Key Evidence Introduced But Questions Blocked

By Walter F. Roche Jr.

Boston- A federal prosecutor literally broke down today after a federal judge blocked her from questioning a witness about an email from the vice president of the drug compounding company blamed for a deadly fungal meningitis outbreak.
The email, which was sent to state regulators on Oct. 1, 2012 included test results showing the drug company had conducted extensive testing and nothing was amiss going back to May 1 at the facility where three batches of suspect sterile drugs were prepared.
U.S. District Judge Richard G. Stearns allowed the email to be entered into evidence, but, on a motion from a defense attorney, blocked further questioning. He did so after the witness, the one time head of quality control at the defunct New England Compounding Center, said she knew nothing about the report.
After the ruling Assistant U.S. Attorney Amanda Strachan coughed and appeared to be on the verge of tears. After a colleague brought her a cup of water she paused a bit longer before resuming questioning of Annette Robinson, a key prosecution witness.
The scene came on the 15th day in the trial of six one-time employees of the now defunct New England Compounding Center. They face charges ranging from racketeering to conspiracy and mail fraud. The six and eight others were indicted in late 2014 following a two year probe of the outbreak which took the lives of some 76 patients, 16 of them in Tennessee.
The email shown briefly on monitors in the courtroom, was sent on Oct.1, 2012 from Gregory Conigliaro, the vice president and part owner of NECC, to James Coffey, then the executive director of the Massachusetts Board of Pharmacy. Attached were a list of test results taken in the clean room where vials of a spinal steroid were prepared, according to Conigliaro's email.
The attached test results indicated key areas had no indications of problems while some contamination was indicated on the floor of the clean room.
Coffey was later fired from his state job after an investigation showed he had failed to inform the board of a complaint filed against NECC in Colorado. The email was also sent the state board investigator Samuel Penta. Lawyers for Conigliaro have filed notice that they may call Coffey as a defense witness.
Conigliaro is facing a single charge of conspiracy to defraud the U.S. Food and Drug Administration.
Strachan asked Robinson, whose job it was to ensure quality control at NECC, if she had ever seen the results attached to Conigliaro's email.
"Are these results you had anything to with?" Strachan asked.
"No," Robinson answered.
Defense lawyers then objected to further questioning.
"You already established she (Robinson) had no role in creating the document," Stearns said in granting the motion to block further questions.
When Strachan resumed she asked Robinson about the events leading to NECC's shutdown in early October of 2012.
The witness, who was testifying under an immunity agreement, said she was asked by NECC President Barry Cadden to alter company records that showed he had failed to perform required tests, called media fills, of his ability to perform a pharmacist's duties. As instructed, Robinson said, she created records to make it appear that Cadden did perform the periodic skills tests.
She said she was also assigned to perform new environmental sampling tests along with an employee of Ameridose LLC, a sister firm to NECC. She said tests could not be performed in the exact area where the suspect drug was compounded because the equipment had been taken apart and was being cleaned. The same finding was included in the test results Conigliaro emailed to the state board on Oct. 1.
Robinson said Cadden then assigned her to send out a variety of drug samples and other laboratory items to be tested for fungus. She said the company had never before had fungus tests performed.
By that time state and federal regulators strongly suspected the growing outbreak was caused by a fungus. A Tennessee victim already had been diagnosed with fungal meningitis, a rare form of the disease.
Robinson said after the Oct. 3, 2012 closure she worked one more week at the Framingham, Mass. facility but stopped abruptly because she was concerned that she might have caused the outbreak. She said she had inadvertently touched a piece of equipment in the area where the suspect drugs were prepared. Later, she said, she learned she wasn't the cause.
Robinson was then questioned extensively by Jerome Sternberg, representing defendant Gene Svirskiy, who worked as a pharmacist at NECC. Going through the resume she submitted when she first applied to NECC, he questioned her experience in quality control at prior employers.
"I did not have training. I trained people," she said in a sometimes testy exchange.
Asked if she was detail oriented, she said, "I did my best at it."
Citing her prior testimony before a grand jury, Sternberg asked if she was embarrassed as she testified at the way she handled the standard operating procedures at NECC, including the requirement for staffers to review and follow them.
"Yes, I was embarrassed because I couldn't get them done," she responded.
A day earlier she had stated that she couldn't get employees to even read the SOPs.
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