Two Former New England Compounding Center Pharmacists Sentenced
BOSTON – Two former clean room pharmacists at New England Compounding Center (NECC) were sentenced this week in federal court in Boston in connection with the 2012 nationwide fungal meningitis outbreak.
Gene Svirskiy, 38, of Ashland, Mass., was sentenced yesterday by U.S. District Court Judge Richard G. Stearns to 30 months in prison and one year of supervised release. Christopher Leary, 34, of Shrewsbury, Mass., was sentenced today by Judge Stearns to two years of probation, of which the first eight months will be in home confinement with electronic monitoring, and 100 hours of community service.
In December 2018, Svirskiy and Leary were convicted with three other NECC co-defendants following an 8-week trial. Svirskiy, a supervising pharmacist at NECC, was convicted of racketeering, racketeering conspiracy, 10 counts of mail fraud, and two counts of introduction of adulterated drugs into interstate commerce with intent to defraud or mislead. Leary was convicted of three counts of mail fraud, one count of introduction of adulterated drugs into interstate commerce with intent to defraud or mislead, and two counts of introduction of misbranded drugs into interstate commerce.
In the fall of 2012, more than 793 patients in 20 states were diagnosed with fungal infections after receiving injections of preservative-free methylprednisolone acetate (MPA) manufactured by NECC. Of those 793 patients, more than 100 patients have now died. The fungal meningitis outbreak was the largest public health crisis ever caused by a pharmaceutical drug.
The criminal investigation revealed that in addition to the contaminated MPA, NECC’s clean room pharmacists, including Svirskiy and Leary, knowingly manufactured and sold hundreds of other substandard drugs that were made in an unsafe manner and in insanitary conditions. The evidence presented at trial demonstrated that NECC’s pharmacists, including Svirskiy and Leary, failed to properly sterilize and test NECC’s drugs and failed to wait for test results before sending the drugs to customers. Svirskiy and Leary approved the use of expired drug ingredients, and the mislabeling of drugs in order to deceive customers. Svirskiy also supervised a pharmacy technician whose license had been revoked. To conceal the technician’s presence inside the clean room, Svirskiy directed the technician to fraudulently complete paperwork without his name appearing and to physically leave the clean room and hide in the warehouse when regulators would inspect the facility.
The insanitary conditions at NECC included, among other things, a lack of proper cleaning, fraudulently completed cleaning logs, and positive environmental monitoring hits for mold and bacteria inside NECC’s cleanrooms throughout 2012. Specifically, NECC recorded alert or action-level environmental monitoring hits for mold and bacteria during thirty-seven out of thirty-eight weeks prior to the shutdown in 2012. Despite these repeated action-level environmental monitoring hits and the presence of fungal blooms inside the clean room, neither Svirskiy, nor Leary, nor anyone else at NECC took any remedial action to eliminate the mold and bacterial contamination, or stop the drug production.
In June 2017, Barry Cadden, the former owner and head pharmacist for NECC, was sentenced to nine years in prison and three years of supervised release after being convicted of 57 counts. In January 2018, Glenn Chin, NECC’s former supervisory pharmacist, was sentenced to eight years in prison and two years of supervised release after being convicted of 77 counts. In total, 13 NECC defendants have been convicted of 178 charges.
United States Attorney Andrew E. Lelling; FDA Acting Commissioner Norman E. Sharpless, M.D.; Joseph R. Bonavolonta, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division; Leigh-Alistair Barzey, Special Agent in Charge, Defense Criminal Investigative Service, Northeast Field Office; Sean Smith, Special Agent in Charge of the Department of Veterans Affairs Office of Inspector General, Criminal Investigations Division; and Joseph W. Cronin, Inspector in Charge of the U.S. Postal Inspection Service, Boston Division made the announcement today. Chief Amanda P.M. Strachan of Lelling’s Health Care Fraud Unit and Assistant U.S. Attorney George P. Varghese prosecuted the case.