Wednesday, July 12, 2017

Hearing Set on Conigliaro Dismissal Motion

By Walter F. Roche Jr.

A hearing is set for next week on the only charge faced by an executive and part owner of a now defunct drug compounding firm blamed for a deadly fungal meningitis outbreak,
Seeking dismissal of a charge that he conspired to defraud the U.S. Food and Drug Administration is Gregory A. Conigliaro, who was vice president and part owner of the New England Compounding Center.
The hearing Tuesday will be held before a federal judge, who already has raised questions about the conspiracy charge.
On March 13 during the 10 week  trial of Barry J. Cadden U.S. District Judge Richard G. Stearns said, "It's hard for me to see what the FDA was defrauded of."
Conigliaro's lawyer cited that comment in a nine-page motion to have the conspiracy charge tossed.
Two other defendants, Alla Stepanets and Sharon Carter, joined in the motion.
Cadden was convicted on 57 counts including racketeering and mail fraud and has been sentenced to a nine year prison term.
Federal prosecutors responded to the dismissal motion by citing the fact that Stearns already has denied similar motions on the same charge.
"Count three clearly sets forth the elements necessary to constitute the crime of conspiracy," the 17-page prosecution filing states.
All of the defendants were indicted in December of 2014 following a two year federal probe of the 2012 fungal meningitis outbreak that took the lives of 76 patients in 20 states. State and federal regulators concluded that fungus riddled steroids produced by NECC caused the outbreak.
In the motion to dismiss, Conigliaro's lawyer cited testimony by FDA officials who told a congressional committee that the FDA did not have clear legal authority over pharmacies like NECC.
"It was impossible for the FDA to be defrauded in the manner the government alleged," the motion states.
The motion concludes that the conspiracy charge is "a pure legal impossibility."
Prosecutors responded by stating, "Tricking and interfering with the FDA is not legally impossible."
The indictment charges that Conigliaro and other NECC employees falsely claimed to the FDA that NECC was not acting as a manufacturer and that it compounded drugs only with patient specific prescriptions.
It cited an Oct. 1, 2004 letter Conigliaro sent to the FDA.
 "We are a small scale, family run compounding pharmacy only, not a manufacturer," Conigliaro wrote.
Conigliaro wore multiple hats at NECC, according to the indictment. In addition to being a vice president, he was secretary, treasurer and general manager.He was also a director and part owner of NECC's sales arm, Medical Sales Management.
Stepanets, who was a licensed pharmacist, already has been cleared of a charge that she violated the federal Food, Drug and Cosmetic Act. Stearns dismissed that charge on Oct. 4 of last year.

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