Sunday, February 28, 2021

Covid Vaccine ... Or Not

By Walter F. Roche Jr.

For some victims of the 2012 fungal meningitis outbreak, whose lives were forever altered by an injection, the prospect of getting the COVID-19 vaccine injection is presenting somewhat of a dilemma.
"Having had one injection that wreaked havoc on my life and others, I am not anxious to obtain one of the new COVID vaccines," said Kathleen Cooley, a Michigan resident.
Cooley said she was not ruling out getting the vaccine "forever" but was adopting a wait and see attitude.
"I am just not sure this vaccine is safe yet," said Dawn Elliott, an Indiana resident who still suffers from her 2012 injection with a contaminated steroid.
"I plan to wait a bit, " Elliott added, noting that a friend of hers had a high fever and blistering gums after getting the second COVID-19 vaccine.
Other victims have expressed concerns on a facebook site which was set up as a communications link for fungal meningitis outbreak victims. Though some have also expressed concern that the after effects of the fungal meningitis outbreak might make them susceptible to a more severe reaction from the vaccine, experts say that is not the case.
"I can think of no reason that persons affected by fungal meningitis should not receive COVID vaccine---unless, as with everyone, they have one of the standard precautions," said Dr. William Schaffner, an infectious disease expert at the Vanderbilt University Medical Center.
Rita Geisler, an Indiana outbreak victim, said she already got the two Pfizer vaccine shots with little effect.
She said she experienced a little hardness around the injection site for a few days after the first shot "but it didn't really hurt."
Joan Peay, a Nashville outbreak victim, said she decided to get the vaccine after her husband got both shots without any ill effects.
She got her first shot over the weekend at the Music City Center.
"I took two ibuprofen on the way there and did not get sick. My arm was a little sore yesterday but it is okay today and I get the second shot in three weeks," Peay said.
Angel Farthing, a Maryland outbreak victim who suffered serious after effects from fungal meningitis, said that she was not at all hesitant about getting the vaccine.
Farthing, who works in education, said she was ready to get back in school and into a normal life.
"I'm done with my life being stolen and my hope is that the shot can give me some of my life back," Farthing added.
Contact: wfrochejr999@gmail.com

Friday, February 26, 2021

Appeals Court Upholds NECC Convictions

By Walter F. Roche Jr.

A federal appeals court has upheld the convictions of three former employees of a drug compounding company blamed for a deadly 2012 fungal meningitis outbreak.
In a 61-page decision the First Circuit Court of appeals sitting in Boston, Mass. upheld the guilty verdicts returned by a jury in late 2018 against Gene Svirskiy, Alla Stepanets and Christopher Leary. All three worked at the now defunct New England Compounding Center.
NECC was the source of contaminated steroids that were shipped to unsuspecting health care providers in 2012. The fungus ridden drugs ultimately took the lives of more than 100 patients.
But as the ruling written by Appeals Court Judge David J. Barron points out, the three defendants played no role in preparing the tainted steroids. They were convicted of other violations turned up in a two year federal probe of NECC.
Svirskiy, who managed one of NECC's clean rooms, was convicted of racketeering, racketeering conspiracy, mail fraud and violations of the Food Drug and Cosmetic Act. He is now serving a 30 month sentence imposed by U.S. District Judge Richard G. Stearns.
Leary was sentenced to eight months of home confinement while Stepanets was sentenced to one year of probation. The apppeals court also upheld the conviction of Stepanets on multiple counts of violating the Food Drug and Cosmetic Act and Leary on mail fraud and Food Drug and Cosmetic Act violations.
In the detailed ruling the three judge panel rejected arguments that the defendants were not actually acting as pharmacists in their jobs at NECC and were not involved in the sales pitches made by NECC's sales staff.
The three were among 14 indicted in late 2014 following the two-year grand jury investigation. Only one of the 14 was acquitted of the charges. Contact: wfrochejr999@gmail.com

Thursday, February 18, 2021

Judge OKs Another Ronzio Sentencing Delay

By Walter F. Roche Jr.

A federal judge today approved a delay in the sentencing of a key figure in the fungal meningitis criminal cases, but he declined to make the delay indefinite.
U.S. District Court Judge Richard G. Strearns, sitting in Boston, Mass., issued a brief order setting June 22 for the sentencing of Robert Ronzio, the former sales chief at the New England Compounding Center, the company blamed for the deadly 2012 outbreak.
Lawyers for Ronzio and federal proscutors had asked for an indefinite delay until an appeals court rules on a closely related case.
Under a plea agreement Ronzio entered a guilty plea to a single count of conspiracy to defraud the U.S. Food and Drug Administration.
Federal prosecutors are appealing a decision by Stearns acquitting two of Ronzio's co-conspirators, Gregory Conigliaro and Sharon Carter, of the same charge.
Ronzio testified extensively for the prosecution in the trials of other NECC connected defendants.
The Ronzio sentencing had been set for April 6.
Contact: wfrochejr999@gmail.com

Tuesday, February 16, 2021

Another Ronzio Sentencing Date Being Delayed

By Walter F. Roche Jr.

Yet another delay is being requested in the sentencing of a key government witness in the criminal case stemming from the deadly 2012 fungal meningitis outbreak.
Lawyers for Robert Ronzio and federal prosecutors filed a joint motion today in U.S. District Court in Boston asking that Ronzio's scheduled April 6 sentencing be postponed until the First Circuit Court of Appeals acts on a closely related appeal.
Under a plea deal with the U.S. Attorney Ronzio, who was the sales chief at the New England Compounding Center, pleaded guilty to conspiring to defraud the U.S. Food and Drug Adminstration.
NECC was the source of thousands of vials of fungus riddled methylprednisolone acetate that was injected into hundreds of unsuspecting patients. Over 100 of them eventually died while hundreds more were sickened with fungal meningitis.
Ronzio was charged with conspiring with two other NECC officials, Gregory Conigliaro and Sharon Carter. The two were found guilty on Dec. 13,2018 following a jury trial, but then had their convictions overturned by U.S. District Judge Richard G. Stearns.
Conigliaro was vice president and part owner for NECC while Carter was director of operations at the Framingham, Mass. drug compounding facility.
Federal prosecutors are appealing Stearn's decision but the three judge panel that heard the case has yet to rule.
In return for his plea deal Ronzio testified extensively for prosecutors in the trials of other NECC defendants.
The April 6 sentencing date was set in late August of 2020.
Contact: wfrochejr999@gmail.com

Friday, February 12, 2021

Book Details Deadly 2012 Outbreak

By Walter F. Roche Jr.

The federal judge who presided over the criminal cases stemming from the 2012 fungal meningitis outbreak was "openly skeptical" of the 25 second degree murder charges brought by federal prosecutors against two pharmacists.
That's one of the conclusions in "Kill Shot" a new book on the deadly outbreak. Written by Jason Dearen, the 254-page book details the suffering of the dozens of outbreak victims who were injected with steroids loaded with deadly fungi. The offficial publication date is Tuesday Feb. 23 but copies can be pre-ordered.
Dearen writes that U.S. District Judge Richard G. Stearns thought the second degree murder charges filed against Barry Cadden and Glenn Chin were "bloated." Stearns, he writes,had made clear from the start that he never believed that a murder case was appropriate."
Though the book ends with details of the criminal case, the account begins years earlier when the deadly fungal meningitis outbreak began striking down its victims, a Kentucky judge, a worker in a Tennessee auto plant and a Michigan construction worker.
Dearen describes in detail the desparate efforts of state and federal regulators to identify the cause of dozens of unexplained deaths that surfaced in the Fall of 2012.
The book explains how a Nashville physician was the first to sound an alarm over the mysterious death of one of her Vanderbilt Medical Center patients.
Though regulators at first thought the problem might be confined to patients at a Nashville pain clinic the deaths began to surface in other states.
Through court testimony, thousands of pages of court exhibits and extensive interviews, Dearen reconstructs what became the worst public health crisis ever caused by a precription drug.
Cadden and Chin were among 14 persons connected to the New England Compounding Center who were indicted in 2014 following a two-year federal probe of the outbreak which ultimately took the lives of more than 100 patients while sickening hundreds of others.
Cadden was president and part-owner of the New England Compounding Center while Chin was the supervising pharmacist in the clean room where the deadly methylprednisolone acetate was produced.
The two were charged with racketeering, conspiracy, mail fraud and violations of the Food Drug and Cosmetic Act. The two were charged with second degree murder as predicate acts on the racketeering charge.
The jury was split on the second degree murder charges and Dearen notes that Stearns did not question the jurors when he was presented with evidence of the split votes. A unanimous vote was needed for conviction.
The two have now been charged with second degree murder in Michigan.
Dearen goes behind the scenes in describing the efforts of the prosecutors, Amanda Strachan and George Varghese to first put the complex case together and then to convince the jurors. He also describes the congressional efforts, largely futile, to bring the little known drug compounding industry under control. Contact: wfrochejr999@gmail.com

Thursday, February 11, 2021

Michigan Judge Agrees to Delay Judgements

By Walter F. Roche Jr.

A Michigan judge today agreed to delay issuing a final ruling in the second degree murder charges against two former Massachusetts pharmacists.
Circuit Court Judge Michael P. Hatty approved the motions filed by lawyers for Glenn Chin and Barry Cadden to delay the issuance of final rulings so that the two can file appeals with the Michigan Court of Appeals.
Hatty agreed to delay a final ruling on his decision to uphold the decision of a district court judge binding the two over for trial on the second degree murder charges.
Cadden and Chin were charged with 11 counts of second degree murder for their roles in the 2012 fungal meningitis outbreak. Cadden was president and part owner of the New England Compounding Center, the company blamed for the outbreak.
Chin was the pharmacist who supervised the clean room where the deadly steroids were prepared.
Gerald Gleeson, Cadden's attorney said, "We believe the appeal has merit and presents an issue that the Michigan Court of Appeals should resolve as it would have wider application to Michigan law and it would vindicate Mr. Cadden."
Contact: wfrochejr999@gmail.com

Friday, February 5, 2021

Final Check to Victims Delayed

By Walter F. Roche Jr.

Some $11.5 million in final benefits to hundreds of victims of the 2012 fungal meningitis outbreak will probably be delayed until summer, according to the attorney overseeing the funds set aside for those victims.
Lynne Riley wrote in an email response to questions that administrative details will prevent the funds from being distributed in March as many had hoped.
"We will need a few months to organize the final payments to tort claimants to ensure the final distribution is correct and complete, since this will be the final payment," Riley wrote.
"If it can be done sooner, it will," Riley added, "but this is our current estimation."
The funds in question represent a portion of the tax refunds that were made to owners of the New England Compounding Center, the company blamed for the 2012 outbreak. Those owners agreed to give up the money as part of a court settlement.
Distribution of the money was delayed because the IRS could still dispute the refunds. They have been held in escrow until the appeal deadline passes.
Another $425,000 has been released from escrow and has been forwarded to Riley.
The $11 million is in addition to the nearly $100 million already distributed to some 2,027 victims.
Other payments totaling $48.8 million have gone to outbreak victims who were injected with tainted methylprednisolone acetate at three clinics, Inspira Health of New Jersey, Insight Imaging of Virginia and the High Point Surgery Center in North Carolina.
Still other payments to victims came from a settlement with the St. Thomas Outpatient Neurosurgical Center in Nashville. The exact amount of that settlement, estimated at more than $20 million, has never been made public.
Contact: wfrochejr999@gmail.com