Conigliaro Wants Acquittal Affirmed

By Walter F. Roche Jr.

Charging that to do otherwise would be "unconscionable and unjust," lawyers for the former part owner of a defunct drug compounding company are asking a federal appeals court to uphold a judge's ruling clearing him of federal conspiracy charges.
In a more than 60-page filing in the First Circuit Court of Appeals in Boston, lawyers for Gregory Conigliaro asked the appeals court to affirm the conclusion by a district court judge that it was a legal impossibility for their client to defraud the U.S. Food and Drug Administration.
Citing the court and congressional testimony of two top FDA officials, the brief charges that the FDA didn't believe it had clear regulatory authority over compounding pharmacies like the New England Compounding Center, where Conigliaro was a vice president.
Conigliaro was one of 14 indicted in 2014 following a two year probe of the deadly 2012 fungal meningitis outbreak caused by contaminated drugs shipped by NECC to health providers in more than 20 states.
Conigliaro was convicted of conspiracy to defraud the FDA by a unanimous jury vote, but that was overturned in June of 2019 by U.S. District Judge Richard G. Stearns.
Federal prosecutors have appealed that decision thus prompting the response from Conigliaro's legal team.
Citing Stearns decision, Conigliaro's lawyers argued, "The FDA functions with which Mr. Conigliaro was accused of impeding did not exist."
Citing testimony by Janet Woodcock, a top FDA official, that the agency's authority was "blurry," the brief states that the FDA had "intentionally abdicated enforcement functions concerning compounding pharmacies."
"Acquittal here was mandatory," the brief continues, adding "The government's position here defies common sense and leads to abusive results."
Dismissing arguments that NECC violated a law requiring patient specific prescriptions, the brief contends that during the time of the alleged conspiracy there was no clear legal distinction between a drug compounder and a drug manufacturer.
"For the government to now rest criminal liability on the ambiguous legal foundation of its own making is unconscionable and unjust," the brief concludes.
The same arguments were raised by co-defendant Sharon Carter, who also had her jury conviction overturned by Stearns. An NECC supervisor, Carter faced the same conspiracy charge as Conigliaro.
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