Outbreak was the largest public health crisis ever caused by a contaminated pharmaceutical drug
BOSTON – The former owner of the now-defunct New England Compounding Center (NECC) was resentenced today in federal court in Boston in connection with the 2012 nationwide fungal meningitis outbreak. The defendant was resentenced after the First Circuit Court of Appeals affirmed his criminal convictions but vacated his sentence and forfeiture order.
Barry Cadden, 54, previously of Wrentham, was sentenced by U.S. District Court Judge Richard G. Stearns to 174 months in prison. Cadden was also ordered to pay forfeiture of $1.4 million and restitution of $82 million.
Cadden was originally sentenced in June 2017 by Judge Stearns to nine years in prison, three years of supervised release and forfeiture in the amount of $7.5 million after being convicted by a federal jury in March 2017 of racketeering, racketeering conspiracy, mail fraud and introduction of misbranded drugs into interstate commerce with the intent to defraud and mislead.
Co-defendant Glenn Chin, NECC’s former supervisory pharmacist, is scheduled to be resentenced tomorrow by Judge Stearns. Chin was sentenced in January 2018 to eight years in prison, two years of supervised release and ordered to pay forfeiture of $175,000 and restitution in an amount to be determined. In October 2017, Chin was convicted by a federal jury of all 77 counts, including racketeering, racketeering conspiracy, mail fraud and introduction of misbranded drugs into interstate commerce with the intent to defraud and mislead.
In 2017, the government appealed the defendants’ sentences. In July 2020, the First Circuit Court of Appeals vacated the defendants’ sentences, finding that the Court failed to impose applicable sentencing enhancements and erred in its forfeiture rulings. Significantly, the First Circuit held that the patients who were injected with NECC’s contaminated preservative-free methylprednisolone acetate (MPA) may be considered victims of the fraud. According to court documents, more than 100 patients died and approximately 800 patients were sickened as a result of contaminated MPA injections. As a result of the First Circuit’s decision, the defendants’ convictions were affirmed, and their sentences and forfeiture orders were vacated and remanded to the District Court for resentencing.
In 2012, 753 patients in 20 states were diagnosed with a fungal infection after receiving injections of MPA manufactured by NECC, and more than 100 patients died as a result. The outbreak was the largest public health crisis ever caused by a contaminated pharmaceutical drug.
Cadden was responsible for directing and authorizing shipments of contaminated MPA to NECC customers nationwide. In addition, he authorized the shipping of drugs before test results confirming their sterility were returned, never notified customers of nonsterile results and compounded drugs with expired ingredients. Furthermore, certain batches of drugs were manufactured, in part, by an unlicensed pharmacy technician at NECC. Cadden also repeatedly took steps to shield NECC’s operations from regulatory oversight by the FDA by claiming to be a pharmacy dispensing drugs pursuant to valid, patient-specific prescriptions. In fact, NECC routinely dispensed drugs in bulk without valid prescriptions. NECC even used fictional and celebrity names on fake prescriptions to dispense drugs, such as “Michael Jackson,” “Freddie Mae” and “Diana Ross.”
Acting United States Attorney Nathaniel R. Mendell; Acting FDA Commissioner Janet Woodcock, M.D.; Joseph R. Bonavolonta, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division; Patrick Hegarty, Special Agent in Charge of the Defense Criminal Investigative Service, Northeast Field Office; Christopher Algieri, Special Agent in Charge of the Department of Veterans Affairs, Office of Inspector General, Northeast Field Office; and Joshua McCallister, Acting Inspector in Charge of the U.S. Postal Inspection Service’s Boston Division, made the announcement today. Assistant U.S. Attorneys Amanda P.M. Strachan, Chief of Mendell’s Health Care Fraud Unit, Christopher R. Looney, David G. Lazarus, Chief of Mendell’s Asset Recovery Unit, and Alexandra W. Amrhein prosecuted the case.