NECC Convictions Face Key Challenge

By Walter F. Roche Jr.

A key face-off will come next week (Tuesday Feb. 26) when attorneys for two convicted defendants in the probe of a deadly 2012 fungal meningitis outbreak attempt to convince a judge to toss and overturn the unanimous decision of 12 jurors who sat through an eight week trial late last year.
Attorneys for Gregory Conigliaro and Sharon Carter are asking U.S. District Judge Richard G. Stearns to acquit them of the charge that they conspired to defraud the U.S. Food and Drug administration by insisting that the New England Compounding Center was a small family run pharmacy filling individual prescriptions for specific patients and subject only to state regulation.
Both Carter and Conigliaro have argued that there was no way they could deceive the FDA because, at the time, top officials at the agency were unsure of their authority over compounding pharmacies.
Federal prosecutors have countered stating that Conigliaro deliberately lied about the operations of his employer, the New England Compounding Center. NECC, they contend, was not a small local company but a large scale drug manufacturer sending out thousands of prescription drugs without required prescriptions.
The purpose of their deceit, prosecutors say, was to avoid the much tighter scrutiny that would come from the FDA and its legion of inspectors.
NECC, a now defunct Framingham, Mass. company, has been blamed for the 2012 fungal meningitis outbreak which sickened nearly 800 patients, over 100 of whom are now dead. Those illnesses were caused by NECC steroids heavily contaminated with deadly fungi.
Conigliaro was a part owner and vice president of NECC, while Carter who was an NECC pharmacy technician. They were among six to go on trial late last year. Five of the six were convicted in verdicts delivered on Dec. 13.
Two others indicted in the original probe, Barry J. Cadden and Glenn A. Chin, already are serving federal prison terms following their conviction on racketeering and mail fraud charges. Cadden and Chin also are facing second degree murder charges in the death of 11 patients from that state. Their arraignment is scheduled for Monday in Livingston County Michigan.
In his motion for acquittal or a new trial, Conigliaro argued that the conspiracy charge cannot be upheld because trial testimony and evidence showed the FDA and its top officials didn't know at the time what if any authority the agency had over drug compounders. Stearns, in an order setting the hearing, had indicated "an interest" in that argument.
Carter's attorney has raised the same argument dubbed the "legal impossibility" defense.
Stearns previously dismissed the charges against Carter, but that decision was overturned by the First Circuit Court of Appeals.
Conigliaro and Carter have both also argued that their cases were prejudiced by evidence introduced against the co-defendants. In his motion for a new trial Conigliaro charged that prosecutors presented "weeks and weeks of testimony" that were completely irrelevant to the charge against him.
They both also have argued that their roles at NECC were minimal with Carter contending that her role, to check outgoing orders,was primarily clerical.
Prosecutors have countered by showing Conigliaro's interactions with state and federal regulators and noting that Carter routinely approved for shipment drugs prescribed for obviously fictitious patients. Patient specific prescriptions were required under state law.
"The evidence at trial was legally insufficient for any rational trier of fact to conclude that the government proved beyond a reasonable doubt that Mr. Conigliaro intended to defraud the FDA," his filing concludes.
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