Cadden Seeks Acquittal on All Charges

By Walter F. Roche Jr.

BOSTON, Mass.- The head of a drug compounding firm blamed for a deadly fungal meningitis outbreak is asking a federal judge to acquit him on all charges, including racketeering and 25 counts of second degree murder.
In a 38-page motion filed today in U.S. District Court, Cadden's attorneys are charging that federal prosecutors failed to present adequate evidence of second degree murder though they conceded the evidence might support "at most" a manslaughter charge.
The motion, which was not unexpected, comes as federal prosecutors are about to call their last witness in a trial that began in January.
In testimony today a former employee described how she and a colleague created dozens of phony prescriptions to present to state officials in response to a complaint that had been filed against Cadden's company, the New England Compounding Center.
Cadden has been charged in only 25 of the 76 deaths recorded in the 2012 fungal meningitis outbreak. He was one of 14 to be charged in late 2014 following a lengthy grand jury probe. Charges against two defendants have been dismissed, Two others pleaded guilty to reduced charges with the remaining facing trial later this year.
Cadden's motion states that federal investigators, despite spending years on the case, still could not explain how vials of methylprednisolone acetate became contaminated with fungus.
"The fact that 25 (people) died is not in dispute," the motion states, adding that federal investigators never found evidence at NECC of the specific fungus, exserohilum rostratum, that was found in the bodies of victims and unopened vials of NECC steroids.
"Despite calling over 50 witnesses over 41 days, the government has failed to prove what caused the contamination," the motion states, adding that Cadden did not compound the steroids that caused the outbreak.
The government, the motion continues, "has provided no evidence that Cadden acted with the requisite intent to commit second degree murder."
Calling the murder charges unprecedented for "a participant in a non-violent business," the motion concludes, "The court should exercise its extreme discretion to grant the motion for acquittal."
At the court session Beth Reynolds, who worked for NECC's sales arm, Medical Sales Management, said that one of her duties was to ensure that pharmacists and technicians were properly licensed and registered.
A hesitant witness who spoke at times in whisper soft tones, Reynolds said she and another worker were assigned in 2012 to take patient names from a list at the Mass. Eye and Ear Infirmary and insert them on prescription forms.
According to previous testimony, the drugs in question already had been delivered to Mass Eye and Ear without patient specific prescriptions as required under state law. In fact the drug, a numbing agent, already had been administered to patients.
Reynold's assignment followed a complaint the health facility had filed with the state Pharmacy Board against NECC. The complaint charged the drugs that didn't have the required potency, prompting complaints from patients and doctors.
The witness identified a series of emails relating to the project.
"The labels have all been created, printed and proofed," Reynolds wrote in one email.
She said that both she and her colleague, Michelle Rivers, thought the project was "out of the ordinary."
She said she didn't like another 2012 assignment from Cadden, which was to compile a list of states that allow prescriptions to be filled under certain circumstances without the name of a patient. Under so-called office use provisions set quantities of drugs can be dispensed for use in a hospital or doctor's office in situations where the patient's identity can't be determined in advance.
She said the assignment made her feel uncomfortable and she did not know what was going to be done with the information.
An official of the Massachusetts Pharmacy Board later testified that there is no such exemption from the patient specific requirement for pharmacies, like NECC, licensed in Massachusetts.
Other witnesses provided additional testimony and evidence about the Mass Eye and Ear Infirmary incident including an email from Cadden with instructions on the need to insert patient names in each prescription.
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Fungus in Victims Matches Fungus in Steroids

By Walter F. Roche Jr.

BOSTON, Mass.- A microbiologist and genetic expert testified today that the DNA of fungus from victims of the 2012 fungal meningitis outbreak matches perfectly the DNA of fungus found in vials of steroids produced by the New England Compounding Center.
"The fungi are exactly the same," said David Engelthaler, director of programs and Operations for TGen, an Arizona-based nonprofit.
Engelthaler was testifying in U.S. District Court in the trial of Barry J. Cadden, who has been charged with racketeering and 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 shipped the contaminated steroids to health providers in more than 20 states.
The outbreak sickened 778 patients, killing 76 of them.
Engelthaler testified that the 22 samples of fungal DNA came from 19 of the outbreak victims. The matching fungal DNA came from vials of two lots of preservative free methylprednisolone acetate seized by federal agents from NECC's Framingham, Mass. facility.
Though he did not identify the victims from whom the samples were taken, he said the samples included victims from Virginia, Michigan, Tennessee, Maryland and Indiana. The fungal DNA, he said came from the brains and spines or injection sites of victims.
He said he was "highly confident" that the fungi in the victims and the fungi in the vials came from the same source.
"They were essentially all the same," he said, adding that the fungus was identified as exserohilum rostratum. He said the results were the same for samples from victims who contracted fungal meningitis and those that suffered fungal infections at the injection site.
The tested vials came from lots produced by NECC in June and August of 2012 , Engelthaler said. He said both the patient samples and the vial samples came from the U.S. Centers for Disease Control and Prevention, which also did parallel testing.
Engelthaler gave the jury, judge and all others in the courtroom a brief description of his organization's DNA testing and matching methods which he described as the equivalent of an Ancestry.com for pathogens or "a family tree or organisms."
He said his organization has worked with the CDC on similar projects including  the anthrax investigation and a probe of a series of fungal infections in patients who had undergone transplants. The transplant victims all had received organs harvested from the same homeless donor.
Engelthaler's testimony came as prosecutors indicated they were winding down their case against Cadden and expect to complete it later this week.
Also testifying today was a CDC supervisor, David Craft, who reported on the findings on the testing of two other lots of NECC steroids which were contaminated but not with the same exserohilum fungus.
Jo Stewart, former pharmacy director at the Mass Eye and Ear Infirmary, testified about shipments of an eye numbing agent used in cataract surgery that turned out to be subpotent. She reported that anesthesiologists and patients complained and eventually a complaint was filed with the Massachusetts Pharmacy Board.
Stewart acknowledged regular prescription forms were not used to order the drugs, instead an NECC order form was used and no names were provided. She said that was included in an agreement between the facility and NECC.

Cadden Learned Sept. 21 of First Victims

By Walter F. Roche Jr.

The New England Compounding Center first learned of a possible problem with its steroid drugs at a Nashville, Tenn. clinic on Sept. 20, 2012 and the next day the news had been passed on to the company president, Barry J. Cadden.
A company notation of the formal complaint was displayed for jurors in U.S. District Court here today as Cadden's trial on second degree murder charges entered another week. Also displayed by Assistant U.S. Attorney George Varghese was an email dated Sept. 21 informing Cadden of the complaint from the Saint Thomas Outpatient Neurosurgical Center.
The timing of the complaint and Cadden's reaction to what became the first warning of an impending national public health crisis has quickly become a key issue in the ongoing trial.
The charges against Cadden stem from a federal probe of the 2012 fungal meningitis outbreak which ultimately sickened 778 patients in more than 20 states. Seventy-six of them died. State and federal regulators have concluded that fungus tainted steroids from NECC caused the outbreak.
Under cross examination by Michelle Peirce, Cadden's lawyer, NECC's former national sales director Rob Ronzio, was questioned repeatedly about the timing of a conversation he had with Cadden in which Cadden conceded NECC was to blame.
"It's us," Ronzio quoted Cadden as saying.
On Friday Ronzio also testified Cadden "knew from the first that it was us."
Citing Ronzio's statement to prosecutors before the trial, Peirce asked whether the conversation actually took place on Sept. 25 or Sept. 26.
"The time frame is very important," Peirce said, questioning whether prosecutors urged him to "move the needle back" on the timing of the conversation
She noted that Cadden himself began calling customers on Sept. 25, a task Ronzio joined when he arrived for work that day.
"He (Cadden) was up all night calling clinics," Peirce said.
Ronzio said the conversation took place "when it first happened. If it wasn't Friday, it was that week."
The complaint from the Saint Thomas clinic was relayed by Mario Giamei Jr., the salesman handling the clinic's account. He reported that "a few" patients had infections following injection with methylprednisolone acetate from NECC and a clinic employee, Cindy McClendon, had expressed concern.
Later, in a brief followup Varghese introduced another NECC email sent from Cadden to Ronzio also on Sept. 21 at 2:17 p.m. inquiring about the company's standard operating procedure for instituting a recall.
Asked if there were any other recalls in that time period, Ronzio said no.
Peirce questioned Ronzio closely about his plea agreement under which he pleaded guilty to a single count of defrauding the federal government. Additional charges were dropped.
Asked if he hoped to avoid jail time, Ronzio said yes.
Peirce also challenged Ronzio's testimony about a meeting of executives of NECC and a sister firm, Ameridose, at the same time the crisis was deepening. Ronzio had testified he was "disgusted" that the main topic of discussion at the meeting was how to separate and save Ameridose.
Ronzio conceded that although Cadden was at the meeting, he was not the one talking about saving Ameridose.
He also acknowledged that Cadden appeared to be in shock and devastated.
Ronzio repeated his Friday testimony that it was on Sept. 25 that NECC got word of a complaint from an Indiana clinic that foreign matter was observed in a vial of NECC drugs.
"Oh no," Cadden responded in an email.
As the questioning neared four hours, U.S. District Judge Richard Stearns told Peirce, "You seem to be running out of material."
Showing a sketch of NECC's Framingham, Mass. facilities, Peirce questioned how he and Cadden could have heard a fax machine spewing out another drug order when it was located a few offices away.
"Absolutely. It was quiet as a church mouse. We were alone," Ronzio said.
He testified last week that Cadden referred to the fax as his personal ATM.
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Cadden "Knew Right Away It Was Us"

By Walter F. Roche Jr.

BOSTON, Mass. "He knew right away it was us."
That was the testimony Friday by the one time national sales director for the now defunct New England Compounding Center.
Referring to his boss, Barry J. Cadden, Rob Ronzio told jurors that as soon as they got word on Sept. 21, 2012 that a patient at the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn. was ill after being injected with an NECC steroid  Cadden knew his company was to blame.
Ronzio, who was testifying under the terms of a plea agreement, delivered the most damaging testimony yet in a trial that is nearing its 40th day. Cadden has been charged with racketeering and 25 counts of second degree murder. Ronzio pleaded guilty late last year to a single count of conspiring to defraud the federal government.
The charges against Cadden and 13 others stem from a lengthy grand jury investigation of the 2012 fungal meningitis outbreak which sickened 778 patients, killing 76 of them. State and federal regulators have concluded the outbreak was caused by fungus riddled spinal steroids shipped from NECC's Framingham facility.
Under questioning for more than three hours by Assistant U.S. Attorney George Varghese, Ronzio also detailed, through a series of emails, how NECC, under Cadden's direction, dodged and darted to get around state laws and regulations requiring patient specific prescriptions for all the drugs they were selling.
In states like Colorado and Oregon where regulators were closing in, Cadden instructed his sales staffers to "just walk away. We have nothing to gain and we have a lot to lose."
  In testimony about the outbreak itself, Ronzio recalled Cadden was in Boston for a hearing on an unrelated matter when he got word that NECC was being forced to surrender its pharmacy license.
"It's over," Ronzio quoted Cadden as saying.
Ronzio said the statement shocked him because he had been led to believe that NECC did extensive product testing and held drugs for two weeks to ensure that they were not contaminated.
"It can't be us" Ronzio said was his first reaction at the time.
Ronzio also recalled that Cadden said, "Oh no," when he got word on Sept. 25, 2012 from a sales representative that an Indiana clinic was complaining about seeing a foreign object in a vial of NECC's methylprednisolone acetate.
Ronzio said he was upset when during the same period the crisis was heightening he attended a meeting of executives of NECC and a sister company Ameridose including Cadden
"It was all about Ameridose, They were trying to created a separation between NECC and Ameridose," Ronzio said, adding that a public relations firm representative was among those in attendance.
"It was all about Ameridose," Ronzio said. "I was disgusted."
Ronzio said until the license was actually surrendered NECC continued shipping other drugs even as they were voluntarily recalling the preservative free methylprednisolone acetate. A recall of all of NECC's products was later issued.
Ronzio said when he came into work on Sept. 26 Cadden was in his office contacting customers about the recall.
"I felt it was my duty to contact as many (customers) as possible," he said, adding that he took over the job of notifying clients. He said he also assembled a spread sheet showing the drugs and lot numbers for all customers.
He said Cadden instructed him not to talk with the clients about infections like the one reported in Nashville.
"I wasn't admitting anything," he said.
He said Cadden was upset when he learned that the sales representative for the Nashville clinic had gone to the clinic and talked to its managers.
He said later that week he issued a bold faced large type email to his staffers telling them not to go on any sales calls. "If you have a meeting do not go to it," the message read.
Much of Ronzio's testimony related to skirmishes with state regulators over a requirement that individual prescriptions had to be written for each patient receiving NECC products.
He described a process called "backfilling" in which clinics and other customers would provide the names of previous patients for subsequent orders to make it appear that the requirement was being met.
He said some customers, especially hospitals resisted providing names and Cadden authorized exemptions for customers with substantial orders, like Partners, the Boston health conglomerate, which he called "our stable".
Ronzio said NECC also was improperly selling at least three drugs that duplicated products by companies licensed as manufacturers by the FDA. They included a form of methylprednisolone acetate with a preservative.
He said Cadden did not want the company registered with the FDA because it could not comply with the agency's mandatory manufacturing standards.
He said the company also used a five percent rule in some states that allowed up to five percent of total sales to be delivered to providers without patient names.
Ronzio said he didn't agree with the five percent device because "I didn't think it was the right thing to do."
Varghese asked Ronzio if despite the assurances that NECC was properly testing its products for sterility and potency, he eventually learned that was not the case.
Ronzio said yes, adding that there were "multiple issues" when  numbing drugs delivered to the Massachusetts Eye and Ear Infirmary for use in cataract surgery turned out to lack sufficient potency.
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For Outbreak Victim Pain Lingers

By Walter F. Roche Jr.

BOSTON, Mass. - Among the outbreak victims watching the proceedings this week in the trial of Barry J. Cadden, is a Western Pennsylvania woman who, more than four years after being stricken, still must take medication to fight fungal meningitis and related illnesses.
Margaret Carmichael of Hookstown, Penn. is one of a stream of victims of the 2012 fungal meningitis outbreak who have been invited to watch the Cadden trial for a week at a time as guests of the U.S. Justice Department.
It was on Sept. 13, 2012 that Carmichael, then a resident of Brighton, Mich., went to a nearby clinic for an injection of methylprednisolone acetate for the relief of severe back pain.
Almost immediately, she said, she was in worse pain than ever. And the pain was not in the usual place but lower in her tailbone.
"I knew something was wrong," she said in an interview outside the courtroom where Cadden is on trial on charges of racketeering and 25 counts of second degree murder.
"Something was wrong, something was not right," she added.
Cadden was president and part owner of the New England Compounding Center, the now defunct Framingham, Mass. company blamed for the outbreak.
The methylprednisolone acetate injected in Carmichael's back that day in 2012 was shipped from NECC  to Michigan Pain Specialists.
A sales representative for a cement company she said she went back to work but also had another new symptom, a low grade headache.
Over the next week she said the pain worsened but she kept working. It was early in October while making a sales call to a client that she noticed a series of calls from her pain clinic. She wondered out loud what the clinic wanted.
"I don't have the time for a phone call," she told her client.
He stopped her and asked if she hadn't heard the news about people dying from injections at pain clinics.
"You need to get to an emergency room right now," he recalled him saying.
She went in for a spinal tap and though it came back negative at first, her white blood cell count spiked. She was sent to an Ann Arbor hospital in an ambulance.
She didn't get out until Christmas.
"I've never been so scared in my life," she said.
When treatment with powerful antifungal drugs was initiated, the reaction was immediate.
"My whole body was jumping off the bed," Carmichael said.
After her December discharge, she was back in the hospital with a relapse.
"They thought I was dying," she said, adding that doctors then decided to give her even higher doses of anti-fungals.
She said she was waiting for the birth of her first grandchild but kept going back and forth to the hospital. In the end she missed the birth of her grandchild on Oct. 23, 2013.
She had developed a serious abscess at the sight of the injection and had to undergo surgery.
She said the doctor had to "fillet me like a fish."
"They couldn't kill the fungus. It was horrible. I lost hair. It's chemo, that's what it is," she said, adding that she lost 30 pounds during the ordeal.
Now she said she may have to remain on oral antifungal medications for the rest of her life.
"I'm in pain constantly," she said.
She did decide to move to Pennsylvania to be near her daughter and grandson.
Returning to work in her current condition is not a option though she says she loved her job.
Like most other victims Carmichael says she has yet to receive a penny from the NECC bankruptcy and other settlements stemming from the outbreak.
"I'm okay," she added. "I'd rather be poor and happy."

CDC Shows Brain Destruction Caused by Fungus

By Walter F. Roche Jr.

BOSTON Mass. -A physician from the U.S. Centers for Disease Control and Prevention vividly described today the extensive damage to the brains and spinal columns of some of the victims of the 2012 fungal meningitis outbreak.
Testifying here in U.S. District Court, Dr. Sherif Zaki showed four slides for each of 17 victims describing how the fungus climbed the spinal columns of the victims and then attacked the brains invading tissue and blood vessels literally in some cases killing brain cells.
Zaki, head of CDC's infectious disease branch, was a prosecution witness in the second degree murder trial of Barry J. Cadden. Prosecutors have charged that drugs produced by the company Cadden headed were laden with the deadly fungus. The outbreak sickened 778 patients, killing 76 of them.
Zaki and Mary Brandt Ph.D also told the fifteen jurors that as the agency rushed to find out what was killing more patients by the day, they came up with new tests that enabled them to double the percentage of cases being diagnosed with fungal meningitis and to do so much more quickly.
"We really had to know what fungus we had," Brandt said.
She said the effort was further complicated by the fact that some of the victims had been treated with antifungal medications in the weeks before their deaths. The drugs would kill the very DNA they were searching for.
She said a new test, known as Real Time PCR uses fluorescent light and a laser to hunt for the fungus and its DNA. She said once the DNA was found, it was processed and duplicated so the sequence could be determined.
Brandt, head of the mycotic diseases branch, said that they first learned of the outbreak from officials of the Tennessee Health Department which had received the first case report.
Both she and Zaki stressed that one of the first challenges was trying to figure out what they were dealing with because fungal meningitis was not at all common.
"It's a very  rare condition. Not much was known about it,"Brandt said. "That was part of the problem. There was very little expertise."
In addition, she said, at least at first the volume of specimens being sent to the CDC from state health departments was sometimes inadequate.
In his presentation Zaki described how the fungus flows to the base of the brain and "moves around and gets into the vessels. You get inflammation, a stroke, thrombi.
Under questioning by Assistant U.S. Attorney George Varghese, Zaki said the first case reported in Tennessee had a fungus called aspergillus fumigatus, but all the other cases he described had a fungus called exserohilum rostratum.
The slides and case files Zaki presented included victims from Michigan, Tennessee, Indiana, Maryland, Florida and Virginia.
He said one of the CDC's first task was to set a case definition.
"You have to make sure you're covering everything," he said.
In the case of Lyn Laperrier, a Michigan victim, Zaki described how the fungus hung on to the wall of a blood vessel, works its way inside and then attacks.
"You can actually see the fungus.
In the case of another Michigan victim, Gayle Gipson, Zaki said it was "a little different with inflammation at the base of the spine.
In the case of Mary Plattl, also from Michigan he described "intense inflammation around the spinal chord and necrosis of the brain.
He said the analysis of the case of Sally Roe showed the fungus obliterated blood vessels.
Diana Reed, a Tennessee victim, had evidence of meningitis in the spine and the base of the brain, while Thomas Rybinski had ballooning of the arteries. It was Rybinski who had the different fungus, aspergillus fumigatus.
Carol Wetton, also a Tennessee victim, had undergone lengthy treatment with antifungal medication but the fungus remained, killing her, Zaki said. Godwin Mitchell, a Florida victim, also had undergone four months of anti-fungal treatment yet the fungus attacked his blood vessels causing inflammation.
Brandt said analysis showed other NECC drugs were found to be contaminated including triamcinolone, cardioplegia and betamethasone.
Under cross examination, Brandt said she was not aware of any patients being sickened by those additional drugs

Prosecution Witness Grilled and Scolded

By Walter F. Roche Jr.

BOSTON, Mass.- A key prosecution witness was grilled and scolded today by the attorney for the man charged with 25 counts of second degree murder stemming from a lengthy probe of the 2012 fungal meningitis outbreak.
In questioning that lasted more than three hours, Bruce Singal, attorney for Barry J. Cadden, repeatedly told Eric S. Kastango that he was the one asking the questions. He cut Kastango's answers short several times, charging that the witness was not answering the question.
"You inserted a phrase in your answer that was not part of the question," Singal said at another point.
The sharp exchanges between Singal and Kastango were hyphenated by objections raised by Assistant U.S. Attorney George Varghese, the lead prosecutor.
Several times U.S. District Judge Richard G. Stearns told Singal to move on to another line of questioning.
"I think we're losing focus," Stearns said after one exchange. "Lets see if we can move this along."
 "You're losing whatever point you were trying to make," Stearns said later in the session.
Singal, using published articles by Kastango himself, questioned whether Kastango had not raised questions about the pharmacy and sterility standards set forth by the non-profit U.S. Pharmacopeia.
Prosecutors have charged that Cadden, as head of the now defunct New England Compounding Center, failed to follow the non-profits standards thus putting patients as risk.
The charges stem from the 2012 fungal meningitis outbreak, which sickened 778 patients killing 78 of them.
On Tuesday the death toll climbed again when Evelyn Bates-March, 86, a Michigan victim passed away after a long battle to recover from fungal meningitis.
"God has another Angel. Mom fought long and hard but she lost the battle early this morning. She went peacefully. Please say a prayer for her. Love, hugs and prayers to all," Pugh wrote on a blog for victims of the outbreak.
Singel's questioning of Kastango, who was qualified as an expert witness, followed lengthy testimony he gave Tuesday supporting his conclusion that NECC did not meet the industry standards thus placing patients at grave risk.
 Kastango, a pharmacist, was hired by the government to assist them in the investigation of the outbreak and disclosed he was paid $225 an hour for 100 hours of work. He is being paid $300 an hour for his court testimony.
Singal questioned Kastango about training materials from his consulting company that omitted part of a section of the U.S. Pharmacopeia on what steps should be taken in the event mold is found in a clean room where sterile drugs are being prepared.
"It didn't reflect the intent of the section," Kastango said.
Singal then charged that Kastango left it out, "because you didn't like it."
He said the full wording limited the testing for mold to air samples and mold was found at NECC by other testing methods.
Singal produced an NECC order form for chemicals to kill spores to refute Kastango's earlier statement that NECC's cleaning efforts were ineffective against mold and fungus.
He produced another document attempting to show that it was an outside testing company that told NECC to send only two samples from each drug lot for testing.
Kastango testified Tuesday that the U.S. Pharmacopeia called for testing at least four and up to 20 samples dependent on the size of the lot.
"I have a problem when they don't send enough samples," Kastango reiterated today.
When Varghese attempted to register one last objection, Stearns turned him down.
"You'll have a chance on redirect... unfortunately," Stearns said, bringing a wave of laughter from jurors and spectators.
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