Home > Article
VOL. 37 | NO. 19 | Friday, May 10, 2013
Court filing suggests pharmacy misled regulators
NASHVILLE (AP) - New court filings suggest a Massachusetts pharmacy blamed for a deadly outbreak of fungal meningitis last year may have used patient lists from a Nashville clinic to mislead regulators.
The suggestion was part of a statement by the former Saint Thomas Outpatient Neurosurgical Center medical director in a lawsuit brought by Wayne Reed. Reed is suing the clinic after his wife died when she was injected with contaminated medicine made by the New England Compounding Center.
The meningitis outbreak caused 55 deaths, including 15 in Tennessee.
The Tennessean reports (http://tnne.ws/13Ibh9v) that Dr. John Culclasure said an NECC salesman told him the Massachusetts pharmacy board was insisting on patient names because NECC was legally required to have patient-specific prescriptions. Clinic officials said it was impossible to know in advance which patients would get the injections, but the salesman told them "that was fine because NECC just needed a list of patient names."
The filings also include an account of a meeting between NECC salesman Mario Giamei and clinic officials on Sept. 24, just as the outbreak was unfolding.
Giamei was questioned by clinic officials about the fungal meningitis outbreak, but said he was "adamant that the problem could not have come from NECC."
"This could not possibly be coming from us," the salesman said, according to the filing.
"Mr. Giamei stated that NECC complied with applicable sterility procedures and had a state-of-the-art facility."
Subsequent inspections found several problems at NECC, including vials of fungus-tainted steroids.
The filing doesn't specify when the clinic began ordering the steroid blamed for the outbreak from NECC, but phone calls about pricing indicate the drug was being purchased from NECC by February 2012.
A staffer at the Nashville clinic called the Giamei just four days before his September visit to ask whether "there had been any other reports of patients with meningitis."
The salesman responded with clinic sterility test results from three lots that became the subject of a nationwide recall.
Lawyers for the clinic have refused to answer several questions, arguing that the information is exempt from disclosure under state and federal laws.