2 NECC Defendants Sentenced

By Walter F. Roche Jr.

Two former pharmacists for a drug compounding firm that caused a deadly fungal meningitis outbreak have been sentenced following their conviction on mail fraud and related charges and while one will serve a prison sentence, the other was given eight months of home confinement.
In two separate sessions before U.S. District Judge Richard G. Stearns Gene Svirskiy was given a 2.5 year prison sentence while Christopher Leary was sentenced to eight months of home confinement and two years of probation.
The two licensed pharmacists were among five former employees of the now defunct New England Compounding Center who were found guilty late last year following an eight week trial in U.S. District Court in Boston, Mass.
Svirskiy was convicted of racketeering, conspiracy, mail fraud and violations of the Food Drug and Cosmetic Act (FDCA). Leary was convicted of three counts of mail fraud and violations of the FDCA.
Federal prosecutors had recommended a 6.5 year sentence for Svirskiy and a two year to 30 month jail sentence for Leary.
The charges stemmed from a two year probe of the 2012 fungal meningitis outbreak which federal prosecutors have described as the worst outbreak ever to be caused by a prescription drug. Over 100 patients injected with NECC steroids have died and over 700 have been sickened.
Svirskiy and Leary, however, were not charged in connection with the contaminated steroids that caused the outbreak. They were charged for their roles in producing other drugs, drugs that were mislabeled, misbranded and untested.
Those drugs included a cancer drug called methotrexate, a subpotent eye block or numbing agent used in eye surgeries and an antibiotic used in surgeries and wound care. The drugs had been shipped to health facilities in California, Florida, New York and Boston, Mass.
Leary and Svirskiy were among 14 indicted by a federal grand jury in late 2014 following a two year probe of the fungal meningitis outbreak. Two of the 14, Barry J. Cadden and Glenn Chin, already are serving prison sentences following their conviction on racketeering, mail fraud and violations of the FDCA. They were both cleared of racketeering second degree murder charges.
Cadden is serving a nine year sentence, while Chin is serving an eight year sentence at separate federal prisons in Pennsylvania.
Only one of the 14 indicted was cleared of all charges.
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Svirskiy Gets 2.5 Year Sentence

By Walter F. Roche Jr

A pharmacist for the company blamed for a nationwide fun gal meningitis outbreak has been sentenced to 2.5 years in federal prison, less than half of the amount recommended by prosecutors but more than twice the amount sought by the defendant.
U.S. District Judge Richard G. Stearns Wednesday imposed the sentence on Gene Svirskiy, who worked as a pharmacist for the New England Compounding Center. The company was permanently shuttered shortly after the 2012 fungal meningitis outbreak caused by contaminated steroids produced at its Framingham, Mass. facilities.
Svirskiy was convicted on racketeering, conspiracy and mail fraud charges late last year, along with four other defendants connected to the New England Compounding Center. The charges against Svirskiy, however, stemmed from the production of drugs not implicated in the outbreak.
Proseccutors had sought a 6.5 year sentence, while Svirskiy's lawyer asked for a sentence of one year of home confinement.
Three others convicted with Svirskiy in December of 2018 are scheduled for sentencing at a later date in U.S. District Court in Boston, Mass. The fifth defendant, Alla Stepanets, was sentenced to one year of probation
The charges against Svirskiy relate to his role in producing an anti-cancer drug that was shipped even though the main ingredient had expired five years before shipment and an untested and contaminated antibiotic solution for use in surgeries.
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Prosecutors Seek 6.5 Year NECC Sentence

By Walter F. Roche Jr.

Charging that he played a critical role in a fraudulent scheme, federal prosecutors are asking for a 6.5 year jail sentence for a licensed pharmacist who worked as a supervisor at the company that caused a deadly fungal meningitis outbreak.
In a 14-page filing today in U.S. District Court in Boston, Mass., government lawyers charged that Gene Svirskiy abused a position of public trust in his role at the New England Compounding Center the company that caused the 2012 outbreak. Over 100 patients who were injected with NECC steroids have died while hundreds of others were sickened.
Prosecutors said that a substantial sentence was necessary to serve as a deterrent to other licensed pharmacists.
Svirskiy was convicted late last year after an eight week trial of racketeering, conspiracy, mail fraud and violations of the federal Food Drug and Cosmetic Act. He was one of 14 indicted by a federal grand jury in late 2014 following a two year probe of the outbreak.
Assistant U.S. Attorneys Amanda Strachan and George Varghese wrote that while Svirskiy was not as culpable as the lead co-defendants, Barry Cadden and Glenn Chin, his criminal actions were an essential part of the conspiracy.
Cadden, NECC's president and part owner, is serving a nine year sentence while Chin, a supervising pharmacist, is serving an eight year sentence.
Svirskiy's lawyers had filed a recommendation that he be sentenced to only one year of home confinement.
Svirskiy, the prosecutors'filing states, conspired with Cadden, Chin and others "to fraudulently produce and sell substandard drugs."
The charges against Svirskiy do not relate to the steroids that caused the outbreak but to other drugs shipped by NECC. They include an anti-cancer drug that was shipped even though the main ingredient had expired five years before shipment and an untested and contaminated antibiotic solution for use in surgeries.
The filing cites Svirskiy's role overseeing a pharmacy technician who had surrendered his certification.
Svirskiy knew Scott Connolly lost his certification and instructed him not to use his own name on company records, prosecutors charged. In addition he instructed Connolly to leave the clean room when
regulators were at the facility.
Prosecutors said Svirskiy should get an enhanced sentence because he was a manager or supervisor and he abused a position of public trust. Additional enhancements are justified, they argued, despite the recommendation of federal probation officials.
Those factors include the large number of victims, the amount of loss caused by fraud and a conscious or reckless disregard of the risk of death or serious injury to victims.
"The seriousness of Svirskiy's crimes should not be overlooked," the prosecutors concluded. "A sentence for Svirskiy must provide adequate deterrence to licensed pharmacists in the future."
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NECC VP Fights to Keep License

By Walter F. Roche Jr.

The former vice president and part owner of a defunct drug compounding firm is fighting to keep his license as a real estate salesman charging that state officials are acting prematurely based on a false premise.
In a four-page motion filed with the Massachusetts Board of Real Estate Brokers and Salesmen, lawyers for Gregory Conigliaro, argued that a final judgment has not been issued following his 2018 conviction on charges of conspiracy to defraud the federal government.
Conigliaro was vice president and part owner of the New England Compounding Center, the company blamed for a deadly 2012 fungal meningitis outbreak. He was one of 14 charged by a federal grand jury following a two year probe of the outbreak.
Conigliaro was convicted late last year along with four other people connected to NECC. The state board subsequently issued an order to show cause why his license should not be revoked because he engaged in conduct demonstrating a lack of good moral character.
Conigliaro's lawyer, Daniel Rabinowitz, however argued that the board could not act until a final judgment was issued by the federal judge presiding over his case.
"Final judgment has not entered and, thus, Mr. Conigliaro has not been convicted," the motion states, adding that the board action was based on a false premise.
Conigliaro was issued a real estate license on Dec. 7, 2013, over a year after NECC was forced to shutdown.
The motion also notes that Conigliaro has appealed the conviction asking U.S. District Judge Richard G. Stearns to issue an acquittal order or grant him a new trial. The judge has yet to act on the motion
The motion also notes that prior cases cited by the board as precedent "involved far more serious charges than the single count Mr. Conigliaro was charged with."
The motion also disputes the charge that Conigliaro violated the terms of his license by failing to report his conviction to the board. Rabinowitz wrote that he had advised Conigliaro not to report the conviction until a final verdict was issued.
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NECC Defendant Seeks No Jail Time

By Walter F. Roche Jr.

A convicted defendant in the criminal case stemming from a deadly fungal outbreak is asking a federal judge not to send him to jail, but sentence him to two years of probation and 100 hours of community service.
The 19-page sentencing memo for Christopher Leary was filed today in U.S. District Court in Boston, Mass by his attorney Paul Kelly.
The memo also urges U.S. District Judge Richard G. Stearns not to impose a fine and rejects the contention of federal probation officials that Leary's sentence should be enhanced because his actions caused losses to victims of $138,160.
Calling the probation estimate "erroneous, unfair and inconsistent with the jury's finding," Leary
said Stearns should find losses caused by his actions totaled only $3,595.
Leary was one of five persons connected to the New England Compounding Center convicted late last year following an eight-week trial. But, as Kelly's memo points, out the jury cleared Leary of the most serious charges, racketeering and racketeering conspiracy.
One of Leary's co-defendants, Gene Svirskiy, filed a sentencing memo last week urging Stearns to impose only one year of home confinement, instead of the maximum 20 year sentence he could have faced. Leary, according to federal prosecutors, also could have faced a maximum sentence of 20 years.
He was convicted of three counts of mail fraud and charges of introducing misbranded and adulterated drugs into interstate commerce.
None of the five were charged with a role in producing the methylprednisolone acetate that NECC shipped in 2012 causing the deaths of over 100 patients and sickening hundreds of others.
Leary, for instance, was charged for his role in shipping drugs that did not meet specifications, including sub-potent eye medications shipped to the Massachusetts Eye and Ear Infirmary.
Even as to that charge, the sentencing memo cites trial testimony showing that a pharmacy technician was responsible for the actual error and there was no way Leary could have known that.
Stating that Leary's brief tenure at NECC was "18 months of hell," the filing contends that Leary's sentence should also be limited because he was "a minor participant," had no supervisory role and had no ownership interest in NECC.
In fact, the memo states, Leary was the youngest and least experienced of those charged and was "bullied and ridiculed" by his colleagues.
Leary, Kelly wrote, "thought about quitting more than once but needed the income with his wedding only months away." He was married four days after NECC was shutdown.
Noting that it was likely Leary's pharmacy license will be permanently revoked, the memo states,"His (Leary's) sentence began the day he was indicted. He carries the guilt of working for a company that caused unprecedented patient harm."
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NECC Defendant Seeks Home Confinement

By Walter F. Roche Jr.

A convicted pharmacist who could face up to 20 years in jail for racketeering, mail fraud and related charges, is asking a federal judge to sentence him to one year of home confinement, two years of probation and 500 hours of community service.
Citing his client's endorsement by a current member of the Massachusetts Board of Pharmacy, attorney Jeremy Sternberg said Gene Svirskiy deserves a sentence that will keep him in the community.
Svirskiy was one of five people connected to the New England Compounding Center who were convicted late last year. He was convicted of racketeering, conspiracy, 10 counts of mail fraud and two counts of introducing adulterated drugs into state commerce.
In a 37-page sentencing memorandum filed in Svirskiy's behalf, Sternberg said his client should get a sentence which "while punitive allows him to remain a vital member of his profession and his community."
Svirskiy, 37, a resident of Ashland, Mass. worked at the New England Compounding Center, the company blamed for a deadly 2012 fungal meningitis outbreak caused by fungus tainted steroids. Svirskiy, however, was charged for his role in NECC's production of other drugs including long outdated methotrexate, an anti-cancer drug and an antibacterial drug shipped before testing to a New York hospital.
The memorandum repeatedly cites Svirskiy's relation with Andrew Stein, a member of the state pharmacy board. Stein also wrote a letter to the judge in support of Svirskiy in which he stated he would hire Svirskiy on the spot for work at compounding pharmacies he owns.
In fact Svirskiy worked for Stein following his indictment in late 2014 and, according to the memo, worked for him up until his 2018 conviction. Svirskiy was barred under a court order from engaging in sterile compounding.
The memo also noted Svirskiy was not an owner of NECC and stated,"Nothing Gene did at any time at NECC caused harm to any patient."
Citing his client's volunteer work in the community, the memo states, "Gene is completely rehabilitated and is at no risk for recidivism."
The memo also contends that the state of drug compounding has changed since 2012 when Svirskiy last worked at NECC.
"There is a wide gulf between what was known and accepted then as opposed to now," the filing states.
Sternberg also argued that all the operations at NECC were closely overseen by NECC's president, Barry Cadden and Supervising Pharmacist Glenn Chin, both of whom are now serving prison terms following conviction on racketeering and mail fraud charges.
Citing Svirskiy's actions before and after his NECC employment, the memo states that the offenses Svirskiy committed were "out of step with the person he was before he took a job at NECC."
The memo also minimizes Svirskiy's role in supervising an unregistered pharmacy technician, citing that technician's skill
Finally the memo notes the case of a Tennessee pharmacist who was charged with producing contaminated compounded drugs that did actually harm patients. That defendant was sentenced to probation with no jail time.
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2nd NECC Defendant Seeks Acquittal

By Walter F. Roche Jr.

Charging that her client was convicted for not doing something that wasn't part of her job, the attorney for a former pharmacist employed by a drug compounding firm is asking a judge to reverse the decision of 11 jurors who found her guilty on all counts
In a 25-page motion filed today in U.S. District Court in Boston, Mass. the lawyer for Kathy Chin, the pharmacist, said prosecutors failed to present sufficient evidence to support the jury's guilty verdict.
Chin was convicted of four violations of the Food Drug and Cosmetic Act when she approved for shipment drugs prescribed for patients with obviously fictitious names. The jurors also found that she acted with the intent to defraud or mislead.
The government, attorney Joan Griffin wrote, "failed to prove Kathy Chin dispensed drugs without a valid prescription.It was not part of the defendants job to check prescriptions or patient names."
Chin and co-defendant Michelle Thomas were convicted earlier this month, following a four day trial. They were among 14 indicted in late 2014 following a two-year probe of the company that employed them, the New England Compounding Center.
The probe was triggered by a deadly outbreak of fungal meningitis caused by fungus laden steroids shipped from NECC to more than 20 states. The charges against Chin and Thomas are not related to the steroids that caused the outbreak, but for other drugs. A similar appeal was filed last week on Thomas'behalf.
In the Chin motion, Griffin said that it wasn't her client's job to check patient names and that task was performed by other NECC employees including NECC's president and part owner Barry Cadden. Cadden already is serving a nine year prison term following his conviction on racketeering and mail fraud charges.
"The evidence is unequivocal that checking prescriptions was not part of the defendant's job," Chin's motion states, adding that she was wrongfully charged with wrongdoing by other NECC higher ups, including Cadden.
Instead, the motion states, Chin, whose husband was also convicted of racketeering and mail fraud, simply checked to see that the right drugs were being sent to the right address. "The prescriptions were complete and valid except the apparently fake patient names," the motion states.
"The fact that she happens to be a pharmacist does not make Ms. Chin responsible for the actions or in-actions of the corporation," Griffin wrote.
Prosecutors had argued that as a licensed pharmacist, Chin was required to check the validity of patient names.
Stating that Kathy Chin simply signed a shipping verification sheet, the motion states that the government "has not produced any evidence to suggest that Kathy Chin did not do her job in complete good faith."
Finally Griffin said the prosecution presented an overwhelming amount of evidence of wrongdoing that his client was not even charged with. That, she said, prejudiced the jury.
As Thomas' lawyer did last week, Griffin asked that if the the acquittal is denied, the judge should order a new trial.
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NECC Defendant Seeks Acquittal

By Walter F. Roche Jr.

A pharmacist found guilty of violating a federal drug law is asking the presiding judge to act in the place of a missing juror and acquit her of the charges on which she was convicted.
In a 17-page filing by her attorney, Michael Bourbeau, Michelle Thomas argued that allowing her conviction to stand "would result in a miscarriage of justice."
Thomas and Kathy Chin, both former employees of the New England Compounding Center, were found guilty of violations of the Food Drug and Cosmetic when they approved for shipment prescription drugs for clearly fraudulent patients. The two were also convicted of doing so with the intent to defraud or mislead, a felony.
The unanimous verdict was reached by an 11 member jury after a four day trial. The 12th juror was dismissed at the last minute after he disclosed he knew an investigator from the U.S. Food and Drug Administration who testified extensively for the prosecution.
In her motion Thomas asked U.S. District Judge Richard G. Stearns to "act as the 12th juror" and acquit her of the charges or grant her a new trial.
Chin and Thomas were employees of the now defunct drug compounding firm blamed for the 2012 fungal meningitis outbreak which ultimately killed over 100 patients. The charges against the two so-called conforming pharmacists did not involve the drugs that caused the outbreak.
They were charged with approving for shipment drugs prescribed for obviously fictitious patients like Filet O Fish.
Thomas, in her filing, noted that she had only been working for NECC for a week when the first charged prescription was filled.
Bourbeau also argued that there was no evidence to support the charge that his client had any knowledge of a longtime NECC practice of issuing drugs without valid prescriptions.
"No evidence was presented that she even had knowledge of the regulations that were required for this compounding center," the motion states.
The government, the motion continues, did not present any evidence that Ms. Thomas, specifically and willfully intended to defraud and mislead the FDA."
Thomas and Chin were among 14 persons indicted in 2014 following a two year probe of the 2012 fungal meningitis outbreak. They were the last to go on trial. The guilty verdicts were returned May 2 following barely two hours of deliberation.
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Sentencing Set for NECC Star Witness

By Walter F. Roche Jr.

A federal judge has set an Aug. 8 sentencing date for a key prosecution witness in the criminal trials stemming from a deadly 2012 fungal meningitis outbreak.
In an order issued today in U.S. District Court in Boston, Mass., U.S. District Judge Richard G. Stearns set the date for Robert A. Ronzio, who has entered a guilty plea to a single count of conspiracy to defraud the federal government.
Ronzio, under the terms of a plea agreement with federal prosecutors, testified in a series of trials against his former colleagues at the New England Compounding Center, the company that caused the outbreak.
Specifically Ronzio, who was NECC's sales chief, entered a guilty plea to the charge that he conspired to defraud the U.S. Food and Drug Administration by agreeing to let NECC's customers ship initial drug orders without patient specific prescriptions and take other actions "to make it appear to federal and state regulators that NECC was dispensing drugs pursuant to valid patient-specific prescriptions when in fact it was not."
The North Providence, R.I. resident testified as a prosecution witness in the trials of former NECC President and part owner Barry J. Cadden and Glenn Chin, NECC's supervising pharmacist. He also testified in two subsequent trials with multiple defendants.
The penalty for the conspiracy charge Ronzio admitted committing can carry a penalty of up to five years in prison, but prosecutors are expected to recommend a much less severe penalty based on his cooperation.
In other action today, Stearns re-set the sentencing dates for Kathy Chin and Michelle L. Thomas, who were recently found guilty in a four-day trial. Chin, the spouse of Glenn Chin, will be sentenced Aug. 8 at 10 a.m. Thomas will be sentenced a day later at the same time.
The two NECC pharmacists were convicted for violations of the federal Food Drug and Cosmetic Act when they okayed prescriptions for patients with obviously fake names.
The defendants were among 14 indicted in 2014 following a two-year investigation of the fungal meningitis outbreak caused by NECC drugs contaminated with deadly fungi.
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Manafort Joins Cadden in PA Prison

By Walter F. Roche Jr.

Paul Manafort, the onetime campaign chairman for President Trump, has been transferred to the same Pennsylvania federal prison where a former pharmacist is serving a nine year sentence for his role in a deadly fungal meningitis outbreak.
Records from the federal Bureau of Prisons show Manafort was transferred to the Federal Correctional Institution in Loretto, PA. this week.
Manafort is serving a 7.5 year sentence following his conviction on tax evasion and related charges. He had been held at a Virginia facility prior to the recent transfer.
Cadden, 52, was convicted on racketeering and mail fraud charges. A co-defendant, Glenn Chin, 51, is serving an eight year sentence at the federal prison in Allenwood, PA. Both were affiliated with the New England Compounding Center, the company that produced the fungus laden drugs that caused the 2012 fungal meningitis outbreak.
Manafort, 70, is due to be released Dec. 25, 2024 while Cadden's release date is June 6, 2025. Chin's scheduled release date is Feb. 26, 2025.
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NECC Defendant Gets Probation

By Walter F. Roche Jr.

BOSTON- A former employee of a Massachusetts drug compounding firm was sentenced to one year of probation today following her conviction on six violations of the federal Food Drug and Cosmetic Act.
U.S. District Judge Richard G. Stearns issued the sentence to Alla Stepanets following a brief hearing. She was one of five former employees of the now defunct New England Compounding Center who were convicted late last year.
Her sentencing came just one day after two other former NECC employees were found guilty on similar charges. All three were licensed pharmacists.
Federal prosecutors had recommended a sentence of two years probation.
In a 10-page brief Assistant U.S. Attorney George Varghese said Stepanets "routinely dispensed drugs without valid prescriptions."
"The evidence at trial showed that Ms. Stepanets eschewed her responsibilities as a licensed pharmacist and verified drug shipments for patently fictitious patients," Varghese wrote, adding that her criminal actions were not accidents or mistakes but rather systematic and deliberate violations of law."
Stepanets was one of 14 persons connected to NECC who were indicted in 2014 following a two year probe of the deadly 2012 fungal meningitis outbreak caused by contaminated drugs produced by the Massachusetts company.
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Latest NECC Indictment Scorecard

Here are the names of those indicted in the probe of the New England Compounding Center and the current status of their cases.

Barry J. Cadden: convicted of racketeering, racketeering conspiracy, mail fraud and violations of the Food Drug and Cosmetic Act (FDC Act). (Cleared of second degree murder)Currently serving nine year federal prison sentence. Release date June 6, 2025.
Glenn Chin: found guilty of racketeering, racketeering conspiracy, mail fraud and violations of the FDCA. (Cleared of second degree murder) Serving an eight year federal prison sentence. Release date Feb. 26, 2025.
Gene Svirskiy: Convicted of racketeering, racketeering conspiracy, violations of the FDCA. Awaiting sentencing.
Scott M. Connolly: entered guilty plea to nine counts of mail fraud. Awaiting sentencing.
Sharon P. Carter: convicted of conspiracy to defraud the federal government. Awaiting sentencing.
Alla V. Stepanets: convicted of six violation of the FDCA. Sentenced to one year probation.
Gregory A. Conigliaro: convicted of conspiracy to defraud the U.S. Food and Drug Administration. Awaiting sentencing
Robert A. Ronzio: entered guilty plea to conspiracy to defraud the FDA. Awaiting sentencing
Christopher Leary: convicted of mail fraud and violations of the FDCA.
Kathy S. Chin: Convicted of four violations of the FDCA with intent to defraud. Sentencing August 8.
Michelle L. Thomas: Convicted of two violations of the FDCA with intent to defraud. Sentencing in August 9.
Carla R. Conigliaro: Pleaded guilty to violations of financial transaction reporting laws. Sentenced to probation
Douglas A. Conigliaro Pleaded guilty to violations of financial transaction reporting laws. Sentenced to probation.
Joseph M. Evanosky: cleared of all charges.

Two NECC RXs Convicted

By Walter F. Roche Jr.

BOSTON- Acting within less than two hours, a federal jury today found two pharmacists guilty of violations of federal drug laws when they worked for a drug compounding firm blamed for a deadly 2012 fungal meningitis outbreak.
Convicted on a total of six felony counts were Kathy Chin and Michelle Thomas. Both worked for the now defunct New England Compounding Center. The two were charged with violations of the Food Drug and Cosmetic Act when they issued drugs based on prescriptions for patients with clearly fake names.
U.S. District Judge Richard G. Stearns set August dates for their sentencing.
They were charged with placing mis-branded drugs in interstate commerce. Chin was convicted on four counts of misbranding with intent to defraud or deceive. While Thomas was convicted on two counts of the same charges.
The two were among 14 indicted following a two year probe of the fungal meningitis outbreak which took the lives of some 100 patients nationwide including at least 16 from Tennessee.
Only one of the 14 has been acquitted of all charges while others have been convicted or entered guilty pleas. They including Chin's husband Glenn, who is serving an eight year prison sentence.
The charges against Kathy Chin and Thomas were not for drugs that caused the outbreak but for other drugs compounded at NECC's Framingham, Mass. facilities.
Specifically they were charged in the compounding of drugs shipped to health providers in Nebraska and Georgia.
During final arguments before the jury began deliberations, Assistant U.S. Attorney Amanda Strachan said the two were part of a massive fraud.
"It was fraud through and through," Strachan said. "It was NECC's business model."
She said the two distributed drugs with prescriptions made out to fake patients. Evidence presented to the jury included prescriptions with patient names including L.L. Bean and Filet O Fish.
Joan Griffin, Chin's lawyer, called the verdict "very disturbing" and said an appeal will be filed.
Both she and Michael Bourbeau, Thomas' lawyer, had argued that NECC's part owner and president Barry J. Cadden was the responsible party. Cadden is serving a nine year sentence in federal prison and he and Chin are facing multiple second degree murder charges in Michigan. They were convicted on racketeering and mail fraud charges in separate federal trials.
Five others affiliated with NECC or its sales arm were recentl convicted of related charges and are awaiting sentencing.
The jury verdict was delivered by only 11 of the original 12. One juror was dismissed after he disclosed that he had prior dealings with one of the prosecution witnesses, a criminal investigator for the U.S. Food and Drug Administration
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State Official Backs Charges

By Walter F. Roche Jr.

BOSTON- A Massachusetts official gave damning testimony today as federal prosecutors indicated they may soon rest their case against two pharmacists charged with violating a federal drug law. The two were swept up in a two year probe of a deadly fungal meningitis outbreak caused by the company that employed them.
Samuel J. Penta, chief investigator for the Massachusetts Board of Pharmacy, said the practices at the New England Compounding Center violated state laws and regulations. He said that while licensed pharmacists were responsible for verifying that valid prescriptions had been issued for drugs being dispensed, some patient names on prescriptions issued by NECC were obviously fake.
U.S. District Judge Richard G. Stearns, meanwhile told jurors that they should be prepared for an extended session tomorrow and disclosed he was preparing final instructions that will be given to jurors before they begin deliberations. Initially lawyers involved in the case had predicted the trial, which began Monday, would go into a second week.
The trial is the fourth and last resulting from the indictment of 14 persons affiliated with NECC, the company blamed for the 2012 outbreak that sickened nearly 800 patients, killing over 100 of them
Chin and Thomas were not charged with compounding the specific drug blamed for the outbreak but for the preparation of other drugs in violation of the the federal Food Drug and Cosmetic Act.
Penta said the forms used by NECC did not comply with Massachusetts laws and regulations mandating that an individual patient-specific prescription be issued for every drug dispensed.
"A prescription has to be verified before dispensing," Penta said, adding that the pharmacist was responsible for ensuring that the prescription was written for a specific patient. And, he added, that responsibility could not be delegated.
Penta also testified about his involvement in the investigation of NECC when the outbreak first surfaced in late September and early October of 2012. He said he and other staffers from the state board visited NECC's facilities and he was immediately overwhelmed by the volume of NECC's business.
He said it appeared to be acting as a drug manufacturer, not a local pharmacy as it was licensed,
He said fork lifts were being used to move around supplies.
"They were compounding on a large scale" Penta said.
On cross examination Chin's lawyer, Joan M. Griffin, confronted Penta with a 2013 letter to her client from the state board informing her that an investigation of her had been closed with no action being taken. And, she noted, Chin still has a valid pharmacist license.
Assistant U.S. Attorney Amanda Strachan later asked Penta whether the state investigation had been closed at the request of the U.S. Attorney's office. He said that was the case.
Griffin also questioned Penta about a letter sent to the board by NECC President Barry J. Cadden describing a new NECC procedure to assure orders were placed for real patients.
Penta said that the letter was Cadden's response to a board inquiry and did not indicate the board approved the new procedure.
It was superseded, Penta said.
Also testifying for the prosecution was Scott Connelly, who already has entered a guilty plea to ten counts of mail fraud. He testified that drugs he compounded were distributed without being checked by a licensed pharmacist. Though jurors were not told the details, Connolly's charges stem from his working as a pharmacy technician when he had surrendered his certification due to an unrelated investigation.
Connolly said he signed in to the computer system using the ID of NECC President Barry J. Cadden. Cadden is serving a nine year federal prison term following his conviction on racketeering and mail fraud charges.
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