The federal murder trial of a pharmacist who oversaw a contaminated cleanroom continues, as a health official this week gave detailed testimony about the deaths of 20 victims of fungal meningitis outbreak.
Ann Burgess, who holds a Ph.D. in nursing, talked yesterday about over two dozen victims of the outbreak from seven states during her testimony in U.S. District Court. She was serving as a prosecution witness in the trial of Barry J. Cadden, former co-owner and president of the New England Compounding Center in Framingham, Mass. Photos of the victims were shown to the jury as Burgess described how, in nearly all cases, fungal meningitis was the direct or secondary cause of death.
An investigator from the FDA also testified in the trial, saying that NECC had shipped three lots of fungus-contaminated methylprednisolone steroids to several health facilities. One facility in Nashville received four shipments of over three thousand vials each between June 2012 and September 2012. NECC shut down in October 2012 after news spread of the outbreak. The FDA official, Joseph Ridgley, also added that some of the drugs didn’t have the required potency, and others contained expired ingredients.
Ridgley further stated that co-defendant Scott Connolly, who was not registered as a pharmacy technician as required under Massachusetts law, compounded the drug cardioplegia, which was shipped to a hospital in Las Vegas hospital prior to its test results coming back. Connolly used Cadden’s initials to sign company records, according to Ridgley.
During cross-examination, Cadden’s lawyer asked how Cadden could be charged with a felony since a NECC cleanroom worker didn’t add enough ingredients to a drug.
Last week, another FDA investigator, Stacey Degarmo (lead FDA investigator assigned to the 2012 fungal meningitis outbreak), testified that the fungus-contaminated steroids had only been sterilized by NECC for under half the recommended time — a practice which dated back to 2009, NECC records show. She stated that NECC records show that the steroids only spent 15 minutes in an autoclave, although the autoclave’s manual recommended 31 minutes, and NECC’s own instructions called for 20 minutes at 121 degrees. Degarmo further stated that she had requested validation from NECC that a 15-minute autoclave treatment would be sufficient but she did not receive a response. Additionally, she testified that NECC tested its steroids in bulk rather than testing individual vials, and the vials were shipped out even before the sterility tests came back.
Degarmo also stated that, upon her arrival at NECC, she observed a large pile of crumbling mattresses was stacked up near the building, and heavy equipment being operated in the area was kicking up clouds of dust and particulates. She performed environmental sampling tests on Oct. 1, 2012, and concluded that 11 of the 41 samples tested positive for mold and/or bacteria. Her tests also detected yeast in the air conditioning and heating unit, and the mold/bacteria findings included specimens in a cleanroom pass-through, inside the glove of a glove box that had been used to assemble sterile drugs, on a floor mat at the cleanroom’s entrance, and around a boiler surrounded by a pool of leaking water.
Cadden’s attorney fired back during cross-examination, asking Degarmo why the FDA waited several days after learning about the outbreak before they dispatched investigators to the compounding center. He cited internal FDA emails and documents when asking her why the FDA was concerned about joining an investigation already begun by the Massachusetts Board of Pharmacy. Degarmo answered that, while she knew that the FDA’s authority over compounding pharmacies had faced past challenges, it wasn’t a major factor in the NECC case, and the FDA obviously possessed the authority to examine any cases involving adulterated drugs. She further stated that she and her team joined the team from the Massachusetts Pharmacy Board on the first inspection because that agency had priority to order the NECC to produce records in case NECC refused.
Samuel Penta, an investigator for the Massachusetts Pharmacy Board, testified on Feb. 15 that he had observed filaments and black spots in containers of methylprednisolone acetate in vials of steroids made by NECC. Penta said that he first heard of a possible meningitis outbreak on Sept. 24, 2012, and joined a conference call the next day along with officials from the Tennessee and Massachusetts health departments, the CDC, the FDA, and the New England Compounding Center.
The FDA was first able to test a vial on Oct. 3, and discovered fungus, Penta said in his testimony. He stated that, when his boss, James Coffey, initially reached out to NECC, Cadden replied that steroids had indeed undergone sterility testing and “they didn’t believe it was their product.” Coffey then ordered that NECC quarantine all products until further notice, and sent Penta to visit the NECC the next day. Penta testified that he smelled “the distinct odor of bleach” upon his arrival at NECC, where he was let inside by Gregory Conigliaro, New England Compounding Center’s vice president — the Conigliaro family ran a mattress recycling business near the NECC building.
“They were cleaning inside the cleanroom, wiping down with alcohol,” Penta stated. Under cross-examination he admitted that Cadden and Conigliaro complied with Penta’s requests for data, but did not provide the requested information about drug expiration dates.
A woman hired to do quality control at NECC from 2005-2012 testified that she received little training, had no prior environmental monitoring experience, and observed lax work ethics during her time at the compounding center. Annette Robinson said that was simply instructed to shadow her predecessor and was not trained in USP guidelines before taking on the role. She stated that Cadden hired her to work as a pharmacy technician in the non-sterile lab, and observed fake prescription names such as “Mickey Mouse” and “I need a nap” on NECC orders signed off by Cadden. She received a promotion in 2007 to the quality control position, and was tasked with monitoring the cleanroom for mold and bacteria as well as dispatching NECC medications for testing. Robinson said that it was tough to nail Cadden down for their scheduled monthly meetings on environmental monitoring, as well as getting him to go over standard operating procedures with her —she testified that SOPs were not followed at NECC.
Robinson further stated that she saw alarming mold and bacteria results from NECC cleanroom testing in 2012 nearly every week, and highlighted them in red on her reports “so it would hit them in the face.” She testified that she notified Cadden about test results reaching “action levels” around one of the cleanroom hoods in the cleanroom, but he advised her to simply change the number considered “action level” for that particular hood. She said that Cadden brought up these concerns with cleaning company Uniclean, which visited NECC once a month, but he did not bring in a microbiologist, order supplementary cleaning, or investigate the cause of the mold. She said that the “report card” NECC showed to customers displayed near-perfect environmental testing results; however, these did not reflect the reports that she had provided to Cadden, she said.
In her testimony, Robinson said she held responsibility for NECC’s cleaning logs but the technicians didn’t fill them out the right way. She also stated that, for weeks, nobody noticed when no cleaning log was available; she observed hair in the cleanroom on several occasions; and the air conditioner was frequently shut off or broken and temperatures climbed up to around 100 degrees.
She also stated that she observed bugs in the cleanroom, which technicians killed using alcohol, and the cleanroom floor was so badly cracked that pieces would come off every time someone mopped. “We’ll wait until they get a little worse,” Cadden replied, according to Robinson, who added that the floor was never fixed.
U.S. Department of Defense investigator Sara Albert took the witness stand on Feb. 14 to read emails from Cadden, which included phrases such as”Bottom line is we cannot get caught with our pants down to our ankles” and “Just relabel the old stuff.” Other emails discussed a “fungal bloom” found at the facility, and mice infesting a restricted area. Other emails from 2012 contained a reference from Cadden about drugs that had expired back in 2007, and another about a cleanroom pharmacy tech still working even though he had lost his license.
Cadden’s lawyer, Bruce Singal, pointed out during cross-examination that Cadden had sent out a series of emails to staff, scolding them for using fake names like Mickey Mouse and Donald Duck rather than getting the actual names of patients who were being treated with NECC drugs (Massachusetts law states that the compound pharmacy was allowed to produce custom drugs for individual patients by prescription, but it was illegal for NECC to mass produce drugs without a prescription for each dose of the medicine).
Barry Cadden is facing 25 counts of murder for the 2012 fungal meningitis outbreak, which resulted from steroids compounded by NECC. He is also facing racketeering charges. The outbreak killed 64 people and sickened over 700 others.