By Walter F. Roche Jr.
Lawyers for a former pharmacist charged with 11 counts of second degree murder told the Michigan Supreme Court today that prosecutors have still failed to prove their client performed any act that caused the deaths.
In a six-page filing, the lawyers for Glenn Chin said that even if Glenn Chin's callousness "may have allowed something (the contamination) to occur," prosecutors still must show that Chin did something to cause the deaths.
It wasn't enough to show Chin was a "bad boss," the filing continues, noting that attorneys from the Michigan Attorney General's never even tried to say what Chin actually did that led to the deaths of 11 Michigan patients.
The appeals by Chin and co-defendant Barry Cadden to the state's Supreme Court are the latest development in the legal aftermath of the 2012 fungal meningitis that eventually took the lives of more than 100 patients across the country.
Chin was the pharmacist in charge of the clean room where contaminated steroids were prepared before they were shipped to dozens of health care providers.
Chin's lawyer, Kevin S. Gentry, was also critical of prosecutors claim that Chin's actions were comparable to a drunk driver who gets behind the wheel and kills innocent bystanders.
The drunken driver actually did something that caused the deaths, Gentry argued, while Chin did nothing.
In a filing on Feb. 18, the Attorney General's office had argued that Chin did take actions that led to the deaths.
"Chin ordered technicians to forego cleaning and ordered that medicatiom be distributed under the false representation that it had been compounded under proper standards," the 29 page prosecution filing states.
Noting that the contaminated drugs were prepared in Chin's clean room, the prosecution filing concluded, "Chin was the person doling out these instructions."
Chin's lawyers have argued that due to the lack of evidence the charges never should have been approved for presentation to a jury.
Contact: wfrochejr999@gmail.com
Monday, March 28, 2022
Monday, March 21, 2022
FDA Discloses Compounded Drug Recall
Olympia Pharmacy has issued a voluntary nationwide recall of seven compounded products due to being out-of-specification. The voluntary recall is for 11 specific lots of Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD, compounded injectables to the consumer level.
Risk Statement: Administration of subpotent Hydroxocobalamin in infants, pregnant/breastfeeding women, and elderly populations are at risk for vitamin B12 deficiency and there is a reasonable probability they could experience adverse events including muscle weakness, neurological peripheral neuropathic numbness or pain, vision loss, and psychiatric disorders (depression, memory loss). Additionally, injectable compounded products, found to contain more or less drug product than the labeled strength or which reconstitute at a different rate than intended, may result in either too much or too little medication being administered. This could result in lower-than-expected effectiveness of the drug or unintended adverse side effects.
Olympia Pharmacy has not received any reports or concerns from patients relating to the safety of the recalled sterile compounded products, and no patients have reported any adverse events attributed to any of the recalled sterile compounded products.
Although compounded drugs can serve an important medical need for certain patients, they also present a risk to patients. FDA’s compounding program aims to protect patients from unsafe, ineffective and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.
Risk Statement: Administration of subpotent Hydroxocobalamin in infants, pregnant/breastfeeding women, and elderly populations are at risk for vitamin B12 deficiency and there is a reasonable probability they could experience adverse events including muscle weakness, neurological peripheral neuropathic numbness or pain, vision loss, and psychiatric disorders (depression, memory loss). Additionally, injectable compounded products, found to contain more or less drug product than the labeled strength or which reconstitute at a different rate than intended, may result in either too much or too little medication being administered. This could result in lower-than-expected effectiveness of the drug or unintended adverse side effects.
Olympia Pharmacy has not received any reports or concerns from patients relating to the safety of the recalled sterile compounded products, and no patients have reported any adverse events attributed to any of the recalled sterile compounded products.
Although compounded drugs can serve an important medical need for certain patients, they also present a risk to patients. FDA’s compounding program aims to protect patients from unsafe, ineffective and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.
Tuesday, March 15, 2022
Indiana Victims Seek Appeal From Setbacks
By Walter F. Roche Jr.
Indiana victims of the 2012 fungal meningitis outbreak are expected to appeal a double setback dealt recently by an Elkhart Superior Court judge.
In a 16-page decision issued in late February Judge Kristin Osterday rejected a motion filed by the victims' attorney to declare that the clinics who injected the patients violated state and federal law.
The judge also granted a motion filed by attorneys for the Orthopedic and Sports Medicine Center which limits the instructions the chairmen of review panels can give to the panel members. The review panels, under Indiana law, must review malpractice claims before they can go before a jury.
"The court orders the panel chairs to remove legal argument from the evidentiary submissions," the ruling states.
In a letter to the outbreak victims he represents, Douglas Small said he was "surprised and greatly disappointed" by the decision. He noted that on a key issue in the case the judge apparently reversed herself.
Small said he intended to appeal Osterday's decision to the Indiana Court of Appeals. In her decision the judge said the issues raised in the suit would be judged under the terms of a federal law and not other state and federal statutes.
Contact: wfrochejr999@gmail.com
Indiana victims of the 2012 fungal meningitis outbreak are expected to appeal a double setback dealt recently by an Elkhart Superior Court judge.
In a 16-page decision issued in late February Judge Kristin Osterday rejected a motion filed by the victims' attorney to declare that the clinics who injected the patients violated state and federal law.
The judge also granted a motion filed by attorneys for the Orthopedic and Sports Medicine Center which limits the instructions the chairmen of review panels can give to the panel members. The review panels, under Indiana law, must review malpractice claims before they can go before a jury.
"The court orders the panel chairs to remove legal argument from the evidentiary submissions," the ruling states.
In a letter to the outbreak victims he represents, Douglas Small said he was "surprised and greatly disappointed" by the decision. He noted that on a key issue in the case the judge apparently reversed herself.
Small said he intended to appeal Osterday's decision to the Indiana Court of Appeals. In her decision the judge said the issues raised in the suit would be judged under the terms of a federal law and not other state and federal statutes.
Contact: wfrochejr999@gmail.com
Wednesday, March 9, 2022
Conigliaro, Carter Seek New Trial
By Walter F. Roche Jr.
Lawyers for two of the defendants in the criminal probe of a deadly fungal meningitis outbreak argued today for a hearing on their plea for a new trial on charges they conspired to defraud the U.S. Food and Drug Administration.
Appearing before U.S. District Judge Richard G. Stearns in his Boston, Mass. courtroom the attorneys for Gregory Conigliaro and Sharon Carter argued that repeated testimony at their trial should have been excluded. They cited dozens of trial transcripts referring to a recycling plant, run by Conigliaro, that abutted the New England Compounding Center.
The two were among 14 people indicted following a two year prove of the deadly 2012 fungal meningitis outbreak that ultimately took the lives of more than 100 patients in more than 20 states.
(The hearing was not included on a daily list of sessions scheduled for the federal court each day.)
Conigliaro was vice president and part owner of NECC, which produced the contaminated drugs triggering the outbreak. Carter was a manager at the Framingham, Mass. company.
The lawyers argued that the testimony about the recycling plant never showed that it was the cause of the contamination and, thus, should have been excluded.
Stearns took the matter under advisement.
Stearns previously acquitted the two of the charges, but they were reinstated by the First Circuit Court of Appeals.
Contact: wfrochejr999@gmail.com
Lawyers for two of the defendants in the criminal probe of a deadly fungal meningitis outbreak argued today for a hearing on their plea for a new trial on charges they conspired to defraud the U.S. Food and Drug Administration.
Appearing before U.S. District Judge Richard G. Stearns in his Boston, Mass. courtroom the attorneys for Gregory Conigliaro and Sharon Carter argued that repeated testimony at their trial should have been excluded. They cited dozens of trial transcripts referring to a recycling plant, run by Conigliaro, that abutted the New England Compounding Center.
The two were among 14 people indicted following a two year prove of the deadly 2012 fungal meningitis outbreak that ultimately took the lives of more than 100 patients in more than 20 states.
(The hearing was not included on a daily list of sessions scheduled for the federal court each day.)
Conigliaro was vice president and part owner of NECC, which produced the contaminated drugs triggering the outbreak. Carter was a manager at the Framingham, Mass. company.
The lawyers argued that the testimony about the recycling plant never showed that it was the cause of the contamination and, thus, should have been excluded.
Stearns took the matter under advisement.
Stearns previously acquitted the two of the charges, but they were reinstated by the First Circuit Court of Appeals.
Contact: wfrochejr999@gmail.com