Testimony Links Trail of Contamination

From Donna Borton

Prosecution witnesses today linked the deadly steroids that killed 11 Michigan patients in 2012 back to their source, a Massachusetts drug compounding company where the two defendants now on trial for second degree murder worked.
The witnesses from the U.S. Food and Drug Administration testified about drugs from a Michigan clinic and traced them back to the New England Compounding Center where filthy and unsanitary conditions were found despite a last minute clean up effort.
The testimony before Livingston District Court Judge Shauna Murphy came in a pre-trial hearing in the cases of Barry J. Cadden and Glenn Chin, who are facing the second degree murder charges for their roles in the 2012 fungal meningitis outbreak which killed dozens of unsuspecting patients, who were injected with steroids laden with deadly fungi.
Eight victims or their survivors were on hand for the session.
The hearing is being held to determine if there is sufficient evidence to bring the case to trial. Cadden and Chin, both pharmacists, already are serving federal prison terms for their roles in the outbreak. Cadden was NECC's president and part owner, while Chin was an NECC supervising pharmacist.
FDA Special Agent Benedict Celso described how 229 vials of methylprednisolone acetetate were sent to the FDA from Michigan Pain Specialists and other sites where Michigan victims had been injected.
He described how the vials were logged in as evidence and then sent out for testing.
The attorney for Barry J. Cadden at one point asked for Celso's testimony to be stricken from the record because he said his cross examination was being limited. The motion was denied.
Celso's testimony was followed by Almaris Alonso Claudio,an FDA microbiologist who went to examine NECC's Framingham, Mass. facilities as the outbreak began to explode in the fall of 2012.
She described finding heavily dirtied sticky mats at the entrance to the clean room where the steroids had been prepared. She said grass, which can be a breeding ground for fungus, was observed on the mats.
She testified that on a tour of the NECC plant she observed leaking water and said records showed humidity spiked at night at NECC because the air conditioning was turned off.
She said that when she learned the identity of the fungus they were searching for - aspergillus fumigatus - she became concerned and ordered specially fitted masks for herself and her staff.
She also described how NECC had an open pass through which was used to transfer items to and from the clean room.
Another concern she cited was that the presence of condensation in an autoclave used to ensure sterility of drugs being produced. Under cross examination she said that once a cycle has been completed the inside of the autoclave should be dry.
The final witness was FDA microbiologist David Craft who testified about the tests conducted on 29 of the vials of methylprednisolone acetate gathered in Michigan. He said five of the 29 tested positive for fungi.
Testimony will continue Thursday at 8:30 a.m.