The medical director of a Nashville clinic told a courtroom that officials from the New England Compounding Center never responded to his question about testing spinal steroids.
Dr. John Culclasure of the St. Thomas Outpatient Neurosurgical Center testified on Oct. 17 that he questioned the NECC after one of his patients had been diagnosed with fungal meningitis. That patient had been treated with methylprednisolone acetate obtained from NECC.
The patient eventually died.
The NECC closed in 2012 after a fungal meningitis outbreak caused by tainted steroid injections killed 64 people in nine states and sickened more than 700 others.
Culclasure said that he was present when one of his employees called the NECC on Sept. 21, 2012, to ask about tests for fungal contamination. Culclasure said that the NECC official promised to get back to him, but never did.
Culclasure eventually had 13 of his patients die, out of a total of 103 who were sickened by the injections.
Culclasure’s testimony in U.S. District Court took place on the second day of the federal criminal trial of six former NECC employees. The charges range from racketeering to mail fraud.
Former salesman for NECC, Kenneth Boneau, also told jurors that there were “multiple errors” in drug production at the compounding pharmacy prior to the nationwide meningitis outbreak, as the company dealt with an influx of orders. Boneau alleges that there was an “uptick” in complaints and that the drugs were mislabeled.
Another salesman, Mario Giamei, testified that he believed he was being truthful when he told the Nashville clinic’s officials in 2012 he believed that products from NECC were not the origin of the meningitis outbreak. Giamei stated that he visited the clinic three days after he was informed that clinic employees doubted the safety of the NECC-provided steroids. Giamei met with Culclasure at the clinic to discuss the matter for about an hour.
Giamei testified that he then phoned his boss at NECC, who told him to not answer customer questions but instead direct them to NECC President Barry Cadden. He also said that Cadden told him and other salespeople, who were employed through a sister company, that all NECC products had indeed been thoroughly tested for sterility and potency, and that NECC adhered to national standards for sterile drug compounding.
Additionally, Claudio Pontoriero, a former pharmacy technician at Massachusetts General Hospital, pleaded guilty on Oct. 11 to making false statements to federal agents related to payments he got from Ameridose LLC, a sister firm of NECC. The drug repackager was co-owned by Barry Cadden.
Glenn Chin, the supervisory pharmacist in charge of the cleanroom; and Barry J. Cadden, former co-owner and president of the NECC; were each tried on charges of second-degree murder in 2017. Both Chin and Cadden were acquitted of the murder charges, but were sentenced to prison (eight years and nine years, respectively) for racketeering and fraud charges. Former NECC pharmacy technician Scott M. Connolly pleaded guilty to mail fraud in August 2018.