Doctor Says Prescriptions Were Faked

By Walter F. Roche Jr.


Boston-The former chief medical officer at a Boston hospital testified that he never issued the prescription that a drug compounding company provided to a state board showing him as the prescribing physician.
Dr. Sunil Eappen also told jurors in U.S. District Court today that the patients listed on some 300 fake prescriptions never even got the drug listed although they were patients at the Massachusetts Eye and Ear Infirmary.
Prosecutors say the fake prescriptions were part of an attempt by the now defunct New England Compounding Center to hide the fact that it was breaking a state law requiring individual patient specific prescriptions for every dose of drug it sold.
The testimony came as the prosecution started to wind up its case against six former employees of NECC, the company blamed for a deadly 2012 fungal meningitis outbreak. The jury is expected to begin deliberations next week.
Eappen, who is now the chief medical officer at Boston's Brigham and Women's Hospital, said the drugs provided by NECC were supposed to numb patients eyes before undergoing eye surgery, but they discovered the so-called eye block did not contain the required amount of lidocaine.
"We learned that the lidocaine was only 10 or 20 percent. The block wouldn't work," Eappen said, adding that not only would patients feel pain but the eye itself would not be immobilized as required during surgery.
He said both patients and doctors had complained, prompting an inquiry that led to the discovery that the NECC drugs were sub-potent.
"I had never seen that before," Eappen said.
Under questioning by Assistant U.S. Attorney George Varghese, Eappen said the names listed on the prescriptions came from a roster of patients who had undergone laser treatments at the hospital and they would not have been treated with the eye block.
Other doctors names on fake prescriptions included physicians, like a plastic surgeon, who would never have use for an eye block, Eappen said.
Asked if the use of the patient names was proper, Eappen said it was not.
He said the hospital considered the problem with the sub-potent eye block to be serious and reported the matter to the state Board of Pharmacy. In fact it was that report which triggered an inquiry by the state board and the subsequent response from NECC, including the 300 fake prescriptions.
In other testimony Eric Kastango, a licensed pharmacist and expert in the compounding of sterile drugs, said NECC was "gaming the system," when it changed the beyond use dates on drugs.
He said that was especially true when the company shipped doses of methotrexate, a cancer treatment drug that had expired years earlier.
He said that natural degradation of that drug could produce toxic chemicals harming patients.
Kastango, who has served as a consultant to federal prosecutors, said NECC failed to take action even when its own monitoring tests showed the presence of mold and bacteria in a clean room where sterile drugs were being prepared.
He said matters only worsened when the company turned off the air conditioning in the building at night.
"It's like saying,'Come on and grow," Kastango said referring to the effect of heat and humidity on bacteria and mold.
Under cross examination by Mark Pearlstein, Kastango was confronted with articles he had co-authored which indicated problems in clean rooms, especially in hospitals, were widespread.
Pearlstein, who represents defendant Joseph Evanosky, also questioned Kastango about a presentation before a group of health officials which concluded that the root cause of calamities like the fungal meningitis outbreak was a lack of leadership.
Kastango said he never made that presentation, but the person who did had used his slides.
Asked if it wasn't NECC President Barry Cadden who, as the pharmacist-in-charge, was ultimately responsible for what went on at the company, Kastango said it was. But, he added, that pharmacists who witnessed unsanitary conditions in the workplace, had "a responsibility" to do something.
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Gov. Expert: NECC Skipped Key Tests

By Walter F. Roche Jr.

Boston-An expert witness testified that the Massachusetts company that caused a deadly outbreak was not even bothering to conduct some critical tests for sterility on its products and even when it did send samples for testing, it did not test a sufficient number to assure a valid result.
The expert, who also has served as a consultant to federal prosecutors, said the company also failed to comply with national standards mandated by the Massachusetts Board of Pharmacy. The testimony came in the trial of six former employees of the New England Compounding Center who are charged with racketeering and mail fraud.
The six on trial in U.S. District Court were among 14 indicted following a two year federal probe of the 2012 fungal meningitis outbreak which took the lives of 76 patients and sickened hundreds more. Closing arguments in the case are expected early next week.
"You can't wing it," said Eric Kastango, who was paid $36,354 for his consulting work for federal prosecutors.
Citing the high risk sterile drug compounding taking place at NECC in 2012, Kastango said NECC pharmacists were removing drugs from an autoclave after only a fraction of the time needed to assure sterility. Shown NECC records, Kastango said one batch of drugs was autoclaved for only 10 minutes when as much as 40 minutes could be required.
In addition he said the Framingham, Mass. company was not using biologic indicators, another method to assure sterility.
Under questioning by Assistant U.S. Attorney George Varghese, Kastango said that although NECC did do some limited end product testing, the number of samples sent to a private testing laboratory was far below that required under the U.S. Pharmacopeia, which sets industry standards
Kastango said NECC was not in compliance with two chapters of the U.S. Pharmacopeia, even though it was required by the Mass. Pharmacy Board, the agency that licensed NECC.
Varghese displayed an email sent to one of the defendants, Alla Stepanets, by NECC President Barry Cadden in which he said NECC should have been doing more testing all along. Cadden already was convicted of racketeering and mail fraud and is serving a nine-year prison sentence.
Kastango said NECC was not even complying with the requirements of its own Standard Operating Procedures on product testing.
Also testifying Thursday was William Frisch, an employee of the Mass. Pharmacy Board, who said he had conducted an inspection at NECC in 2011 after the company opened a new clean room where sterile drugs were to be compounded.
He said he found everything to be satisfactory, though he never actually went into the clean room. A year later he said he was assigned to investigate a complaint that drugs shipped by NECC to a Boston hospital did not have a sufficient amount of a numbing agent. The drug was supposed to numb the eye during surgical procedures.
He said that investigation never concluded because of the meningitis outbreak which put NECC out of business.
Sarah Walsh, attorney for defendant Christopher Leary, questioned Frisch about letters from the state Pharmacy Board to the four pharmacists on trial including Leary, informing them that an investigation by the agency initiated after the outbreak had been closed without any disciplinary action.
Asked if the state board would allow a pharmacist to continue to practice if he or she was a threat to the public, Frisch said, "No."
Court records show that the four are under an order barring them from engaging in any drug compounding but allowing them to dispense drugs.
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NECC Staffer Helped "Create" 300 Prescriptions

By Walter F. Roche Jr.

Boston-- A former license coordinator for a defunct drug compounding firm said she was concerned when she was assigned to help "create" some 300 prescriptions for drugs the company had already shipped to a Boston hospital.
Under questioning today in U.S. District Court, Beth Reynolds said she was given a list of patients and told to fill in the prescription forms which were being sent to the state Pharmacy Board in response to a complaint.
Her testimony came in the trial of six former employees of the New England Compounding Center, the firm blamed for a deadly 2012 fungal meningitis outbreak. U.S. District Judge Richard G. Stearns, who has been presiding over the case since opening arguments on Oct. 15 told lawyers on both sides to be prepared to deliver closing arguments on Monday.
Reynolds, who was called as a prosecution witness, said she got the unusual assignment in 2012 from her boss, Michele Rivers, who in turn had been given the task by NECC president Barry J. Cadden. She said Rivers had begun the job but it was passed along to her when her boss was out for a day.
She said she was told to take blank prescription forms and fill in the names of patients and the prescribing doctor. When she ran out of patient names she said she was told to randomly repeat as many names as needed.
Prosecutors have argued repeatedly that under Massachusetts law, NECC was required to have an individual patient specific prescription for every drug dose it delivered.
Stating that creating the forms was an unusual assignment, Reynolds said, "I didn't know why we didn't have them. I had concerns."
She said she got the list of patients from NECC Vice President Gregory Conigliaro's office and returned the completed prescription forms to his office when she was done.
Conigliaro, vice president and part owner of NECC, is one of the six now on trial. He has been charged with conspiring to defraud the U.S. Food and Drug Administration by pretending that NECC was just a state licensed pharmacy and not a drug manufacturer subject to stricter FDA regulation.
The list of patients produced by Reynolds and her boss was part of a response NECC filed with the Massachusetts Board of Pharmacy to a complaint that NECC had shipped sub-potent drugs to the eye and ear infirmary. The drug was used to numb patients' eyes prior to cataract and other eye surgery.
Questioned by Conigliaro's attorney Dan Rabinowitz, Reynolds said she wasn't sure where the list of patient names originally came from.
Rabinowitz also asked whether the prescription assignment along with other tasks were really coming from Cadden, the NECC president, and not from his client. Cadden, a co-defendant, already has been convicted of racketeering and is serving a jail sentence.
Among her other assignments, she acknowledged, was compiling a list of states where hospitals can have so-called shared services agreements with companies like NECC to purchase needed drugs without requiring individual prescriptions.
Asked if knowing that NECC had a contract with MEEI would have allayed her concerns about the prescription assignment, Reynolds said she didn't know.
In earlier testimony, Rabinowitz quizzed Jason Kravetz, an investigator from the U.S. Department of Veterans Affairs about Conigliaro's 20 year military record and the fact that he was awarded medals for meritorious service.
Rabinowitz read from one such award but was stopped short by Stearns when he asked whether or not Conigliaro also had a "top secret" military clearance.
Kravetz also was questioned by John H. Cunha Jr., who represents defendant Alla Stepanets, a former NECC pharmacist. Cunha charged that some of the documents contained in a government exhibit presented by Kravetz were "bogus" and hinted they were created after-the-fact.
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Heat, Humidity Out of Control at NECC

By Walter F. Roche Jr.

Boston-One government microbiologist said she couldn't believe what she was hearing when the environmental quality supervisor at a drug compounding firm told her that the air conditioning was turned off at night in a clean room where sterile drugs were being prepared.
Another witness, also a microbiologist from the U.S.Food and Drug Administration, said he had never before seen the level of contamination as he did in the drugs he tested from the same Massachusetts company.
The testimony came as the presiding judge told prosecutors to wrap up their case by the end of the week...or else. The developments came in the trial of six former employees of the New England Compounding Center, the now defunct company blamed in the deaths of 76 patients.
Stearns stated he was setting deadlines and limiting testimony "in the interest of bringing this trial to a conclusion."
He issued an order to prosecutors to provide him by the end of the day with a list of their final witnesses and why their testimony is "essential."
The trial, which began in mid-October, is the third phase in prosecutions stemming from the 2012 fungal meningitis outbreak caused by steroids loaded with deadly fungi that were injected into hundreds of unsuspecting patients. All six now on trial were employees of the New England Compounding Center. They face charges ranging from racketeering and conspiracy to mail fraud.
Much of Monday's testimony came from a government investigator who described and read from a series of internal emails implicating many of the defendants, including NECC's former vice president and part owner Gregory Conigliaro.
Jason Kravetz of the Inspector General's office in the U.S. Department of Veterans Affairs read from one email in which Conigliaro expressed concerns that some of the company practices "could come back to haunt us."
In other emails to and from Conigliaro, he and company President Barry Cadden strategized about ways to use differing state laws mandating individual prescriptions to utilize loopholes and maximize profits.
Cadden already is serving a nine-year jail term following his conviction on racketeering and mail fraud charges.
FDA microbiologist Almaris Alonso-Claudio said she was shocked when NECC's quality control chief told her that the company turned off the air conditioning at night in the clean room where sterile drugs were prepared.
Under questioning she verified NECC records showing temperatures soared at night at the Framingham, Mass. facility.
Stating that she was appalled when she learned about that and other practices at NECC, she said,"I couldn't believe what I was hearing." She said that both the temperature and humidity "were out of control."
Philip Istafanos, the second FDA witness, said that in decades of work he had never seen the level of contamination that showed up in the vials of methylprednisolone acetate from NECC that he tested in the Fall of 2012.
He said those and other NECC drugs he tested showed contamination with fungi and yeast, an unusual finding.
"I have never seen that before," he said when questioned about the findings on one NECC drug that had a black filament within the vial.
He said mold like that found at NECC was particularly troubling because it can be difficult if not impossible to eradicate. It was, he said, "a very huge problem."
Under cross examination defense attorneys made note of the fact that of 41 environmental samples collected at NECC and tested only 11 came back with bacterial or fungal contamination and not all of those were actually in the clean room, but found in adjacent areas.
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NECC Pharmacist Under State Order

By Walter F. Roche Jr.

A pharmacist now on trial on racketeering and mail fraud charges has been the subject of a separate investigation by state regulators on charges stemming from his role in compounding drugs that were 100 times more potent than prescribed.
Under a six-page consent agreement Gene Svirskiy had his pharmacy license placed on probation for one year, but the probation was stayed for a year as long as Svirskiy complies with certain conditions including submitting periodic test results to the state. If he doesn't comply the stay could be lifted and he could face penalties ranging up to a license suspension.
Svirskiy is one of six former employees of the New England Compounding Center, facing the racketeering and mail fraud charges in a trial now being held in U.S. District Court in Boston, Mass.
After the six were arrested and arraigned in late 2014, Svirskiy, as a condition of his release, agreed not to engage in pharmacy compounding.
"Not to engage in compounding medications," the Order Setting Conditions for Release states.
Similar restrictions were placed on other defendants who were licensed NECC pharmacists or pharmacy technicians.
Svirskiy's lawyer Jeremy M. Sternberg, did not immediately respond to questions about the possible effect of the consent agreement, including Svirskiy's admissions, on his client's parole status.
Svirskiy and 13 others were indicted in December of 2014 following a two year federal investigation of the 2012 fungal meningitis outbreak that sickened nearly 800 patients in more than 20 states. Seventy-six of them, including 19 in Tennessee, died. NECC has been named by federal regulators as the source of fungus laden steroids that caused the deadly outbreak.
According to the consent agreement with the Massachusetts Board of Pharmacy, Svirskiy was a pharmacist employed at the Boulevard Pharmacy Compounding Center in Worcester, Mass. in 2016 when he was involved in compounding a drug used by patients with a thyroid condition.
Svirskiy, the agreement states, prepared an incorrect master formulation worksheet for liothyronine sodium and levothyroxine sodium aliquots." Another pharmacist then verified Svirsiky's incorrect calculation.
A pharmacist technician then prepared aliquots based on the incorrect worksheet resulting in aliquots that were 100 times more potent than required.
Subsequently the incorrectly compounded chemicals were used to fill prescriptions for two unnamed patients. The super-potent drugs were dispensed to the two patients, according to the agreement, in late January 2016, but were recalled after the errors were discovered by Svirskiy on Feb. 1.
The patients and prescribers were notified, the document states. It does not indicate whether the patients actually took the drugs and/or suffered any ill effects.
However, following the discovery, the pharmacy failed to notify state board officials as required. The manager in charge at the time for Boulevard Pharmacy was Joseph Rossetti, according to the agreement. Rossetti died last month.
Under the consent agreement, if Svirskiy complies with all the conditions the board "will not prosecute the complaint and the licensee shall have no history of discipline upon his records related to the complaint."
Testimony in the ongoing trial is scheduled to resume Monday before U.S. District Judge Richard G. Stearns. Svirskiy and the other five defendants now on trial were not charged with preparing the steroids blamed for the outbreak but for their roles in preparing other drugs at NECC.
Two co-defendants already have been convicted on racketeering and mail fraud charges and are serving federal prison sentences.
Svirskiy's consent agreement became effective Sept. 5 of this year, a little over a month before the current trial got underway.
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FDA Ignored Early Warning

By Walter F. Roche Jr.

One year before a deadly fungal meningitis outbreak first emerged in Tennessee, a former salesman for the company that caused the outbreak went to the Stoneham, Mass. office of the U.S. Food and Drug Administration with a warning.
The salesman, in that meeting and in subsequent communications, had a simple message: If the FDA did not step in people were going to die.
The dire prediction turned out to be frighteningly true. Nearly 800 patients were sickened and 76 died in the outbreak caused by contaminated spinal steroids injected into unsuspecting patients.
The FDA visitor was Daniel Carney, a former salesman for Medical Sales Management, the sales arm of the New England Compounding Center, the now defunct company that shipped thousands of vials of a spinal steroid contaminated with deadly fungi.
Carney said he went to the FDA office in the Fall of 2011 to express his concerns about the practices of NECC and a sister company Ameridose.
The agency did not respond to requests for comment on its dealings with Carney, citing the ongoing criminal trial. It issued a statement expressing its continuing concerns with compounding pharmacies and expressed regret at the lives lost in the 2012 outbreak.
Carney had been employed until the summer of 2011 by Medical Sales Management, which served as the sales arm for both NECC and Ameridose.
The role of MSM and its sales force has come into focus during the ongoing trial of six former employees of NECC, who are charged with racketeering and mail fraud.
In recent testimony, Rose Mann, a former pharmacy buyer at a Los Angeles hospital testified about Carney's visit to her facility and the subsequent purchase of NECC products.
Robert Ronzio, who headed NECC's sales efforts, has entered a guilty plea to conspiracy charges as part of a plea agreement with federal prosecutors and has testified at prior trials of NECC's former president Barry J. Cadden and its supervising pharmacist Glenn Chin. Both are now serving federal prison sentences.
Carney said he clashed frequently with Ronzio, especially when he expressed concerns to his boss about the safety and quality of the company's products.
Carney said he visited the FDA in both 2011 and 2012, but he never heard from the agency again until a day in December of 2012 when FDA agents showed up at his home with guns drawn. That was the same day federal agents arrested Cadden and other NECC employees who had been indicted by a federal grand jury. Carney was not arrested and was never charged.
He said that in one of his meetings with the FDA he was told he was going to be issued an official designation as a confidential informant.
Carney said he first contacted the FDA by phone in September of 2011 and subsequently a meeting was scheduled for Oct. 20 at the agency's Stoneham office. There he met with some of the agency officials including Stacey Degarmo who would later turn up as prosecution witnesses in the on going criminal trials.
At the meeting he said he expressed his concerns that patients were going to be hurt by the poor practices at NECC
He said a subsequent meeting was held at the FDA's Wakefield office.
The list of concerns Carney said he raised at the meetings reads like an outline of the ongoing criminal trials.
NECC was not properly testing the drugs for sterility; NECC was actually acting as a drug manufacturer, not a pharmacy; quality assurance reports were being falsified; beyond use dates for drugs were being ignored or altered; NECC was producing drugs it was not authorized to sell; fake names were being used on prescriptions.
"I pleaded with the inspectors to do something," he said
Carney said the message he got from the FDA officials he met was that he should hire a lawyer and file a whistleblower suit so he could make a lot of money.
He said he reiterated to one of the agents that his concern was not money but that patients might be hurt.
He said he and his wife, a registered nurse who attended the session with him, were disgusted when they left the FDA office.
Even then, however, he followed up by sending anonymous complaints to the Inspector General for the U.S. Department of Human Services, all to no apparent avail.
That only added to his outrage when armed agents showed up at his door in October of 2012.
He said he yelled to the agents that they should have listened to him. One of them yelled back, "Why didn't you come back to us."
He said his young daughter was terrified and he told her to go hide in the bathtub.
"If only the FDA had listened," Carney said. "I just want the victims to know somebody cared."

FDA Asserts Authority on Masquerading Compounder

By Walter F. Roche Jr.

Boston- A top official of the U.S. Food and Drug Administration testified today that the company blamed for a deadly fungal meningitis outbreak was masquerading as a pharmacy and her agency clearly did have the authority in 2012 to take action against it.
Janet Woodcock, an FDA director, was testifying in the criminal case against six former employees of the New England Compounding Center. Under lengthy cross examination by the attorney for one of the defendants, Woodcock acknowledged there was some confusion at the time about the FDA's authority over state licensed pharmacies and new legislation was needed. But she said the FDA always had the authority to inspect companies like NECC.
"The FDA always had the authority to inspect," said Woodcock, who is the director of FDA's Center for Drug Evaluation and Research. "We always have had that authority."
Woodcock was confronted with videotapes of her and her boss's testimony before congressional committees in 2013 following the outbreak which sickened nearly 800 patients and killing 76 of them.
Woodcock said that when she and her then boss-Margaret Hamburg told Congress that the FDA had limited authority "we didn't mean that we had no authority."
Dan Rabinovitz, representing Gregory Conigliaro, an NECC vice president and part owner, peppered Woodcock with questions about the FDA's interaction with NECC dating back more than a decade including meetings between state and federal regulators in which the FDA ceded primary authority to the Massachusetts Board of Pharmacy.
Conigliaro is charged with conspiring to defraud the FDA by portraying NECC as a state licensed drug compounder when it was in fact a drug manufacturer.
Woodcock acknowledged that developments in the drug industry had left many hospitals dependent on large drug compounders. She said the FDA was reluctant to initiate vigorous enforcement because hospitals that had come to rely on compounders "would not have been able to respond. We would have created patient harm," she said.
Rabonovitz questioning finally brought a response from U.S. District Judge Richard G. Stearns who said the attorney had asked the same question three times.
"I know it's fun" Stearns said later in reference to Rabinovitz questions,"Can we wrap it up?"
Rabinovitz charged that FDA inspectors used standards that had yet to be put in place when they entered NECC in October of 2012.
Woodcock said the inspection report was not a final determination. He also asked her where she first heard the word "masquerading" in connection with NECC
She said that NECC, as a state licensed pharmacy, was required to have an individual patient specific prescription for every dose of a drug shipped by the company. Prosecutors already have presented evidence that patient lists maintained by NECC included numerous examples of fake names.
At another point Rabinovitz quizzed Woodcock about the differing appeals court rulings on the FDA's authority under a 1997 law.
"Even I don't know that," Stearns interjected, bringing laughter from the jury.
Returning to the witness stand was FDA inspector Stacey Degarmo, one of the agency officials sent to NECC's offices when the outbreak began. She said company records showed drug products were not being sterilized properly because they were not left in an autoclave for the required time.
After the jury had been dismissed for the day, Stearns told lawyers that one juror already was being discharged for personal reasons and another was likely to be discharged next week. As he did last week, Stearns expressed concern that the the case would have a final outcome. Opening arguments began in mid-October.
He asked both sides to consider whether they would agree to proceed with the case if the jury was reduced to less than 12. Fifteen jurors were originally picked to hear the case.
Additional testimony is scheduled for Tuesday but then the jury will not meet for the rest of the week, Stearns has informed both sides. The six are among 14 indicted in 2014 following a two year federal grand jury probe of the outbreak.

Indicted Pharmacists Retain State Licenses

By Walter F. Roche Jr.

Boston- Four pharmacists on trial for racketeering and mail fraud still have their state licenses due to a request from federal prosecutors.
Some details of why the four still have the pharmacist licenses were disclosed today in testimony from a state official in the ongoing trial of six defendants including the four pharmacists.
Samuel Penta, an official of the Massachusetts Pharmacy Board, said the U.S. Attorney's office had requested that the board put their investigations of the four on hold. He was asked by Assistant U.S. Attorney George Varghese if there were any restriction on their licenses but defense attorneys immediately objected and U.S. District Judge Richard G. Stearns barred Penta from answering.
The disclosure came in the trial of six people who were among 14 indicted following a two year probe of the 2012 fungal meningitis outbreak.
Records displayed by attorneys for the pharmacists showed that while a complaint investigation was opened in 2013, charges were dismissed with the notation "discipline not warranted."
However, court documents show the pharmacists are barred from doing any compounding as a condition of their release following their indictment.
Prior to the day's testimony Stearns told both sides that he hoped the trial could be finished by the end of the first full week in December.
"I really am concerned about the jury," Stearns stated."I have no stake in the outcome...just that there be an outcome."
The judge also questioned the need for prosecutors to bring in nearly a dozen government microbiologists to testify in the case. Defense attorneys told Stearns they would be willing to stipulate to the testimony which is expected to detail the results of af laboratory tests on specimens seized from the New England Compounding Center, the defunct firm blamed for the outbreak which sickened nearly 800 patients in 22 states.
Opening arguments in the current trial, the third stemming from the 2012 outbreak indictments, were on Oct. 15. Stearns,in an order before testimony began set time limits on both prosecutors and defense attorneys.
Under cross examination today, Penta stuck by his prior testimony that he was surprised by the volume of drugs being produced by NECC when he visited the Framingham, Mass. facility on Sept. 26, 2012.
Dan Rabinovitz, the attorney for Gregory Conigliaro, who was NECC's vice president and part owner, cited a 2011 inspection of a new clean room which stated that the company was producing 100 drugs a day and was selling its products in 48 states. He also that prior to the outbreak the state agency had issued several "Certificates of Good Standing" on NECC.
Penta said he assumed that 100 orders a day meant NECC was filling 100 individual prescriptions per day and not individual bulk orders for dozens of drug doses apiece.
Rabinovitz also cited pharmacy board approval of so-called shared services agreements under which one pharmacy could refer customers to another pharmacy to pick up prescriptions.
Penta said that provision only applied to pharmacies under common ownership, like different CVS outlets.
He said it would not apply to NECC's practice of providing bulk drugs to health facilities with patient specific prescriptions.
Paul Kelly, attorney for defendant Christopher Leary, questioned Penta about a provision of state law that places the responsibility for the operation of a pharmacy on the "manager of record" and not any licensed pharmacist working in the same store. At NECC that The manager-of-record at NECC was Barry J. Cadden, who was already been convicted of racketeering and mail fraud and is serving a nine-year federal prison sentence.
In a related matter Stearns set a March 25, 2019 trial date for co-defendants Kathy Chin and Michelle Thomas, both former NECC employees. The two were granted separate trials after Stearns concluded that it would be unfair to try them along with other defendants facing more serious charges. The two are charged with dispensing misbranded drugs.

Regulators Confused as Tragedy Unfolded

By Walter F. Roche Jr.


Boston- Even as the details of a deadly outbreak first began to emerge in Tennessee, regulators at the state and federal level reached out to each other as their lines of authority remained blurred.
In Massachusetts the state's top pharmacy inspector said he knew after just one visit that he needed help and turned to the U.S. Food and Drug Administration. Meanwhile federal officials worried that they lacked authority to move into the state licensed drug compounding company which appeared to be the source of deadly contamination.
That was the scene painted in U.S. District Court today by witnesses for the prosecution in the criminal case against six former employees of that suspect firm, the soon to be infamous New England Compounding Center. The lawyer for one of the defendants, a former vice president and part owner of NECC, Gregory Conigliaro, seized on the indecision, challenging the two witnesses on just what they thought they could do as the tragedy unfolded.
Samuel Penta, the Massachusetts Pharmacy Board's top investigator, said he knew after his initial visit to NECC's Framingham, Mass. headquarters in late September 2012 that he needed help and asked his boss to alert the FDA.
He had gone to NECC following initial reports that a Tennessee patient had been diagnosed with fungal meningitis shortly after injection with a spinal steroid from NECC.
Officials at the federal agency Penta turned to had been struggling for years to determine exactly what authority they had over drug compounders.
Samir Nasn, who headed the FDA unit dealing with drug compounders until her 2011 retirement,
testified just before Penta that due to that confusion it took her agency two years to respond to a filing from NECC.
Confusion about the FDA's authority followed a U.S. Supreme Court decision striking down a drug regulation statute.
Drug compounders, she said, would not even allow FDA regulators to look at their records or even respond to questions.
"They wouldn't allow us in because we didn't have jurisdiction," she told Assistant U.S. Attorney George Varghese
She said complaints about NECC, including the volume of drugs it was producing, had triggered a 2006 warning letter to the firm. NECC responded but it took another two years till October of 2008, for the FDA to respond to NECC's filing.
"It was put on hold till we could figure out what to do next," she said in response to questions from Dan Rabinowitz, Conigliaro's lawyer.
"We had to do what the lawyers tell us," she said, adding that there were also additional complaints against NECC to consider.
Penta, who was on the witness stand for a second day, said that following the initial visit to NECC, his agency, accompanied by FDA inspectors, returned the following week.
Ultimately NECC would surrender its license and the outbreak death toll would reach 76
Penta said he had several immediate concerns on the subsequent visits, including the fact that NECC was shipping out drugs by the hundreds but the company could not produce a single patient specific prescription, a requirement under state law. He said he did not go into the clean room where sterile drugs were prepared but noted from looking in a window that a key piece of equipment did not look right.
"It looked really dirty. It was discolored and didn't look clean," Penta said.
Penta also was asked about a series of contracts NECC had with major Massachusetts health providers which stated that NECC would provide drugs in bulk without requiring prescriptions. Penta said those were all illegal and patient specific prescriptions still were mandatory.
Varghese then presented a series of NECC drug order forms with patient names like Calvin Klein, Donald Trump and Jinny Lopez.
No, Penta responded, they (the order forms)do not comply with state law.
Recounting the October 2012 visit to NECC, Penta said when they looked over the quarantined drugs some had no names or multiple doses for the same patient. Still others listed the doctor and the patient as the same person.
Those, Penta said, did not meet the state requirements.
Penta also described the recycling center, another Conigliaro business located about 100 feet from the drug compounding operation. He said recycled mattresses were piled in the area.
On another NECC visit Penta said they questioned supervisory pharmacist Glenn Chin about his procedures producing the now suspect steroids. He said they determined the steroids were not being treated for long enough in an autoclave to ensure sterility and too few samples were being sent out for testing.
Under questioning by Rabinowitz, Penta acknowledged that at the time of the outbreak, "I was not trained in sterile compounding." His training came after the outbreak.
Nor, Penta acknowledged, did he have the authority to take a drug sample from NECC and have it tested. That was left to the FDA.

Mass. Board Let NECC Off With Warnings

By Walter F. Roche Jr.

Boston-The Massachusetts Pharmacy Board got multiple notifications that a drug compounding company it licensed was violating state law but let the firm off with advisory letters that imposed no discipline.
Eight years later that same company was identified as the cause of a deadly outbreak that killed 76 patients. The early warnings were detailed today by a state board official who testified in the trial of six former employees of the New England Compounding Center. They are charged with racketeering and mail fraud, but the state board official reported today that four of the six still have their pharmacist licenses. Another defendant is a registered pharmacy technician.
The sixth defendant, Gregory Conigliaro, was an officer and part owner of the company but was never a licensed pharmacist.
Samuel Penta, supervising investigator for the state pharmacy board, testified that his agency received complaints from three other states that NECC was selling drugs without patient specific prescriptions, a requirement under state law.
Penta said the complaints that NECC was selling prescription drugs out-of -state without prescriptions came in 2004 from pharmacists and health providers in South Dakota, Idaho and Wisconsin.
Penta said the board also learned a year later that NECC was attempting to sell drugs in bulk and without prescriptions to Partners Health, a Massachusetts health care firm.
In yet a fifth instance, a board inspector, after reviewing company records, cited NECC for selling a prescription drug with invalid patient names.
All of the three out-of-state violations were dealt with in a Sept. 21, 2004 meeting of the state board, according to records entered into the court record by federal prosecutors. That meeting came just three months after Sophia Pasedis was named to the pharmacy board.
Pasedis was an officer of Ameridose, another drug company with common ownership with NECC. Her name has surfaced in prior court testimony about an unlicensed pharmacy technician at NECC who was trying to get his state credentials restored.
Massachusetts officials initially stated that Pasedis abstained from any votes involving NECC or Ameridose. They later said some board records were unclear. When the outbreak became public state officials, including then Gov. Deval Patrick, called on Pasedis to resign. She refused and remained on the board until her term expired just weeks later.
Penta, under questioning Wednesday by Assistant U.S. Attorney George Varghese, said NECC had told Partners Health that they could sell up to 5 per cent of their drugs in bulk without prescriptions.
Though some states do have a so-called 5 percent rule, Penta said that was not the case in Massachusetts and individual prescriptions are required. He said he advised Health Partners of that fact.
In other testimony Kristina Donohue, an official of the U.S. Food and Drug Administration recounted her visit to NECC in response to an adverse event complaint registered against the company in 2002. She said that NECC President Barry Cadden was cordial and cooperative the first day she went to the company's Framingham, Mass. offices, but the next day she said Cadden refused to answer questions or provide any documents.
Cadden was convicted of racketeering and mail fraud charges and is now serving a nine year federal prison sentence.
Donohue said that when she returned to NECC a year later, the company had grown from eight to 12 employees. She said that reviews of NECC's operations raised concerns about the sterility of its products. The FDA, however, deferred to the state board for any further action.
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Emails Show NECC Skipped Tests

By Walter F. Roche Jr.

Just weeks before a deadly outbreak became public the head of the company that caused the national health crisis told his workers that it was time that they started performing the product tests they should have been doing all along.
The email from Barry Cadden to his staffers at the New England Compounding Center was one of dozens of company records entered into the record Tuesday in the trial of six former NECC employees charged with racketeering, conspiracy and mail fraud.
Cadden, who already is serving a nine-year jail term, wrote in a 2012 email that NECC should have been doing end product testing prior to shipping drugs to hospitals and other health care providers across the country.
In fact, Cadden warned his colleagues that without those tests "People can die."
In a matter of weeks, the warning came true as the outbreak of fungal meningitis began to take the lives of patients in Tennessee and 19 other states. Ultimately 76 would die among nearly 800 that were sickened after being injected with fungus laden spinal steroids produced by NECC at its Framingham, Mass. facilities.
The six on trial before U.S. District Judge Richard G. Stearns were among 14 indicted in late 2014 following a two year federal probe of the outbreak.
Sara Albert, an investigator from the U.S. Defense Department, presented the exhibits which she said were gathered in the federal probe.
"We can't do what you are doing anymore," Cadden wrote in one email. "We're way to big to be cutting corners."
"We can't be caught with our pants around our ankles," he wrote in another.
In an email just days before the outbreak became public Cadden wrote,"We should do fungal testing on every lot of the steroids in the future."
Nonetheless in other emails entered in the case Tuesday, Cadden instructed staffers to "just re-label the old stuff" to ship a pending order.
Asked whether an expired chemical should be used for another shipmen, Cadden said to go ahead.
"Chemicals rarely expire," he wrote in an email.
In other emails, Cadden and Gregory Conigliaro, a defendant and former NECC vice president and part owner, discussed efforts to get an employee who had been working illegally as an NECC pharmacy technician, back his state registration. The effort included contact with a member of the state Pharmacy Board, Sophia Pasedis, who was also a top official at a sister company, Ameridose.
Lawyers for the six defendants subsequently challenged Albert, charging that prosecutors only presented parts of email chains, omitting messages that showed their clients were trying to do the right thing.
Noting that many of the exhibits focused on the steroids contaminated with fungus, Paul Kelly the attorney for defendant Christopher Leary turned the focus to emails in which his client was simply seeking a decision from Cadden.
"None of these defendants had anything to do with the MPA (steroids)," Kelly added.
In other emails cited by the defense lawyers, Sharon Carter, another defendant, repeatedly called on NECC customers to provide real names for the patients who were to receive NECC products. Prosecutors previously cited NECC records showing obviously fictitious patient names.
Still other emails showed Carter refusing to ship drugs until the customers provided real names. Other emails showed it was Cadden who made the final decision on whether to fill orders without real patient names.
In another email Cadden told Carter and others that only NECC's sales representatives would deal with the patient names issue and Carter and her colleagues should have no contact with customers.
Following Albert as a prosecution witness was Kristina Donahue of the U.S. Food and Drug Administration who was questioned about the standards her agency uses to evaluate drug compounders like NECC.
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Disputed NECC Exhibits Defended by Prosecutors

By Walter F. Roche Jr.

Boston- Five of the six former employees of a drug compounding firm blamed for a deadly outbreak are asking a federal judge to block prosecutors from presenting some two dozen exhibits which they contend would be prejudicial and irrelevant.
In a nine-page Veteran's Day filing, lawyers for the five charge that most of the exhibits set to be introduced this week relate to the 2012 fungal meningitis outbreak and none of the five are charged with playing any role in the preparation of the spinal steroid that caused the outbreak. The trial is set to resume tomorrow.
The sixth defendant, Gregory Conigliaro, who was vice president and part owner of the New England Compounding Center, did not join in the motion.
"None of these defendants had anything to do with the MPA (methylprednisolone acetate)," the motion states.
The five are charged with racketeering and mail fraud, but the charges relate to the preparation and shipping of other drugs sold by NECC, the motion states.
In a response filed late today federal prosecutors urged rejection of the motion charging that the defendants request was based on "false assumptions and mischaracterizations."
The prosecution intends "to stay within the boundaries defined by the court," the response states, adding that they will "meticulously follow the court's limitations.
The list of exhibits and expected witnesses were presented to the defense attorneys on Friday, as the trial ended its fourth week.
In today's filing the defendants noted that U.S. District Judge Richard G. Stearns has ruled in the past to limit the evidence relating to the outbreak, which took the lives of at least 76 patients among nearly 800 who were sickened.
They noted that Stearns has ruled that jurors can be presented some evidence on the outbreak, but only to provide context about the current case.
Many of the prosecutions exhibits run "well past setting context" and will be cumulative and unnecessary, the motion states.
The five were among 14 indicted in late 2014 following a two year probe of the outbreak. Two of the original defendants were tried separately and are now serving sentences based on their conviction on mail fraud and racketeering charges.
Among the exhibits the defendants seek to block are those due to be presented by two employees of the U.S. Food and Drug Administration, Haydee Romero and Jeffrey Kohn.
The defendant's attorneys noted Romero's testimony in a prior NECC trial was focused on tests on NECC's MPA that showed mold that grew so fast it nearly pushed the cover off the petri dish.
Still other exhibits and anticipated testimony, the motion charges, concern interactions between NECC and the FDA that occurred before any of the five defendants even went to work there.
In their response, prosecutors said some evidence from the outbreak is necessary to show the overall deficiencies in NECC's operations.
"These deficiencies apply to all of the drugs NECC was making," the six-page response states.
The five filing the motion to block the exhibits are Gene Svirskiy, Joseph Evanosky, Sharon Carter, Alla Stepanets and Christopher Leary.
The two remaining defendants, Kathy Chin and Michelle Thomas, are expected to go on trial when the current case is concluded.
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State Regulators Moved on NECC as Outbreak Loomed

By Walter F. Roche Jr.

Boston-Regulators in at least three states were closing in on a little known Massachusetts drug compounding firm in 2011 and 2012 even as that company was gearing up production to send out thousands of vials of a spinal steroid that turned out to be deadly.
The steroids, laced with deadly fungi and shipped from the New England Compounding Center, ultimately sickened nearly 800 patients killing 76 of them in an outbreak of fungal meningitis that became public in the Fall of 2012.
In U.S. District Court Friday regulators from Oregon, Colorado and Missouri described how they had uncovered evidence in 2011, a year before the outbreak, that the New England Compounding Center was shipping drugs to health providers in their individual states in violation of laws and regulations. The regulators disclosures came in the trial of six former NECC employees charged with racketeering, conspiracy and mail fraud.
In testimony clearly targeted at former NECC vice president and part owner Gregory Conigliaro, two of the witnesses detailed dealings with Conigliaro. A former Colorado Pharmacy Board employee said Conigliaro got angry and yelled at her in one telephone conversation.
Conigliaro is charged with conspiring to defraud the U.S. Food and Drug Administration by insisting the company was only subject to state and not federal regulation.
Wendy Anderson, the former Colorado board employee, said Conigliaro was calling from his car in 2011 questioning her about the board's charge that NECC had shipped drugs to the state without individual patient specific prescriptions.
She said an agency investigator had become suspicious when she found records at a local hospital indicating NECC had shipped 46 doses to the facility for a single patient.
Anderson said that in the 2011 phone call Conigliaro insisted that what NECC was doing was legal.
"He was yelling at me," Anderson said under questioning by Assistant U.S. Attorney George Varghese.
Asked if Conigliaro was "angry and upset," Anderson said yes.
Dan Rabinovitz, Conigliaro's lawyer, challenged her assertion that Conigliaro yelled at her, suggesting that he was merely trying to make himself heard since he was driving at the time.
Also testifying Friday was Michele Cale, a former official of the Oregon Pharmacy Board, who said NECC's license in that state was ultimately revoked.
She said Conigliaro at first insisted NECC had individual contractual agreements with health providers that, in effect, exempted them from the individual prescription requirement
Cale said she later concluded NECC officials were lying to her about the agreements. While NECC promised to provide copies of the agreements, the company ultimately sent agreements that didn't go into effect until after she had requested them. Then, she said, they asserted there were "verbal agreements" preceeding the written ones.
She said she was stunned when she finally saw the pages and pages of prescriptions NECC had delivered to Oregon customers over a three year period.
Evoking laughter several times during her testimony, Cale said simply,"They are prescriptions not post-criptions."
Cale said she concluded the responses she was getting from NECC were just "lawyer-talk."
Kimberly Grinston, executive director of the Missouri Pharmacy Board, also testified Friday that NECC was shipping drugs into her state without patient specific prescriptions.
There was no agreement that NECC could ship prescription drugs into the state without specific prescriptions, she said in response to questions from Varghese.

Missouri Officlals Found NECC in Violation

By Walter F. Roche Jr.

A former official of the Missouri Board of Pharmacy agreed today that he told a federal prosecutor in 2012 he believed the Massachusetts Pharmacy Board "dropped the ball" when it failed to act against the drug compounding firm eventually blamed for a 2012 deadly outbreak.
The former official, Kevin Kinkade and an other Missouri pharmacy official, also testified that an investigator from his agency had concluded years before the outbreak that that the New England Compounding Center was shipping drugs into that state in violation of a requirement that there be a patient a patient specific prescription for each dose of drugs shipped.
Kinkade, his successor and the Missouri board investigator, recounted a long battle with the New England Compounding Center that appeared to be near a compromise seven years ago. But the now defunct company ultimately let its Missouri license lapse and the compromise was never implemented. That was on Oct. 31, 2011, just a year before the deadly outbreak surfaced in Tennessee.
The testimony came in U.S. District Court on the 21st day in the trial of six former NECC employees including it's vice president and part owner, Gregory Conigliaro, who was heavily involved in the Missouri negotiations. The fungal meningitis outbreak first detected in Tennessee killed at least 76 patients across the country among nearly 800 who were sickened
According to the Missouri officials Conigliaro himself traveled to their state for a negotiation session with board officials. Though an apparent compromise was later reached, it was never implemented before NECC's Missouri license expired in the Fall of 2011.
Conigliaro, NECC's vice president, is facing a single charge of conspiracy to defraud the U.S. Food and Drug Administration by portraying to state and federal regulators that NECC was simply a Massachusetts licensed pharmacy and not subject to stricter FDA requirements.
It was under cross examination by Conigliaro's lawyer, Dan Rabinovitz, that Kinkade acknowledged he told Assistant U.S. Attorney George Varghese during the outbreak investigation and prior to any indictments that he thought the Mass. pharmacy board"dropped the ball" by not taking action against NECC earlier.
"It appeared the Massachusetts Board of Pharmacy could have done more," Kinkade said.
Another prosecution witness and the Missouri board's chief investigator, Thomas Glenski, said that a Missouri inspector first learned that NECC might be in violations of the state requirements when he found records at a health facility indicating NECC had shipped prescription drugs to the facility without prescriptions listing the patient who was getting the drug.
He said that a subsequent review of records at other health facilities brought the same conclusion. As a result, he said, the agency was moving toward placing NECC's license on probation.
In negotiations that followed, emails and other records placed in the record showed, Conigliaro sent documents to the Missouri board that raised even more questions. Those records, according to Glenski, showed some of the drugs were shipped only with the name of a health facility. In addition the records showed that even when patients names were listed the number of doses per patient appeared excessive.
He said the records indicated that 12 doses of one drug were prescribed for one patient, all on the same day. Another record obtained by the board showed details for only one patient, but nothing for nine others.
He said NECC contended contractual agreements with hospitals covered the patient specific requirement, but promised copies of the contracts were never provided.
The jury also heard testimony from a hospital pharmacy buyer in Los Angeles who testified that her facility bought multiple doses of methotrexate from NECC, but the hospital was never told the expiration date of the main ingredient in the cancer fighting drug had passed years earlier. She said an NECC salesman assured her the drug "would be safe."
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NECC Cancer Drug Expired Years Before Shipment

By Walter F. Roche Jr.

Boston - A chemical company executive testified today that the drug distributed to health facilities by a Massachusetts drug compounding company in 2012 had a 2007 expiration date and should not have been used beyond that date.
Testifying in U.S. District Court Tom Tyner of Spectrum Chemical, told jurors that his company would not have shipped the methotrexate beyond the Jan. 23, 2007 deadline set by the original producer of the chemical.
The testimony came on the 20th day in the trial of six former employees of that now defunct compounding firm blamed for the deaths of the deaths of at least 76 patients, including 16 in Tennessee.
Another prosecution witness, a pharmacist from an Illinois hospital, testified that her facility ended up unwittingly purchasing the expired drug for use on a patient suffering from cancer.
Also appearing before U.S. District Judge Richard G. Stearns was an FBI agent who investigated the deadly 2012 outbreak caused by the New England Compounding Center. The six defendants are charged with racketeering and mail fraud.
Tom Tyner of Spectrum Chemical identified one of the containers of methotrexate seized in a 2012 search of the New England CompCenter
Under questioning from Assistant U.S. Attorney George Varghese, Tyner said NECC had ordered two containers of the drug in February It was shipped with a label setting a Jan. 23, 2007 expiration date.
Asked if there had ever been a request to extend the 2007 date, Tyner said, "No."
He added that any extensions were rare and that Spectrum would not normally guarantee the strength or purity of the product beyond that date.
Under cross examination by Jerome Sternberg, representing defendant Gene Svirskiy, Tyner acknowleged that Spectrum got into trouble with federal officials because it sold excessive quantities of a pain medication. He said the company entered into a memorandum of understanding as a result.
Spectrum, Tyner acknowledged, was also cited for mislabeling a drug.
"We got a warning letter," he said.
"We're getting off track here," Stearns stated, following an objection by prosecutors.
Kandie Dino from the Decatur Memorial Hospital in Illinois told Assistant U.S. Attorney Amanda Strachan that her facility purchased methotrexate from NECC in 2017. Records and seized evidence showed it came from the same lot shipped by Spectrum to NECC in 2007.
Dino said the drug was never actually administered because of a change in the cancer patient's condition, but said she never would have purchased the drug had she known its history. She said it was eventually discarded. Records from the hospital showed NECC was paid $1,770 for the drugs.
Under cross examination Dino said that even though there was a shortage of methotrexate at the time, the hospital would not used an expired product.
Defense attorneys Wednesday also completed the cross examination of Philip Sliney, the lead FBI agent assigned to the case
The agent had testified earlier this week about an interview he conducted with Evanosky, a defendant who worked in the same clean room where contaminated spinal steroids were produced.
Asked by Evanosky's lawyer, Mark Pearlstein, if he had any information showing his client's involvement in producing the steroids. Sliney said there was none that he was aware of.
Sliney also acknowledged there was "not a single allegation" he could recall regarding the intrathecal pumps his client worked on.
Sliney previously testified that he interviewed Evanosky at his home on Nov. 8, 2012 and while the former NECC employee denied any wrongdoing, he acknowledged he was aware that NECC was sending out drugs before promised testing could be completed.
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FBI: NECC RX Implicated Others

By Walter F. Roche Jr.


Boston- An FBI agent testified today that one of the defendants now on trial on racketeering and mail fraud charges told him drugs were being shipped before promised testing and some of his colleagues had been dumping drugs as a federal investigation began to close in on the them.
FBI agent Philip Sliney said the defendant, Joseph Evanosky, also told him that he and others falsified cleaning logs at the New England Compounding Center, the company blamed for a deadly fungal meningitis outbreak.
Testifying in U.S. District Court, Sliney detailed his Nov. 8, 2012 interview with Evanosky, a licensed pharmacist and one of six former NECC employees now on trial following a two year probe of a deadly fungal meningitis outbreak, that first became public in Nashville.
Sliney said he and another agent interviewed Evanosky at his Westborough home, just a few miles from NECC's then offices and headquarters.
Sliney said they knocked on Evanosky's door and he invited them into his home agreed to be interviewed at a dining room table.
He said Evanosky, who was seated only a few feet away in the seventh floor courtroom of U.S. District Judge Richard G. Stearns, agreed to discuss his involvement in the clean room where prosecutors allege deadly fungus contaminated drugs were being produced.
He said Evanosky told him that he had nothing to do with the tainted drugs and his only work was processing controlled substances for use in intravenous medications and feeding tubes.
He said Evanosky did express concern about the increasing volume of orders being processed at the Framingham, Mass. facility and that he had recently observed other clean room workers discarding stock solutions.
The agent said it was supervising pharmacist Glenn Chin who oversaw some NECC drugs being shipped out to health care providers before they could be tested for sterility and potency.
"He said it was being carried out by Chin" Sliney said, adding that Evanosky told him the practice of shipping drugs before testing testing had become more prevalent in recent months. Chin was convicted of racketeering and mail fraud is now serving an eight0year prison sentence.
The interview came a little over a month after NECC was shutdown following the public disclosure of the growing public health care crisis caused by fungal contamination of thousands of vials of a steroid, methylprednisolone acetate, injected in the spines and joints of unsuspecting patients in 20 states.
Sliney said that while Evanosky denied any involvement in shipping drugs before testing a coworker, Sharon Carter, would have known of the practice. Like Evanosky, Carter is now on trial.
The FBI agent said Evanosky denied any knowledge of labels being changed on drugs to disguise expiration dates, but he was aware that drugs from a sister company had been processed at NECC. Sliney said Evanosky told him that he had never seen evidence of mold in the cleaning room and that he was "shocked" when he first heard news accounts about mold and fungus being present in the room where he worked.
As for the doctored cleaning logs, Sliney said Evanosky told him that at the end of each month he and other clean room workers were instructed to fill in the cleaning logs as if they had been doing so on a daily basis. He said Evanosky acknowledged that he might have filled in the form indicating he mopped the clean room on a day when he may not have actually done it.
In other testimony, Sliney detailed NECC records he and other agents collected and a summary sheet he compiled listing drugs shipped by NECC before tests were performed. He also detailed dozens of instances in which drugs were shipped out even though tests showed key ingredients were below or above the prescribed amount.
On cross examination, Mark Pearlstein, Evanosky's lawyer, pointed out that some of the defendants hadn't even gone to work at NECC when many of the defective drugs were shipped.
Asked if any patients were actually harmed by the under-powered or over-powered NECC drugs, Sliney said he didn't know. Defense lawyers also challenged testimony from two employees of the Oklahoma testing firm hired by NECC to test its drugs for sterility and potency.
Tommy Means of Analytical Research Laboratories, who testified as a prosecution witness, acknowledged his company had been cited in a federal inspection for some deficiencies in late 2012. He said the inspectors cited "some things we could improve upon."
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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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