WORCESTER – A former clean room pharmacist at New England Compounding Center [NECC] was sentenced on Thursday in federal court in Boston in connection with the 2012 nationwide fungal meningitis outbreak — the largest public health crisis ever caused by a pharmaceutical drug.
Christopher Leary, 34, of Shrewsbury, Mass., was sentenced 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 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.
In December 2018, Leary and four other NECC co-defendants were convicted following an eight-week trial.
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.
According to the Dept. of Justice, the criminal investigation revealed that in addition to the contaminated MPA, NECC’s clean room pharmacists, including 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 failed to properly sterilize and test NECC’s drugs and failed to wait for test results before sending the drugs to customers. Leary approved the use of expired drug ingredients, and the mislabeling of drugs in order to deceive customers.
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, no one 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.
