Prosecutors Say Outbreak Death Toll Tops Official Figure.

By Walter F. Roche Jr.

Federal prosecutors disclosed Tuesday that the death toll from a 2012 fungal meningitis outbreak exceeded the official figure of 64 set by the U.S. Centers for Disease Control and Prevention.
"We know the number is much higher," said Assistant U.S. Attorney Amanda Strachan, who also said the victims were not limited to patients injected with a spinal steroid, methylprednisolone acetate.
"Our investigation found a much higher number than that," Strachan said referring to the CDC case count.
Strachan and U.S. Attorney George P. Varghese, both working from the U.S. Attorney's office in Boston, Mass., made the disclosure in a conference call with victims of the outbreak or their survivors.
Though victims were allowed to listen in, they were not allowed to ask questions during the 25 minute session.
The official CDC count set the deaths at 64, with a total of 751 patients suffering illness or death.
In the 25 minute call, the two prosecutors stressed that they were aware that there were many more victims than the 25 specifically named in the 73-page 131 count indictment.
The indictment charges two persons, Barry Cadden and Glenn Chin with 25 counts of second degree murder. Cadden was part owner of the New England Compounding Center, the company blamed for the outbreak. Chin was the supervisory pharmacist.
Twelve other owners or employees of NECC were also charged in the indictment on charges ranging from racketeering, mail fraud, conspiracy to defrauding the U.S. government.
Strachan said Cadden and Chin were charged with the most serious crimes because they were the two most directly responsible for shipping fungus tainted drugs to doctors and healthcare facilities around the country.
She explained that to prove second degree murder prosecutors don't have to prove that the two intended to kill anyone, but that they acted "with wanton and willful disregard for human life."
Strachan said that by picking 25 specific cases, the prosecutors realized there were many more victims."
"You are all victims," she said.
She noted that records showed that in 37 out of 38 weeks in 2012, tests showed that there were not sterile conditions at NECC, but no action was taken despite state and federal requirements to do so.
The prosecutors noted that other non-sterile drugs were shipped out even though tests had shown they were contaminated
Strachan said that one of those charged, Scott Connelly, was overseeing preparation of a drug called cardioplegia, which is used to stop the heart beat during surgery.
Connolly was not licensed as a pharmacy technician and in fact had given up his license in 2009, she said.
Two pending suits in federal court charge that two children died in a Las Vegas hospital after being injected with cardioplegia shipped from NECC.
"It was not just about the methylprednisolone acetate," Strachan said.
Varghese warned the victims that it could be up to two years before all the charges are resolved, but said they would be advised of major developments. He also said that victims might be eligible for aid through victim assistance programs.
Varghese also outlined how two of those charged, Carla and Douglas Conigliaro, withdrew some $33.3 million from various accounts even though a freeze had been placed on them by a U.S. Bankruptcy judge.
A plan now under consideration in bankruptcy court would provide some $146 million for victims and creditors of NECC. Prosecutors stressed in the call Tuesday that the funds set aside in that settlement would not be affected by the criminal case and related forfeiture efforts.
"This does not affect the settlement," Varghese said.
Dozens of civil suits arising from the outbreak have been merged in federal court in Boston.
wfrochejr999@gmail.com

Meningitis Outbreak Victims Offered Explanation from Prosecutors

By Walter F. Roche Jr.

Victims of the 2012 fungal meningitis outbreak or their survivors are being offered a chance to listen to an official explanation of the recent indictment of 14 owners and employees of the Massachusetts company blamed for the fatal outbreak.
In a two-page letter sent to the victims or their survivors last week, U.S. Attorney Carmen Ortiz said prosecutors will offer the explanations in conference calls on Tuesday Dec. 30 and Tuesday Jan. 6, 2015. Both calls are scheduled for 2:30 p.m. (see call in information below).
In the letter, Ortiz described the indictments including the second degree murder charges against one of the NECC owners, Barry Cadden, and NECC's chief pharmacist, Glenn Chin.
"You are receiving this letter because you were identified as a victim or the designated contact person for a victims," the letter states.
According to federal officials 64 patients died and 751 were sickened after being injected with fungus tainted methylprednisolone acetate shipped from NECC's Framingham, Mass. headquarters.
Ortiz noted that to get a conviction of second degree murder, prosecutors don't have to prove that the defendants intended to kill the victims, "but rather that Cadden and Chin acted with extreme recklessness likely to cause death."
She also acknowledged that 25 murder counts represent a small fraction of the total number of victims.
She wrote that determining which cases to include was a "difficult decision" based on "numerous factors."
"Even if you or your loved one were not named in the indictment, you are still recognized as a victims," Ortiz wrote.
Other charges in the indictment include mail fraud, racketeering and conspiracy.
Victims will be able to listen in on the conference calls but will not be able to ask questions.

Call-In Information:
Tuesday Dec. 30, 2014 2:30 P.M. Eastern Time
Tuesday Jan. 6, 2015 2:30 p.m.

Call-In numbers 1-888-970-4169 toll free 1-212-547-0140  toll call
Pass Code 3586140


Named Victims
Michigan: Karina Baxter, Paula Brent, Gayle Gipson, Donna Kruzich, Lynn Laperriere, Mary Pletti,
Sally Roe, Emma Todd
Tennessee: Marie Hester, Eddie Lovelace, Donald McDavid, Diana Reed, Thomas Rybinski, Carol Wetton, Earline Williams
Indiana: Pauline Burema, Kathy Dillon, Alice Machowiak
Maryland: Bahman Kashi, Brenda Rozek, Edna Young
Virginia: Kathy Sinclair, Douglas Wingate
Florida: Godwin Mitchell
North Carolina: Elwina Shaw

wfrochejr999@gmail.com

Judge in Meningitis Cases Blocks Release of Trust Records

By Walter F. Roche Jr.

A magistrate judge has rejected a request by lawyers for Nashville area victims of a national fungal meningitis outbreak to force the disclosure of the details of a trust agreement related to the insurance coverage of the Saint Thomas Health.
The six-page order by Magistrate Judge Jennifer Boal, which already is being appealed, concludes that lawyers for the victims cannot force Saint Thomas Health to make details of the trust agreement available.
The issue was the subject of a Dec. 4 hearing in Boston.
Citing court rules, Boal wrote, "The court finds that the trust agreement is not discoverable."
The victims' lawyers contend that the information is needed to discover how much money might be available to reach a settlement in some 100 cases. They have accused the hospital parties of engaging in "a corporate shell game in an attempt to shield the Saint Thomas entities from the liability of its agent."
The victims were injected with a fungus laden steroid at the Saint Thomas Outpatient Neurosurgical Center, which is described in court filings as an agent of the Saint Thomas parties. Nationwide the outbreak took the lives of 64 patients and sickened 751.
In her ruling Boal concluded that "the trust appears to qualify as self insurance" and that the victims through their lawyers had "not sufficiently shown here how the trust documents are relevant to any claims or defenses in this action."
In an appeal now pending before U.S. District Judge Rya W. Zobel, Nashville attorney Mark Chalos wrote that Boal's decision was in error and the trust documents "are subject to mandatory disclosure."
"They are relevant to this action and will promote settlement and will help parties move this litigation to just, speedy and inexpensive solution,"the 18-page appeal states.
 "Disclosure is needed for the plaintiffs' steering committee to understand the terms of coverage," Chalos concluded, adding that the documents would help them determine "what may or may not be covered."
wfrochejr999@gmail.com

Meningitis Outbreak Victim Gets Early Xmas Gift

By Walter F. Roche Jr.

For Joan Peay of Nashville, Tenn., a victim of the 2012 fungal meningitis outbreak, Christmas came a little early this year.
It was in mid-October in fact when Peay got back the results from a new test:  there was no trace of fungal bacteria in her blood.
For Peay the news was especially good because she was one of a handful of known victims of the outbreak to suffer a relapse. A little over a year ago just about a year after she was first stricken Peay ended up in the hospital again with an even worse case of fungal meningitis.
"This last one almost killed me," Peay said
Federal health officials say they are aware of only about a half dozen victims of the outbreak who suffered relapses. The original outbreak killed 64 patients and sickened 751. The outbreak has been traced to thousands of vials of methylprednisolone acetate laced with a deadly fungus. The victims had been injected with the steroid in the spine, neck or joints.
After recovering from the second bout, Peay said she lived with the constant fear that traces of the fungal bacteria remained and could flair up hitting her yet another time.
"As September of 2014 grew closer, I became very concerned and nervous. I would wake up in the middle of the night and start thinking about it and could not get back to sleep."
 "I told one of my sons that I did not have the energy nor the desire to go through it again, so if it started to have someone put a pillow over my face and kill me instantly," she wrote, adding that because of her religious beliefs suicide was not an option.
That's why, she said she wanted to find a test that could detect with greater certainty whether even small traces of the fungus were still lurking in her body.
Peay said she learned of the new test which could do just that, developed by  scientists at the Public Health Research Institute at Rutgers University Medical School.  A friend she had become acquainted with on a blog devoted to victims of the 2012 outbreak first told her about the new test that required only a blood sample.
At first they traded emails and later met in person, Peay recounted.
"I was positive I needed a better way of detecting the existence of fungus in my body and this new way was the answer," Peay wrote. 
But after learning that she would be a good candidate Peay still  had to convince her Nashville doctor to order the test so she could send a sample of her blood to the Rutgers group conducting the studies.
Peay said she encountered some initial reluctance from "the doctor who saved my life," but
eventually he agreed.
Peay said she has since learned that other victims of the outbreak have encountered similar resistance.
Peay said she had her blood sample shipped to Rutgers at a cost of $50, money gladly spent.
A few days later, she got a two- page letter telling her that the testing of her blood showed no traces of fungal bacteria.
The results of a research study on the new real time DNA testing method have been  published in several reports with the latest in the Journal of Clinical Microbiology. The tests showed, that unlike Peay, who is now free of fungal infection, several victims still had traces of an infection in tests conducted from Feb. 22, 2013 to Dec. 11 of last year.
The report states that "surprisingly" some 29 per cent of those samples tested showed remaining fungal infection.
For Peay, however, the news was all good.
"I don't know if I have the words to describe how relieved and happy I was when I received the good results," Peay wrote. "It made the world seem a whole lot brighter."

wfrochejr999@gmail.com

Judge Rejects Summary Judgment in Meningitis Cases

By Walter F. Roche Jr.

A federal judge Tuesday denied a motion for summary judgment filed by the Connecticut firm that built a sterile room later used to manufacture the tainted steroids that caused a nationwide fungal meningitis outbreak.
In a six-page ruling U.S. District Judge Rya W. Zobel rejected the motion filed by Liberty Industries, Inc., concluding that there too many issues of fact still to be decided by a jury,
Libery was hired in 2005 and 2006 to construct clean rooms for the New England Compounding Center, the Framingham, Mass. firm that shipped fungus tainted methylprednisolone acetate to doctors and healthcare facilities in 2012.
Liberty had been named as a defendant in 99 cases filed by Indiana victims of the outbreak that killed 64 patients and sickened hundreds more.
Liberty's lawyers had argued that the company could not be held liable for something that occurred some six years after the work was completed.
"Though the question is a close one," Zobel wrote, "summary judgment is not appropriate at this time. Genuine issues of fact remain for a jury to decide."
Though the ruling only applies to Indiana cases, it may impact cases from other states including those in Tennessee.
Zobel is presiding over hundreds of cases filed by outbreak victims and their survivors.
Last week a federal grand jury issued indictments against 14 former employees and owners of NECC following a two year federal probe of the outbreak. Two of the defendants were charged with second degree murder in 25 of the 64 deaths.
wfrochejr999@gmail.com

Two Defendants in Compounding Case Get Home Confinement

Two former officials of a defunct drug compounding firm have been ordered to remain in home confinement on second degree murder and related charges by a federal judge.
Magistrate Judge Jennifer Boal Friday ordered home confinement for Barry Cadden and Glenn Chin, both formerly involved in the New England Compounding Center, which has been blamed for a nationwide fungal meningitis outbreak.
Boal, who also is playing a role in dozens of pending civil suits stemming from the outbreak, set bail at $500,000 for Cadden and $50,000 for Chin. Cadden was a founder and part owner of NECC, while Chin was the chief pharmacist.
Both had been held in a federal lockup since their Wednesday arrest.
Twelve other employees and owners of NECC also were charged in the 73-page indictment made public this week.
Cadden and Chin face the most serious charges for their alleged involvement in the deaths of 25 patients injected with fungus tainted methylprednisolone acetate from NECC.
Overall 751 patients were sickened in the outbreak and 64 died.
All the defendants have entered not guilty pleas.
wfrochejr999@gmail

Not Guilty Pleas Entered in Drug Compounding Murder Case

By Walter F. Roche Jr.

Two of the defendants charged in a 73-page federal indictment with second degree murder entered not guilty pleas Thursday in U.S. District Court in Boston, Mass.
The pleas were entered by Barry Cadden, one of the owners of the now defunct New England Compounding Center, and Glenn Chin, NECC's one time chief pharmacist.
The two were arrested Wednesday and remain in a federal lockup while a judge decides whether they can be released on home detention, bail or a combination of both.
The two were among 14 indicted by a federal grand jury this week following a two-year federal investigation of a national fungal meningitis outbreak that killed 64 people and sickened 751. State and federal regulators blamed the 2012 outbreak on fungus tainted steroids shipped by NECC to health facilities across the country.
In the indictment Cadden, Chin and 12 other owners and employees of NECC were charged with conspiracy, racketeering and multiple violations of state and federal statutes and regulations setting sterility requirements for drugs injected into the human body.
NECC shut down shortly after the outbreak became public. Dozens of civil lawsuits filed by victims of the outbreak and their survivors are now pending before a federal judge. A proposed settlement of a related bankruptcy case is scheduled for a Feb. 24 hearing.
wfrochejr999@gmail.com

Indicted Drug Compounder Shipped Other Drugs to Health Care Facilities

By Walter F. Roche Jr.

The long awaited indictment from a probe of a nationwide fungal meningitis outbreak shows that there may be even more victims of the now defunct drug compounding firm already officially blamed for 64 deaths and 751 illnesses in 20 states.
The 73-page indictment made public in Boston Wednesday states that additional injectable drugs were shipped from the New England Compounding Center even though testing showed they were not sterile.
The 2012 outbreak has been linked to fungus tainted vials of a single spinal steroid, methylprednisolone acetate, which is generally injected into the spine, neck or joints.
According to the indictment those other drugs include cardioplegia, a drug used during cardiac surgery to slow or stop the heart from beating, bags of potassium chloride and bacitracin. All were injectable drugs that were supposed to be sterile but weren't, the indictment charges.
And the grand jury found that those unsterile drugs were shipped to health facilities in states not previously implicated in the 2012 fungal meningitis outbreak.
For instance bacitracin syringes were  shipped to a hospital in Illinois and other injectables were shipped to a Glens Falls, N.Y. hospital despite failing tests for sterility. Cardioplegia found not sterile was shipped to Brigham and Women's Hospital in Boston, the indictment states. Injectable drugs made from expired components were shipped to the USC University Hospital in Los Angeles, Calif.
Already there are at least two pending federal suits blaming the deaths of two children at a Las Vegas hospital on tainted cardioplegia injections from NECC.
The defendants, the indictment charges, acted "in a manner inherently dangerous to human life."
The 131-count indictment charges  NECC owner Barry Cadden and its chief pharmacist, Glenn A. Chin, with 2nd degree murder in the deaths of 25 patients in seven states, including Tennessee, Michigan, Virginia and Indiana.
Ten others charged include Cadden's partners in the Framingham, Mass. business and former employees of the now defunct compounding firm.
The charges include racketeering, creating fraudulent prescriptions for patients and multiple violations of state and federal drug statutes and regulations.
According to the indictment, the faked prescriptions listed names like Big Baby Jesus, Mickey Mouse and Flash Gordon. Those names were used despite warnings to NECC salesmen not to use obvious faked names.
NECC officials, the indictment charges, lied repeatedly to state and federal regulators to conceal the fact that they were not in compliance with laws and regulations, including a requirement that before drugs could be compounded a prescription had to be issued in an individual patient's name.
The indictment also charges that Douglas and Carla Conigliaro, who are relatives and partners of Cadden, violated a temporary restraining order issued in a related bankruptcy case by withdrawing $33.3 million from bank and investment accounts over the past 18 months.
The indictment charges that they attempted to hide their actions by keeping multiple withdrawals below the amount which would have triggered an automatic report to the federal government.
Another defendant, Gregory Conigliaro, recently transferred more than $1 million of his interest in real estate to his wife.
Among the NECC employees indicted was Scott M Connolly, who had voluntarily surrendered his license as a pharmacy technician years earlier yet continued to compound drugs for NECC until the facility was shut down in the Fall of 2012.
The indictments, which come more than two years after the outbreak was first reported, are providing at least some relief to the living victims.
Joan Peay, one of several Tennessee victims said she was "very relieved and grateful to know that these criminals will be prosecuted. These are truly criminals," she added. "I hope they (federal officials) find and take even more of their assets."
Under a pending plan filed in U.S. Bankruptcy Court in Massachusetts about $135 million would be available for victims and their survivors. That total includes nearly $50 million from NECC's owners.
Lawyers for the victims, including Mark Chalos of Nashville, said they were hopeful additional assets would be made available.
wfrochejr999@gmail.com

 

Operators of Drug Compounding Firm Arrested, 2nd Degree Murder Charged

By Walter F. Roche Jr.
Owners and employees of a defunct drug compounding firm have been arrested on charges ranging from second degree murder to racketeering in an investigation of a deadly fungal meningitis outbreak that sickened 751 patients and killed 64.
Arrested Wednesday in the Greater Boston area were Barry Cadden, Gregory Conigliaro, Carla Conigliaro and her husband Douglas, all part owners of the New England Compounding Center, the Massachusetts firm blamed for the 2012 fatal outbreak.
Cadden and Glenn Chin, the former NECC chief pharmacist, were charged with second degree murder in the deaths of some of the victims.
Ten other people connected with NECC were also charged, according to a 73 page 131 count indictment handed down by a federal grand jury this week.
The indictment for the first time discloses that health facilities in even more states than previously reported received drugs from NECC that may not have have been sterile. The additional drugs include cardioplegia, a compound used to slow the heart during surgery. The additional drugs were sent to health care facilities in states from California to Massachusetts.
The sudden arrests follow the disclosure that Gregory Conigliaro last month transferred more than a million dollars of real estate he owned to his wife for a fraction of the assessed value. U.S. Justice Department officials declined to comment this week when asked whether they were aware of the transfers.
The indictment seeks a court order to seize real estate and other assets of the defendants under a forfeiture statute. It includes everything from a late model BMW to jewelry to a sailboat.
Mail fraud charges already had been brought against Glenn Chin, who was the lead pharmacist for NECC. His wife Kathy was named in the new indictment.
The 2012 outbreak was caused, state and federal health officials have concluded, by fungus tainted methylprednisolone acetate injected into the victims at health facilities across the country. Particularly hard hit were patients in Tennessee, Michigan, Indiana and Virginia.
The indictment lists seven victims in Tennessee, including Kentucky Judge Eddie Lovelace, and eight in Michigan who died in the outbreak.
Mark Chalos, a Nashville attorney representing some of the victims said, "these arrests are a significant step toward achieving justice for the families who have had loved ones sickened or killed," but adding "There is still much work to be done."
Gerard Stranch, who also represents Tennessee victims, said he was hopeful the indictments would lead to an increase in funding available to victims. Thus far about $135 million has been gathered by the trustee overseeing the NECC bankruptcy.
wfrochejr999@gmail.com

Drug Compounding Owner Sells Real Estate to Wife at Bargain Price

By Walter F. Roche Jr.

One of the owners of the drug compounding company blamed for a fatal fungal meningitis outbreak has sold his interest in two properties assessed at more than $2.5 million for a fraction of their apparent value.
Registry of Deeds records in two Massachusetts counties show Gregory A. Conigliaro sold his interest in both properties for a total of $380,000 to his wife Cynthia. Both sales were recorded on Nov. 7 of this year.
The sales come at a critical time as a $135 million bankruptcy settlement proposal is awaiting action by a federal judge. It also comes as a federal criminal investigation into the outbreak is continuing.
Conigliaro is one of the owners of the New England Compounding Center, the now defunct firm blamed for the 2012 outbreak which sickened 751 and killed 64 patients.
According to records in the Barnstable County Registry of Deeds, Gregory Conigliaro sold his interest in property at 155 Salten Point Road on Cape Cod to his wife for $155,000. The property is assessed for $2.1 million. They purchased it for $2.35 million on March 2, 2012.
In Worcester County, land records show Conigliaro sold his interest in property at 50 Sears Road in Southborough for $225,000. That property is assessed for $450,300, according to local tax records. The Conigliaros purchased the property for $300,000 on Feb. 1, 2010.
The sales took place after the release of a $21 million lien that had been placed on properties owned by Conigliaro and the other owners of NECC.
Paul D. Moore, the court appointed bankruptcy trustee, said in an email, "It does not appear to present an issue with respect to the settlement, the attachments or related injunctions. Under the terms of the settlement, the attachments were released and the injunctions lifted upon the funding into escrow of the cash deposits, all of which were in fact funded."
Conigliaro's lawyer could not be reached for comment.
Lawyers for victims of the outbreak said they were not aware of the property transfers but said they were now investigating the transactions.
The criminal investigation of the outbreak already has led to the indictment of NECC's chief pharmacist Glenn Chin. He is awaiting trial on a mail fraud charge.
In addition to the bankruptcy case, hundreds of civil suits have been merged before a federal judge in Boston.
The outbreak has been blamed by state and federal regulators on thousands of fungus tainted vials of methylprednisolone acetate that were shipped from NECC to health care providers across the country. Most of the victims were injected in the spine with the drugs and were stricken with fungal meningitis.
According to court filings Gregory Conigliaro owned 10 percent of NECC's stock with the balance owned by other members of his family and in-laws. Under the bankruptcy settlement plan, Gregory Conigliaro contributed $2.75 million to the $135 million total.
wfrochejr999@gmail.com

Court Date Set for Meningitis Bankruptcy Plan

By Walter F. Roche Jr.

A federal bankruptcy judge has set a Feb. 24 date for a hearing on a liquidation plan that could provide a total of $135 million to victims and creditors of a 2012 fungal meningitis outbreak.
The hear date was set this week by federal Judge Henry J. Boroff just days after a massive liquidation plan was filed by the trustee and a committee representing some of the creditors in the case of the New England Compounding, the Massachusetts firm blamed for the fatal outbreak.
The hearing will be held at 10 a.m. in the federal court building in Springfield, Mass.
The plan provides a total of about $135 million to pay victims and some of NECC's creditors, but $19.5 million of that total will be earmarked for victims who were treated at two health facilities, one in New Jersey and the other in North Carolina.
A total of $16 million will go to victims treated at the High Point Surgery Center in High Point, NC, while $3.5 million will go to victims treated at the Inspira Health Network in southern New Jersey.
Those special allotments, according to the plan filed by Trustee Paul Moore, came from mediated agreements with the two health providers.
Other health facilities where victims were treated with tainted spinal steroids, including the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn., did not enter the mediation program. Claims by victims against those facilities have yet to be resolved.
Most of the remaining $115.5 million will go to victims on a point system based on the type of illness the victim suffered and its severity. The highest point scores go those who died following treatment with fungus infested methylprednisolne acetate shipped from NECC.
But the pot of money going directly to victims will be reduced by expenses, including reimbursements to health insurers, including the federally funded Medicare and Medicaid programs, which were billed for many of the victims.
According to the filings, there may be an attempt to work out a master agreement with the federal government on a set level of reimbursement covering all cases, otherwise each case will have to be settled individually.
According to attorneys representing victims, it is unlikely that victims will have to pay any taxes on their final awards. They will, however, be required to pay fees to their individual lawyers.
In addition the liquidation plan states that Duane Morris has incurred $3.4 million in fees representing the trustee and an additional $2 million is expected. Mesirow Financial, a financial advisor, has incurred fees of $420,00 and an additional $750,000 in fees are anticipated.
Other fees include $3.3 million to the Brown Rudnick law firm with $1.25 million more anticipated. The plan also calls for an overall eight per cent levy on the total payout for fees incurred under a so-called combined benefit fund that would go to some of the law firms closely involved in the overall settlement.
wfrochejr999@gmail.com

TN Drug Compounding Firm Pleads Guilty

 By Walter F. Roche Jr.

A Tennessee pharmacist and his compounding firm have pleaded guilty to violations of federal law in the shipping of a spinal steroid across state lines.
The guilty pleas were entered by David A. Newbaker and the Main Street Family Pharmacy in Newbern to charges of shipping an adulterated drug across state lines.
The pharmacy shipped the steroid, methylprednisolone acetate, which was contaminated with bacteria. The pharmacy recalled all of its sterile products last year but not before some 26 patients reported adverse events such as abscesses at the injection sites.
Under a plea agreement Newbaker will be on probation for a year and a total of $50,000 in fines will be assessed against him and the pharmacy.
The court also imposed a civil consent decree barring Newbaker and his wife from shipping drugs until they come into compliance with federal drug requirements. The decree and the criminal charges were filed in U.S. District Court in Memphis.
The New Bern pharmacy was producing the same steroid which has been blamed for a 2012 outbreak of fungal meningitis that took the lives of 64 patients and sickened 751. Those drugs came from the New England Compounding Center, which has shut down.
State records show the pharmacy is closed and Christy Newbaker is serving a two-year probation on her pharmacist license. She was fined $12,800 in 2013, David Newbaker's license is active.
A state Health Department spokeswoman said that the pharmacy voluntarily ceased operation in August.
wfrochejr999@gmail.com

Point System Proposed to Pay Fungal Meningitis Outbreak Victims

By Walter F. Roche Jr.

A proposed bankruptcy plan for the firm blamed for a national fungal meningitis outbreak includes a point system that would be used to determine the amount of money allotted to each victim.
The point system was just one element of a voluminous three-part filling this week by trustee Paul D. Moore in U.S. Bankruptcy Court in Massachusetts. The hundreds of pages of documents detail how an estimated $135 million could be distributed in the case of the defunct New England Compounding Center.
A general outline of that liquidation plan was presented Thursday in a hearing in Boston before U.S. District Judge Rya Zobel. She is presiding over several hundred civil complaints stemming from the 2012 outbreak that took the lives of 64 patients and sickened 751.
The victims were injected with a fungus tainted doses of methylprednisolone acetate, with some getting the shots in the spine and others in peripheral joints or the neck.
Zobel and lawyers in the case praised Moore and others involved in putting the plan together.
The plan is subject to approval by creditors and Bankruptcy Judge Henry J. Boroff. Lawyers for Moore's attorney, Michael Gottfried, told Zobel that the plan could be finalized in 90 to 100 days.
Under the proposed distribution plan points would be allocated to victims based on the severity of their illness.
For instance, the survivors of a victim who died in the outbreak would be awarded 55 points, while a patient who suffered fungal meningitis would be allotted 30 points. The lowest number, a half point, would go to those who were injected with the tainted steroid but suffered no symptoms.
According to the plan, those points could be increased by other factors including the length of treatment or complications.
"The amount of the distribution that will ultimately be made to each individual tort claimant is based on the claimant's point total," one of the filings states, adding that "a number of adjustments " could boost that total.
The filings disclose that 3,350 claims were filed for patients claiming to be victims.
Although the trustee's report includes a substantial increase- from $100 million to $135 million - in the estimated assets available to victims and creditors, some fear the actual payouts will not be that substantial.
Joan Peay, a Nashville Tenn. victim, said that not only may the amounts be small to  begin with, but they may well be reduced by the counterclaims of insurance carriers that paid the original bills. Victims will also face legal fees.
Peay's bills were especially high because she was not only stricken in the 2012 outbreak, but then suffered a relapse a year later. She said the bills for her first bout alone came to $53,000.
"Although I'm glad something is being accomplished, the amount is really not good news," Peay said
One roadblock to Tennessee victims was eliminated yesterday when lawyers for the Saint Thomas Outpatient Neurosurgical Center in Nashville agreed to respond by mid-month to a series of questions or interrogatories posed by the victims' attorneys.
Peay and dozens of other Tennessee claimants were injected with the tainted steroid at the Nashville facility.
wfroche999@gmail.com

$135 Million Plan filed in Fungal Meningitis Bankruptcy

By Walter F. Roche Jr.

The trustee in the bankruptcy of the firm blamed for a nationwide fungal meningitis outbreak has filed a liquidation plan that would provide at least $135 million, with most of that amount earmarked for victims and their survivors.
The massive plan was filed late Wednesday in U.S. Bankruptcy Court in Massachusetts. The agreement is subject to court and creditor approval. The settlement plan includes previously disclosed contributions of $47.75 million from the owners of the now defunct New England Compounding Center.
The 2012 outbreak sickened 751 persons taking the lives of 64, many from Michigan, Tennessee, Virginia and New Jersey.
The settlement total jumped by some $35 million since preliminary details were revealed to U.S. Bankruptcy Judge Henry Boroff earlier this year. The new contributions include payments from two major providers and their insurance companies plus settlements with a testing company hired by NECC, a contractor used by the compounding firm and agreements with a sister drug firm and its insurance carrier.
There was no settlement, however, with the Saint Thomas Outpatient Neurosurgical Center, the Nashville site where most of the Tennessee victims were injected with fungus tainted methylprednisolone acetate.
According to the filings some 3,500 claims filed in the case were for death or illness caused by the outbreak.
In a statement announcing the details, Paul D. Moore, the trustee, said the plan was the result of "substantial efforts."
Anne Andrews, a California representing victims said the settlement should give victims "a sense of closure," while Thomas Sobol, another plaintiff lawyer from Boston, said the settlement "should provide much needed compensation."
"It is encouraging that some wrongdoers have stepped up and are accepting responsibility for the harm they have caused," said Mark Chalos, a Nashville  attorney for several outbreak victims, adding that they were committed "to fighting for our clients to make sure all wrongdoers are held accountable."
The plan also includes current and anticipated expenses including legal fees and expenses totaling $3.4 million from  Moore's law firm and that number is expected to climb by another $2 million.
Additional funds could be available if NECC's sister firm, Ameridose, can be sold.
The settlements include $10 million from Ameridose and its insurance carrier, $3.75 million from NECC's landlord, $25.2 million from insurance companies, $16 million from the Inspira Health Network in New Jersey and $6.4 million from ARL Biopharma, a testing firm. Many of those settlements include contributions from the respective insurance carriers.
Under an agreement with Tennessee's Board of Pharmacy, Tennessee  could recoup up to $5 million for the costs it incurred in investigating the outbreak.
wfrochejr999@gmail.com

Sale of Drug Compounder's Assets Sought, Minus Autoclave

By Walter F. Roche Jr.

A federal judge is being asked to authorize the sale and disposition of nearly all of the remaining assets of the drug compounding firm blamed for a nationwide fungal meningitis outbreak that killed 64 patients and sickened 751.
The request to sell most of the assets of the bankrupt New England Compounding Center was filed Monday even as more details were disclosed on an overall plan to compensate victims of the 2012 outbreak and their survivors.
A heavily redacted filing with some details of the bankruptcy plan was filed in the same pending case. Five of the seven pages in the document had all or some of their content blacked out. The actual plan is expected to be filed in the next few weeks, according to court testimony.
The filing describes a process under which appeals of individual victims' claims would be reviewed by federal Magistrate Judge Jennifer C. Boal "according to specific criteria."
That criteria, which is not disclosed was "created with input from physicians who have treated hundreds of victims." 
The plan, court filings show, will include a matrix "designed to distinguish among the most serious and the less serious cases."
An Oct. 23 letter to Boal from the plaintiff's lawyers ask her to assume the role of considering any appeals to the awards. Her decisions would be final.
"Due to the limited funds that will be available," the filing states, "a primary goal was balancing the need to compensate distinctly situated claimants differently, while also minimizing the administrative expenses of reviewing and approving claims." 
As has been previously disclosed, those involved in the case expect that $100 million to $108 million will be available for a fund to compensate victims. Those funds, the filing states, will come from NECC's owners and insurance companies.
Additional funding could come from other sources such as health facilities where the victims were injected with fungus tainted methylprednisolone acetate.
Paul D. Moore, the trustee in the bankruptcy case, said in an email response to questions that the asset sale would not only produce additional income for victims, but also reduce expenses.
One exception in the disposal request is an autoclave, which two parties, including the Saint Thomas Outpatient Neurosurgical Center of Nashville, Tenn. and related parties have asked to be preserved for possible use in their defense.
Moore said in an email that if the order is approved, "it would permit me to me to sell or otherwise dispose of the property other than the autoclave."
 " It would be my goal to try to sell anything that would have any remaining value. Likewise, that would permit me to move out of the space or to consolidate the property that is out there in a smaller area and thereby reduce the monthly expense of maintaining it," Moore wrote.
wfroche999@gmail.com

Widow of First to Die in Fungal Meningitis Outbreak Joins Suit

By Walter F. Roche Jr.

On June 19, 2012 70-year-old Kenneth Denesha visited a Florida pain clinic for an injection of a steroid to ease extreme pain in his neck and shoulder. Less than a month later he was dead, the first of 64 to die in a nationwide fungal meningitis outbreak.
Now Denesha's widow, Amy, has joined hundreds of other victims of the outbreak and their survivors in a massive lawsuit before a federal judge in Boston. The outbreak also sickened 751 patients in 20 states.
Though the outbreak would not become public until several months later, Denesha's death on July 15, 2012 is the earliest recorded by the U. S. Centers for Disease Control and Prevention for the outbreak later blamed on a Massachusetts drug compounding drug firm.
A retired drill operator and a one time high school wrestling and football player, Denesha collapsed just two days before his death while cutting his lawn. He died July 15, 2012 in a Florida hospice.
Though it was first assumed he had died of a massive stroke, his family only later learned that it was the June injection of methylprednisolone acetate that killed him.
In addition to his wife he left three children, four stepchildren and two siblings.
According to the recently filed lawsuit, Denesha got the June 2012 injection at the Florida Pain Clinic and it was administered by Dr. Stephen T. Pyles. Neither Pyles or the pain clinic are named as defendants in the 45-page amended complaint.
CDC spokeswoman Christine Pearson said this week in an email response to questions that the July 15 Florida death was the earliest recorded in the outbreak.
The company blamed for the outbreak, the New England Compounding Center, shutdown and filed for bankruptcy on Dec. 21, 2012.
The Denesha lawsuit charges the owners of NECC and affiliated companies with gross negligence, wrongful death and violations of state consumer protection statutes.
"Kenneth Denesha died as the direct and proximate result of the contaminated steroid injection," the complaint states.
The first public notice of the outbreak would not come until late September of 2012 when Tennessee state health officials reported a cluster of deaths from fungal meningitis among patients, it turned out, who had recent steroid injections in the back or neck.
The first Tennessee victim to die was Eddie C. Lovelace, a Kentucky judge who had traveled to a Nashville clinic for a steroid injection. He died Sept. 17, 2012. The last Tennessee victim to die, according to court filings, was Gokulbhai Patel, who passed away on Jan. 13, 2013.
While 15 Tennessee patients and seven from Florida died in the outbreak, Michigan with 19 deaths had the most victims.
wfrochejr999@gmail.com

NECC Bankruptcy Plan Could Come in Two Weeks

By Walter F. Roche Jr.

A proposed bankruptcy plan which could provide millions of dollars in relief to victims of a nationwide fungal meningitis outbreak could be filed within the next two weeks, according to the attorney for the bankruptcy trustee.
"We are very, very close," Michael Gottfried, the attorney representing trustee Paul D. Moore, told U.S. District Judge Rya Zobel in an hour long court session Thursday in Boston.
He added that the plan could be filed in early November, which would be a little over two years after the fatal outbreak became public.
Previously Moore disclosed that an agreement had been reached with some of the defendants and insurance companies on a plan that would provide over $100 million for victims and creditors.
Gottfried did not provide any additional information on a settlement plan Thursday.
Zobel is presiding over hundreds of civil cases stemming from the outbreak which killed 64 patients and sickened 751.
The bankruptcy case of the New England Compounding is pending before a separate judge, but the plan will be the source of funds for the victims and other creditors seeking compensation. State and federal regulators have concluded that NECC caused the outbreak by shipping fungus tainted steroids to health facilities across the country.
Also appearing at the afternoon session were attorneys for Tennessee victims of the outbreak and the Saint Thomas Outpatient Neurosurgical Center and two other Tennessee facilities where patients were injected with spinal steroids supplied by NECC.
Gerard Stranch, representing Tennessee victims, told Zobel that a major dispute has been developing over the scheduling of depositions in which key figures will be questioned under oath. He said he will likely be asking the court's assistance in resolving the matter.
Stranch said another issue that will have to be resolved is whether the Saint Thomas parties must disclose details of one of their agreements with insurance carriers. Lawyers for the Nashville facility contend the information does not have to be provided.
Zobel also heard arguments over whether equipment and other materials from NECC must be preserved for possible use in the cases. Zobel did not rule on that matter.
The bankruptcy trustee had argued that the cost of maintaining the items, such as a 10 foot long bench, was too burdensome.
Lawyers for Saint Thomas, which wants some items preserved, stated that they were working on an agreement that would not draw on the assets in the bankruptcy case.
wfrochejr999@gmail.com

Long Delays Likely in Drug Compounding Criminal Trial

By Walter F. Roche Jr.

Citing 637,000 pages of evidence and some 1.1 million internal emails, prosecutors and the lawyer for drug compounder Glenn Chin have agreed to waive speedy trial rules in the first criminal case stemming from a nationwide fungal meningitis outbreak.
In a four-page joint document filed today in U.S. District Court in Boston, Mass. the lawyers asked a federal judge to waive rules that could force a trial in the case in a little over two months. The motion was signed by Stephen J. Weymouth, Chin's attorney and Assistant U.S. Attorney Amanda Strachan.
Chin, the one-time supervisory pharmacist for the defunct New England Compounding Center, is charged with mail fraud in the probe of a nationwide fungal meningitis outbreak that killed 64 patients and sickened 751.
State and federal regulators have concluded that NECC caused the outbreak by distributing thousands of vials of fungus tainted steroids to health facilities around the country.
According to the filing the investigation into Chin and other officials of NECC is "ongoing."
"The United States produced initial discovery of 607,000 documents," the report states, adding that Chin's lawyer received those records between Oct. 9 and Oct. 21.
In addition prosecutors provided Weymouth with eight electronic databases including 1.1 million internal NECC emails.
"The United States is aware of its continuing duty to disclose newly discovered evidence or material," the filing states, adding that currently there are no pending discovery requests.
The report notes that a magistrate judge already has approved a protective order barring the release of those discovery materials to third parties.
Stating that the case is "sufficiently unusual and complex" to waive normal time limits, the report states, "The parties anticipate that it will take a significant period of time to review the substantial discovery in this case."
The 2012 fungal meningitis outbreak also has prompted hundreds of civil suits that have been merged before a federal judge. A hearing on those cases is scheduled for tomorrow before U.S. District Judge Rya Zobel. Dozens of new cases from New Jersey victims were recently added to the docket.
NECC was shutdown in 2012 and its owners filled for bankruptcy later that year. That case is still pending.

Research Project Tracks Victims of Meningitis Outbreak

Unusual and alarming levels

"As far as long term effects, we don't have a handle on it. This is a difficult situation. These patients have a lot of other problems. It is kind of a perfect storm

CDC said we wouldn't be able to detect it in the blood.
It is strictly a research protocol and not a clinical study.. We get referrals from physicians.
Found fungal traces in 20 to 30 percent of the samples. Nucleic acid
A lot have unexplained problems

Judge in Meningitis Cases Approves Trustee's Plan

By Walter F. Roche Jr.

A federal judge in Boston has given her assent to a proposed $100 million settlement of claims against a Massachusetts drug compounding firm by approving a procedural plan proposed by the bankruptcy trustee for the defunct pharmaceutical firm.

In two separate orders issued Thursday, Judge Rya W. Zobel rejected claims by lawyers for Nashville's Saint Thomas Outpatient Neurosurgical Center that the trustee's plan to limit depositions and halt further action against some of the defendants in dozens of pending civil suits was "overly broad and vague."

Zobel noted that the trustee, Paul Moore, had argued that the limits were "critical to the implementation" of proposed settlements with the owners of the New England Compounding Center and related parties.

Those settlements with NECC's owners, insurers and other related parties emerged in a parallel bankruptcy case, also in federal court in Massachusetts.

NECC, according to state and federal regulators, shipped fungus tainted steroids to medical facilities across the country, including the Saint Thomas clinic, triggering the outbreak of fungal meningitis that killed 64 patients and sickened 751.

"I find that the trustee's proposed order is sufficiently clear and reasonable," Zobel wrote, adding that it does not prevent lawyers from the Nashville clinic from pursuing affirmative defenses.
"The court has determined that the requested stay of these proceedings and limitation of discovery with respect to the settling parties is warranted," she concluded in a five-page order.

Zobel did, however, order a stay effectively stopping the clock on statutory claims that might otherwise expire.

Lawyers for victims of the outbreak, many of them in Tennessee, said they were pleased with Zobel's decision.

“We are glad that discovery is moving forward and we are focusing on the clinics in Tennessee.  We look forward to presenting our case to a jury as soon as possible,” said Gerard Stranch, one of the attorneys representing victims of the fatal 2012 outbreak.
Saint Thomas' attorney Chris Tardio said, "The decision allows us to begin the process of discovering how NECC contaminated these medications despite promising their customers that they followed the proper safety standards. We have asked for that opportunity, and the decision allows us to do that."
Zobel is presiding over hundreds of cases stemming from the outbreak that were merged in her court. The number of those cases Zobel is overseeing has been steadily increasing as statutes of limitations in affected states are running out. 
wfrochejr999@gmail.com

Victims of Outbreak Seek Saint Thomas' Insurance Policies

Lawyers for victims of the 2012 fungal meningitis outbreak are asking a federal judge to order Saint Thomas Health and related entities to provide full details of insurance policies that could benefit their clients.
In a motion filed Friday in U.S. District Court in Boston, attorney J. Gerard Stranch of Nashville charged that Saint Thomas officials have steadfastly refused to provide copies of their insurance agreements.
In the motion and an accompanying brief, the plaintiffs' attorneys noted that a federal magistrate judge already had ordered disclosure of the coverage details.
While some general information was provided, critical details, including copies of actual insurance agreements have not been provided, the motion states.
Lawyers for the victims contend that knowing the available coverage is critical in efforts to reach a settlement.
"Plaintiffs first asked for insurance information almost 14 months ago," the filing states.
The motion comes in a massive case combining claims by hundreds of victims of the outbreak caused by tainted spinal steroids. Most of the Tennessee victims were injected at the Saint Thomas Outpatient Neurosurgical Center in Nashville.

Meningitis Outbreak Prosecutor Seeks Order to Protect Probe Records

By Walter F. Roche Jr.

The U.S. Attorney prosecuting a pharmacist charged in the probe of a fatal fungal meningitis outbreak is asking a judge to order that records relating to the investigation be kept confidential.
The motion for a protective order was filed Thursday in U.S. District Court in Boston by U.S. Attorney Carmen Ortiz.
The move comes in the criminal case against Glenn Chin, 46, who worked as a pharmacist for the New England Compounding Center. Chin, a Canton, Mass. resident who has been charged with mail fraud, has entered a not guilty plea to the charge.
Under Ortiz' motion Chin's lawyers would be barred from disclosing to third parties any information about the investigation provided by prosecutors during the discovery phase of the criminal case.
Chin's lawyers, according to the filing, are not opposed to the order.
Ortiz said in the filing that disclosure of the investigation details to third parties "could jeopardize the ongoing criminal investigation."
"Some of the discovery materials," the motion states, "would inform potential targets or subjects of the status and direction of the ongoing criminal investigation."
In addition Ortiz wrote that the same discovery material could reveal the identities of government witnesses.
Finally, Ortiz' motion states,  the discovery information includes specific health information on victims who received  tainted steroid injections at Michigan Pain Specialists.
The protective order proposed by Ortiz would require that once the Chin case is completed the discovery materials would have to either be destroyed or returned to the federal government.
The 2012 outbreak sickened some 751 patients. Sixty-four of them died. Michigan and Tennessee were among the hardest hit of the 20 states where victims were treated.
wfrochejr999@gmail.com

Clinic Lawyers Say Any Blame for Outbreak Should Be Shared

By Walter F. Roche Jr.

Lawyers for the Saint Thomas Outpatient Neurosurgical Center have named nearly a dozen other parties, including three government agencies, who they say should share any blame for a fatal 2012 fungal meningitis outbreak.
In a 113-page filing in U.S. District Court in Boston, Mass. Tuesday the attorneys for the Nashville clinic and other Tennessee defendants listed a testing company and the supplier of bulk chemical compounds along with a half dozen other parties, as bearing some responsibility for the outbreak.
The filing came in a series of suits which have been merged before U.S. District Judge Rya Zobel.
At the same time clinic lawyers said the facility and other defendants "complied with the laws and regulations applicable to them and with industry standards."
They also stated that the defendants had no reason to suspect that the steroids shipped by a now shuttered drug compounder, the New England Compounding Center, were tainted with fungus.
The outbreak led to the deaths of 64 patients while 751 were sickened. Tennessee was among the hardest hit with 16 deaths.
The filing also names state agencies in Tennessee and Massachusetts along with the U.S. Food and Drug Administration as sharing in the blame and calls the outbreak "a colossal regulatory failure."
The FDA failed to act against NECC even though the drug firm's activities "fell squarely within FDA's definition of its own regulatory authority,"clinic lawyers charged.
Others named as bearing possible liability by Saint Thomas lawyers were an organization that provided training for NECC employees and sold the company the "recipe" for the steroid drug, a heating contractor and the company that installed clean rooms for NECC.
The filing charges that Medisca, the firm that supplied NECC with the bulk materials for its products should have known NECC was not in compliance with the law simply because of the high volume of base chemicals it was purchasing.
wfrochejr999@gmail.com

TN Drug Compounder Forged Prescriptions for Diet Drugs, State Charges

By Walter F. Roche Jr.

The owner of a Cleveland, Tenn. drug compounding pharmacy repeatedly forged prescriptions for a diet drug in her son's name, the state Pharmacy Board has charged.
The forgeries, which took place over a nearly four year period, were just one of several charges that led the state board to summarily suspend the license of Robin Terrero and her pharmacy, The Wellness Store Compounding Center.
In a 13-page order made public Thursday, the board spelled out multiple violations noted by a state inspector in three separate August visits to the pharmacy. The inspections, according to the state, were triggered by a complaint alleging multiple violations filed earlier that month.
The pharmacy did not respond to a request for comment.
While state Health Department officials released the suspension orders, they declined to release the inspection report leading to the regulatory action.
The order of summary suspension states that the inspector found that prescriptions, both new and refills, were left lying on an open counter for customers to retrieve. The pharmacy routinely operated when no pharmacist was present, the order states.
Other allegations include the dispensing of prescription drugs compounded from outdated and deteriorated products, preparation of prescriptions by staffers not licensed or trained to do so and failure to maintain sanitary conditions, even for drugs required to be sterile.
According to the complaint Terrero forged prescriptions for a drug called benzphetamine "in the name of her son and dispensed them herself from The Wellness Store."
In addition, the state charged Terrero, the chief pharmacist and owner, was often absent from the store and even when she was present she failed to provide proper supervision for the staff.
The investigator observed that "Terrero also failed to verify prescriptions being dispensed to patients" or to counsel customers on the use of the drugs being dispensed.
  Other charges include dispensing prescription drugs without a valid prescription and allowing unlicensed staffers to take prescription orders by phone.
"Wellness Store's staff routinely and systematically altered records, including the beyond-use dates on dispensing labels and compounding logs, in order to override software safeguards designed to prevent the use or dispensing of expired products," the order states.
Though state health officials say there have been no reports of illness from injectable drugs dispensed by the Cleveland pharmacy, they are urging consumers not to use any unused remaining doses.
The suspension comes on the second anniversary of a fungal meningitis outbreak caused, according to state and federal regulators, by tainted spinal steroids shipped around the country by a now defunct Massachusetts compounder.
Tennessee was one of the hardest hit in the outbreak with 16 patients dying and 153 sickened.  The outbreak triggered changes in both state and federal laws and regulations governing drug compounders.

Tennessee Compounding Pharmacy Cited for Unlawful Dispensing, Intentional Falsification

By Walter F. Roche Jr.
A Tennessee compounding pharmacy has been cited for using outdated, deteriorated or otherwise unsafe ingredients and state health officials are warning patients who may have received injectable drugs from the Cleveland druggist not to use them.
The warning applies to products from The Wellness Store Compounding Pharmacy at 3555 Keith St. NW in Cleveland.
In announcing the warning, state health officials said they were not aware of any illnesses caused by drugs sold by the pharmacy and that the volume of drugs produced was small.
"However, this warning is being issued out of an abundance of caution," the agency said in a statement.
Symptoms of possible contamination include pain, swelling or redness at or near the injection site.
The state is asking that any unused medications from the pharmacy be sent to the state for further testing.
Other violations found in an August inspection of the pharmacy include intentional falsification of records, the unsupervised production of compounded drugs and illegal dispensing of controlled substances.
According to the department the licenses for the pharmacy and pharmacist Robin Terrero  were summarily suspended.
The action is one of the first since the enactment of a new law and supporting regulations adopted after Tennessee became one of the hardest hit in the nation from tainted injectable steroids issued by a now defunct Massachusetts drug compounding firm.
Clinics known to have received injectable medications from the Cleveland pharmacy are Associates in Spine and Joint Medicine, Cleveland Medical Associates, Internal Medicine Group and Voytik Center for Orthopedics, all in Cleveland, East Tennessee Vein Clinic in Knoxville, Hollywood Body Spa in Athens, Kennedy Clinic in Ooletewah, Lynn Garden Weight Loss in Kingsport and Premier Weight Management in LaFollete.

Deaths, Infections Increase in 2012 Meningitis Outbreak

By Walter F. Roche Jr.

There have been yet more deaths and illnesses from a 2012 fungal meningitis outbreak but just who those victims are and where they were stricken remains a mystery amidst an ongoing federal criminal investigation.
The increased toll was disclosed in a footnote to an affidavit filed in federal court on Sept. 4. The affidavit was filed to back a move by federal prosecutors to arrest Glenn A. Chin, 46, a former employee of the now defunct Massachusetts drug compounding firm blamed for the outbreak.
The last official count from the U.S. Centers for Disease Control and Prevention showed 751 patients across the country were stricken with infections in the outbreak. Sixty-four patients died.
A CDC official, in response to an inquiry, stated that the agency stopped collecting data from state health departments in October of 2013. After that individual state health departments were left with the responsibility to report any additional cases.
A survey of some 20 state health agencies where cases had been previously reported turned up only a single additional victim. That patient in the state of Virginia boosted the total number of victims in that state to 55. Deaths in that state from the outbreak remained at five.
Calls to other state health agencies including the hardest hit, like Michigan and Tennessee, turned up no additional cases
An FDA spokesman declined to state how many additional cases have been uncovered because the investigation is still ongoing.
The five-page affidavit filed by FDA Special Agent Benedict Celso in Chin's case states, "the total of patients (sickened) has continued to rise as have the total number of patients who died."
Recently filed documents in a massive civil suit stemming from the outbreak give further evidence of a possible undercount.
According to a report prepared by attorneys for victims of the outbreak, four cases have been filed in behalf of four patients who contend they became infected after being treated at three different California health facilities.
Nonetheless the official CDC case report includes no cases from California.
Lynn Janssen, an official of the California Department of Public Health, said her agency was not aware of any illnesses  or deaths in California patients who received injections from medications  distributed by the Massachusetts compounding firm.
Suits have been filed in other states, such as Alabama and Nevada, where no cases have been reported by the CDC.
Another unanswered question is the number of patients who have suffered relapses of fungal meningitis or other infections caused by the fungus tainted methylprednisolone acetate.
According to CDC spokewoman Christine Pearson, five relapse cases have been confirmed. A sixth case, she said, has not been confirmed and is still under investigation.
One person to suffer a relapse was Joan Peay of Nashville, Tenn., who underwent nearly two months of hospital treatment followed by two weeks of rehabilitation for a relapse just over a year ago. The other relapse victims have not been publicly identified.

Judge Moves Meningitis Cases Forward

By Walter F. Roche Jr.

A federal judge helping oversee more than 200 lawsuits filed by victims of a 2012 nationwide fungal meningitis outbreak has issued a series or orders setting a schedule that could move the massive litigation to a quicker conclusion.
The orders issued by U.S. Magistrate Judge Jennifer C. Boal clear the way for victims' lawyers to begin collecting evidence and taking testimony from defendants in the case.
"We're very happy with this," said Nashville, Tenn. attorney Gerard Stranch. "This is what we've wanted for a long time."
Boal issued the orders Thursday in Boston, Mass. following a hearing on the cases which have been consolidated under U.S. District Judge Rya Zobel. Zobel had referred the scheduling issue to Boal.
Stranch said the order means that the defendants in the cases, including the Saint Thomas Outpatient Neurosurgical Center in Nashville, will have to respond to subpoenas for records. Clinic officials will also be required to answer questions under oath in a series of depositions.
Stranch said the plaintiffs in the case also will have to produce new information including profiles of the patients making the claims.
Those profiles will not be required, however, for victims whose cases are involved in a mediation process.
Chris Tardio, one of the lawyers representing the Saint Thomas outpatient center, said he too was pleased with the Boal order, which he added included many provisions they had requested.
 "We are looking forward to demonstrating that, in the setting of complete abandonment of oversight by the U.S. Food and Drug Administration and Massachusetts Board of Pharmacy, our clients had no reason to foresee the Massachusetts pharmacy would send us contaminated medication despite assuring us they followed proper safety procedures."

Another filing in the case by attorneys for the plaintiffs shows that of the 212 cases now before Zobel, 118 were filed in behalf of Tennessee patients. Ninety-one of the cases involve patients of the Saint Thomas outpatient center, while the remaining 27 were treated at two clinics.
Other cases include 39 from Virginia, seven from Ohio and four from California.  Two of those California claims were filed by patients of an Encino outpatient facility. Twenty-three claims have been filed in behalf of New Jersey patients, but 13 of that total are involved in mediation.
Only six suits before Zobel come from Michigan patients, but dozens of others remain in state courts.
Michigan had the most victims, according to data compiled by the U.S. Centers for Disease Control and Prevention.
According to the CDC, 751 patients were sickened in the outbreak, while 64 died. There were 264 victims in Michigan with 19 deaths, while Tennessee reported 153 sickened and 16 dead. Virginia had 54 sickened and five dead while New Jersey listed 51 sickened but no deaths.
Lawyers involved in the case predict that actual trials are not likely to take place until 2016, nearly four years after the outbreak was discovered.

Drug Compounding Probe "Active and Ongoing"

By Walter F. Roche Jr.

The chief federal prosecutor in a probe of a deadly fungal meningitis outbreak has written to victims across the country assuring them that the investigation is "very active and ongoing" and a recent arrest does not signal the end of the inquiry.

U.S. Attorney Carmen M. Ortiz signed the Sept. 8 two page letter sent to the victims, including Joan Peay, a Nashville resident who has suffered two bouts of fungal meningitis.

Peay received the Ortiz letter Thursday, the same day Glenn A. Chin, 46, was arraigned in U.S. District Court in Boston on a mail fraud charge. Chin, who entered a not guilty plea and was released on bond, was a supervising pharmacist for the now shuttered New England Compounding Center, the firm blamed for the 2012 outbreak that killed 64 patients and sickened 751.

In the letter, Ortiz wrote that Chin's arrest came because federal officials learned of his plans leave the country. The suburban Boston resident was arrested at Logan International Airport as he was preparing to board a flight to China.

"The federal criminal investigation of Mr. Chin and others remains very active ongoing," Ortiz stated in the letter, adding that the arrest "does not signify the end of the investigation."

In a five-page indictment filed earlier this week, a grand jury charged that Chin not only personally compounded tainted steroids, but supervised others who he instructed to certify that the drugs were sterile and fit for injection into patients.

State and federal officials eventually concluded thousands of vials of the NECC steroids were tainted with fungus due to unsanitary conditions at its Massachusetts facility, where Chin was in charge of sterility.

The letter also notified victims that they can  monitor the progress in the case on-line or by phone by utilizing a unique sign-on and password to a victims service center.

Peay said she was pleased to learn that the investigation is continuing and that she already had signed up to get continuing updates..

Peay was administered doses of the steroid, methylprednisolone acetate, at the Saint Thomas Outpatient Neurosurgical Center. She has been hospitalized on multiple occasions for the fungal meningitis she subsequently contracted.

Formal Indictment in Drug Compounding Case Gives New Details, Not Guilty Plea Entered

UPDATE: Glenn A. Chin entered a not guilty plea Thursday in a one count indictment charging him with mail fraud.

By Walter F. Roche Jr.
A formal one count indictment was issued today by a federal grand jury in Boston giving new details on the charges being leveled against a supervising pharmacist for the firm blamed for a nationwide fungal meningitis outbreak.
The five-page indictment spells out the charges against Glenn A. Chin, 46, who was in charge of maintaining sterility in special clean rooms at the New England Compounding Center, the now defunct firm blamed for the fatal outbreak.
The indictment states that Chin engaged in a scheme to defraud NECC's customers to enrich himself and NECC "by selling for a profit preservative free methylprednisolone acetate labeled as injectable."
Chin, the indictment states, failed to properly clean and maintain and oversee proper cleaning and maintenance of the NECC clean room.
He was charged with one count of mail fraud.
Chin was arrested last week as he was preparing to board a plane headed to China.  He had been scheduled to appear tomorrow at a show cause hearing on the original arrest warrant, but that session has now been canceled. Instead Chin will be formally arraigned on the grand jury charges in a 10 a.m. hearing.
According to the indictment, Chin was first employed as a pharmacist at NECC in 2004 and was promoted to a supervisory position in January of 2010.
In the new post, the court filing states, Chin was "overseeing all aspects of NECC's clean room."
The 2012 outbreak caused some 751 patients across the country to be sickened. Sixty-four died including 19 in Michigan, 16 in Tennessee  and 11 in Indiana.
The indictment states that in addition to personally compounding a lot of the fungus tainted drugs, Chin "instructed pharmacy technicians to fraudulently complete cleaning logs...purporting to show that the NECC clean room was properly cleaned and maintained."

Pharmacist Charged in Meningitis Outbreak Files Emergency Motion

By Walter F. Roche Jr.
Lawyers for the pharmacist charged in the 2012 fatal fungal meningitis outbreak have filed an emergency motion to force a federal agent to appear at a show cause hearing later this week.
The motion filed Monday in U.S. District Court in Boston seeks an order compelling Food and Drug Administration Special Agent Benedict Celso to appear at the hearing scheduled for Thursday.
It was Celso's affidavit that led to last week's arrest of Glenn A. Chin, 46, the supervising pharmacist for the now defunct New England Compounding Center.
The Framingham, Mass. firm has been blamed by state and federal officials for the fungal meningitis outbreak that sickened more than 750 patients and killed at least 64.
In the motion filed, Paul W. Shaw, one of Chin's lawyers said Celso was "a necessary and material witness" for the hearing.
He wrote that because of the short time frame, they were unable to comply with the usual requirements for issuing a subpoena to an FDA employee.
The motion states that Celso's presence is necessary because of the "various conclusionary assertions made in the affidavit."
In the affidavit made public last week, Celso charged that Chin was personally responsible for overseeing the production of a spinal steroid that was tainted with fungus and led to the deaths and illnesses recorded during the outbreak.
Chin was charged with a single count of mail fraud for his role in the shipping of the drugs and the certification that the drugs met federal purity and sterility standards.
Chin was arrested last week at Boston's Logan International Airport as he was preparing to board a plane for China.

First Arrest In Drug Compounding Probe

By Walter F. Roche Jr.

Federal authorities have made the first arrest in the probe of the Massachusetts drug compounding firm blamed for the deaths of at least 64 patients.
Arrested at Boston's Logan International Airport Thursday was Glenn A. Chin, 46, one of the pharmacists who worked at the New England Compounding Center, the now shuttered drug compounding firm blamed for the deaths and illnesses suffered by over 750 patients. The record breaking outbreak of fungal meningitis became public in September of 2012.
Chin a resident of Canton, a Boston suburb, was charged with one count of mail fraud. Federal officials said they made the arrest when they learned Chin was trying to flee the country.
An affidavit filed by a federal agent in the Chin case states that the number of victims is actually higher than the the official count issued nearly a year ago by the federal Centers for Disease Control and Prevention.
Noting that the CDC stopped revising its count in 2013, U.S. Food and Drug Administration Special Agent Benedict Celso wrote in a footnote that based on his personal knowledge, "the total number of patients (sickened) has continued to increase as have the total number of patients who have died."
The affidavit specifically cites multiple cases of victims in Michigan and Tennessee. Six Tennessee victims are mentioned while 217 patients at a Michigan clinic were stricken.
According to the complaint Chin caused contaminated vials of a spinal steroid, methylprednisolone acetate, to be issued and shipped in interstate commerce with the certification that it was injectable, when in fact, it was contaminated with a lethal fungus.
According to the complaint and a U.S. Justice Department press release, Chin was a supervising pharmacist for NECC.
The affidavit states that Chin supervised four other pharmacists who performed sterile drug compounding and that he was personally involved in preparing some of the vials of steroids later injected into unsuspecting patients.
He also supervised technicians and staffers and instructed them "to mislabel medication" and to "fraudulently complete cleaning logs."
The affidavit states that Chin was responsible for labels stating the steroids were injectable, "meaning that the medication was sterile and fit for human use."
The affidavit states that among the unsafe practices Chin oversaw were "improper sterilization and improper testing of supposedly sterile medication."
There have been recent indications that the lengthy federal probe was stepping up as FBI agents questioned some of the victims of the nationwide outbreak. Those victims included Joan Peay of Nashville who was sickened in the initial outbreak and suffered a lengthy relapse a year later.
Peay said she was glad to learn of Chin's arrest and added that she hoped federal authorities are also keeping a close eye on other NECC officials.
If convicted on the charge, Chin could face a jail term of up to 20 years and a fine of up to $250,000. He was arraigned Thursday in U.S. District Court in Boston and will remain under home confinement pending further court action.

Judge Rules Meningitis Victims Can Pursue Product Liability Claims

In a ruling lawyers for victims of a fatal fungal meningitis outbreak are calling a major victory, a federal judge has ruled they can continue to pursue millions of dollars in claims against health care providers under a Tennessee product liability law.
In the decision issued just before a long holiday weekend, U.S. District Judge Rya Zobel ruled against a series of dismissal motions filed by the attorneys for Tennessee health care providers who contended the claims were subject to the strict new requirements of the new state health care liability law.
Attorneys for the Saint Thomas Outpatient Neurosurgical Center had also argued that the suits did not comply with the requirements of that state health care law, including giving 60 days prior notice to health care providers before filing a suit.
Rejecting that argument, Zobel wrote that the "claims are not really about the provision of health care services, but the defects of a product... Plaintiffs did not have to give pre-suit notice." 
The 2012 meningitis outbreak has been blamed by state and federal regulators on tainted spinal steroids produced at NECC, the now defunct Massachusetts drug compounding company.
Mark Chalos, a Nashville attorney representing several victims called Zobel's decision a clear victory and that she had clearly rejected the defendant's arguments
"This is an important victory for Tennessee victims," he said.
 C.J. Gideon, one of the Saint Thomas attorneys, noted in an email response that Zobel's ruling did dismiss several of the claims by the plaintiffs.
He said he was very pleased with the ruling.
 Zobel did grant some of the Saint Thomas dismissal motions including an allegation by the plaintiffs that NECC and the Nashville clinic had engaged in a civil conspiracy to violate a Massachusetts requirement for compounding pharmacies. Some claims under the Tennessee consumer protection act also were dismissed.
She concluded that the evidence provided did not back up that claim.
Nonetheless Zobel  took note of the charge that Saint Thomas provided NECC with a "bogus list" of patients including one named "Mickey Mouse."
Zobel also dismissed some claims against Ascension Health, the parent company of Saint Thomas.
The 2012 outbreak caused 64 deaths across the country and sickened 751 patients. All were injected with methylprednisolone acetate shipped by NECC.
In a pending bankruptcy case in federal court in Massachusetts, a judge has approved a settlement that would provide some $100 million to creditors, including victims and their survivors. NECC filed for bankruptcy in late 2012.

Bankruptcy Settlement OK'd by court

 July 31, 2014

Bankruptcy Settlement OK'd by court

U.S. Bankruptcy Court Judge Henry Boroff today formally approved a $100 million settlement in the case of the New England Compounding Company, the firm blamed for a nationwide fungal meningitis outbreak.
In a six-page decision, Boroff granted a motion filed by the bankruptcy trustee Paul Moore.
The settlement includes payments from NECC's owners and related parties along with insurance companies that had provided NECC with coverage.
The payments will go to creditors including hundreds of victims of the outbreak and their survivors.
Boroff said Moore's settlement motion "is granted in all respects."
Just how the money will be divvied up among victims and creditors will be determined after a formal plan is submitted and approved by the judge.
The 2012 outbreak killed 64 patients, with the largest number of victims getting treatment in Michigan. Over 750 were sickened.

Rothman, Nazareth battle tainted steroid claim

The well known Rothman Institute and Nazareth Hospital have been named as defendants in a suit now pending in U.S. District Court in Boston in which a 73-year-old Philadelphia man contends he was injected with a tainted steroid which sickened him.
The suit is one of dozens filed as a result of illnesses, some of them fatal, blamed on drugs produced by the now defunct New England Compounding Company, which operated in Framingham, Mass.
The case is unusual, however, because the victim, William Lewis, contends he was infected with a different steroid than the methylprednisolone acetate which state and federal officials say sickened 751 patients across the country, killing 64. No deaths were reported by the CDC in Pennsylvania, but one case of fungal meningitis was confirmed.
According to the complaint, which was originally filed in Philadelphia Common Pleas Court, Lewis was injected in the spine with a drug called triamcinolone acetonide on Sept. 25, 2012 at Nazareth Hospital in Philadelphia.
Lawyers for Rothman, Nazareth and Dr. William A. Anderson, have denied charges ranging from negligence to violations of product liability statutes. The attorneys did not respond to email requests for comment.
According to the complaint, Lewis was informed by Anderson and Nazareth Hospital that he had been injected with a drug produced by NECC that may have been contaminated.
Within days of getting the injection, court records state, Lewis "experienced sharp head pain, blurred vision and pain in the eyes."
The complaint states that Anderson told Lewis to go the an emergency room immediately.
"Upon learning of the contamination in October 2012, plaintiff became hysterical, unnerved, distraught, fearful of additional complications," the suit states.

While denying any negligence, lawyers for Nazareth acknowledged informing Lewis that he had been injected with a drug from NECC
In their responses, lawyers for Rothman, Nazareth and Anderson denied any negligence and asserted that as healthcare providers they were not subject to product liability statutes because they provided a service and were not sellers of the steroid in question. Nazareth is one of multiple sites in the Philadelphia are where Rothman provides orthopedic services.
The Lewis' suit is one of only a handful in which plaintiffs contend they were sickened by an NECC drug other than the methylprednisolone acetate cited by state and federal regulators as the cause of the record 2012 outbreak of fungal meningitis.
In one recent development in the case, lawyers for Lewis and his wife, have filed a motion in U.S. Bankruptcy Court in Massachusetts seeking a waiver from a deadline for filing a claim in the pending NECC bankruptcy.
Under a proposed settlement in the bankruptcy, victims and other creditors would share a little over $100 million in insurance payments and contributions by NECC's owners.