical sold included oncology drugs, orthopedic injections, and cosmetic injections, but FDA had not approved any of these drugs, and they lacked required labels, warnings, and instructions. To get these misbranded drugs into the country, members of the conspiracy falsified customs forms and broke large shipments down into multiple smaller packages to avoid detection by U.S. Customs and Border Protection inspectors.

Members of the conspiracy received and stored the products at their private residences, often disregarding safety regulations put in place to maintain the safety and efficacy of cold-chain drugs. Shipments were then repackaged and mailed to customers across the U.S. If TC Medical received a complaint about cold-chain drugs arriving warm, they sent a new package of drugs to the initial buyer and sent the rejected drugs onto another doctor. More details about the activities and callous attitude of members of this conspiracy can be read in PSM’s A Conspiracy of Warm Boxes.  The FDA warned in a letter that “counterfeit Botox distributed by TC Medical, was found in the United States and may have been sold to doctors’ offices and medical clinics nationwide.”

Lexier fought extradition to the U.S. in the Canadian court system but ultimately lost. Assistant U.S. Attorneys Jay V. Prabhu, Kellen S. Dwyer, and Nathaniel Smith III all prosecuted this case for the U.S. Department of Justice.