Pharmaceutical executive gets time behind bars for her role in a deadly disease outbreak.
Earlier this month, Sharon Carter, who served as the director of operations for the New England Compounding Center (NECC) at the time of a deadly meningitis outbreak, was sentenced to five months in prison and one year of supervised release for her role in the outbreak. She was also ordered to pay a $4,000 fine. Her sentence comes over a decade after the incident.
In September 2012, the deadly fungal meningitis outbreak took the lives of over 100 people across the nation and sickened almost 800. It remains the largest public health crisis to ever originate from a contaminated pharmaceutical drug.
The victims were patients who had received methylprednisolone acetate (MPA) preservative-free steroid injections. Upon investigation, the Center for Disease Control and Prevention (CDC) found 18 different types of fungi in the MPA vials and patient samples. The vials, tainted with mold, were traced back to the NECC, a Framingham, Massachusetts compounding pharmacy.
Carter was one of 14 people associated with the tainted drugs and indicted in the aftermath of the deadly outbreak. While Carter was not charged in relation to the tainted drugs, prosecutors argued she was involved in a conspiracy to defraud the Food and Drug Administration (FDA). According to prosecutors, Carter and her co-conspirators falsely represented the NECC as an ordinary pharmacy, rather than a drug manufacturer.
Because of this, the NECC was subject to state regulation, rather than stricter federal regulation. Prosecutors specifically emphasized Carter’s role in misleading the FDA into believing the NECC was dispensing drugs according to patient prescriptions, rather than distributing drugs in bulk.
In 2018, a jury convicted Carter, alongside her co-defendants, for their involvement in the outbreak. However, U.S. District Judge Richard Stearns threw out her conviction as well as that of co-owner of the NECC, Gregory Conigliaro. According to Stearns, their guilt was a “legal impossibility” because there was no distinction between drug manufacturers and drug compounding centers enshrined in federal law.
Then, in September of 2021, a federal appeals court decided to restore their convictions and open the way for their sentencing. Conigliaro had his hearing first, on December 1st, and was sentenced to one year in prison.
Speaking on Carter’s sentencing, United States Attorney Rachael S. Rollins said, “One may think that making misrepresentations or lying to federal regulators is a victimless crime. This case proves otherwise…The victims in this case–all trusting, innocent people–were simply seeking pain relief. Instead, those who survived were sentenced to a lifetime of anguish and trauma. This sentence speaks to my office’s ongoing commitment to the safety and protection of our residents in all areas of life and ensuring those who seek to do harm are held accountable.”
Other NECC executives convicted for their involvement include the president at the time of the outbreak, Barry Cadden, as well as the former supervisory pharmacist, Glenn Chin. The former was sentenced to 14 years and six months in prison, and the latter, 10 years and six months. They were among those convicted in the original multi-defendant trial in 2018.
Sources:
Multistate Meningitis Outbreak
U.S. court revives two convictions stemming from 2012 meningitis outbreak
‘Legal Impossibility’ Lets Convicted Ex-NECC Execs Off Hook
Former Director of Operations for New England Compounding Center Sentenced
Ex-employee of pharmacy in deadly 2012 meningitis outbreak gets prison
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