Update: On December 13, 2017, the U.S. Court of Appeals for the Second Circuit vacated William Scully's conviction because a lower court "declined to allow Scully to introduce evidence at his 2015 trial showing he sought legal advice about importing drugs with foreign labels from one of his lawyers." Ultimately Scully pleaded guilty to one charge of introducing misbranded drugs into interstate commerce, and received a sentence of 32 months. An August 17, 2016 forfeiture order of $889,875 remained the same.
Between 2009 and 2013, two New York-based entrepreneurs worked to make money by importing medications sold at cheaper prices from “safe” foreign countries to American doctors and medical clinics and make money on the difference. They bought cancer medication, birth control devices (“IUDs”), and other medications from Finland, the UK, and other countries often cited as having similar safety standards to the United States.
Sadly, this scheme ran into the same problems that happen whenever anyone breaks the secure pharmaceutical supply chain, which regulates the secure chain of custody from manufacturer to consumer.
The owners of Medical Device King purchased one of many shipments of cancer treatment medication and sold it to an oncology practice in Iowa. The medication was from a supposedly “safe” country (the UK) but turned out to have been trans-shipped through the UK from a different third-party country. That medication was tested and turned out to have no active ingredient. If FDA agents hadn’t caught that medication, the patients who received it might have succumbed to their cancer and died, taking the evidence of their cause of death with them.
An investigation by the Justice Department revealed that Medical Device King's overseas suppliers included Ozay Pharmaceuticals, a Turkish company that sold counterfeit Altuzan made of mold and water. At least one American patient experienced an extreme reaction to Ozay's fake medicine. She–anyone else who received an infusion of that lot of Altuzan–was denied life-saving treatment.
Authorities do not know how much of the other $17 million dollars worth of unapproved cancer drugs, birth control devices, and medications might have been counterfeit. Medical Device King owners William Scully and Shahrad Rodi Lameh were recently convicted on 66 charges and ordered to pay $17 million dollars in restitution and $250,000 in fines.
In response to recent importation proposals at the federal level, Partnership for Safe Medicines wrote: Letter to the US Congress Regarding Drug “Importation” Proposals
- United States District Court Eastern District of New York, “United States of America against plaintiff William Scully, Verdict Sheet (pdf)”November 12, 2015
- Robert E. Kessler, “Federal jury convicts Commack man of distributing unapproved drugs, officials say” Newsday, November 17, 2015, http://www.newsday.com/long-island/suffolk/william-scully-of-commack-convicted-of-distributing-unapproved-drugs-officials-say-1.11135936?qr=1
- United States Food and Drug Administration, “Doctors warned about Medical Device King (pdf)", June 27, 2013, http://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/UCM358844.pdf
- United States Food and Drug Administration, “Letters to Doctors about Suspect Prescription Drugs Distributed by Medical Device King”, June 27, 2013.
- United States District Court Eastern District of New York, “United States of America against plaintiff William Scully, Superseding Indictment (pdf)”, July 22, 2015, http://www.safemedicines.org/wp-content/uploads/2015/12/Medical_Device_King_Superceding_Indictment_7-15.pdf
- Department of Justice, U.S. Attorney’s Office, Eastern District of Missouri, “Two Turkish Nationals Indicted For Smuggling Counterfeit Cancer Drug,” January 16, 2014, http://www.justice.gov/usao-edmo/pr/two-turkish-nationals-indicted-smuggling-counterfeit-cancer-drug
- Department of Justice, U.S. Attorney’s Office, Eastern District of Missouri, “Turkish Man Pleads Guilty To Smuggling Counterfeit Cancer Drugs,” July 22, 2014, http://www.justice.gov/usao-edmo/pr/turkish-man-pleads-guilty-smuggling-counterfeit-cancer-drugs
- Department of Justice, U.S. Attorney’s Office, Eastern District of Missouri, “Turkish Man Pleads Guilty To Smuggling Adulterated Cancer Drugs,” August 12, 2014, http://www.justice.gov/usao-edmo/pr/turkish-man-pleads-guilty-smuggling-adulterated-cancer-drugs
- Department of Justice, U.S. Attorney’s Office, Eastern District of Missouri, “Turkish Man Sentenced For Smuggling Counterfeit Cancer Drugs,” October 28, 2014, http://www.justice.gov/usao-edmo/pr/turkish-man-sentenced-smuggling-counterfeit-cancer-drugs
- Department of Justice, U.S. Attorney’s Office, Eastern District of New York, “Two Officers Of Long Island Based Company Indicted For Sale Of $17 Million Worth Of Misbranded Prescription Drugs Including Counterfeit Cancer Drugs,” April 30, 2014, http://www.justice.gov/usao-edny/pr/two-officers-long-island-based-company-indicted-sale-17-million-worth-misbranded