Monday, April 16, 2018

Two NECC Defendants Seek Separate Trial


By Walter F. Roche Jr.

Two of the nine remaining defendants in a criminal case stemming from a deadly fungal meningitis outbreak are asking the presiding judge to either exclude major pieces of evidence or grant them a trial separate from the remaining defendants who are facing more serious charges.
In a nine-page filing today lawyers for Kathy Chin and Michelle Thomas, said the evidence prosecutors plan to present against the seven other defendants would be highly prejudicial.
The evidence in question relates to the deaths and injuries caused by fungus riddled steroid drugs produced by the New England Compounding Center, the now defunct company that employed Chin and Thomas.
The two were among 14 persons connected to NECC who were indicted in late 2014 following a two year probe of the 2012 fungal meningitis outbreak. Some 76 patients died among nearly 800 who were sickened after being injected with fungus laden methylprednisolone acetate shipped from NECC's facility in Framingham, Mass.
In their filing today, attorneys Michael Bourbeau and Joan Griffin, wrote that the evidence in question "has no relevance whatsoever" to the charges against" their respective clients.
Thomas and Chin, the filing states, had nothing to do with the clean room where the tainted drugs were produced.
The two face charges of misbranding drugs, while the others face racketeering and conspiracy among other charges.
"It will be difficult if not impossible for the jury to make a reliable judgment," the motion states, citing the prospect of confusion among the jurors.
Chin is the wife of Glenn Chin who was a supervising pharmacist at NECC. Chin was convicted on racketeering and conspiracy charges and is currently serving an eight sentence at a federal prison in Pennsylvania. He was in charge of the clean room where the tainted drugs were manufactured.
Contact: wfrochejr999@gmail.com

Friday, April 13, 2018

Another Sterile Drug Recall

U.S. Food and Drug Administration Header





MedWatch - The FDA Safety Information and Adverse Event Reporting Program






Sterile Injectable Products by Premier Pharmacy Labs: Recall - Lack of Sterility Assurance

AUDIENCE: Pharmacy, Nursing

ISSUE: Premier Pharmacy Labs is voluntarily recalling injectable products due to a potential lack of sterility assurance. Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Administration of non-sterile injection products that are intended to be sterile may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or a fatal outcome.

BACKGROUND: The product can be identified by the product description in the above table and beyond use date (BUD) on the individual product or shipping bag. The listed product lots were distributed Nationwide to hospital pharmacy, clinic, and healthcare facilities.

RECOMMENDATION: Premier Pharmacy Labs is notifying its distributors and customers by certified letter and is arranging for return/replacement of all recalled products. Hospital pharmacy, clinic, and healthcare facilities that have product which is being recalled should stop using and return to Premier Pharmacy Labs per the official recall notification/customer reply form included in the certified letter sent to all affected clients.

Consumers with questions regarding this recall can contact Premier Pharmacy Labs by calling 1-800-752-7139 between the hours of 8:30 am and 5:00 pm Eastern Time, Monday through Friday or sending an email to recalls@premierpharmacylabs.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: •Complete and submit the report Online: www.fda.gov/MedWatch/report
•Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including a link to the press release, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm604466.htm

Wednesday, April 11, 2018

Conference Call with U. S. Attorney

Hello:

If you listened in on today's conference call with the U.S. Attorneys re. restitution etc, could you send an email describing what happened and what you concluded from their answers.

Thanks,

Wally Roche
wallyroche@hotmail.com

Sterile Injectable Recall Disclosed


From the FDA


Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance







Premier Pharmacy Labs is voluntarily recalling the following products due to a potential lack of sterility assurance.





Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Administration of non-sterile injection products that are intended to be sterile may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or a fatal outcome. To date, Premier Pharmacy Labs has not received any reports of adverse events related to this issue, but understanding the potential risk, is voluntarily initiating this product recall.


Tuesday, April 10, 2018

Prosecutors Oppose Separate Conigliaro Trial


By Walter F. Roche Jr.

Charging that a separate trial for the former part owner and vice president of a defunct drug company is unjustified and a waste of time, federal prosecutors say Gregory Congilario should be tried in October along with eight other defendants.
In an 11-page filing in U.S. District Court in Boston, Mass, prosecutors said that Congiliaro, the former vice president of the New England Compounding Center "has failed to demonstrate any basis for severance.
Conigliaro was one of 14 indicted in late 2014 following a two year federal probe of the 2012 fungal meningitis outbreak which was caused by fungus tainted drugs shipped by NECC to health facilities across the country. The drugs sickened nearly 800 patients killing at least 76 of them.
Lawyers for Conigliaro asked for a separate trial contending that trying his case along with the other remaining defendants would be prejudicial because while he is charged with a single count of conspiracy to defraud the U.S. Food and Drug Administration, other defendants are facing multiple charges.
Noting that Congliaro's role at NECC was to oversee regulatory compliance, prosecutors said that the former NECC vice president played a key role in trying to convince the FDA that NECC was not a drug manufacturer but a pharmacy subject only to state regulation.
"Conigliaro made these false representations to not only the FDA, but also several regulatory agencies from different states across the country," prosecutors charged.
Assistant U.S. Attorneys George Varghese and Amanda Strachan said Conigliaro should go on trial on Oct. 2 as scheduled along with others facing the same conspiracy charge. They said giving him a separate trial would force them to present much of the same evidence all over again.
Two codefendants already have gone on trial and are now serving lengthy federal prison sentences. Both Barry Cadden, the former NECC president, and Glenn Chin, a supervising pharmacist, were convicted on racketeering and mail fraud charges. A majority of the jurors in the Cadden trial also voted to convict him on the charge of conspiracy to defraud the FDA, but a unanimous verdict was required.
Cadden and Chin were also cleared in two separate trials of second degree murder charges.
While Conigliaro's lawyers said their client would be severely prejudiced if tried with the others, Varghese and Strachan said he played a critical role at the now defunct Framingham, Mass. company.
"Conigliaro's conduct is inexplicably intertwined with NECC's fraudulent drug production by virtues of his lies to regulators about what NECC was doing," the filing states.
In a separate filing today Strachan and Varghese asked U.S. District Judge Richard G. Stearns to reject a motion by the remaining defendants to limit evidence of patient harm stemming from the outbreak at the October trial. They argued that the evidence was "direct and intrinsic" and necessary to show evidence of a conspiracy,
They wrote that they do not intend to introduce autopsies of the victims or to have next-of-kin of victims testify.
Contact: wfrochejr999@gmail.com

Wednesday, April 4, 2018

Last 2 Nashville Meningitis Suits Settled


By Walter F. Roche Jr.

Lawyers for victims of the two remaining lawsuits against a Nashville clinic stemming from a fungal meningitis outbreak are reporting that the cases have been have been finally settled, according to a motion filed today in U.S. District Court in Boston, Mass.
In the motion filed by lawyers for the clinic and the victims, the parties agreed that all 106 suits against the Saint Thomas Outpatient Neurosurgery Center have been resolved reportedly for payments totaling more than $20 million.
Records show 104 of the suits were settled and dismissed late last year. In the latest filing, attorneys for both sides reported that a suit brought by survivors of Reba Temple, who died in the 2012 outbreak, and a suit by Patricia and Harold Sellers, had been resolved and the parties had received payments from a settlement fund.
Temple, a Centerville, Tenn. resident died Oct. 6, 2012.
In addition to the Saint Thomas clinic, the defendants in the cases included the Howell Allen Clinic and staffers of the Saint Thomas clinic. All would be dismissed as defendants under the proposed order. Howell Allen was a half owner of the Saint Thomas clinic where victims were injected with methylprednisolone acetate.
The filing also disclosed that settlements have been reached in 10 of 15 suits filed against the Specialty Surgery Center in Crossville, Tenn.
Both the Nashville and Crossville clinics purchased steroids from the now defunct New England Compounding Center. Those drugs turned out to be contaminated with deadly fungi. Nationwide nearly 800 patients were sickened by steroids from the Framingham, Mass. drug compounder. At least 76 of those patients, including Temple, died.
Contact: wfrochejr999@gmail.com

Monday, April 2, 2018

2,027 Meningitis Claims Approved


By Walter F. Roche Jr

A total of 2,027 claims have been approved for full or partial payment, according to a report from the administrator of a fund established to benefit victims of the 2012 fungal meningitis outbreak.
The report was filed in U.S. District Court in Boston, Mass. by Lynne F. Riley.
According to her report a total of 2,353 claims were filed and 283 were fully denied.
"All appeals have been resolved and all claim determinations have been finalized," the two-page report states.
Riley reported that a single claim was still pending because needed paperwork from a state Medicaid agency has yet to be submitted.
The report states that 1,924 victims have received initial payments while 1,902 have also received a second payment. Riley has stated that yet a third payment is expected but when that will come depends on actions by the IRS.
A total of $144,426,805 has been paid to date, Riley reported. The figure includes 283 payments made from separate funds earmarked for victims who were treated at specific clinics.
The 2012 outbreak was caused by fungus riddled steroids shipped from a now defunct drug compounding firm, the New England Compounding Center. At least 76 victims died and nearly 800 were sickened by the methylprednisolone acetate shipped to healthcare providers across the country.
Contact: wfrochejr999@gmail.com