NECC Quality Conrtrol Non-Existent

By Walter F. Roche Jr.

Boston- When the head of quality control at a Massachusetts company producing thousands of vials of sterile steroids expressed concern about the refusal of staffers to perform essential safety and sanitary tasks, the supervising pharmacist responded with an expletive.
That was just one of the alarms that sounded in 2012 at the company later blamed for a deadly fungal meningitis outbreak. Testifying today in the criminal trial of six of her former colleagues Annette Robinson testified that she had no experience in quality control when she was given the job and that she was not only the head of the department but also its only employee.
Testifying for the prosecution under a grant of immunity Robinson said safety and sanitation concerns were virtually ignored as the company careened towards a major disaster that ultimately sickened nearly 800 patients, killing 76 of them. Federal prosecutors have called it the worst public health crisis in the country's history caused by a prescription drug
The testimony came in the racketeering and mail fraud case against former employees of the New England Compounding Center, the now defunct firm that shipped steroids laden with a deadly fungus to health providers in 20 states including Tennessee.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Robinson said a quality control committee established after her 2010 appointment at first met monthly but in 2011 stopped meeting altogether.
She said her tasks included collecting environmental samples from the clean rooms where sterile drugs, like the methylprednisolone acetate blamed for the outbreak, were prepared. She said that despite findings of bacteria and mold, nothing was done
She said periodic competency tests required of pharmacists were not being performed and the pharmacists should not be allowed to compound drugs till those tests were completed. In fact that was an issues she raised in the Feb. 2. 2012 email to NECC supervising pharmacist Glenn Chin. He responded with two words "F--- Off."
Chin, one of 14 indicted following a two year probe of the outbreak, already is serving an eight year federal prison sentence following his conviction on racketeering and mail fraud charges. Chin's
boss, Barry Cadden, NECC's president and part owner, is serving a nine-year sentence following his conviction on similar charges.
Robinson, who testified at both prior trials, said she had no experience in quality control and her previous jobs at NECC and a sister company included spraying down bags prior to their filling by clean room technicians.
Robinson said she learned from the conversations of fellow employees that the prescriptions purportedly written for NECC products listed patient names like Donald Duck. People joked about it, she said.
She said that notwithstanding the lack of response to her quality control efforts, the only criticism she heard from superiors was that she wasn't working fast enough.
Asked what led to her appointment as the chief of quality control Robinson said she had heard that the then current head was leaving. She applied to Cadden and got the job. Asked if she had any formal training in quality control she said she didn't. She said her predecessor in the job "told me how he did it."
Though she had prior laboratory jobs Robinson said she had no training in microbiolgy and did not even know how beyond-use or expiration dates were determined for chemicals or medications.
Asked specifically about some of the defendants, she testified that pharmacist Sharon Carter, whose job was to check on outgoing orders after they left the clean room, reported to Cadden and she observed them having a lot of "closed door conversations" at NECC's Framingham, Mass. facility.
She said Gene Svirskiy, another clean room supervisor, "just stopped talking to me."
She said she didn't have that much to do with defendant Christopher Leary, who like Svirsiky was a licensed pharmacist.
Shown an NECC sales brochure distributed to potential customers, she said that claims, such as the use of strict standard operating procedures (SOPs) for drug production, were not followed. She said she couldn't even get employees to read the SOPs, never mind follow them.
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RX Tech May Have Forgotten Key Ingredient

By Walter F. Roche Jr.

Boston- A former pharmacy technician acknowledged in court testimony today that he may have forgotten to include a key ingredient, a pain killer, in drugs he prepared for injection into the eyeballs of patients under treatment at a famed treatment facility.
"I assume I made a mistake," Cory Fletcher told jurors hearing the criminal case against six of his former colleagues at the New England Compounding Center, the company blamed for a deadly nationwide 2012 fungal meningitis outbreak.
Testifying in U.S. District Court as a prosecution witness under an immunity agreement, Fletcher said that as the outbreak approached he and his colleagues were told the emphasis was on getting drugs out while safety and sanitation concerns were secondary.
Fletcher said that the problem with the eye block came just months before the meningitis outbreak, when patients at the Massachusetts Eye and Ear Infirmary complained of a burning sensation in their eyes following injections. The shots preceded cataract surgery or other eye treatments.
Fletcher said that when word first surfaced a few weeks later that a Tennessee patient, who had been injected with an NECC steroid, had been diagnosed with fungal meningitis production abruptly stopped.
All employees were ordered to begin a clean up, especially in the clean room where Fletcher worked preparing the suspect spinal steroid, methylprednisolone acetate.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Fletcher said that the cleanup was just as suddenly halted and production began again. But it was shortly after that when all NECC employees were summoned to a meeting where a temporary closure was announced. It soon became permanent.
Clean out your lockers, Fletcher said he and other employees were told at the meeting in early October.
Strachan led Fletcher through a series of NECC internal documents, including those for the preparation of a cancer treatment drug that had expired in 2007, but was relabeled to indicate it had yet to expire.
He said that less than the normal amount of fluid was added to the methotrexate powder to make it appear more potent than it actually was.
He said when another expired drug was about to be used, someone went into the company compounder and changed the expiration date.
One by one, Strachan led Fletcher through documents showing some of the defendants were involved in approving expired or untested drugs. One document even showed the initials of two defendants on paperwork approving the same drug.
The drugs were then shipped to health providers from Massachusetts to Illinois, the records showed.
Asked what happened when environmental tests showed bacteria or mold in his clean room, Fletcher said nothing was done.
Under cross examination by defense lawyer Mark Pearlstein, Fletcher acknowledged that after the mistake with the eye block was discovered, he went right back to producing more of the same drug.
Fletcher acknowledged that he had little to do with Pearlstein's client, Joseph Evanosky, a pharmacist who worked alone in a clean room corner producing parenteral drugs containing controlled substances.
He also agreed that he did not recall discussing the use of expired drugs with Evanosky or defendants Christopher Leary or Gene Svirskiy.
Fletcher acknowledged that Evanosky was quiet, did not participate in the verbal and physical horseplay with other clean room workers and was "a good guy."
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NECC Tech Worked Illegally for 2+ Years

By Walter F. Roche Jr.

Boston- A former pharmacy technician who already has pleaded guilty to nine counts of mail fraud testified today that he worked illegally for nearly three years at the drug compounding company blamed for the deadly 2012 fungal meningitis outbreak ..and the company knew it.
The prosecution witness testifying in U.S. District Court here told jurors he worked at the New England Compounding Center with the full knowledge of key officials of the now defunct firm. Those included three former NECC officials now on trial on charges ranging from racketeering to mail fraud and conspiracy.
Scott Connolly, the one time pharmacy technician, said he already had surrendered his technician's license before NECC and an affiliated company hired him in 2009. In fact, he was told they thought the clean room, where sterilized drugs were being prepared, would be "a good place to hide" him.
He said company officials told him to leave the clean room on six or seven subsequent occasions when regulators were visiting the Framingham, Mass. facility.
"It was my understanding that regulators were coming and they wanted me out," Connolly said.
Connolly's damning testimony came at the end of the second week in the trial of six former employees of NECC, the now defunct firm that shipped thousands of contaminated vials of a spinal steroid to health facilities across the country including three in Tennessee. Sixteen Tennessee patients were among 76 that died after injection with NECC's fungus laden steroids.
Connolly testimony followed that of another former NECC technician who told jurors that he and his colleagues"knew what they were doing was not right," when they shipped untested medications to healthcare providers across the country. Nicholas Booth testified that was especially true as the company ratcheted up production in the fall of 2012 on the eve of a forced shutdown.
Under questioning by Assistant U.S. Attorney, Connelly acknowledge he had reached a plea agreement with federal prosecutors that is contingent on his continued cooperation with prosecutors. His sentencing has been oput on hold pending the completion of the ongoing case.
Connolly, whose brother was also an NECC employee already has testified for the prosecution, said he had signed a confidentiality agreement in 2009 with NECC's vice president and part owner Gregory Conigliaro, one of the six defendants. He said he also discussed the loss of his state certification with his immediate boss at NECC, Gene Svirisky, another defendant in the ongoing trial.
He said a third NECC pharmacist, Christopher Leary, also a defendant, had asked him about the circumstances surrounding his license surrender.
Connolly acknowledged that he received notice of the loss of his registration from Sophia Pasedis, then the head of the Mass. Board of Pharmacy also a top official at NECC's sister firm Ameridose.
Describing his hiring Connolly said he met with now jailed NECC President Barry Cadden and Supervisory Pharmacist Glenn Chin on a weekend in 2009 in what turned out to be a tryout for the job.
Calling it"kind of a competition" Connolly said he was asked to prepare drugs in a clean room. He was asked to come again the next day and ultimately won a full time job.
Chin, like Cadden, is now serving a federal prison sentence following his conviction on racketeering and mail fraud charges.
Connolly said he was assigned to one of the two NECC clean rooms and first prepared small doses of Avastin, a drug used to treat serious eye problems. Later he began preparing cardioplegia, a drug used to stop the heart during open heart surgery. He said he worked in that clean room under the supervision of Svirskiy, though he said Svirskiy regularly left the room, leaving he and other technicians without required supervision.
Svirskiy, he said, was also "my friend" and the two socialized together and, at times, talked about getting his license back.
He said it was generally known by colleagues and superiors that he had lost his registration. That included NECC's quality control chief Annette Robinson, who hasn't been charged and has appeared as a prosecution witness in prior trials.
"They didn't come out and say it, but it was generally known," Connolly said of his license status.
He said that when he was warned that regulators were coming he went to other NECC departments, like shipping not requiring special clearance.
He said he was instructed to further shield his presence from regulators by using Barry Cadden's name to log into NECC's compounding system. He also used a secret symbol to initial company records and used a nickname "Mud Gum" on other records. The nickname was also embossed on his coffee mug, which was displayed to jurors by Varghese.
Earlier in the day Booth described his tenure at NECC. He like Connelly, started out at Ameridose, the sister firm, and later transferred to NECC, working his way up to a pharmacy technologist slot in a clean room.
Responding to Varghese's questions, Booth, speaking in a barely audible voice, was led through records showing NECC drugs were often prepared with components drawn from separate drug lots.'
Yet labels affixed to the final product reflected only the date of the lot that actually had been tested and not the newer untested lot. He agreed with Varghese that there would be no way for customers to know they were getting a partially untested product.
"At the end we were definitely doing too much," he said, citing the 2012 upsurge in orders.
Under cross examination by Dana McSherry, the attorney for Booth's supervisor Joseph Evanosky, Booth was asked if there was anything inherently wrong with mixing drug lots. The witness said he wasn't sure what was required under the industry standard.
Comparing Booth's testimony before a grand jury with his trial testimony, McSherry said Booth appeared to now remember conversations he did not mention previously.
"After six years, you now have a specific recollection," she stated.
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Tech Discloses He Filled Steroid Vials

By Walter F. Roche Jr.

Boston- A former pharmacy technician disclosed today that he was the employee primarily assigned to fill the vials of a spinal steroid that were eventually identified as the cause of a deadly 2012 fungal meningitis outbreak.
The witness, who had been called to the stand by federal prosecutors Wednesday, was cross examined rigorously today by lawyers for his former colleagues who are on trial in U.S District Court on charges ranging from racketeering to mail fraud. The outbreak killed at least 76 patients including 16 in Tennessee.
The one time technician, Owen Finnegan, said he did not feel any guilt about his role and that he did not believe anything he did caused the outbreak. He did tells jurors he thinks about it daily.
Asked if he was the one who filled the specific three lots later identified as the outbreak cause, Finnegan said, "I don't know which they were." He did acknowledge he was "the primary filler" of the vials during the key time period.
It was Finnegan's second day on the stand and all but one of the six defense lawyers questioned him on his background and training and even on something he posted on his Instagram account on his way to the courthouse.
That message, which Finnegan did not dispute, was displayed in court, along with the face page of his account: "One day when this is all over, I'll have a story to tell and no one will believe it."
Recounting the day, Oct. 3, 2012, when the New England Compounding Center shut down, Finnegan said it was during a meeting in the company lunch room that he and his colleagues were warned that regulators were on their way and they were to say nothing to the media.
Though Finnegan said it was co-defendant Gregory Conigliaro who reminded employees of company confidentiality agreements, Paul Kelly, the lawyer for one of the defendants, suggested it was Barry Cadden, the president of NECC who already has been convicted of related charges, who told employees to keep quiet.
"No," Finnegan responded when asked if he recalled that it actually was Cadden who actually delivered the message.
Under further questioning by Kelly, Finnegan said, he took over the role of filling vials of methylprednisolone acetate in 2011 when another technician quit. He acknowledged he remained in that role until NECC's final shutdown.
Finnegan, who now works as a salesman for a computer company, said he placed the steroid in vials after it had been prepared by Glenn Chin, a supervising pharmacist, with the assistance of another technician. Chin, who like Cadden was convicted of racketeering and related charges, is now serving an eight year federal prison sentence.
Finnegan agreed that the vast majority of his work as a pharmacy technician was reviewed by Chin with the remainder reviewed by one of the three licensed pharmacists now on trial.
In questioning Finnegan about his Instagram account posting, Kelly charged that the message was attached to a picture taken through his car windshield while traveling to the courthouse.
"You sent this photograph while driving," Kelly said, adding that another posting stated, "Time to thin the heard (cq)."
Though Finnegan insisted he was referring to the heavy traffic, Kelly suggested he was referring to a plan to turn on his former NECC colleagues.
Kelly then questioned the witness about his divorce and a court order attaching his pay to recoup past due child support payments. Finnegan did not dispute the court order though Assistant U.S. Attorney George Varghese entered another in a series of objections to Kelly's questions.
Citing Finnegan's purchase of a new Toyota Tundra, Kelly said, "So you decided to buy a new truck instead of paying child support."
Finnegan said his father helped with the truck purchase.
While Finnegan said Chin was a competent pharmacist, he said his supervisor lacked people skills and, he agreed, was at times a bully.
As for his other NECC colleagues, Finnegan said defendant Gene Svirskiy was "one of the most intelligent people I've ever met, while another defendant, Joseph Evanosky never engaged in the verbal and physical horseplay that predominated in their workplace.
Asked if he always performed his duties, including the cleaning of his and other work areas, Finnegan answered, "I did what was asked of me."
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Key NECC Witness Challenged by Defense

By Walter F. Roche Jr.

Boston--The testimony of a key prosecution witness was challenged today when the lawyer for a defendant said his client was vacationing in the Dominican Republic at the very time she was alleged to have been involved in an incriminating event at her Massachusetts workplace.
The challenge came during the cross examination of a former employee of the company blamed for a deadly fungal meningitis outbreak. That witness, Joseph Connolly, also has been a key prosecution witness in the prior trials of two co-defendants.
Challenging Connolly was Michael Pineault representing defendant Sharon Carter, who is one of six people on trial in U.S. District Court on racketeering and conspiracy charges stemming from a two year probe of the outbreak caused by contaminated drugs from the company that employed Carter and Connolly.
Also appearing on the witness stand Wednesday was another former employee of the defunct New England Compounding Center who testified in detail about the involvement of some of the defendants, who were licensed pharmacists yet approved the shipment of drugs that were untested. He also told jurors that NECC routinely disguised the actual source of drugs, mixing the origin of tested drugs with those that weren't.
The 2012 outbreak caused by fungus laden NECC steroids sickened 778 patients across the country killing 76 of them. Sixteen of the dead were patients in Tennessee, the state where the outbreak was first detected.
Connolly, who had been on the witness stand for several hours Tuesday, was confronted on cross examination by Michael Pineault, Carter's lawyer, who displayed passport records showing his client was vacationing in the Dominican Republic at the time when a disputed order came in.
Connolly had testified that he spoke with Carter on May 30, 2012 about the order and, after she met with NECC President Barry Cadden, he was ordered to send out the untested drugs.
Pineault said his client wasn't even at NECC on May 25 when the order was placed nor was she there on May 30, the date of the alleged conversation with Connolly.
He said that internal NECC emails showed she also had set up an automated message stating that she would be out of the office from May 25 through May 31 of that year. The emails were entered into evidence but the passport records were not.
Connolly had testified that the order to ship an untested drug came just one day after he and other NECC employees were told the operation had to be "fireproofed" and hence forward all drugs would be quarantined for two weeks, the time needed for an outside laboratory to test for purity and potency.
"So your prediction came true," Pineault said to Connolly, after noting that Connolly had predicted that the May 30 testing order would be reversed as soon as a rush order came through.
Connolly, however, said he did talk with Carter about the order and that it was his boss, Glenn Chin, who told him to ship the untested order to the Hawaii client.
Following Connolly's testimony another former NECC employee, Owen Finnegan, a pharmacy technician, told jurors that all of his work at NECC, had to be done under the supervision of a licensed pharmacist, including three of the defendants. One of the three also had to review his work preparing prescriptions before they could be shipped out, he said.
Finnegan reaffirmed much of Connolly's testimony including the extensive verbal and physical horseplay in the clean room where sterile drugs were being prepared. He described how one worker was shoved headfirst along a conveyor belt used to send completed drugs to NECC's shipping department.
"I was over there myself," Finnegan said.
Though the technician said he at first looked forward to going to work at NECC, that changed in 2012 when there was a substantial uptick in work and a downturn in quality.
Citing the increased tension to fill orders quickly Finnegan said he was at the point of looking for another job when NECC was shutdown in October 2012 as the federal investigation of the outbreak intensified.
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Witness: RX Dumped Drugs Down Sink

By Walter F. Roche Jr.

Boston- A key prosecution witness testified today for the first time that he saw one of his colleagues dumping drugs down a sink just as the word had surfaced that their employer was suspected as the source of a deadly fungal meningitis outbreak.
The surprise testimony in U.S. District Court brought a protest from the lawyer for the worker accused of disposing of he drugs. His client, Christopher Leary, and five other former employees of the New England Compounding Center are facing charges ranging from racketeering to mail fraud for their role in the deadly 2012 outbreak first detected in Tennessee.
Leary's lawyer, Paul V. Kelly, charged that prosecutors failed to inform him of the new testimony. He noted the witness, Joseph Connelly, had not disclosed the dumping incident during the prior trials of two co-defendants.
"If a witness presents new information prosecutors have an obligation to disclose it," Kelly told U.S. District Judge Richard G. Stearns, after jurors had been sent home for the day.
Assistant U.S. Attorney George Varghese acknowledged that prosecutors are obliged to to disclose so-called exculpatory evidence which would tend to clear a defendant, but argued the same precedent does not apply to incriminating evidence.
While downplaying the importance of the disclosure, Stearns advised prosecutors that "going forward" in the ongoing case such information should be disclosed.
Connelly, an NECC pharmacy technician, said he witnessed the drug dumping in early October of 2012 after employees of the New England Compounding Center were told the facility was being shutdown in the wake of the ongoing federal probe.
Connelly said Leary, a licensed pharmacist, was dumping bottles of drugs down a sink and there was a cart beside him "with more bottles to be dumped."
He said supervising pharmacist Glenn Chin was crying following a company meeting in a break room where workers were told of the imminent closure. Other employees, Connelly said, were busy cleaning the facility.
State investigators have testified the facility was heavy with the smell of bleach when they arrived later that week.
Chin already has been convicted of racketeering and mail fraud and is serving an eight year sentence in a federal prison in Pennsylvania. NECC President and part owner Barry Cadden is serving a nine-year sentence following his conviction on similar charges.
The 2012 outbreak, caused by heavily contaminated steroids injected into unsuspecting patients across the country sickened some 778 people, killing 76 of them. The six now on trial were among 14 indicted following a two year federal probe of the outbreak.
Kelly, Leary's lawyer, charged that the new Connelly testimony followed multiple sessions with federal prosecutors, sessions in which witnesses "are being prepared." The testimony, he added, was "highly prejudicial to my client."
Under questioning from Assistant U.S.Attorney Amanda Strachan, Connelly said he didn't think the NECC employee, Annette Robinson, charged with monitoring the facility for possible contamination was competent and that she never told employees what they were supposed to do to correct any problems.
Connelly, who was on the witness stand for the second day, provided detailed testimony on drugs prepared at NECC and signed off on by some of the six defendants.
They included drugs shipped the day they were produced and before promised testing could be completed. He said that as the company business expanded rapidly in 2012 "more mistakes were being made."
He said he even learned that one drug order he had personally prepared had "popped," meaning it was found to be contaminated. Another worker, he said, mistakenly filled an order for a solution of sodium bicarbonate with potassium chloride, a mistake if not detected, could have resulted in serious patient harm.
He said yet another worker sent out vials only filled with water and containing none of the ordered drugs.
"There were a lot of discrepancies," he said, adding that morale in the clean room where he worked was very low.
He recalled stating to a co-worker,"We're overtaxed. Someone's going to get hurt. We're going to get shutdown."
Under cross examination, Connelly was questioned about his brother Scott, who worked as a pharmacy technician at NECC even though he had surrendered his certification in the midst on an unrelated state investigation. He said he told Cadden his brother was a good technician but unreliable.
Scott Connelly has already entered a guilty plea to nine counts of mail fraud and is awaiting sentencing.
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Expiration Dates Falsified Even as Probe Began

By Walter F. Roche Jr.

BOSTON, Mass- Even as the investigation of a deadly outbreak was getting underway, workers at the drug compounding firm that caused the outbreak continued to falsify the expiration dates on dozens of drug doses being shipped to health care facilities across the country.
That was the testimony today of a former pharmacy technician at the defunct New England Compounding Center. He told jurors it was a routine practice to put expiration dates on drugs that went well beyond the expiration dates of its components.
The witness, Joseph Connelly, also testified about the atmosphere in the room where sterile drugs were prepared. "A locker room on steroids," he told jurors in U.S. District Court when asked to describe the verbal and physical horseplay in the NECC clean room.
His testimony came as the trial of six former NECC employees entered its second week. The six face charges ranging from racketeering to conspiracy and mail fraud.
Another prosecution witness, who was employed by an affiliated company, told jurors that he saw a mat at the entrance to that clean room that had turned dark brown apparently from accumulated dirt from the shoes of workers. He also described autoclaves turned brown in the same clean room.
However, the witness, Michael Andolina, underwent sharp cross examination from a defense attorney who used floor plans to question what he saw and where he saw it.
The 2012 outbreak was caused by fungus laden steroids shipped from NECC's Framingham, Mass. facilities to more than 20 states. The outbreak killed 76 patients including 16 in Tennessee. Hundreds more were sickened. Though not made public till early October, the probe began in September based on the report of a rare form of fungal meningitis by a Nashville physician.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Connelly detailed how the expiration dates on eight different drug shipments were falsified so that the expiration date of the final product exceeded the expiration of its components.
They included drugs shipped in late September of 2012 that carried a Jan. 25, 2013 expiration date even though a components had a Nov. 29, 2012 expiration date. Connelly testified the drugs were shipped to three health facilities with the false dates.
Connelly, whose brother also worked at NECC and has already entered a guilty plea to a related charge, said NECC routinely shipped drugs on the same day they were processed, making it impossible for promised testing by an outside laboratory to be completed.
Asked about one drug batch he prepared, Connelly said it was shipped the same day it was processed with the approval of one of the defendants, Gene Svirskiy, a licensed pharmacist.
He said another defendant, Alla Stepanets, told him that the expiration date on another batch of drugs was being extended from 120 to 180 days on orders from Barry Cadden, NECC's president.
Cadden, who was tried separately, is serving a nine year prison sentence following his conviction on racketeering and mail fraud charges. Both Andolina and Connelly testified at Cadden's trial.
Andolina, who said he was hired to work for an affiliated marketing firm, said he set up cameras to record Barry Cadden conducting training sessions for NECC's sales force.
On excerpts from the training sessions played for jurors Cadden bragged that inspectors from the state agency that licensed NECC "don't even know what they are looking for."
"I had to educate them," Cadden said, adding that later when complaints came in from other states, the Massachusetts inspectors "just told them to go away."
Andolina, however, was challenged about his testimony about what he saw in the NECC clean room. Confronted with floor plans of NECC's facilities, Andolina said his original description "was the best I can recall."
Asked about the original condition of the dirty sticky mat he saw at the entrance to the clean room, Andolina said he knew they were white.
Attorney Paul Kelly then presented a video showing the new mats are actually blue.
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