NECC Drugs Tested up to 5,000 Per Cent Potent

By Walter F. Roche Jr.

BOSTON, Mass. Drugs produced by the company blamed for a nationwide fungal meningitis outbreak contained ingredients that tested up to 5,019 per cent stronger than they were supposed to while other products contained not even a trace of a mandated ingredient.
That was the testimony today by Tommy Means, the quality control manager for Analytic Research Laboratories (ARL), in a hearing in U.S. District Court in the murder trial of Barry Cadden the one time president of the drug company, the New England Compounding Center.
Means told jurors that Oklahoma based ARL, which had been doing testing for NECC for over a decade, was asked by an investigator for the U.S. Food and Drug Administration to produce records of its NECC tests during the investigation of the outbreak.
Cadden is on trial on charges of racketeering and 25 counts of second degree murder. He was one of 14 owners and employees of the now defunct NECC blamed for the outbreak, which first surfaced in Tennessee. NECC steroids contaminated with fungus sickened 778 patients, killing 76 of them. 
Under questioning by Assistant U.S. Attorney Amanda Strachan, Means went through a list of aberrant test results including an antibiotic solution that ARL found contained 5,019 percent of the level of bacitracin that was prescribed.
While Means called that drug "superpotent," he cited other tests with the opposite result. A drug that was supposed to contain famotidine and dexamethasone contained not a trace of famotidine.
A drug that was supposed to contain clindamycin and gentamicin had subpotent amounts of both ingredients, Means testified.
An eye drug lacked the required dose of lidocaine.
But a syringe containing a drug called Mannitol, contained 169.1 per cent of the prescribed dose.
Means was not asked what effect the errant dosages might have had on patients, but he was grilled by Michelle Peirce, one of Cadden's lawyers about ARL's own record.
Citing an FDA inspection report prompted by the outbreak, Peirce asked Means about the FDA finding that ARL had not been collecting adequate samples of the drugs the company had been testing.
Means acknowledged that ARL changed its order forms following the FDA inspection. Peirce also produced internal ARL records showing that a consultant had raised concerns about the number of samples being tested from any given drug lot.
Means said the revised order form was meant to make it clear that the number of samples were supposed to comply with an industry standard.
Twice during the cross examination, U.S. District Judge Richard G. Stearns told Peirce to end her line of questioning.
"That's the last word on that subject," Stearns said following a series of questions on sterility testing.
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Widow Details Husband's Outbreak Death

By Walter F. Roche Jr.

BOSTON, Mass. The widow of a Virginia victim of the 2012 meningitis outbreak told a jury today that doctors were confused and couldn't figure why the antibiotics they were giving him weren't working. Days later he was dead after suffering four strokes.
Sharon Wingate broke down in tears several times as she described her husband's final days. He died Sept. 18, 2012, just 12 days after being injected with a fungus loaded steroid from a Massachusetts drug compounder.
Wingate said she and her husband were getting ready to take a long awaited ocean cruise when he began to experience a painful recurrence of neck and back pain. His right arm was going numb. He had gotten injections before and they had provided some relief, so they went to Insight Imaging in Roanoke where he was injected on Sept. 12
Her testimony came in the trial of Barry J. Cadden, the president and part owner of that Massachusetts drug firm, the New England Compounding Center. Cadden has been charged with second degree murder in the death of Douglas Wingate and 24 others.
NECC shipped the contaminated methylprednisolone acetate to health facilities in more than 20 states. Federal health officials say those drugs sickened 778 patients, killing 76 of them.
Sharon Wingate said the doctors treating her husband assumed he was suffering from bacterial meningitis, but a subsequent autopsy showed it was fungal meningitis, a form of the disease requiring a completely different drug regimen.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Wingate recounted how she and her husband first met when they worked for the same company. They had two children, Amber and Austin. He doted on them.
He was in good health, she said, except for his back.
After getting the shot, she said he had some improvement, but was hit almost immediately with a piercing headache.
"Nothing could alleviate the pain," she said, adding that he also had extreme sensitivity to light.
After a trip to the emergency room and a spinal tap, doctors concluded he had meningitis, but they assumed it was the more common bacterial firm.
The antibiotics weren't working and she got a call from the hospital on a Saturday morning informing her that he had become unresponsive.
"He couldn't speak. He couldn't respond. He could squeeze my hand, that was it," she said.
In other testimony, the chief pharmacists at hospitals in Illinois and Florida told jurors how they came to purchase drugs from NECC. Both said they relied on assurances from NECC that they complied with national standards to assure the sterility and quality of their products.
Derek Carvalho, a former worker in NECC's clean room and a prosecution witness testified that at times expired and untested drugs were used by he and other workers. He also acknowledged that on more than two dozens occasions, tests showed bacteria on his gloves.
He said that another clean room worker, Scott Connelly, did not have a required license from the state and that Connelly used Cadden's license number and initials on official forms for the drugs he had processed.
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Doctor Says Some Outbreak Victims Face Lifelong Battle

By Walter F. Roche Jr.

BOSTON, Mass. A physician who unknowingly injected dozens of his patients with a fungus tainted steroid says some of the victims will be fighting lingering infections for the rest of their lives.
Dr. Edward Washabaugh testified in U.S. District Court that federal officials concluded 17 patients at Michigan Pain Specialist clinics died as a result of being injected with methylprednisolone acetate contaminated with fungus.
His testimony came in the trial of Barry J. Cadden, who has been charged with racketeering and 25 counts of second degree murder for his role in the deadly 2012 outbreak. Cadden was president and part owner of the New England Compounding Center, the company that produced the deadly steroids.
The 15 juror also heard further testimony from a former NECC employee, Owen Finnegan, who described how he and other workers switched labels on drug products concealing the fact that components had expired.
He also described how completely unlabeled and undated drugs were stored in plastic bags within the NECC clean room for use when orders overwhelmed the staff.
Washabaugh, the Michigan physician, said he first learned of the outbreak on Oct. 3 from a message that had been left on the clinic's voice mail the night before.
At first, he said, he didn't grasp how serious the situation was. He learned fast.
"By Oct. 5 two of my patients had died," Washabaugh said.
Asked to describe his first telephone conversations with the victims and survivors of victims, the pain specialist turned away, paused and then, trying to collect himself poured a glass of water, before continuing his testimony.
He said his first call was to a patient who was indeed sickened and died two weeks later.
He said as the days passed the clinic went into triage mode, first, on instructions from state and federal regulators, calling all the patients who had received shots from the lot of drugs identified by those officials as the likely source. The clinic had been shipped one of three suspect lots of methylprednisolone acetate.
He said the clinic tried to reach NECC, but the calls went unanswered.
Washabaugh said that the apparent cases quickly began to multiply, ultimately some 230 clinic patients were sickened.
He said a special unit was set up at a nearby hospital, Saint Joseph's Medical Center. Doctors, he said were working double shifts performing spinal taps on patients to test for any traces of fungal meningitis. Some patients had to undergo multiple taps.
In addition to meningitis, Washabaugh said they were discovering patients who had injections in joints, such as hips and knees were suffering from abscesses caused by the NECC steroid.
"These were very painful," he said.
The infected patients were treated with powerful antifungal medicines which Washabaugh said were the equivalent of chemo.
"These drugs are very very harsh," he said.
In addition to Washabaugh, a clinic employee, Deborah Kushman, testified about how the clinic became an NECC customer. She said she saw a company display at a trade show in 2005 and saw a display describing NECC's state of the art facilities and its compliance with highest sterility standards set by a nation agency.
"I wanted to make it was what it said it was," she stated, adding that she contacted a sales representative who assured her that NECC drugs would only be shipped after they tested negative for the presence of endotoxins or micro-organisms.
The jury also heard testimony from Andrew Cordiale, a drug buyer from a Glens Falls, NY hospital, who said after the facility became an NECC customer they were instructed to include fake names of patients when submitting orders. He said they were instructed to make sure the names sounded legitimate.
"They just needed a name to fill it in," he said, "a name that sounded real enough."
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Key Witness Challenged in Cadden Trial

By Walter F. Roche Jr.

BOSTON, Mass. A key prosecution witness was challenged repeatedly today by attorneys for Barry J. Cadden, who is on trial on charges that could put him in jail for life.
Cadden's lawyer, Michele Peirce, asked Joseph Connolly how he could possibly have seen Cadden from the safe room at the New England Compounding Center when there were two walls between Connelly's vantage point and Cadden's office.
The lengthy questioning came as the racketeering and second degree murder trial of Cadden entered its third week in U.S. District Court.
Cadden is the first to go on trial in the indictment stemming from the 2012 fungal meningitis outbreak. State and federal regulators say the Cadden's company, the New England Compounding Center, sent out fungus riddled steroids that sickened 778 unsuspecting patients, killing 76 of them beginning in the Fall of 2012.
Connolly, a pharmacy technician, who was questioned Friday by Assistant U.S. Attorney Amanda Strachan, testifed that he saw Cadden conferring with NECC supervising pharmacist Glenn Chin, just before he was ordered by Chin to send out an order of drugs made under a new formulation without first having it tested.
The incident came just a day after Connolly testified he and other employees were informed of a new "bullet proof" policy calling for all NECC products to be tested before shipping to customers.
Responding to Peirce's questions, Connolly that he could see the Cadden, Chin and a third NECC employee conferring because the door to Cadden's office was open.
Peirce then questioned whether there was such a door, stating it was not indicated in a blueprint for the NECC building.
"I could see Barry's office door," Connolly stated. "There was a doorway."
Despite the grilling, Connolly stood firm on his previous testimony about an array of apparent problems at NECC's Framingham, Mass. facility including mold and rusting equipment in the clean or sterile room and the use of drug components beyond their expiration dates.
"There was rust all over the place," Connolly said.
Asked why he didn't bring his concerns directly to Cadden, Connolly said he had heard that another employee was fired after going over Chin's head to bring complaints directly to Cadden.
Peirce also challenged Connolly's testimony about the use of expired drugs, stating that there was a blue container in the clean room where expired drugs were deposited for disposal by an outside company.
Connolly said that that was not the case with all expired drugs.
Peirce asked whether Connolly had yelled at another NECC employee who was supposed to be performing tests to ensure that the clean room was sterile.
Connolly said that he didn't think the worker was qualified for her job and she spent most of her time gossiping.
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Former NECC Technician Details Outdated Drug Use

By Walter F. Roche Jr.

BOSTON, Mass. A pharmacy technician detailed how outdated drugs were routinely used to produce drugs at the now defunct New England Compounding Center.
Taking the witness stand for the second day in a row Joseph Connolly went through a list of more than a dozen drugs he compounded at the Framingham, Mass. headquarters of NECC.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Connolly said the company routinely produced drugs made from components that had expired. A new expiration date was then placed on the newly produced drug.
Connolly also testified that drugs were often shipped out the day they were produced and not waiting for after production testing to determine whether the drug was sterile and had the required potency.
NECC has been blamed for a deadly nationwide outbreak of fungal meningitis 
His testimony came at the end of the second week in the trial of Barry J. Cadden, NECC's president and part owner. Cadden has been charged with racketeering and 25 counts of second degree murder.
NECC has been blamed for the 2012 outbreak of fungal meningitis, which sickened 778 patients, killing 76 of them.
Among the drugs was an injectable, aromine, which was compounded with a drug that had gone three months past its expiration date. Another drug he testified was made from a component seven months past it expiration date.
Connolly also testified that his brother Scott, who had surrendered his pharmacy technicians license was allowed to work as a technician in the clean rooms at NECC. Scott Connolly is a defendant in the case and is expected to go on trial in April.
Joseph Connolly said his brother told him that he used Barry Cadden's initials on company documents because he couldn't use his own because he lacked a license.
Massachusetts Pharmacy Board records show Scott Connolly surrendered his license while under investigation for improper handling of a compounded drug.
Under cross examination by Michele Peirce, Connolly was questioned extensively about his training while at NECC. Her questioning will continue Monday

Cadden Boasted of Control Over Regulators

By Walter F. Roche Jr.

BOSTON, Mass. The head of a now defunct Framingham, Mass. drug compounding firm boasted to his sales staff that state and federal regulators didn't know what they were doing and he had to educate them so they'd stop bothering him.
That was one of the messages Barry J. Cadden delivered to the sales staff for the New England Compounding Center in a series of taped training sessions in 2011 and 2012.
The tapes were played today in U.S. District Court during Cadden's trial on charges of racketeering and second degree murder. The trial, which is expected to last several months, will end its second week of testimony Friday.
Cadden was the president and part owner of the drug compounding firm that has been blamed for a deadly 2012 fungal meningitis outbreak which sickened 778 patients, killing 76 of them.
The jurors who will decide Cadden's fate also heard from a former pharmacy technician at NECC who described the atmosphere in the company clean or sterile rooms as "a locker room on steroids."
Joseph Connelly testified that despite claims that it tested all of its products before shipping them out
NECC did not do so for most of the time he worked there.
And even when an end testing policy was finally initiated in 2012, Connelly said he was told the very next day to ship out an order without testing.
The Cadden training tape excerpts, which were introduced over the objections of his lawyers, show Cadden giving instructions to sales staffers of an affiliated firm, Medical Sales Management. Dressed in blue scrubs Cadden's sessions included a tutorial on the attempts by state and federal regulators to train scrutiny on his operations.
Stating that the Massachusetts Board of Pharmacy had issued NECC its first license, Cadden told the staffers, who were employed by Medical Sales Management, an affiliated firm, they are the ones who "hold my life in their hands."
"They don't want to deal with us," Cadden said, adding "They don't know what they are looking at. They were coming down here all the time. I had to educate them. Then they got to understand."
He boasted that now when complaints come in from other states, the Massachusetts Pharmacy Board just says, "Go away."
He also boasted of turning back efforts by the U.S. Food and Drug Administration to inspect and regulate NECC.
"The FDA was trying to take over drug compounding," he said, adding that they were calling compounders "the wolf in sheep's clothing."
(The lack of either state or federal oversight of NECC prompted investigations both in Massachusetts and Washington, D.C. Ultimately tighter regulation was imposed in the wake of the deadly outbreak.)
Cadden told the staffers that NECC went way beyond regulatory requirements in the compounding of drugs.
"A lot of what we do is way above the standard," Cadden said, adding that "As far as quality goes, we do it. We're not selling jelly beans. We need to bat one thousand."
He instructed the sales staffers to "drop those names" of NECC's big customers when soliciting new business and to stress to potential hospital customers that buying from NECC would eliminate the risk of something going wrong in in-house operations."
In his testimony Connolly, the pharmacy technician, said it was difficult to raise safety comcerns because any efforts would be rebuffed by his boss Glenn Chin. Chin like Cadden is facing racketeering and second degree murder charges. His trial will be held when Cadden's is completed.
He said when he raised concerns, they went nowhere.
With photos displayed by prosecutors, Connolly described rusted equipment, floor defects covered with plastic and tape, and a wide opening to non-sterile areas, all in the rooms that were supposed to be perfectly sterile.
He said that when spiders, flies and other insects appeared, he and other workers would spray them with alcohol.
Connolly said the air conditioning in the clean room area frequently failed sending temperatures soaring especially in summer months. This despite the fact that the some of the chemicals they were using were temperature sensitive. He said one co-worker had to leave the area because he was getting faint.
He said that when the company's regulatory problems heated up in 2012, they were ordered to stop making drugs and clean up the area because inspectors were coming.
On another occasion he said a worker from a sister company, Ameridose, came into the clean room area with some drugs from that firm.
"You don't see this," Connolly said the Ameridose worker told him.
Connolly said there was a big increase in product being produced at NECC in the Spring of 2012. He said he warned that "Something's going to happen. We're going to get shut down."
NECC shuttered its doors for good in October of 2012, just a month after the deadly outbreak became public.
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Widow Details Tennessee Victim's Final Battle

By Walter F. Roche Jr.

BOSTON, Mass. -The widow of one of the first victims of the 2012 fungal meningitis outbreak told a jury today about her husband's fight to stay alive and his last minute recognition of what was killing him.
Colette Rybinski of Smyrna, Tenn. testified that her husband' Thomas' doctors were struggling for days to figure out how he had contracted meningitis. They needed the answer in order to know how to treat him.
Recalling his deteriorating condition, Rybinski said that at times he was unable to communicate but then he would become lucid.
"He looked at me and said, 'It was the shot,'"she said describing one of those lucid moments.
The shot, a spinal injection with methylprednisolone acetate, was administered on July 30, 2012 at a Nashville, Tenn. clinic. Laden with fungus the vial had been shipped, along with more than 17,000 others, from the New England Compounding Center in Framingham, Mass.
Rybinski's testimony came on the eighth day in the trial of Barry Cadden, the former president of that now defunct drug compounding firm. Cadden has been charged by a federal grand jury with racketeering and 25 counts of second degree murder. One of those murder charges is the death of Thomas Rybinski.
The outbreak sickened 778 patients killing 76 of them.
Rybinski said her husband had a prior spinal injection for persistent lower back pain at the same clinic, the Saint Thomas Outpatient Neurosurgical Center, but this time he was not getting the relief he expected.
Instead, she said he woke up with a screaming headache. He was eventually admitted to the Vanderbilt University Medical Center, also in Nashville, where doctors tried to figure out what was happening.
At first they thought it was a contagious form of meningitis, she said, so they put him into isolation. But treatment with antibiotics proved ineffective.
"It was very up and down," she said.
Rybinski recalled one day during the illness when a television program about Alaska came on and she asked him if he wanted to watch it. They had honeymooned in Alaska
"Do you want to watch it. He said no," she testified.
"Do you remember our honeymoon, I asked. He said no."
She said she got the same answer when she asked him if he remembered getting married, but he said he did know who she was.
Meanwhile doctors were doing test after test trying to determine how the meningitis got into his body.
Rybinski said she eventually learned he had suffered multiple strokes, and even a last minute surgical procedure was of no help. Though the fungus, aspergillus, was finally identified, it was too late.
He was transferred to a hospice where he died on Sept. 29. He was 55.
In other testimony Kenneth Boneau, a salesman for an affiliate of NECC, Medical Sales Management, described the company sales efforts including brochures which touted the testing and sterility of the company's drug drug products.
He said the company claim's that it complied with the strictest standards was a big selling point. He was also questioned repeatedly about the company efforts to get the names of real patients for each dose of drugs sold to healthcare providers.
Earlier in the day Dr. John Culclasure, the medical director at the Nashville clinic, acknowledged that one patient list submitted to NECC included the name Mickey Mouse. But he said the use of the names Mickey and Minnie Mouse were "spaceholders" so that he and other doctors would not get booked to do two procedures at once.
Culclasure, who said he has performed some 50,000 spinal injections in his career, said the use of the cartoon characters' names was not intended to fool anyone.
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Outbreak Doctor Breaks Down on Witness Stand

By Walter F. Roche Jr.

BOSTON, Mass. A doctor who suddenly found himself in the midst of a growing public health crisis broke down in tears as he told a jury about his first encounter with patients who had been sickened from injections he administered.
Testifying in U.S. District Court, Dr. John Culclasure said he and his colleagues had expected the patients to be angry and blame them for the fungal meningitis they were suffering from.
"Instead they were concerned about us. I was shocked," Culclasure said.
U.S. District Judge Richard G. Stearns called a short recess as Culclasure wiped tears from his eyes.
Culclasure was the medical director and chief physician at the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn., the clinic where 115 patients were sickened after being injected with fungus laden spinal steroids shipped from a now defunct Massachusetts drug compounder.
The testimony came at the beginning of the second week in the criminal trial of Barry J. Cadden, the president and part owner of the New England Compounding Center, the company blamed for the 2012 outbreak which sickened some 778 patients, killing 76 of them. Cadden is facing charges of racketeering and 25 counts of second degree murder.
Culclasure said that 13 patients from the Nashville clinic eventually died, including Thomas Rybinski, the first patient to be identified as a victim. He said they later learned that there was an even earlier Tennessee victim, Kentucky Judge Eddie Lovelace. The judge's body had to be exhumed to determine the cause.
The doctor described the first hints of the outbreak, including the news that Rybinski was under treatment for a fungal infection at the nearby Vanderbilt University Medical Center.
"I was trying to see what was common among the victims," Culclasure said. He said in addition to the methylprednisolone acetate from NECC, patients were treated with a numbing agent and a dye before the spinal injection.
He said they closed the clinic and then started calling all the patients recently injected to see if they were showing symptoms of meningitis.
"The patients kept coming," he said. "It didn't make sense to me. I've never seen anything like that in all my years of training."
Though at first there was concern that something at the clinic was to blame, he said that was eventually eliminated when outbreak cases began popping up across the country. That left the NECC steroid as the common denominator.
Once victims were identified, he said they were put on powerful anti-fungal medications. He said those medications were extremely toxic. "The cure was almost as bad as the disease itself," he said
He said that as the enormity of the crisis became more apparent Tennessee Department of Health officials stepped in and began directing the efforts. He said those state officials directed his staff not to use the word meningitis in talking with patients.
Under cross examination by Bruce Singal, Cadden's attorney, Culclasure was questioned about the clinic's decision to purchase drugs from NECC.
Asked if NECC filled an important need, Culclasure said yes. He said the clinic began sending NECC lists of patients after the company told them they were needed due to a Massachusetts law. But he acknowledged they couldn't really identify which patients would be injected ahead of time.
He also acknowledged that the fungus found in Rybinski, aspergillus, was different than the fungus found in other clinic victims.
Court records show the Nashville clinic reached a settlement in a civil suit brought by outbreak patients, but the terms of that settlement have not been made public.
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Ex NECC Salesman Gives Outbreak Details

By Walter F. Roche Jr.

BOSTON, Mass - A former salesman for the company blamed for the deadly 2012 fungal meningitis outbreak provided new details of the onset of the tragic event  as he made a sales call to the Tennessee clinic when the first victims were becoming ill.
Testifying under a grant of immunity, Mario Giamei Jr.  also testified that the man on trial, Barry J. Cadden, gave his personal approval to allow healthcare providers to purchase drugs without the names of patients, as required by law.
Testifying in U.S. District Court here in the trial of Barry Cadden, Giamei, said when he visited the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn. in September of 2012  the outbreak had not yet been made public, but some patients had already been sickened.
Cadden has been charged with racketeering and 25 counts of second degree murder as a result of a two year federal probe of the outbreak, which took the lives of 76 patients and sickened 778.
He said the clinic had contacted his office looking for test results on the lots of drugs the clinic had purchased.
He said officials of the clinic asked whether the drug company headed by Cadden, the New England Compounding Center, had received any reports of problems with their drugs.
By the time he got to the Nashville clinic he said it had already closed down. He said a patient came in who had not gotten the message his appointment had been postponed. He said the patient was sent home and told the clinic had shutdown due to a mechanical issue.
Giamei, who was in charge of the clinic's account, said he assured clinic officials, including Dr. John Culclasure, that there were no problems with  the spinal steroids from NECC.
"I assured him it couldn't be us and we would stand behind him," he testified.
He said Culclasure expressed concern that the needles he used for the spinal injections might be involved because he used a different type of needle than most physicians.
Giamei said another clinic employee told him that the Tennessee Health Department was already investigating the illnesses. He said Culclasure told him there were six patients who had taken ill after receiving steroid injections at the clinic.
He said after the visit he got a call from Cadden, who wanted to know what happened.
He said Cadden told him he shouldn't have gone.
"They're going to blame us. It's a legal matter," Giamei said Cadden told him.
Giamei said he later wrote a lengthy email describing his Nashville visit.
Under questioning from Assistant U.S. Attorney George Varghese, Giamei, who was actually employed by an NECC affiliate, Medical Sales Management, described how Cadden's personal approval was necessary when a customer wanted to purchase drugs without naming the patient, a legal requirement in Massachusetts and many other states.
Varghese showed emails in which Cadden did just that.
"It's okay to ship without the names," Cadden wrote in an email to Giamei.
"OK, no names is no problem" Cadden wrote in another email 
He said the size of the order and the client's history as a customer were factors in getting Cadden's approval.
He said in some cases the clinics would "backfill,"  by using the names of past patients to place subsequent orders.
The emails displayed by Varghese showed Cadden approved sales without patient names for a clinic in Thomasville, Ga. and another in New Jersey.
Giamei did acknowledge that Cadden frequently told the sales staff they did have to have names.
 In one email to sales staffers Cadden wrote that the problem was with Massachusetts law.
"We must not appear to be a manufacturer," the memo stated.
Under cross examination, Giamei agreed that his customers often resisted providing patient names due to confidentiality laws.
And he acknowledged that he told customers that NECC's products were tested and safe. He said at that time he believed  that to be the truth.
Asked if he still believed it, he said, "I don't know what to believe anymore."
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Victims Watching as Cadden Case Proceeds

By Walter F. Roche Jr.

BOSTON, Mass. As the case of the worst American public health tragedy in recent memory unfolds in a 7th floor federal courtroom here, one spectator has a perspective vastly different from the lawyers, regulators and reporters filling the benches.
Dawn Elliott was injected not once, not twice but five times with steroids from the company blamed for the deadly 2012 fungal meningitis outbreak. And now the former head of that company, Barry J. Cadden, is on trial here on racketeering and second degree murder charges stemming from a grand jury probe of the outbreak and his company.
Elliott, who lives in Bristol, Ind., is one of the victims who took after filling out a questionnaire took advantage of an offer by the U.S. Department of Justice to attend at least part of the trial.
Elliott, 55, is spending the current week watching the proceedings before U.S. District Judge Richard G. Stearns.
"I hope this gives me some mental closure. I'll never have physical closure," Elliott said in an interview after a recent session. In fact she had to leave the courtroom early after becoming nauseous.
Even now, more than four years after first becoming ill, Elliott suffers not only from the after effects of fungal meningitis but also from lingering effects of the powerful anti-fungal drugs that had a crippling and debilitating effect.
"It was like going through chemo every day," Elliott recalled. "I actually prayed for my death, while my family prayed for me to live."
She said there were hallucinations and flashing lights and a feeling of going through a tunnel.
At one point, she said her sister called their father to tell him that he better come right away if he wanted to be able to say good bye.
At another point she was so desperate she threatened suicide, sending her sister into a panic as she rushed to her side.
In the aftermath she learned that all of her injections with methlyprednisolone acetate came from the three NECC lots contaminated with fungus. Two came from the lot most badly contaminated.
There are ironies in her story.
She has spent much of her life working in the pharmaceutical field, where part of her job was to make sure that all the rules were followed.
"That was what I dedicated my life to," she said.
She said she said she chose to get spinal injections because she wanted to avoid surgery and its after effects. And she wanted to keep her job and continue her active hobbies like scuba diving.
In the end she had multiple surgeries, had to quit her job and has severe limits on physical activities
"It's taken everything away from me," she said.
Elliott like other survivors also faces the uncertainty of what lies ahead. The outbreak was without precedent and long term effects including possible relapses are a possibility.
"We're a bunch of lab rats," she said.
As for the trial, which has been marked thus far by lengthy technical testimony, procedural hurdles and the introduction of dozens of exhibits, Elliott says she just hopes that the jurors will be able to understand it all.
"I can't believe all that I've learned," she said referring to complex regulatory details that allowed NECC to become what it was.
 Christina Sterling, spokeswoman for the U.S. Attorneys Boston Office, said the agency regularly offers victims the opportunity to attend court sessions of the cases they are involved in. That included victims in the Boston Marathon bombing case.
 "Victim travel is funded through the Department of Justice," Sterling said. "We always try to accommodate victims who wish to be present for court proceedings."
In addition to victims from Indiana, others who either have come or are scheduled to attend future sessions are from Tennessee and Michigan, two of the hardest hit states in the outbreak.

New Evidence Links Cadden to Faked Prescriptions

By Walter F. Roche Jr.

BOSTON, Mass - Federal prosecutors presented new evidence today linking Barry Cadden to fake prescription lists produced as part of the case against him on racketeering and second degree murder charges.
Documents introduced into evidence show Cadden, the former president and part owner of the New England Compounding Center, was the verifying pharmacist on fake prescription lists including such names as Chris Rock, David Spade and Matthew Perry.
The documents were filed at the tail end of a long session in which Cadden's lawyer, Bruce Singal, repeatedly challenged and questioned Frank Lombardo, a special investigator for the U.S. Food and Drug Administration, who has been on the witness stand since Tuesday.
The records introduced included NECC drug order forms with a verification page attached. On each verification page, Cadden's name was checked as the verifying pharmacist.
After the 15 jurors left for the day U.S. District Judge Richard G. Stearns called on Singal and Assistant U.S. Attorney Amanda Strachan to stop wasting time on irrelevant issues.
"Can't you agree on these exhibits?" Stearns asked.
"Yes, we will try" Strachan replied.
The exchange came on the fourth day of testimony in the case against Cadden who faces 25 counts of second degree murder. He was indicted following a lengthy probe of the 2012 fungal meningitis outbreak, which took the lives of some 76 patients across the country.
NECC, the now defunct Framingham, Mass. drug compounding firm has been blamed for shipping more than 17,000 vials of fungus laden steroids to health facilities across the country.
Earlier in the session Singal repeatedly challenged Lombardo, who Wednesday introduced a series of items seized from NECC in 2012 including over a dozen chemicals used in drug production that had passed their expiration dates.
Singal asked whether there were bottles of the same chemicals at NECC that had not expired and, if so, why they weren't they produced.
Lombardo said he didn't know.
"Nobody looked, did they?" Singal retorted.
Singal also asked whether Lombardo had any proof the expired chemicals were ever used after the expiration dates, which ranged from 2003 to 2012.
Lombardo said he didn't know.
Strachan raised repeated objections to Singal's questions. Most were turned down by Stearns.
At one point Singal repeatedly challenged Lombardo over the wording of a document. After 10 minutes in which Lombardo said he couldn't answer the questions, Singal conceded that he was looking at the wrong document.
Singal also questioned NECC environmental monitoring reports Lombardo had produced earlier in the week showing mold and other contamination. Charging that there were many other reports that
showed no contamination, Singal said, "You didn't show us those pages, did you, Mr. Lombardo?"

Outdated Drugs Displayed in Compounding Case

By Walter F. Roche Jr.

Expired drugs, some nearly a decade old, seized from a drug compounding firm, were entered into the record today in the second degree murder case against Barry Cadden, the former head and part owner of the New England Compounding Center.
U.S. Food and Drug Administration Special Agent Frank Lombardo identified the drugs which he said had been seized from NECC's Framingham, Mass. headquarters in 2012. Most of them were found in so-called clean rooms where sterile drugs are supposed to be compounded.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Lombardo also identified a series of files also seized from NECC  in which fake names had been entered as the patients receiving the drugs. The lists came from orders placed by health providers in Texas and Nebraska.
The names included Burt Backarek, Miles Davis, Donald Trump, Wayne Gretzky, Ja Ja Gabor and Tom Brady.
Emails entered into evidence included one from Barry Cadden in which he warned staffers not to use obviously fake names.
"All names must resemble real names," Cadden wrote, adding, not obviously fake names like Mickey Mouse.
In another email Cadden reported that the company "had run into some issues with hospitals" in Colorado.
Records show that the Colorado Pharmacy Board  eventually barred NECC from operating in the state because of its failure to comply with a requirement for patient  specific prescriptions.
The testimony came on the third day of the trial of Cadden, who has been charged with racketeering and 25 counts of second degree murder. The charges stem from a federal probe of the 2012 national fungal meningitis outbreak blamed on fungus riddled steroids shipped from NECC to health providers across the country.
 Lombardo testified that in addition to a raid on NECC's Framingham offices in October of 2012, additional records were obtained under a subpoena in subsequent visits to the facility after NECC closed down.
The FDA agent also testified about records of an NECC employee working as a pharmacy technician, a job requiring a state license.
Connolly, who also has been charged in the case, had voluntarily surrendered his license following charges that he had violated state regulations.
Lombardo produced a letter seized from NECC, showing that Connolly was fired on Oct. 12, 2012, shortly after the raid.
The expired drugs seized from NECC included methotrexate, a cancer drug, that had expired in 2007 and a formaldehyde solution that expired in 2003.
In cross examination, Bruce Singal, Cadden's attorney, questioned Lombardo about who was in charge of the clean rooms and presented a chart showing that co-defendant Glenn Chin oversaw the clean rooms.
"Glenn Chin, he was in charge of the clean room," Singal said.
Lombardo acknowledged that was the case. Singel also noted that the lists of phony patient names had been submitted by NECC's customers and the verification of those orders had been made by other NECC employees, not Cadden.
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CDC Official "Very Scared" by Outbreak

By Walter F. Roche Jr.

A federal health official testified today that he became "very scared" as the 2012 fungal meningitis began to unfold and patients were dying at an alarming rate.
"I remember feeling very scared," Dr. Benjamin Park, a division chief at the U.S. Center for Disease Control and Prevention.
In his second day as the prosecution's first witness, Park laid out a sketch of the rapidly developing outbreak from the time in September when the first alarm was sounded by the Tennessee Health Department.
Park described the events following that initial alarm, including a telephone conversation with
Barry Cadden, the man on trial on charges of racketeering and second degree murder. Cadden was a part owner and president of the New England Compounding Center, the firm blamed for the outbreak.
Park said NECC did provide a list of its customers following the conference call with Cadden and Gregory Conigliaro, another part owner of NECC.
At the time of the call, Park said the spinal steroids from NECC were on the list of possible causes of the outbreak. Other candidates included a numbing agent administered before patients were injected with the methylprednisolone acetate, and a dye used in the procedure.
"We did not rule out other causes," Park said, adding, "We didn't know if it was this single (Nashville) clinic."
He described the unfolding tragedy as "remarkable" including the unusual strokes victims were suffering. He said this strokes were in the middle of the brain were "very uncommon."
"I'll never forget it," he said, "something truly tragic was happening."
Park said he became even more apprehensive after learning that NECC had sent out some 17,000 vials of the spinal steroid from the three suspect lots.
On Oct. 4, Park said, the U.S. Food and Drug Administration reported that they had found fungus in an unopened vial of methylprednisolone acetate.
"There's not supposed to be mold in an unopened vial," Park said, adding "they could actually see the fungus."
"About half the people were dying," Park said. "It was very important for us to act quickly."
He said a press conference was called in early October to send out an alarm, along with health alerts to health professionals. "We were looking at a large amount of deaths."
He said those victims treated quickly had a greater chance of survival and recovery, but doctors were  having difficulty making diagnoses.
He said one of the first steps was to identify all those patients injected with the suspect drugs and then contact them to see if they were displaying any of the symptoms.
Calling it "a massive effort," Park said with the help of state and local health officials they were eventually able to contact 99 percent of the 14,000 potential victims."
Park also was questioned extensively about how federal health officials set the parameters of what cases qualified to be part of the outbreak.
He said the concern was that too narrow a definition would leave out many cases, while too broad a definition would likely include many cases that were not part of the outbreak.
"There was a back and forth," he said of the discussions leading to the official case definition.
"The outbreak was very significant, really a public health tragedy," he said adding that only the recent ebola outbreak was comparable.
Park was questioned extensively by Michelle Peirce, part of Cadden's defense team, about a study he co-authored on the outbreak.
She asked if it was possible that some of the vials were not at all contaminated and, if so, what effect that would have on the study results. She also asked if it was possible that vials from the same suspect lots might have been filled on separate days.
Park said that would be a question for the FDA, which was looking into procedures in the NECC facility.
A second witness called by prosecutors was Frank Lombardo, an FDA special agent who led raids on NECC's Framingham, Mass headquarters in 2012.
Lombardo identified numerous records that he said were found in Cadden's office. Responding to questions from Assistant U.S. Attorney Amanda Strachan, Lombardo said the documents included records relating to subpotent drugs shipped to the Massachusetts Eye and Ear Infirmary. The drugs were supposed to numb the eyes of patients undergoing surgery, such as cataract removal.
He also testified about the NECC office setup, which abutted a recycling business run by Gregory Conigliaro.
He also detailed other records seized including the agenda of an upcoming "barnstorming opportunities" session that was to be held among company officials.

Checks Mailed to Over 1,000 Outbreak Victims

By Walter F. Roche Jr.

BOSTON, Mass- Payments from a national trust fund have been mailed to 1,011 victims of the 2012 fungal meningitis outbreak, according to a report filed today in U.S. District Court.
The report which was detailed in a session before Senior U.S. District Judge Rya W. Zobel, shows that payments made thus far from the $130 million to $157 million fund total a little over $34 million.
According to the fund trustee, Lynne Riley, 1,126 claims had been submitted by a Dec. 15 deadline. Claims submitted by that date were to get payments before the end of the calendar year.
Riley reported that 225 of the 1,126 were held up even though they made the deadline because either further information was needed or required releases had not been obtained.
While 901 claims were paid before the end of the year, Riley reported an additional 110 were paid this year.
Overall Riley reported that of the 2,341 claims originally filed 1,996 have been fully or partially approved.
Riley also reported that $6.25 million has been paid to lawyers who performed work beneficial to all the victims. The payment represents one half of the total amount those lawyers are expected to eventually collect.
 Those payments had been approved conditionally by Zobel provided most of the eligible victims were paid one half of their total claims by the end of 2016.
The trust fund was created under the bankruptcy of the New England Compounding Center, the now defunct firm blamed for the 2012 fungal meningitis outbreak. NECC, according to state and federal regulators shipped some 17,000 vials of fungus laden methylprednisolone acetate to health care providers across the country.
Zobel's session began only an hour after a recess was called in the trial of former NECC President Barry Cadden, who is charged with racketeering and 25 counts of second degree murder, among other charges.
Riley also reported that 57 payments have been made to victims from settlements with the clinics where they were treated.
Zobel also received progress reports on still pending cases against clinics in New Jersey, Maryland and Illinois.
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Deadly Outbreak Surfaced In Tennessee

By Walter F. Roche Jr.

BOSTON, Mass. A federal health official testified today that the first word of a deadly fungal meningitis outbreak came from officials of the Tennessee Department of Health, who had learned of a very rare case at a local hospital.
Dr. Benjamin Park, an official of the U.S. Centers for Disease Control and Prevention, was the initial witness called in the case of Barry Cadden, who has been charged with 25 counts of second degree murder following a federal probe of the outbreak.
Park, the chief of CDC's division of infection control, said the call from Tennessee came in September of 2012 and it appeared to be a rare and unusual case of meningitis caused not by bacteria but a fungus.
He said that first report was very quickly followed by three other cases and five more after that.
"All the cases had the same type of infection. They all received injections at the same clinic" Park said. "That's when we knew there was something going on."
Park said that several possible scenarios were considered, including whether there was a problem at the Nashville clinic where all the victims has been injected with a spinal steroid, methylprednisolone acetate.
Eventually he testified they also learned that the spinal steroid injected into all the victims came from the New England Compounding Center in Framingham, Mass.
Park.
"We were concerned because the steroid was compounded," he added. "There have been outbreaks before from compounded drugs."
Though Park's testimony was cut short and will continue Tuesday, the initial case reported was at the Vanderbilt University Medical Center in Nashville, Tenn. A Vanderbilt physician, April Pettit,  has been credited with spotting that initial unsual case.
That patient, like the ones that followed had been injected with methylprednisolone acetate at  the Saint Thomas Outpatient Neurosurgical Center, also in Nashville.
He noted that sterile drugs produced by compounding are considered "high risk."
Park said the CDC asked Tennessee officials to go back to the clinic to get more information.
Meanwhile, as the case count mounted, Park said the CDC issued an alert to health care providers across the country to find out if the outbreak was more widespread.

Prosecutor: Cadden Viewed Company as His ATM

By Walter F. Roche Jr.

BOSTON, Mass.  The head of a now defunct drug compounding firm blamed for the death of 76 patients treated the company as his own personal ATM machine, Assistant U.S. Attorney George P. Varghese told jurors today.
In opening arguments in the case against Barry Cadden, who is facing charges of 25 counts of second degree murder, Varghese said Cadden placed profits over patients and literally made millions in the process.
"NECC was Barry Cadden's baby" Varghese said.
Bruce Singal, Cadden's lawyer, countered charging that Varghese was distorting the truth and there was no evidence of murder.
Acknowledging that the patients' deaths were "shocking to say the least," Singal said Cadden was trying to do the right thing and displayed emails in which Cadden wanted to investigate and correct any errors.
The opening arguments before U.S. District Judge Richard G. Stearns centered on the 2012 fungal meningitis outbreak caused by tainted spinal steroids shipped from the New England Compounding Center in Framingham. According to court documents some 778 patients were sickened in the outbreak.
Cadden is specifically charged with second degree murder in the deaths of 25 patients. Varghese displayed pictures of those victims one by one, including an Ocala Florida man, who had lived "a very healthy lifestyle" and was in good health until he was injected with methylprednisolone acetate produced by NECC.
Varghese charged that even as the outbreak was unfolding Cadden was not forthcoming when first contacted by state and federal regulators. Meanwhile as more victims were sickened doctors were left scrambling for a diagnosis.
"Every single day mattered," Varghese charged but "Cadden didn't tell the truth."
The prosecutor said he would be presenting evidence of multiple incidences of contamination of NECC products including the use of outdated chemicals to produce a pediatric cancer drug.
He said in another case NECC issued doses of a numbing drug for patients undergoing cataract surgery at a Boston hospital, but the numbing agent was completely missing.
Singal disputed both of those examples contending that NECC produced the cancer drugs because doctors were begging for it. And, he said, the chemical when tested proved 97 per cent effective regardless of the age of its components.
He said Cadden himself ordered an inquiry into the incident with the eye numbing agent.
Singal also displayed a copy of an email in which Cadden was critical of an outside testing firm which had not been doing its job.
And Singal said far from failing to notify officials,  Cadden had personally called a hospital administrator to warn that a suspect drug should be set aside and placed "in quarantine." He played a recording of that phone call for jurors.
He read from an email in which Cadden warned employees not to "pencil whip" environmental reviews. Some NECC employees, Singal said, were trying to trick Cadden.
Singal also said that NECC in fact had an excellent record of complying with sanitary and environmental standards.
"Of course mistakes were made," Singal said, "but they weren't criminal. They weren't murder."
He said that Varghese had implied that Cadden was "the owner" of NECC when in fact he only owned 17.5 per cent. His wife had an equal share, but the majority owner held 55 percent.
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Judge Loosens Cadden's House Arrest

By Walter F. Roche Jr.

Defendant Barry Cadden will be allowed to be away from his Wrentham, Mass. home for 17 hours a day during his trial on second degree murder and racketeering charges.
U.S. District Judge Richard G. Stearns Friday approved a motion filed by Cadden's lawyer, Bruce Singal, to allow his client to be away from home from 5 a.m. to 10 p.m. on weekdays to attend court sessions and prepare for those court sessions.
Under his former confinement order Cadden was only allowed to leave his home from 7 a.m. to 7 p.m.
The 7 a.m. to 7 p.m. limit will remain in effect on weekends.
Under a schedule set by Stearns both sides will make opening statements in a session set for 9 a.m. Monday. A heavy snowstorm moving through New England over the weekend could cause delays.
Cadden is one of 14 persons charged in a 131 count indictment issued by a federal grand jury following a two year probe of the 2012 fungal meningitis outbreak, which, according to court documents, caused the death of 76 patients across the country. The dead were among the 778 sickened by fungus loaded drugs produced by the company Cadden helped found, the New England Compounding Center.
Two of the defendants have entered guilty pleas to reduced charges and two other have had charges dismissed. Some of the charges were dismissed against another defendant, but she and seven others are scheduled for trial in April.
Glenn Chin, a supervising pharmacist at NECC, who faces the same charges as Cadden, will go on trial after Cadden's trial is completed.
Contact: wfrochejr999@gmail.com

Twelve Jurors, Three Alternates Selected

By Walter F. Roche Jr.

With opening statements just days away, twelve jurors and three alternates have been chosen to hear the second degree murder charges against the part owner of a Massachusetts drug compounding firm blamed in the deaths of 76 patients.
The jurors were selected today from a panel of 175 called to jury duty earlier this week. They will hear the case by federal prosecutors against Barry J. Cadden, who has been charged with racketeering and 25 counts of second degree murder.
Five men and ten women were selected to hear the case which could last several months. Opening arguments are scheduled to begin Monday morning in U.S. District Court in Boston, Mass.
U.S. District Judge Richard G. Stearns is presiding over the case. A former federal prosecutor, Stearns was presiding over the trial of mobster James "Whitey" Bulger until Bulger's lawyers succeeded in having him disqualified due to his role at the U.S. Justice Department while the case was being investigated.
Cadden's legal team is headed by Bruce Singal, a veteran criminal defense lawyer, who once served as the head of the state Consumer's Council.
Pretrial filings indicate that Cadden will contend that he was not personally aware of adverse laboratory reports and other warning signs that NECC was producing highly contaminated drugs.
In papers filed by codefendant Glenn Chin, Chin's lawyer stated that he had learned that Cadden planned to blame Chin for all the lapses.
NECC has been blamed by state and federal regulators for the deadly 2012 outbreak of fungal meningitis. Court filings in a related case show that some 76 patients died in the outbreak, out of 778 who were sickened.
The victims were injected with methylprednisolone acetate riddled with fungus. One federal regulator referred to the NECC Framingham, Mass. operation as a "fungal zoo."
The company ceased operations in the fall of 2012 and filed for bankruptcy at year's end.
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Jury Won't Hear Outbreak Death Toll

 By Walter F. Roche Jr.

 Next week a federal jury in Boston, Mass. will begin hearing arguments on the largest and deadliest drug contamination disaster in the country's history, but federal prosecutors will be barred from telling the jurors just how deadly it was.
Scheduled for opening arguments Monday is the criminal trial of Barry Cadden, a former pharmacist and drug company owner, who is facing charges of racketeering, 25 counts of second degree murder and mail and wire fraud charges.
According to a filing by a federal agent in a related case, 76 patients died from fungus riddled steroids shipped by Cadden's company, the now defunct New England Compounding Center in Framingham, Mass.
 Joseph Ridgley, a special agent for the U.S. Food and Drug Administration, wrote in the affidavit, that the criminal investigation turned up 12 more deaths than had been reported by the U.S. Centers for Disease Control and Prevention. And, the total number of patients sickened was 778, up from the the 751 in the official CDC count.
But neither the FDA count nor the lower CDC count can be mentioned in Cadden's trial under a ruling issued this week by U.S. District Judge Richard G. Stearns. Under his order prosecutors can refer to the outbreak in general terms and cite "multiple deaths" but not the case counts.
Nor can prosecutors provide details of any deaths beyond the 25 specifically cited in the 131 count indictment.
In a series of pre-trial motions Cadden's lawyer, Bruce Singal, has sought to limit or even eliminate testimony from some of the prosecution witnesses. Stearns has granted some, but not all of those requests.
The Cadden trial will be followed by the trial of NECC's supervising pharmacist Glenn Chin, who also faces second degree murder charges.
Pretrial filings indicate that Cadden intends to charge that it was "Chin and Chin alone" who was responsible for the deaths.

The death toll in a 2012 fungal meningitis outbreak jumped by 12 to a total of 76, according to a massive filing in the criminal case against those blamed for the outbreak

.
The new death toll numbers were included in an affidavit filed by federal agents to justify the seizure of additional assets from the owners of the New England Compounding Center, the now defunct firm blamed for the outbreak.
According to the filing, the number of victims of the outbreak continued to climb even after officials from the U.S. Centers for Disease Control and Prevention stopped updating the case count.
According to the affidavit the number of patients sickened also continued upward reaching 778, 27 higher than the last CDC count of 751.
"The CDC stopped updating its official count as of Oct. 31, 2013," Joseph Ridgley, a special agent for the U.S. Food and Drug Administration, wrote in one court filed affidavit.
"This investigation, however, revealed that the total number of infected patients increased and is approximately 778, of which 76 have died," he continued.
The new numbers were included in filings made by federal officials to justify the seizure of $18.3 million in assets held by NECC founder and stockholder Barry Cadden and co-owners Lisa and Douglas Conigliaro.
All three were named in a 131-count indictment handed up by a federal grand jury in Boston last month.
The three and 11 others - all owners or employees of NECC- were indicted on charges ranging from second degree murder to mail fraud. They all have entered not guilty pleas. No trial date has been set.
The affidavits totaling 128-pages, which were unsealed this week, detail how Cadden and the Conigliaros paid themselves millions of dollars which had been paid to NECC to provide a fungus tainted spinal steroid injected into the spines and joints of unsuspecting victims.
The 25 counts of second degree murder were lodged against Cadden, who was the chief pharmacist for NECC, and Glenn Chin, a supervisory pharmacist for the Framingham, Mass drug compounding firm.
Under the seizure order assets totaling $1.5 million were seized from Cadden while $16.8 million was seized from Douglas and Lisa Conigliaro.
The Conigliaros were charged in the indictment with violating a bankruptcy court order that had placed a freeze on the $16.8 million.
The owners of NECC already had agreed to contribute nearly $50 million to a $136 million fund to compensate victims of the outbreak. It was not immediately clear how much if any of the additional $18.3 million would be allotted to the victims' fund.
The victims' fund was created as part of the proposed settlement of NECC's bankruptcy case and is subject to approval by U.S. Bankruptcy Judge Henry Boroff.
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Judge Blocks Subpoena For Victims' Records

By Walter F. Roche Jr.

An attempt by the man charged in the deaths of 25 patients to use some of those patients records from a civil case as part of his defense has been blocked at the last minute by a federal judge.
In a decision issued late Tuesday, U.S. District Judge Richard G. Stearns granted a motion to quash the subpoena that had been filed in behalf of Barry Cadden, whose trial on racketeering and second degree murder charges gets underway todayBoston, Mass..
Cadden had sought victims' records compiled in a civil suit filed in behalf of victims of the 2012 fungal meningitis outbreak, but Stearns concluded that the materials Cadden sought were not subject to subpoena.
"The testimonial statements and expert disclosures are specifically excluded from subpoena," Stearns wrote.
The motion to quash was filed by the Plaintiffs Steering Committee (PSC), a panel of lawyers representing victims of the 2012 outbreak.
In their motion the PSC charged that Cadden was trying to skirt the rules that govern evidence and discovery in criminal cases.
Noting that Cadden "is before this court on serious criminal charges for his actions resulting in deaths and serious injuries," the PSC added, "now he asks his own victims to help him get away with murder."
Under the subpoena the records, including deposition testimony and expert witness reports, were to be turned over by tomorrow.
The PSC charged that the subpoena failed to comply with the detailed requirements set in previous court cases and was designed to allow Cadden "to go on a fishing expedition for evidence that might help his criminal case."
The 2012 outbreak was caused by fungus contaminated methylprednisolone acetate shipped from NECC's Framingham, Mass. facility to health care providers across the country. Seventy seven patients died and hundreds of others were sickened.
Cadden's case is the first to go to trial following a two-year federal probe of the outbreak. The jury selection process began today with prospective jurors filling out a questionnaire. A panel of 16 jurors is expected to be selected by Friday.
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Judge Limits Outbreak Testimony in Cadden Trial

By Walter F. Roche Jr.

Federal prosecutors will not be allowed to present evidence of specific fungal meningitis outbreak deaths unless that evidence relates to one of the 25 victims for which a former drug company executive is facing racketeering and second degree murder charges.
The exclusion was one of several approved today by U.S. District Judge Richard G. Stearns in a decision issued on the eve of jury selection in the case set to begin in Boston, Mass.
Stearns concluded that while prosecutors can refer to "multiple deaths" in the 2012 outbreak, use of the specific case counts compiled by the U.S. Centers for Disease Control and Prevention will be barred.
Stearns also ruled on more than a dozen other requests by lawyers for Barry Cadden, the defendant, to limit or bar testimony by government witnesses.
Cadden is facing 25 counts of second degree murder and could be sentenced for life if convicted on those and other charges. Cadden was chief pharmacist and part owner of the New England Compounding Center, the Framingham, Mass. firm blamed for the deadly outbreak of fungal meningitis.
Stearns wrote that prosecutors could in their opening statement "refer to the larger picture of the bacterial(sic) meningitis outbreak," but not the "precise unverified raw number estimates provided by the CDC."
The CDC has reported that the outbreak sickened 753 patients across the country, killing 64 of them. In fact filings in a related case show that federal investigators uncovered additional illnesses and deaths pushing the illness total to 778 and the deaths to 77.
Stearns also ruled that experts from the U.S. Food and Drug Administration will be allowed to give testimony on whether NECC violated industry sanitation standards but not on whether any violations amounted to a criminal act.
Testimony from other FDA officials not designated as expert witnesses also will be limited to "their percipient observations".
As to the existence of a mattress recycling operation in close proximity to NECC, Stearns ruled that the recycling operation could be mentioned along with its impact on NECC's operations, "but not alleged violations of federal or state environmental laws and regulations concerning the plant itself."
Stearns did grant a motion by prosecutors to bar evidence of a civil settlement in a suit brought against NECC, insurance companies, Cadden and other owners and related parties.
Stearns previously ruled that prosecutors could not present evidence of a New York law suit charging that an NECC drug caused a patient's death. The case was settled out of court. He also limited the testimony on Cadden's wealth, but not his ownership interest in NECC.
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Trial to Begin in 25 Outbreak Deaths

 

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BAXTER, KARINA

Age 56, of Burton (formerly of Grand Blanc), died Sunday, September 23, 2012. Memorial services will be held at 3:00 P.M. Saturday, September 29, 2012 at Bristol Road Church of Christ, 1315 W. Bristol Rd, Flint, with dinner to follow. Minister Dr. Brian Stogner will officiate. Those desiring may make contributions to P.A.W.S. Rescue of Swartz Creek (www.pawsanimalrescue.org). Karina was born November 10, 1955 in Flint. She graduated from Grand Blanc High School in 1973 and was recruited to work for Chevrolet Motors shortly thereafter. She left Chevrolet to begin a family in 1981 and later earned a B.A. in Mathematics and with teaching certifications in Mathematics and Science from the University of Michigan-Flint in 2001. She loved teaching, tutoring, cars and helping those in need, whether they were human, furred or feathered. She is survived by her three children, Anita, Andrew and Brian Baxter; their father, Kenneth Baxter; her mother, Margaret Newberry; brother, Gary Michael; close friends, Cathy Hyrman and Mike Joslin; and her many beloved pets. She was preceded in death by her father, Clare Mintline and her brother, David Mintline.

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By Walter F. Roche Jr.


They came from six different states and ranged in age from 47 to 89. There were 25 in all and they all died after being injected with a drug that was supposed to relieve their pain.
Beginning this week the trial will begin for one of two Massachusetts men charged with second degree murder in all 25 deaths.
Jury selection begins Wednesday in the trial of Barry Cadden, chief pharmacist and part owner of the New England Compounding Center, the Framingham, Mass. firm that shipped the fatal fungus tainted drugs to health providers in 20 states.
Cadden's lawyers already have conceded that NECC drugs killed the 25 patients, but he denies any responsibility. His co-defendant, Glen Chin, has disputed the assertion that the victims died from NECC drugs and will be tried separately.
The 25 named victims were not the only ones to die. Fifty-four  other victims died out of the total 778 who were sickened. Federal prosecutors however, narrowed the field to 25 when crafting the 131 count 73-page indictment handed up by a federal grand jury in late 2014.
Some of the 25 already had been identified as outbreak victims, but others had not. Here are just some.
                                                             The Victims
Pauline Burema, a Michigan resident, died on October 10 of 2012. She was 89 and left three sons and two daughters. 
For years she worked as a volunteer at a local hospital. According to her obituary, she died at her daughter's home.
"She loved her dog Lucky and would help anyone who needed help," her obituary states.
Nearly a month earlier, Douglas Wingate, a resident of Salem, Va. died at the age of 49. He was a longtime employee of Pepsi Cola and left his wife and two daughters.
Two days before Wingate died, Brenda Rozek, a Maryland resident, passed away. Her death on Sept. 16, 2012, was the earliest listed in the federal indictment.
Just a day after Rozek, Eddie Lovelace a Kentucky judge who had travelled to Nashville, Tenn.   to be injected with methylprednisolone acetate also passed away. It was only after Lovelace body was exhumed that his family learned that he too was a victim of the outbreak.
Godwin Mitchell, 88, a resident of Reddick, Fla. died on March 18, 2013. Born in the West Indies, Mitchell left his wife, five sons and four daughters.
He was active in the Shiloh SDA Church serving as an elder and Sunday School Teacher.
Donald F. McDavid, 67, died on Nov. 4, 2012. A veteran employee of the Florida Department of Corrections, McDavid turned to raising horses in Rockwood, Tenn. in his retirement. He left his wife and three children.
Karina Baxter, died on Sept. 23, 2012. She worked for General Motors for several years, before leaving to raise a family. She took time out from her household duties long enough to earn a B.A. degree in mathematics and then embarked on a teaching career.
Carol Wetton, a Guthrie Ky resident, was 71 when she died on April 16, 2013. Of the 25 victims named in the indictment, she was the last to die. Wetton, who was injected at Nashville's Saint Thomas Outpatient Neurosurgical Center, had sought the injection in hopes of putting off surgery for severe back problems.
But soon after her Sept. 17 injection she became ill. Like Loveless, she had traveled from Kentucky to Nashville in hopes for relief. Almost seven months to the day later, she died.
Cadden's trial will begin Wednesday with jury selection. Opening statements will come next week under the schedule set by U.S. District Judge Richard G. Stearns, a former federal prosecutor.
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Named Victims and Dates of Death

Michigan: Karina Baxter (9/23/12), Paula Brent (11/17/12), Gayle Gipson (10/26/12), Donna Kruzich (10/8/12), Lynn Lapierre  10/17/12), Mary Pletti (8/23/12), Sally Roe (10/18/12), Emma Todd

Tennessee: Marie Hester (11/1/12), Eddie Lovelace (9/17/12), Donald McDavid (11/4/12), Diana Reed (10/3/12) , Thomas Rybinski (9/29/12), Carol Wetton (4/16/13), Earline Williams (10/15/12)

Indiana: Pauline Burema (10/10/12), Kathy Dillon (11/5/12), Alice Machowiak (12/10/12)

Maryland: Bahman Kashi (1/28/13), Brenda Rozek (9/16/12), Edna Young (12/31/12)

Virginia: Kathy Sinclair (1/9/13), Douglas Wingate (9/18/12)

Florida: Godwin Mitchell (3/18/13)

North Carolina: Elwina Shaw (10/19/12)