Expiration Dates Falsified Even as Probe Began

By Walter F. Roche Jr.

BOSTON, Mass- Even as the investigation of a deadly outbreak was getting underway, workers at the drug compounding firm that caused the outbreak continued to falsify the expiration dates on dozens of drug doses being shipped to health care facilities across the country.
That was the testimony today of a former pharmacy technician at the defunct New England Compounding Center. He told jurors it was a routine practice to put expiration dates on drugs that went well beyond the expiration dates of its components.
The witness, Joseph Connelly, also testified about the atmosphere in the room where sterile drugs were prepared. "A locker room on steroids," he told jurors in U.S. District Court when asked to describe the verbal and physical horseplay in the NECC clean room.
His testimony came as the trial of six former NECC employees entered its second week. The six face charges ranging from racketeering to conspiracy and mail fraud.
Another prosecution witness, who was employed by an affiliated company, told jurors that he saw a mat at the entrance to that clean room that had turned dark brown apparently from accumulated dirt from the shoes of workers. He also described autoclaves turned brown in the same clean room.
However, the witness, Michael Andolina, underwent sharp cross examination from a defense attorney who used floor plans to question what he saw and where he saw it.
The 2012 outbreak was caused by fungus laden steroids shipped from NECC's Framingham, Mass. facilities to more than 20 states. The outbreak killed 76 patients including 16 in Tennessee. Hundreds more were sickened. Though not made public till early October, the probe began in September based on the report of a rare form of fungal meningitis by a Nashville physician.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Connelly detailed how the expiration dates on eight different drug shipments were falsified so that the expiration date of the final product exceeded the expiration of its components.
They included drugs shipped in late September of 2012 that carried a Jan. 25, 2013 expiration date even though a components had a Nov. 29, 2012 expiration date. Connelly testified the drugs were shipped to three health facilities with the false dates.
Connelly, whose brother also worked at NECC and has already entered a guilty plea to a related charge, said NECC routinely shipped drugs on the same day they were processed, making it impossible for promised testing by an outside laboratory to be completed.
Asked about one drug batch he prepared, Connelly said it was shipped the same day it was processed with the approval of one of the defendants, Gene Svirskiy, a licensed pharmacist.
He said another defendant, Alla Stepanets, told him that the expiration date on another batch of drugs was being extended from 120 to 180 days on orders from Barry Cadden, NECC's president.
Cadden, who was tried separately, is serving a nine year prison sentence following his conviction on racketeering and mail fraud charges. Both Andolina and Connelly testified at Cadden's trial.
Andolina, who said he was hired to work for an affiliated marketing firm, said he set up cameras to record Barry Cadden conducting training sessions for NECC's sales force.
On excerpts from the training sessions played for jurors Cadden bragged that inspectors from the state agency that licensed NECC "don't even know what they are looking for."
"I had to educate them," Cadden said, adding that later when complaints came in from other states, the Massachusetts inspectors "just told them to go away."
Andolina, however, was challenged about his testimony about what he saw in the NECC clean room. Confronted with floor plans of NECC's facilities, Andolina said his original description "was the best I can recall."
Asked about the original condition of the dirty sticky mat he saw at the entrance to the clean room, Andolina said he knew they were white.
Attorney Paul Kelly then presented a video showing the new mats are actually blue.
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