Investigator Details Unraveling of Deadly Outbreak

By Walter F. Roche Jr.

An investigator for the Massachusetts Pharmacy Board said that when he finally took a close look at the vials of steroids in a Framingham, Mass. drug company he knew something was very wrong.
Samuel Penta testified that he saw filaments and black spots in the containers of methylprednisolone acetate at the New England Compounding Center. He said he didn't know at first what it was but knew it shouldn't be there and certainly not injected into someone's spine.
"What we saw were visible contaminants," Penta said. "We just knew it shouldn't be there."
Penta was called as a prosecution witness in the trial of Barry J. Cadden, the one time NECC president and chief pharmacist. He has been charged with racketeering and 25 counts of second degree murder in the death of 25 patients, including seven from Tennessee.
The deadly 2012 fungal meningitis outbreak federal and state regulators have concluded was caused by fungus riddled spinal steroids produced by NECC. In fact Cadden's lawyers have conceded that NECC products caused the outbreak.
Penta said he first got word of a possible outbreak on Sept. 24 and the next day participated in a conference call with officials of the Tennessee and Massachusetts health departments, the U.S. Centers for Disease Control and Prevention, the U.S. Food and Drug Administration and NECC.
He said the Tennessee cases were the first to signal an impending outbreak, though they later learned there was an earlier case in North Carolina.
But it wasn't until Oct. 3, Penta testified, when the FDA was able to test a vial and found fungus.
Penta said that the Tennessee cases were "a likely cluster" and attention at first centered on three possible sources: the steroid, a dye used in injecting patients and lidocaine, a painkiller.
He said when his boss first contacted NECC, Cadden told him that the steroids had been tested for sterility and "they didn't believe it was their product."
Nonetheless James Coffey, then Penta's boss, ordered NECC to quarantine all products until further notice.
He said when he made a visit to NECC the next day he was hit with "the distinct odor of bleach" as soon as Gregory Conigliaro, NECC's vice president, let him in the door.
"We took a walking tour of the facility," he said adding that he was surprised at the volume of drug products being processed.
"It was massive. It was manufacturing not compounding," Penta said under questioning from Assistant U.S.Attorney George Varghese. "It was well beyond compounding."
"They were cleaning inside the clean room, wiping down with alcohol," he said. Later he was shown a photo of the clean room and said signs of contaminants on a hood used for sterilizing drugs were visible through a window outside the room.
He was shown a picture of a boiler with a pool of water at its base and said it was located within the NECC facility.
Penta said that when they took a walk around the outside of the NECC building they discovered a mattress recycling operation only 100 yards from the drug compounding area. (The mattress recycling business was run by the Conigliaro family)
Penta said that when he did finally get a chance to inspect a vial of the methylprednisolone acetate, "We saw floaters and black spots," he said, adding that powder was gathered at the bottom of the vial and was sticking to the side. "You could see there was some defect in the product."
Under questioning from Michelle Peirce, one of Cadden's lawyers, Penta acknowledged that Cadden and Conigliaro were cooperative and responsive to his requests for data, but said he never did get requested information about drug expiration dates.
He also acknowledged that NECC underwent a successful inspection in 2011 after some renovations were completed.
Responding to a question from Peirce, Penta agreed that research was conducted by regulators to determine if NECC could be forced to provide samples.
"We had to have a plan in case he said no," Penta said.
Penta was also asked if Dr. Marion Kainer, a Tennessee Public Health official, was among the people participating in the Sept. 25 conference call. He said he didn't know.
Kainer, who played a major role in handling the Tennessee outbreak, has been listed as a possible prosecution witness.
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