NECC Sales Chief: "Didn't Realize It Was Illegal"

By Walter F. Roche Jr.

Boston --The prosecution's star witness testified today that at first he didn't think the drug compounding company he worked for was doing anything wrong. He said it was an official of a South Carolina hospital who told him that what they were doing was illegal.
The witness was Robert Ronzio, the one time sales director at the New England Compounding Center, the company blamed for a deadly 2012 fungal meningitis outbreak. Ronzio described the company's constant struggle to come up with patient names, a requirement under state law.
On trial in U.. District Court are six former employees of NECC charged with racketeering and mail fraud. The trial, which began in mid-October, will go to the jury Tuesday following closing arguments.
Ronzio, who already has entered a guilty plea to a charge of conspiring to defraud the U.S. Food and Drug Administration, was testifying under the terms of a plea agreement with federal prosecutors. The current trial marks the third time he has testified against former NECC employees and owners.
"I didn't realize that what we were doing was wrong at the time," Ronzio said.
He said that it was an official of a South Carolina hospital who first told him that NECC's practices for coming up with patient names were illegal.
He described how NECC would "backfill" patient names by using lists of prior patients on future orders.
Led through a series of company emails by Assistant U.S. Attorney George Varghese, Ronzio said the names were needed in case the Massachusetts Board of Pharmacy ever asked the company to produce them. Patient specific prescriptions were required under Massachusetts law for every dose of a drug the company sold.
He said that in some cases hospitals or other customers would come up with more names than needed. He said in yet other cases it turned out that the patients names provided were actually employees of the health facility placing the order.
He said that NECC would stop shipping drugs to customers in states like Oregon and Colorado, when regulators from those states raised issues about NECC's practices. He said that Tennessee was put in that category after a potential Oak Ridge customer raised questions about NECC's compliance with the law.
He said NECC President Barry Cadden would in some cases waive the patient name requirement but in at least one case later retracted it.
Ronzio also insisted that he never had any doubts about the quality of NECC's products and he believed the claims the company made to its customers about quality assurance practices.
Ronzio recounted one conversation with Cadden in which the company president bragged about how well NECC was doing and that the company fax machine had turned into his own personal ATM.
Under cross examination by attorneys for the six defendants, Ronzio acknowledged that it was Cadden, who is now serving a nine-year prison sentence, who ultimately decided about granting waivers to the patient name requirement.
He was also shown emails in which one defendant, Sharon Carter wrote that she was holding orders until she got needed patient names.
Under questioning by Dan Rabinowitz, the attorney for Gregory Conigliaro, Ronzio said that he and Conigliaro ended up taking over the task of contacting clients when a recall of contaminated products was underway in 2012.
He agreed that Conigliaro wanted Cadden kept away from regulators "because he was hysterical, crying and upset." Conigliaro was an NECC vice president and part owner.
Joseph Evanovsky's attorney noted that he was a fairly new employee and was involved in handling only 12 of the ingredients cited in the thick prosecution files.
The final witness was Joseph Ridgley, a special FDA agent, who amassed thousands of pages of documents to back up the individual charges in the original 2014 indictment.
Contact:wfrochejr999@gmail.com