Tuesday, December 30, 2014

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.
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Sunday, December 28, 2014

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

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Thursday, December 25, 2014

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."
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Tuesday, December 23, 2014

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."

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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.
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Saturday, December 20, 2014

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.
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Thursday, December 18, 2014

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.
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