Outbreak's Aftermath Rolls On

Major events in 2019* **

January- Gregory Conigliaro, former part owner and vice president of the New England Compounding Center files appeal of his jury conviction on the charge he conspired to defraud the U.S. Food and Drug Administration.
Appeals court orders the release of the addresses of jurors who heard a major NECC trial.

February- Barry Cadden and Glenn Chin are arraigned in Michigan on second degree murder charges.
Defefendant Alla Stepanets has her appeal denied.

April- Kathy Chin and Michelle Thomas on trial for violations of the Food Drug and Cosmetic Act(FDCA).

May- Alla Stepanets sentenced to one year of probation for FDCA violations.
Gene Svirskiy sentenced to 30 month prison sentence. Christopher Leary gets eight month home confinement.

June- U.S. District Judge Overturns Jury Verdicts on Conigliaro, Carter.
Cadden, Chin face first hearing on Michigan Murder Charges.

July- Gene Svirskiy begins serving 30 month sentence for racketeering, mail fraud and related charges.

September- Chin, Cadden face Michigan hearing on second degree murder charges.
Seventh anniversary of the outbreak shows victims still suffering serious after effects.

October- Kathy Chin, Michelle Thomas Appeals Denied.
Michigan Judge Rules Cadden, Chin must attend hearing.

November- Three judge panel hears appeals in Cadden, Chin cases.
Michigan murder hearings resume. Next session in February.

December- Cadden House sold for $1.3 million.
Chin, Cadden remain in Michigan lock-up.
Kathy Chin and Michelle Thomas get probation.

* See www.meningitis-etc.blogspot.com for complete details.
** See https://meningitis-etc.blogspot.com/2019/12/necc-scorecard.html for indictment scorecard.

Victims Question Chin's Offer

By Walter F. Roche Jr.

In a Boston, Mass. courtroom last week a former employee of the New England Compounding Center,the company blamed for a deadly outbreak told a federal judge that she wanted to start a campaign to raise funds for the victims of that 2012 public health disaster.
Kathy Chin made the disclosure during her sentencing hearing. She made the statement to U.S. District Judge Richard G. Stearns moments before he imposed a sentence following her conviction of four violations of the Food Drug and Cosmetic Act.
She told Stearns that she hoped federal prosecutors would supply her with the names of the victims so she could contact them. Subsequently she was sentenced to two years of probation.
Though there were no victims present for the Thursday hearing, a subsequent query to victims brought a less than favorable response.
"I do not believe anything she or the others (defendants) say. They have had seven plus years to try to help the victims. And there was nothing done. They are only looking out for themselves," wrote Linda S. Boggs, a Virginia victim of the outbreak in an email response to requests for comment.
She, like other victims expressed concerns about the possible disclosure of her name and any contact information.
"If she is sincere she can work through our attorneys," Boggs added.
Donna Borton, the spouse of a Michigan victim, said she was surprised to hear of Chin's offer in light of the fact that the Chins sought a court appointed attorney because they couldn't afford one.
Kathy Chin's husband, Glenn, was also a defendant in the case and is now serving an eight year prison sentence following his conviction on racketeering and mail fraud charges.
Stating that she was unsure of Kathy Chin's motive for making the offer, Borton said she and her husband Ken were "a little suspicious of her intentions."
"We really don't want her to have any of our personal information," Borton wrote, adding that they and other victims "pretty much agree that no one trusts anyone with any ties to NECC."
Dawn Elliott, an Indiana Victim,was equally skeptical.
"In my opinion I will truly be surprised if Kathy Chin does anything. I feel it is too little too late and had she wanted to really do anything she would have done it a long time ago. I truly do not believe she is sincere. She may truly be sorry, but I don’t think she will truly do a thing to help anyone," Elliott wrote.
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Sentencing Set for Key NECC Witness

By Walter F. Roche Jr.

An April 22 date has been set for the long delayed sentencing of a key government witness in the criminal case stemming from the deadly 2012 fungal meningitis outbreak.
In an order issued late last week U.S. District Judge Richard G. Stearns set the date for Robert Ronzio of North Providence, R.I., who was the head of sales at the New England Compounding Center, the company that produced thousands of vials of an injectable steroid laden with deadly fungi.
Under a plea agreement with federal prosecutors, Ronzio entered a guilty plea to conspiracy to defraud the U.S. Food and Drug Administration in December of 2016.
Ronzio was a key witness in the trials of Barry Cadden and Glenn Chin. Cadden was NECC's president and part owner while Chin was a supervising pharmacist in the clean room where the contaminated methylprednisolone acetate was prepared.
Both Cadden and Chin were found guilty of racketeering, conspiracy and mail fraud charges and are now serving federal prison sentences. The two are also facing second degree murder charges in Michigan.
Ronzio also testified in subsequent trials of NECC defendants, including the most recent trial of two former NECC pharmacists.
Ronzio's sentencing had been scheduled for Jan. 31, 2018 but was then delayed indefinitely under a joint agreement between federal prosecutors and Ronzio's lawyers.
Under his plea agreement Ronzio admitted to being involved in a conspiracy to defraud the U.S. Food and Drug Administration.
Ronzio's sentencing is scheduled for 3 p.m. on April 22 in Stearns' Boston, Mass. courtroom.
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NECC Scorecard

NECC Indictment Scorecard
Here are the names of those indicted in the probe of the New England Compounding Center and the outcome 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 charges) 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 charges) Serving an eight year federal prison sentence. Release date Feb. 26, 2025.
Gene Svirskiy: Convicted of racketeering, racketeering conspiracy, violations of the FDCA. Serving 30 month prison sentence. Release date Aug. 26, 2021
Scott M. Connolly: entered guilty plea to nine counts of mail fraud. Sentenced to two years probation.
Sharon P. Carter: convicted of conspiracy to defraud the federal government. Acquitted on appeal.
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. Acquitted on appeal.
Robert A. Ronzio: entered guilty plea to conspiracy to defraud the FDA. Sentencing delayed indefinitely.
Christopher Leary: convicted of mail fraud and violations of the FDCA. Sentenced to eight months home confinement.
Kathy S. Chin: Convicted of four violations of the FDCA with intent to defraud. Sentenced to two years probation.
Michelle L. Thomas: Convicted of two violations of the FDCA with intent to defraud. Sentenced to one year probation.
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.
* Cadden and Chin are still facing second degree murder charges in Michigan.
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Final Defendant Gets 1 Year Probation

By Walter F. Roche Jr.

The final defendant in the criminal case stemming from a deadly fungal meningitis outbreak was sentenced to one year of probation today in a session before U.S. District Judge Richard G. Stearns in his Boston, Mass. courtroom.
Michelle Thomas, who was a pharmacist at the New England Compounding Center, was sentenced to one year of probation and ordered to pay a $200 special assessment. She is the last of 14 originally indicted following a two year probe of the deadly 2012 fungal meningitis outbreak.
Eleven of the 14 were found guilty or entered guilty pleas. Two of the 14 had their jury convictions overturned by Stearns and one of the 14 was acquitted on a jury verdict.
Thomas was convicted on two counts of violating the Food Drug and Cosmetic Act (FDCA). Prosecutors charged that she approved the shipping of prescriptions for patients with obviously fake names.
The one year of probation was one year less than that recommended by federal prosecutors.
Co-defendant Kathy Chin was sentenced Thursday to two years of probation. Chin was convicted of four counts of violating the FDCA.
Three of the original 14, Glenn Chin, Barry Cadden and Gene Svirskiy are currently serving jail sentences. Kathy Chin is the spouse of Glenn Chin.
Kathy Chin and Thomas were not charged with any involvement in the production of the fungus riddled drugs that caused the 2012 fungal meningitis outbreak.
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NECC Pharmacist Gets 2 Years Probation

By Walter F. Roche Jr.

A one time licensed pharmacist who approved prescriptions for shipment that were prescribed for obviously fictitious patients was sentenced today to two years of probation by U.S. District Judge Richard G. Stearns sitting in Boston, Mass.
The sentence was imposed on Kathy Chin who worked as a pharmacist at the now defunct New England Compounding Center, the company blamed for a 2012 deadly fungal meningitis outbreak. The charges against Chin did not involve the contaminated drugs that caused the outbreak.'
She was charged with violations of the Food Drug and Cosmetic Act.
The sentence imposed by Stearns was the same as recommended by the U.S. Attorney's office.
Kathy Chin is the spouse of Glenn Chin, who was a supervising pharmacist at NECC and in charge of the clean room where the contaminated drugs were produced. He is currently serving an eight year sentence following his conviction on racketeering, conspiracy and mail fraud charges.
The Chins were two of 14 persons with ties to NECC who were indicted following a two year probe of the fungal meningitis outbreak. Another defendant, Michelle Thomas, is scheduled for sentencing tomorrow.

Cadden, Chin Remain in Michigan

By Walter F. Roche Jr.

The two primary defendants in the criminal case stemming from a deadly fungal meningitis outbreak remain jailed in Michigan where they are facing 11 additional second degree murder charges.
Officials of the Michigan Attorney General's office say that Barry J. Cadden and Glenn Chin will be kept in the Livingston County jail in Howell until mid February when two days of hearings are scheduled on the second degree murder charges.
The two already are serving sentences in federal prison following their conviction on racketeering, mail fraud and conspiracy charges.
According to Michigan officials the two are being kept in Michigan to avoid the expense of transporting them back and forth to federal prisons in Pennsylvania where they have been serving their federal sentences.
Cadden has been serving a nine year sentence at the federal prison in Loretto, PA., while Chin has been serving an eight year sentence at the federal prison in Allenwood, PA.
They were brought to Michigan for a pre-trial hearing in November and are scheduled for appearances on Feb.13 and 14th in Livingston County District Court.
Assistant John Buck of the Michigan Attorney General's office said the continued hearings are being held to determine if there is probable cause to bring the two to trial on the second degree murder charges.
The two were charged in the deaths of Donna Kruzich; Paula Brent; Lyn Laperriere; Sally Roe; Mary Plettl; Gayle Gibson; Patricia Malafouris; Emma Todd; Jennie Barth; Ruth Madouse and Karine Baxter.
Cadden was president and part owner of the New England Compounding Center, the company that produced the contaminated steroids that cause the 2012 outbreak. Chin was the supervising pharmacist in the clean room where the tainted drugs were produced.
The November sessions marked the second time Cadden and Chin appeared in a Michigan court room. They both were present for an arraignment session in February, following which they were sent back to Pennsylvania.
Lawyers for the two had asked that they not be required to attend the February sessions but Judge Shauna Murphy ruled that both must be present.
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Final NECC Sentencing Delayed

Sentencing sessions for the two final defendants in the criminal case stemming from a deadly fungal meningitis outbreak has been delayed once again.
In brief orders issued today in U.S. District Court in Boston, Mass. U.S. District Judge Richard G. Stearns set separate dates for the sentencing of Michelle Thomas and Kathy Chin, two pharmacists who worked at the New England Compounding Center, the company that caused the 2012 outbreak.
Kathy Chin will be sentenced on Dec. 19 at 3 p.m. while Michelle Thomas will be sentenced 24 hours later.
Both were convicted of violations of the Food Drug and Cosmetic Act when they approved for shipment drugs prescribed for obviously fake named patients.
The two had most recently been scheduled for sentencing on Dec. 17 and Dec. 19.
Chin is the spouse of Glenn Chin, also a former NECC pharmacist, who is serving an eight year prison sentence following his conviction on racketeering, conspiracy and mail fraud charges. Glenn Chin was a supervising pharmacist in the clean room where drugs contaminated with a deadly fungus were prepared.
Kathy Chin and Thomas were not involved in the preparation of the deadly steroids.
Federal prosecutors have recommended that Thomas and Kathy Chin be sentenced to two years of probation.
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Probation Urged for Final NECC Defendants

By Walter F. Roche Jr.

Federal prosecutors are recommending a sentence of two years probation with no jail time for the two final defendants in the criminal case stemming from a deadly fungal meningitis outbreak.
In an 11-page filing today in U.S. District Court in Boston, Mass., the U.S. Attorneys office asked U.S. District Judge Richard G. Stearns to impose the identical sentences on Michelle Thomas and Kathy Chin, who were both employed at the New England Compounding Center, the company blamed for the 2012 outbreak. Both were licensed pharmacists at the time of their employment
Chin and Thomas were both convicted of violations of the Food Drug and Cosmetic Act when they approved the shipment of drugs with prescriptions made out for obviously fake named patients.
The two were among 14 indicted in December of 2014 following a two year probe of the outbreak. Three of those 14 are now serving federal prison sentences.
Alla Stepanets, another of the 14 who held a similar job to Thomas and Chin, was given a sentence of one year of probation.
In the filing today Assistant U.S. Attorney Amanda Strachan wrote that while the crimes committed by Chin and Thomas were not as serious as those committed by other pharmacists working at NECC, their crimes "were an abuse of the position of trust that each held as a licensed pharmacist."
Stating that the issuance of prescription drugs in bulk without valid prescriptions put patients at risk, the brief adds that the Thomas and Chin's "intentional misconduct allowed NECC to perpetuate fraud."
Chin and Thomas "turned their backs on their responsibilities as licensed pharmacists," the filing continues.
Citing the trial testimony of Samuel Penta, a Massachusetts Pharmacy Board official, the brief states that the jobs performed by Thomas and Chin, final verification, was "a necessary step in the process."
Prescriptions approved by the two were made out for patients named Chester Cheeto, L.L. Bean and Coco Puff, the brief adds.
Charging that there were obvious red flags the two defendants ignored, Strachan noted that neither of them had accepted responsibility for their actions.
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Palatial Cadden Home Sold for $1.3 Million

By Walter F. Roche Jr.

The palatial suburban Boston home of a convicted former drug company owner has been sold for $1.3 million and half the proceeds will go to the federal government.
A deed filed today at the Norfolk County Registry of Deeds in Dedham, Mass. transfers the ownership of the 9,000 square foot former home from Barry J.. Cadden and his wife, Lisa to Michael and Lisa Ferdenzi.
Cadden headed the New England Compounding Center and his former home was subject to a forfeiture order approved by U.S. District Judge Richard G. Stearns. Under a negotiated forfeiture agreement half of the proceeds go to the federal government with the other half going to Lisa Cadden. She was never charged with any wrongdoing.
The Caddens owned a 35 per cent share of NECC and together they collected some $72 million from the company in the six years before the drug compounding firm was shutdown in 2012, according to court filings.
Stearns today approved an order officially authorizing the sale.Other documents filed in Dedham transfer Barry Cadden's interest in the property to the U.S. Justice Department.
Barry Cadden is currently serving a nine year federal prison sentence following his conviction on racketeering, conspiracy and mail fraud charges. He was one of 14 indicted in late 2014 following a two year investigation of the 2012 fungal meningitis outbreak which sickened some 800 patients. Over 100 of them have died.
The home had been on the market for nearly a year and the final sales price is less than half of the original $2.9 million asking price. The deed covers the main house at 13 Manchester Drive and two adjacent lots.
Real estate listings for the home describe it as "a magnificent private enclave" with five bedrooms, a heated salt water pool and a bocce lawn.
"Exemplary Craftsmanship and boutique materials highlight the construction of this fabulous estate," the listing states. (https://www.youtube.com/watch?v=MXZXykJXuh0)

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Recent Study on Fungal Meningitis

Current treatment for fungal meningitis is fueling drug resistance

by University of Liverpool
Gram stain of meningococci from a culture showing Gram negative (pink) bacteria, often in pairs. Credit: public domain

A common first-line treatment approach for cryptococcal meningitis in low-income countries is being compromised by the emergence of drug resistance, new University of Liverpool research warns.

Published in the journal mBio, the findings highlight the need to develop new drugs and treatment regimens for the lethal brain infection, which kills around 180,000 people each year.

Cryptococcal meningitis is a leading cause of death among adults with HIV/AIDS in sub-Saharan Africa. In many parts of the world, the antifungal drug fluconazole is the only agent that is available for the initial treatment of the infection, despite considerable evidence that long-term outcomes are poor.

Drug resistance is thought to play a role in these poor outcomes, but solid data is currently lacking and a better understanding of the relationship between fluconazole exposure and the emergence of resistance has been needed.

In an experimental study in a novel hollow fibre model and mice, the relationship between drug exposure and both antifungal killing and the emergence of resistance to fluconazole was quantified. These results were then bridged to patients in a clinical study where patients with cryptococcal meningitis in Tanzania receiving fluconazole were studied.

The findings showed that fluconazole resistance is caused by duplication of the fungus' chromosomes and occurs while patients are on therapy. Simulations from mathematical models fitted to the patients' data suggested that only 12.8 percent of patients receiving fluconazole at the recommended 1,200 mg/day were completely free of the fungus after two weeks. Furthermore, 83.4 percent had a persistent subpopulation that was resistant to fluconazole. Preventing this would require significant dosage escalation of fluconazole beyond what is currently recommended.

William Hope, Professor of Therapeutics and Infectious Diseases at the University of Liverpool, said: "This study is unique in that it combines information from experimental models of cryptococcal meningitis with data from patients receiving fluconazole as monotherapy, which remains the norm in much of Africa, despite not being consistent with current treatment recommendations from the WHO.

"We've shown that the emergence of resistance is related to drug exposure and occurs with the use of clinically-relevant monotherapy regimens. Hence the only drug available to many patients in Africa is compromised by the ability of the fungus to develop resistance while the patient is taking fluconazole.

"Our findings underscore the urgent need for the development of new agents and combinations to reduce the global toll of cryptococcal meningitis."

Antimicrobial resistance is a growing threat and there has been a global push to address to develop new drugs. Led by Professor Hope, the University of Liverpool's Centre for Antimicrobial Pharmacodynamics provides state-of-the-art research facilities for PK/PD studies and offers preclinical and early phase clinical support to ensure new drugs are developed in a streamlined manner.

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Cadden House Sale for $1.3 Million

By Walter F. Roche Jr.

The home of a jailed former drug company executive is being sold for $1.3 million, less than half of the original asking price.
The sales price and the names of the purchasers were disclosed today in filings in U.S. District Court in Boston, Mass. The details were disclosed in a series of filings in the criminal case of Barry J. Cadden, the one time president and part owner of the defunct New England Compounding Center.
The filings, which were approved by U.S. District Judge Richard G. Stearns, lift liens that were placed on the Wrentham, Mass. property following Cadden's conviction on racketeering, conspiracy and mil fraud charges.
Cadden is now serving a nine year prison sentence at the federal prison in Loretto, Pa.
According to the filings the purchasers of the property are Michael and Lisa Ferdenzi.
Under the terms of a negotiated forfeiture agreement one half of the proceeds of the house sale will go to the federal government. The other half goes to Lisa Cadden, the wife of Barry.
The five bedroom home was first put on the market with an asking price of nearly $3 million. It has been on the market for 343 days.
Described as "a magnificent private enclave," the 9,000 square foot home has five bedrooms, a salt water pool, a six person bar and a bocce lawn.
Cadden headed NECC, which is the company blamed for the deadly 2012 fungal meningitis outbreak. Cadden was one of 14 persons tied to NECC who were indicted following a two year probe of the outbreak.
NECC shipped out thousands of vials on methylprednisolone acetate contaminated with deadly fungi. The drugs were then injected into the spines and joints of unsuspecting patients. More than 800 of them were sickened and over 100 have died.
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