Friday, February 17, 2017

Former NECC Official Thought She Caused Outbreak

By Walter F. Roche Jr.

The quality control manager at the New England Compounding Center said she had to leave the office in 2012 when she broke down because she mistakenly thought she was the cause of a deepening fungal meningitis outbreak with a mounting death toll.
"Oh my God people are dying," Annette Robinson recalled thinking. "I actually felt I had caused this."
Robinson was testifying Friday for the second day in the trial of Barry Cadden, the former president and part owner of now defunct NECC. Cadden, a Wrentham, Mass. resident, has been charged with racketeering and 25 counts of second degree murder,
Robinson, who also testified that Cadden ordered her to falsify multiple NECC drug mixing records, said she thought she might have caused the outbreak when she did some surface testing on NECC equipment. That equipment, a glove box, was used in making the steroid ultimately blamed for the 2012 fungal meningitis outbreak which took the lives of 78 patients across the country.
Robinson said she had been called into work by Cadden to help with the recall of the thousands of vials methylprednisolone acetate, the cause of the outbreak.
"I couldn't do it anymore," Robinson said and then burst into tears. "I went home. Everyone was looking at me."
Robinson, who a day earlier testified that Cadden did nothing when she reported that mold and bacteria had turned up in a clean room used for making sterile drugs, underwent extensive cross examination by Cadden attorney Michelle Peirce.
Peirce repeatedly challenged Robinson's Thursday testimony on several key points including the assertion that Cadden did nothing when informed of adverse test results both from within NECC and an outside testing laboratory.
Showing Robinson a report on one drug that was found out of specification, Peirce said, "You didn't remember seeing it, did you?"
Flustered Robinson responded,"I don't remember anything, You're answering my questions for me. Barry does know about them," she said, adding that she always sent the adverse test results to Cadden.
In earlier questioning by Assistant U.S. Attorney Amanda Strachan, Robinson recounted how Cadden called her into his office and told her to alter on records of media fills, chemicals mixed for microbiological testing.
She said he instructed her to cross out the name of the employee who actually performed the task and put his initials in its place.
"It took a few hours," she said.
Some of the records altered dated back to 2008.
She said the task was assigned at the same time Cadden wanted to eliminate any"paper trail" showing that an unlicensed technician, Scott Connolly, had been working in the NECC clean room.
"My heart sank," Robinson said. "He asked me to do something that was wrong, but I did it because he was my boss."
Connolly is a codefendant in the case and is scheduled for trial in April.

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