Nashville Physician Lead Witness in NECC Case

By Walter F. Roche Jr.

A Nashville physician who saw 13 of his patients die in a deadly 2012 outbreak is slated to be the lead off witness as testimony in the criminal trial of six employees of a defunct drug compounding gets underway in a Massachusetts courtroom.
Culclasure, who was on hand but out of the courtroom as opening arguments were delivered Monday, was the physician at the Saint Thomas Outpatient Neurosurgical Center in Nashville when evidence of a deadly fungal meningitis first emerged a little over six years ago.
U.S. District Judge Richard G. Stearns rejected as moot a motion by lawyers for the six defendants to bar or at least limit Culclasure's testimony. He did so after prosecutors agreed to limit their questions to factual issues regarding the outbreak. The six face 38 felony charges ranging from racketeering to mail fraud.
Defense attorneys had noted that in prior testimony in a codefendant's case, Culcalsure had sobbed during his testimony about the deaths of his patients.
Stating that such testimony would be extremely unfair and prejudicial, the defense attorneys stressed that none of the six had been charged in any of those deaths. In fact, they asserted, no deaths or injuries were attributed to any of the drugs in which their clients were involved.
"Not a single person was harmed in anyway," said Mark Pearlstein, attorney for one of the defendants
In opening arguments, Assistant U.S. Attorney George Varghese told the panel of 16 jurors, eleven female with the balance male, that the company that employed the six, the New England Compounding Center, was a criminal enterprise that shipped hundreds and thousands of contaminated drugs to health facilities around the country "week after week."
NECC he said was ultimately forced to recall all of its drugs, not only the spinal steroids that caused the outbreak.
Gregory Conigliaro, an NECC vice president and part owner "made millions" from NECC," Varghese charged. Conigliaro, prosecutors have stated, was in charge of ensuring NECC's compliance with state and federal regulatory authorities. He is charged solely with conspiring to defraud the U.S. Food and Drug Administration.
The prosecutor then laid out the roles of the five other defendants ranging from a supervisor in one of the so-called clean rooms where sterile drugs were prepared to a worker who "oversaw everything."
"The fraud was not limited to the methylprednisolone acetate," Vargehes said in a one hour presentation.
He said the two year federal investigation showed that drugs injected into the eyes of patients at a Boston hospital to prevent pain were subpotent and patients suffered.
"Their eyes were not numb. They could feel it," he said.
A cancer drug produced at NECC was made with chemicals whose effective date passed four years earlier. And a drug used to stop the heart during surgery was made by a pharmacy technician who had surrendered his certification in the midst of an unrelated investigation.
Acknowledging that the six, including vice president and partial owner Conigliaro, were not involved in producing the deadly fungus laden steroids, Varghese said the company also shipped out drugs that were untested and encouraged customers to come up with fraudulent lists of patients who were to receive the drugs.
Daniel Rabinowitz, Conigliaro's lawyer, said the charges that state and federal regulators didn't know exactly what was going on at NECC was "ridiculous." He then cited numerous visits to the facility by the U.S. Food and Drug Administration and the Massachusetts Board of Pharmacy.
Citing congressional testimony by two top FDA officials stating that the regulatory authority over companies like NECC were blurred, he played video tapes of the two official saying just that.
John Cunha, the attorney for defendant Alla Stepanets, noted that his client, like the other defendants, had no reason to question the way the company was operated. In fact, he said, an official of a sister company, Ameridose, was a member of the state Board of Pharmacy.
Stating that his client had no motive to violate any laws, he said she acted at "all times in good faith."
He, like the other defense lawyers, repeatedly laid the blame on NECC's president Barry Cadden and Glenn Chin, a supervising pharmacist. Both are now serving prison terms following conviction of racketeering mail fraud and related charges. The two were cleared, however, of second degree murder charges.
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