Thursday, September 21, 2017

Outbreak Judge OKS $6.2 Million in Legal Fees

By Walter F. Roche Jr.

Boston, Mass. - A federal judge said today that she will approve a request to pay $6.2 million in fees and expenses for attorneys who worked on a massive civil case stemming from the 2012 fungal meningitis outbreak.
The payment from a so-called common benefit fund will go to lawyers representing victims of the deadly outbreak which sickened 778 patients, killing 76 of them.
U.S. District Judge Rya Zobel said she would approve the request during a one hour status conference today in her fifth floor courtroom.
During the same session a report was issued showing that a little over $136.6  million has been distributed to victims of the outbreak or their survivors from a trust fund. The fund was created under the bankruptcy of the company blamed for the outbreak. The New England Compounding Center shipped contaminated steroids to health providers across the country.
The $6.2 million Zobel promised to approve is the second and final installment on the payment of some $12.4 million in legal fees and expenses.
In a separate but related matter, Ben Gastel, a Nashville, Tenn. attorney, told Zobel payments from a separate fund have gone to 107 of 114 victims who were injected with fungus laden steroids at the Saint Thomas Outpatient Neurosurgical Center, also in Nashville.
Details of the Saint Thomas settlement have been filed under seal but Zobel did say she will approve fees of $26,300 from that settlement to a firm hired to administer the fund and issue checks.
Though status reports in the multi-district litigation have been held on monthly basis, Zobel set the next hearing for Dec. 19.
"You are coming to the end of this matter," Zobel said, noting that most of the issues in the litigation have been resolved.

Outbreak Victim's Daughter Details His Final Hours

Boston, Mass. - Holding back tears, the daughter of one of the first victims of the deadly fungal meningitis outbreak described his final fight for survival in a Nashville hospital.
Karen Talbott, the daughter of Kentucky Judge Eddie Lovelace, said doctors could not explain how or why the healthy 78-year-old suffered an unusual stroke centered in the middle of his brain.
His death came in early September of 2012, weeks before the public learned that a deadly fungal meningitis outbreak was taking lives in some 20 states.
"We thought it was just a stroke," Talbott told the jury in U.S. District Court. That panel is hearing testimony in the racketeering and second degree murder trial of Glenn Chin, a supervising pharmacist at the New England Compounding Center which produced thousands of vials of a spinal steroid laced with fungus.
Lovelace, who regularly walked five or six miles a day, was in a car accident earlier in the year and suffered a back injury. The fatal injections were supposed to relieve his pain, Talbott said.
She testified that it was only after state and federal officials publicly announced the growing outbreak, that she and her family figured out what took his life.
Lovelace, she said, had received three injections of methylprednisolone acetate at Nashville's Saint Thomas Outpatient Neurosurgical Center in the months before his death.
Talbott said that when they heard early October news reports about the outbreak they immediately suspected what had caused the judge's death.
His body was exhumed and the diagnosis was confirmed.
She said a grand daughter was the first to notice that Lovelace was having difficulty understanding and one day he fell walking out of the courthouse.
"He was complaining he had a headache," she said.
After he fell twice in one morning and complained his fingers were numb, she said they decided to take him to a local hospital, which quickly transferred him to Nashville.
She said doctors were baffled and couldn't explain why he would have an unusual stroke when he didn't have stroke risk factors
Though he rallied briefly, even asking when he could go back to work, his condition deteriorated. She said it broke her heart when she had to restrain the one arm he still could move because he kept pulling out a breathing tube.
Earlier in the Thursday court session, the doctor who unknowingly injected Lovelace with the contaminated steroid, told the court the epidural steroid injections acted as a powerful anti-inflammatory agent.
Using a model provided by federal prosecutors, Dr. John Culclasure described and demonstrated the two methods of injecting the steroid into the affected area of the spine.
As the deaths among his patients grew, Culclasure said he became worried that his method of injecting the steroid might be the cause.
Other possible sources of contamination were a dye used to target the injection, a numbing drug and the steroid itself, he testified.
Under questioning, Culclasure estimated he had performed some 50,000 spinal injections in his career. He said that the Saint Thomas clinic began using steroids from NECC after experiencing supply problems. He said the procedure takes about 5 to 7 minutes and the clinic does 150 to 160 such injections a week.
He said 116 of the clinic's patients were sickened and 13 died.
He said the NECC version of the steroid, unlike the brand used previously was made without preservatives. He said the clinic, which was shut down for weeks after the outbreak, now uses steroids containing preservatives.
Calling the events "a slow moving mass casualty," he said he went to visit some of his patients who had been stricken with fungal meningitis and was surprised by their reaction.
"I thought they would be very worried and upset. They were not. They were worried about us," Culclasure said.

Wednesday, September 20, 2017

2nd Checks Sent to 1,760 Outbreak Victims

By Walter F. Roche Jr.

Boston, Mass.-The trustee of a fund for victims of the 2012 fungal meningitis outbreak says that second checks have been approved for 1,760 claimants, according to documents filed today in U.S. District Court.
According to the report from Lynne F. Riley, a total of $136.6 million in victims' payments have now been approved. In addition to the second payments that total includes 1,836 initial checks to victims deemed qualified.
The payments are coming from funds amassed in the bankruptcy of the New England Compounding Center, the now defunct Massachusetts firm blamed for the outbreak.
Riley reported that all appeals have now been processed either by Epiq, the company hired to administer the fund or the federal judge assigned to handle appeals. As a result a total of 2,036 claims have been fully or partially approved, 41 were deemed invalid and two were withdrawn.
In an earlier report Riley stated that a third payment to victims will come at a later date following the resolution of tax issues.
In addition to the payments from the so-called national settlement, Riley said that 226 checks have been approved for payment from funds derived from settlements with individual clinics where victims were injected with fungus contaminated steroids.
Still other clinic settlements, including one in Nashville, are being handled separately and not by Riley.
In another filing today attorneys asked a federal judge to approve a payment of $26,129 to the company administering the Nashville settlement. Other details of the Nashville settlement with the Saint Thomas Outpatient Neurosurgical Center have been filed under seal.
The 2012 outbreak sickened some 778 patients in at least 20 states. Seventy-six of those have died.
The report comes as a supervising pharmacist for NECC is in trial on racketeering and second degree murder charges.
Testimony continued today in the trial of Glenn Chin. A codefendant, Barry J. Cadden, is already serving a nine-year federal prison sentence. He was convicted of racketeering and mail fraud but cleared of 25 counts of second degree murder.

Tuesday, September 19, 2017

First Suspicion in Outbreak Focused on Nashville

By Walter F. Roche Jr.

Boston, Mass. -- A top federal health official testified today that he first thought that the cause of a growing and deadly outbreak would be found in the Nashville clinic where the first case of fungal meningitis was reported.
Dr. Benjamin Park, testifying as the lead witness in the racketeering and second degree murder trial of Glenn Chin, said that while he first suspected the outbreak was limited to the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn. he soon learned the outbreak traced back to the Massachusetts drug compounding firm that shipped contaminated steroids to clinics in 23 states, including Tennessee.
Park testified after Assistant U.S. Attorney George Varghese told jurors it was Chin who was responsible for sending out contaminated drugs that killed the 25 patients in seven states.
Citing the case of Kentucky Judge Eddie Lovelace, who was injected at the Nashville clinic, Varghese said it was Chin who certified that the vials of methylprednisolone acetate were sterile.
Instead, he said, they were contaminated with deadly fungi that traveled to Lovelace's brain eating blood vessels and causing a massive stroke.
Chin's legal team made an immediate call for a mistrial because he said Varghese had given jutors misinformation about the standards required of the New England Compounding Center, which employed Chin as a supervisory pharmacist.
U.S. District Judge Richard G. Stearns denied the mistrial motion but then clarified for jurors the source of the standards NECC was expected to meet.
Stephen Weymouth, Chin's lawyer said in his opening statement that prosecutors were attempting to portray Chin as "a horrible villain" who was responsible for the outbreak.
Citing statements by prosecutors in the recent trial of codefendant Barry J. Cadden, Weymouth noted that they called NECC "Cadden's baby" and that they repeatedly claimed that everything that happened at the now defunct Framingham, Mass. company happened because Cadden ordered it.
Cadden was convicted of racketeering and mail fraud charges but cleared of the same 25 second degree murder charges now facing Chin. Cadden was given a nine year prison sentence.
Park, an official of the U.S. Centers for Disease Control and Prevention who also testified in the Cadden trial, said the first word of a possible outbreak came from Dr. Marion Kainer of the Tennessee Health Department. In a call in early September of 2012, Kainer told the CDC a patient had died after being injected with a spinal steroid at the Nashville clinic.
As additional cases were reported, Park said he became more and more concerned. He said the strokes were in an unusual area at the center of the brain.
He said there were a lot of common denominators in the initial cases which caused him to think something was going wrong at the Nashville clinic. He said that feeling was reinforced after a conference call with Cadden and another NECC officer who told the CDC there had been no other complaints from NECC customers.
A turning point came when a new case was reported at a North Carolina clinic on Sept. 26. That clinic also had purchased steroids from NECC and the victim suffered the same unusual stroke.
"This told us it was outside the (Nashville) clinic," Park said.
While relieved they had found the source, Park said he also learned that some 14,000 doses of suspect steroids already had been injected in patients in 23 states.
"I was quite scared," Park said.
On cross examination by Weymouth, Park was challenged on his comparison of the meningitis outbreak with an ebola epidemic that killed thousands of victims.
Weymouth also presented records showing thousands of vials of NECC drugs were shipped and injected in patients without any evidence of injury. He also raised questions about the lack of evidence that one of the three lots of suspect steroids actually harmed anyone.
In his opening statement Weymouth said the second degree murder charges were unjustified.
"It's not murder," he said, adding "he (Chin) did make mistakes for sure."
Instead he said that despite the intensive federal investigation, the exact fungus contained in the steroids was never found at NECC.
"No one could determine exactly what happened in that clean room," he said.
In his opening statement Varghese showed jurors an email from Cadden to Chin in which he reported a "fungal bloom" had been detected in the clean room. That was just one day before one of the suspect lots was prepared.
Nonetheless, Varghese said, NECC failed to inform federal investigators about that finding when the investigation was underway.
And the prosecutor said there were multiple other problems with NECC drugs including some contaminated with bacteria and others made with outdated components.
He cited an email from Chin to Cadden in which he described one component of a juvenile cancer drug this way.
"When I say old, I mean old," Chin wrote.
"They used it anyway," Varghese concluded.

Monday, September 18, 2017

Chin Seeks to Block Prosecution Testimony

Walter F. Roche Jr.

Contending they have nothing to do with the case against his client, the attorney for the pharmacist facing 25 counts of second degree murder, is asking that federal prosecutors be barred from putting on two witnesses who testified in a related case.
The lawyer for Glenn Chin is asking U.S. District Judge Richard G. Stearns to bar prosecutors from putting Ken Boneau and Michele Adelina on the witness stand in a trial due to start tomorrow in U.S. District Court in Boston, Mass.
In his motion Stephen Weymouth said the two witnesses knew little or nothing about Chin, who was a supervising pharmacist for the defunct New England Compounding Center, the company blamed for a deadly 2012 fungal meningitis outbreak.
Stephen Weymouth, Chin's attorney, noted that Boneau and Adelina were prosecution witnesses in the trial of Barry Cadden, who was part owner and president of NECC. Cadden was convicted of racketeering, conspiracy and mail fraud, but was cleared on second degree murder charges.
Weymouth's motion charges that Chin had nothing to do with the creation of a series of training videos used for NECC's sales force. Adelina testified at Cadden's trial that he was involved in the taping of those training tapes.
The motion states that Chin also had nothing to do with the NECC promotional materials that Boneau testified about in the Cadden trial.
The U.S. Attorney responded by stating that witnesses' testimony should be allowed because their statements would help establish the existence of a conspiracy, in which Chin was a party, to deceive NECC's customers about the quality and sterility of NECC's products.
The charges against Cadden and Chin stem from the criminal probe of the 2012 fungal meningitis outbreak which sickened 778 patients in 20 states, killing 76 of them. The now defunct NECC shipped thousands of contaminated vials of methylprednisolone acetate to health providers across the country.
Cadden is now serving a nine year prison sentence following his March conviction on 57 felony counts.

Sunday, September 17, 2017

Outbreak Victims to Attend Chin Trial

By Walter F. Roche Jr.

Several victims of a deadly fungal meningitis outbreak will be on hand in a Boston, Mass. courtroom when federal prosecutors begin Tuesday to present their case against a pharmacist charged with second degree murder in the death of 25 patients.
Some of the victims or their survivors will be attending as guests of the federal government while others plan to attend at their own expense.
They will be coming from several states including Kentucky, Florida, Indiana and Georgia. The outbreak, caused by spinal steroids contaminated with deadly fungi, sickened 778 patients in more than 20 states. Seventy-six of them died.
Those slated to attend include the family of Eddie Lovelace, a Kentucky judge who died after getting a spinal injection at a Nashville, Tenn. clinic. Others include a retired police officer from Indiana and an X-Ray technician from New Jersey.
Susan Engel Edwards, who was sickened after an injection at a Minnesota clinic, said she is scheduled to observe the trial in early October. She now lives in Georgia.
Several victims already attended the trial of co-defendant Barry Cadden, the former president of the New England Compounding Center, the now defunct company that produced the tainted steroids. Cadden, who was found guilty of racketeering and conspiracy charges, is serving a nine-year prison sentence.
Dawn Elliott, an Indiana victim of the outbreak, is hoping to attend. Injected five times with tainted steroids, Elliott was on hand for a good portion of the Cadden trial.
The Chin trial is expected to include testimony from former NECC employees, some of who testified at the Cadden trial.
Chin was a supervising pharmacist at NECC and he was in charge of the clean room where contaminated methylprednisolone acetate was produced.

Thursday, September 14, 2017

DOJ Seeks to Block NECC Depositions

By Walter F. Roche Jr.

Federal prosecutors are asking a federal judge to block an effort by a Rhode Island clinic to depose key figures from the now defunct company blamed for a deadly fungal meningitis outbreak.
In a six-page motion filed today in U.S. District Court in Boston, Mass., Assistant U.S. Attorney Amanda Strachan charged that Ocean State Pain Management was "forum shopping" and trying to bypass a previous ruling barring depositions of officials of the New England Compounding Center and a related sales company.
Lawyers for Ocean State have moved to depose Barry Cadden, the convicted former president of the New England Compounding Center, Joseph Connelly, a former NECC employee and NECC's one time sales chief Robert Ronzio. Also on the list is John Notarianni, another sales official employed by Medical Sales Management, an NECC affiliate.
"The court should not sanction the defendant's' forum shopping," the U.S. Attorney's motion states. "The Ocean State defendants are bound by that (prior) ruling."
Ocean State is one of dozens of health facilities that injected patients with  fungus laden steroids purchased from NECC in 2012.
Strachan noted that Ocean State joined in a similar motion filed by attorneys for a Tennessee clinic. That motion was denied.
"The court should not allow them to proceed," the government motion states.
The action comes as the second major defendant in the criminal case stemming from the outbreak is about to go to trial.
Opening arguments are scheduled for Tuesday in the case against Glenn Chin, who was a supervising pharmacist at NECC. He has been charged with racketeering and 25 counts of second degree murder.
Cadden, who is now serving a nine-year prison sentence was convicted of racketeering and mail fraud charges in a 10-week trial ending in March. He was cleared of second degree murder charges.