Bacteria, Fungus Found in NECC Samples

By Walter F. Roche Jr.

Boston - An official from an Oklahoma testing laboratory testified today that increasing numbers of drug samples from a Massachusetts compounding firm were testing positive for bacterial or fungal contamination in the Fall of 2012.
In fact, Tiffany Hyde, a senior microbiologist,from the Analytical Research Laboratories (ARL)in Oklahoma, testified that some samples from the New England Compounding Center (NECC) tested positive for the presence of both bacteria and fungi.
Hyde, was testifying in the criminal case against six former employees of NECC who are facing charges ranging from racketeering to conspiracy. They were indicted following a two year federal grand jury probe of the 2012 fungal meningitis outbreak. Some 76 patients, including 16 from Tennessee, died in the 2012 outbreak.
Hyde said ARL was hired by NECC to perform tests on the drugs the compounding firm was shipping to doctors and health facilities across the country.
Nonetheless, Hyde told jurors, NECC only sent two samples from each lot for testing, an amount far below the numbers mandated under minimum requirements set by the U.S. Pharmacopoeia, the non-profit industry standard setter.
And, she added, only one of the two samples was tested for bacteria. The second was tested for potency.
The alarming test results showing bacterial and fungal contamination came just as the details of the deadly outbreak were becoming public. The outbreak source was eventually traced to fungus laden steroids from NECC. Hyde also testified that the initial tests on the specific three drug lots ultimately tied to the deaths showed no contamination.
But, she said that NECC had only asked her firm to test for bacterial contamination and it was only after the outbreak began to emerge that the Framingham, Mass. company began asking for fungal tests.
They (NECC) had never asked for the fungal tests before, Hyde said, adding that the company also then asked for the first time for fungal tests on vials and stoppers used by the company.
Hyde said the NECC samples tested at the time eventually showed fungi growth she had never seen before. It was so strange, she said she took photographs.
One fungus, she said, was a large cotton-like ball with white filament but it later took on a blackish green color.
"I thought it was interesting," she said under questioning by Assistant U.S. Attorney George Varghese.
Hyde said that on one occasion when she contacted NECC about the contaminated samples, she was instructed not to do any further testing because it would be cheaper for NECC to just throw out the whole lot.
Later she said the company stopped responding to her calls and emails. Ultimately federal investigators advised ARL to stop communicating with NECC.
She said ARL testing showed bacterial growth in NECC antibiotics used to irrigate open surgical wounds. Other NECC drugs cleared preliminary tests, only to show contamination after two weeks, the standard waiting period.
Other witnesses testifying were officials from hospitals in Virginia and New York, who detailed the NECC drugs purchased and the promises by NECC sales representatives that the company complied with all industry sanitary standards.
Under cross examination by defense attorneys, the witnesses acknowledged they never had any direct dealings with any of the six defendants.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Andrew Cordiale, the former drug purchaser at the Glens Falls Hospital, said he was advised that when he made up names of patients when ordering from NECC to make them sound real, otherwise it would be "a red flag."
Prosecutors have charged that NECC sought the patient names to get around state and federal laws requiring a patient specific prescription for every dose of a compounded drug.
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Outbreak Victims Still Face Roadblocks to Aid

By Walter F. Roche Jr.

Martha Schulz, a 77 year-old Columbia resident, was injected three times with a steroid produced by a now defunct Massachusetts compounding firm. Not long after the last shot she became ill and suffered a stroke and several other ailments.
That was the same fate suffered by dozens of other Tennessee victims who were injected with tainted drugs from the then little known drug firm.
Like others sickened by drugs produced at the New England Compounding Center, she and her husband applied for funds set up in the NECC bankruptcy. They applied and were qualified. They also qualified and received payment from a separate fund set up for Tennessee victims of the outbreak.
So when they learned that $40 million had been allocated by the U.S. Justice Department to a separate fund to provide assistance to NECC victims they submitted an application to the Massachusetts Attorney General's office, the agency designated as the administrator of the Crime Victims Compensation Fund.
Under the program victims of NECC can collect up to $25,000 to reimburse them for out of pocket and other expenses incurred as a result of the injections. Survivors of victims who died can collect even more.
But the Schulz family was in for a surprise. Their claim was rejected not because the cause of her illness was disputed but because she became ill too soon.
Massachusetts officials contend they can only make awards to victims who were injected with methylprednisolone acetate in three specific lots of the drug produced by NECC between May 1, 2012 and Oct. 15, 2012.
Records show Martha Stuart was injected from an NECC lot shipped to the Saint Thomas Outpatient Neurosurgical Center on June 16 of 2011.
A physician who examined her after she suffered a stroke in August of 2011 signed a statement concluding that in his medical opinion "it was more likely than not" that her illnesses "occurred as a direct result of bacterial contaminated methylprednisolone acetate manufactured by the New England Compounding Center."
Terri Lewis, a Tennessee resident and patient advocate, is not an outbreak victim, but has helped dozens of victims who have run into a variety of roadblocks in getting assistance. She says the Schulz family is but the latest example of victims being denied assistance on a technicality.
Lewis said that despite loud and repeated protests the U.S. Centers for Disease Control and Prevention (CDC) limited the class of victims to those injected with the three 2012 lots.
She said this was so even though all unused NECC drugs were eventually ordered recalled, including some produced in 2011.
"The exposure was in my estimation completely and inappropriately delimited," Lewis wrote in an email response to questions," adding that the arbitrary boundary omitted victims sickened by other NECC products contaminated by bacteria and fungus.
In fact in criminal cases stemming from the outbreak federal investigators have testified about several other contaminants found in other NECC products. And NECC owners have been charged with conducting a criminal enterprise dating back to at least 2008.
Two of the 14 originally indicted already have been convicted on the racketeering charges and are serving jail terms. Six more are now on trial in U.S. District Court in Boston.
Schulz noted that the Tennessee Health Department issued a notice of recall for any NECC products issued from May of 2011 till the company's Oct.3, 2012 shutdown.
Stuart Schulz said a bacteria found at NECC's production facility in Framingham, Mass. was related to the same bacteria that infected Martha's heart, damaging her heart valves and leading to the stroke.
"Many more organisms of illness were producing sick people who were never included in the recall class," Lewis said.
Stuart Schulz said his wife has never fully recovered from the illnesses brought on by the 2011 injections,
"My wife has dementia now, hastened by the stroke, and cannot recall what has happened. I'm trying to cover all of her bases that are out there for her and this "Victims Fund" is one of them," he said.

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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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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