NECC Defendant Wants Jury Overturned

By Walter F. Roche Jr.

One of the defendants in the recent trial stemming from a deadly fungal meningitis is asking the the presiding judge to overturn the jury's guilty verdict on charges that she conspired to defraud the U.S. Food and Drug Administration.
In a 21-page motion filed today in U.S. District Court in Boston, Mass. lawyers for Sharon Carter said it was a legal impossibility for her to conspire to defraud the FDA of its legal authority because top agency officials themselves didn't think they had that authority to regulate state licensed drug compounders.
The argument was one that presiding U.S. District Judge Richard G. Stearns specifically urged defense attorneys to explore when he set the schedule for the acquittal motions. The same argument has been raised by lawyers for co-defendant Gregory Conigliaro, who is seeking acquittal.
Carter was one of five employees of the New England Compounding Center convicted late last year following a more than two month trial in Stearn's courtroom. The trial was the third stemming from the 2014 indictment of 14 NECC connected individuals who were charged following a two year probe of the deadly fungal meningitis outbreak caused by contaminated NECC drugs.
"The FDA did not believe that it possessed clear statutory or regulatory authority - or necessary tools - to oversee the compounders during the relevant time period," attorney Michael Pinneault wrote in the 21-page filing in support of an acquittal on the same conspiracy charge.
The motion cites testimony by Dr. Janet Woodcock during last year's trial and in congressional hearings. Former FDA Commissioner Margaret Hamburg's congressional testimony also was cited.
The filing notes that when the FDA was informed by Colorado regulators of NECC's illegal activity in that state, the FDA merely forwarded the information to Massachusetts regulators, effectively deferring jurisdiction.
The brief also argues that there was insufficient evidence presented by federal prosecutors to justify a conviction
"The evidence failed to prove that Ms. Carter knew of the existence of an agreement to deceive, obstruct and impede the FDA,"the filing states.
Prosecutors charged that NECC was actually acting as a drug manufacturer subject to strict FDA regulation, but disguised itself as a small family owned company subject only to state regulation.
"There was no testimony that Ms. Carter contributed to, or even knew about NECC's" communicators with regulators," the filing continues.
Noting that Carter's role at NECC involved supervising other workers in verifying orders for drugs, the brief states that that the evidence did not support the conclusion that Carter was even aware of a conspiracy to defraud the FDA.
Carter's brief cites the testimony of Robert Ronzio, the prosecution's star witness who testified that, "I didn't realize at the time what we were doing was illegal."
The jury's conviction, the filing concludes,"is contrary to the substantial weight of the evidence."
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