Outbreak was the largest public health crisis ever caused by a contaminated pharmaceutical drug
BOSTON – The former supervisory pharmacist 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.
Glenn Chin, 53, previously of Canton, was sentenced by U.S. District Court Judge Richard G. Stearns to 126 months in prison and three years of supervised release. Chin was also ordered to pay forfeiture of approximately $473,584 and restitution of $82 million.
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.
On July 7, 2021, co-defendant Barry Cadden, a former owner of NECC, was resentenced by Judge Stearns to 174 months in prison and ordered to pay forfeiture of $1.4 million and restitution of $82 million. Cadden was previously sentenced in June 2017 by Judge Stearns to nine years in prison and three years of supervised release 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.
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 re-sentencing.
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.
Chin manufactured and oversaw the manufacturing of contaminated MPA. In doing so, Chin ignored pharmacy regulations and NECC’s own drug formulation worksheets and standard operating procedures. Specifically, he improperly sterilized the MPA, failed to verify the sterilization process and improperly tested it to ensure sterility. Despite knowing these deficiencies, Chin directed the MPA to be filled into tens of thousands of vials and shipped to NECC customers nationwide. During the fungal meningitis outbreak, the U.S. Centers for Disease Control identified 18 different types of fungi from MPA vials and patient samples.
Chin directed the shipping of drugs prior to receiving test results confirming their sterility, and he directed NECC staff to mislabel drugs to conceal this practice. He also directed the compounding of drugs with expired ingredients, including chemotherapy drugs that had expired several years prior. Chin prioritized drug production over cleaning, directed the forging of cleaning logs and routinely ignored mold and bacteria found inside the clean rooms.
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.
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