Tuesday, December 20, 2016
Key NECC Defendant Enters Guilty Plea
By Walter F. Roche Jr.
A key figure in the investigation of a deadly fungal meningitis outbreak has entered a guilty plea and has agreed to give critical testimony in upcoming trials against his former colleagues.
The guilty plea to conspiracy to defraud the U.S. Food and Drug Administration was entered by Robert Ronzio, 42, the former national sales manager for the New England Compounding Center, the company that shipped thousands of vials of steroids laden with deadly fungus.
Ronzio, a North Providence, R.I. resident, admitted to working with other sales staffers to create phony lists of patients who supposedly had been issued valid prescriptions for the steroids NECC was shipping to health facilities across the country.
"Specifically Ronzio admitted that NECC sales representatives requested that customers send in a list of patient names with their orders," federal prosecutors said in announcing the plea deal.
The ruse was designed "to make it appear to federal and state regulators that NECC was dispensing drugs pursuant to valid patient-specific prescriptions when in fact it was not."
Evidence produced in related civil cases showed that the patient names submitted by one clinic included "Donald Duck"
Ronzio's plea was entered before U.S. District Judge Richard G. Stearns who set a Sept. 27 date for sentencing. The maximum sentence for the single charge is five years and a fine of $250,000, but prosecutors have agreed to recommend a lighter sentence dependent on Ronzio's continued cooperation.
Ronzio's scheduled sentencing will be well after nine other defendants, including Barry Cadden and Glenn Chin, will have faced trial. Cadden is scheduled to go on trial Jan. 4 on charges including 25 counts of second degree murder. Chin's trial on the same murder charges will begin as soon as Cadden's ends.
The 2012 outbreak sickened 778 patients killing at least 77 of them.
According to prosecutors Ronzio has admitted that Cadden, the chief pharmacist and part owner of NECC created ratios of patient names to match the number of doses being shipped to specific customers.
"The MAX total number of units per patient must make sense," Cadden told Ronzio, according to prosecutors, adding "I must be able to logically explain to a regulator why we processed X# of units per patient."
"Ronzio admitted the reason for these work-around methods was to maintain NECC's status as a pharmacy and avoid heightened regulatory oversight of the FDA," prosecutors stated, adding that NECC was actually acting as a drug manufacturer.
Ronzio, Cadden and Chin were among 14 named in a 131 count indictment issued by a federal grand jury in late 2014 following a two year federal probe. According to the indictment Ronzio sent an email to sales staffers at an affiliated company, Medical Sales Management, warning them to avoid using certain terms that would trigger federal charges.
In one email, entitled "HUUUUUUGGE IMPORTANCE," Ronzio wrote, "Do not give ratios. It's the wrong thing to say period!!!! I cannot stress this enough to all of you. Its (cq) will be a fatal error for you."
Two of the 14 defendants recently entered guilty pleas to reduced charges. Two others had charges dismissed. Besides Cadden and Chin, the remaining defendants are scheduled for trial in April.