(WPRI) — Former employees as well as an owner of New England Compounding Center (NECC) faced a judge Thursday, for their roles at NECC.
Eleven former owners, executives, and employees of NECC have been convicted of federal criminal charges after the company caused the nationwide fungal meningitis outbreak back in 2012.
“A key aspect of the FDA’s mission is to ensure that drugs are made under high-quality conditions to prevent patient harm due to poorly compounded products,” said FDA Commissioner Scott Gottlieb, M.D.
“This episode was a tragic reminder of why compounding and compounded drugs can present serious risks to patients. We’ve taken significant new steps to ensure the quality of compounded drugs and improve patient safety, in order to prevent another calamity like the episode involving NECC,” Gottlieb says.
The Department of Justice reports the following defendants were found guilty by a federal jury:
Gene Svirskiy, 37, of Ashland, Mass., a former NECC clean room pharmacist, who supervised NECC’s production of high-risk heart medications, 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.
Judge Richard G. Stearns scheduled Svirskiy’s sentencing for March 11, 2018. Svirskiy faces a sentence of no greater than 20 years in prison.
Christopher Leary, 34, of Shrewsbury, Mass., an NECC clean room pharmacist, 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.
Leary’s sentencing is scheduled for March 14, 2018. Leary faces a sentence of no greater than 20 years in prison.
Sharon Carter, 54, of Hopkinton, Mass., NECC’s former director of operations, was convicted of conspiracy to defraud the United States. Carter’s sentencing is scheduled for March 21, 2018. She faces a sentence of no greater than five years in prison.
Alla Stepanets, 38, of Framingham, Mass., one of NECC’s verification pharmacists, was convicted of six counts of introduction of misbranded drugs into interstate commerce. Sentencing is scheduled for March 26, 2018. She faces a sentence of no greater than one year in prison.
Greg Conigliaro, 53, of Southborough, Mass., a former owner of NECC, was convicted of conspiracy to defraud the United States. Judge Stearns scheduled Conigliaro’s sentencing for March 28, 2018. He faces a sentence of no greater than five years in prison.
Joseph Evanosky, 46, of Westford, Mass., a former clean room pharmacist, was acquitted.
753 patients in 20 states were diagnosed with a fungal infection after receiving preservative-free methylprednisolone acetate (MPA) injections from the NECC in 2012. Of those patients, more than 64 died in nine states.
The government has since identified 793 patients throughout the country have been affected by the NECC’s contaminated MPA.
“It is appalling that NECC staff engaged in this blatant fraudulent activity with such reckless disregard for patient safety,” said Sean Smith, Special Agent in Charge of the Department of Veterans Affairs Office of Inspector General, Criminal Investigations Division.
“This verdict should send a clear message to individuals and businesses that VA OIG and its law enforcement partners will vigorously investigate healthcare fraud that puts the public and veterans at risk,” Smith says.
The Department of Justice says two remaining defendants, Kathy Chin, and Michelle Thomas, of Cumberland, R.I., both of whom were former verification pharmacists, are scheduled to stand trial on March 25, 2019.