Prosecutors Appeal Conigliaro Acquittal

By Walter F. Roche Jr.

Contending that it was simply wrong, federal prosecutors are asking an appeals court to overturn the decision that cleared the part owner and an employee of a rogue drug compounding company of criminal conspiracy charges.
In a more than 100-page filing including multiple appendices, the U.S. Attorney wrote that the two defendants were motivated by greed and their actions had "disastrous public health consequences."
The appeal to the First Circuit Court of Appeals in Boston, Mass. comes in a criminal case stemming from the deadly 2012 fungal meningitis outbreak, which eventually took the lives of more than 100 patients among nearly 800 who were sickened.
In the filing prosecutors said U.S. District Court Judge Richard G. Stearns erred when he overturned the unanimous jury verdicts which had found Gregory Conigliaro and Sharon Carter guilty of conspiring to defraud the U.S. Food and Drug Administration.
Stearns June 7, 2019 ruling, the appeal states, is not only unprecedented, "it is also wrong."
Conigliaro, according to the appeal, was the number two person at the New England Compounding Center. He held the title of vice president and was part owner of the Framingham, Mass. company. Carter was NECC's director of operations and was involved in processing orders prior to shipment.
The two were among 14 people connected to NECC who were indicted in late 2014 following a two year probe of the deadly outbreak caused by NECC drugs contaminated with fungus.
Cited in the appeal were letters sent by Conigliaro to state and federal regulators in which he stated that NECC was a small family owned pharmacy that prepared compounded drugs based on individual patient specific prescriptions.
"The deception worked," the filing states, "but the consequences were devastating."
Citing the history of the statutes governing the FDA's legal authority to regulate drug manufacturers, the appeal states that despite conflicting court opinions the agency always had the authority to regulate companies manufacturing drugs.
"The district court erred in concluding that the defendants' convictions were legally impossible," the filing states.
Stating that NECC knew it had to have patient specific prescriptions to avoid being subject to stricter regulation by the FDA, the brief notes that Conigliaro personally directed an employee to create fake prescriptions for drugs shipped to a Boston hospital.
The appeal also disputes Stearns' conclusion that Conigliaro and Carter, due to confusion over the FDA's regulatory authority, did not have fair notice that what the company was doing was illegal.
"The defendants and others at NECC knowingly provided false information to the FDA," the appeal states, adding that "there was no ambiguity or lack of notice."
"If the FDA had known the truth about NECC's operations, the FDA would have taken action," the appeal states.