NECC Criminal Case Goes to Jury

By Walter F. Roche Jr.

Boston--Federal prosecutors charged today that a Massachusetts drug compounder defrauded its customers and the federal government when it masqueraded for years as a local family owned pharmacy when it was really a drug manufacturer engaging repeatedly in dangerous practices.
The charges came in the closing arguments in the federal court trial of six former employees of the now defunct firm, the New England Compounding Center.
Attorneys for the defendants countered with claims that the company was operating in a regulatory "dead zone" and federal officials didn't even know at the time if they had jurisdiction over the company. They also stated that their clients never had any contact with the customers they are accused of defrauding.
The arguments were followed by instructions for the jury, which is expected to begin serious deliberations tomorrow.
The case stems from a two year probe of the 2012 fungal meningitis outbreak which took the lives of 76 patients including 16 from Tennessee. Presiding U.S. District Judge Richard G. Stearns noted that none of the six were involved in producing the specific drug, methylprednisolone acetate, that caused the outbreak.
Assistant U.S. Attorney Amanda Strachan told the jurors that the two defendants already convicted in the case "couldn't have done it alone. All six defendants made it possible."
Calling NECC "a fraudulent criminal enterprise, Strachan said that the company was "flying under the radar" of the U.S. Food and Drug Administration which licenses and inspects drug manufacturers.
She said NECC with the help of the six defendants shipped drugs made from expired and contaminated ingredients, mislabeled drugs and used fake patient names to escape the stricter FDA scrutiny.
She replayed for the jury a training tape made by the now convicted president and part owner of NECC Barry Cadden in which he bragged that inspectors from the Massachusetts Pharmacy Board didn't even know what they were looking at when they visited NECC's Framingham, Mass. facilities.
Cadden and NECC supervisory pharmacist Glenn Chin already are serving prison terms following their conviction on racketeering and mail fraud charges.
Strachan listed the crimes each of the six has been charged with committing including racketeering, conspiracy and mail fraud. They include shipping a cancer fighting drug that had expired years earlier and shipping subpotent drugs used in eye surgery.
She said defendant Gregory Conigliaro, an NECC vice president and part owner, played a central role in efforts to keep the company out of the grip of the FDA.
Attorneys for the defendants went through those same lists stating that their clients did nothing wrong.
Jeremy Sternberg, representing defendant Gene Svirskiy, said his client was a "decent, careful and quiet man" who had absolutely no contact with doctors and hospitals he is accused of defrauding. His client had no authority or control over his co-workers or of the physical condition of the workplace.
Paul V. Kelly said his client, Christopher Leary, was the youngest of the defendants and was often the target of locker room type pranks in the clean room where he worked.
There was no way, Kelly said, for Leary to be able to detect that a colleague had failed to put the required amount of an anesthetic in drugs shipped to a Boston clinic.
Mark Pearlstein, representing Joseph Evanosky, said his client worked by himself and there was no evidence to back up a charge that he was involved in mislabeling drugs through a process dubbed "botching the lots."
Dan Rabinowitz, Conigliaro's lawyer, said prosecutors were trying to put a square peg in a round hole with arguments that NECC should have been subject to FDA scrutiny. He noted that there was a four year gap between the time the federal agency was informed of allegations against NECC and when the federal agency responded.
Referring to "regulatory craziness," he said his client actually wanted to register NECC with the FDA.