
BOSTON, Mass. — In the months before the fatal meningitis outbreak struck nationwide, the hoods in the clean room where the New England Compounding Center made tainted steroids went without cleaning for a month at a time, a former worker testified yesterday.
The hoods were supposed to be cleansed and made sterile once a day, but disinfection took a back seat to trying to keep up with soaring demand for NECC's medications, said Owen Finnegan, a former pharmacy technician whose job it was to place spinal steroids in vials for shipment to medical facilities.
Mr. Finnegan's testimony came in the trial of Barry J. Cadden, the one-time NECC president and part-owner, who has been charged with racketeering and 25 counts of second-degree murder. The now-defunct Framingham, Mass. company has been blamed for a deadly fungal meningitis outbreak that killed 76 patients across the country.
Mr. Finnegan, who said he remained at NECC until it shut down after the outbreak became public, said the sterilization lapses came in the months before the October 2012 closure. Describing the frenzied atmosphere, Mr. Finnegan said he and his coworkers were putting in 13-hour days and working 6 days a week.
He recalled a coworker warning that "something bad" was going to happen. He said workers were told that orders had to be shipped and "you've got to finish it today."
When Mr. Finnegan first went to work for NECC in 2010, he said the hoods were being cleansed and sterilized daily. He said that Glenn Chin, the supervising pharmacist, stressed to him that sterility was especially important with steroids, like the methylprednisolone acetate, which were being injected into patients' spines.
He said Mr. Chin told him that an unsterile steroid would go right up a patient's spinal column and damage the brain. "He (Chin) seemed overly concerned about a shutdown," said Mr. Finnegan.
Mr. Chin, a co-defendant in the case, is scheduled to go on trial, also on second-degree murder charges, when Mr. Cadden's case is concluded.
Under questioning by Assistant U.S. Attorney George Varghase, Mr. Finnegan said that sometimes the clean room staff would change the lot number on sterile products to fill out an order. The practice even had a name: "botching the lot," he said. He acknowledged that the practice would make it impossible for a vial to be accurately traced in the event of an outbreak or recall.
Earlier in the session, Debbie Faint, a drug buyer for the Winchester Medical Center in Winchester, Va. testified that she had been assured by multiple sales representatives for NECC that the company exceeded industry standards for sterility and its facility was "state of the art."
Ms. Faint said that when she learned that all NECC products were being recalled after the outbreak became public, the hospital immediately quarantined the drugs that had not yet been used.
She also said an NECC salesman "specifically said that we did not need patient names." Prosecutors have charged that NECC repeatedly violated state laws by shipping drugs without a patient specific prescription.
Mr. Roche, a former reporter for the Baltimore Sun and Nashville Tennessean, is covering the NECC trial in Boston for Outpatient Surgery.