Prosecutors: NECC Conspiracy Evidence "Overwhelming"

By Walter F. Roche Jr.

Citing overwhelming evidence of a conspiracy to defraud federal regulators, prosecutors charged that even in the face of an unfolding national tragedy, officials of a Massachusetts drug compounding firm were not motivated to "come clean."
The charges were included in a 30-page filing urging a federal judge not to overturn the unanimous guilty verdict issued late last year against Gregory Conigliaro, who was vice president and part owner of the company blamed for the deadly 2012 fungal meningitis outbreak.
Citing evidence and testimony in the eight week trial that ended in early December, Assistant U.S. Attorneys Amanda Strachan and George Varghese, said Conigliaro lied repeatedly to both state and federal regulators, insisting the the New England Compounding Center only issued drugs in response to individual prescriptions written for specific patients.
Conigliaro, the brief states, made those representations when he knew NECC was actually distributing drugs in bulk.
Rejecting Conigliaro's argument that there could be no conspiracy because the U.S. Food and Drug Administration was confused about its authority, prosecutors cited trial testimony of Janet Woodcock, a top FDA official, who told jurors that NECC was acting as a manufacturer, thus making it subject to FDA oversight.
Citing Conigliaro's role in ordering the mass production of fraudulent prescriptions for drugs already shipped to a Boston eye hospital, prosecutors said neither state nor federal regulators could determine what NECC was actually up to.
"As a result of this fraudulent prescription scheme, the FDA did not get a true understanding of the scope of NECC's business practices until it was all over," the filing states.
According to the prosecutors it wasn't until the outbreak became public and NECC's drugs were recalled that the FDA was able to uncover the thousands of fraudulent prescriptions.
"NECC's fraud had in fact succeeded. The evidence at trial demonstrated not only was it factually possible to defraud the United States, it actually occurred," the prosecutors stated.
In addition prosecutors cited federal appeals court rulings concluding that "a conviction of defrauding the United States does not require underlying unlawful activity."
The brief also argues that Conigliaro should not be granted a new trial because of prejudicial evidence presented at the trial. Prosecutors said evidence of Conigliaro's profits from NECC operations were limited as was testimony and evidence about the deadly fungal meningitis outbreak caused by NECC's fungus infested steroids.
The outbreak took the lives of over 100 patients among some 800 who were sickened in more than 20 states.
Conigliaro's motion for acquittal or a new trial is scheduled for a Tuesday hearing before U.S. District Judge Richard G. Stearns.
Contact: wfrochejr999@gmail.com