Majority NECC Owner Pleads to Single Charge

By Walter F. Roche Jr.


The majority owner of the company blamed for a deadly nationwide fungal meningitis outbreak and her husband entered guilty pleas to vastly reduced charges today under a plea agreement with federal prosecutors that will likely lead to no jail time.
Under the agreement Douglas Conigliaro of Dedham, Mass. entered a guilty plea to a single count of structuring bank transactions to avoid reporting requirements. Carla Conigliaro pled to a similar charge that she violated financial statutes when she made 11 withdrawals from a Florida bank
They had been charged originally with several counts of structuring and withdrawing some $33 million  from bank accounts that were under a court ordered freeze.
Some of the charges, however, had already been dismissed by U.S. District Judge Richard Stearns, the same judge who presided over today's session.
Recently Stearns ruled that prosecutors could  not present evidence about multiple bank withdrawals that the couple had made, concluding that the evidence would be "highly prejudicial  to the defendants and would serve no useful purpose."
Absent the plea agreement, the case was scheduled to go to trial on Monday. The Conigliaros had waived their right to a jury trial, contending publicity surrounding the case would make it impossible for them to get a fair jury trial.
The two are scheduled to be sentenced Nov. 1 but no jail time is expected under their agreement with prosecutors.
Carla Conigliaro owned 65 per cent of the New England Compounding Center, the Framingham, Mass. firm blamed for the 2012 outbreak that sickened 778 patients across the country, killing 77 of them.
The couple was never charged with direct involvement in producing the  fungus loaded sterile drugs that caused the outbreak. Douglas, according to court records, was primarily involved in a sister company, Medical Sales Management, which sold compounded drugs from NECC to healthcare providers across the country.
Douglas Conigliaro was a licensed physician in Florida and was fined $10,000 by Florida regulators over a decade ago in a case involving a patient who was paralyzed while he was attempting to implant a pain medicine pump. A related malpractice suit against Conigliaro was settled for $1 million, according to Florida records.
 Florida health department records show his license has lapsed and he is listed as retired.
Carla and Douglas Conigliaro are two of 14 owners and former employees of NECC who were indicted in 2014 following a two year federal probe of the deadly outbreak.
Two of the remaining defendants, Barry Cadden and Glenn Chin have been charged with 25 counts of second degree murder. Other charges by the grand jury range from mail and wire fraud to racketeering. All of the remaining defendants  have entered not guilty pleas.
Victims of the outbreak only learned of the plea deal in a conference call earlier Friday with officials of the U.S. Attorneys Office in Boston.
Cadden and Chin are scheduled to go to trial Jan. 5 of next year.

Garretson Resolution Group

https://www.garretsongroup.com/

Federal Judge Steps In On Outbreak Claims

By Walter F. Roche Jr.

A federal judge says she wants to hear from federal officials about the delay in reaching an agreement that could free up some $200 million earmarked for victims of a deadly 2012 fungal meningitis outbreak.
At a hearing in her Boston, Mass. courtroom today U.S. District Judge Rya Zobel told the attorney for some of the outbreak victims to contact officials from the U.S. Department of Health and Human Services and the Justice Department and arrange an Aug 16 session.
"I'll rely on you to set it up," Zobel told Thomas Sobol, the lead attorney for victims of the outbreak.
Earlier Sobol had told Zobel there was an agreement in principal with the federal agencies, but final approval was still awaited.
"It's working its way up," Sobol said.
At issue is how much the federal Medicare program will be reimbursed from the trust fund for the costs it incurred for Medicare recipients who were victims. Similar agreements are needed with state Medicaid agencies and private insurers.
Because of the lack of final approval, Sobol told Zobel initial payments to victims, initially slated for August, could be delayed till September.
"I am doing what I can to push this along," Sobol said, adding that he was aware that victims felt frustrated by the delays.
It was then that Zobel suggested federal officials be convened at the August session either by phone or in person.
"That would be very helpful," Sobol said. "I would encourage the court to do that."
Sobol said a company called the Garretson Resolution Group had been engaged to negotiate with state Medicaid agencies and that agreements in principal had been reached with two major private insurance groups.
The 2012 outbreak was caused by fungus laden steroids that were shipped from a now defunct Framingham, Mass. drug compounding firm.
The $200 million trust fund was created in the bankruptcy case of the drug compounding firm, the New England Compounding Center. Former owners and employees of the firm are facing charges ranging from racketeering to second degree murder. All have entered not guilty pleas.
Some 778 patients were sickened in the outbreak and 77 died.
Contact: wfrochejr999@gmail.com

Agreement Signed on Nashville Clinic Cases

By Walter F. Roche Jr.

A memorandum of understanding has been signed by all parties that could lead to a settlement of the legal claims of more than 100 Nashville, Tenn. victims of the deadly 2012 fungal meningitis outbreak, a federal judge was told today.
Appearing before U.S. District Judge Rya Zobel in her Boston courtroom, Nashville attorney Mark Chalos said the memorandum of understanding had been signed and individual attorneys were now talking with their clients to seek their approval.
The settlement, if finalized and approved by the court, would end some 110 suits filed against the Saint Thomas Outpatient Neurosurgical Center and related parties. The suits were filed in behalf of victims and their survivors who were sickened after getting spinal injections at the clinic.
"We are moving as fast as we can," Chalos told Zobel, adding that he was aware that a 90-day deadline was in place.
"We remain hopeful," he concluded.
The details of the memorandum were not disclosed and attorneys involved said they were barred from discussing any details.
Gerard Stranch, one of the victims' attorneys, confirmed that the memorandum, if finally approved, would settle all the pending Nashville clinic cases.
He said he could not comment further.
The disclosure was the strongest indication yet that an imminent settlement could end litigation that dates back nearly four years. The first hint came earlier this summer when Zobel announced that she was putting the Nashville cases on hold for 90 days as settlement talks appeared to be bearing fruition.
Saint Thomas officials, meanwhile, disclosed recently in a bond issue filing that they did not expect the pending suits to have a significant impact on the health care firm's finances.
Just when victims will be getting payments either from a Saint Thomas settlement or from a $200 million victims trust fund remains unclear.
During yesterday's court session, Thomas Sobol reported that a near final agreement was in place with the federal Centers for Medicare and Medicaid Services on the amount of money that will be taken from the settlement for reimbursement of health care claims it paid for outbreak victims.
That agreement must be in place before any of the $200 million can be released.
Though Sobol had previously said checks to nearly 1,200 victims would come in August, he told Zobel today that a delay till September was possible.
Zobel then suggested that she convene a session with federal officials next month when the court is scheduled to hold another session.
Sobol agreed to try to set up such a session for Aug. 16.
"I'll rely on you to set it up," Zobel said.
Sobol said talks were also progressing on the settlement of liens from the Medicaid program and private insurance companies.
The 2012 outbreak has been blamed on a now defunct Massachusetts drug compounding firm that shipped thousands of fungus loaded vials of spinal steroids to healthcare providers across the country.
The outbreak sickened 778 patients killing 77 of them. In Tennessee 153 patients were sickened and 16 died.
Though most of the Tennessee victims were treated at the Nashville clinic, other victims had been treated at facilities in Oak Ridge and Crossville.
Contact: wfrochejr999@gmail.com

Prosecutors Oppose Lifting Chin 's Home Detention

By Walter F. Roche Jr.

Noting that he was first arrested as he was about to board a plane for Hong Kong, federal prosecutors are asking a judge to deny the request by a primary defendant in the New England Compounding Center criminal case to be released from home detention.
In the six-page filing this week, prosecutors said the facts surrounding Glenn Chin's case are different from co-defendant Barry Cadden who already has been freed from 24-hour home detention.
Noting that the restrictions on Chin already have been eased, Assistant U.S. Attorney Amanda Strachan said the defendant already has permission to visit with his attorneys.
Cadden and Chin are facing multiple charges stemming from the probe of NECC, the defunct company blamed for a deadly fungal meningitis outbreak. Charges against the two include 25 counts of second degree murder.
"The defendant has put forth absolutely no reason why his current amended release conditions cannot accommodate his meeting with counsel and family obligations," Strachan and Assistant U.S. Attorney George Varghese wrote in the filing.
Prosecutors noted that the trial for Cadden and Chin less than six months away and motions to dismiss the most serious charges have now been denied.
"Now is not the time to expand the defendant's risk of flight," the filing states.
Prosecutors noted that victims of the 2012 outbreak also have expressed their opposition to Chin's request.
Stating that Chin's position differs from Cadden's, they noted that Chin and his family were about to board a plane for China when he was arrested on Sept. 4, 2014.
The 2012 fungal meningitis outbreak has been attributed to fungus laden spinal steroids shipped from NECC to health providers in some 20 states. A total of 778 patients were sickened and 77 died.
Contact: wfrochejr999@gmail.com

Two NECC Defendants Don't Want Jury Trial

By Walter F. Roche Jr.

Two of the defendants in the criminal case stemming from a deadly fungal meningitis outbreak don't want their case to go before a jury because of the widespread adverse publicity surrounding the case.
In one of several motions filed this week in U.S. District Court in Boston, Mass. the lawyer for Douglas and Carla Conigliaro waived their right for a jury trial, stating that the publicity surrounding the case would make it impossible to get a fair trial before a jury.
A federal judge already has agreed that the two will be tried separately from the other 12 defendants in the case.
In the 14-page brief, the couple asked that a non-jury trial be held even if federal prosecutors objected.
In another motion filed Monday, attorney David Meier asked that three of the charges against the two be dismissed. Those charges stem from some 776 banking transaction by the couple over a four year period. The withdrawals totaled nearly $600,000.
The two are charged with three counts of structuring the withdrawals to evade reporting under a federal law covering transactions over $10,000.
The motion argues that the withdrawals from three different banks were the "normal cash withdrawal patterns and money use of high net worth individuals."
Rather than an attempt to evade the reporting requirement the facts "show two wealthy individuals who made withdrawals from their bank accounts for ordinary household living expenses."
The other defendants in the case, all employees or owners of the defunct New England Compounding Center, are facing charges ranging from mail and wire fraud to second degree murder.
NECC triggered the deadly 2012 outbreak of fungal meningitis by shipping thousands of vials of fungus loaded steroids to health facilities across the country.
The outbreak sickened 778 patients, killing 77.
Contact:wfrochejr999@gmail.com

Texas Drug Compounder in Recall

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Talon Compounding Pharmacy Issues Voluntary Nationwide Recall of HCG and Sermorelin Due to Lack of Sterility Assurance

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For Immediate Release

July 21, 2016

Contact

Consumers

Talon Compounding Pharmacy
 talonrecall@gmail.com
 830-816-5910

Announcement

Talon Compounding Pharmacy ("TCP") of San Antonio, Texas, is voluntarily recalling all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP and that remain within expiry due to the Food and Drug Administration's ("FDA") concern over a lack of sterility assurance. Although no complaints of illness or injury have been received regarding the recalled lots, administration of a sterile drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications. The sterile products were distributed to patients and providers nationwide between January 18 and July 18, 2016. The recalled lots were used for a variety of indications. The recalled lots were packaged in 10ml amber glass vials bearing a label containing the name and strength of the drug, the lot number and the beyond-use date. The vials were shipped in zippered plastic bags bearing the patient name, date, directions for use, prescription number, lot number of dispensed medication, beyond-use date, vial size, prescriber name, and pharmacy name, address, phone number and logo. Please see attached photo for an example of what a recalled vial may have looked like. The recall does not pertain to any other medication prepared by TCP or to any other form of HCG/sermorelin (oral tablets).
Though no vial or portion of any lot of these medications has been found to be non-sterile, because the process of lyophilizing HCG and sermorelin has not been verified, patients may be at risk. TCP takes the utmost care to ensure patient safety and out of an abundance of caution is asking all patients and providers that received lyophilized HCG and sermorelin compounded products from TCP between January 18 and July 18, 2016, and that remain within expiry, to take the following actions:

• Discontinue use of the products;
• Quarantine any unused product until further instructions are received on how to return the product; and
• Contact TCP at 830-816-5910 from the hours of 8:30AM – 5:00PM central time Monday – Friday, or e-mail at talonrecall@gmail.com to discuss the return of any unused lyophilized HCG and/or sermorelin.

Customers with questions regarding this recall can contact TCP at 830-816-5910 from the hours of 8:30AM – 5:00PM central time Monday – Friday, or e-mail at talonrecall@gmail.com. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products. Providers who have dispensed any lyophilized HCG or sermorelin to a patient(s) for use outside of the provider's office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall.
Adverse reactions or quality problems experienced with the use of these products 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 and in cooperation with the FDA.
Again, TCP’s primary concern is your safety, and TCP is taking this action out of an abundance of caution. Thank you for your support.
List of products recalled
Unused or in-use vials of lyophilized HCG in any strength
Unused or in-use vials of lyophilized HCG with B12 in any strength
Unused or in-use vials of lyophilized sermorelin of any strength

###

Settlement Financial Report Shows Limited Amount to National Victims

By Walter F. Roche Jr.

Although estimates of the reimbursement to victims of a fungal meningitis outbreak have ranged to $215 million, a recent financial report shows the amount currently available to all victims is slightly under $120 million.
The report filed in U.S. Bankruptcy Court last week by Lynne Riley shows the balances in a victims' trust fund is just under $76.3 million. Another $44.2 million was reported to be in an expense fund. However, all but $500,000 of that total is going to the victims' fund, according to post confirmation officer Paul Moore.
That brings the total available to all victims under the so-called national settlement to $119.9 million.
According to the report 1,199 claims by victims from that national fund have been approved and are expected to be paid in August. Another 262 were approved at  a later date, while 451 were denied in part. Denied in full were 386 claims.
Pending appeals could change those totals.
The report shows a third separate fund with a $55.5 million balance is earmarked specifically to victims who were treated at three facilities, one each in North Carolina, New Jersey and Virginia.
The $55 million is the total balance remaining after expenses from the following settlements: $3.5 million for victims treated at the Highpoint Surgery Center in North Carolina, $16 million for victims treated at the Inspira Health Network in New Jersey and $40 million for victims treated at the Insight Health facilities in Virginia.
Victims treated at other facilities will not benefit from the $55 million. Those victims, however, may benefit from previously approved settlements or possible future settlements or awards in pending litigation.
According to the report 19 of 20 claims have been approved for Highpoint victims, while 47 claims have been approved for Inspira claimants and 183 of 187 claims have been approved for Insight victims.
The nearly $120 million available to all eligible claimants may be increased depending on future tax refunds that the former owners of the New England Compounding Center have pledged to the bankruptcy settlement. Estimates of that, according to court records and interviews, could total $40 million.
That would boost the total available to all victims to about $160 million.
NECC, long since shuttered, has been blamed for the 2012 outbreak that sickened 778 patients across the country killing 77.

 FUND BALANCES AS Of May 20, 2016

National Victims Fund (Tort Trust)  - $76,295,793
Expense Fund - $44,182,046 ($43.6 million being transferred to tort trust)
Clinic or Providers Fund  - $55,512,927

Judge Rules Out Evidence on Bank Withdrawals

By Walter F. Roche Jr.

Evidence of multiple withdrawals from the bank accounts of two of the defendants in the fungal meningitis criminal case would be highly prejudicial and will not be allowed in an upcoming trial, a federal judge has ruled.
In a decision issued Monday U.S. District Judge Richard Stearns ruled that prosecutors cannot present evidence about withdrawals from three separate banks by Douglas and Carla Conigliaro, two of the 14 defendants in the criminal case stemming from the deadly 2012 fungal meningitis outbreak.
Prosecutors had proposed to use the multiple withdrawals as evidence of a conspiracy by the couple.
They are charged with structuring some $570,000 in bank withdrawals to avoid currency transaction reporting requirements and for transferring funds in defiance of an order from a bankruptcy judge.
  "The government offers no rational basis for believing that a conspiratorial agreement entered into in September of 2010 could have foreseen the onset of the fungal meningitis outbreak in September of 2012," Stearns wrote in the brief decision.
He added that presenting that evidence along with "the consequences of the outbreak with the many deaths and grave illnesses that followed would be highly prejudicial to the defendants and would serve no meaningful purpose."
Stearns previously ruled that Carla and Douglas Conigliaro will be tried separately from other defendants, including two who face charges of second degree murder. Previously Stearns denied a motion to dismiss the charges against the two.
The outbreak has been blamed on a drug compounding firm owned by the Conigliaros and Barry Cadden, who is related by marriage. The New England Compounding Center, shuttered shortly after the outbreakbecame public, shipped thousands of vials of fungus loaded steroids that were injected into the spines and joints of patients across the country.
The outbreak sickened 778 patients and killed 77 of them.
Contact:wfrochejr999@gmail.com

Judge Strikes Claims In RI NECC Case

By Walter F. Roche Jr.

Citing her own prior rulings on the issue, a federal judge has dismissed warranty claims filed by a Rhode Island man, a victim of the 2012 fungal meningitis outbreak.
In a four-page ruling this week, U.S District Judge Rya Zobel dismissed product warranty claims against Ocean State Pain Management filed by Craig and Joan Simas.
Zobel has issued similar rulings on product liability claims by Tennessee victims of the meningitis outbreak caused by fungus tainted spinal steroids.
"As this court has repeatedly held, the provision of the methylprednisolone acetate was part and parcel with the service of its injection- the only purpose of the visit was the injection itself, something only a physician with special skill could provide," Zobel wrote..
Zobel, however, denied Ocean State's motion to dismiss claims under Massachusetts' and Rhode Island's consumer protection statutes.
Craig Simas was a patient at Ocean State and he and his wife sued the clinic and physician Abdul Barakat.
The suit is one of more than 100 filed following the 2012 outbreak caused by fungus laden steroids from the now defunct New England Compounding Center.

Second NECC Defendant Seeks Home Detention Release

By Walter F. Roche Jr.

A second key defendant in the criminal case stemming from a deadly fungal meningitis outbreak is asking a judge to release him from 24-hour detention in his Canton, Mass. home.
The attorney for Glenn Chin, chief pharmacist for the New England Compounding Center, has asked that he be placed on a curfew allowing him to leave his home from 7 a.m. to 7 p.m.
The request comes as a federal judge turned down an appeal by federal prosecutors seeking to have co-defendant Barry Cadden placed back on 24-hour a day detention in his Wrentham, Mass. home.
Like Cadden, Chin is facing charges of 25 counts of second degree murder for his role in the outbreak which claimed the lives of 77 patients across the country.
Chin and Cadden played key roles at the New England Compounding Center, the defunct company blamed for the fungal meningitis outbreak.
In the petition, Chin's lawyer argued that his client was not a risk for flight and noted he has a wife and two children.
He said that Chin, like Cadden, would remain under constant GPS monitoring and his bail would remain unchanged.
Chin was arrested in Sept. 2014 as he was about to board a plane for China. While prosecutors contended that Chin might be fleeing prosecution, his lawyer said he was simply going to attend a family event in China.
"He has never been a flight risk or posed a threat to any person in the community," the petition states.
The filing notes that Magistrate Judge Jennifer Boal previously rejected a motion by prosecutors to have Chin jailed pending his trial on the second degree murder and related charges.
Cadden's recent release from home detention prompted a protest from victims of the outbreak who wrote letters opposing the request.
Earlier this week U.S. District Judge Richard Stearns denied an appeal by prosecutors to overturn Boal's decision to allow Cadden, a founder and part owner of NECC to leave his home for 12 hours a day to meet with his lawyers and tend to family chores.
Calling the 24-hour detention "onerous," Chin's lawyer said it was "unnecessary to assure his appearance at trial."
He noted that his client had previously been allowed by the court to go to Florida and no problems were reported.
Cadden and Chin are scheduled to go on trial on Jan. 5, 2017.
Contact:wfrochejr999@gmail.com

Judge Upholds Cadden's Release

By Walter F. Roche Jr.

A federal judge has upheld the decision of a federal magistrate to release from 24-hour home detention a primary defendant in the criminal probe of the New England Compounding Center.
In a one-page order issued Tuesday U.S. District Judge Richard Stearns denied an appeal by federal prosecutors who had sought to have Barry Cadden confined to his home.
"I see no compelling reason to revisit the findings and order of Magistrate (Jennifer) Boal," Stearns wrote in the brief order.
The swift action came without a court hearing.
Under Boal's order, Cadden can leave his Wrentham, Mass. home each day from 7 a.m. to 7 p.m. He must wear a GPS device and his bail remains at $500,000.
Cadden is facing 25 counts of second degree murder stemming from the federal probe of the New England Compounding Center. The now defunct company has been blamed for the 2012 fungal meningitis outbreak which sickened 778 patients in 20 states. Seventy-seven died.
Cadden, a founder of NECC, was also a stockholder of the now defunct drug compounding firm located in Framingham, Mass.
Cadden's lawyers had argued that he needed to be able to meet with his lawyers on short notices as his scheduled Jan. 5, 2017 trial dates approaches.
Prosecutors argued that with the approaching court date and the denial of Cadden's motion to dismiss the most serious charges, he was at a greater risk for fleeing before trial.
Prosecutors also read into the record at a recent hearing letters sent by victims of the outbreak expressing strong opposition to Cadden's release from house arrest.
Cadden had been under house arrest since shortly after his indictment in late 2014.
Also scheduled to go on trial with Cadden is Glenn Chin, the chief pharmacist for NECC. Chin is also facing 25 second degree murder charges. He remains under home detention.
NECC, according to federal regulators, shipped thousands of vials of fungus loaded vials of spinal steroids to health care providers across the country.
Contact: wfrochejr999@gmail.com

NECC Trust Expense Annual Report Filed

By Walter F. Roche Jr.

The first annual report filed by the administrator of a trust set up to aid victims of the 2012 fungal meningitis outbreak shows that nearly $3 million has been paid out in expenses and the total in the trust is below the $200 million some expected.
The annual report was filed Monday by Lynne Riley, the Boston attorney serving as the administrator of the trust fund. Her report also details the number of claims filed by victims, 2,361, and the number approved in full, 1,199.
Thus far none of the funds have been paid to victims of the outbreak which occurred nearly four years ago. The fund was established under the bankruptcy of the New England Compounding Center, the now defunct firm blamed for the outbreak which sickened 778 patients, killing 77 of them.
The victims were injected with steroids loaded with fungus due to unsanitary conditions at NECC's Framingham, Mass. headquarters.
Riley's report shows proceeds from the bankruptcy settlement of NECC have been divided into three funds. She reported $76,295,793.98 is in a tort trust fund, which will eventually be used to pay victims. An additional $44,182,046.58 is on deposit in a separate expense account. A total of $55,512,927 is in yet a third account known as a Qualified Settlement Fund.
That comes to a total of a little over $175 million.
According to the report a little over $1.1 million has been paid from the expense fund for bankruptcy trustee fees and an additional $392,120.96 was paid for professional services with non-professional fees totaling an additional $57,037.87.
In the tort trust account non professional fees were listed at $135,345.28 while professional fees totaled $1,354,724.41 U.S. Trustee fees were $30,255, according to the report leaving the balance of $76,295,793.98.
In the Qualified Settlement Fund $33,419.98 has been paid in tort trustee fees and $700,000 went to Edmund Gentle, listed as the Provider Funds Settlement Administrator.
Riley said in her report that addition to the 1,199 victims claims allowed in full, 262 additional claims have been approved. A total of 386 claims were denied in full while 451 were partially denied. She said 104 claims have been "finally denied."
Checks to the 1,199 approved claimants, the report states, are scheduled to be mailed out in August.
She reported that a settlement agreement has been reached with the U.S. Centers for Medicare and Medicaid Services for the reimbursement to the Medicare program for expenses it paid for the health care of victims. She did not disclose the details and added that the agreement was subject to approval by the U.S. Justice Department.
Riley reported that many additional reimbursement claims have been filed by private insurance carriers, but she provided no details.
She also reported on the status of claims filed against three clinics, for which three different settlement funds have been established. Some of the victims were injected with the tainted steroids at those three facilities, which subsequently agreed to settlements.
Twenty claims were filed against High Point Surgery Center, a North Carolina clinic and 19 of those were approved.
Claims against Inspira Health Network, a New Jersey clinic totaled 47, while 187 claims were filed against Insight Health, a Virginia clinic operator.
According to court testimony the amount available to victims could be boosted substantially by tax refunds, which the owners of NECC have agreed to forfeit when and if they are actually paid.
Contact: wfrochejr999@gmail.com

NECC Exec Urges Denial of Appeal on Home Confinement

By Walter F. Roche Jr.



The main defendant in the criminal investigation of a deadly fungal meningitis outbreak says he is not responsible for the illnesses of victims and furthermore. letters from victims are not relevant to whether he should be released from home detention.
In a nine-page filing in U.S. District Court in Boston, Mass. the lawyer for Barry Cadden states that he intends to prove at trial that the condition of outbreak victims "was not caused by any criminal conduct on the part of Mr. Cadden."
"Furthermore," the filing by attorney Bruce A. Singal states, "while they deserve
 compassion for the great suffering they have endured, it is respectfully submitted that these letters and their authors requests are not relevant to the court's analysis under the Bail Reform Act."
The filing comes following an appeal by federal prosecutors seeking to reverse the decision of U.S. Magistrate Jennifer Boal to release Cadden from 24-hour a day home detention.
The appeal was filed to U.S. District Judge Richard Stearns, who is presiding over the criminal cases stemming from the outbreak.
Cadden was part owner of the New England Compounding Center, the Framingham, Mass. company blamed for the outbreak. Cadden has been charged with 25 counts of second degree murder as a result of the criminal probe of NECC. His trial is scheduled for Jan. 5 of next year.
Cadden's lawyer  was referring to letters from victims of the outbreak that were read in to the record during a hearing on Cadden's request to be released from home detention. Despite the pleas from victims to keep Cadden confined, Boal granted the motion and ordered that Cadden could be away from his Wrentham home daily from 7 a.m. to 7 p.m. He remains on $500,000 bail and must wear a GPS monitor, which constantly tracks his location.
Prosecutors last week filed a quick appeal of Boal's order arguing that with his trial now approaching and a dismissal motion denied, Cadden is at even more risk of fleeing.
Cadden's lawyer, however, said Cadden has never been a flight risk and is looking forward to proving his innocence at trial.
He noted that some 18 months before he was indicted in late 2014, Cadden knew he would be facing serious charges but did not flee.
"If Mr. Cadden was going to flee, he would have done so then," the brief states.
Stating that the law requires that the least restrictive requirements be utilized before trial, the motion adds that Cadden "is looking forward to proving his innocence at trial."
"Barry Cadden is not and has never been a risk of flight or danger to he community," the motion concludes.
According to the filing Cadden's only prior arrest was for driving while his license had been revoked. The date of that incident was not disclosed.

Link to Info on Massachusetts Crime Victims Compensation Program

Officials of the U.S. Department of Justice say that payments to victims of the 2012 fungal meningitis outbreak will be made under Massachusetts Crime Victims Compensation Program.
Here is a link to the site for that program which includes links for an application form and other needed information.
According to federal officials the maximum amount of compensation under Massachusetts law is $50,000 but most will probably get less than that based on the severity of their illness. Exact guidelines have not been announced.
http://www.mass.gov/ago/public-safety/resources-for-victims/victims-of-violent-crime/victim-compensation.html

Outbreak Victims Could Get $50,000 Each

By Walter F. Roche Jr.

Though most will get less, victims of the 2012 fungal meningitis outbreak could be eligible for payments of up to $50,000 apiece under a federally funded victims compensation fund, now that a dispute over the fund's use has been resolved.
The funding stream finally opened up Thursday following an intensive lobbying campaign spearheaded by victims of the outbreak and members of congress led by U.S. Rep. Mike Bishop, a Michigan Republican whose district counted 15 lives lost in the deadly outbreak.
U.S. Justice Department officials confirmed Thursday that they agreed to free up as much as $40 million for outbreak victims. The money will come from a fund maintained by DOJ's Office for Victims of Crimes from fines, penalties and assessments imposed upon defendants convicted of federal crimes.
According to DOJ officials the money will be channeled through Massachusetts's Attorney General Maura Healey's office. The state agency must first formally apply to DOJ for the funds, agency officials said.
It will be up to Healey's office to determine eligibility standards for the awards, according to those familiar with the program. Justice Department officials said they would be working closely with Healey's staff to implement the awards program.
Healey did not immediately respond to a request for comment.
Under Massachusetts law victims may be eligible to receive a maximum of $50,000 if they suffered "catastrophic injuries," which is defined as an injury that creates a permanent impairment. 
The decision to free up the money came after a review of the history of the outbreak which sickened 778 patients in 20 states, killing 77 of them.
State and federal regulators concluded that the outbreak was caused by fungus loaded steroids (methylprednisolone acetate) shipped to hospitals and clinics across the country by the now defunct New England Compounding Center.
According to the U.S. Centers for Disease Control and Prevention the NECC case is the largest public health crisis caused by a drug in the country's history.
Fourteen owners and employees of NECC were indicted on charges ranging from racketeering and second degree murder to mail and wire fraud following a lengthy federal grand jury investigation. All have entered not guilty pleas and none have gone to trial.
As Bishop noted in announcing the fund allotment, most victims have yet to receive any compensation even though the outbreak occurred nearly four years ago.
Although $200 million has been placed in a fund created under the NECC bankruptcy, none of that money has yet gone to victims. In addition victims still face claims from the Medicare program and insurance companies for reimbursement of health care costs previously paid.
Attorneys contacted Thursday said it was unclear whether similar claims could be lodged against any awards from the victims' compensation fund.
Victims expressed elation yesterday when they learned DOJ had allotted the $40 million.
"It's nice to know our voices were heard. Hopefully this will come to fruition," wrote one of the victims.
"Since I heard this I can't stop crying! A true voice for the victims has finally been heard! Amen and hallelujah!" wrote Jona Angst, another victim.
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$40 Million May Go to Outbreak Victims

By Walter F. Roche Jr.

Up to $40 million in additional assistance could be available for the hundreds of victims of the 2012 deadly fungal meningitis outbreak.
U.S. Rep. Mike Bishop, a Michigan Republican, announced today that the U.S. Justice Department had agreed to set aside $40 million from a national crime victims' compensation fund for payments to the victims of the outbreak.
A total of 778 patients from across the country were sickened during the outbreak blamed on the New England Compounding Center, a defunct drug compounding firm in Framingham, Mass. Seventy-seven of those patients died with one death coming in March.
Bishop's district was one of the hardest hit with 15 area patients dying as a result.
"Every victims deserves an advocate. It's been nearly four long years for these victims and their families," Bishop said in an announcement of the DOJ action.
Bishop was joined by more than a dozen other members of Congress in a lobbying effort  to get the funds released.
DOJ and U.S. Office of Management and Budget officials had disagreed with each other over the use of the fund for outbreak victims. Some had argued that the funds should go only to victims of violent crimes.
Bishop said that the funds would be distributed through the Massachusetts' Attorney General's office, since NECC was located in that state.
Bishop said further details on the distribution of the funds would be forthcoming.
The $40 million will be in addition to some $200 million set aside in the bankruptcy of NECC. Some payments from that fund to victims are expected to go out next month.
Fourteen former employees and owners of NECC have been indicted and await trial on charges ranging from second degree murder to racketeering and wire and mail fraud. All have entered not guilty pleas.
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Federal Prosecutors Appeal Cadden's Release From Home Detention

By Walter F. Roche Jr.

 Federal prosecutors, citing the risk he will flee, are appealing an order releasing Barry Cadden from home detention pending his January 2017 trial on second degree murder and related charges.
In an eight-page motion filed Friday Assistant U.S. Attorney Amanda Strachan argued that the risk of Cadden fleeing from his Wrentham, Mass. home has increased since his motions for dismissal of the most serious charges has been denied.
"His current release conditions do not reasonably assure his appearance to stand trial on these serious charges," the motion states.
Cadden, one of 14 charged in the probe of a deadly 2012 fungal meningitis outbreak, was released from 24-hour-per day home detention in a June 24 order from Magistrate Judge Jennifer C. Boal. Under her order Cadden is free to leave his home from 7 a.m. to 7 p.m.
Noting that if convicted on all the charges Cadden could face life imprisonment, Strachan also cited the fact that victims of the outbreak had submitted statements opposing Cadden's motion.
Cadden's lawyers had argued that he had close ties to the community and that he needed to be able to meet with his attorneys on short notice as the trial date approaches. They also said Cadden needed to be able to leave his home to tend to the needs of his children.
"The defendant has put forth no reason why his current release conditions cannot accommodate his meeting with counsel and summer child care and other household duties," the prosecution appeal states.
Strachan noted that Cadden currently is allowed to meet with his attorneys twice a week and can request additional meetings with 72-hours advance notice.
She stressed the seriousness of the charges Cadden faces, including second degree murder and racketeering in the deaths of patients in Michigan, Tennessee, Indiana, Maryland, Virginia, Florida and North Carolina.
Citing recent rulings in which Cadden's motions for dismissal were denied, the appeal states," The following months thus present an even more serious risk of Cadden's flight, not one that is lessened."
The 2012 outbreak sickened 778 patients and killed 77 of them. Federal officials say Cadden's company, the New England Compounding Center, caused the outbreak by shipping fungus loaded vials of a spinal steroid to health facilities around the country.

"Huge Progress" Reported On Negotiations With Feds

"
By Walter F. Roche Jr.

Major progress has been made in negotiations with federal officials over the amount victims of the 2012 fungal meningitis outbreak will have to pay to reimburse the Medicare program for medical care they received, according to an attorney involved in the talks.

"Huge progress has been made,” said Thomas Sobol, a Boston, Mass. Attorney representing victims. He said in an email Friday that he and other victims’ representatives are now awaiting formal approval from the U.S. Department of Health and Human Services and the U.S. Justice Department.
The agreement is crucial if victims are to begin receiving payments from a $200 million trust fund created under the bankruptcy of the firm blamed for the deadly outbreak. The administrator of the fund has stated that no checks will be sent out without an agreement with the federal government.
In a recent court hearing in Boston Sobol told U.S. District Judge Rya Zobel that checks to some 1,250 victims could be mailed out in August.
There had been hopes checks could go out in July, but stalled lengthy negotiations nixed that possibility.
The outbreak, blamed on fungus infested spinal steroids, sickened 778 patients across the country and killed 77 of them. Hundreds more had to undergo painful tests to find out whether they too had been sickened.
Sobol did not give any details of the proposed agreement, but it is likely to include a percentage payment that the federal government is willing to accept in reimbursement for the bills it paid for victims of the outbreak.
It also could include a sliding scale based on the length of time a victim was hospitalized or under treatment. Medicare ended up paying more for those with lengthy stays.
Most, but not all of the victims were covered under the Medicare program. Others face reimbursement demands from private insurers.
Negotiations also have been underway with major private insurers for claims paid for private pay patients and Medicare recipients with supplemental coverage.
The trust fund was created during the bankruptcy of the New England Compounding Center, the Framingham, Mass. firm that shipped thousands of vials of fungus infested methylprednisolone acetate to health care providers in more than 20 states. The tainted drugs were then injected into the spines and joints of unsuspecting victims.
Fourteen owners and employees of NECC have been indicted under charges ranging from second degree murder to racketeering and mail and wire fraud charges. Criminal trials are scheduled for September of this year and January 2017.

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