December 13, 2018: Owner and Four Former Employees of New England Compounding Center Convicted Following Trial
Food and Drug Administration
U.S. Department of Justice Press Release
For Immediate Release
United States Department of Justice
District of Massachusetts
BOSTON – An owner and four former employees of New England Compounding Center (NECC) were convicted today by a federal jury for their roles at NECC, the company that caused the 2012 nationwide fungal meningitis outbreak. The outbreak was the largest public health crisis ever caused by a pharmaceutical drug. With today’s convictions, 11 former owners, executives, and employees of NECC have been convicted of federal criminal charges.
“These defendants were professionals who acted recklessly to the extreme detriment of public health,” said United States Attorney Andrew Lelling. “Over the course of years, the defendants callously disregarded patient health by cutting corners and prioritizing profits over safety. And they got away with it by defrauding federal and state regulators. The result was contaminated, deficient, deadly drugs that never should have been made or distributed. Ultimately, the jury found the defendants’ fraudulent conduct wrong and deserving of punishment. I applaud the prosecutors and the investigative team on their dogged determination to bring us another step closer to justice for the victims and their families.”
“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. However, we continue to see significant risk associated with some compounded drugs, and firms that produce and ship drugs in bulk without any regard for product quality and patient safety. We’re increasing our oversight in this space to crack down on activity that puts patients at risk. At the same time, we’re continuing to advance new policies to help responsible firms that are seeking to stay in compliance with quality standards find efficient ways to meet those requirements.”
“These defendants callously ignored their professional responsibilities to protect patient safety,” said Harold H. Shaw, Special Agent in Charge of the FBI Boston Division. “Their failure to safeguard the public played a significant role in the distribution of medicines that were harmful. The FBI will continue to work with our law enforcement partners to combat fraud and abuse in the health care system, so that we can do everything we possibly can to protect the American public from harm.”
Following an 8-week trial, 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.
Sentences are imposed by a federal district court judge based upon the U.S. Sentencing Guidelines and other statutory factors.
Joseph Evanosky, 46, of Westford, Mass., a former clean room pharmacist, was acquitted.
In 2012, 753 patients in 20 states were diagnosed with a fungal infection after receiving injections of preservative-free methylprednisolone acetate (MPA) manufactured by NECC. Of those 753 patients, the U.S. Centers for Disease Control and Prevention (CDC) reported that 64 patients in nine states died. The government has since identified a total of 793 patients throughout the country harmed by NECC’s contaminated MPA. More than 100 patients have now died.
The criminal investigation revealed that in addition to the contaminated MPA, NECC’s other pharmacists, including Svirskiy and Leary, knowingly made and sold numerous drugs in a similar unsafe manner and in insanitary conditions. The unsafe manner included, among other things, the pharmacists’ failure to properly sterilize NECC’s drugs, failure to properly test NECC’s drugs for sterility, and failure to wait for test results before sending the drugs to customers. They also approved the use of expired drug ingredients, and the mislabeling of those drugs in order to deceive customers. The insanitary conditions included, among other things, NECC’s lack of proper cleaning and NECC’s failure to take any action when its own environmental monitoring repeatedly detected mold and bacteria within NECC’s clean rooms throughout 2012.
NECC repeatedly took steps to shield its 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. Despite this practice, Conigliaro, an owner of NECC, repeatedly misrepresented to the FDA and the Massachusetts Board of Pharmacy that NECC was only dispensing drugs pursuant to patient-specific prescriptions. Carter, NECC’s director of operations, directed employees to engage in a number of fraudulent prescription schemes to deceive regulators by creating the appearance that NECC had prescriptions for the drugs it was selling. To that end, defendant Stepanets, one of NECC’s verification pharmacists, was convicted of approving shipments of drugs for patients with names such as Wonder Woman, Fat Albert, Bud Weiser, Samuel Adams, Hindsight Man, Betty Ford, Jimmy Carter, Bill Clinton, Donald Trump, Calvin Klein and Jennifer Lopez.
“Today’s verdicts demonstrate the ongoing commitment of the Defense Criminal Investigative Service (DCIS) to ensure the integrity of TRICARE, the U.S. Defense Department’s health care program,” stated Special Agent-in-Charge Leigh-Alistair Barzey, DCIS Northeast Field Office. “DCIS will continue to work with its law enforcement partners and the U.S. Attorney's Office to identify individuals and companies who disregard laws and regulations involving pharmaceuticals and, in so doing, endanger the health and safety of U.S. military members and their families.”
“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.”
“Today’s verdicts demonstrate the commitment of the U.S Postal Inspection Service to bring justice to those who put our customers, the American public, at risk,” said U.S. Postal Inspection Service’s Inspector in Charge, Joseph W. Cronin of the Boston Division. “The cooperation and hard work of our fellow law enforcement agencies and the Department of Justice illustrates the common mission of protecting our citizens.”
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 racketeering, racketeering conspiracy, mail fraud and introduction of misbranded drugs into interstate commerce with the intent to defraud and mislead. 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.
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.
U.S. Attorney Lelling, FDA Commissioner Gottlieb, M.D., FBI SAC Shaw, DCIS SAC Barzey, VA OIG SAC Smith, and Inspector Cronin made the announcement today. Assistant U.S. Attorneys George P. Varghese and Amanda P.M. Strachan of Lelling’s Criminal Division prosecuted the case.
Health Care Fraud