Ex-NECC Salesman Grilled on TN Visit

By Walter F. Roche Jr.


Boston, Mass. - The drug salesman in charge of the account at a Nashville clinic testified today that he believed he was telling the truth when he told clinic officials in 2012 that he was certain that products from his employer could not be the cause of a just emerging deadly outbreak.
"I was sure it wasn't us. I truly believed there was no way it could be us," Mario Giamei, a former salesman for the New England Compounding Center, told jurors in recounting his Sept. 24 2012 visit to the St. Thomas Outpatient Neurosurgical Center in Nashville.
Giamei, whose territory included Tennessee and California, was the second prosecution witness in the federal criminal trial of six former NECC employees. They face charges ranging from racketeering to mail fraud stemming from a federal probe of the 2012 national fungal meningitis outbreak, which first became public in Tennessee days after Giamei's visit.
Giamei, who would later undergo sharp questioning by lawyers for two of the defendants, said he went to the clinic after learning three days earlier that clinic employees were questioning whether steroids from NECC could be the cause for patients getting sick. Eventually 13 clinic patients would die, all injected with NECC steroids.
Testifying in U.S. District Court Giamei said the lights were out and the clinic was closed when he arrived there on a Monday morning, but staffers were inside. He said once he got in he met with three clinic employees including the medical director, John Culclasure MD.
He said he spent 45 minutes to an hour at the clinic and witnessed a patient being turned away after being told "equipment problems" had forced a shutdown.
He said that Culclasure, who was the prosecution's first witness, told him he was initially concerned that the type of needle he used might have been the cause.
Giamei said that after he left the clinic he called his boss at NECC's Framingham, Mass. headquarters.
"I probably shouldn't have gone (to the clinic), Giamei said, adding that he was eventually told not to answer any questions from customers but just forward them to NECC President Barry Cadden. At first Giamei said he was assured the company expected ultimately to be cleared
Michael Pinneault, the attorney for defendant Sharon Carter, a pharmacist employed by NECC, later questioned whether Giamei really thought NECC was blameless and whether the Tennessee case was the first in which he heard a patient had been sickened.
"I don't recall any other," he responded, adding that the call in September was "the first I heard of anyone being sick."
The witness was also questioned closely about NECC complying with laws and regulations in Massachusetts and several other states requiring an individual signed prescription for every drug dose issued.
He said Cadden, who is now serving a nine year prison sentence on related charges, "was the only one" who could waive the requirement and that was on a customer-by-customer basis.
He was led through a series of NECC emails in which waivers had been sought. He said that Cadden would allow some customers to "backfill" the names of patients. Under that process customers would get an in initial order without providing patient names and then submit those patients names in subsequent orders.
He acknowledged receiving emails from his superiors insisting that customers provide "real names."
He was also questioned about the assurances he gave to customers that all NECC products were thoroughly tested and complied with national standards set by the U.S. Pharmacopeia, a nonprofit.
He said that in some cases NECC would ship drugs before sterility and other test results were received. That was the case in an order from the University of Michigan, he said, adding that test results were to be sent a week after the drugs were shipped.
He said that Cadden repeatedly assured salesman, who, like he were technically employed by a sister company, that all NECC products were thoroughly tested for sterility and potency and that NECC followed national standards for the compounding of sterile drugs.
John Cunha, the attorney for defendant Alla Stepanets, questioned Giamei about an order for an eye medication from the Vanderbilt University Medical Center. The order had been submitted without patient names. Giamei said he did not recall whether the order was eventually filled.
The former salesman said some customers just refused" to send patient names because of concerns about federal privacy limits on health records.
Shown an email he acknowledged that yet another Tennessee customer got NECC drugs without providing patient names.
Though not raised in Wednesday's testimony federal prosecutors have previously cited records showing bogus NECC customer lists including names like Donald Duck and Donald Trump.
Cunha also challenged Giamei''s assertion that it wasn't until an email on Feb. 10, 2011 that he learned that not all NECC products were being tested.
"That was the first case," Giamei responded.
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