By Walter F. Roche Jr.
The 30-month federal prison sentence of a pharmacist is nearing an end and records filed in U.S. District Court in Boston, Mass.indicate he plans to go to work at a pharmacy run by a member of the state board regulating pharmacies in Massachsetts.
Gene Svirskiy, 40, is due to be released from the federal prison facility in Devens, Mass on Aug. 26.
An early release assessment form filed in Svirskiy's criminal case states that upon his release Svirskiy is slated to go to work at the Birds Hill Compounding Pharmacy in the Boston suburbs. Andrew Stein is listed as the contact person.
Stein is also a current member and former chairman of the Massachusetts Board of Pharmacy, which regulates pharmacists and pharmacies in the state.
Svirskiy's lawyer did not respond to questions about his client's future employment plans. Stein did not respond either.
Svirskiy was given the 30-month sentence following his conviction on racketeering, conspiracy and mail fraud charges. He was one of 13 people connected to the New England Compounding Center to be convicted following a series of trials. The company was the source of contaminated steroids that ultimmately killed over 100 patients.
Though he worked in one of NECC's clean rooms, Svirskiy never handled the fungus laden steroids blamed for the outbreak.
Svirskiy never lost his pharmacist license but under a 2019 agreement with the state board he agreed to a series of restrictions including a 30 month suspension of his license beginning on July 10, 2019. He also is barred from engaging in
any sterile compounding unless he has the express approval of the board.
When the suspension expires Svirskiy's license will be in probationary status until Jan. 10, 2025.
That means he could act as a pharmacist early next year provided he first passes a competence examination (Multistate Pharmacy Jurisprudence Examination).
Svirskiy's relationship with Stein became public when he faced sentencing in May 2019. Stein wrote a letter to U.S. District Judge Richard G. Stearns urging leniency and stated that he would hire Svirskiy "on the spot" to work in his pharmacies.
Earlier this year Svirskiy petitioned prison officials and Stearns asking for an early release due to the presence of Covid-19 within the Devens prison facility, but his multiple requests were denied.
Contact: wfrochejr999@gmail.com
Monday, May 24, 2021
Thursday, May 20, 2021
Judge Tosses Drug Company Compounding Suit
By Walter F. Roche Jr.
A federal judge has dismissed a suit filed by a Woburn, Mass. pharmaceutical firm which had charged a competitor with violating a federal law by illegally copying one of its drug products.
In a five-page ruling Senior Judge Rya Zobel ruled that it was up to the U.S. Food and Drug Administration, not the courts, to determine if Edge Pharma LLC illegally copied Firvang, an antibiotic drug produced by Azurity Pharmaceutical.
In a footnote to her decision Zobel suggested Azurity could file an administrative complaint with the FDA and, if the agency concurred with the allegation, Azurity would then have standing to seek court intervention.
At issue in the suit are provisions of a 2013 federal law passed following the deadly 2012 fungal meningitis outbreak caused by a now defunct Massachusetts drug compounding firm.
Edge, under the provisions of that statute, was designated by the FDA as a drug outsourcer, authorized to compound large volumes of specified drugs without patient specific prescriptions.
But the Azurity suit charged that Edge was in violation of another provision of federal law barring compounders from mass producing a drug that is essentially a copy of another FDA approved drug, Firvang.
Zobel, who presided over a massive civil case stemming from the outbreak, concluded that it was not up to her to resolve matters relating to such "thorny questions."
"It would be inappropriate for the court to resolve plaintiff's Lanham Act claim," Zobel wrote, adding that Congress has expressly delegated that authority to the FDA.
She added that to resolve the issue the court itself might ultimately have to rely on the FDA.
"The FDA itself has not determined that defendant is violating the requirements the plaintiff is identifying in its complaint," Zobel added. She did note, however, that the FDA had identified "compliance issues" in an inspection of Edge's Colchester, VT. facilities.
Contact: wfrochejr999@gmail.com
A federal judge has dismissed a suit filed by a Woburn, Mass. pharmaceutical firm which had charged a competitor with violating a federal law by illegally copying one of its drug products.
In a five-page ruling Senior Judge Rya Zobel ruled that it was up to the U.S. Food and Drug Administration, not the courts, to determine if Edge Pharma LLC illegally copied Firvang, an antibiotic drug produced by Azurity Pharmaceutical.
In a footnote to her decision Zobel suggested Azurity could file an administrative complaint with the FDA and, if the agency concurred with the allegation, Azurity would then have standing to seek court intervention.
At issue in the suit are provisions of a 2013 federal law passed following the deadly 2012 fungal meningitis outbreak caused by a now defunct Massachusetts drug compounding firm.
Edge, under the provisions of that statute, was designated by the FDA as a drug outsourcer, authorized to compound large volumes of specified drugs without patient specific prescriptions.
But the Azurity suit charged that Edge was in violation of another provision of federal law barring compounders from mass producing a drug that is essentially a copy of another FDA approved drug, Firvang.
Zobel, who presided over a massive civil case stemming from the outbreak, concluded that it was not up to her to resolve matters relating to such "thorny questions."
"It would be inappropriate for the court to resolve plaintiff's Lanham Act claim," Zobel wrote, adding that Congress has expressly delegated that authority to the FDA.
She added that to resolve the issue the court itself might ultimately have to rely on the FDA.
"The FDA itself has not determined that defendant is violating the requirements the plaintiff is identifying in its complaint," Zobel added. She did note, however, that the FDA had identified "compliance issues" in an inspection of Edge's Colchester, VT. facilities.
Contact: wfrochejr999@gmail.com
Friday, May 14, 2021
400 Outbreak Victims Miss $$$ Restitution
By Walter F. Roche Jr.
More than 400 victims of the 2012 fungal meningitis outbreak apparently failed to qualify for a share of what could be even more than $82 million in restitution funds being sought from former officials of a defunct drug compounding company.
In a recent motion filed in U.S. District Court in Boston, Mass.,federal prosecutors stated that only 389 victims would be sharing in the requested restitution.
That figure contrasts with the 800 victims of the outbreak frequently cited by the U.S. Attorneys Office.
That means some 411 victims who could have shared in the restitution funds have been left out. And it is long past the deadline for making a claim.
Victims had 90 days following the sentencing of Barry J. Cadden to file a claim against him. He was sentenced to a nine year prison term on June 26, 2017. That means victims had to file claims by Sept. 24, 2017.
Co-defendant Glenn Chin was sentenced to an eight-year term on Jan. 31, 2018. That means victims had until April 30, 2018 to file a claim against him.
The two were convicted of racketeering, conspiracy, mail fraud and violations of the Food Drug and Cosmetic Act.
If more victims had qualified then prosecutors also would very likely have increased their request to more than $82 million.
To qualify victims had to submit an application or request citing specific losses or expenses incurred as a result of their encounters with the outbreak.
The process included several notifications to all 800 victims of the requirements to qualify.
The exact amount of restitution will be the subject of a July 7 hearing in Boston, Mass. before U.S. District Judge Richard G. Stearns.
Contact: wfrochejr999@gmail.com
More than 400 victims of the 2012 fungal meningitis outbreak apparently failed to qualify for a share of what could be even more than $82 million in restitution funds being sought from former officials of a defunct drug compounding company.
In a recent motion filed in U.S. District Court in Boston, Mass.,federal prosecutors stated that only 389 victims would be sharing in the requested restitution.
That figure contrasts with the 800 victims of the outbreak frequently cited by the U.S. Attorneys Office.
That means some 411 victims who could have shared in the restitution funds have been left out. And it is long past the deadline for making a claim.
Victims had 90 days following the sentencing of Barry J. Cadden to file a claim against him. He was sentenced to a nine year prison term on June 26, 2017. That means victims had to file claims by Sept. 24, 2017.
Co-defendant Glenn Chin was sentenced to an eight-year term on Jan. 31, 2018. That means victims had until April 30, 2018 to file a claim against him.
The two were convicted of racketeering, conspiracy, mail fraud and violations of the Food Drug and Cosmetic Act.
If more victims had qualified then prosecutors also would very likely have increased their request to more than $82 million.
To qualify victims had to submit an application or request citing specific losses or expenses incurred as a result of their encounters with the outbreak.
The process included several notifications to all 800 victims of the requirements to qualify.
The exact amount of restitution will be the subject of a July 7 hearing in Boston, Mass. before U.S. District Judge Richard G. Stearns.
Contact: wfrochejr999@gmail.com
Wednesday, May 12, 2021
Most Final Victims' Checks Sent Out
By Walter F. Roche Jr.
Nearly all of the final checks to victims of the 2012 fungal meningitis outbreak have been sent out, according to the attorney in charge of the distributions.
Lynne Riley, the administrator, said today that over 94 per cent of the checks have been sent. Most of those checks were sent to attorneys representing outbreak victims.
Riley said the remaining checks were being held due to unresolved liens against the payments.
"There are a minimal number of claims that have still not cleared liens, and those will be sent when claimants and lienholders resolve those liens," Riley wrote in an email response to questions.
Many outbreak victims have reported that checks have been sent either to them directly or to their attorneys.
Those liens have been filed by the Medicare program, insurance companies and other parties. Most of the victims will also have to share a portion of the final payment with their lawyers.
While some have reported that the final payments are about equal to the first two, most have reported the final checks were smaller than the previous two.
The total final distribution was an estimated $11.5 million and is going to some 2,000 claimants.
The funds are the final chuck of a multimillion dollar settlement with the owners of the now defunct New England Compounding Center, the company blamed for the deadly outbreak. The company shipped out thousands of vials of a steroid contaminated with a deadly fungus.
Over a hundred patients have died after being injected in the spines and joints with NECC's methylprednisolone acetate. Some more 700 were sickened. The bankruptcy settlement is seperate from up to $82 million that federal prosecutors are seeking to extract from former NECC owners and affiliates who were convicted in the criminal cases stemming from the outbreak.
A hearing on the proposed restitution is scheduled for July 7 in U.S. District Court in Boston, Mass. Prosecutors say that money would go to 379 victims.
Riley said that those final checks from the bankruptcy settlement will be sent out as soon as she is notified that any outstanding liens have been resolved.
Contact: wfrochejr999@gmail.com
Nearly all of the final checks to victims of the 2012 fungal meningitis outbreak have been sent out, according to the attorney in charge of the distributions.
Lynne Riley, the administrator, said today that over 94 per cent of the checks have been sent. Most of those checks were sent to attorneys representing outbreak victims.
Riley said the remaining checks were being held due to unresolved liens against the payments.
"There are a minimal number of claims that have still not cleared liens, and those will be sent when claimants and lienholders resolve those liens," Riley wrote in an email response to questions.
Many outbreak victims have reported that checks have been sent either to them directly or to their attorneys.
Those liens have been filed by the Medicare program, insurance companies and other parties. Most of the victims will also have to share a portion of the final payment with their lawyers.
While some have reported that the final payments are about equal to the first two, most have reported the final checks were smaller than the previous two.
The total final distribution was an estimated $11.5 million and is going to some 2,000 claimants.
The funds are the final chuck of a multimillion dollar settlement with the owners of the now defunct New England Compounding Center, the company blamed for the deadly outbreak. The company shipped out thousands of vials of a steroid contaminated with a deadly fungus.
Over a hundred patients have died after being injected in the spines and joints with NECC's methylprednisolone acetate. Some more 700 were sickened. The bankruptcy settlement is seperate from up to $82 million that federal prosecutors are seeking to extract from former NECC owners and affiliates who were convicted in the criminal cases stemming from the outbreak.
A hearing on the proposed restitution is scheduled for July 7 in U.S. District Court in Boston, Mass. Prosecutors say that money would go to 379 victims.
Riley said that those final checks from the bankruptcy settlement will be sent out as soon as she is notified that any outstanding liens have been resolved.
Contact: wfrochejr999@gmail.com
Tuesday, May 4, 2021
Ronzio Sentencing Set For Aug. 18
By Walter F. Roche Jr.
A federal judge has set an Aug. 18 date for the sentencing of a key government witness in the criminal probe of the deadly 2012 fungal meningitis outbreak.
Ronzio, who was the sales chief for the New England Compounding Center, testified extensively for prosecutors in the trials of 13 others affiliated with NECC and charged in late 2014 with crimes ranging from racketeering to mail fraud.
Under a plea agreement Ronzio entered a guilty plea to one count of conspiring to defraud the U.S. Food and Drug Administration.
Ronzio's sentencing has been postponed and rescheduled multiple times and prosecutors and Ronzio's attorney had asked for an indefinite postponement until the First Circuit Court of Appeals issues a ruling on a pending government appeal.
Prosecutors are seeking to overturn the acquittals of Gregory Conigliaro and Sharon Carter. Conigliaro was an NECC vice president and part owner. Carter was NECC's director of operations.
U.S. District Judge Richard G. Stearns agreed to cancel a scheduled June sentencing hearing but declined to approve an open ended delay. Instead he set the Aug. 18 date and the session will be held virtually.
Drugs from NECC were contaminated with deadly fungus, killing over 100 patients and sickening over 700.
Contact: wfrochejr999@gmail.com
A federal judge has set an Aug. 18 date for the sentencing of a key government witness in the criminal probe of the deadly 2012 fungal meningitis outbreak.
Ronzio, who was the sales chief for the New England Compounding Center, testified extensively for prosecutors in the trials of 13 others affiliated with NECC and charged in late 2014 with crimes ranging from racketeering to mail fraud.
Under a plea agreement Ronzio entered a guilty plea to one count of conspiring to defraud the U.S. Food and Drug Administration.
Ronzio's sentencing has been postponed and rescheduled multiple times and prosecutors and Ronzio's attorney had asked for an indefinite postponement until the First Circuit Court of Appeals issues a ruling on a pending government appeal.
Prosecutors are seeking to overturn the acquittals of Gregory Conigliaro and Sharon Carter. Conigliaro was an NECC vice president and part owner. Carter was NECC's director of operations.
U.S. District Judge Richard G. Stearns agreed to cancel a scheduled June sentencing hearing but declined to approve an open ended delay. Instead he set the Aug. 18 date and the session will be held virtually.
Drugs from NECC were contaminated with deadly fungus, killing over 100 patients and sickening over 700.
Contact: wfrochejr999@gmail.com
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