Companies plead guilty to illegally sourcing, distributing pharmaceuticals in US
The companies received more than $33 million in proceeds from the illegal smuggling and sale of misbranded prescription pharmaceuticals, which included those sourced from foreign countries, including: India, Turkey, France, Italy, and included Lucentis, Mabthera, Botox, Dysport, Euflexxa, Remicade, Restylane, Synvisc, Prolia, Orencia, Orthovisc and other products.
The investigation by the US FDA’s Office of Criminal Investigations, US Immigration and Customs Enforcement’s Homeland Security Investigations and the US Postal Inspection Service found that employees working for the companies used false names to sell the products to doctors and clinics in the US.
Large shipments were broken down into multiple small shipments to get across the border, and then these shipments were sent to addresses in Maryland, New Jersey, Florida and other locations under different false names over several days.
Customs forms also falsely stated the contents and value of the shipments while “drop shippers” in the US, including Stein, received the packages, removed indications that they were from abroad, and reshipped them to doctors and clinics in the US so the packages would have a US-based return address.
According to the statements of facts and plea agreements filed with the court, SB Medical said it smuggled orthopedic injections, rheumatology infusions, cosmetic devices, ophthalmology products, and oncology drugs into the US from at least 2011 through 2014.
“The smuggling and distribution of misbranded drugs and medical devices of uncertain foreign origin has the potential for serious harm to patients,” said Dana Boente, US attorney for the Eastern District of Virginia. “They could be improperly stored and transported, ineffective, adulterated, or unsafe. With our law enforcement partners, we will aggressively investigate and prosecute those who illegally distribute such products.”
Many of the cold-chain products were stored in unregistered commercial mailboxes, residential backyards and porches, basement rooms, garages, kitchen fridges and freezers, which did not have adequate lighting, ventilation, temperature, humidity and security.