FDA Cites Continuing Deaths from Compounded Drugs

By Walter F. Roche Jr.

Citing multiple deaths and serious adverse events, two officials from the U.S. Food and Drug Administration say much more needs to be done to avoid a recurrence of a deadly 2012 fungal meningitis outbreak.
In an article published in the New England Journal of Medicine, Janet Woodcock and Julie Dohm noted it has been five years since the 2012 fungal meningitis which sickened 778 patients, killing 76 of them. The outbreak triggered passage of a new law in 2013.
Stating that more than 425 inspections have been conducted since the passage of the Drug Quality and Security Act, the report states that the FDA found during these inspections "problematic conditions during the vast majority of these inspections." There are currently 75 registered mass compounders.
"The FDA's experience in monitoring pharmacy compounding demonstrated the need for further improvement in compounding practices," the report states.
Cited were multiple violations turned up including dead insects found in compounding areas and visible mold on ceiling tiles and dog beds and dog hairs in close proximity to compounding areas.
According to the report the FDA has overseen the recall of 140 compounded drugs during the same six-year period.
Despite the new law the regulators noted that both before and after the outbreak small clusters of problems with compounded drugs have been reported.
Included in the report is a page-long list of events, some resulting in deaths that have been recorded since 2012. Citing "a steady stream of reports of serious adverse events, including deaths, the report notes that in July of this year 43 patients experienced diminished vision after treatment with a compounded drug.
In an August event two patients had severe sensitivity reactions to a compounded drug containing a substance not considered suitable for human consumption. One of those patients died.
In 2016 three infants were injected with a compounded morphine sulfate that had 25 times the labeled strength. And in 2013 bacterial bloodstream infections were reported for 15 patients, two of whom died.
The regulators noted that the adverse events they reported probably amounted to a small fraction of the actual number because most such events were not reported to the FDA.
Noting the outsourcing industry is in a state of rapid growth, the report states that it is critical that the efforts continue for compounders to meet Current Good Manufacturing Practice requirements.
"Five years after the tragic fungal meningitis outbreak is a good time to invigorate efforts to ensure that the compounded drugs given to patients...are made in facilities that are held to appropriate production standards," the report concludes.
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Initial Checks Going to Outbreak Victims

By Walter F. Roche Jr.




Initial payments are in the mail for some victims of the 2012 fungal meningitis outbreak and a second payment is expected next year.
Interviews with victims and the attorneys representing victims show the payments from a $40 million victims compensation fund are being mailed out this week from the Massachusetts Attorney General's office, which is administering the payment program.
Those familiar with the program said the total payments could range from $25,000 to $50,000.
The funds were allocated to the Massachusetts Attorney General through the efforts of U.S. Rep. Mike Bishop, whose Michigan district was especially hard hit by the outbreak which sickened some 778 victims, killing 76 of them.
Bishop issued a statement applauding the efforts by Mass. Attorney General Maura Healey to begin distributing the grants.
"While no dollar amount will ever make these victims whole, I am happy to know that victims are finally getting some much needed additional financial help," Bishop said.
He noted that victims still have until March 1 to file a claim. The original December deadline was extended earlier this year.
The $40 million came from a U.S. Justice Department fund established to reimburse victims of serious crimes.
The president and a supervising pharmacist at the New England Compounding Center have been convicted of racketeering and mail fraud as a result of a federal grand jury probe of the outbreak.
Barry J. Cadden, NECC's president, already is serving a nine year prison term following his March conviction on 57 counts. Chin is scheduled for sentencing on Jan. 31.
NECC shipped fungus laden steroids to health providers across the country.
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Info Needed for 67 Outbreak Victims to Get Checks

By Walter F. Roche Jr.




The trustee for a fund established to pay victims of a deadly 2012 fungal meningitis outbreak is asking a federal judge to order a California law firm to explain why it has failed to submit paperwork so that 67 victims can get paid.
In a two-page motion filed today in U.S. District Court in Boston, Mass., Lynne F. Riley, the trustee, asked U.S. District Judge Rya Zobel to order the law firm of Andrews Thornton Higgins and Razmara to explain why it has not submitted the needed information.
She states in the motion that there are a total of 142 victims whose checks cannot be released because information relating to liens or outstanding claims against those victims' payments hasn't been submitted.
According to the motion Andrews Thornton has not responded despite "a significant lapse of time" since the information was requested.
Riley reported previously that substantially all of the eligible victims had been paid. In a report to the court she said a total of $149.4 million has been distributed to a little more than 2,000 victims.
The victims' fund was created during the bankruptcy of the New England Compounding Center, the now defunct Framingham, Mass. firm blamed for the outbreak that took the lives of at least 76 patients.
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Tennessee Outbreak Suits Formally Settled

By Walter F. Roche Jt.

Lawyers for Tennessee victims of the 2012 fungal meningitis outbreak have agreed to formally dismiss their claims under a confidential settlement with two Nashville clinics and related parties.
In papers filed this week in U.S. District Court in Boston, Mass. lawyers for the victims and the clinics said all but two of the 106 who filed claims have been paid under the settlement terms.
Only technical paperwork will be needed to finalize the last two claims.
Among the defendants in the cases were the Howell Allen Clinic and the Saint Thomas Outpatient Neurosurgical Center, both in Nashville. Lawyers for the clinics declined to comment.
A joint four-page petition seeks the approval of senior U.S. District Judge Rya Zobel for the dismissals. Suits brought by Tennessee victims and some 20 other states were merged in Zobel's court in late 2013.
"This fully and finally resolves all claims against all defendants in the cases listed in the consent order," the filing states.
The outbreak, federal and state regulators agree, was caused by fungus laden methylprednisolone acetate shipped from the New England Compounding Center to clinics across the country.
Complaints filed in subsequent cases showed most of Tennessee victims had sought treatment for spinal and related problems at the Howell Allen Clinic. There doctors prescribed injections of methylprednisolone acetate to be administered at the Saint Thomas Outpatient Neurosurgical Center.
That center was owned in equal shares by Saint Thomas Health and the Howell Allen Clinic.
In addition to the clinics defendants included the doctor who administered the shots and related firms. The petition would resolve the claims against all defendants.
Though all parties have declined to discuss the terms of the settlement it is believed to be in excess of $20 million.
The 2012 outbreak sickened some 778 patients nationwide, killing at least 76 of them.
In addition to payments from the Nashville clinic settlements, victims also were eligible to collect payments from a national settlement fund established in the NECC bankruptcy.
The trustee of that fund reported this week that payments totaling nearly $150 million have been paid to a little over 2,000 victims.
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Trustee Reports $149.4 Million Going to Victims

By Walter F. Roche Jr.

A total of $149.4 million has been approved for payment to victims of the 2012 fungal meningitis outbreak, according to a report filed today in U.S. District Court in Boston, Mass.
Lynne F. Riley, who is in charge of overseeing the distributions, also reported that action has been taken on all 2,353 claims filed. All appeals have been resolved and payments to 2,026 have been fully or partially approved.
According to her four-page report, 284 claims were fully denied, 41 were determined to be invalid and two were withdrawn.
The funds stem from the bankruptcy of the New England Compounding Center, the now defunct Framingham, Mass. firm blamed for the outbreak. Funds are also being distributed through Riley from a settlement agreement with a Virginia clinic where victims were injected with fungus riddled methylprednisolone acetate.
Riley wrote that 237 initial checks have been distributed to victims who were injected at Insight Imaging, theVirginia firm that reached a settlement agreement. She reported that 165 of those Insight victims also received a second check.
Riley is not in charge of other clinic settlements including those reached with two Tennessee clinics where victims were injected with contaminated steroids. Payments from those settlements are being distributed separately.
The 2012 outbreak sickened at least 778 patients. Seventy-six of them died.
Riley also reported that the approved claims have also been submitted to federal and state agencies who can seek to recoup money they paid for the care of the victims.
Riley wrote that as of Friday, 1,884 victims have received a first check, while 1,857 of those have also received a second payment.
Checks for another 142 victims will be released once they or their attorneys submit needed documentation. She stated that 87 of that 142 have claims of less than $3,000.
Riley has indicated that a third smaller payment will be distributed at a later date after tax issues relating to NECC's owners are finally resolved.

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Judge Re-affirms Restitution Delay

By Walter F. Roche Jr.

A federal judge has rejected a request that he consider immediately a proposal to award some $73.7 million to victims of the 2012 fungal meningitis outbreak.
In a brief order issued today, U.S.  District Judge Richard G. Stearns denied the reconsideration motion filed by the U.S. Attorney.
Stearns declined to reverse an earlier decision delaying action on the restitution order until the First Circuit Court of Appeals acts on an appeal of the conviction of Barry J. Cadden, the one time president of the drug compounding firm blamed for a deadly fungal meningitis outbreak.
While conceding that arguments could be made for both sides, Stearns wrote, "I am persuaded as a prudential matter, the wiser course is to stay restitution pending the resolution of the First Circuit appeal."
Assistant U.S. Attorneys George Varghese and Amanda Strachan had asked Stearns to reconsider his initial ruling on the issue.
Cadden's lawyers argued that precedent required that the matter be delayed.
Stearns noted that if the appeals court disagrees with his decision, the panel can remand the issue to his court.
"It is decidedly the First Circuit, as the higher court, that is now the boss," Stearns wrote.
Cadden already has begun serving a nine year prison sentence following his March conviction on racketeering and mail fraud charges.
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NECC, Ameridose Profits Topped $200 Million

By Walter F. Roche Jr.

The company blamed for a deadly fungal meningitis outbreak and a closely related firm earned over $200 million in profits in the six year period preceding the 2012 outbreak, according to a filing in U.S. District Court in Boston, Mass.
The filing by the wife of the now jailed president of the defunct drug firms, shows that Barry and Lisa Cadden earned $72 million during that period from their 35 per cent ownership share in the New England Compounding Center and Ameridose.
Lisa Cadden disclosed the profit details in a 25-page motion filed in protest of a recently issued order from U.S. District Judge Richard G. Stearns. The Cadden's children also signed on to the motion which was filed by Bruce Singal, the same lawyer who represented Cadden in his recent criminal trial.
Lisa Cadden argues that because payments for a Wrentham home, along with adjoining properties, jewelry, an $89,220 sailboat, an $86,662 BMW and savings and investment accounts, came from a joint account, she retains ownership in all of those assets.
"Mrs. Cadden has legal right, title and interest in all of this property," the motion states in the request for Stearns to reverse his approval.
Also ordered seized was a $31,875 antique clock and jewelry purchased for $26,302.
Barry Cadden is now serving a nine-year federal prison term following his March conviction on racketeering, mail fraud and related charges.
NECC, the company Cadden helped found, filed for bankruptcy in late 2012. Ameridose, a related drug firm, was closed down by federal regulators and never reopened.
According to the filing Lisa Cadden earned $28 million from her 17.5 per cent share of Ameridose and $8 million from NECC. Barry Cadden had equal shares and profits.
The Caddens and other NECC owners did agree to pay a total of $47.5 million to a settlement fund that has been used to pay outbreak victims. That amount is likely to be increased because the NECC shareholders also agreed to put any tax refunds into the same fund.

Prosecutors Oppose Chin Acquittal Motion

By Walter F. Roche Jr.

Citing prior rulings in a parallel case, federal prosecutors are asking a federal judge to reject an acquittal plea from a pharmacist who played a key role at a drug compounding company that shipped thousands of vials of deadly fungus laden steroids.
In a 25-page filing in U.S. District Court in Boston, Mass. prosecutors said Glenn Chin's conviction on racketeering, conspiracy and mail fraud charges should stand and all five of his arguments for acquittal were without merit.
Chin, the government brief notes, was convicted on 77 counts following a five week trial. His sentencing is scheduled for Jan. 30 before U.S. District Judge Richard G. Stearns.
Assistant U.S. Attorneys Amanda Strachan and George Varghese noted that many of the arguments for acquittal  offered by Chin already have been rejected by Stearns in the case of co-defendant Barry J. Cadden. Cadden, who was president and part owner of the now defunct New England Compounding Center, is serving a nine year prison sentence in Pennsylvania.
Cadden and Chin were among 14 persons connected to NECC who were indicted in late 2014 following a two year probe of a deadly 2012 fungal meningitis outbreak that killed 76 patients and sickened 702 others.
"Chin, like Cadden before him, has presented no new arguments, nor cited any new case that calls into question the court's two prior rulings on this issue," the filing states.
Chin's lawyers had argued that the racketeering and conspiracy charges against him were too vague.
Charging that Chin was a manager of a criminal enterprise that sold "grossly substandard drugs" that were prepared in "filthy conditions."
"The evidence at trial showed Chin conspired with Cadden ... to operate NECC as a criminal enterprise. Chin, in his role as the supervising pharmacist of NECC's clean rooms, was part of that conspiracy," the brief states.
Cited was Cadden's role in using outdated drugs, shipping untested drugs and mislabeling drugs that hadn't been tested to make it appear that they had.
They noted evidence that under Chin's direction, drugs that were supposed to be placed in an autoclave for 20 minutes were only treated for 15 minutes.
They also noted the jury rejected Chin's claim that he was just following orders.
In a related development seven civil suits against a Maryland clinic where victims were injected with fungus laden NECC steroids were dismissed as the result of a settlement.'
Suits by outbreak victims against a Crossville, Tenn. clinic also have been settled and papers were filed this week to create a settlement fund for distribution to victims. Terms of the settlement with the Specialty Surgery Center were filed under seal.

Feds Move to Seize Cadden's House, Cash, Diamonds

By Walter F. Roche Jr.

Federal agents have executed preliminary forfeiture orders against more than a half dozen assets owned by the man now serving a nine year prison term for his role in a deadly 2012 fungal meningitis outbreak.
In filings today in U.S. District Court in Boston, Mass. the forfeiture orders were issued for the residence of Barry J. Cadden, along with jewelry, a "luxury clock or timepiece" purchased from an antique dealer and a sail boat purchased by the former drug company owner.
Cadden was convicted in late March on racketeering and mail fraud charges. He is now serving a nine year prison sentence in a federal prison in Pennsylvania.
U.S. District Judge Richard G. Stearns subsequently issued an order authorizing the forfeiture of Cadden's assets of $7.5 million.
In addition to Cadden's Wrentham, Mass. home the forfeiture orders apply to two adjacent properties, jewelry purchased by Cadden on Dec. 23, 2010 and Oct. 21, 2011 from DeScenza Diamonds, $1.4 million in a Lee Munder Wealth Planning account and $95,923 from a Middlesex Savings Bank account.
A total of eight preliminary forfeiture orders were filed. According to the filing, a copy of the seizure order was posted on Cadden's residence.
Cadden was president and part owner of the New England Compounding Center, the company blamed for the fungal meningitis outbreak which killed 76 patients across the country.
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Prosecutors Push for Outbreak Restitution Order

By Walter F. Roche Jr.

Federal prosecutors are asking a judge to reverse a decision which could delay for months a decision on a $74 million restitution order to benefit victims of a deadly 2012 fungal meningitis outbreak.
In a seven-page motion filed today in U.S. District Court in Boston, Mass. Assistant U.S. Attorneys George Varghese and Amanda Strachan asked U.S. District Court Judge Richard G. Stearns to reverse himself and immediately consider the order which could bring financial relief to outbreak victims.
Stearns, in a decision issued Nov. 21, concluded that he could not consider the restitution because of pending appeals in the case of Barry J. Cadden. A decision on those appeals is not expected for months.
Cadden, who was president and part owner of the company blamed for the outbreak, was convicted in March on racketeering and mail fraud charges and is serving a nine-year federal prison sentence. Both his conviction and sentence are on appeal. Prosecutors have asked that Cadden be forced to make restitution of $73.7 million.
"The government submits that this court's jurisdiction is unaffected by Cadden's appeal from his conviction (or the government's appeal of his sentence)," the motion states.
While acknowledging that in many cases an appeal would delay such decision, the prosecutors cited two U.S. Supreme Court rulings to the contrary.
In addition they noted the federal Mandatory Victims Restitution Act of 1996 makes restitution "a mandatory component of sentencing for criminal offenses, including crimes for which Cadden has now been convicted."
They also noted a provision of the restitution statute that mandates restitution where an identifiable victim or victims have suffered a physical injury."
"The notice of appeal following the original judgment does not divest the sentencing court from resolving the restitution issue," the decision states.
Stearns already has issued an order requiring Cadden to forfeit $7.5 million in assets, including his BMW and Wrentham, Mass. home.
The 2012 fungal meningitis outbreak caused by fungus laden steroids sickened some 778 patients killing 76 of them.
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Chin Seeks Reversal and Acquittal

By Walter F. Roche Jr.

The pharmacist convicted of racketeering and mail fraud in the wake of a deadly fungal meningitis outbreak is asking a judge to throw out the jury verdict and acquit him of the charges.
In a nine-page filing in U.S. District Court in Boston, Mass., Glenn A. Chin said the fact that the jury found him not guilty on second degree murder charges undermines all the remaining racketeering and mail fraud charges.
"Without the second degree murder racketeering charges this case is even farther afield from RICO (racketeering) than where it started," the filing by Stephen J. Weymouth, Chin's attorney, states.
Adding that "constitutional concerns" were heightened by the "jury's acquittal" on 25 second degree murder charges, the motion states that Chin had no way of knowing that the conduct he was engaging in could lead to a racketeering charge.
"The RICO (racketeering) charge is unconstitutionally vague as to Chin on an alleged mail fraud scheme," the motion continues. "Chin was not - and could not have been - aware that the New England Compounding Center's (NECC's) compounding drugs, even if deficient, could amount to racketeering."
The motion states that restrictions have been set on similar charges "to prevent the government from targeting individuals based on personal bias or public pressure.. just as the government did here."
In addition, the motion states that the government presented no evidence, explicit or implicit, that Chin conspired with five of the codefendants.
As to the charge he conspired with co-defendant Barry J. Cadden, NECC's president, the motion states that Chin simply followed Cadden's instructions in order to keep his job.
"Throughout his employment Chin followed the directives and practices taught to him by Cadden. Cadden closely controlled the details of the operation," the brief states.
Finally the motion argues that any charges relating to one lot of drugs produced at NECC in May of 2012 should be tossed because the government never proved the lot was contaminated or that anyone was sickened from it.
The 2014 indictment of Chin and Cadden followed a two year grand jury probe of the 2012 fungal meningitis outbreak which sickened some 778 patients, killing 76 of them. The outbreak was blamed on vials of spinal steroids shipped by NECC while loaded with deadly fungi.
Cadden already is serving a nine-year prison sentence while Chin is scheduled for sentencing on Jan. 30 before U.S. District Judge Richard G. Stearns.
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Tennessee Outbreak Victim Passes

By Walter F. Roche Jr.

One of the earliest Tennessee victims of the deadly nationwide fungal meningitis outbreak has died just a little over five years after he was sickened by fungus laden steroids injected into his cervical spine.
Dennis O'Brien of Cookeville  died Nov. 16 in a local hospital days after he suffered a massive stroke.
A retired school teacher, O'Brien had turned to the injections seeking relief from chronic pain. He said in an interview that the injections actually did ease his pain. That was until August and September of 2012.
Court records show O'Brien was injected with methylprednisolone acetate from the New England Compounding Center on Aug. 17 and Sept. 14 of 2012. He was one of the more than 100 patients who got the injections at the Saint Thomas Outpatient Neurosurgical Center only to be taken ill. Several patients at the Nashville, Tenn clinic died.
It was on Oct. 2, 2012 when he went to the Saint Thomas emergency room suffering from a severe headache, vomiting and diarrhea. A test of his spinal fluid showed he was suffering from fungal meningitis. He was hospitalized for 10 days.
O'Brien and the other victims were treated with powerful anti-fungal drugs that often have severe side effects including hallucinations and vision problems.
In several interviews over the past five years O'Brien described the pain he continued to suffer from the after effects of the meningitis and the underlying neck problems that drove him to seek the injections in the first place.
In fact he had retired early from teaching due to his neck pain.
In interviews as he tried to spring back from the meningitis, O'Brien said he was forced to use a cane and was unable to do many of the tasks a 64-year-old would regularly perform.
"I'm a third of my former self," he said in one interview.
The outbreak caused by contaminated steroids from NECC eventually killed 76 patients out of the 778 who were sickened. More victims, O'Brien included, have died over the past few years, some of them also suffering strokes. Other victims also have reported ongoing ailments triggered, if not caused, by the meningitis.
In addition to his wife of nearly forty years, Kaye, O'Brien was survived by his mother, Marion O'Brien of Nashville, a daughter, Katie Little of Cookeville, a son Patrick of Rockvale, three sisters and a brother.
His wife said she and the family were grateful he would suffer no more pain.
"Dennis was ready to go on to heaven," she said.
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Prosecutors Reassert $73.7 Million Restitution Claim

By Walter F. Roche Jr.

Calling arguments by a former drug company executive absurd and nonsensical, federal prosecutors have reasserted their claim that Barry J. Cadden should pay $73.7 million in restitution to victims of a deadly fungal meningitis outbreak.
In a 13-page filing today in U.S. District Court in Boston, Mass. the U.S. Attorney charged that actions by Cadden were directly responsible for the deaths and injuries to some 352 identifiable victims.
Cadden is now serving a nine-year prison sentence following his March conviction on charges of racketeering, conspiracy and mail fraud. He already has been ordered to forfeit $7.5 million.
The filing by Assistant U.S. Attorneys Amanda Strachan and George Varghese also defends providing restitution to clinics that purchased drugs from the New England Compounding Center, the now defunct company Cadden headed. Their proposal also would bring restitution to insurance companies who paid some of the victims' medical expenses.
"The clinics endured substantial out-of-pocket losses as a result of Cadden's fraudulent schemes," they argued.
Most of the $73.7 million, however would go to patients sickened by NECC drugs. Some 778 patients were sickened and 76 of them died after being injected with fungus laden steroids produced by NECC.
"These patients were directly and proximately harmed by Cadden's criminal conduct," the filing states.
Cadden has argued that he was convicted for misrepresenting the processes utilized at NECC and not the quality of the company's drugs. His lawyers contend restitution should be limited to $5,377.60
"This statement is wrong and nonsensical," the prosecutors stated. "The quality of the drugs is the reason the production process mattered to customers."
Asserting  that Cadden was convicted on 27 separate fraud and racketeering charges, the prosecutors stated that if not for Cadden's "voluminous misrepresentations.. not a single victim would have been harmed."
They also rejected Cadden's claim that because there were so many victims suffering so many different injuries, no restitution could be calculated.

NECC Defendant Gets U.S. Paid Attorney

By Walter F. Roche Jr.

A federal magistrate judge has approved a request by a defendant in the criminal case stemming from a deadly fungal meningitis outbreak to have the federal government pick up the tab for the lawyer she hired to defend her.
In a four-page order issued today U.S. Magistrate Judge Jennifer Boal agreed that the government should pick up the tab for Sharon Carter's continued defense with her current attorney.
Carter is charged with racketeering conspiracy and conspiracy to defraud the U.S. Food and Drug Administration. She was one of 14 indicted in late 2014 following a two-year probe of the 2012 fungal meningitis outbreak.
Carter was director of operations for the New England Compounding Center, the company that shipped highly contaminated steroid drugs to dozens of health care facilities. The 2012 outbreak sickened 778 patients, killing 76 of them.
Under the decision Carter's current lawyer, Michael J. Pineault, can continue as her counsel even though he is not a member of a panel of lawyers selected to represent indigent defendants.
"The court finds that she (Carter) is financially unable to obtain counsel at this time," Boal wrote, adding that the defendant "has exhausted the personal assets available to fund her defense."
Though she noted that appointing a counsel not on the panel is only allowed in exceptional cases under the Criminal Justice Act, Pineault has been representing her for five years in a complex case.
"The court finds that exceptional circumstances are present in this case," the ruling states.
She added that Pineault's request that a colleague also be appointed to assist him should be resubmitted separately.
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Ronzio Sentencing Delayed Indefinitely

By Walter F. Roche Jr.


The sentencing of a key witness in the criminal probe of a deadly fungal meningitis outbreak has been delayed indefinitely under an agreement between his lawyers and federal prosecutors.
The two-page joint motion was filed today in U.S. District Court in Boston, Mass. Robert Ronzio's sentencing had been scheduled for Jan 31, 2018.
Ronzio, the head of sales for the New England Compounding Center, entered into a plea agreement with the U.S. Attorney's office on Dec. 19, 2016. He entered the plea to a single conspiracy count.
In the motion, prosecutors said Ronzio is expected to testify in the upcoming trial of seven co-defendants.
"His cooperation is not yet complete," the motion states, adding that his sentencing should be delayed until the final trial is completed.
Under his agreement Ronzio  admitted being involved in a conspiracy to defraud the U.S. Food and Drug Administration.
Ronzio already testified in the  trial of NECC's one time president Barry J. Cadden. The former pharmacist is serving a nine-year prison sentence in a federal prison in Pennsylvania.
Cadden and Ronzio were two of 14 persons connected to the defunct drug compounding firm named in a 2016 indictment. Seven of those defendants have yet to be tried on charges ranging from racketeering to mail fraud to violations of the federal Food Drug and Cosmetic Act.
Co-defendant Glenn Chin, who was a supervising pharmacist at NECC, was found guilty of racketeering and mail fraud charges but, like Cadden, he was cleared of 25 counts of second degree murder.
The 2012 outbreak, caused by fungus riddled steroids produced at NECC, took the lives of 76 patients.
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Seven NECC Defendants Now Face Trial

By Walter F. Roche Jr

With the trials of the two most prominent defendants now complete, seven more of the 14 indicted in the aftermath of a deadly national fungal meningitis outbreak are nearing a yet to be finally determined trial date in U.S. District Court in Boston, Mass.
One of those defendants, Sharon P. Carter, is asking the court to pick up the tab for her defense, according to papers filed last week. Carter, citing her depleting financial resources, is asking for the court, to allow her to continue with her existing attorney but with the federal government picking up the tab.
Carter also sought to have her personal financial records filed under seal with the court. U.S. District Court Judge Richard G. Stearns granted that motion but left it to Magistrate Judge Jennifer C. Boal to determine whether Carter qualifies for a court paid counsel.
Carter was the director of operations at the New England Compounding Center, the company blamed for the fungal meningitis outbreak.
The trial for Carter and the six other remaining defendants follows the convictions of Barry J. Cadden and Glenn Chin. Cadden, the president and part-owner of NECC already is serving a nine-year sentence following his conviction on racketeering, mail fraud and related charges. Chin's sentencing is set for Jan. 30.
Chin was also convicted of racketeering and mail fraud. Both Chin and Cadden avoided conviction on 25 counts of second degree murder connected to the racketeering charges.
Stearns had previously indicated that the trial for the remaining defendants would take place following the Cadden and Chin trials.
The others facing trial with Carter are Gene Svirskiy, a supervisor in one of the clean rooms where sterile drugs were prepared, Christopher Leary, who worked in a clean room, Joseph Evanosky, who also worked in a clean room, Scott M. Connolly, a one time pharmacy technician, Alla Stepanets, a licensed pharmacist, and Gregory A. Conigliaro, an NECC vice president, in charge of regulatory compliance.
Robert Ronzio, who was NECC's sales chief, has entered a guilty plea to conspiracy charges and awaits sentencing. Douglas and Carla Conigliaro entered guilty pleas to vastly reduced charges and were fined and placed on probation.
Stearns dismissed charges against two other NECC defendants, Kathy Chin and Michele Thomas. The dismissal is under appeal. He dismissed the same charges against Stepanets but she still faces a conspiracy charge.
The outbreak, caused by NECC steroids contaminated with deadly fungi sickened 778 patients, killing at least 76 of them.
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Chin Easement Requests Denied

By Walter F. Roche Jr.

A magistrate judge in Boston, Mass. has turned down a request to ease the restrictions imposed on a former druggist recently convicted on charges of racketeering, conspiracy and mail fraud.
Magistrate Judge Jennifer C. Boal turned down the request submitted in behalf of Glenn A. Chin, who is awaiting sentencing following his conviction last month.
Chin had asked that a requirement that he wear a location monitoring device be eliminted and that a limit on the hours he is allowed to leave his Canton, Mass. residence be lifted.
 Noting that Chin's recent conviction eliminated any presumption of innocence, Boal wrote that the sole justification offered by Chin for the easements was the need to get his personal affairs in order.
"His current curfew is 8 p.m to 6 a.m. on weekdays and 7 p.m. to 7 a.m. on weekends. This curfew allows Chin more than adequate time to place his personal affairs in order," Boal concluded.
The easement had been opposed by federal prosecutors who noted that Chin was originally placed under arrest as he was preparing to board a plane for China.
Chin has stated that he and his family were only headed to a family event and that he had a return ticket.
Chin was one of 14 persons indicted following a two year probe of the 2012 fungal meningitis outbreak which was caused by fungus laden steroids prepared by Chin at the now defunct New England Compounding Center. Seventy-six patients died in the outbreak while 778 were sickened.
Chin was charged with second degree murder in 25 of those deaths but the jury cleared him of those charges.
Codefendant Barry J. Cadden, who was convicted on similar charges, is serving a nine year prison sentence. Cadden was president and part owner of NECC while Chin was a supervising  pharmacist at the Framingham, Mass. company.
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Pain Compounded on 5th Anniversary of Outbreak

By Walter F. Roche Jr.

For Vicki Scott, a Virginia victim of the 2012 fungal meningitis outbreak, the pain continued even as the fifth anniversary of the outbreak's discovery quietly passed last month.
Scott, who at first had a difficult time getting officials to even acknowledge she was a victim, says she now has found it virtually impossible to find healthcare providers willing to treat her continuing ailments.
The Roanoke resident said she has been told she will have to move to another state to get needed care.
For Patricia Martin, a Nashville, Tenn. resident the pain is of a different sort. She lost her mother, Mary, to the outbreak..
"It's been five years since I was last with Mom. She left this earth not of her own accord but at the hands of a compounding pharmacy," Martin wrote in an email.
The toll of the outbreak at the anniversary date was itself compounded by the October verdict in the trial of Glenn Chin, the pharmacist who personally compounded the methylprednnisolone acetate badly contaminated with a deadly fungus.
While jurors in U.S. District Court in Boston, Mass. found Chin guilty of racketeering and mail fraud they cleared him of  25 counts of second degree murder. Victims, including several who witnessed parts of the trial, expressed anger and disappointment with the verdict.
They had the same emotions earlier this year when another federal jury cleared co-defendant Barry J. Cadden of the same 25 second degree murder counts. Cadden, like Chin, was convicted on racketeering and mail fraud charges and is already serving a nine-year prison sentence at a federal prison in Western Pennsylvania. Chin's sentencing is set for Jan. 30.
"I want to scream out about the wrong that was inflicted on her, the sad way she left this earth and the fact she deserved so much better," Martin wrote on Oct. 25, the anniversary of her mother's death.
Martin said she is very conscious of the fact that other victims of the outbreak who survived are now suffering from a variety of ailments, some caused by the fungal meningitis they contracted and others from the after effects of powerful anti-fungal drugs they were forced to tolerate.
Stating that she cannot imagine the pain living victims are enduring, Martin said, "Often I think I got off easy. Today I allow myself to feel the pain and disgust."
Scott is one for whom the physical pain continues.
"My health is terrible," Scott said in a recent interview.
She said when she finally was able to get an appointment with a specialist, it was canceled at the last minute.
"I am extremely ill and I'm being denied care," she said.
Other victims from Maryland to Indiana say they have confronted the same problem with physicians and other health care providers declining to treat them.

Scott said one physician told her that her condition was just "too complex" to handle.
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Compounded Drug Recall

Compounded Glutamine, Arginine, and Carnitine Product for Injection by United Pharmacy: Compounding Risk Alert - FDA Investigates Two Adverse Events

Prosecutors Oppose Easing Chin's Restrictions

By Walter F. Roche Jr.

Citing a series of "suspicious financial transactions," federal prosecutors are asking a judge to reject a request for an easement of restrictions on a former pharmacist just convicted of 77 counts in the aftermath of the probe of a deadly fungal meningitis outbreak.
In a motion filed Wednesday in U.S. District Court in Boston, Mass., Assistant U.S, Attorney George Varghese cited a series of financial transactions executed in recent months by Glenn A. Chin, the former supervising pharmacist for the company blamed for a deadly fungal meningitis outbreak.
Chin had requested that the judge presiding over his case lift an order that required him to wear a location monitor and remain under house arrest at his suburban Boston residence. In requesting the easement earlier this week, Chin's lawyers said they anticipated government lawyers would oppose the request.
"During his time on pretrial release, the government has continued to monitor Chin's activities, including a number of suspicious financial transactions," the motion states.
Cited in the seven-page motion are a series of withdrawals from Chin's retirement account that initially totaled $635.000.
Citing its previous charge that Chin was arrested the day before he and his family were set to leave the country, the government charged that Chin has spent $250,000 to purchase a sports utility vehicle, pay off a large credit card debt and to repay loans to relatives.
"It is unknown what Chin is doing with this additional cash, but these transaction appear to demonstrate a concerted effort to obtain significant available cash resources," the government motion states.
The motion notes that Chin was convicted on 77 counts by a federal jury following a trial that spanned nearly five weeks. As a result, the motion continues, Chin is likely to face a substantial federal prison sentence similar to the nine year sentence given to co-defendant Barry J. Cadden.
Cadden, who was convicted in late March already is serving that nine year sentence.
Citing a report by a government expert, the motion states that Chin's estimated net worth is $1.3 million
Prosecutors also challenged Chin's contention that easing his restrictions pending a Jan. 30 sentencing hearing would better enable him to place his personal affairs in order.
"This reason is specious," the motion states, adding that the Chin motion provides no explanation for why he can't place his affairs in order during the hours of 6 a.m. to 8 p.m., the time period he is now allowed to leave his Canton, Mass. residence.
"Given all the realities Chin faces, flight may now be more tempting to him than at any point since his arrest. This is not the time to relax his release conditions," the motion concludes.
Chin and Cadden were charged following a two year probe of the fungal meningitis outbreak which was caused by the company headed by Cadden, the New England Compounding Center. Chin, as a supervising pharmacist at NECC, reported to Cadden.
The outbreak sickened 778 patients, killing 76 of them.
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Judge Blocks FDA Depositions on Outbreak

By Walter F. Roche Jr.

A federal magistrate judge has ruled that a Rhode Island clinic cannot depose officials of the U.S. Food and Drug Administration in its efforts to defend against civil litigation stemming from the 2012 fungal meningitis outbreak.
In a seven-page ruling issued today in Boston, Mass., U.S. Magistrate Judge Jennifer C. Boal said lawyers for the Ocean State Pain Management "may not attempt an end run" of an earlier order by taking depositions of individual FDA employees.
Ocean State had also sought Boal's approval to depose other individual's involved in pending criminal action including former employees of the New England Compounding Center and its sales arm, Medical Sales Management.
Boal, however, reaffirmed a ban on depositions of the FDA, former NECC employee Joseph Connelly, MSM salesman John Notarrianni, now imprisoned former NECC President Barry J. Cadden and former NECC sales chief Robert Ronzio.
Boal concluded that a federal law does not prevent the court from staying the depositions because the action was sought by federal prosecutors. Injunctions are warranted, she added, to prevent state courts from interfering with a federal court's consideration of a case "so as to seriously impair the federal court's flexibility and authority to decide the case."
She did add that her order did not prevent Ocean State from deposing other NECC related witnesses "not specifically stayed by the court's prior order."
The Ocean State cases are just a few of hundreds filed in the wake of the meningitis outbreak that took the lives of 76 patients and sickened hundreds of others.
Just last week NECC's supervising pharmacist Glenn Chin was convicted on racketeering and mail fraud charges. He was cleared of second degree murder charges. His sentencing is set for Jan. 30. Co-defendant Barry J. Cadden already is serving a nine year prison sentence.
Still other related defendants are awaiting trial.
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Chin Wants Out of Monitor, Curfew

By Walter F. Roche Jr.

The ex-pharmacist just convicted on racketeering and mail fraud charges is asking a judge to lift his current curfew and remove the requirement that he wear a location monitor.
The lawyer for Glenn Chin today submitted the request asking for the current requirements to be lifted until Jan. 30 when Chin is scheduled to appear for a sentencing hearing.
Currently Chin must wear the monitor 24-7 and he is only allowed to leave his Canton, Mass.  residence between 6 a.m. and 8 p.m. on weekdays and from 7 a.m. to 7 p.m. on weekends.
Stating that "Mr. Chin has been in complete compliance with the pre-trial conditions of release during the pendency of this action," Stephen Weymouth wrote that Chin needed "to put his personal affairs in order.
"He will need to make arrangements for his family as well as for other aspects of his personal life," the two-page motion states.
The motion states that opposition is expected from the U.S. Attorney.
 Federal prosecutors are likely to cite the fact that Chin was originally arrested as he was about to board a plane for China. Chin's lawyers have countered that Chin was simply traveling to attend a family event and had already purchased a return flight ticket.
"It will be easier for Mr. Chin to properly discharge these duties and responsibilities if he was not wearing a location monitoring device and if he was not subject to a curfew," the motion continues.
In the event the judge declines that request, Chin is asking U.S. District Judge Richard G. Stearns to loosen the curfew hours so that he can leave his residence between 6 a.m. and 10 p.m. seven days a week.
In a related development Stearns has denied a request from lawyers for radio station WBUR that he promptly release the names and home addresses of the members of the jury that delivered the guilty verdicts this week.
Stearns said he would not release the addresses of the jurors but he would release the names of jurors after the Jan. 30 sentencing session if WBUR's lawyers submit an amended request.
Stearns took similar action on the same request following the conviction of co-defendant Barry J. Cadden.
"While the court supports the role of the media in maintaining an open judicial process, it will not release jurors' home addresses," Stearns wrote.
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Cadden to Forfeit $7.5 Million

By Walter F. Roche Jr.

BOSTON- A federal judge has approved an order authorizing the seizure of $7.5 million in assets from the former president and part owner of a drug compounding company blamed for a deadly fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns this week approved the order requested by prosecutors from the U.S. Justice Department.
Stearns' order approves the seizure of four properties owned by Cadden and his wife along with a boat, a BMW and funds in two accounts.
Under the order federal agents can auction off the three properties Cadden and his wife own in Wrentham, Mass. and an oceanside home in Rhode Island.
Cadden was convicted in March of mail fraud, racketeering and violations of the Food Drug and Cosmetic Act. He was cleared on 25 counts of second degree murder.
Yesterday Cadden's co-defendant, Glenn Chin was convicted and acquitted on parallel charges. He faces a Jan. 30, 2018 sentencing.
Cadden was the president of the New England Compounding Center and Chin was a supervising  pharmacist for the now defunct Framingham, Mass. firm.
In addition to the properties Stearns' order approved the seizure of jewelry and $95,923 in a bank account and $1.4 million in an investment account.
Assistant U.S. Attorneys Amanda Strachan and George Varghese also have asked Stearns to approve a $73 million restitution order. They have indicated they will attempt to have funds recovered go to victims of the 2012 outbreak. Stearns has yet to rule on that request and Cadden has asked for additional time to respond.
Cadden began serving a nine year federal prison sentence in August.
The outbreak sickened 780 patients killing 76 of them. The illnesses and deaths were caused by fungus contaminated methylprednisolone acetate produced by NECC.
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Chin Guilty on Racketeering, Cleared of Murder

By Walter F. Roche Jr.

BOSTON- The pharmacist who compounded steroids that eventually killed 76 patients was convicted on racketeering, mail fraud and multiple other charges today but cleared on 25 counts of second degree murder.
The verdict, following three full days of deliberations, was delivered shortly before 6 p.m. Wednesday. The clerk read through several dozen charges, announcing guilty in each instance.
Chin was convicted on charges including conspiracy,  43 counts of mail fraud and 30 counts of introducing adulterated drugs into interstate commerce.
The verdict follows nearly five weeks of testimony, some of it detailing the deaths of victims, many stricken with fungal meningitis after being injected with methylprednisolone acetate heavily contaminated fungus.
The outbreak first surfaced in Nashville in the Fall of 2012 when a Vanderbilt physician discovered her patient was suffering from an extremely rare form of fungal meningitis. That victim, Thomas Rybinski, was one of the first of 16 to die in Tennessee. Other hard hit states were Michigan, Indiana and Virginia.
"There is no celebration," said Stephen Yarmouth, Chin's attorney, who noted that but for the second degree murder counts and some racketeering charges, his client was found guilty of dozens of other charges."
"Chin is not responsible for the deaths," he said, adding that his client was remorseful.
Acting U.S. Attorney William Weinreb said,"Mr. Chin ran NECC's clean room operations with depraved disregard for human life."
Victims of the  outbreak expressed disappointment and anger, but not surprise at the verdict.
"What can I say, once again there is no justice for us and a slap on the hand for the bad guy," said Susan Edwards, a Minnesota victim of the outbreak.
"I am beyond saddened with what can be done to people today and it's okay," said Dawn Elliott, an Indiana victim.
Chin's verdict mirrors, though not precisely, the verdict against codefendant Barry J. Cadden, who like Chin was convicted on mail fraud and related charges but cleared of the same 25 second degree murder  counts. Cadden already has begun serving a nine-year prison sentence,
Both were charged in the deaths of victims from Tennessee, Virginia, Michigan, Indiana, Florida, North Carolina and Maryland.
The case was somewhat unusual in that both sides were given time limits to present their cases. The limits were imposed by Stearns in apparent reaction to the unusual length of the Cadden trial.
In Chin's case prosecutors presented a parade of witnesses testifying about the contamination found in NECC's drugs and the bacteria and fungus found in and around NECC's clean rooms where sterile drugs were being compounded, including the spinal steroid blamed for the outbreak.
Their testimony was augmented by former NECC employees, including the firm's sole quality control officer who testified that her warnings about contamination went totally unheeded.
 One former technician was highly critical of Chin's abilities and actions. That same witness told jurors his own brother was working under Chin in an NECC cleanroom even though he was no longer registered to do so.
Weymouth countered by stressing that the teams of microbiologists and investigators combing through NECC's facilities never found even a trace of the exact fungi that killed 76 patients. He said federal investigators inexplicably rushed their investigation dooming efforts to ever identify the actual cause.
Chin did not testify in his own defense nor did his lawyers present a single witness. Instead Weymouth read an excerpt from the prosecution's closing statement in the trial of co-defendant Barry J. Cadden. In it prosecutors said that NECC was "Cadden's baby" and that he was "the conductor" who controlled everything at the drug compounding firm.
In closing arguments as well as throughout the trial, Cadden's lawyers pointed to Cadden as the decisionmaker, even suggesting that Chin and the sole quality control officer were chosen for key roles not at all for competence but for their willingness to say yes.
Chin was indicted along with 13 others in late 2014 following a two year federal grand jury probe of the 2012 fungal meningitis outbreak which sickened at least 780 patients  in 13 states. Seventy-six of them died.  Two additional victims were recently added to the list of those made ill.
Cadden went on trial in January in a marathon case finally ending in late March. He was convicted of racketeering, mail fraud and violations of the Food Drug and Cosmetic Act. The jury acquitted him on the 25 counts of second degree murder.
Douglas and Carla Conigliaro pleaded guilty to vastly reduced charges relating to their handling of some of NECC's profits. They were given probation. Carla, who was NECC's majority stockholder was fined $4,500 and ordered to forfeit $4,600. Douglas was fined $55,000 and forfeited $119,647.
Chin's wife Kathy was one of two of the original 14 to have the charges dismissed. Charges were also dismissed against Michelle Thomas. The dismissal is on appeal.
Robert Ronzio, NECC's sales chief has entered a guilty plea to conspiracy charges but has yet to be sentenced.
Chin's sentencing is set for Jan. 30.
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Outbreak Jury Moving Towards Verdict?

By Walter F. Roche Jr.

BOSTON- Jurors gave the first hint they may be nearing a verdict in the racketeering trial of a druggist blamed for a deadly 2012 fungal meningitis outbreak.
The jurors asked U.S. District Judge Richard G. Stearns whether they could convict Glenn Chin on a racketeering charge if they unanimously agreed on just two of the so-called  68 predicate acts, which include 25 counts of second degree murder. U.S. District Judge Richard G. Stearns told them that the answer to that question was yes, but added that they also must consider the remaining 66 predicate criminal acts.
Stearns called the jurors into his seventh floor courtroom at mid-afternoon to answer their questions. The jurors have been deliberating since Monday in a trial that began in September.
Some observers were predicting, based on the questions posed, that a verdict could come as soon as tomorrow.
Stearns said that if the jurors could not vote unanimously on any of the remaining racketeering charges then no further action was required.  
In addition to second degree murder charges, the predicate acts include mail fraud and violations of the Food Drug and Cosmetics Act.
Chin was one of 14 indicted in late 2014 following a two year federal probe of the fungal meningitis outbreak caused by fungus laden steroids shipped from the New England Compounding Center, the now defunct firm that employed Chin as a supervising pharmacist.
The outbreak sickened 778 patients, killing 76 of them. Sixteen Tennessee patients were among the dead, while 153 were sickened.
After the brief courtroom session, Chin's lawyers speculated that the jurors may be split on the second degree murder charges. Co-defendant Barry J. Cadden was convicted on racketeering and mail fraud charges but cleared of the second degree murder charges. His trial began in January and did not end until late March.
Cadden, who is serving a nine year prison sentence, is appealing his conviction. His verdict was returned after a little more than three days of deliberation.
Earlier in the day jurors had asked for physical copies of exhibits detailing testing results inside NECC's clean rooms where the drugs that caused the outbreak were processed. One of the two binders requested was provided. The other had already been submitted in electronic form.
Chin faces other charges beyond those in the racketeering counts including violations of the Food Drug and Cosmetics Act, aiding and abetting, false and misleading labeling and mail fraud.

Chin Jury Deliberates for 1st Day

By Walter F. Roche Jr.

BOSTON-The jury considering the racketeering and second degree murder charges against one of the druggists blamed for a nationwide fungal meningitis outbreak completed its first full day of deliberations today without reaching a verdict.
Glenn A. Chin, who spent the day in a federal court house hallway waiting for news, is charged with racketeering, 25 counts of second degree murder and mail fraud. He was a supervising pharmacist at the New England Compounding Center, which produced fungus laden steroids that sickened 778 patients, killing 76 of them.
In a brief morning session before U.S. District Judge Richard G. Stearns, one of Chin's lawyers complained that Assistant U.S. Attorney George Varghese's closing argument left jurors with the impression that it was Chin who handed an autoclave manual to a federal investigator in October of 2012.
Stearns said he had reviewed the testimony of Stacey Degarmo, the investigator with the U.S. Food and Drug Administration, and concluded she did not say that Chin handed her the manual.
The manual has become an issue because it contained instructions on the length of time that items had to be placed in the autoclave to ensure sterilization. Prosecutors say Chin only left items in the autoclave for 15 minutes when up to 27 minutes were required.
The jury will resume deliberations Tuesday.
Chin's is the second major trial to occur since a federal grand jury issued an indictment of 14 persons connected with NECC.
Chin's boss, Barry J. Cadden, was found guilty of racketeering and mail fraud but cleared of the second degree murder charges. Three other defendants have entered guilty pleas while charges were dismissed against two others, including Chin's wife.
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Chin Case Goes to Jury

Friday, October 20, 2017

Chin Murder Case Goes to Jury

By Walter F Roche Jr.

BOSTON-.The lawyer for a former supervising pharmacist charged with 25 counts of second degree murder told a jury today that his client was not at all qualified for his job and couldn't supervise anyone.
 Delivering closing arguments for Glenn Chin, Stephen Weymouth also said that state and federal investigators mishandled the investigation of the deadly fungal meningitis outbreak Chin is accused of causing. As a result, he said the real cause of the outbreak will never be known.
Federal prosecutors, meanwhile, said Chin knew that the reckless way he was compounding steroids could result in deaths. The jury is scheduled to begin deliberations on Monday. In addition to second degree murder, Chin is charged with racketeering, mail fraud and violations of the Food Drug and Cosmetics Act.
Citing multiple action level alerts that something was wrong, Assistant U.S. Attorney Amanda Strachan said Chin "saw the flashing lights, but chose to ignore them."
"It was entirely preventable," said Strachan.
Even after people were dying, Strachan said Chin instructed his staff to clean up before state and federal investigators arrived.
The outbreak, caused by fungus loaded steroids, sickened some 778 patients in 13 states, killing 76 of them. State and federal regulators eventually concluded that thousands of contaminated vials of methylprednisolone acetate produced at the New England Compounding Center were the cause.
Weymouth, however, said that even as the outbreak unfolded, agents from the U.S. Food and Drug Administration rushed and botched their investigation.
"The FDA dropped the ball," he said."The government failed to proved how the methylprednisolone acetate became  contaminated."
Citing testimony during Chin's 21 day trial, Weymouth said the investigators didn't even take samples from the very area of the clean room where the steroids were compounded.
After the closing arguments, U.S. District Judge Richard G. Stearns read instructions to the jurors, telling them that they needed to vote on each count of the indictment and their decision, whether it be guilty or not guilty, must be unanimous.
That became an issue in the recent trial of Chin's co-defendant and former boss, Barry J. Cadden, who is now serving a nine year federal prison sentence. He was convicted of mail fraud and racketeering but acquitted on the same 25 second degree murder charges now facing Chin.
Records of the Cadden trial show that a majority of the jurors voted for conviction on some, but not all of the murder counts. The records do not show whether a unanimous vote for acquittal was ever recorded.
Weymouth in his closing remarks said that it was Cadden who oversaw every aspect of NECC's operations, including the clean rooms Chin was charged with supervising.
"Every decision was made by Barry Cadden," Weymouth said, adding that it was Cadden who taught Chin what little he knew about sterile compounding.
Calling his client a competent regular pharmacist, Weymouth said Chin "was not trained in sterilization" and had no training in that field whatsoever.
As for being put in charge, "he didn't no how to supervise anyone," said Weymouth.
Strachan said Chin chose to violate an oath he took when he became a pharmacist not to harm any patients.
She said records showed Chin repeatedly failed to adequately sterilize  steroids when he removed them from an autoclave after only 15 minutes. She said in some cases the steroids were "cooked" for only four minutes at the proper temperature and pressure. She said 27 minutes were required, based on a manual for the machine.
She cited records showing other drugs besides the methylprednisolone acetate proved to be contaminated with fungus and bacteria. His clean room, she said, was "a fungal zoo."
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No Witnesses as Defense Rests in Outbreak Trial.

By Walter F. Roche Jr.

BOSTON- Without calling a single witness, lawyers for a man facing 25 counts of second degree murder rested their case today even as prosecutors introduced evidence that hundreds of additional non-sterile drugs were shipped by a drug compounding company to dozens of health facilities.
Glenn Chin's lawyers rested their case after reading from the transcript of the prosecution's closing argument in the recent federal trial of Barry J. Cadden, a codefendant. Cadden was president and a stockholder in the New England Compounding Center, the company that employed Chin as a supervising pharmacist.
Cadden was found guilty of racketeering and mail fraud charges but acquitted of second degree murder. He is serving a nine year prison sentence. Chin is facing the same racketeering, second degree murder and mail fraud charges
In the four paragraph excerpt read by Chin's attorney, Stephen Weymouth, prosecutors stated that the New England Compounding Center was "Barry's baby" and that he was the "master conductor" controlling all aspects of the company operations.
They have also argued that Chin was just an employee doing as Cadden instructed.
Weymouth also read from an email Cadden sent to a prospective customer in which he stated that he started the company and made every important decision on a daily basis.
Closing arguments by federal prosecutors and Chin's lawyer are scheduled for Friday to be followed by instructions from U.S. District Judge Richard G. Stearns. The jury is expected to begin deliberations on Monday.
Weymouth's announcement that the defense was resting followed testimony by a special agent for the U.S. Food and Drug Administration that NECC had shipped additional nonsterile  and outdated drugs to dozens of health care facilities. Those shipments are over and above those included in the indictment of Cadden and Chin.
Joseph Ridgley, the FDA investigator, detailed a long list of  "allegedly nonsterile" drugs that turned up in the NECC investigation.
 He said those contaminated sterile drugs were in addition to multiple shipments of the three contaminated lots of methylprednisolone acetate that went to facilities not listed in the indictment. State and federal officials say the three lots, loaded with deadly fungus, caused the outbreak that sickened 778 patients, killing at least 76 of them.
Prosecutors displayed FDA test reports on some of those drugs nonsterile. Other reports showing contamination were performed by a private testing company on contract to NECC.
He said the list covered nine-pages and was compiled from NECC and bank records.
Health facilities receiving the tainted drugs ranged from a medical center in Albany, N.Y. to a hospital in Belleville, Ill. to a physician and an eye clinic, both in Knoxville, Tenn.
Expired drugs not included in the indictment were sold to physicians in Quincy, Mass. and Victoria, Tenn., and a medical practice in Dickson, Tenn, records show.
Outdated or unsanitary drugs included under the indictment include shipments to Florida, Nevada and New York.
After the outbreak became public in 2012, all of NECC's unused drugs were recalled.
Ridgley also provided a list of drugs compounded by an unregistered NECC pharmacy technician, Scott Connolly, that are not included in the indictment. Connolly is also a defendant in the case and is expected to go on trial with the six other remaining defendants after Chin's trial has ended.
Drugs compounded by Connolly were shipped to facilities in Nashville and Clarksville, Tenn., the 
records show.
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Jurors Get Details on Outbreak Deaths

By Walter F. Roche Jr.

BOSTON - Case by case, picture by picture jurors hearing the second degree murder trial of Glenn Chin were shown pictures of the 25 victims named in the indictment charging him with second degree murder.
Ann Burgess, a registered nurse specializing in forensics, read from the autopsies and death certificates for each of the victims. Many of the documents listed contaminated steroid injections as a cause. Some also named the deadly fungus, exserohilum rostratum.
Chin, whose case could go to the jury by the end of the week, has been charged with racketeering, and mail fraud in addition to the 25 counts of second degree murder.
The charges stem from a two year federal grand jury probe of the deadly fungal meningitis outbreak caused by steroids Chin compounded at the now defunct New England Compounding Center.
There were eight victims from Michigan, seven from Tennessee, three each from Indiana and Maryland, two from Virginia and one each from North Carolina and Florida.
Prosecutors began questioning their last witness Wednesday, a criminal investigator from the U.S. Food and Drug Administration. Chin's lawyer Stephen Weymouth said he only plans to call two witnesses, one of them another FDA investigator whose testimony is likely to be brief.
Closing arguments could come before the weekend leaving only the instructions from U.S. District Judge Richard G. Stearns to the jury before deliberations can begin.
Burgess said Diana Reed, 56, a Nashville, Tenn. victim had been injected three times with methylprednisolone acetate from NECC. The records showed the injections were administered at the Saint Thomas Outpatient Neurosurgical Center on Aug, 21, Sept. 4 and Sept. 18. She died on Oct. 3, 2012, leaving behind her husband who suffers from Lou Gehrig's Disease.
Thomas Rybinski, the victim whose case first signaled the oncoming outbreak, died of "complications of aspergillus meningitis" after receiving a single injection at the same Nashville clinic, the jury learned.
Donald McDavid, 67, died after two injections at a Crossville, Tenn. clinic. His original death certificate listed "pending further study" as the cause. It was later amended to list an aneurysm and exserohilum as the cause.
In other testimony, one of Chin's lawyers, Robert Sheketoff, cross examined a key prosecution witness, Eric Kastango. Kastango had testified Tuesday that NECC and Chin had test results showing multiple problems in the clean room where sterile drugs were prepared, but then did nothing to remediate the problems.
Sheketoff questioned whether Kastango's testimony was influenced by the fact that prosecutors had hired him as a consultant during the NECC investigation.
"Do you have a bias because one side has paid you?" Sheketoff asked.
No, said Kastango, who earlier testified he was paid about $30,000.
Shetekoff  repeatedly questioned whether it was Chin or his boss, Barry Cadden, who made all the decisions at NECC.
"He (Chin) was the supervisor of the clean room," Kastango responded, adding that it was Chin's responsibility to read the industry rules for the operation of a clean room.
Asked if Cadden, NECC's president, was concerned about following the rules for a compounding pharmacy, Kastango said, "He (Cadden) was concerned about the bottom line."
Cadden, who was indicted along with Chin and 12 others, already has begun serving a nine year federal prison sentence after being found guilty of racketeering and mail fraud charges. He was acquitted on the second degree murder charges.
Thetakoff also asked whether Chin and "everyone in that clean room" should have quit their jobs because of all the violations.
"Absolutely," Kastango responded, "all should have quit."

---------------------
TENNESSEE VICTIMS

Marie Hester, 78, died Nov. 1, 2012
Eddie Lovelace, 78, died Nov. 2, 2012
Donald McDavid, 67, died Nov. 4, 2012
Diana Reed, 56, died Oct. 3, 2012
Thomas Rybinski, 55, died Sept. 29, 2012
Carol Wetton, 71, April 14, 2013
Earline Williams, 72, died Oct. 15, 2012



MICHIGAN DEATHS

Karina Baxter
Paula Brent
Gail Gipson
Donna Kruzich
Lyn Laperriere
Mary Plettl
Sally Roe
Emma Todd

INDIANA DEATHS

Pauline Burema
Kathy Dillon
Alice Machowiak

MARYLAND DEATHS

Bahman Kashi
Brenda Rozek
Edna Young

VIRGINIA DEATHS

Kathy Sinclair
Douglas Wingate

FLORIDA DEATH

Godwin Mitchell

NORTH CAROLINA DEATH

Elwina Shaw

Warning Signs Ignored as Outbreak Approached

By Walter F. Roche Jr.

BOSTON-A sterility expert testified today that a drug compounding company and its supervising pharmacist failed repeatedly to conduct proper tests on its products and ignored industry standards mandated by state boards of pharmacies.
 Answering repeatedly with "Absolutely not" or "No, they did not," Eric Kastango detailed failures by the New England Compounding Center and its supervising pharmacist, Glenn Chin, to adequately prepare and test drugs that would be injected into the bodies of unsuspecting patients.
Hired by federal prosecutors to assist in the investigation leading up to Chin's 2014 indictment, Kastango said NECC shipped drugs without proper tests or with no testing at all. Even when tests showed a need for immediate action, nothing was done.
Kastango said Chin did not properly sterilize hundreds of vials of methylprednisolone acetate that were shipped to health facilities across the country. State and federal regulators have concluded that those vials, loaded with fungus and injected into the spines and joints of patients, caused a nationwide outbreak of fungal meningitis that sickened 778 patients, killing 76 of them.
Kastango said that NECC's own records showed the methylprednisolone acetate was supposed to be placed in an autoclave for 20 minutes, yet NECC's records showed Chin generally removed the steroids after only 15 minutes.
In addition he said Chin failed to use biological indicators needed to ensure the steroids were sterile.
And, Kastango said, Chin should have been adding an additional eight to 11 minutes in each autoclave cycle to ensure that the large volume of liquid had reached the 121 degree mark needed to achieve sterility.
Kastango, who said he was paid about $30,000, for his consulting work for federal prosecutors, said it was critical that the types of drugs Chin was preparing be sterile because they were being injected into patients' bodies.
"Once you inject something, you can't get it back," he said.
Under questioning by Assistant U.S. Attorney George Varghese, Kastango described promotional material from NECC in which the company called its operations "state of the art" and fully compliant with the minimum standards set by the U.S. Pharmacopiea.
"They said they were the best," he said.
Asked by Varghese if indeed NECC was in compliance with those standards, Kastango said, "No they were not."
Kastango testified that while the industry standards did not have the force of law, state pharmacy boards, including Massachusetts, have made compliance mandatory.
Varghese also led Kastango through emails gathered in the investigation including a chain in which Chin described what he did after discovering that a key ingredient was missing from a beaker of a drug. The email showed that instead of discarding the deficient bottle, he mixed it with three other containers of the same drug that had the proper ingredients.
The result, Kastango said, was that all the containers were deficient, including one shipped to a Massachusetts hospital.
Other deficiencies Kastango said included failure to conduct end product testing, using outdated chemicals, falsely labeling drugs and failure to have the proper number of vials sent out for independent testing.
Varghese also introduced emails from Chin's then boss Barry Cadden.
In one Cadden acknowledged required testing was not being done.
"What you are not seeing is what we are not currently doing, but should be doing," Cadden wrote referring to a sterility test.
Cadden is now serving a nine year sentence following his March conviction on racketeering and mail fraud charges. That same email was entered as an exhibit in Cadden's trial.
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CDC Raced to Find Quick Outbreak Test

By Walter F. Roche Jr.

BOSTON- With the death toll mounting and quick treatment essential,  a federal health official said her agency had to come up with a new and speedier test to determine what was causing patients to contract fungal meningitis.
Mary Brandt, head of the myotic diseases branch of the U.S. Centers for Disease Control and Prevention, testified Monday in the racketeering and second degree murder trial of pharmacist Glenn Chin. The charges stem from a two-year probe of the 2012 fungal meningitis outbreak which first surfaced in Tennessee.
Under questioning by Assistant U.S. Attorney George Varghese, Brandt went through a list of victims, starting with Thomas Rybinski of Smyrna, who became the so-called index or lead case.
Brandt said that the existing tests either took too long or were not precise enough to quickly identify the fungus causing the outbreak.
She said without rapid diagnosis victims would be showing up at emergency rooms with the staffers having no idea of the real cause or the best treatment.
"Strokes would kill patients before the cause would be realized," she said.
The test developed, called Real Time PCR, enabled a quicker identification of the fungus contained in specimens of tissue and liquid extracted from victims being delivered to CDC's Atlanta laboratories.
Brandt said her unit also tested and matched vials of the suspect steroid, methylprednisolone acetate, gathered from Chin's employer, the New England Compounding Center and health facilities around the country.
Stating that it was critical to precisely identify the fungus, Brandt said the results showed that the predominant fungus turned out to be exserohilum rostratum, while tests on specimens from Rybinski contained a different fungus, aspergillus fumigatus.
She testified that subsequent tests on other NECC products showed a variety of different fungi and bacteria.
"It's very unusual to see such a diverse group of organisms," she said.
Brandt said the CDC had little to no experience with treatment of the dominant fungus so they quickly assembled a panel of experts to come up with treatment plans.
"We stopped all work in the bureau for three months," she said, referring to multiple teams set up to address the crisis. "Everybody had a job."
She said some 1,000 specimens were tested including spinal fluid and brain and spinal tissue extracted from victims.
She said the fungus appeared as long strands "which are very difficult to capture." The analysis was made more difficult because some of the patients were already being treated with anti-fungal medications which destroyed some of the evidence.
She said the new Real Time PCR test improved
from 10 per cent to 50 per cent the number of cases being correctly diagnosed.
Other victims cited in Brandt's testimony included Diana Reed and Marie Hester of Nashville along with victims from Indiana and Michigan. Chin, whose initials appeared on the vials put in evidence, has been charged with second degree murder in 25 of those deaths.
 Under cross examination by Chin's lawyer, Stephen Weymouth, Brandt acknowledged that there were NECC vials, 41 in fact, that contained no evidence of fungus. Weymouth challenged the prosecution's contention that a lot of steroids produced in May were contaminated.
Weymouth also noted that the new "Real Time" test has not received formal approval from the U.S. Food and Drug Administration.
But another prosecution witness, Dr. Sudha Chaturvedi, said tests done under her supervision at the New York State Health Department showed at least one NECC vial from the May lot was contaminated with the suspect fungus. Calling the results "devastating," she said tests on other NECC steroids showed they were heavily contaminated with another fungus.
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Deadline Extended for Outbreak Victim Grants

By Walter F. Roche Jr.

The deadline for victims of the fungal meningitis outbreak to apply for grants of up to $25,000 has been extended to March and officials say there is no longer any fear that any grants may have to be paid back.
The changes were disclosed by U.S. Rep. Mike Bishop who led efforts to get $40 million allocated to outbreak victims.
The new filing deadline is March 1, 2018. Originally there was a Dec. 15, 2017 cutoff.
Bishop also said that he has received assurances that victims will not be required to pay back any grants if they eventually collect under insurance policies.
According to Bishop, the Massachusetts Attorney sought and obtained a waiver from a state law that would have automatically triggered a pay back requirement.
"By doing so, they removed the distribution of funds from their state law and thus have removed any concerns about potentially needing to pay these funds back at a later date," Bishop's office said in a statement.
"This will give victims and families, many of whom still struggle with day-to-day finances much needed peace of mind ... that the money they are receiving is actually theirs," the statement continued.
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Information about applying for compensation

·         The Massachusetts Attorney General’s office is currently establishing a process through which claims will be disbursed. To be eligible for these funds, victims must apply by March 1, 2018 (please note, that date has changed from the previous deadline of December 15, 2017). After the applicant’s case is verified, they will be eligible to receive a direct payment of $25,000, with the option to submit additional documentation to receive compensation beyond that amount.

Eligible victims have received a Victim Identification Number from the FBI. If you believe you or a loved one was harmed by a contaminated injection from the New England Compounding Center (NECC) in the fall of 2012, please contact Congressman Bishop’s D.C. office at 202-225-4872 for more information.

Potentially Deadly Bacteria Found in NECC Drugs

By Walter F. Roche Jr.

BOSTON-Microbiologists from the U.S. Food and Drug Administration testified today that they found mold, yeast and bacteria, some of it potentially deadly, in several drugs shipped from a Massachusetts drug compounder.
The FDA scientists, testifying in the trial of one-time supervising pharmacist Glenn Chin, said that a variety of bacteria were found in multiple drugs shipped by the New England Compounding Center to health facilities from Massachusetts to Florida and Washington.
Chin has been charged with racketeering and second degree murder for his role in the 2012 fungal meningitis outbreak which eventually sickened some 778 patients, killing 76 of them.
Henry Lau, from FDA's San Francisco office, said that his tests of cardioplegia that had been shipped by NECC to Brigham and Women's Hospital in 2012 contained the bacteria brevibacillus choshinensis.
Asked about the possible effects of that bacteria should it be injected in a patient, Lau answered with a single word: "Deadly."
Forty seven bags of the drug used to stop the heart during surgery, had been shipped to the Boston hospital, according to an exhibit displayed for jurors.
The testimony from Lau and other FDA officials showed that contamination at NECC was not limited to the steroid, methylprednisolone acetate, the drug blamed for the deadly fungal meningitis outbreak.
Lau said an NECC steroid, triamcinolone, was found to have three different bacteria, some of them harmful. He said testing of 10 vials of betamethasone shipped to an Indiana clinic showed five had bacteria that would be harmful to patients with a compromised immune system.
Stephen Yarmouth, one of Chin's lawyers, countered by questioning another FDA microbiolgist in the same California office about test results that showed possible contamination in the clean room at the same office.
Jonathan Yenovkian, Lau's colleague, said that growth, indicating the presence of some contamination, was discovered in the FDA's San Francisco clean room, but despite several tests said, the exact identity of the organism could not be determined.
"We did our best," Yenovkian said, adding "It was viable. It grew."
He said there was no evidence it affected the tests performed on NECC drugs.
Yenovkian said that betamethasone NECC had sold to an Orlando outpatient surgery center had two different bacteria and samples of the same steroid shipped to a Kentucky clinic contained potentially harmful bacteria.
Haydee Romero, who works in a New York FDA laboratory, said that she tested 78 vials of the methylprednisolone acetate that had been shipped to the Saint Thomas Outpatient Neurosurgery Center in Nashville.
She said tests showed 48 vials were contaminated, with 28 showing yeast and 19 with mold. She said there was so much mold in one sample that it was growing off the plate used to conduct the test.
She said tests on 25 vials of the same drug sent to another clinic showed all were contaminated.
"It is unusual to get so much growth from a single drop," she said noting only a single drop of a drug is used to conduct the sterility test.
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Critical Minutes Lost in Outbreak Probe

By Walter F. Roche Jr.

BOSTON -As critical minutes passed, top state and federal investigators trying to find the source of a deadly and growing fungal meningitis outbreak sat in their cars hiding behind a drug store awaiting a signal they could continue their probe.
That was the testimony Wednesday from an official of the U.S. Food and Drug Administration as federal prosecutors moved toward wrapping up their case against a pharmacist employed by the drug compounding firm blamed for the 2012 outbreak that took the lives of 76 patients..
In a related development U.S. District Judge Richard G. Stearns denied a motion to dismiss filed by three other defendants in the same case.
Stearns ruled the three will have to stand trial at a later date on conspiracy charges.
They were indicted in late 2014 at the same time as Glenn Chin, who was a supervising pharmacist at the New England Compounding Center in Framingham, Mass. He has been charged with racketeering and second degree murder.
In the Chin case FDA micro-biologist Almaris Alonso testified that she and other state and federal investigators sat for an entire day on Oct. 3, 2012 awaiting word on when and if they could continue their investigation inside the New England Compounding Center.
She said that during Oct. 3 U.S. Marshals were in NECC's building apparently executing search warrants. She said both state and federal investigators in her group eventually went back to their offices and did not return to the company until the next day. She said negotiations apparently were also going on over whether NECC would surrender its pharmacy license.
Alonso's revelation came in response to questions posed by Chin's attorney, Stephen Weymouth, who asked why the FDA team only collected a limited number of samples.
"We didn't have enough time," Alonso said. "We had to go. We had to do an inventory."
She said the team, which included investigators from the Massachusetts Pharmacy Board, had only 24 hours to get samples collected at NECC back to FDA testing laboratories.
Asked why she didn't go back on Oct. 5, Alonso said she was under orders to wrap things up by Oct. 4.
Alonso also said that Annette Robinson, who headed NECC's quality control efforts, had no training in micro-biology and didn't follow up when insanitary conditions were found.
In other testimony, Philip Istafanos, another FDA microbiologist, said that samples from NECC, which were delivered in person to his laboratory in New York, were "highly contaminated."
He said the vials of methylprednisolone acetate contained both bacteria and mold. Several also turned up evidence of yeast.
He said he performed the analysis on the very first vials and described how black filaments could be seen in nine vials even without the aid of a microscope.
He described seeing clumps of the black filament bunching together. Describing the initial findings as "very significant," Istafanos said it showed there was excessive mold growth in the samples.
A lab report on one of those initial samples shown to jurors states, "Blackish/whitish mold and yeast like cells detected."
The FDA scientist said that about half of those original vials were kept by the FDA and the rest were sent to the U.S. Centers for Disease Control and Prevention for testing. Two were turned over to the state Pharmacy Board.
Stearns in his ruling on the dismissal motion filed by three of Chin's co-defendants, concluded that the argument raised by the three-- that the charge that they conspired to defraud the FDA was a legal impossibility - was not applicable.
The motion was filed in behalf of Gregory Conigliaro, an NECC officer and stockholder, and Alla Stepanets and Sharon Carter, NECC employees.
"Had the FDA known what the alleged conspirators were up to, it might have imposed more stringent safety standards," Stearns wrote.
"The court has no choice but to put the matter down for trial," Stearns concluded.
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Mold Found at NECC After 2 Day Cleaning

By Walter F. Roche Jr.

BOSTON- A microbiolgist from the U.S. Food and Drug Administration said she was surprised to still find nearly a dozen mold growths in the clean room of a drug compounding company even after the facility had undergone two days of cleaning.
Testifying at the racketeetering and second degree murder trial of Glenn Chin, Almaris Alonzo said she found evidence of mold in nearly a dozen locations in her examination of the area where sterile drugs were being compounded. There was "a high level of contamination," she said.
Chin was charged following a two year probe of the 2012 fungal meningitis outbreak which took the lives of 76 patients in 20 states. More than 700 others were sickened after being injected with spinal steroids loaded with fungus.
Chin was a supervising pharmacist at the New England Compounding Center, the company blamed by state and federal regulators for the outbreak. Opening arguments in the case were delivered on Sept. 19 and the case is expected to go to the jury next week.
Alonzo said she saw a evidence of a likely source for mold even before entering the clean room where thousands of vials of methylprednisolone acetate were prepared. Pooled water was found near a boiler and grass was evident on the sticky mats NECC cleanroom workers walked over on their way into the drug preparation area.
"Mold loves to eat grass," Alonzo said, adding that standing water was a perfect place for mold to take hold.
She said some of the grass from the sticky mat was likely dragged into the clean room. She described the general condition of the room and some of its equipment as "very dirty."
She said the goal for her and the other investigators was to isolate the microbes causing a growing number of victims to become ill. She said the original case was a victim from Tennessee who suffered fungal meningitis from an organism called aspergillus fumigatus. He died.
She said some of the grass on the sticky mat likely was dragged into the clean room itself.
Remaining members of the jury - two were absent Tuesday - were shown pictures of Alonzo and other investigators examining the clean room wearing gas masks. Also shown in the pictures was Chin, who was a supervising pharmacist at NECC overseeing the clean rooms.
Alonzo said the on-site inspection took place in early October, just as the growing outbreak was becoming public. Under questioning by Assistant U.S. Attorney George Varghese, the FDA scientist said that the in-house cleaning, while far from thorough, actually made the job of investigators more difficult.
"It would have been a more useful result," she said if the area had been left alone.
She said that when she questioned Annette Robinson, who was in charge of NECC's environmental monitoring, she learned that NECC was using a medium intended to show growth of bacteria but not the medium to best show mold growth.
She said that Robinson also told her that when contamination was found, it was never investigated nor was remedial action taken.
In other testimony, Robert Sheketoff, one of Chin's lawyers, challenged an FDA investigator, Stacey Degarmo, who had testified that NECC was sterilizing drugs for only 15 minutes when 20 minutes was recommended by the manufacturer.
Sheketoff had her read from internal NECC documents that had listed 15 minutes as the standard for some time.
But on redirect by Varghese, Degarmo repeated that 20 minutes in the autoclave at 121 degrees was the minimum necessary to achieve sterility.
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