In one of the largest prosecutions of its kind, illicit Canadian pharmaceutical wholesaler SB Medical Inc./TC Medical Group were fined $45 million and forced to forfeit another $30 million in profits due to their years-long conspiracy to smuggle misbranded and counterfeit medications into the United States. From 2011-2014, TC Medical 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. They included the injectable medications Lucentis, Mabthera, Botox, Dysport, Euflexxa, Remicade, Restylane, Synvisc, Prolia, Orencia, Orthovisc, and other products.
The evidence in the case centered around dozens of emails between the conspirators that described shipments of cold-chain medications arriving at customers’ offices warm, removal of foreign language labels on medication to fool customers, and re-shipment to other customers of medication that was sent back due to damage or melted cool packs. TC Medical made $33 million in profits from sale of misbranded drugs to doctors and clinics all over the United States. In addition to the judgement against the company itself, four individuals that were part of the conspiracy have pleaded guilty to charges, and the alleged ringleader of the conspiracy is currently fighting extradition from Canada.
Who: U.S. Food and Drug Administration, Office of Criminal Investigations; US Postal Inspection Service; and Homeland Security Investigations.
When: May 7, 2015, 2011-December 2, 2014.
Where: Toronto, Canada.
How: Investigation in partnership between U.S. Postal Service, the FDA-OCI, and Homeland Security Investigations.
Additional details: In one case, a doctor who had purchased misbranded Botox from TC Medical contacted the company because 5 out of 10 of her patients who she treated with the TC Medical Botox experienced side effects, with some ending up in the emergency room due to these side effects.
“ TC Medical Indictment,” United States Court for the Eastern District of Virginia, December 3, 2014.
“ Counterfeit Version of Botox Found in the United States,” Food and Drug Administration, April 16, 2015.
“ Canadian Companies Fined $45 Million and Ordered to Forfeit an Additional $30 Million for Smuggling Misbranded Pharmaceuticals into the United States,” U.S. Department of Justice, August 21, 2015.
“ Canadian Company and Drop Shipper Plead Guilty to Conspiracy to Smuggle and Sell Misbranded Prescription Pharmaceuticals,” U.S. Department of Justice, May 7, 2015.
“ Nurse Who Operated Spa in Laguna Niguel Agrees to Plead Guilty to Illegally Dispensing Botox Not Approved for Use in United States,” U.S. Department of Justice, November 10, 2016.
“ Toronto man accused of smuggling drugs into U.S. freed on bail,” Toronto Sun, September 28, 2016.