By Walter F. Roche Jr.
The former pharmacist charged with 11 counts of second-degree murder says those charges must be thrown out because prosecutors have failed to prove that any act of the defendant led to the deaths.
In a three-page motion and a seven-page brief, James Buttrey, the lawyer for Glenn Chin, said prosecutors still don't know how the drugs that killed 11 Michigan residents became contaminated with deadly fungus.
"The prosecution has identified no act of Glenn Chin that caused these deaths," the motion states.
Glenn Chin and co-defendant Barry Cadden were charged with the deaths of 11 patients who died after being injected in 2012 with fungus laden methylprednisolone acetate (MPA) at the Michigan Pain Specialists.
The MPA was produced at a Massachusetts drug compounding firm where Chin was a supervising pharmacist and Cadden was president and part owner.
Though Chin did compound the bulk MPA, the motion states that tests showed the drugs were sterile when they left Chin's hands.
"The stock of the MPA that Mr. Chin prepared always tested sterile going back years and years," the motion states.
Chin is asking Livingston County Circuit Judge Michael Hatty to effectively throw out the charges and reverse the decision of District Court Judge Shauna Murphy, who found there was probable cause to conclude Chin and Cadden were guilty as charged.
The case is being prosecuted by the Michigan Attorney General Dana Nessel's office.
The Chin motion states that there were multiple possible sources of the contamination after the bulk drugs left his hands. Noting that the MPA was later placed in individual vials by other NECC employees, the motion states that prosecutors produced "zero evidence...tending to show that Glenn Chin caused these deaths."
"The evidence proved that the MPA must have become contaminated after it left Glenn Chin's hands," according to the filing.
Contending that there is no precedent for murder charges to be brought in what is in effect a wrongful death/product liability case, the Chin motion concludes that dismissal of the charges is "mandated."
Contact: wfrochejr999@gmail.com
Tuesday, November 24, 2020
Thursday, November 12, 2020
Judge Denies Defense Motions in Outbreak Case
By Walter F. Roche Jr
A Michigan judge today denied a motion to dismiss second degree murder charges against a former pharmacist and also rejected a move to have the case transferred to another county.
Judge Michael P. Hatty issued the rulings following arguments by the Michigan Attorney General and attorneys representing the defendant, Barry J. Cadden. Cadden and Glenn Chin face 11 second degree murder charges stemming from their roles in the deadly 2012 fungal meningitis outbreak.
Cadden's lawyer had argued that it would be impossible for his client to get a fair trial in Livingston County because many of the outbreak victims or their survivors reside there.
Cadden's lawyers also argued that since a federal jury declined to convict Cadden of second degree murder charges as part of a racketeering charge, Cadden would face double jeopardy.
Hatty, after hearing arguments from both sides, turned down both motions. He cited prior rulings that concluded the state, as a separate sovereignty, could bring charges despite parallel federal action.
In denying the motion to move the case to another Michigan county, he noted that the defense could raise the same issue at a later date.
But Hatty said he was confident that he could appoint an impartial jury.
Cadden's lawyer argued that Livingston County was the epicenter of the 2012 outbreak and potential jurors would have direct connections to the case.
Contact: wfrochejr999@gmail.com
A Michigan judge today denied a motion to dismiss second degree murder charges against a former pharmacist and also rejected a move to have the case transferred to another county.
Judge Michael P. Hatty issued the rulings following arguments by the Michigan Attorney General and attorneys representing the defendant, Barry J. Cadden. Cadden and Glenn Chin face 11 second degree murder charges stemming from their roles in the deadly 2012 fungal meningitis outbreak.
Cadden's lawyer had argued that it would be impossible for his client to get a fair trial in Livingston County because many of the outbreak victims or their survivors reside there.
Cadden's lawyers also argued that since a federal jury declined to convict Cadden of second degree murder charges as part of a racketeering charge, Cadden would face double jeopardy.
Hatty, after hearing arguments from both sides, turned down both motions. He cited prior rulings that concluded the state, as a separate sovereignty, could bring charges despite parallel federal action.
In denying the motion to move the case to another Michigan county, he noted that the defense could raise the same issue at a later date.
But Hatty said he was confident that he could appoint an impartial jury.
Cadden's lawyer argued that Livingston County was the epicenter of the 2012 outbreak and potential jurors would have direct connections to the case.
Contact: wfrochejr999@gmail.com
Tuesday, November 10, 2020
Cadden, Chin Hearing Thursday
By Walter F. Roche Jr.
A key hearing in the case of a former pharmacists charged with second degree murder is scheduled for Thursday in a Michigan court room.
The 8:30 a.m. hearing will be held before Livingston County Circuit Court Judge Michael P. Hatty.
Barry J. Cadden has been charged with 11 counts of second degree murder for his role in the 2012 fungal meningitis outbreak which took a particularly heavy toll in Livingston County.
Lawyers for Cadden will be arguing for a change in venue, contending that it will be impossible to find a panel of jurors who were not personally impacted by the outbreak.
Cadden was the president and part owner of the New England Compounding Center.
NECC shipped thousands of vials of contaminated methylprednisolone to health facilities across the country.
Cadden already has been convicted of racketeering, conspiracy and mail fraud charges in federal court, but a jury declined to convict him of racketeering second degree murder.
The change of venue is only one of several motions filed in behalf of Cadden and co-defendant Glenn Chin. Other motions raise issues of double jeopardy and a challenge to the decision of a district court judge sending the case to the circuit court.
Here is the livestream link for the Thursday hearing:
https://www.youtube.com/channel/UC3oBtCVpxXoTZplfTP1zWmg
Contact: wfrochejr999@gmail.com.
A key hearing in the case of a former pharmacists charged with second degree murder is scheduled for Thursday in a Michigan court room.
The 8:30 a.m. hearing will be held before Livingston County Circuit Court Judge Michael P. Hatty.
Barry J. Cadden has been charged with 11 counts of second degree murder for his role in the 2012 fungal meningitis outbreak which took a particularly heavy toll in Livingston County.
Lawyers for Cadden will be arguing for a change in venue, contending that it will be impossible to find a panel of jurors who were not personally impacted by the outbreak.
Cadden was the president and part owner of the New England Compounding Center.
NECC shipped thousands of vials of contaminated methylprednisolone to health facilities across the country.
Cadden already has been convicted of racketeering, conspiracy and mail fraud charges in federal court, but a jury declined to convict him of racketeering second degree murder.
The change of venue is only one of several motions filed in behalf of Cadden and co-defendant Glenn Chin. Other motions raise issues of double jeopardy and a challenge to the decision of a district court judge sending the case to the circuit court.
Here is the livestream link for the Thursday hearing:
https://www.youtube.com/channel/UC3oBtCVpxXoTZplfTP1zWmg
Contact: wfrochejr999@gmail.com.
Sunday, November 8, 2020
FDA Issues Compounding Guidance
By Walter F. Roche Jr.
Unsealed or loose ceiling tiles in production areas, using outdated disinfecting agents and visible microbial contamination: those were just some of the things seen by federal inspectors examining drug compounders across the country.
In a 12-page final guidance issued late last week, officials of the U.S. Food and Drug Administration, acknowledged that the agency does not inspect the vast majority of drug compounding operations.
The guidance, which is nearly identical to a proposed version issued two years ago, is yet another example of government efforts to avoid a repeat of the 2012 fungal meningitis outbreak which sickened hundreds and killed more than 100.
The outbreak was traced to a Massachusetts drug compounding company that had successfully evaded federal regulation as it shipped out thousands of vials of a spinal steroid laced with deadly fungus.
Compounding is preparation of a custom formulation of a medication to fit the unique need of a patient which cannot be met with commercially available products. The 12-page FDA document is intended to serve as a guide to drug compounders on what standards the FDA expects them to meet to avoid unsanitary condition.
The guidance acknowledges that the adverse events from contaminated compounded drugs are very likely under reported and a large number of drug compounders are subject only to state regulation.
"The agency is often not aware of these pharmacies, their conditions and practices and potential problems with the quality and safety of their products," the guidance states.
The guidance urges state regulators to "take appropriate action" when unsanitary conditions are identified. It also asks those state regulators to inform the FDA of their findings.
The guidance does urge drug compounders to take immediate action when unsanitary conditions are discovered. Dr. Michael Carome of Public Citizen, which has pushed repeatedly for tighter regulation of compounders, said the guidance should help drug compounders in meeting expected standards.
"The numerous detailed examples of insanitary conditions provided in the guidance should assist compounding facilities in preventing, identifying and remediating insanitary conditions," Carome said.
While he said Public Citizen generally supports the guidance, it does not support a footnote in which the agency gives what appears to be a blanket exemption to drugs compounded in a doctor's office.
The footnote states that the "FDA generally does not intend to take action ...against a physician who is compounding a drug product, repackaging an FDA-approved drug product, or who is mixing, diluting, or repackaging an FDA-licensed biological product, provided that such production by the physician occurs in the physician’s office for in-office administration, to his patients."
Carome said Public Citizen had urged the FDA to drop the footnote during the extended comment period.
Contact: wfrochejr999@gmail.com
Unsealed or loose ceiling tiles in production areas, using outdated disinfecting agents and visible microbial contamination: those were just some of the things seen by federal inspectors examining drug compounders across the country.
In a 12-page final guidance issued late last week, officials of the U.S. Food and Drug Administration, acknowledged that the agency does not inspect the vast majority of drug compounding operations.
The guidance, which is nearly identical to a proposed version issued two years ago, is yet another example of government efforts to avoid a repeat of the 2012 fungal meningitis outbreak which sickened hundreds and killed more than 100.
The outbreak was traced to a Massachusetts drug compounding company that had successfully evaded federal regulation as it shipped out thousands of vials of a spinal steroid laced with deadly fungus.
Compounding is preparation of a custom formulation of a medication to fit the unique need of a patient which cannot be met with commercially available products. The 12-page FDA document is intended to serve as a guide to drug compounders on what standards the FDA expects them to meet to avoid unsanitary condition.
The guidance acknowledges that the adverse events from contaminated compounded drugs are very likely under reported and a large number of drug compounders are subject only to state regulation.
"The agency is often not aware of these pharmacies, their conditions and practices and potential problems with the quality and safety of their products," the guidance states.
The guidance urges state regulators to "take appropriate action" when unsanitary conditions are identified. It also asks those state regulators to inform the FDA of their findings.
The guidance does urge drug compounders to take immediate action when unsanitary conditions are discovered. Dr. Michael Carome of Public Citizen, which has pushed repeatedly for tighter regulation of compounders, said the guidance should help drug compounders in meeting expected standards.
"The numerous detailed examples of insanitary conditions provided in the guidance should assist compounding facilities in preventing, identifying and remediating insanitary conditions," Carome said.
While he said Public Citizen generally supports the guidance, it does not support a footnote in which the agency gives what appears to be a blanket exemption to drugs compounded in a doctor's office.
The footnote states that the "FDA generally does not intend to take action ...against a physician who is compounding a drug product, repackaging an FDA-approved drug product, or who is mixing, diluting, or repackaging an FDA-licensed biological product, provided that such production by the physician occurs in the physician’s office for in-office administration, to his patients."
Carome said Public Citizen had urged the FDA to drop the footnote during the extended comment period.
Contact: wfrochejr999@gmail.com
Friday, November 6, 2020
Chin Case to Investigative Unit
The Massachusetts Board of Pharmacy today voted to send the case of a convicted pharmacist to the agency's prosecution unit to determine whether disciplinary action is warranted.
The vote comes after attempts to reach a settlement agreement with Kathy S. Chin failed.
The board had proposed an agreement under which Chin would retain her pharmacist license but with restrictions.
Chin was convicted in federal court in 2019 on four felony counts of violating the Food Drug and Cosmetic Act. She was one of 14 persons connected to the New England Compounding Center who were indicted in 2014 following a two year probe of a deadly fungal meningitis outbreak.
According to state records Chin has a currently valid pharmacist license. She was sentenced to two years probation following conviction on the federal charges.
The vote comes after attempts to reach a settlement agreement with Kathy S. Chin failed.
The board had proposed an agreement under which Chin would retain her pharmacist license but with restrictions.
Chin was convicted in federal court in 2019 on four felony counts of violating the Food Drug and Cosmetic Act. She was one of 14 persons connected to the New England Compounding Center who were indicted in 2014 following a two year probe of a deadly fungal meningitis outbreak.
According to state records Chin has a currently valid pharmacist license. She was sentenced to two years probation following conviction on the federal charges.
Thursday, November 5, 2020
K. Chin Before Mass. Pharmacy Board
By Walter F. Roche Jr.
The Massachusetts Pharmacy Board is scheduled to vote Friday on a motion to refer the case of a convicted pharmacist to board prosecutors for possible disciplinary action.
The subject of the motion is Kathy S. Chin who was convicted in 2019 of four felony counts of violating the Food Drug and Cosmetic Act for her role at a now defunct compounding pharmacy. She was sentenced to two years of probation.
Chin was one of 14 people connected to the New England Compounding Center, the company blamed for the deadly 2012 fungal meningitis outbreak who were indicted following a two year federal probe.
Following her conviction state pharmacy board officials attempted to reach a settlement with Chin that would allow her to retain her license but with a series of restrictions.
According to board officials Chin never responded to the offer leading to the motion to refer her case to the prosecution unit for further adjudication.
Chin's conviction came after federal prosecutors presented evidence that she approved for shipment drugs prescribed for obviously fake named patients including Filet O Fish and Flash Gordon.
Under the proposed settlement Chin would have been barred from working as a compounding pharmacist and would have to work under the supervision of another pharmacist.
In addition her license would be on probationary status for three years.
Chin's husband Glenn already is serving an eight-year federal prison sentence following his conviction on racketeering, conspiracy and mail fraud charges. Glenn Chin has also been charged with 11 counts of second degree murder by the Michigan Attorney General and is awaiting trial.
Contact: wfrochejr999@gmail.com
The Massachusetts Pharmacy Board is scheduled to vote Friday on a motion to refer the case of a convicted pharmacist to board prosecutors for possible disciplinary action.
The subject of the motion is Kathy S. Chin who was convicted in 2019 of four felony counts of violating the Food Drug and Cosmetic Act for her role at a now defunct compounding pharmacy. She was sentenced to two years of probation.
Chin was one of 14 people connected to the New England Compounding Center, the company blamed for the deadly 2012 fungal meningitis outbreak who were indicted following a two year federal probe.
Following her conviction state pharmacy board officials attempted to reach a settlement with Chin that would allow her to retain her license but with a series of restrictions.
According to board officials Chin never responded to the offer leading to the motion to refer her case to the prosecution unit for further adjudication.
Chin's conviction came after federal prosecutors presented evidence that she approved for shipment drugs prescribed for obviously fake named patients including Filet O Fish and Flash Gordon.
Under the proposed settlement Chin would have been barred from working as a compounding pharmacist and would have to work under the supervision of another pharmacist.
In addition her license would be on probationary status for three years.
Chin's husband Glenn already is serving an eight-year federal prison sentence following his conviction on racketeering, conspiracy and mail fraud charges. Glenn Chin has also been charged with 11 counts of second degree murder by the Michigan Attorney General and is awaiting trial.
Contact: wfrochejr999@gmail.com
Monday, November 2, 2020
Cadden, Chin Hearing Will Be On Line
An upcoming hearing for the two former pharmacists facing second degree murder charges can be viewed on-line or in person at the Livingston County courthouse in Howell, Mich.
Victims of the 2012 fungal meningitis outbreak were advised today that the Nov. 12 hearing on pre-trial motions would be accessible although there may be limits on those actually attending the 8:30 a.m. session before Judge Michael P. Hatty.
Chin and Cadden have been charged with 11 counts of second degree murder for their roles in the outbreak.
The hearing will be on a motion to move tha case to another county due to the large number of victims in Livingston County.
Cadden's lawyer has also filed a motion to have the charges dismissed due to double jeopardy. The two faced related charges in a federal criminal case in Boston, Mass. Two separate juries declined to convict them on second degree murder charges as predicate acts in a racketeering conspiracy. They were convicted on other charges.
Cadden was president and part owner of the New England Compounding Center, the company blamed for the outbreak. The company shipped thousands of vials of contaminated methylprednisolone acetate to health facilties across the country. Chin was a supervising pharmacist at NECC.
Here is the livestream link for the hearing:
https://www.youtube.com/channel/UC3oBtCVpxXoTZplfTP1zWmg
The case is being prosecuted by the Michigan Attorney General's office.
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