In 2012, a nationwide meningitis outbreak caused by contaminated steroids killed 64 people and sickened nearly 800 others. Last week in a federal courthouse in Boston, an owner of the company that started it all, New England Compounding Center (NECC), along with four other employees, were convicted of numerous federal crimes for their roles in the outbreak. With the additional convictions last week, 11 former owners, executives, and employees of NECC have been convicted or pled guilty to federal criminal charges.
Following an 8-week trial, the following individuals were found guilty:
Gene Svirskiy, 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. Svirskiy faces a sentence of up to 20 years in prison.
Christopher Leary, also 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 faces a sentence of up to 20 years in prison.
Sharon Carter, was NECC’s former director of operations. She was convicted of conspiracy to defraud the United States. She faces a sentence of up to five years in prison.
Alla Stepanets, was one of NECC’s verification pharmacists. She was convicted of six counts of introduction of misbranded drugs into interstate commerce. She faces a sentence of no greater than one year in prison.
Greg Conigliaro, a former owner of NECC, was convicted of conspiracy to defraud the United States. He faces a sentence of up to five years in prison.
The only defendant acquitted was Joseph Evanosky, a former clean room pharmacist.
Sentencing for all of the defendants is scheduled for March 2019.
Two remaining defendants, Kathy Chin and Michelle Thomas, both of whom were former NECC verification pharmacists, are scheduled to stand trial on March 25, 2019.
In an alert last week, we noted that FDA Commissioner Scott Gottlieb had already stressed that compounding and compounded drugs were an area targeted for additional scrutiny in 2019 (“FDA Head Gottlieb Spells Out Enforcement Priorities for 2019”). He issued the following statement on the additional convictions in the NECC case:
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.
For further information on the subject matter of this alert or assistance in putting in place an effective compliance program for your compounding pharmacy, please contact any of the following FisherBroyles attorneys.