The quality control agent in charge of environmental monitoring in the New England Compounding Center’s cleanroom has testified that her email to the supervising pharmacist — which expressed concern that lab technicians had not completed reading the standard operating procedures — was met with a crude and abrupt reply.
Glenn A. Chin, the supervisory pharmacist said to be involved in the 2012 meningitis outbreak that killed 64 people and sickened more than 700 others throughout the U.S., is facing federal trial in Boston. The former New England Compounding Center employee is being charged with second-degree murder and conspiracy, as well as other racketeering charges.
Annette Robinson was hired as a quality control agent by former NECC president Barry Cadden, who earlier this year was acquitted of second-degree murder charges but was later sentenced to nine years in jail for racketeering and fraud charges.
Robinson, who had no professional qualifications when she was brought on board as QC, said she replaced another employee who had left, and her duties included conducting environmental monitoring in NECC’s cleanrooms, dispatching products for testing, ensuring staff members read the Standard Operating Procedures for compounding various drugs.
Robinson testified that she was afraid of Chin, saying that he regularly cursed at her and raised his voice. She described a 2010 email to Chin concerning three lab technicians that read that they “still haven’t read the SOPs. I know you guys are still busy. Any suggestions?” followed by two smile emojis.
Chin’s reply, according to Robinson: “F— off!!!!”
Read more: Pharmacist’s Email: Cleanroom Practices “A Disaster Waiting to Happen” https://www.cemag.us/blog/2017/10/pharmacists-email-cleanroom-practices-disaster-waiting-happen
Robinson also said that environmental tests showing nearly perfect scores were falsified, and she didn’t even see the document before it was sent the Massachusetts Board of Pharmacy by Barry Cadden. She also wept on the stand (as she had at Cadden’s trial) for what she felt was her role in the meningitis outbreak, because she had inadvertently touched a piece of cleanroom equipment … she did not report this to Chen, she said, because another employee cautioned her that Chin would throw her under the bus if he found out.
Robinson stated that nothing was done after her environmental tests showed evidence of fungus or bacteria, including a “hot spot” where methylprednisolone acetate — the drug which caused the deadly meningitis outbreak — was being prepared. She also stated that staff members didn’t perform their required daily and monthly cleaning assignments, and only initialed the cleaning log sheet at the end of the month. She further stated that, on occasion, she found both bugs and human hair in the cleanrooms. “Yes there are a lot of hairy zoo animals in the room,” read Chin’s email reply to Cadden on this subject.
The prosecution also produced an email sent by Chin to an official of a sterilizing device manufacturer which stated that he wasn’t sure how long drugs had to be placed in an autoclave to assure sterility. The email was sent from Chin’s personal computer on Oct. 12, 2012, which was more than a week after the outbreak had become public and victims had died.
Chin’s lawyers cross-examined Robinson, asking her if she held a personal grudge against Chin and questioned her about her earlier testimony that Chin was present when Cadden stated that a necessary test wasn’t being performed — Robinson replied that she wasn’t sure if Chin had been in the room. Chin’s attorney also questioned Robinson about how she was testifying after being granted immunity and how she had a lawyer representing her during her initial questioning by federal prosecutors, suggesting that she might be out simply to save herself. Robinson replied that the NECC and Cadden had supplied the lawyer for her. The defense further asked her why she hadn’t reported any of the cleanroom violations or cleaned them herself, and why Cadden would possibly hire someone with no professional experience for a QC position.
An FDA microbiologist also took the stand to express her surprise at finding almost a dozen mold growths in the cleanroom even after the facility had been cleaned for two days. Almaris Alonzo said there was a “high level of contamination” in the cleanroom, describing pooled water near a boiler and grass on the sticky mats — some of which was dragged into the cleanroom — positioned before the drug preparation area. Jury members were shown were shown photos of Alonzo and other investigators examining the cleanroom while clad in gas masks. Chin was also included in the photos.
Chin’s trial comes six months after Barry J. Cadden, former co-owner and president of the New England Compounding Center in Framingham, Mass., was acquitted of murder in March 2017. Cadden was facing 25 counts of second-degree murder. The jury heard nine weeks of testimony and then deliberated for five days before presenting their verdict. Cadden was convicted of racketeering and fraud charges in June 2017, and was sentenced to nine years in prison — he is currently serving his time in low-security federal penitentiary in Pennsylvania.
Read more: Verdict Reached in Meningitis Case https://www.cemag.us/blog/2017/03/verdict-reached-meningitis-case