Wednesday, November 28, 2018

NECC Staffer Helped "Create" 300 Prescriptions


By Walter F. Roche Jr.

Boston-- A former license coordinator for a defunct drug compounding firm said she was concerned when she was assigned to help "create" some 300 prescriptions for drugs the company had already shipped to a Boston hospital.
Under questioning today in U.S. District Court, Beth Reynolds said she was given a list of patients and told to fill in the prescription forms which were being sent to the state Pharmacy Board in response to a complaint.
Her testimony came in the trial of six former employees of the New England Compounding Center, the firm blamed for a deadly 2012 fungal meningitis outbreak. U.S. District Judge Richard G. Stearns, who has been presiding over the case since opening arguments on Oct. 15 told lawyers on both sides to be prepared to deliver closing arguments on Monday.
Reynolds, who was called as a prosecution witness, said she got the unusual assignment in 2012 from her boss, Michele Rivers, who in turn had been given the task by NECC president Barry J. Cadden. She said Rivers had begun the job but it was passed along to her when her boss was out for a day.
She said she was told to take blank prescription forms and fill in the names of patients and the prescribing doctor. When she ran out of patient names she said she was told to randomly repeat as many names as needed.
Prosecutors have argued repeatedly that under Massachusetts law, NECC was required to have an individual patient specific prescription for every drug dose it delivered.
Stating that creating the forms was an unusual assignment, Reynolds said, "I didn't know why we didn't have them. I had concerns."
She said she got the list of patients from NECC Vice President Gregory Conigliaro's office and returned the completed prescription forms to his office when she was done.
Conigliaro, vice president and part owner of NECC, is one of the six now on trial. He has been charged with conspiring to defraud the U.S. Food and Drug Administration by pretending that NECC was just a state licensed pharmacy and not a drug manufacturer subject to stricter FDA regulation.
The list of patients produced by Reynolds and her boss was part of a response NECC filed with the Massachusetts Board of Pharmacy to a complaint that NECC had shipped sub-potent drugs to the eye and ear infirmary. The drug was used to numb patients' eyes prior to cataract and other eye surgery.
Questioned by Conigliaro's attorney Dan Rabinowitz, Reynolds said she wasn't sure where the list of patient names originally came from.
Rabinowitz also asked whether the prescription assignment along with other tasks were really coming from Cadden, the NECC president, and not from his client. Cadden, a co-defendant, already has been convicted of racketeering and is serving a jail sentence.
Among her other assignments, she acknowledged, was compiling a list of states where hospitals can have so-called shared services agreements with companies like NECC to purchase needed drugs without requiring individual prescriptions.
Asked if knowing that NECC had a contract with MEEI would have allayed her concerns about the prescription assignment, Reynolds said she didn't know.
In earlier testimony, Rabinowitz quizzed Jason Kravetz, an investigator from the U.S. Department of Veterans Affairs about Conigliaro's 20 year military record and the fact that he was awarded medals for meritorious service.
Rabinowitz read from one such award but was stopped short by Stearns when he asked whether or not Conigliaro also had a "top secret" military clearance.
Kravetz also was questioned by John H. Cunha Jr., who represents defendant Alla Stepanets, a former NECC pharmacist. Cunha charged that some of the documents contained in a government exhibit presented by Kravetz were "bogus" and hinted they were created after-the-fact.
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