(Reuters) – A federal appeals court on Monday restored the convictions of a co-owner and former employee of a Massachusetts pharmacy accused of defrauding regulators before its drugs triggered a fatal outbreak of fungal inflammation in 2012.
The first U.S. Circuit The Boston Court of Appeals found that a judge erred in finding that it was legally impossible for New England Compounding Center co-owner Gregory Conigliaro and former employee Sharon Carter to defraud the U.S. Food and Drug Administration.
Judgment could clear ways to judge them. Defense attorneys did not respond to a request for comment.
Mr. Conigliaro and Carter were among 14 people associated with the NECC who were prosecuted for mold-producing steroids that it produced triggered a fungal outbreak that killed 793 people nationally, including more than 100 who died.
The defendants included Barry Cadden, the former president and co-founder of the NECC, and Glenn Chin, its former supervising pharmacist, who was convicted of racketeering and fraud and is serving 14-1 / 2 and 10-1 / 2 years in prison, respectively.
Unlike Mr. . Cadden and Mr Chin, Conigliaro and Carter were not accused of having played a direct role in the outbreak.
A 2018 federal jury instead found them guilty of misleading the FDA into believing that Framingham, the Massachusetts-based NECC, functioned as a conventional pharmacy that should be subject to state supervision, rather than a drug manufacturer.
State-regulated compounding pharmacies produce tailor-made medicines according to patient-specific prescriptions. But prosecutors said the NECC was actually a drug manufacturer that manufactured drugs in bulk without valid prescriptions.
U.S. District Judge Richard Stearns said the FDA at the time was unsure that it could regulate compound pharmacies such as the NECC and as a result did not, making it impossible to obstruct the agency's functions.
But U.S. Circuit Judge David Barron, who wrote for Monday's three panel of judges, said Judge Stearns never identified any case in which the FDA denied authority to treat a compound pharmacy as a manufacturer subject to increased oversight. Catalog