Judge Sets Final NECC Trial Date

By  Walter F. Roche Jr.

A federal judge has set a March trial date for the nine remaining defendants in a case triggered by a deadly fungal meningitis outbreak caused by a rogue Massachusetts drug compounding firm.
U.S. District Judge Richard G. Stearns today set March 16 as the date the trial will begin, with opening arguments scheduled for March 20.
The order comes just days before one of the two main defendants in the case is scheduled to be sentenced following his conviction on racketeering and mail fraud charges. Glenn Chin, who was a supervisory pharmacist at the New England Compounding Center, will appear before Stearns on Tuesday.
In a series of orders issued today Stearns told attorneys for the nine remaining defendants to be prepared to make opening arguments on March 20. He also set deadlines for both sides to submit lists of proposed witnesses and other data by March 8.
He set Feb. 15 as the date for a final pre-trial conference.
The nine were among 14 persons connected to NECC to be indicted in late 2014 following a two year criminal probe of the 2012 fungal meningitis outbreak. Caused by fungus laden spinal steroids, the outbreak sickened some 778 patients across the country, killing at least 76 of them.
Chin and Barry J. Cadden, the two primary defendants, already have been convicted on racketeering and mail fraud charges, but two separate juries concluded that there was not sufficient evidence to convict them on 25 counts of second degree murder.
Cadden already has begun serving a nine-year sentence at a federal prison in western Pennsylvania.
Those now scheduled for trial in March are Gregory Conigliaro, Gene Svirsky, Christopher M. Leary, Joseph Evanosky, Scott Connolly, Alla Stepanets, Kathy Chin, Michelle Thomas and Sharon Carter. Conigliaro was an NECC vice president and part owner. The others held various positions at NECC.
Two of the original 14 defendants, Carla and Douglas Conigliaro, entered guilty pleas to vastly reduced charges. They were fined and placed on probation with no prison sentences.
Robert Ronzio, an NECC salesman, has entered a guilty plea and is awaiting sentencing. He already has testified as a witness for the prosecution.
Contact: wfrochejr999@gmail.com

$611,774 Forfeiture Order Sought on Chin.

By Walter F. Roche Jr.

Federal prosecutors are asking a judge to issue a $611,774 forfeiture order against, Glenn Chin, the pharmacist convicted of racketeering, conspiracy and mail fraud for his role in deadly fungal meningitis outbreak.
In a nine-page motion filed this week in U.S. District Court in Boston, Mass. the prosecutors said the $611,774 represented the traceable wages paid to Chin from 2006 to October of 2012, when the New England Compounding Center, Chin's employer, was forced to shutdown.
According to an affidavit filed along with the motion the figure does not include any income for 2008 and 2009, because records for those years could not be located.
Chin was convicted in October of racketeering, conspiracy, mail fraud and violations of the Food Drug and Cosmetic Act. He is scheduled to be sentenced Jan. 31.
Chin was a supervising pharmacist at NECC, the Framingham, Mass. company blamed for the 2012 fungal meningitis outbreak. He was the supervisor in the clean room where steroids laden with a deadly fungus were produced and shipped all over the country.
Chin's earnings were not made public during his 27-day trial. In contrast earnings and profits netted by co-defendant Barry J. Cadden were detailed during his trial which preceded Chin's. Cadden, the president and part owner of NECC has been hit with a $7.5 million forfeiture order and already is serving an 11 year prison sentence following his March conviction on parallel charges.
A government  witness testified at Cadden's trial that he and his wife earned $18 million in profits between 1998 and 2012.
Both Chin and Cadden were cleared by separate juries of 25 counts of second degree murder.
According to the motion and affidavit filed this week, federal investigators were unable to locate the $611,774 because Chin apparently used the wages to pay ongoing living expenses.
Chin, Cadden and a dozen others were indicted in December of 2014 following a two year probe of the fungal meningitis outbreak which sickened 778 patients, killing 76 of them.
Contact: wfrochejr999@gmail.com

Nine Still Face Trial in NECC Case

By Walter F. Roche Jr.

Though it has been more than five years since a deadly fungal meningitis sickened 778 patients across the country nine of the 14  charged criminally for their roles in the public health disaster have yet to go to trial.
That number jumped from seven to nine just last week when a federal appeals court reinstated the charges against some of the original 14. The First Circuit Court of Appeals overturned a ruling by U.S. District Judge Richard G. Stearns who had dismissed charges against two former employees of the New England Compounding Center, the company blamed for the outbreak.
In a 19-page decision the three judge panel reinstated the charges against two licensed pharmacists, Kathy S. Chin and Michelle L. Thomas. A third defendant, Alla Stepanets, also had charges against her restored but she was already facing a trial on a related conspiracy charge.
The other defendants awaiting trial held various positions at NECC ranging from Gregory Conigliaro, an officer and part owner, to Gene Svirskiy, a supervisory pharmacist in charge of one of the so-called clean rooms where sterile drugs were prepared.
A trial date has not yet set.
Others awaiting trial are Christopher M. Leary, Joseph Evanosky, Scott Connolly and Sharon Carter. The charges range from racketeering to mail fraud and conspiracy.
Two of the original 14, Carla and Douglas Conigliaro, entered guilty pleas to vastly reduced charges. They were fined and placed on probation with no prison sentences.
Robert Ronzio, an NECC salesman, has entered a guilty plea and is awaiting sentencing.
Two of the original defendants, Barry J. Cadden and Glenn Chin already have been tried and were convicted of some, but not all the charges. Separate juries concluded prosecutors failed to prove 25 counts of second degree murder.
Cadden already is serving a nine year prison sentence. Chin is scheduled for sentencing on Jan. 31.
Contact: wfrochejr999@gmail.com

Charges Reinstated in NECC Case

By Walter F. Roche Jr.

A federal appeals court has reversed the decision of a district court justice who had dismissed charges against three defendants indicted in the aftermath of the deadly 2012 fungal meningitis outbreak.
In a 19-page decision issued in Boston, Mass. the First Circuit Court of Appeals said the three must face trial on charges that they participated in the distribution of mis-branded drugs.
The decision means two of the three, Kathy Chin and Michele Thomas will face trial along with several other remaining defendants.
The third defendant, Alla Stepanets, had a remaining conspiracy charge that was not dismissed by U.S. District Judge Richard G. Stearns.
Stearns had concluded that the work the three licensed pharmacists performed at the New England Compounding Center was merely clerical because they were matching up a list of drugs with lists of patients. He concluded their tasks did not rise to the level of dispensing.
The appeals court, however, concluded that the three were not merely present, but were "culpably present" when they matched up drugs with what were obviously fake patient names. The names included Wonder Woman, Fat Albert, L.L. Bean and Coco Puff.
The court found the 131 count indictment "easily passes muster" in providing sufficient notice to the three defendants.
"So the indictment gives the defendants enough info to prepare a defense and to invoke double jeopardy protections to forestall a later trial on the same charges," the ruling states.
The three were among 14 indicted in late 2014 by a federal grand jury investigating the 2012 fungal meningitis outbreak caused by fungus laden drugs shipped to health facilities across the country.
Some 778 patients were sickened and 76 of them died.
Two of the defendants already have gone to trial and were found guilty of some, but not all of the charges.
Barry Cadden, a part owner and president of NECC, already is serving a nine-year prison sentence while Glenn Chin faces sentencing on Jan. 31 following his conviction on racketeering and mail fraud charges.
Glenn Chin, is the spouse of Kathy Chin.
Several other defendants have entered guilty pleas.

Massive Compounded Drug Recall Ongoing

Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance

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For Immediate Release

January 11, 2018

Contact

Consumers

Leigh Briscoe-Dwyer, Vice President Clinical Affairs
  lbriscoe@pharmedium.com
 (847) 457-2801

Media

Andrew Harrison, Vice President of Legal and Compliance
  aharrison@pharmedium.com
 (847) 457-2271
Sanjeev Bahl, Vice President Quality
  sbahl@pharmedium.com
 (847) 457-2256

Announcement

PharMEDium Services, LLC (PharMEDium) is voluntarily expanding the recall issued on December 27, 2017 to include the below lots of sterile drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.  To date, PharMEDium has not received any reports of adverse events related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility.
The recall is being expanded because PharMEDium conducted  an extensive review of all commercially distributed product lots compounded in the Memphis location currently within their labeled expiration date in response to an FDA request regarding microbial program controls for the ISO5 environment, personnel glove sampling results, media fill results, sterility testing results, and endotoxin results following the most recent inspection.  The original recall included a total of 55 lots of different products impacting 25,327 units.  The expanded recall includes all lots within expiry compounded at our Memphis, TN facility. Finished product release testing for both sterility and endotoxin were acceptable for all lots. Although there were no defects identified in these products, as a conservative measure, this recall is being expanded.
The products can be identified by referring to the sample labels provided below.  These products were distributed nationwide in the USA to hospitals/clinics.  A complete list of all recalled products can be found on pharmedium.com.
PharMEDium Services is notifying customers of the voluntary recall by phone and email. Customers that have any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy per their hospital protocol. Customers with any of the affected medications can also reference PharMEDium Services website (pharmedium.com) for more information on the specific lot numbers affected and contact information.
Patients and healthcare providers with questions regarding this recall can contact PharMEDium Services Clinical Pharmacist at 1-800-523-7748, Monday through Friday, between 8am and 5pm Central Standard Time or via e-mail at recall17023@pharmedium.com.
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of these products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Initial Press Release

###

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Victims Blocked From Needed Care

By Walter F. Roche Jr.

Five years later Vicki Scott, a Virginia victim of the 2012 fungal meningitis outbreak, is still suffering after effects of the original disease and the powerful anti-fungal drugs used to treat it, but she, like many other outbreak victims, is finding it increasingly difficult to get medical care.
In recent interviews Scott, a Roanoke resident, cited repeated instances of physicians and other health care providers either refusing to even give her an appointment or cancelling a scheduled visit before she could even get in the door.
She is not alone.
Terri Lewis, a Tennessee resident who has taken on the role of advocate for dozens in similar situations, there are victims from many other states including Indiana and Kentucky where they are having difficulty getting needed follow up care.
"She's been blackballed," Lewis said of Vicki Scott.
Lewis also blames federal agencies for failing to take an active role in helping victims get needed care.
"They clearly didn't do their jobs," she added.
As for the victims, Lewis said many are continuing to experience multiple health problems related both to the original disease - in many cases fungal meningitis - and the lingering health issues caused by Voriconazole, or other antifungal drugs.
The 2012 fungal meningitis outbreak sickened at least 778 patients, killing 76 of them. It was caused by highly contaminated vials of a steroid called methylprednisolone acetate, which was produced as a now defunct Massachusetts drug compounding company. The steroids were injected into the spines and joints of unsuspecting patients in more than 20 states.
Scott says some have even questioned whether she really was a victim, even though her medical records indicate she was being treated for fungal meningitis.
Lewis noted that another roadblock facing victims is the ongoing efforts to reduce or eliminate pain treatment with opiods.
"Many doctors are afraid to prescribe those drugs," Lewis said, adding that federal regulators are "criminalizing pain care. A lot of these patients have no alternatives.
Scott, who describes herself as "very angry and upset," says she really doesn't know where to turn for help.
When she questioned officials at one area health facility about the reason her appointments were cancelled, she said she was told she should never have been given an appointment in the first place.

Drug Recall Due to Sterility Concerns

ompounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance AUDIENCE: Risk Manager, Pharmacy ISSUE: PharMEDium Services is voluntarily recalling certain lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. See the press release for a listing of affected products. BACKGROUND: PharMEDium conducted a retrospective review of all commercially distributed product lots compounded in the Memphis location currently within their labeled expiration date in response to an FDA request regarding microbial control program during recent inspection to provide verification of acceptable microbiological testing results of the ISO5 environment, personnel glove sampling results, media fill results, sterility testing results, and endotoxin results. The review indicated that a total of 55 lots of different products impacting 25,327 units had two unsuccessful media fills. The remaining lots were associated with environmental monitoring or personnel monitoring excursions in the ISO 5 space on hood/surface and glove tip. Finished product release testing for both sterility and endotoxin were acceptable. Although there were no defects identified in these products, as a conservative measure, a recall is being initiated. The recalled products were distributed nationwide in the USA to hospitals/clinics. RECOMMENDATION: PharMEDium Services is notifying customers of the voluntary recall by phone. Customers that have any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy per their hospital protocol. Customers with any of the affected medications can also reference PharMEDium Services website for more information on the specific lot numbers affected and contact information: www.pharmedium.com. Patients and healthcare providers with questions regarding this recall can contact PharMEDium Services Clinical Pharmacist at (847) 457-2220, Monday through Friday, between 8am and 5pm Central Standard Time or via e-mail at dantonio@pharmedium.com. 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/ucm591048.htm