Judge Defers Action on Patient Harm Evidence

A federal judge has taken under advisement arguments over whether prosecutors can present evidence of patient harm in the upcoming trial of the nine remaining defendants indicted following a federal probe of a deadly fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns heard arguments Monday in his Boston, Mass. courtroom from lawyers for the defendants and federal prosecutors.
Prosecutors have stated that evidence of patient harm is essential to prove their case against defendants, including Gregory Conigliaro, who was Vice President and part owner of the New England Compounding Center, the company blamed for the outbreak that took the lives of at least 76 patients across the country. NECC shipped thousands of vials of fungus tainted methylprednisolone acetate to health care providers across the country.
Lawyers for Conigliaro and the eight other defendants have argued that they had nothing to do with the production of the methylprednisolone acetate and evidence related to illnesses and deaths caused by the steroid would be highly prejudicial.
Prosecutors, Assistant U.S. Attorneys Amanda Strachan and George Varghese, have stated that they do not intend to seek testimony from relatives of the deceased victims or to present autopsy reports on outbreak victims.
That victim testimony was key in the recent trials of NECC President Barry Cadden and supervising pharmacist Glenn Chin. Both were found guilty of racketeering, conspiracy and mail fraud. Both are serving lengthy prison terms in federal prisons in Pennsylvania.
All of the defendants were employed by NECC or a sales affiliate.
Contact: wfrochejr999@gmail.com

Judge Sets Hearing on Patient Harm

By Walter F. Roche Jr.

A federal judge has set a hearing for next week on a key issue in the upcoming trial of the nine remaining defendants indicted in the federal probe of a deadly fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns has agreed to hold a hearing Tuesday in his Boston, Mass. courtroom on the issue of whether or not prosecutors can present evidence of harm caused to patients as a result of the 2012 outbreak caused by fungus riddled drugs produced by the now defunct New England Compounding Center.
Lawyers for the defendants have argued that presenting evidence of patient harm would be highly prejudicial.
They also have stated that their clients had nothing to do with the production of contaminated methylprednisolone acetate causing the deaths of some 76 patients around the country. Those victims were among nearly 800 sickened by contaminated NECC drugs.
In their motion the attorneys stated that their clients did not "have any responsibility whatsoever for any methylprednisolone related act or omission that caused harm to patients."
Assistant U.S. Attorneys Amanda Strachan and George Varghese have asked Stearns to reject the request to bar evidence of patient harm.
They argued that the evidence was "direct and intrinsic" and necessary to show the existence of a conspiracy. They also noted that they already have agreed not to call victims as witnesses or to present autopsy reports on the victims who died.
Also pending before Stearns are motions from three of the defendants seeking separate trials. Currently all nine are slated to go on trial on Oct. 2.
The nine defendants were among 14 indicted by a federal grand jury in late 2014. Two, Barry Cadden and Glenn Chin, are already serving lengthy prison sentences.
Contact: wfrochejr999@gmail.com

FDA Gets Injunction vs. Compounder

Federal judge enters consent decree against
Cantrell Drug Company
U.S. District Judge Kristine G. Baker for the Eastern District of Arkansas entered a consent decree of permanent injunction between the U.S. and Cantrell Drug Company of Little Rock, Arkansas, and the company’s Chief Executive Officer and co-owner, James L. McCarley, Jr.

The consent decree prohibits Cantrell and McCarley from manufacturing, processing, packing, holding, or distributing drugs until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations, in addition to other requirements.

“As a public health agency, the FDA is committed to fully implementing the Drug Quality and Security Act for compounded drugs set forth by Congress that helps ensure compounded drugs are made under appropriate production standards,” said FDA Commissioner Scott Gottlieb, M.D. “We’ll continue to take action against compounders who produce drugs under substandard conditions and put the health of patients at risk."

The complaint filed with the consent decree alleges that Cantrell manufactured and distributed purportedly sterile drug products, such as injectable opioids and antibiotics, that were adulterated under the FD&C Act because the drugs were made under insanitary conditions and in violation of current good manufacturing practice (CGMP) requirements. Drugs that are prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health are adulterated under the FD&C Act.

The consent decree requires Cantrell to cease operations until it completes corrective actions, including hiring a qualified independent expert to inspect its facility to ensure the company is complying with the FD&C Act and CGMP requirements. Under the consent decree, Cantrell cannot resume operations until it receives authorization from the FDA.

Cantrell is registered as an outsourcing facility under section 503B of the FD&C Act. The Drug Quality and Security Act, signed into law on Nov. 27, 2013, added a new section -- 503B – to the FD&C Act. Under section 503B, a compounder can elect to register as an outsourcing facility. Outsourcing facilities must comply with CGMP requirements, are inspected by the FDA according to a risk-based schedule and must meet certain other conditions, such as reporting adverse events and providing the FDA with certain information about the products they compound.

The complaint was filed by the U.S. Department of Justice on behalf of the FDA.

For more information, please visit: Cantrell Drug Company Consent Decree.

Chin to Appeal, Seeks New Lawyer

By Walter F. Roche Jr.

A former pharmacist convicted of racketeering and mail fraud charges has filed notice of appeal and wants the government to pay for a new lawyer to represent him in that effort.
Glenn Chin, 49, filed the notices today in U.S. District Court in Boston, Mass. He is already serving an eight year sentence at a federal prison in Pennsylvania.
In a related development federal prosecutors filed an 11-page brief opposing the move by a codefendant to have his trial severed from eight other codefendants.
Chin and 13 others were indicted in late 2014 following a two year probe of the 2012 fungal meningitis outbreak which took the lives of at least 76 patients in 20 states. All 14 defendants were affiliated were affiliated with the now defunct New England Compounding Center and and a relate sales company. NECC caused the outbreak by distributing fungus riddled drugs to health providers.
Chin's notice states that he plans to appeal his guilty verdict, the sentence imposed and a forfeiture order imposed by U.S. District Judge Richard G. Stearns.
Chin, who has been represented by Stephen Weymouth, also said he is seeking a new government-paid lawyer to represent him.
The government motion filed today opposes a motion by former NECC Vice President Gregory Conigliaro to have his upcoming trial separated from the other eight remaining defendants. Conigliaro is charged with conspiring to defraud the U.S. Food and Drug Administration by falsely claiming that NECC was operating as a state regulated pharmacy and not a drug manufacturer under FDA jurisdiction.
Federal prosecutors George Varghese and Amanda Strachan wrote that severance was not warranted. While Conigliaro is not charged in as many counts as the others he is "not less culpable than his codefendants," the filing states.
They also denied that any so-called "prejudicial spillover" would occur because of evidence applying to the other defendants (but not Conigliario) could easily be avoided by instructions to jurors by the presiding judge.
Conigliaro's conduct "is inextricably intertwined with NECC's fraudulent drug production," the filing states.
They argued that jurors could discern the differences between the charges against Conigliaro versus the other defendants.
"This is what jurors do in this courthouse every day," they wrote.
Contact: wfrochejr999@gmail.com

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

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

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.

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

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

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