By Walter F. Roche Jr.
One of the defendants in the fungal meningitis outbreak criminal case has been released from federal custody after completing his 2.5 year sentence.
Gene Svirskiy, 40, who was a pharmacist at the New England Compounding Center, was released from custody at a Philadelphia pre-release facility Thursday.
He was one of 14 people indicted following a two-year probe of the deadly 2012 fungal meningitis outbreak. He was convicted on charges of racketeering, conspiracy, mail fraud and violations of the Food Drug and Cosmetic Act. In addition to the jail time, Svirskiy will serve one year of supervised release.
Svirskiy served nearly all of his sentence at a federal prison in central Massachusetts. He tried multiple times to get an early release due to the Covid-19 pandemic, but the requests were denied.
Svirskiy was not involved in the production of the contaminated methylprednisolone acetate which caused the outbreak, although he did work in one of the two NECC clean rooms.
Two other NECC defendants, Barry Cadden and Glen Chin, are still serving their sentences and are also facing second degree murder charges in Livingston County Michigan. Both recently had their federal prison sentences substantially increased.
Cadden's sentence was increased from nine years to 14.5 years while Chin's sentence was hiked from eight to 10.5 years.
Contact: wfrochejr999@gmail.com
Court records show Svirskiy plans to go back to work in drug compounding at a pharmacy part owned by a member of the Massachusetts Board of Pharmacy.
Sunday, August 29, 2021
Monday, August 9, 2021
Chin in Final Supreme Court Plea
By Walter F. Roche Jr.
Charging that Michigan prosecutors have still failed to provide a key element in a second degree murder case, lawyers for a former Massachusetts pharmacist are asking the state's highest court to effectively erase the charges against their client.
In a five-page filing with the Michigan Supreme Court lawyers for Glenn Chin say prosecutors have still failed to identify a single act by the former pharmacist that led to the deaths of 11 patients.
"There must have been an act, not just an attitude," the filing states.
Chin and co-defendant Barry Cadden were charged with 11 counts of second degree murder for their roles in the 2012 fungal meningitis outbreak. Both were tied to the New England Componding Center, the company that shipped thousands of vials of a steroid riddled with deadly fungus to health providers across the country.
"They simply can't say what act it was," the brief states, adding that all the prosecution can do is say "Somehow, somewhere, some act that was somehow his (Chin's) fault must have occurred."
Citing the example of a Navy captain who has grounded his ship and can be stripped of his rank, the brief states that a higher standard is required for a second degree murder charge.
Second degree murder requires a "specific act," the brief concludes. Lawyers for Chin and Cadden are asking the state's high court to overturn the decision of a Livingston County judge who concluded there was sufficient evidence against the two to put the case before a jury.
Contact: wfrochejr999@gmail.com
Charging that Michigan prosecutors have still failed to provide a key element in a second degree murder case, lawyers for a former Massachusetts pharmacist are asking the state's highest court to effectively erase the charges against their client.
In a five-page filing with the Michigan Supreme Court lawyers for Glenn Chin say prosecutors have still failed to identify a single act by the former pharmacist that led to the deaths of 11 patients.
"There must have been an act, not just an attitude," the filing states.
Chin and co-defendant Barry Cadden were charged with 11 counts of second degree murder for their roles in the 2012 fungal meningitis outbreak. Both were tied to the New England Componding Center, the company that shipped thousands of vials of a steroid riddled with deadly fungus to health providers across the country.
"They simply can't say what act it was," the brief states, adding that all the prosecution can do is say "Somehow, somewhere, some act that was somehow his (Chin's) fault must have occurred."
Citing the example of a Navy captain who has grounded his ship and can be stripped of his rank, the brief states that a higher standard is required for a second degree murder charge.
Second degree murder requires a "specific act," the brief concludes. Lawyers for Chin and Cadden are asking the state's high court to overturn the decision of a Livingston County judge who concluded there was sufficient evidence against the two to put the case before a jury.
Contact: wfrochejr999@gmail.com
Friday, August 6, 2021
Key Defendant Back in Compounding Business
By Walter F. Roche Jr.
The prosecution's star witness in a case involving a deadly compounded drug outbreak is back in the employ of another drug compounding firm despite his guilty plea to conspiracy charges.
Robert Ronzio, the onetime sales director for a now defunct Massachusetts drug firm, is a vice president for Florida based KRS Global Biotechnology. That firm compounds drugs by the thousands for use in health facilities.
Ronzio was sales manager for the New England Compounding Center, the company blamed for the 2012 fungal meningitis outbreak which has taken the lives of over 100 patients. As part of a plea deal following a two year probe of that outbreak Ronzio entered a guilty plea to conspiring to defraud the federal government for his role at NECC.
His sentencing has been re-scheduled several times and has now been postponed indefinitely.
Ronzio was the prosecution's lead witness in the trials of a dozen of his former NECC colleagues including NECC's part owner and president, who is now serving a 14.5 year federal prison sentence.
Court records show Ronzio, as a condition of release after his indictment, was barred from working in the pharmaceutical industry unless his employer was informed of the federal charges. The conditions also indicate the U.S. Attorney would be involved in any such employment arrangement.
Peter Horstmann, Ronzio's attorney, declined comment when asked whether the U.S. Attorney had approved Ronzio's employment in Florida. The U.S. Attorney's Office in Boston, Mass. also declined comment.
While NECC was shuttered by federal regulators KRS has had its own problems, including a massive recall due to possible contamination of its sterile products. That forced the company into bankruptcy and its recent sale to a new owner.
KRS is licensed as a 503B U.S. Food and Drug Administration drug producer, a new category created by Congress in the wake of the fungal meningitis outbreak.
Records in the KRS 2020 bankruptcy in federal court in Florida show Ronzio was listed as a priority creditor seeking unpaid wages of $32,807. He also was listed with a $5,264 "trade debt."
Contact: wfrochejr999@gmail.com
The prosecution's star witness in a case involving a deadly compounded drug outbreak is back in the employ of another drug compounding firm despite his guilty plea to conspiracy charges.
Robert Ronzio, the onetime sales director for a now defunct Massachusetts drug firm, is a vice president for Florida based KRS Global Biotechnology. That firm compounds drugs by the thousands for use in health facilities.
Ronzio was sales manager for the New England Compounding Center, the company blamed for the 2012 fungal meningitis outbreak which has taken the lives of over 100 patients. As part of a plea deal following a two year probe of that outbreak Ronzio entered a guilty plea to conspiring to defraud the federal government for his role at NECC.
His sentencing has been re-scheduled several times and has now been postponed indefinitely.
Ronzio was the prosecution's lead witness in the trials of a dozen of his former NECC colleagues including NECC's part owner and president, who is now serving a 14.5 year federal prison sentence.
Court records show Ronzio, as a condition of release after his indictment, was barred from working in the pharmaceutical industry unless his employer was informed of the federal charges. The conditions also indicate the U.S. Attorney would be involved in any such employment arrangement.
Peter Horstmann, Ronzio's attorney, declined comment when asked whether the U.S. Attorney had approved Ronzio's employment in Florida. The U.S. Attorney's Office in Boston, Mass. also declined comment.
While NECC was shuttered by federal regulators KRS has had its own problems, including a massive recall due to possible contamination of its sterile products. That forced the company into bankruptcy and its recent sale to a new owner.
KRS is licensed as a 503B U.S. Food and Drug Administration drug producer, a new category created by Congress in the wake of the fungal meningitis outbreak.
Records in the KRS 2020 bankruptcy in federal court in Florida show Ronzio was listed as a priority creditor seeking unpaid wages of $32,807. He also was listed with a $5,264 "trade debt."
Contact: wfrochejr999@gmail.com
Tuesday, August 3, 2021
Cadden Appeals Sentence, Restitution Order
By Walter F. Roche Jr.
The lawyer for a jailed former pharmacist filed notice of an appeal of the July 7 order increasing his jail sentence to 14.5 year and ordering $82 million in restitution.
In a filing in U.S. District Court in Boston, Mass. Bruce Singal, the attorney for Barry J. Cadden, said that the appeal would be filed with the 1st Circuit Court of Appeals.
Co-defendant Glenn Chin, who had his eight year sentence increased to 10.5 years already has filed notice of appeal.
The two were indicted in late 2014 following a two year federal probe of the 2012 fungal meningitis outbreak caused by contaminated drugs shipped from the company where both worked.
Cadden was re-sentenced at a July 7 hearing in which Singal argued that the original nine year sentence met legal requirements and should not be increased. Prosecutors sought a 17.5 year sentence.
But U.S. District Court Judge Richard G. Stearns said he was bound by a decision from the same appeals court, which found that he had been too lenient in setting the original sentence.
Chin and Cadden were convicted in separate trials on charges of racketeering, conspiracy, mail fraud and violations of the Food Drug and Cosmetic Act.
The two are now jailed in Livingston County Michigan awaiting trial on 11 counts of second degree murder. Those charges stem from the same 2012 fungal meningitis outbreak, which took the lives of 11 county patients.
They were all injected with fungi-riddled methylprednisolone acetate produced at the New England Compounding Center, where Cadden was president and Chin was a supervising pharmacist.
Contact: wfrochejr999@gmail.com
The lawyer for a jailed former pharmacist filed notice of an appeal of the July 7 order increasing his jail sentence to 14.5 year and ordering $82 million in restitution.
In a filing in U.S. District Court in Boston, Mass. Bruce Singal, the attorney for Barry J. Cadden, said that the appeal would be filed with the 1st Circuit Court of Appeals.
Co-defendant Glenn Chin, who had his eight year sentence increased to 10.5 years already has filed notice of appeal.
The two were indicted in late 2014 following a two year federal probe of the 2012 fungal meningitis outbreak caused by contaminated drugs shipped from the company where both worked.
Cadden was re-sentenced at a July 7 hearing in which Singal argued that the original nine year sentence met legal requirements and should not be increased. Prosecutors sought a 17.5 year sentence.
But U.S. District Court Judge Richard G. Stearns said he was bound by a decision from the same appeals court, which found that he had been too lenient in setting the original sentence.
Chin and Cadden were convicted in separate trials on charges of racketeering, conspiracy, mail fraud and violations of the Food Drug and Cosmetic Act.
The two are now jailed in Livingston County Michigan awaiting trial on 11 counts of second degree murder. Those charges stem from the same 2012 fungal meningitis outbreak, which took the lives of 11 county patients.
They were all injected with fungi-riddled methylprednisolone acetate produced at the New England Compounding Center, where Cadden was president and Chin was a supervising pharmacist.
Contact: wfrochejr999@gmail.com
Monday, August 2, 2021
Cadden Barred from Role in Drug Applications
By Walter F. Roche Jr.
Though it has garnered little public notice the U.S. Food and Drug Administration has placed a lifetime ban on the role a former drug company owner can play in seeking approval of new drugs.
The lifetime ban was imposed on Nov. 30 of last year on Barry J. Cadden, the former president and part owner of the New England Compounding Center, the company at the center of a deadly 2012 fungal meningitis outbreak.
The FDA order, which Cadden did not contest, bars him from providing services in any capacity to a party that has an approved or pending drug product application.
In addition the order states that any party with an approved or pending drug product application "who knowingly employs or retains " Cadden as a consultant, contractor or in any capacity "will be subject to civil penalties."
Finally the notice states that the FDA will not accept or review any abbeviated drug application from Cadden.
The notice states that the debarment was prompted by Cadden's June 27, 2017 conviction on racketeering, conspiracy, mail fraud charges and violations of the Food, Drug and Cosmetic Act. It specifically notes Cadden's conviction for defrauding the FDA.
Cadden, whose federal sentence was recently upped from nine years to 14.5 years is also facing second degree murder charges in Michigan. If convicted on those state charges he could likely be jailed for life.
Cadden already surrendered his Massachusetts pharmacist license.
The notice states Cadden can petition to end the disbarment.
Contact: wfrochejr999@gmail.com
Though it has garnered little public notice the U.S. Food and Drug Administration has placed a lifetime ban on the role a former drug company owner can play in seeking approval of new drugs.
The lifetime ban was imposed on Nov. 30 of last year on Barry J. Cadden, the former president and part owner of the New England Compounding Center, the company at the center of a deadly 2012 fungal meningitis outbreak.
The FDA order, which Cadden did not contest, bars him from providing services in any capacity to a party that has an approved or pending drug product application.
In addition the order states that any party with an approved or pending drug product application "who knowingly employs or retains " Cadden as a consultant, contractor or in any capacity "will be subject to civil penalties."
Finally the notice states that the FDA will not accept or review any abbeviated drug application from Cadden.
The notice states that the debarment was prompted by Cadden's June 27, 2017 conviction on racketeering, conspiracy, mail fraud charges and violations of the Food, Drug and Cosmetic Act. It specifically notes Cadden's conviction for defrauding the FDA.
Cadden, whose federal sentence was recently upped from nine years to 14.5 years is also facing second degree murder charges in Michigan. If convicted on those state charges he could likely be jailed for life.
Cadden already surrendered his Massachusetts pharmacist license.
The notice states Cadden can petition to end the disbarment.
Contact: wfrochejr999@gmail.com
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