Convictions of Key NECC Defendants Reinstated

By Walter F. Roche Jr.

In a stunning reversal a federal appeals court has reinstated the convictions of two key figures in the 2012 fungal meningitis outbreak, concluding that the two did indeed conspire to defraud the U.S. Food and Drug Administration.
In a 61-page decision handed down today the court rejected the conclusion of U.S. District Court Judge Richard G. Stearns that it was legally impossible to defraud the FDA because the agency doubted its own authority to regulate state licensed drug compounders.
The Boston ruling sends the cases against Gregory Conigliaro and Sharon Carter back to Stearns to determine a sentence. Stearn's June 6, 2019 ruling had overturned the unanimous jury conclusion that the two that were guilty.
The court also sent back to Stearns for further inquiry the defendants claim for a new trial.
Conigliaro was vice president and part owner of the New England Compounding Center, the company that shipped thousands of vials of a contaminated steroid to health care providers across the country. Carter was NECC's director of operations.
The two had argued that because the FDA was unsure of its authority to regulate drug compounders, it was impossible for the defendants to conspire to defraud the FDA of the authority, it wasn't even sure it had.
Stearns, in fact, had suggested to the defense lawyers,that the legal impossibility argument was the one that most interested him.
The appeals court, however, looked to the underlying statute, the Food Drug and Cosmetic Act and concluded that whether or not the FDA chose to regulate compounders, the law gave the agency the authority to do so.
Stating that it did not understand the district court's reasoning, the ruling concludes that "the district court erred as the government contends."
The panel also rejected the argument that the jury's guilty verdict deprived the defendants of legally required fair notice.
"There is no due process based bar to the defendants being convicted," the ruling states.
The panel cited internal emails and other documentary evidence in which Carter instructed sales staff on the procedure to be followed when orders were placed without patient specific prescriptions as legally required. She told sales staff that the patient names must ressemble real names.
The names listed on NECC records included Ted Bundy and Barney Fife, the panel noted. It states that Conigliaro told federal regulators that NECC was a small family owned compounding pharmacy.
Also cited was the testimony of Robert Ronzio, NECC's national sales director, who already entered a guilty plea to the conspiracy charge.
"The district court's judgments of acquittal must be reversed," the ruling concludes.
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