Lawyers for victims of the 2012 fungal meningitis outbreak are asking a federal judge to order Saint Thomas Health and related entities to provide full details of insurance policies that could benefit their clients.
In a motion filed Friday in U.S. District Court in Boston, attorney J. Gerard Stranch of Nashville charged that Saint Thomas officials have steadfastly refused to provide copies of their insurance agreements.
In the motion and an accompanying brief, the plaintiffs' attorneys noted that a federal magistrate judge already had ordered disclosure of the coverage details.
While some general information was provided, critical details, including copies of actual insurance agreements have not been provided, the motion states.
Lawyers for the victims contend that knowing the available coverage is critical in efforts to reach a settlement.
"Plaintiffs first asked for insurance information almost 14 months ago," the filing states.
The motion comes in a massive case combining claims by hundreds of victims of the outbreak caused by tainted spinal steroids. Most of the Tennessee victims were injected at the Saint Thomas Outpatient Neurosurgical Center in Nashville.
Friday, October 3, 2014
Thursday, October 2, 2014
Meningitis Outbreak Prosecutor Seeks Order to Protect Probe Records
By Walter F. Roche Jr.
The U.S. Attorney prosecuting a pharmacist charged in the probe of a fatal fungal meningitis outbreak is asking a judge to order that records relating to the investigation be kept confidential.
The motion for a protective order was filed Thursday in U.S. District Court in Boston by U.S. Attorney Carmen Ortiz.
The move comes in the criminal case against Glenn Chin, 46, who worked as a pharmacist for the New England Compounding Center. Chin, a Canton, Mass. resident who has been charged with mail fraud, has entered a not guilty plea to the charge.
Under Ortiz' motion Chin's lawyers would be barred from disclosing to third parties any information about the investigation provided by prosecutors during the discovery phase of the criminal case.
Chin's lawyers, according to the filing, are not opposed to the order.
Ortiz said in the filing that disclosure of the investigation details to third parties "could jeopardize the ongoing criminal investigation."
"Some of the discovery materials," the motion states, "would inform potential targets or subjects of the status and direction of the ongoing criminal investigation."
In addition Ortiz wrote that the same discovery material could reveal the identities of government witnesses.
Finally, Ortiz' motion states, the discovery information includes specific health information on victims who received tainted steroid injections at Michigan Pain Specialists.
The protective order proposed by Ortiz would require that once the Chin case is completed the discovery materials would have to either be destroyed or returned to the federal government.
The 2012 outbreak sickened some 751 patients. Sixty-four of them died. Michigan and Tennessee were among the hardest hit of the 20 states where victims were treated.
wfrochejr999@gmail.com
The U.S. Attorney prosecuting a pharmacist charged in the probe of a fatal fungal meningitis outbreak is asking a judge to order that records relating to the investigation be kept confidential.
The motion for a protective order was filed Thursday in U.S. District Court in Boston by U.S. Attorney Carmen Ortiz.
The move comes in the criminal case against Glenn Chin, 46, who worked as a pharmacist for the New England Compounding Center. Chin, a Canton, Mass. resident who has been charged with mail fraud, has entered a not guilty plea to the charge.
Under Ortiz' motion Chin's lawyers would be barred from disclosing to third parties any information about the investigation provided by prosecutors during the discovery phase of the criminal case.
Chin's lawyers, according to the filing, are not opposed to the order.
Ortiz said in the filing that disclosure of the investigation details to third parties "could jeopardize the ongoing criminal investigation."
"Some of the discovery materials," the motion states, "would inform potential targets or subjects of the status and direction of the ongoing criminal investigation."
In addition Ortiz wrote that the same discovery material could reveal the identities of government witnesses.
Finally, Ortiz' motion states, the discovery information includes specific health information on victims who received tainted steroid injections at Michigan Pain Specialists.
The protective order proposed by Ortiz would require that once the Chin case is completed the discovery materials would have to either be destroyed or returned to the federal government.
The 2012 outbreak sickened some 751 patients. Sixty-four of them died. Michigan and Tennessee were among the hardest hit of the 20 states where victims were treated.
wfrochejr999@gmail.com
Wednesday, October 1, 2014
Clinic Lawyers Say Any Blame for Outbreak Should Be Shared
By Walter F. Roche Jr.
Lawyers for the Saint Thomas Outpatient Neurosurgical Center have named nearly a dozen other parties, including three government agencies, who they say should share any blame for a fatal 2012 fungal meningitis outbreak.
In a 113-page filing in U.S. District Court in Boston, Mass. Tuesday the attorneys for the Nashville clinic and other Tennessee defendants listed a testing company and the supplier of bulk chemical compounds along with a half dozen other parties, as bearing some responsibility for the outbreak.
The filing came in a series of suits which have been merged before U.S. District Judge Rya Zobel.
At the same time clinic lawyers said the facility and other defendants "complied with the laws and regulations applicable to them and with industry standards."
They also stated that the defendants had no reason to suspect that the steroids shipped by a now shuttered drug compounder, the New England Compounding Center, were tainted with fungus.
The outbreak led to the deaths of 64 patients while 751 were sickened. Tennessee was among the hardest hit with 16 deaths.
The filing also names state agencies in Tennessee and Massachusetts along with the U.S. Food and Drug Administration as sharing in the blame and calls the outbreak "a colossal regulatory failure."
The FDA failed to act against NECC even though the drug firm's activities "fell squarely within FDA's definition of its own regulatory authority,"clinic lawyers charged.
Others named as bearing possible liability by Saint Thomas lawyers were an organization that provided training for NECC employees and sold the company the "recipe" for the steroid drug, a heating contractor and the company that installed clean rooms for NECC.
The filing charges that Medisca, the firm that supplied NECC with the bulk materials for its products should have known NECC was not in compliance with the law simply because of the high volume of base chemicals it was purchasing.
wfrochejr999@gmail.com
Lawyers for the Saint Thomas Outpatient Neurosurgical Center have named nearly a dozen other parties, including three government agencies, who they say should share any blame for a fatal 2012 fungal meningitis outbreak.
In a 113-page filing in U.S. District Court in Boston, Mass. Tuesday the attorneys for the Nashville clinic and other Tennessee defendants listed a testing company and the supplier of bulk chemical compounds along with a half dozen other parties, as bearing some responsibility for the outbreak.
The filing came in a series of suits which have been merged before U.S. District Judge Rya Zobel.
At the same time clinic lawyers said the facility and other defendants "complied with the laws and regulations applicable to them and with industry standards."
They also stated that the defendants had no reason to suspect that the steroids shipped by a now shuttered drug compounder, the New England Compounding Center, were tainted with fungus.
The outbreak led to the deaths of 64 patients while 751 were sickened. Tennessee was among the hardest hit with 16 deaths.
The filing also names state agencies in Tennessee and Massachusetts along with the U.S. Food and Drug Administration as sharing in the blame and calls the outbreak "a colossal regulatory failure."
The FDA failed to act against NECC even though the drug firm's activities "fell squarely within FDA's definition of its own regulatory authority,"clinic lawyers charged.
Others named as bearing possible liability by Saint Thomas lawyers were an organization that provided training for NECC employees and sold the company the "recipe" for the steroid drug, a heating contractor and the company that installed clean rooms for NECC.
The filing charges that Medisca, the firm that supplied NECC with the bulk materials for its products should have known NECC was not in compliance with the law simply because of the high volume of base chemicals it was purchasing.
wfrochejr999@gmail.com
Saturday, September 27, 2014
Thursday, September 25, 2014
TN Drug Compounder Forged Prescriptions for Diet Drugs, State Charges
By Walter F. Roche Jr.
The owner of a Cleveland, Tenn. drug compounding pharmacy repeatedly forged prescriptions for a diet drug in her son's name, the state Pharmacy Board has charged.
The forgeries, which took place over a nearly four year period, were just one of several charges that led the state board to summarily suspend the license of Robin Terrero and her pharmacy, The Wellness Store Compounding Center.
In a 13-page order made public Thursday, the board spelled out multiple violations noted by a state inspector in three separate August visits to the pharmacy. The inspections, according to the state, were triggered by a complaint alleging multiple violations filed earlier that month.
The pharmacy did not respond to a request for comment.
While state Health Department officials released the suspension orders, they declined to release the inspection report leading to the regulatory action.
The order of summary suspension states that the inspector found that prescriptions, both new and refills, were left lying on an open counter for customers to retrieve. The pharmacy routinely operated when no pharmacist was present, the order states.
Other allegations include the dispensing of prescription drugs compounded from outdated and deteriorated products, preparation of prescriptions by staffers not licensed or trained to do so and failure to maintain sanitary conditions, even for drugs required to be sterile.
According to the complaint Terrero forged prescriptions for a drug called benzphetamine "in the name of her son and dispensed them herself from The Wellness Store."
In addition, the state charged Terrero, the chief pharmacist and owner, was often absent from the store and even when she was present she failed to provide proper supervision for the staff.
The investigator observed that "Terrero also failed to verify prescriptions being dispensed to patients" or to counsel customers on the use of the drugs being dispensed.
Other charges include dispensing prescription drugs without a valid prescription and allowing unlicensed staffers to take prescription orders by phone.
"Wellness Store's staff routinely and systematically altered records, including the beyond-use dates on dispensing labels and compounding logs, in order to override software safeguards designed to prevent the use or dispensing of expired products," the order states.
Though state health officials say there have been no reports of illness from injectable drugs dispensed by the Cleveland pharmacy, they are urging consumers not to use any unused remaining doses.
The suspension comes on the second anniversary of a fungal meningitis outbreak caused, according to state and federal regulators, by tainted spinal steroids shipped around the country by a now defunct Massachusetts compounder.
Tennessee was one of the hardest hit in the outbreak with 16 patients dying and 153 sickened. The outbreak triggered changes in both state and federal laws and regulations governing drug compounders.
The owner of a Cleveland, Tenn. drug compounding pharmacy repeatedly forged prescriptions for a diet drug in her son's name, the state Pharmacy Board has charged.
The forgeries, which took place over a nearly four year period, were just one of several charges that led the state board to summarily suspend the license of Robin Terrero and her pharmacy, The Wellness Store Compounding Center.
In a 13-page order made public Thursday, the board spelled out multiple violations noted by a state inspector in three separate August visits to the pharmacy. The inspections, according to the state, were triggered by a complaint alleging multiple violations filed earlier that month.
The pharmacy did not respond to a request for comment.
While state Health Department officials released the suspension orders, they declined to release the inspection report leading to the regulatory action.
The order of summary suspension states that the inspector found that prescriptions, both new and refills, were left lying on an open counter for customers to retrieve. The pharmacy routinely operated when no pharmacist was present, the order states.
Other allegations include the dispensing of prescription drugs compounded from outdated and deteriorated products, preparation of prescriptions by staffers not licensed or trained to do so and failure to maintain sanitary conditions, even for drugs required to be sterile.
According to the complaint Terrero forged prescriptions for a drug called benzphetamine "in the name of her son and dispensed them herself from The Wellness Store."
In addition, the state charged Terrero, the chief pharmacist and owner, was often absent from the store and even when she was present she failed to provide proper supervision for the staff.
The investigator observed that "Terrero also failed to verify prescriptions being dispensed to patients" or to counsel customers on the use of the drugs being dispensed.
Other charges include dispensing prescription drugs without a valid prescription and allowing unlicensed staffers to take prescription orders by phone.
"Wellness Store's staff routinely and systematically altered records, including the beyond-use dates on dispensing labels and compounding logs, in order to override software safeguards designed to prevent the use or dispensing of expired products," the order states.
Though state health officials say there have been no reports of illness from injectable drugs dispensed by the Cleveland pharmacy, they are urging consumers not to use any unused remaining doses.
The suspension comes on the second anniversary of a fungal meningitis outbreak caused, according to state and federal regulators, by tainted spinal steroids shipped around the country by a now defunct Massachusetts compounder.
Tennessee was one of the hardest hit in the outbreak with 16 patients dying and 153 sickened. The outbreak triggered changes in both state and federal laws and regulations governing drug compounders.
Wednesday, September 24, 2014
Tennessee Compounding Pharmacy Cited for Unlawful Dispensing, Intentional Falsification
By Walter F. Roche Jr.
A Tennessee compounding pharmacy has been cited for using outdated, deteriorated or otherwise unsafe ingredients and state health officials are warning patients who may have received injectable drugs from the Cleveland druggist not to use them.
The warning applies to products from The Wellness Store Compounding Pharmacy at 3555 Keith St. NW in Cleveland.
In announcing the warning, state health officials said they were not aware of any illnesses caused by drugs sold by the pharmacy and that the volume of drugs produced was small.
"However, this warning is being issued out of an abundance of caution," the agency said in a statement.
Symptoms of possible contamination include pain, swelling or redness at or near the injection site.
The state is asking that any unused medications from the pharmacy be sent to the state for further testing.
Other violations found in an August inspection of the pharmacy include intentional falsification of records, the unsupervised production of compounded drugs and illegal dispensing of controlled substances.
According to the department the licenses for the pharmacy and pharmacist Robin Terrero were summarily suspended.
The action is one of the first since the enactment of a new law and supporting regulations adopted after Tennessee became one of the hardest hit in the nation from tainted injectable steroids issued by a now defunct Massachusetts drug compounding firm.
Clinics known to have received injectable medications from the Cleveland pharmacy are Associates in Spine and Joint Medicine, Cleveland Medical Associates, Internal Medicine Group and Voytik Center for Orthopedics, all in Cleveland, East Tennessee Vein Clinic in Knoxville, Hollywood Body Spa in Athens, Kennedy Clinic in Ooletewah, Lynn Garden Weight Loss in Kingsport and Premier Weight Management in LaFollete.
A Tennessee compounding pharmacy has been cited for using outdated, deteriorated or otherwise unsafe ingredients and state health officials are warning patients who may have received injectable drugs from the Cleveland druggist not to use them.
The warning applies to products from The Wellness Store Compounding Pharmacy at 3555 Keith St. NW in Cleveland.
In announcing the warning, state health officials said they were not aware of any illnesses caused by drugs sold by the pharmacy and that the volume of drugs produced was small.
"However, this warning is being issued out of an abundance of caution," the agency said in a statement.
Symptoms of possible contamination include pain, swelling or redness at or near the injection site.
The state is asking that any unused medications from the pharmacy be sent to the state for further testing.
Other violations found in an August inspection of the pharmacy include intentional falsification of records, the unsupervised production of compounded drugs and illegal dispensing of controlled substances.
According to the department the licenses for the pharmacy and pharmacist Robin Terrero were summarily suspended.
The action is one of the first since the enactment of a new law and supporting regulations adopted after Tennessee became one of the hardest hit in the nation from tainted injectable steroids issued by a now defunct Massachusetts drug compounding firm.
Clinics known to have received injectable medications from the Cleveland pharmacy are Associates in Spine and Joint Medicine, Cleveland Medical Associates, Internal Medicine Group and Voytik Center for Orthopedics, all in Cleveland, East Tennessee Vein Clinic in Knoxville, Hollywood Body Spa in Athens, Kennedy Clinic in Ooletewah, Lynn Garden Weight Loss in Kingsport and Premier Weight Management in LaFollete.
Monday, September 22, 2014
Deaths, Infections Increase in 2012 Meningitis Outbreak
By Walter F. Roche Jr.
There have been yet more deaths and illnesses from a 2012 fungal meningitis outbreak but just who those victims are and where they were stricken remains a mystery amidst an ongoing federal criminal investigation.
The increased toll was disclosed in a footnote to an affidavit filed in federal court on Sept. 4. The affidavit was filed to back a move by federal prosecutors to arrest Glenn A. Chin, 46, a former employee of the now defunct Massachusetts drug compounding firm blamed for the outbreak.
The last official count from the U.S. Centers for Disease Control and Prevention showed 751 patients across the country were stricken with infections in the outbreak. Sixty-four patients died.
A CDC official, in response to an inquiry, stated that the agency stopped collecting data from state health departments in October of 2013. After that individual state health departments were left with the responsibility to report any additional cases.
A survey of some 20 state health agencies where cases had been previously reported turned up only a single additional victim. That patient in the state of Virginia boosted the total number of victims in that state to 55. Deaths in that state from the outbreak remained at five.
Calls to other state health agencies including the hardest hit, like Michigan and Tennessee, turned up no additional cases
An FDA spokesman declined to state how many additional cases have been uncovered because the investigation is still ongoing.
The five-page affidavit filed by FDA Special Agent Benedict Celso in Chin's case states, "the total of patients (sickened) has continued to rise as have the total number of patients who died."
Recently filed documents in a massive civil suit stemming from the outbreak give further evidence of a possible undercount.
According to a report prepared by attorneys for victims of the outbreak, four cases have been filed in behalf of four patients who contend they became infected after being treated at three different California health facilities.
Nonetheless the official CDC case report includes no cases from California.
Lynn Janssen, an official of the California Department of Public Health, said her agency was not aware of any illnesses or deaths in California patients who received injections from medications distributed by the Massachusetts compounding firm.
Suits have been filed in other states, such as Alabama and Nevada, where no cases have been reported by the CDC.
Another unanswered question is the number of patients who have suffered relapses of fungal meningitis or other infections caused by the fungus tainted methylprednisolone acetate.
According to CDC spokewoman Christine Pearson, five relapse cases have been confirmed. A sixth case, she said, has not been confirmed and is still under investigation.
One person to suffer a relapse was Joan Peay of Nashville, Tenn., who underwent nearly two months of hospital treatment followed by two weeks of rehabilitation for a relapse just over a year ago. The other relapse victims have not been publicly identified.
There have been yet more deaths and illnesses from a 2012 fungal meningitis outbreak but just who those victims are and where they were stricken remains a mystery amidst an ongoing federal criminal investigation.
The increased toll was disclosed in a footnote to an affidavit filed in federal court on Sept. 4. The affidavit was filed to back a move by federal prosecutors to arrest Glenn A. Chin, 46, a former employee of the now defunct Massachusetts drug compounding firm blamed for the outbreak.
The last official count from the U.S. Centers for Disease Control and Prevention showed 751 patients across the country were stricken with infections in the outbreak. Sixty-four patients died.
A CDC official, in response to an inquiry, stated that the agency stopped collecting data from state health departments in October of 2013. After that individual state health departments were left with the responsibility to report any additional cases.
A survey of some 20 state health agencies where cases had been previously reported turned up only a single additional victim. That patient in the state of Virginia boosted the total number of victims in that state to 55. Deaths in that state from the outbreak remained at five.
Calls to other state health agencies including the hardest hit, like Michigan and Tennessee, turned up no additional cases
An FDA spokesman declined to state how many additional cases have been uncovered because the investigation is still ongoing.
The five-page affidavit filed by FDA Special Agent Benedict Celso in Chin's case states, "the total of patients (sickened) has continued to rise as have the total number of patients who died."
Recently filed documents in a massive civil suit stemming from the outbreak give further evidence of a possible undercount.
According to a report prepared by attorneys for victims of the outbreak, four cases have been filed in behalf of four patients who contend they became infected after being treated at three different California health facilities.
Nonetheless the official CDC case report includes no cases from California.
Lynn Janssen, an official of the California Department of Public Health, said her agency was not aware of any illnesses or deaths in California patients who received injections from medications distributed by the Massachusetts compounding firm.
Suits have been filed in other states, such as Alabama and Nevada, where no cases have been reported by the CDC.
Another unanswered question is the number of patients who have suffered relapses of fungal meningitis or other infections caused by the fungus tainted methylprednisolone acetate.
According to CDC spokewoman Christine Pearson, five relapse cases have been confirmed. A sixth case, she said, has not been confirmed and is still under investigation.
One person to suffer a relapse was Joan Peay of Nashville, Tenn., who underwent nearly two months of hospital treatment followed by two weeks of rehabilitation for a relapse just over a year ago. The other relapse victims have not been publicly identified.
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