Friday, January 13, 2017

Ex NECC Salesman Gives Outbreak Details

By Walter F. Roche Jr.

BOSTON, Mass - A former salesman for the company blamed for the deadly 2012 fungal meningitis outbreak provided new details of the onset of the tragic event  as he made a sales call to the Tennessee clinic when the first victims were becoming ill.
Testifying under a grant of immunity, Mario Giamei Jr.  also testified that the man on trial, Barry J. Cadden, gave his personal approval to allow healthcare providers to purchase drugs without the names of patients, as required by law.
Testifying in U.S. District Court here in the trial of Barry Cadden, Giamei, said when he visited the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn. in September of 2012  the outbreak had not yet been made public, but some patients had already been sickened.
Cadden has been charged with racketeering and 25 counts of second degree murder as a result of a two year federal probe of the outbreak, which took the lives of 76 patients and sickened 778.
He said the clinic had contacted his office looking for test results on the lots of drugs the clinic had purchased.
He said officials of the clinic asked whether the drug company headed by Cadden, the New England Compounding Center, had received any reports of problems with their drugs.
By the time he got to the Nashville clinic he said it had already closed down. He said a patient came in who had not gotten the message his appointment had been postponed. He said the patient was sent home and told the clinic had shutdown due to a mechanical issue.
Giamei, who was in charge of the clinic's account, said he assured clinic officials, including Dr. John Culclasure, that there were no problems with  the spinal steroids from NECC.
"I assured him it couldn't be us and we would stand behind him," he testified.
He said Culclasure expressed concern that the needles he used for the spinal injections might be involved because he used a different type of needle than most physicians.
Giamei said another clinic employee told him that the Tennessee Health Department was already investigating the illnesses. He said Culclasure told him there were six patients who had taken ill after receiving steroid injections at the clinic.
He said after the visit he got a call from Cadden, who wanted to know what happened.
He said Cadden told him he shouldn't have gone.
"They're going to blame us. It's a legal matter," Giamei said Cadden told him.
Giamei said he later wrote a lengthy email describing his Nashville visit.
Under questioning from Assistant U.S. Attorney George Varghese, Giamei, who was actually employed by an NECC affiliate, Medical Sales Management, described how Cadden's personal approval was necessary when a customer wanted to purchase drugs without naming the patient, a legal requirement in Massachusetts and many other states.
Varghese showed emails in which Cadden did just that.
"It's okay to ship without the names," Cadden wrote in an email to Giamei.
"OK, no names is no problem" Cadden wrote in another email 
He said the size of the order and the client's history as a customer were factors in getting Cadden's approval.
He said in some cases the clinics would "backfill,"  by using the names of past patients to place subsequent orders.
The emails displayed by Varghese showed Cadden approved sales without patient names for a clinic in Thomasville, Ga. and another in New Jersey.
Giamei did acknowledge that Cadden frequently told the sales staff they did have to have names.
 In one email to sales staffers Cadden wrote that the problem was with Massachusetts law.
"We must not appear to be a manufacturer," the memo stated.
Under cross examination, Giamei agreed that his customers often resisted providing patient names due to confidentiality laws.
And he acknowledged that he told customers that NECC's products were tested and safe. He said at that time he believed  that to be the truth.
Asked if he still believed it, he said, "I don't know what to believe anymore."

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