NECC Quality Conrtrol Non-Existent

By Walter F. Roche Jr.

Boston- When the head of quality control at a Massachusetts company producing thousands of vials of sterile steroids expressed concern about the refusal of staffers to perform essential safety and sanitary tasks, the supervising pharmacist responded with an expletive.
That was just one of the alarms that sounded in 2012 at the company later blamed for a deadly fungal meningitis outbreak. Testifying today in the criminal trial of six of her former colleagues Annette Robinson testified that she had no experience in quality control when she was given the job and that she was not only the head of the department but also its only employee.
Testifying for the prosecution under a grant of immunity Robinson said safety and sanitation concerns were virtually ignored as the company careened towards a major disaster that ultimately sickened nearly 800 patients, killing 76 of them. Federal prosecutors have called it the worst public health crisis in the country's history caused by a prescription drug
The testimony came in the racketeering and mail fraud case against former employees of the New England Compounding Center, the now defunct firm that shipped steroids laden with a deadly fungus to health providers in 20 states including Tennessee.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Robinson said a quality control committee established after her 2010 appointment at first met monthly but in 2011 stopped meeting altogether.
She said her tasks included collecting environmental samples from the clean rooms where sterile drugs, like the methylprednisolone acetate blamed for the outbreak, were prepared. She said that despite findings of bacteria and mold, nothing was done
She said periodic competency tests required of pharmacists were not being performed and the pharmacists should not be allowed to compound drugs till those tests were completed. In fact that was an issues she raised in the Feb. 2. 2012 email to NECC supervising pharmacist Glenn Chin. He responded with two words "F--- Off."
Chin, one of 14 indicted following a two year probe of the outbreak, already is serving an eight year federal prison sentence following his conviction on racketeering and mail fraud charges. Chin's
boss, Barry Cadden, NECC's president and part owner, is serving a nine-year sentence following his conviction on similar charges.
Robinson, who testified at both prior trials, said she had no experience in quality control and her previous jobs at NECC and a sister company included spraying down bags prior to their filling by clean room technicians.
Robinson said she learned from the conversations of fellow employees that the prescriptions purportedly written for NECC products listed patient names like Donald Duck. People joked about it, she said.
She said that notwithstanding the lack of response to her quality control efforts, the only criticism she heard from superiors was that she wasn't working fast enough.
Asked what led to her appointment as the chief of quality control Robinson said she had heard that the then current head was leaving. She applied to Cadden and got the job. Asked if she had any formal training in quality control she said she didn't. She said her predecessor in the job "told me how he did it."
Though she had prior laboratory jobs Robinson said she had no training in microbiolgy and did not even know how beyond-use or expiration dates were determined for chemicals or medications.
Asked specifically about some of the defendants, she testified that pharmacist Sharon Carter, whose job was to check on outgoing orders after they left the clean room, reported to Cadden and she observed them having a lot of "closed door conversations" at NECC's Framingham, Mass. facility.
She said Gene Svirskiy, another clean room supervisor, "just stopped talking to me."
She said she didn't have that much to do with defendant Christopher Leary, who like Svirsiky was a licensed pharmacist.
Shown an NECC sales brochure distributed to potential customers, she said that claims, such as the use of strict standard operating procedures (SOPs) for drug production, were not followed. She said she couldn't even get employees to read the SOPs, never mind follow them.
Contact: wfrochejr999@gmail.com

RX Tech May Have Forgotten Key Ingredient

By Walter F. Roche Jr.

Boston- A former pharmacy technician acknowledged in court testimony today that he may have forgotten to include a key ingredient, a pain killer, in drugs he prepared for injection into the eyeballs of patients under treatment at a famed treatment facility.
"I assume I made a mistake," Cory Fletcher told jurors hearing the criminal case against six of his former colleagues at the New England Compounding Center, the company blamed for a deadly nationwide 2012 fungal meningitis outbreak.
Testifying in U.S. District Court as a prosecution witness under an immunity agreement, Fletcher said that as the outbreak approached he and his colleagues were told the emphasis was on getting drugs out while safety and sanitation concerns were secondary.
Fletcher said that the problem with the eye block came just months before the meningitis outbreak, when patients at the Massachusetts Eye and Ear Infirmary complained of a burning sensation in their eyes following injections. The shots preceded cataract surgery or other eye treatments.
Fletcher said that when word first surfaced a few weeks later that a Tennessee patient, who had been injected with an NECC steroid, had been diagnosed with fungal meningitis production abruptly stopped.
All employees were ordered to begin a clean up, especially in the clean room where Fletcher worked preparing the suspect spinal steroid, methylprednisolone acetate.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Fletcher said that the cleanup was just as suddenly halted and production began again. But it was shortly after that when all NECC employees were summoned to a meeting where a temporary closure was announced. It soon became permanent.
Clean out your lockers, Fletcher said he and other employees were told at the meeting in early October.
Strachan led Fletcher through a series of NECC internal documents, including those for the preparation of a cancer treatment drug that had expired in 2007, but was relabeled to indicate it had yet to expire.
He said that less than the normal amount of fluid was added to the methotrexate powder to make it appear more potent than it actually was.
He said when another expired drug was about to be used, someone went into the company compounder and changed the expiration date.
One by one, Strachan led Fletcher through documents showing some of the defendants were involved in approving expired or untested drugs. One document even showed the initials of two defendants on paperwork approving the same drug.
The drugs were then shipped to health providers from Massachusetts to Illinois, the records showed.
Asked what happened when environmental tests showed bacteria or mold in his clean room, Fletcher said nothing was done.
Under cross examination by defense lawyer Mark Pearlstein, Fletcher acknowledged that after the mistake with the eye block was discovered, he went right back to producing more of the same drug.
Fletcher acknowledged that he had little to do with Pearlstein's client, Joseph Evanosky, a pharmacist who worked alone in a clean room corner producing parenteral drugs containing controlled substances.
He also agreed that he did not recall discussing the use of expired drugs with Evanosky or defendants Christopher Leary or Gene Svirskiy.
Fletcher acknowledged that Evanosky was quiet, did not participate in the verbal and physical horseplay with other clean room workers and was "a good guy."
Contact: wfrochejr999@gmail.com

NECC Tech Worked Illegally for 2+ Years

By Walter F. Roche Jr.

Boston- A former pharmacy technician who already has pleaded guilty to nine counts of mail fraud testified today that he worked illegally for nearly three years at the drug compounding company blamed for the deadly 2012 fungal meningitis outbreak ..and the company knew it.
The prosecution witness testifying in U.S. District Court here told jurors he worked at the New England Compounding Center with the full knowledge of key officials of the now defunct firm. Those included three former NECC officials now on trial on charges ranging from racketeering to mail fraud and conspiracy.
Scott Connolly, the one time pharmacy technician, said he already had surrendered his technician's license before NECC and an affiliated company hired him in 2009. In fact, he was told they thought the clean room, where sterilized drugs were being prepared, would be "a good place to hide" him.
He said company officials told him to leave the clean room on six or seven subsequent occasions when regulators were visiting the Framingham, Mass. facility.
"It was my understanding that regulators were coming and they wanted me out," Connolly said.
Connolly's damning testimony came at the end of the second week in the trial of six former employees of NECC, the now defunct firm that shipped thousands of contaminated vials of a spinal steroid to health facilities across the country including three in Tennessee. Sixteen Tennessee patients were among 76 that died after injection with NECC's fungus laden steroids.
Connolly testimony followed that of another former NECC technician who told jurors that he and his colleagues"knew what they were doing was not right," when they shipped untested medications to healthcare providers across the country. Nicholas Booth testified that was especially true as the company ratcheted up production in the fall of 2012 on the eve of a forced shutdown.
Under questioning by Assistant U.S. Attorney, Connelly acknowledge he had reached a plea agreement with federal prosecutors that is contingent on his continued cooperation with prosecutors. His sentencing has been oput on hold pending the completion of the ongoing case.
Connolly, whose brother was also an NECC employee already has testified for the prosecution, said he had signed a confidentiality agreement in 2009 with NECC's vice president and part owner Gregory Conigliaro, one of the six defendants. He said he also discussed the loss of his state certification with his immediate boss at NECC, Gene Svirisky, another defendant in the ongoing trial.
He said a third NECC pharmacist, Christopher Leary, also a defendant, had asked him about the circumstances surrounding his license surrender.
Connolly acknowledged that he received notice of the loss of his registration from Sophia Pasedis, then the head of the Mass. Board of Pharmacy also a top official at NECC's sister firm Ameridose.
Describing his hiring Connolly said he met with now jailed NECC President Barry Cadden and Supervisory Pharmacist Glenn Chin on a weekend in 2009 in what turned out to be a tryout for the job.
Calling it"kind of a competition" Connolly said he was asked to prepare drugs in a clean room. He was asked to come again the next day and ultimately won a full time job.
Chin, like Cadden, is now serving a federal prison sentence following his conviction on racketeering and mail fraud charges.
Connolly said he was assigned to one of the two NECC clean rooms and first prepared small doses of Avastin, a drug used to treat serious eye problems. Later he began preparing cardioplegia, a drug used to stop the heart during open heart surgery. He said he worked in that clean room under the supervision of Svirskiy, though he said Svirskiy regularly left the room, leaving he and other technicians without required supervision.
Svirskiy, he said, was also "my friend" and the two socialized together and, at times, talked about getting his license back.
He said it was generally known by colleagues and superiors that he had lost his registration. That included NECC's quality control chief Annette Robinson, who hasn't been charged and has appeared as a prosecution witness in prior trials.
"They didn't come out and say it, but it was generally known," Connolly said of his license status.
He said that when he was warned that regulators were coming he went to other NECC departments, like shipping not requiring special clearance.
He said he was instructed to further shield his presence from regulators by using Barry Cadden's name to log into NECC's compounding system. He also used a secret symbol to initial company records and used a nickname "Mud Gum" on other records. The nickname was also embossed on his coffee mug, which was displayed to jurors by Varghese.
Earlier in the day Booth described his tenure at NECC. He like Connelly, started out at Ameridose, the sister firm, and later transferred to NECC, working his way up to a pharmacy technologist slot in a clean room.
Responding to Varghese's questions, Booth, speaking in a barely audible voice, was led through records showing NECC drugs were often prepared with components drawn from separate drug lots.'
Yet labels affixed to the final product reflected only the date of the lot that actually had been tested and not the newer untested lot. He agreed with Varghese that there would be no way for customers to know they were getting a partially untested product.
"At the end we were definitely doing too much," he said, citing the 2012 upsurge in orders.
Under cross examination by Dana McSherry, the attorney for Booth's supervisor Joseph Evanosky, Booth was asked if there was anything inherently wrong with mixing drug lots. The witness said he wasn't sure what was required under the industry standard.
Comparing Booth's testimony before a grand jury with his trial testimony, McSherry said Booth appeared to now remember conversations he did not mention previously.
"After six years, you now have a specific recollection," she stated.
Contact: wfrochejr999.gmail.com

Tech Discloses He Filled Steroid Vials

By Walter F. Roche Jr.

Boston- A former pharmacy technician disclosed today that he was the employee primarily assigned to fill the vials of a spinal steroid that were eventually identified as the cause of a deadly 2012 fungal meningitis outbreak.
The witness, who had been called to the stand by federal prosecutors Wednesday, was cross examined rigorously today by lawyers for his former colleagues who are on trial in U.S District Court on charges ranging from racketeering to mail fraud. The outbreak killed at least 76 patients including 16 in Tennessee.
The one time technician, Owen Finnegan, said he did not feel any guilt about his role and that he did not believe anything he did caused the outbreak. He did tells jurors he thinks about it daily.
Asked if he was the one who filled the specific three lots later identified as the outbreak cause, Finnegan said, "I don't know which they were." He did acknowledge he was "the primary filler" of the vials during the key time period.
It was Finnegan's second day on the stand and all but one of the six defense lawyers questioned him on his background and training and even on something he posted on his Instagram account on his way to the courthouse.
That message, which Finnegan did not dispute, was displayed in court, along with the face page of his account: "One day when this is all over, I'll have a story to tell and no one will believe it."
Recounting the day, Oct. 3, 2012, when the New England Compounding Center shut down, Finnegan said it was during a meeting in the company lunch room that he and his colleagues were warned that regulators were on their way and they were to say nothing to the media.
Though Finnegan said it was co-defendant Gregory Conigliaro who reminded employees of company confidentiality agreements, Paul Kelly, the lawyer for one of the defendants, suggested it was Barry Cadden, the president of NECC who already has been convicted of related charges, who told employees to keep quiet.
"No," Finnegan responded when asked if he recalled that it actually was Cadden who actually delivered the message.
Under further questioning by Kelly, Finnegan said, he took over the role of filling vials of methylprednisolone acetate in 2011 when another technician quit. He acknowledged he remained in that role until NECC's final shutdown.
Finnegan, who now works as a salesman for a computer company, said he placed the steroid in vials after it had been prepared by Glenn Chin, a supervising pharmacist, with the assistance of another technician. Chin, who like Cadden was convicted of racketeering and related charges, is now serving an eight year federal prison sentence.
Finnegan agreed that the vast majority of his work as a pharmacy technician was reviewed by Chin with the remainder reviewed by one of the three licensed pharmacists now on trial.
In questioning Finnegan about his Instagram account posting, Kelly charged that the message was attached to a picture taken through his car windshield while traveling to the courthouse.
"You sent this photograph while driving," Kelly said, adding that another posting stated, "Time to thin the heard (cq)."
Though Finnegan insisted he was referring to the heavy traffic, Kelly suggested he was referring to a plan to turn on his former NECC colleagues.
Kelly then questioned the witness about his divorce and a court order attaching his pay to recoup past due child support payments. Finnegan did not dispute the court order though Assistant U.S. Attorney George Varghese entered another in a series of objections to Kelly's questions.
Citing Finnegan's purchase of a new Toyota Tundra, Kelly said, "So you decided to buy a new truck instead of paying child support."
Finnegan said his father helped with the truck purchase.
While Finnegan said Chin was a competent pharmacist, he said his supervisor lacked people skills and, he agreed, was at times a bully.
As for his other NECC colleagues, Finnegan said defendant Gene Svirskiy was "one of the most intelligent people I've ever met, while another defendant, Joseph Evanosky never engaged in the verbal and physical horseplay that predominated in their workplace.
Asked if he always performed his duties, including the cleaning of his and other work areas, Finnegan answered, "I did what was asked of me."
Contact: wfrochejr999@gmail.com

Key NECC Witness Challenged by Defense

By Walter F. Roche Jr.

Boston--The testimony of a key prosecution witness was challenged today when the lawyer for a defendant said his client was vacationing in the Dominican Republic at the very time she was alleged to have been involved in an incriminating event at her Massachusetts workplace.
The challenge came during the cross examination of a former employee of the company blamed for a deadly fungal meningitis outbreak. That witness, Joseph Connolly, also has been a key prosecution witness in the prior trials of two co-defendants.
Challenging Connolly was Michael Pineault representing defendant Sharon Carter, who is one of six people on trial in U.S. District Court on racketeering and conspiracy charges stemming from a two year probe of the outbreak caused by contaminated drugs from the company that employed Carter and Connolly.
Also appearing on the witness stand Wednesday was another former employee of the defunct New England Compounding Center who testified in detail about the involvement of some of the defendants, who were licensed pharmacists yet approved the shipment of drugs that were untested. He also told jurors that NECC routinely disguised the actual source of drugs, mixing the origin of tested drugs with those that weren't.
The 2012 outbreak caused by fungus laden NECC steroids sickened 778 patients across the country killing 76 of them. Sixteen of the dead were patients in Tennessee, the state where the outbreak was first detected.
Connolly, who had been on the witness stand for several hours Tuesday, was confronted on cross examination by Michael Pineault, Carter's lawyer, who displayed passport records showing his client was vacationing in the Dominican Republic at the time when a disputed order came in.
Connolly had testified that he spoke with Carter on May 30, 2012 about the order and, after she met with NECC President Barry Cadden, he was ordered to send out the untested drugs.
Pineault said his client wasn't even at NECC on May 25 when the order was placed nor was she there on May 30, the date of the alleged conversation with Connolly.
He said that internal NECC emails showed she also had set up an automated message stating that she would be out of the office from May 25 through May 31 of that year. The emails were entered into evidence but the passport records were not.
Connolly had testified that the order to ship an untested drug came just one day after he and other NECC employees were told the operation had to be "fireproofed" and hence forward all drugs would be quarantined for two weeks, the time needed for an outside laboratory to test for purity and potency.
"So your prediction came true," Pineault said to Connolly, after noting that Connolly had predicted that the May 30 testing order would be reversed as soon as a rush order came through.
Connolly, however, said he did talk with Carter about the order and that it was his boss, Glenn Chin, who told him to ship the untested order to the Hawaii client.
Following Connolly's testimony another former NECC employee, Owen Finnegan, a pharmacy technician, told jurors that all of his work at NECC, had to be done under the supervision of a licensed pharmacist, including three of the defendants. One of the three also had to review his work preparing prescriptions before they could be shipped out, he said.
Finnegan reaffirmed much of Connolly's testimony including the extensive verbal and physical horseplay in the clean room where sterile drugs were being prepared. He described how one worker was shoved headfirst along a conveyor belt used to send completed drugs to NECC's shipping department.
"I was over there myself," Finnegan said.
Though the technician said he at first looked forward to going to work at NECC, that changed in 2012 when there was a substantial uptick in work and a downturn in quality.
Citing the increased tension to fill orders quickly Finnegan said he was at the point of looking for another job when NECC was shutdown in October 2012 as the federal investigation of the outbreak intensified.
Contact: wfrochejr999@gmail.com

Witness: RX Dumped Drugs Down Sink

By Walter F. Roche Jr.

Boston- A key prosecution witness testified today for the first time that he saw one of his colleagues dumping drugs down a sink just as the word had surfaced that their employer was suspected as the source of a deadly fungal meningitis outbreak.
The surprise testimony in U.S. District Court brought a protest from the lawyer for the worker accused of disposing of he drugs. His client, Christopher Leary, and five other former employees of the New England Compounding Center are facing charges ranging from racketeering to mail fraud for their role in the deadly 2012 outbreak first detected in Tennessee.
Leary's lawyer, Paul V. Kelly, charged that prosecutors failed to inform him of the new testimony. He noted the witness, Joseph Connelly, had not disclosed the dumping incident during the prior trials of two co-defendants.
"If a witness presents new information prosecutors have an obligation to disclose it," Kelly told U.S. District Judge Richard G. Stearns, after jurors had been sent home for the day.
Assistant U.S. Attorney George Varghese acknowledged that prosecutors are obliged to to disclose so-called exculpatory evidence which would tend to clear a defendant, but argued the same precedent does not apply to incriminating evidence.
While downplaying the importance of the disclosure, Stearns advised prosecutors that "going forward" in the ongoing case such information should be disclosed.
Connelly, an NECC pharmacy technician, said he witnessed the drug dumping in early October of 2012 after employees of the New England Compounding Center were told the facility was being shutdown in the wake of the ongoing federal probe.
Connelly said Leary, a licensed pharmacist, was dumping bottles of drugs down a sink and there was a cart beside him "with more bottles to be dumped."
He said supervising pharmacist Glenn Chin was crying following a company meeting in a break room where workers were told of the imminent closure. Other employees, Connelly said, were busy cleaning the facility.
State investigators have testified the facility was heavy with the smell of bleach when they arrived later that week.
Chin already has been convicted of racketeering and mail fraud and is serving an eight year sentence in a federal prison in Pennsylvania. NECC President and part owner Barry Cadden is serving a nine-year sentence following his conviction on similar charges.
The 2012 outbreak, caused by heavily contaminated steroids injected into unsuspecting patients across the country sickened some 778 people, killing 76 of them. The six now on trial were among 14 indicted following a two year federal probe of the outbreak.
Kelly, Leary's lawyer, charged that the new Connelly testimony followed multiple sessions with federal prosecutors, sessions in which witnesses "are being prepared." The testimony, he added, was "highly prejudicial to my client."
Under questioning from Assistant U.S.Attorney Amanda Strachan, Connelly said he didn't think the NECC employee, Annette Robinson, charged with monitoring the facility for possible contamination was competent and that she never told employees what they were supposed to do to correct any problems.
Connelly, who was on the witness stand for the second day, provided detailed testimony on drugs prepared at NECC and signed off on by some of the six defendants.
They included drugs shipped the day they were produced and before promised testing could be completed. He said that as the company business expanded rapidly in 2012 "more mistakes were being made."
He said he even learned that one drug order he had personally prepared had "popped," meaning it was found to be contaminated. Another worker, he said, mistakenly filled an order for a solution of sodium bicarbonate with potassium chloride, a mistake if not detected, could have resulted in serious patient harm.
He said yet another worker sent out vials only filled with water and containing none of the ordered drugs.
"There were a lot of discrepancies," he said, adding that morale in the clean room where he worked was very low.
He recalled stating to a co-worker,"We're overtaxed. Someone's going to get hurt. We're going to get shutdown."
Under cross examination, Connelly was questioned about his brother Scott, who worked as a pharmacy technician at NECC even though he had surrendered his certification in the midst on an unrelated state investigation. He said he told Cadden his brother was a good technician but unreliable.
Scott Connelly has already entered a guilty plea to nine counts of mail fraud and is awaiting sentencing.
Contact: wfrochejr999@gmail.com

Expiration Dates Falsified Even as Probe Began

By Walter F. Roche Jr.

BOSTON, Mass- Even as the investigation of a deadly outbreak was getting underway, workers at the drug compounding firm that caused the outbreak continued to falsify the expiration dates on dozens of drug doses being shipped to health care facilities across the country.
That was the testimony today of a former pharmacy technician at the defunct New England Compounding Center. He told jurors it was a routine practice to put expiration dates on drugs that went well beyond the expiration dates of its components.
The witness, Joseph Connelly, also testified about the atmosphere in the room where sterile drugs were prepared. "A locker room on steroids," he told jurors in U.S. District Court when asked to describe the verbal and physical horseplay in the NECC clean room.
His testimony came as the trial of six former NECC employees entered its second week. The six face charges ranging from racketeering to conspiracy and mail fraud.
Another prosecution witness, who was employed by an affiliated company, told jurors that he saw a mat at the entrance to that clean room that had turned dark brown apparently from accumulated dirt from the shoes of workers. He also described autoclaves turned brown in the same clean room.
However, the witness, Michael Andolina, underwent sharp cross examination from a defense attorney who used floor plans to question what he saw and where he saw it.
The 2012 outbreak was caused by fungus laden steroids shipped from NECC's Framingham, Mass. facilities to more than 20 states. The outbreak killed 76 patients including 16 in Tennessee. Hundreds more were sickened. Though not made public till early October, the probe began in September based on the report of a rare form of fungal meningitis by a Nashville physician.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Connelly detailed how the expiration dates on eight different drug shipments were falsified so that the expiration date of the final product exceeded the expiration of its components.
They included drugs shipped in late September of 2012 that carried a Jan. 25, 2013 expiration date even though a components had a Nov. 29, 2012 expiration date. Connelly testified the drugs were shipped to three health facilities with the false dates.
Connelly, whose brother also worked at NECC and has already entered a guilty plea to a related charge, said NECC routinely shipped drugs on the same day they were processed, making it impossible for promised testing by an outside laboratory to be completed.
Asked about one drug batch he prepared, Connelly said it was shipped the same day it was processed with the approval of one of the defendants, Gene Svirskiy, a licensed pharmacist.
He said another defendant, Alla Stepanets, told him that the expiration date on another batch of drugs was being extended from 120 to 180 days on orders from Barry Cadden, NECC's president.
Cadden, who was tried separately, is serving a nine year prison sentence following his conviction on racketeering and mail fraud charges. Both Andolina and Connelly testified at Cadden's trial.
Andolina, who said he was hired to work for an affiliated marketing firm, said he set up cameras to record Barry Cadden conducting training sessions for NECC's sales force.
On excerpts from the training sessions played for jurors Cadden bragged that inspectors from the state agency that licensed NECC "don't even know what they are looking for."
"I had to educate them," Cadden said, adding that later when complaints came in from other states, the Massachusetts inspectors "just told them to go away."
Andolina, however, was challenged about his testimony about what he saw in the NECC clean room. Confronted with floor plans of NECC's facilities, Andolina said his original description "was the best I can recall."
Asked about the original condition of the dirty sticky mat he saw at the entrance to the clean room, Andolina said he knew they were white.
Attorney Paul Kelly then presented a video showing the new mats are actually blue.
Contact: wfrochejr999@gmail.com

Fake Names Common at Mass. Drug Firm

By Walter F. Roche Jr.

A former salesman for a defunct drug compounding company testified extensively today about the frequent use of fake names like Johnny Cash and Al Bundy to purchase prescription drugs from his former employer in violation of the law in Massachusetts and other states.
The testimony came as the trial of six former employees of the New England Compounding Center ended its first week.
Kenneth Boneau, a former salesman for the drug firm, acknowledged records showing the use of fake names like Wayne Gretzky and Paul Harvey was common while defense lawyers countered with company records showing that in some cases other NECC employees demanded real patient names. Under Massachusetts law and laws and regulations in many other states signed patient specific prescriptions are required.
The six former NECC employees are charged with racketeering, mail fraud and conspiracy. The charges followed a two year federal probe of the 2012 fungal meningitis outbreak which killed 76 patients across the country including 16 from Tennessee.
As the session began U.S. District Judge Richard G. Stearns gave the jurors a primer on the three requirements to meet the legal definition of a conspiracy. He promised details on other charges, such as racketeering, when the trial resumes Monday.
Under questioning from Assistant U.S. Attorney George Varghese, Boneau acknowledged there were numerous fake names submitted by a Nebraska pain clinic dating back to 2009. The fake names were listed, not on individual prescription forms, but on sheets attached to standard NECC ordering forms.
Varghese read from multiple NECC order forms with names ranging from James Dean to Roy Rogers and Dick Van Dyke.
"I think we get the point," Stearns said after Varghese had cited numerous examples.
Earlier lawyers for some of the defendants presented other NECC records showing that their clients and others at NECC responded to the fake names by insisting that Boneau and his sales colleagues go back to their customers and get real names.
In one email Sharon Carter, one of the defendants, stated that an order was being held pending the submission of real patient names.
"I'll see what I can do," Boneau responded to another Carter email asking for patent names.
Lawyers for the defendants also pointed to memos showing that orders without real names only went through with the personal approval of NECC President Barry Cadden.
In one memo from Cadden himself, staffers were told,"I'm the only one that make this decision."
Cadden, who was convicted last year on racketeering and mail fraud charges, is serving a nine year sentence at a federal prison in Pennsylvania.
Jurors also were told that some NECC customers were specifically exempted from listing individual patient names under contractual agreements. Under the contracts, the health care providers agreed to keep the real names and provide them to NECC if it later became necessary.
Defense lawyers also used internal emails to show that there were instances when drug orders were delayed until test results from an outside firm were submitted. Prosecutors have charged that the opposite was often the case and drugs were shipped before tests were completed or in some cases sh without any testing at all.
Contact: wfrochejr999@gmail.com

Attorney: Expired Chemicals Not Meant for Drugs

By Walter F. Roche Jr.


Boston, Mass. An attorney for one of the defendants charged in the wake of a deadly meningitis outbreak today charged that some of the expired drugs seized by federal investigators and paraded before jurors in an ongoing criminal trial were never intended for use as active ingredients in medicines meant for human consumption.
Paul V. Kelly, the attorney for a former pharmacist at the New England Compounding Center, charged that the large vial of outdated formaldehyde along with containers of five other expired drugs seized from a now defunct drug compounding center and paraded before jurors was never intended as active ingredients for use in drugs for human consumption.
Kelly's statement came as he cross examined Michael Mangiacotti, a criminal investigator for the U.S. Food and Drug Administrator and one of more than a dozen federal agents who searched NECC's Framingham, Mass. headquarters in October of 2012.
Kelly represents Christopher Leary, one of six former NECC employees on trial for charges ranging from racketeering to mail fraud and conspiracy. They were among 14 indicted in 2014 following a two year probe of the 2012 outbreak that killed 76 patients across the country including 16 from Tennessee.
Federal regulators concluded that fungal contamination of an NECC steroid, methylprednisolone acetate, caused the outbreak which also sickened over 700 other patients in 20 states.
Asked by Kelly if the acetic acid or other expired drugs would have been used in the production of drugs for use in humans, Mangiacotti said he was not a pharmacist and couldn't answer the question. E
Mangiacotti did testify about other seized and expired drugs which went unchallenged by Kelly and the other defense attorneys. Those included long expired methotrexate, a drug used to treat cancer patients. In prior related trials prosecutors presented evidence showing NECC did ship the methotrexate to health care providers, despite its age.
Kelly and other defense attorneys also questioned Mangiacotti about the involvement of Sophia Pasedis in the operation of NECC and a sister drug firm, Ameridose. Pasedis was also a member of the state Board of Pharmacy, which licensed NECC.In the midst of the outbreak, Pasedis was asked to resign but refused. Her term later ran out and was not renewed.
Noting that Pasedis was never charged, Kelly asked if she also held a position at NECC at some point in time. Mangiacotti said he did not know.
Michael Pinneault, the attorney for defendant Sharon Carter, also questioned Mangiacotti about a document seized in 2012 showing Pasedis was among a group of NECC and Ameridose officials slated to attend a company strategy session prior to the raid.
Mangiacotti said he did not know whether the strategy session ever took place.
In addition to the seized and expired drugs Mangiacotti testified about hundreds of pages of other records seized from NECC during two raids in October of 2012. Those included emails and memos in which NECC officials discussed problems in complying with a requirement in Massachusetts and many other states for an patient specific prescription for every dose of a compounded drug.
One of those emails stated that in the future all new customers would have to provide patient names unless approved by then NECC President Barry Cadden or sales chief Robert Ronzio.
Cadden has already been convicted of racketeering and related charges and is serving a nine year prison term. Ronzio has entered a guilty plea to a single conspiracy charge and is awaiting sentencing. He is expected to appear as a prosecution witness.

Ex-NECC Salesman Grilled on TN Visit

By Walter F. Roche Jr.


Boston, Mass. - The drug salesman in charge of the account at a Nashville clinic testified today that he believed he was telling the truth when he told clinic officials in 2012 that he was certain that products from his employer could not be the cause of a just emerging deadly outbreak.
"I was sure it wasn't us. I truly believed there was no way it could be us," Mario Giamei, a former salesman for the New England Compounding Center, told jurors in recounting his Sept. 24 2012 visit to the St. Thomas Outpatient Neurosurgical Center in Nashville.
Giamei, whose territory included Tennessee and California, was the second prosecution witness in the federal criminal trial of six former NECC employees. They face charges ranging from racketeering to mail fraud stemming from a federal probe of the 2012 national fungal meningitis outbreak, which first became public in Tennessee days after Giamei's visit.
Giamei, who would later undergo sharp questioning by lawyers for two of the defendants, said he went to the clinic after learning three days earlier that clinic employees were questioning whether steroids from NECC could be the cause for patients getting sick. Eventually 13 clinic patients would die, all injected with NECC steroids.
Testifying in U.S. District Court Giamei said the lights were out and the clinic was closed when he arrived there on a Monday morning, but staffers were inside. He said once he got in he met with three clinic employees including the medical director, John Culclasure MD.
He said he spent 45 minutes to an hour at the clinic and witnessed a patient being turned away after being told "equipment problems" had forced a shutdown.
He said that Culclasure, who was the prosecution's first witness, told him he was initially concerned that the type of needle he used might have been the cause.
Giamei said that after he left the clinic he called his boss at NECC's Framingham, Mass. headquarters.
"I probably shouldn't have gone (to the clinic), Giamei said, adding that he was eventually told not to answer any questions from customers but just forward them to NECC President Barry Cadden. At first Giamei said he was assured the company expected ultimately to be cleared
Michael Pinneault, the attorney for defendant Sharon Carter, a pharmacist employed by NECC, later questioned whether Giamei really thought NECC was blameless and whether the Tennessee case was the first in which he heard a patient had been sickened.
"I don't recall any other," he responded, adding that the call in September was "the first I heard of anyone being sick."
The witness was also questioned closely about NECC complying with laws and regulations in Massachusetts and several other states requiring an individual signed prescription for every drug dose issued.
He said Cadden, who is now serving a nine year prison sentence on related charges, "was the only one" who could waive the requirement and that was on a customer-by-customer basis.
He was led through a series of NECC emails in which waivers had been sought. He said that Cadden would allow some customers to "backfill" the names of patients. Under that process customers would get an in initial order without providing patient names and then submit those patients names in subsequent orders.
He acknowledged receiving emails from his superiors insisting that customers provide "real names."
He was also questioned about the assurances he gave to customers that all NECC products were thoroughly tested and complied with national standards set by the U.S. Pharmacopeia, a nonprofit.
He said that in some cases NECC would ship drugs before sterility and other test results were received. That was the case in an order from the University of Michigan, he said, adding that test results were to be sent a week after the drugs were shipped.
He said that Cadden repeatedly assured salesman, who, like he were technically employed by a sister company, that all NECC products were thoroughly tested for sterility and potency and that NECC followed national standards for the compounding of sterile drugs.
John Cunha, the attorney for defendant Alla Stepanets, questioned Giamei about an order for an eye medication from the Vanderbilt University Medical Center. The order had been submitted without patient names. Giamei said he did not recall whether the order was eventually filled.
The former salesman said some customers just refused" to send patient names because of concerns about federal privacy limits on health records.
Shown an email he acknowledged that yet another Tennessee customer got NECC drugs without providing patient names.
Though not raised in Wednesday's testimony federal prosecutors have previously cited records showing bogus NECC customer lists including names like Donald Duck and Donald Trump.
Cunha also challenged Giamei''s assertion that it wasn't until an email on Feb. 10, 2011 that he learned that not all NECC products were being tested.
"That was the first case," Giamei responded.
Contact: wfrochejr999@gmail.com

Tests Results On Deadly Drug Never Produced

By Walter F. Roche Jr.

Boston, Mass.-The medical director at a Nashville, Tenn. clinic testified today that officials of the company blamed for a deadly fungal meningitis outbreak never answered his question about whether spinal steroids shipped to his clinic had been tested for fungus.
Dr. John Culclasure said he asked the question of the New England Compounding Center because he had just learned that one of his patients had been diagnosed with fungal meningitis. That patient, who subsequently died, had been injected with methylprednisolone acetate obtained from NECC.
Culclasure's testimony in U.S. District Court came in the second day of the federal criminal trial of six former employees of NECC, the company blamed for the deadly 2012 outbreak. They face charges 18 ranging from racketeering to mail fraud.
Also testifying for federal prosecutors was a former salesman for NECC, Kenneth Boneau who told jurors that there were "multiple errors" in drug production at the firm in the months leading up to the 2012 outbreak as the company attempted to deal with a surge of orders.
"There was an uptick as far as the amount of complaints," he testified, adding that the errors included the mislabeling of drugs.
Culclasure, who still serves as medical director at the St. Thomas Outpatient Neurosurgical Center, said he was standing by the phone when another clinic employee called NECC with questions. The call was made on Sept. 21, 2012, just as word of the outbreak was emerging. Eventually 13 of Culclasure's patients, including the one whose case triggered the alarm, would die among the 103 of his patients who were sickened.
The physician said when the clinic employee asked NECC about tests for fungal contamination the NECC official said they would have to get back to him.
They never did.
Culclasure said the clinic not only contacted NECC but other suppliers because the victims could have been infected from the needle used for the injection, a dye used to aim the needle or even a numbing agent.
He said that the other suppliers, like NECC, reported no reports of patient problems.
Cuclasure said that early the next week, Debra Schamberg, a clinic employee, told him that an NECC salesman, Mario Giamei Jr., had called to tell her that NECC could not be the source of any problem because of its state-of-the art production facilities. He said Giamei also invited him to visit NECC to see the facilities for himself. He never did.
Though not brought out in the day's testimony, federal investigators would conclude that 76 patients in more than 20 states died from fungus laden NECC steroids. They were among 778 who were sickened.
Boneau, who was an employee of NECC's sales arm, Medical Sales Management, was led through a series of exhibits showing the materials distributed to NECC's customers.
The brochures, he acknowledged, included claims that NECC met or exceeded all federal and industry standards.
"We told them we were doing more than the FDA (U.S. Food and Drug Administration)required," Boneau testified.
He said it was only later that he learned NECC wasn't testing all of it products before shipping them out and some products weren't tested at all.
He said clients were assured NECC not only complied with but exceeded industry standard set by the U.S. Pharmacopeia, a nonprofit.
The former salesman was questioned extensively about NECC's enforcement of a Massachusetts legal requirement that all customers provide patient specific prescriptions for each dose of drugs ordered.
He said he discovered that some health providers had gone for years with out complying.
When customers complained, he said NECC would allow them to "backfill" patient names.
He said under that system customers could get an initial order without patient names and then use the names of the old patients for subsequent orders.
He said working as an NECC was "slave driving for the most part" especially toward the end when the company was rapidly growing its sales volume. He said salesman would spend three weeks on the road and then spend a week in the office.
"Most people got fired," Boneau said.

Nashville Physician Lead Witness in NECC Case

By Walter F. Roche Jr.

A Nashville physician who saw 13 of his patients die in a deadly 2012 outbreak is slated to be the lead off witness as testimony in the criminal trial of six employees of a defunct drug compounding gets underway in a Massachusetts courtroom.
Culclasure, who was on hand but out of the courtroom as opening arguments were delivered Monday, was the physician at the Saint Thomas Outpatient Neurosurgical Center in Nashville when evidence of a deadly fungal meningitis first emerged a little over six years ago.
U.S. District Judge Richard G. Stearns rejected as moot a motion by lawyers for the six defendants to bar or at least limit Culclasure's testimony. He did so after prosecutors agreed to limit their questions to factual issues regarding the outbreak. The six face 38 felony charges ranging from racketeering to mail fraud.
Defense attorneys had noted that in prior testimony in a codefendant's case, Culcalsure had sobbed during his testimony about the deaths of his patients.
Stating that such testimony would be extremely unfair and prejudicial, the defense attorneys stressed that none of the six had been charged in any of those deaths. In fact, they asserted, no deaths or injuries were attributed to any of the drugs in which their clients were involved.
"Not a single person was harmed in anyway," said Mark Pearlstein, attorney for one of the defendants
In opening arguments, Assistant U.S. Attorney George Varghese told the panel of 16 jurors, eleven female with the balance male, that the company that employed the six, the New England Compounding Center, was a criminal enterprise that shipped hundreds and thousands of contaminated drugs to health facilities around the country "week after week."
NECC he said was ultimately forced to recall all of its drugs, not only the spinal steroids that caused the outbreak.
Gregory Conigliaro, an NECC vice president and part owner "made millions" from NECC," Varghese charged. Conigliaro, prosecutors have stated, was in charge of ensuring NECC's compliance with state and federal regulatory authorities. He is charged solely with conspiring to defraud the U.S. Food and Drug Administration.
The prosecutor then laid out the roles of the five other defendants ranging from a supervisor in one of the so-called clean rooms where sterile drugs were prepared to a worker who "oversaw everything."
"The fraud was not limited to the methylprednisolone acetate," Vargehes said in a one hour presentation.
He said the two year federal investigation showed that drugs injected into the eyes of patients at a Boston hospital to prevent pain were subpotent and patients suffered.
"Their eyes were not numb. They could feel it," he said.
A cancer drug produced at NECC was made with chemicals whose effective date passed four years earlier. And a drug used to stop the heart during surgery was made by a pharmacy technician who had surrendered his certification in the midst of an unrelated investigation.
Acknowledging that the six, including vice president and partial owner Conigliaro, were not involved in producing the deadly fungus laden steroids, Varghese said the company also shipped out drugs that were untested and encouraged customers to come up with fraudulent lists of patients who were to receive the drugs.
Daniel Rabinowitz, Conigliaro's lawyer, said the charges that state and federal regulators didn't know exactly what was going on at NECC was "ridiculous." He then cited numerous visits to the facility by the U.S. Food and Drug Administration and the Massachusetts Board of Pharmacy.
Citing congressional testimony by two top FDA officials stating that the regulatory authority over companies like NECC were blurred, he played video tapes of the two official saying just that.
John Cunha, the attorney for defendant Alla Stepanets, noted that his client, like the other defendants, had no reason to question the way the company was operated. In fact, he said, an official of a sister company, Ameridose, was a member of the state Board of Pharmacy.
Stating that his client had no motive to violate any laws, he said she acted at "all times in good faith."
He, like the other defense lawyers, repeatedly laid the blame on NECC's president Barry Cadden and Glenn Chin, a supervising pharmacist. Both are now serving prison terms following conviction of racketeering mail fraud and related charges. The two were cleared, however, of second degree murder charges.
Contact: wfrochejr999@gmail.com

Conigliaro Money Can be Disclosed

By Walter F. Roche Jr.

Federal prosecutors will be able to tell jurors about the estimated $20 million in profits collected by the vice president of a drug company blamed for a deadly 2012 fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns has denied a motion by Gregory Conigliaro's lawyers to bar the prosecutors from disclosing the amount earned by Conigliaro in his upcoming trial on conspiracy charges.
Conigliaro is one of six defendants going on trial Monday in U.S. District Court in Boston, Mass. on charges ranging from racketeering to mail fraud.
The six were employees of the New England Compounding Center, the company that sold thousands of vials of fungus laden medications to health facilities across the country. The outbreak killed 76 patients among nearly 800 that were sickened.
In a motion filed earlier this week Conigliaro's lawyers asked Stearns to block prosecutors from disclosing how much money he had earned from NECC charging that the disclosure "would improperly taint the jury's ability to be fair."
In a brief ruling issued shortly after the motion was filed Stearns denied the request.
Though full details of Conigliaro's earnings have not been disclosed, documents and testimony in the trial of a co-defendant, Barry Cadden, show that Gregory Conigliaro likely earned $20 million in profits alone from the New England Compounding Center and a related firm, Ameridose, over the six year period ending in 2012.
Cadden and his wife owned 35 percent of the two companies and other court filings show Gregory Conigliaro had a 10 percent stake in the same two firms. Cadden and his wife, according to testimony, earned $72 million over the six year period from their 35 percent share. A 10 percent share would thus equal a little over $20 million.
That figure does not include any salary earned by Conigliaro during that same time period.
Conigliaro's lawyer had not only asked that the earnings be kept secret, but also that his motion to seal the records be shielded from public view lest the details be made public by the media and then to the jurors hearing the case.
"This evidence is completely irrelevant" to the single charge against Conigliaro, " attorney Daniel Rabinovitz argued.
Stearns denied the motion without comment.
Opening arguments in the case against Conigliaro and five others are scheduled for 9 a.m. Monday.
Contact: wfrochejr999@gmail.com

Plea Deal in NECC Related Case

By Walter F. Roche Jr.

The details of a plea agreement between a pharmacy technician and federal prosecutors shows that he lied when he was asked in 2015 about why he was paid $5,000 a month by a now defunct Westborough,Mass. drug company.
In a nine-page plea agreement filed in U.S. District Court in Boston, Mass. Claudio Pontoriero acknowledged that he lied when he was questioned by federal agents about the $355,000 he was paid by Ameridose, a drug company closely tied to the New England Compounding Center. Both firms are now out of business.
NECC was the source of contaminated steroids that caused a deadly 2012 fungal meningitis outbreak.
Under the plea agreement Pontoriero admitted to making materially false statements to investigators from the U.S. Food and Drug Administration when they interviewed him on Oct. 19, 2015.
In a July filing in the case, federal prosecutors said Pontoriero was paid the fees in return for recommending that his employer, Massachusetts General Hospital, purchase drugs from NECC and Ameridose.
The agreement is subject to Pontoriero's continued cooperation with federal prosecutors. The maximum sentence he could face is five years in prison and a fine of $250,000.
Pontoriero was a pharmacy buyer for the hospital, but is no longer employed there.
Contact:wfrochejr999@gmail.com

NECC Defendant Wants Money Hidden

By Walter F. Roche Jr.

A key defendant in the upcoming criminal trial stemming from a deadly outbreak does not want jurors to hear how much money he earned from the company that caused the 2012 public health crisis.
In a motion filed in U.S. District Court in Boston, Mass. Gregory Conigliaro, who was a vice president and part owner of the New England Compounding Center, said that disclosure of his income "would improperly taint the jury's ability to be fair."
The filing comes on the eve of opening arguments in the case against Conigliaro and five others who were employed at NECC in Framingham, Mass. NECC shipped thousands of vials of fungus riddled steroids to health providers in some 20 states triggering an outbreak sickening at least 778 patients and killing 76 of them.
Congiliaro, who was NECC's vice president for government affairs and regulatory compliance, is charged with a single count of conspiring to defraud the U.S. Food and Drug Administration.
Other motions filed as the Monday trial approaches include a motion to allow the attorneys to use the words of prosecutors themselves to defend their clients. Those statements were made in opening and closing remarks during the trials of two co-defendants, Barry Cadden and Glenn Chin, both now serving prison terms.
In one earlier trial, prosecutors argued that Cadden, NECC's president,"ran everything. NECC was Barry Cadden's baby."
As for Chin, prosecutors told his jury that he was Barry Cadden's "right hand man."
Prosecutors responded today asking U.S. District Judge Richard G. Stearns to bar the use of statements made in opening or closing statements.
Assistant U.S. Attorneys George Varghese and Amanda Strachan argued that nothing from the openings or closings should be allowed and they noted that it was the six defendants who insisted on a separate trial.
"They cannot have it both ways," they said in the response, charging that the defendants were cherry picking favorable items from the prior trials.
Conigliaro in his motion to bar disclsoure of his NECC income also argued that his motion itself should be sealed from the public lest the jurors, who already have been selected, find out the income information from media accounts.
"This evidence is completely irrelevant" to the single charge against Conigliaro, " his attorney Daniel Rabinovitz wrote.
"It is undisputed," he added, "that Mr. Conigliaro had a financial incentive for NECC to be an ongoing business."
Opening arguments are scheduled for 9 a.m. in Stearns' Boston, Mass. courtroom.
Contact:wfrochejr999@gmail.com

Cadden Boat on Auction Block

By Walter F. Roche Jr.

A federal judge has approved an order to put up for auction a sailboat seized from the president of a now defunct drug compounding company blamed for the deaths of 76 patients in a 2012 fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns order issued today in U.S. District Court in Boston, Mass. comes as the trial of six employees of that same drug company are about to face trial on racketeering and conspiracy charges. Opening arguments in the case are set for Monday.
Stearns order authorizes the U.S. Marshall's Service to auction off the sailboat seized from Barry J. Cadden, who was president and pharmacist-in-charge at the New England Compounding Center.
The boat was one of several Cadden assets subject to seizure under an agreement between the U.S. Justice Department and the Cadden family. According to court records Cadden purchased the sailboat from Port Harbor Marine and it was seized from a Rhode Island vacation home owned by the Caddens.
As part of the settlement agreement the Caddens will get to keep the Rhode Island shore property in exchange for a $369,000 payment to the federal government.
The seizure agreement also calls for the sale of Cadden's multimillion dollar Wrentham, Mass. home and several bank accounts.
Cadden, who is now serving a nine year prison sentence was convicted of racketeering and mail fraud but cleared of 25 counts of second degree murder.
The trial set to begin Monday charges the six one time NECC employees with conspiracy, defrauding the U.S. Food and Drug Administration and mail fraud. Only one of the defendants, Gregory Conigliaro, was an officer and part owner of NECC. He faces a single conspiracy count.
The six facing trial are Gene Svirskiy, Christopher Leary, Joseph Evanosky, Sharon Carter and Alla Stepanets, along with Conigliaro.
Those listed as possible witnesses include employees of the FDA and the U.S. Centers for Disease Control and Prevention. Conigliaro has listed as possible witnesses two ex-employees of the Massachusetts Board of Pharmacy, the agency which licensed NECC.
Other defendants have listed as possible witnesses employees of health care providers who purchased drugs from NECC.
Contact: wfrochejr999@gmail.com

Cadden Forfeiture Agreement Disclosed

By Walter F. Roche Jr.

Federal prosecutors have reached a forfeiture settlement agreement with the principal defendant in the criminal case stemming from a deadly 2012 fungal meningitis that will bring in nearly $1 million immediately and millions of dollars more when three properties are sold.
The proposed settlement filed today in U.S. District Court in Boston, Mass. will be subject to the approval of U.S. District Judge Richard G. Stearns.
In addition to Cadden, the one time drug company president, the agreement was signed by his wife Lisa and his three children.
Lisa Cadden had previously petitioned the court to allow her to retain the three Wrentham properties.
Under the agreement some of the properties and assets originally subject to seizure will be retained by the Caddens in return for cash payments to the U.S. Department of Justice. For instance the government will accept payment of $369,000 in lieu of the seizure of a home the Caddens own in North Kingston, R.I.
The original seizure order carried a value of $7,545,501.
Cadden already has appealed the forfeiture order and if his appeal is successful the order could be amended or reversed.
Cadden was convicted of racketeering, conspiracy and mail fraud but cleared of second degree murder charges. He is serving a nine-year sentence at a Western Pennsylvania federal prison in Loretto.
In the petition filed today government lawyers asked Stearns to approve an interlocutory order authorizing the sale of Cadden's Sailfish boat. The government will get half of the proceeds.
The settlement includes payment of $13,387 in lieu of the seizure of Cadden's 2011 BMW and $9,200 in lieu of jewelry placed under the original seizure order and $7,500 in lieu of seizure of an antique clock.
The largest single item under the agreement is a payment of $882,201, representing 50 percent of a
bank account held by the Caddens.
The three properties to be sold are located on Manchester Drive in Wrentham, Mass. They are assessed for a combined total of a little over $1.8 million.
The main house on the three properties with five bedrooms and nine baths is currently listed at just under $3 million.
Federal prosecutors also are seeking some $73 million in restitution from Cadden but Stearns has delayed action on that request until other defendants have their cases resolved. Six of those defendants are scheduled to go on trial Oct. 15.
A total of 14 persons were indicted in late 2014 following a two year federal probe of the outbreak which took the lives of at least 76 patients across the country.
Contact: wfrochejr999@gmail.com

NECC Defendant In Land Deals

By Walter F. Roche Jr.

One of the remaining defendants in the criminal case stemming from a 2012 public health crisis has been involved in a series of recent real estate deals with the total price tag in the millions.
Records show that Gregory Conigliaro has sold two properties and purchased a third in the months leading up to his scheduled trial in U.S. District Court in Boston, Mass.
According to records at the Worcester County Registry of Deeds Conigliaro sold two parcels for a combined total of $4.15 million. At the same time in May of this year Conigliaro and his wife Cynthia purchased a nearby parcel for $900,000. All three properties are located on Sears Road in Southborough, Mass.
Conigliaro was the vice president for regulatory affairs and compliance and a stockholder in the New England Compounding Center, the company that shipped thousands of contaminated vials of steroids to health facilities across the country. The ensuing outbreak sickened 778 patients killing 76 of them.
Conigliaro was one of 14 indicted in 2014 following a two year federal probe of the outbreak. He faces a single charge of conspiracy to defraud the U.S. Food and Drug Administration.
This week lawyers for Conigliaro renewed their request for a separate trial, contending that he would be prejudiced by the evidence against co-defendants who face more serious charges. U.S. District Judge Richard G. Stearns, who is presiding over the case, already has denied a similar request.
The Worcester County records show Conigliaro and his wife sold property at 52 Sears Road for $3.25 million to David and Ana Ferris. The same couple bought the property at 50 Sears Road from the Conigliaros for $900,000.
At the same time the Conigliaros bought the property at 45 Sears Road from a separate couple for $1 million. All three transactions were dated May 15.
The registry records show that there was a lien on some of the Conigliaro property stemming from the NECC bankruptcy. That lien was lifted on Dec. 30, 2014 after the bankruptcy was settled with Conigliaro and other owners agreeing to pay $48 million to a fund to benefit outbreak victims.
The Conigliaros still own a property on Cape Cod at 155 Salt Pond Road which they purchased in 2012 for $2.35 million. The couple sold another property in Barnstable County which they sold on April 3, 2017 for $791,250
Opening arguments in the case against Conigliaro and five other defendants is set for Oct. 15.
Conigliaro's lawyer did not respond to a request for comment on the real estate transactions
Contact: wfrochejr999@gmail.com