Some NECC Drugs Super-Potent, Im-Potent

By Walter F. Roche Jr.

BOSTON--Tests on one New England Compounding Center drug showed it had more than 6,000 percent of one ingredient while analysis of another drug showed it had no traceable amount of the primary component.
That's what an official of an Oklahoma drug testing firm told jurors last week as the second week of testimony came to a close in the trial of Glenn Chin, who is facing charges of racketeering and second degree murder.
Chin, 49, who was a supervising pharmacist for NECC, has paid close attention to the testimony, often taking detailed notes and conversing with his attorneys. He has displayed virtually no emotion.
The test results on NECC products were detailed by Tommy Means from Analytic Research Laboratories, the company NECC hired to run tests on samples of its drugs.
Chin was charged in late 2014 following a two year federal probe of the deadly 2012 fungal meningitis outbreak caused by fungus ridden drugs shipped from NECC's Framingham offices to health providers across the country.
Means' Friday testimony was similar though briefer than he gave in the trial of co-defendant Barry J. Cadden, who is serving a nine-year prison sentence following his conviction on racketeering and mail fraud charges. He was acquitted of the second degree murder charges.
Cadden was the president and part owner of NECC. While Cadden's lawyers continually sought to pin the blame on Chin, Chin's lawyers are now returning the favor by continually referring to Cadden, even noting the comments by prosecutors in the Cadden case who repeatedly told jurors NECC was "Cadden's baby." Those same Assistant U.S. Attorneys, Amanda Strachan and George Varghese, are handling the Chin case.
Though there are numerous parallels in the Cadden and Chin cases, there are differences, one imposed by the presiding judge.
 At one point in the Cadden case, U.S. District Judge Richard G. Stearns, in a bench conference out of the hearing of jurors, expressed his frustration with the pace and direction of the trial. The transcript of that bench conference was not made public until weeks after it took place.
In contrast, in a brief session last week, also out of the hearing of jurors,  Stearns expressed satisfaction with the way the prosecution has been presenting the case.
Under his orders, time limits have been placed on both the prosecution and defense in the case. Stearns imposed the limits in midst of the Cadden trial, which started in January and ended in late March.
In other testimony last week, hospital administrators from Massachusetts, Virginia and Illinois stated that they were assured that NECC met the highest standards for drug compounders and said they never would have purchased the company's drugs had they known otherwise.
This week's testimony will begin with Philip Sliney, the lead FBI investigator in the NECC investigation.
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NECC Exec Facing $7.5 Million Forfeiture Order.

By Walter F. Roche Jr.

BOSTON- Assets of a former drug company executive could soon be going on the auction block as a federal judge has issued a $7.5 million forfeiture order against Barry J. Cadden, who already is serving a nine year prison sentence following his conviction on racketeering and fraud charges.
The order from U.S. District Judge Richard G. Stearns comes as federal prosecutors have moved to force Cadden to pay $73.7 million in restitution to victims of the 2012 fungal meningitis outbreak caused by contaminated drugs shipped by Cadden's company, the New England Compounding Center.
Stearns five-page order makes clear that the forfeiture order is separate from any restitution order the court may eventually approve. Nor will the forfeiture order be considered as a credit against any restitution.
The action against Cadden comes even as the trial against his codefendant, Glenn Chin, continues in Stearn's court room. Prosecution witnesses testified that a variety of NECC drugs were found to be contaminated with bacteria and fungus in the days and months leading to the deadly fungal meningitis outbreak.
In his order, Stearns rejected the request by federal prosecutors to order the forfeiture of $13.2 million because that figure included profits earned by his wife, who was a part-owner of the now defunct drug Framingham, Mass. compounding firm.
Originally the U.S. Attorney had sought a $132.8 forfeiture order, but lowered the request as a result of a recent U.S. Supreme Court ruling limiting the amount of forfeiture that can be imposed in a racketeering conviction.
As Stearns noted the forfeiture now must be limited to assets obtained by a defendant as a result of the criminal activity. Prosecutors had originally sought an order recovering all of NECC's income dating back to the beginning of the racketeering conspiracy.
Stearns noted that while Cadden owned 17.5 percent of NECC, his wife owned an equal share and prosecutors had attempted to lump together both of their earnings from the company.
Records show Cadden owns three adjacent parcels in Wrentham, Mass. assessed for nearly $1.8 million and an oceanside home in North Kingston, R.I. he purchased for nearly $800,000 in 2009.
In testimony in Stearns' 7th floor court room Thursday, Tiffany Hyde, testified about the testing her Oklahoma firm, ARL, performed for NECC.
Under questioning by Assistant U.S. Attorney George Varghese, Hyde described the fungus that tests of NECC products produced.
"I had never seen a fungus like that," she said in explaining why she took a picture of it. Her picture  was displayed for the jury.
She said the fungus was white with filaments along the edge. It subsequently turned partially black, Hyde said.
She identified a series of documents detailing testing done by ARL for NECC and the subsequent results. She said NECC would invariably submit a single sample for a sterility test, even though industry standards required that the samples be increased based on the number of vials in the overall batch.
She was also questioned extensively about the amount of time required for the sterility testing results to be considered reliable.
She said that while NECC was given preliminary results after three days and seven days, results could not be considered final until at least 14 days had passed. In some cases yet another four days is needed.
Hyde testified that when she informed NECC that some of its samples had tested positive for bacteria,
NECC's quality control manager responded in an email, ordering that no more testing be performed and stating that the whole batch would just be discarded.
In other testimony, a pharmacist from Decatur Memorial Hospital in Illinois, said she only learned after the fact that a cancer treatment drug sold to the hospital by NECC in 2012 was compounded with an ingredient that had expired five years earlier.
"You don't use expired products," she said when asked if she would have ordered the drug had she known about the expiration date.
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Prosecutors Seek $73.7 Million for Outbreak Victims

By Walter F. Roche Jr.

BOSTON- Federal prosecutors are asking a judge to approve a $73.7 million restitution order against the former president of a drug compounding firm, who already is serving a nine year prison sentence following his conviction on racketeering and fraud charges.
The motion seeks to have the $73.7 million distributed to 349 of the victims of the 2012 fungal meningitis outbreak who filed claims with the U.S. Attorney. It includes $1.9 million requested by insurance companies and medical facilities as reimbursement for drugs purchased from NECC.
The restitution would be imposed on Barry J. Cadden, who was convicted in March following a 10-week jury trial.
Cadden was president and part owner of the New England Compounding Center, the firm blamed for the outbreak that took the lives of 76 patients.
Citing provisions of the Mandatory Victims Compensation Act, the six-page motion states, "Restitution to the victims is mandatory in this case."
The filing comes as the criminal case of Cadden's codefendant, Glenn Chin is proceeding with prosecution witnesses testifying about NECC's operations. Two former employees testified Wednesday.
Accompanying the restitution motion is a 15-page report prepared by a government expert who gathered the names of victims and the necessary data to prove their losses.
According to the motion, there were hundreds of additional victims of the outbreak, but the order would only benefit those who filed claims and provided documentation of their losses.
Expenses that qualify include medical expenses, costs for physical and occupational therapy, rehabilitation, lost income and funeral costs.
According to the report by Thomas Barocci of TAB Consultants, claims were filed by the survivors of 62 victims who died, 210 who became disabled, 37 partially disabled, 23 who recovered and 17 with no known injuries.
While valid claims were filed for restitution, the filing states that overall 780 persons were considered victims of the outbreak caused by NECC steroids contaminated with deadly fungi.
At Chin's trial Wednesday, former NECC technician Cory Fletcher, testified about expired and outdated ingredients NECC used to compound drugs, including an anti-cancer drug prescribed for children.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Fletcher said that when tests showed presence of bacteria or mold in so-called clean rooms, nothing was done.
Under cross examination by Chin's attorney Stephen Weymouth, Fletcher described how the NECC cleanroom was moved to a new location in the company's Framingham, Mass offices.
Fletcher acknowledged that he became friends with Chin and "I enjoyed him as a supervisor."
Weymouth, however, questioned whether Chin really was his supervisor and cited instances when Fletcher had direct contact with Cadden.
Steven Sanda, who helped process orders for NECC customers, testified about patient lists that included obviously fake names, like Mickey Mouse and Donald Duck. He said he would call sales staffers to complain about the practice.
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Witness Says Compounding Records Altered

By Walter F. Roche Jr.

BOSTON- A pharmacy technician testified today that his boss ordered him to falsify records to hide the fact that pediatric cancer fighting drugs being shipped to health facilities across the country had passed their effective date years before.
The same witness, testifying in the racketeering and second degree murder trial of Glenn Chin, said records showed that Chin only kept steroids in an autoclave for 15 minutes when 20 minutes was required to assure sterilization.
Some of those same steroids have been blamed for the 2012 fungal meningitis outbreak which took the lives of 76 patients. Chin has been charged in 25 of those deaths. He was one of 14 persons associated with the now defunct New England Compounding Center to be indicted following a two year federal probe of the outbreak.
The witness, Corey Fletcher, whose work station was only inches away from Chin's, detailed his work at NECC including the use of expired drugs. He walked jurors through the process of making and packaging the methylprednisolone acetate. Vials of the drug contaminated with fungus eventually sickened some 778 patients.
He also described how the lot numbers for NECC drugs were altered to make it appear that they had been tested. He said newer batches which hadn't been tested were relabeled with the lot numbers of older drugs that had been tested for sterility.
He said the practice, called "botching the lots" was done at Chin's direction multiple times.
He was shown an Aug. 13, 2012 email in which he asked another NECC employee to send 1,000 new labels to accomplish the botching of an untested lot about to be shipped out.
He was shown another email in which Chin reported that NECC still had a container of methotrexate, a drug used in pediatric cancer,  which had a Jan. 23, 2007 expiration date. The drug was in sudden demand.
Fletcher said that subsequently he was told to create new labels listing an expiration date six months later than the date the orders were filled. He verified a series of new labels listing expiration dates ranging from 2010 to 2015. He said Chin told him to only change the year to make it easier to alter records.
Chin's initials were on related documents indicating he had verified the drug was properly labeled.
He said Chin also ordered him to put a reduced amount of water in the methotrexate powder to make up for the fact that the drug was less than 100 per cent potent.
As prosecutors led Fletcher through a series of related records, U.S. District Judge Richard G. Stearns said that "as mesmerizing" as the testimony was, it was time to send the jurors home.

Corners Cut, Tests Omitted as Outbreak Loomed

By Walter F. Roche Jr.

BOSTON, Mass. Former employees of the company that caused a deadly 2012 fungal meningitis outbreak testified that as the volume of drugs being compounded jumped by 300 percent, sterility test results were ignored or omitted and corners were cut to meet the demand.
"Orders were getting bigger," Owen Finnegan told the jurors, adding that he and other employees were wondering out loud about how much money the company needed.
Finnegan was testifying as a prosecution witness in the trial of Glenn Chin, who was a supervising pharmacist at the now defunct New England Compounding Center. Chin is facing racketeering and second degree murder charges.
He was one of 14 charged following a two year grand jury probe of the outbreak which sickened 778 patients in 20 states. Seventy six of them died.
Finnegan, who was a pharmacy technician, said that "back when the orders weren't crazy," he and his colleagues followed established procedures, such as waiting for a set period of time after spraying vials with alcohol.
"Wait times had to be reduced. We had to get it done," Finnegan said.
He said the orders for the increase came from Chin, who told NECC workers "the big boss," NECC President Barry Cadden, wanted it that way.
Cadden is already serving a nine-year sentence following his March conviction on racketeering and mail fraud charges. Cadden, however, was acquitted on 25 counts of second degree murder.
Finnegan said that when he first went to work for NECC in 2010, he and other technicians would be fighting over who got to fill the pending orders. But then "it spiked" and production increased drastically, he said.
He said that Chin himself compounded the methylprednisolone acetate that caused the outbreak because he was the only one who knew how to operate the machine.
According to state and federal regulators, thousands of vials of the NECC steroid were contaminated with deadly fungi.
Nicholas Booth, another pharmacy technician, said he first worked for a sister company, Ameridose, but was eventually transferred to NECC where one of his chores was cleaning in the so-called cleanroom where sterile drugs were prepared.
He said that as the volume of orders jumped in 2012 he and other workers were no longer able to perform all of the daily, weekly and monthly cleanings of equipment and work surfaces. As for the logs used to document that the cleaning had been completed, he said those were filled out after the fact whether or not the cleaning had taken place.
"We all knew that stuff was being sent out that hadn't been tested," Booth said.
"It was happening more and more," he added. "The more orders we got, the more corners were cut."
He said that when he questioned why orders were being sent out before test results were received he was told "They have to be sent out."
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Judge Formally Approves $12.4 Million Legal Fees, Expenses

By Walter F. Roche Jr.

BOSTON, Mass.-The top earning law firm from civil litigation stemming from the 2012 fungal meningitis outbreak collected some $4.8 million in fees, according to records filed in U.S. District Court here.
As promised in a court session Thursday, U.S. District Court Judge Rya W. Zobel formally approved the fee requests and expenses Friday.
Half of the approved fees and expenses were paid previously. The remainder will now be paid by the trustee for the so-called common benefits fund.
The payments are going to firms who did work benefiting all victims of a 2012 fungal meningitis outbreak that killed 76 of 778 patients sickened by contaminated methylprednisolone hydrate.
Those same law firms will also collect fees ranging up to 40 percent of any amount awarded to their individual clients.
The same trustee reported that a total of $136.6 million has been paid thus far to victims of the outbreak.
The top earner Hagens Berman acted as the lead counsel for the Plaintiffs Steering Committee.


                                      FEES              EXPENSES

Hagens Berman         $4,864,672      $169,220   
Ellis & Rapacki         $2,977,612      $125,290
Branstetter Stranch    $2,572,108      $348,474
Janet Jenner               $1,968,038      $107,608
Lief Cabraser             $1,645,564      $349,402
Crandall Law Firm    $1,558,590      $170,922
Miller Law Firm        $1,166,902      $80,736
Orlando Law Firm     $1,046,188      $58,618
Lipton Firm                $957,748         $74,544
Andrews & Thornton $828,902        $86,722
Cohen Placitella         $804,760        $44,572
Leader Bulso              $732,330        $154,038
Colling Gilbert           $233,180        $65,544
Golom & Honik         $203,294            0
Sommers Schwartz    $241,428            0
Saltz Mongelozzi       $213,462         $4,880
Riley Williams           $233,389            0

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Key Outbreak Witness Hammered

By Walter F. Roche Jr.

BOSTON, Mass.-A key prosecution witness was hammered today by the lawyer for his former boss in the trial of a drug compounder charged with racketeering and second degree murder.
For some two hours in U.S. District Court, Joseph Connolly, a pharmacy technician, once employed by the New England Compounding Center, was questioned on everything from his motivation for agreeing to testify for the prosecution to the details of a 1995 auto accident that left him in a coma for five days.
Questioning Connolly was Robert Shekatoff, part of the defense team for Glenn A. Chin, 49, who faces the racketeering, mail fraud and 25 counts of second degree murder.
Before the cross examination Connolly, under questioning by Assistant U.S. Attorney Amanda Strachan, detailed repeated instances in which NECC shipped drugs that were outdated and  untested and how they were instructed to generate fictitious reports about environmental monitoring at the company's Framingham, Mass. facility.
NECC has been blamed by state and federal regulators for causing a deadly 2012 fungal meningitis outbreak that took the lives of 76 patients in 20 states. Chin has been charged with second degree murder in 25 of those deaths, including five in Tennessee.
Co-defendant Barry Cadden, who was NECC's president and chief pharmacist, is already serving a nine year sentence following his conviction of racketeering and mail fraud charges. He was acquitted on the murder charges.
Shekatoff repeatedly asked Connolly why he didn't just quit his NECC job if he was so appalled by what was going on there.
"But you didn't resign," said Shekatoff, after one testy exchange.
"I should have," said Connolly.
Connolly said he had two small children at the time and didn't even consider leaving the job.
Connolly did describe how he and other NECC employees were called into a break room in early October 2012 and told the company was shutting down because five Tennessee patients already had died after being treated with spinal steroids from NECC.
Though they were told the shutdown was temporary, it soon became permanent.
Earlier Connolly testified about how Chin came to be in charge of the two clean rooms where high risk drugs, like the methylprednisolone acetate, were prepared and placed in vials.
Connolly said it was Chin who actually compounded the spinal steroid.
Though Connolly insisted he had no opinion about Chin when he was promoted to oversee the cleanrooms, Shekatoff asked whether Connolly didn't share the opinion of two fellow workers who immediately questioned Chin's competence.
Under Shekatoff's questioning, Connolly acknowledged that he and some of his NECC colleagues held weekly get-togethers.
"You thought you were the smartest man in the room," Shekatoff asserted.
Connolly responded that he didn't think so, though he did eventually conclude Chin was unqualified.
Shekatoff also questioned Connolly about' statements he made to federal investigators when the outbreak investigation first began.
He said Connolly told the officials from the U.S. Food and Drug Administration that the three most likely causes of the outbreak were Chin, non sterile stoppers used in preparing the steroid or vials that were not properly prepared.
Connolly said he named Chin because it was Chin who actually compounded the methylprednisolone acetate.
The cross examination will continue on Monday.
 

Outbreak Judge OKS $6.2 Million in Legal Fees

By Walter F. Roche Jr.

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

Outbreak Victim's Daughter Details His Final Hours

Boston, Mass. - Holding back tears, the daughter of one of the first victims of the deadly fungal meningitis outbreak described his final fight for survival in a Nashville hospital.
Karen Talbott, the daughter of Kentucky Judge Eddie Lovelace, said doctors could not explain how or why the healthy 78-year-old suffered an unusual stroke centered in the middle of his brain.
His death came in early September of 2012, weeks before the public learned that a deadly fungal meningitis outbreak was taking lives in some 20 states.
"We thought it was just a stroke," Talbott told the jury in U.S. District Court. That panel is hearing testimony in the racketeering and second degree murder trial of Glenn Chin, a supervising pharmacist at the New England Compounding Center which produced thousands of vials of a spinal steroid laced with fungus.
Lovelace, who regularly walked five or six miles a day, was in a car accident earlier in the year and suffered a back injury. The fatal injections were supposed to relieve his pain, Talbott said.
She testified that it was only after state and federal officials publicly announced the growing outbreak, that she and her family figured out what took his life.
Lovelace, she said, had received three injections of methylprednisolone acetate at Nashville's Saint Thomas Outpatient Neurosurgical Center in the months before his death.
Talbott said that when they heard early October news reports about the outbreak they immediately suspected what had caused the judge's death.
His body was exhumed and the diagnosis was confirmed.
She said a grand daughter was the first to notice that Lovelace was having difficulty understanding and one day he fell walking out of the courthouse.
"He was complaining he had a headache," she said.
After he fell twice in one morning and complained his fingers were numb, she said they decided to take him to a local hospital, which quickly transferred him to Nashville.
She said doctors were baffled and couldn't explain why he would have an unusual stroke when he didn't have stroke risk factors
Though he rallied briefly, even asking when he could go back to work, his condition deteriorated. She said it broke her heart when she had to restrain the one arm he still could move because he kept pulling out a breathing tube.
Earlier in the Thursday court session, the doctor who unknowingly injected Lovelace with the contaminated steroid, told the court the epidural steroid injections acted as a powerful anti-inflammatory agent.
Using a model provided by federal prosecutors, Dr. John Culclasure described and demonstrated the two methods of injecting the steroid into the affected area of the spine.
As the deaths among his patients grew, Culclasure said he became worried that his method of injecting the steroid might be the cause.
Other possible sources of contamination were a dye used to target the injection, a numbing drug and the steroid itself, he testified.
Under questioning, Culclasure estimated he had performed some 50,000 spinal injections in his career. He said that the Saint Thomas clinic began using steroids from NECC after experiencing supply problems. He said the procedure takes about 5 to 7 minutes and the clinic does 150 to 160 such injections a week.
He said 116 of the clinic's patients were sickened and 13 died.
He said the NECC version of the steroid, unlike the brand used previously was made without preservatives. He said the clinic, which was shut down for weeks after the outbreak, now uses steroids containing preservatives.
Calling the events "a slow moving mass casualty," he said he went to visit some of his patients who had been stricken with fungal meningitis and was surprised by their reaction.
"I thought they would be very worried and upset. They were not. They were worried about us," Culclasure said.
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2nd Checks Sent to 1,760 Outbreak Victims

By Walter F. Roche Jr.

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

By Walter F. Roche Jr.

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

Chin Seeks to Block Prosecution Testimony

Walter F. Roche Jr.

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

By Walter F. Roche Jr.

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

By Walter F. Roche Jr.

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

By Walter F. Roche Jr

Under a judge's streamlined schedule the trial of the second major defendant stemming from the criminal probe of a deadly 2012 fungal meningitis outbreak is set to begin later this month.
Jury selection in the trial of Glenn A. Chin is set for Sept. 15 with opening arguments scheduled to begin four days later. The trial in U.S. District Court in Boston, Mass. follows the March conviction of co-defendant Barry J. Cadden, who was convicted  following a marathon 10-week trial.
Cadden was president and part owner of the New England Center, the company that produced the contaminated steroids blamed for the outbreak that sickened 778 patients, killing at least 76 of them.
Chin was NECC's chief pharmacist and he faces many of the same charges as Cadden.
Chin's trial, however, won't be a repeat of the Cadden trial due to an order issued this summer by U.S. District Judge Richard G. Stearns.
In an initial July order Stearns limited prosecutors to 60 hours to present their case with Chin's lawyers capped at 20 hours. After an appeal by the U.S. Attorney, Stearns upped the prosecution limit to 75 hours while keeping Chin's lawyers to a 20-hour limit.
The revised limits would indicate the trial could last five weeks or about half the time consumed in the Cadden trial. Stearns order states that he will consider extensions on the limits only as the trial proceeds.
Like Cadden, Chin is charged with racketeering and 25 counts of second degree murder. But Cadden, who is now serving a nine-year prison sentence, was acquitted on all the murder charges. He was convicted on a total of nearly 60 counts of racketeering, conspiracy and mail fraud.
While Chin now faces the same charges as Cadden, there are key differences in the facts charged against the two defendants.
Cadden was the president and a stockholder of NECC. Evidence presented at his trial showed the millions of dollars he and his wife profited from NECC. Chin, a supervising pharmacist, was an employee with no ownership interest.
While Cadden was the chief pharmacist, prosecutors never charged that he had any hands-on role in the production of the steroids that triggered the outbreak. In contrast the indictment charges that Chin was directly involved in the production of fungus laden methylprednisolone acetate.
For instance the indictment states that Chin "attempted to sterilize" one of the deadly drug lots by placing the drugs in an autoclave for 15 minutes and five seconds, instead of the required 20 minutes.
In addition, it charges, he failed to verify the sterilization process and to follow the accepted industry standards for sterilized drugs.
Chin was not only directly involved in the production of the suspect drugs, he was the supervisor in the clean room where that production occurred, prosecutors have charged
Another key difference in the two cases is the contention by prosecutors that NECC produced the fungus laden steroids that caused the outbreak.
While Cadden conceded at the outset that NECC produced the deadly lots of methylprednisolone acetate, Chin has made no such concession. During the Cadden trial, government witnesses conceded that they never found the exact fungi found in victims in the lengthy and detailed examination of NECC's Framingham, Mass. factory.
While there are marked differences in the Cadden and Chin cases, prosecutors are likely to seek to replicate testimony from the Cadden trial in which a string of NECC employees  described a locker room atmosphere with frequent lapses in the proper preparation of sterile drugs destined for injection in the spines and joints of unsuspecting patients.
It is also likely that Chin will seek to blame Cadden for any problems at NECC, just as Cadden's lawyers repeatedly argued during his trial that it was Chin who cut corners and opened the door to tainted and deadly drugs being shipped to hundreds of unsuspecting health care providers.
Stearns cited the likely blame shifting when he reluctantly agreed not to put both defendants on trial at the same time, as originally planned.
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Maryland Clinic Moves For Dismissal

By Walter F. Roche Jr.

A Maryland clinic where dozens of victims of a deadly outbreak were injected with fungus laden steroids is moving to have the remaining cases against it dismissed.
In a five-page motion filed today in U.S. District Court in Boston, Mass. lawyers for the Box Hill Clinic in Abingdon sought approval from Senior U.S. District Judge Rya Zobel to file another motion for dismissal, citing evidence compiled thus far.
The clinic noted that it bought the tainted steroids from the same company that was selling its products to "some of the nation's most prestigious" health facilities. It was not "reasonably forseeable" that its products would cause illness and death, the motion states.
The suits are among hundreds filed in the wake of a deadly 2012 fungal meningitis outbreak caused by tainted steroids shipped from the now defunct New England Compounding Center.
"Box Hill defendants complied with the recognized standards of acceptable practice, the motion states.
The clinic lawyers also noted that even if patient specific prescriptions had been written for each of its patients, that would not have prevented the outbreak.
The motion applies to the handful of Box Hill cases that remain in federal court. Still more were filed in state courts in Maryland.
Overall the 2012 outbreak sickened 778 patients in more than 20 states. Seventy-six of them died. In Maryland 26 patients were sickened and three died.
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Hospira Initiates Another Recall

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. To date, Hospira, Inc., a Pfizer company has not received any reports of adverse events related to this recall.
In the event that impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur. The possibility of a breach in sterility assurance in distributed product, while not confirmed, cannot be eliminated.  No batches of product have been identified as containing microorganisms. To date, Hospira has not received reports of any adverse events associated with this issue for these lots. Hospira places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.
Hydromorphone Hydrochloride Injection, USP, CII is indicated for the relief of moderate to severe pain. Levophed® (Norepinephrine Bitartrate Injection, USP) is indicated in adults for blood pressure control in certain acute hypotensive states.
The following lots were distributed Nationwide in the U.S.A (including Puerto Rico), Singapore, and Taiwan to wholesalers and hospitals from May 2017 to July 2017. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
Product/Lot Information (for US/Puerto Rico lots)

Product	NDC	Lot Number