Canadian Companies Fined $45 Million and Ordered to Forfeit an Additional $30 Million for Smuggling Misbranded Pharmaceuticals into the United States

ALEXANDRIA, Va. – SB Medical Inc., and TC Medical Group, companies based in Toronto, Canada, and St. Michael, Barbados, were fined $45 million and required to forfeit another $30 million for orchestrating a multi-year conspiracy to smuggle misbranded prescription pharmaceuticals into the United States. During the conspiracy, SB Medical Inc. and TC Medical Group received over $33 million in proceeds from selling misbranded prescription pharmaceuticals to U.S. doctors and clinics.

SB Medical, Inc. and TC Medical Group pleaded guilty on May 7, 2015. According to court documents, from at least 2011 through 2014, the companies smuggled orthopedic injections, rheumatology infusions, cosmetic devices, optomology products, and oncology drugs into the United States. The non-FDA approved prescription pharmaceuticals were sourced from other foreign countries, including India, Turkey, France, Italy, and other countries. The pharmaceuticals included Lucentis, Mabthera, Botox, Dysport, Euflexxa, Remicade, Restylane, Synvisc, Prolia, Orencia, Orthovisc, and other products.

Members of the conspiracy working for SB Medical Inc. and TC Medical Group used false names to sell the pharmaceutical products throughout the United States. To smuggle pharmaceuticals across the U.S. border, large shipments were broken down into multiple small shipments. Those shipments were sent to addresses in Maryland, New Jersey, Florida, and other locations under different false names over several days. Customs forms falsely stated the contents and value of the shipments. Drop shippers in the United States received these packages, removed indicia that they were from abroad, and re-shipped them to doctors and clinics in the United States so that packages would have a United States-based return address. These drop shippers stored the drugs and medical devices in the basements of their private residences, often in violation of safety regulations requiring the pharmaceuticals to be stored at cool temperatures.

Dana J. Boente, U.S. Attorney for the Eastern District of Virginia; George M. Karavetsos, Director, FDA Office of Criminal Investigations; Clark E. Settles, Special Agent in Charge of U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) Washington; and David G. Bowers, Inspector in Charge of the Washington Division of the U.S. Postal Inspection Service, made the announcement after the sentence was imposed by U.S. District Judge Anthony J. Trenga.

This case was investigated by the FDA’s Office of Criminal Investigations, ICE-HSI, and the U.S. Postal Inspection Service. Assistant U.S. Attorneys Kellen S. Dwyer and Jay V. Prabhu are prosecuting the case.

A copy of this press release may be found on the website of the U.S. Attorney’s Office for the Eastern District of Virginia. Related court documents and information may be found on the website of the District Court for the Eastern District of Virginia or on PACER by searching for Case No. 1:14-cr-397.