NECC Tech Worked Illegally for 2+ Years

By Walter F. Roche Jr.

Boston- A former pharmacy technician who already has pleaded guilty to nine counts of mail fraud testified today that he worked illegally for nearly three years at the drug compounding company blamed for the deadly 2012 fungal meningitis outbreak ..and the company knew it.
The prosecution witness testifying in U.S. District Court here told jurors he worked at the New England Compounding Center with the full knowledge of key officials of the now defunct firm. Those included three former NECC officials now on trial on charges ranging from racketeering to mail fraud and conspiracy.
Scott Connolly, the one time pharmacy technician, said he already had surrendered his technician's license before NECC and an affiliated company hired him in 2009. In fact, he was told they thought the clean room, where sterilized drugs were being prepared, would be "a good place to hide" him.
He said company officials told him to leave the clean room on six or seven subsequent occasions when regulators were visiting the Framingham, Mass. facility.
"It was my understanding that regulators were coming and they wanted me out," Connolly said.
Connolly's damning testimony came at the end of the second week in the trial of six former employees of NECC, the now defunct firm that shipped thousands of contaminated vials of a spinal steroid to health facilities across the country including three in Tennessee. Sixteen Tennessee patients were among 76 that died after injection with NECC's fungus laden steroids.
Connolly testimony followed that of another former NECC technician who told jurors that he and his colleagues"knew what they were doing was not right," when they shipped untested medications to healthcare providers across the country. Nicholas Booth testified that was especially true as the company ratcheted up production in the fall of 2012 on the eve of a forced shutdown.
Under questioning by Assistant U.S. Attorney, Connelly acknowledge he had reached a plea agreement with federal prosecutors that is contingent on his continued cooperation with prosecutors. His sentencing has been oput on hold pending the completion of the ongoing case.
Connolly, whose brother was also an NECC employee already has testified for the prosecution, said he had signed a confidentiality agreement in 2009 with NECC's vice president and part owner Gregory Conigliaro, one of the six defendants. He said he also discussed the loss of his state certification with his immediate boss at NECC, Gene Svirisky, another defendant in the ongoing trial.
He said a third NECC pharmacist, Christopher Leary, also a defendant, had asked him about the circumstances surrounding his license surrender.
Connolly acknowledged that he received notice of the loss of his registration from Sophia Pasedis, then the head of the Mass. Board of Pharmacy also a top official at NECC's sister firm Ameridose.
Describing his hiring Connolly said he met with now jailed NECC President Barry Cadden and Supervisory Pharmacist Glenn Chin on a weekend in 2009 in what turned out to be a tryout for the job.
Calling it"kind of a competition" Connolly said he was asked to prepare drugs in a clean room. He was asked to come again the next day and ultimately won a full time job.
Chin, like Cadden, is now serving a federal prison sentence following his conviction on racketeering and mail fraud charges.
Connolly said he was assigned to one of the two NECC clean rooms and first prepared small doses of Avastin, a drug used to treat serious eye problems. Later he began preparing cardioplegia, a drug used to stop the heart during open heart surgery. He said he worked in that clean room under the supervision of Svirskiy, though he said Svirskiy regularly left the room, leaving he and other technicians without required supervision.
Svirskiy, he said, was also "my friend" and the two socialized together and, at times, talked about getting his license back.
He said it was generally known by colleagues and superiors that he had lost his registration. That included NECC's quality control chief Annette Robinson, who hasn't been charged and has appeared as a prosecution witness in prior trials.
"They didn't come out and say it, but it was generally known," Connolly said of his license status.
He said that when he was warned that regulators were coming he went to other NECC departments, like shipping not requiring special clearance.
He said he was instructed to further shield his presence from regulators by using Barry Cadden's name to log into NECC's compounding system. He also used a secret symbol to initial company records and used a nickname "Mud Gum" on other records. The nickname was also embossed on his coffee mug, which was displayed to jurors by Varghese.
Earlier in the day Booth described his tenure at NECC. He like Connelly, started out at Ameridose, the sister firm, and later transferred to NECC, working his way up to a pharmacy technologist slot in a clean room.
Responding to Varghese's questions, Booth, speaking in a barely audible voice, was led through records showing NECC drugs were often prepared with components drawn from separate drug lots.'
Yet labels affixed to the final product reflected only the date of the lot that actually had been tested and not the newer untested lot. He agreed with Varghese that there would be no way for customers to know they were getting a partially untested product.
"At the end we were definitely doing too much," he said, citing the 2012 upsurge in orders.
Under cross examination by Dana McSherry, the attorney for Booth's supervisor Joseph Evanosky, Booth was asked if there was anything inherently wrong with mixing drug lots. The witness said he wasn't sure what was required under the industry standard.
Comparing Booth's testimony before a grand jury with his trial testimony, McSherry said Booth appeared to now remember conversations he did not mention previously.
"After six years, you now have a specific recollection," she stated.
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