Tennessee Victims Could Get Checks Next Month

By Walter F. Roche Jr.

An estimated $20 million has been deposited in a settlement fund for Nashville, Tenn. area victims of a deadly fungal meningitis outbreak and initial payments could be forthcoming within a month.
Some details on the settlement were given today to U.S. District Court Judge Rya Zobel in a 45 minute session in her Boston, Mass. courtroom.
Benjamin Gastel  told Zobel that money has been deposited in the fund and an administrator to distribute payments has been appointed.
Though the exact amount of the settlement has never been disclosed, it is estimated to be in excess of $20 million.
The funds will go to the more than 100 outbreak victims who were sickened after being injected with fungus laden steroids at the Saint Thomas Outpatient Neurosurgical Center in Nashville.
Zobel has been presiding over hundreds of cases brought by outbreak victims against hospitals and clinics that purchased contaminated vials of methylprednisolone acetate from the now defunct New England Compounding Center.
Gastel reported that a mediated settlement might be possible for some 13 cases filed by victims against the Specialty Surgery Center in Crossville, Tenn. He said the effort included the services of the same mediator used in the Saint Thomas cases.
Chris Tardio, one of the surgery center's lawyers, said his client supported the effort for a mediated settlement.
During the session Zobel gave her  approval to settlements for the survivors of two Virginia patients who were among some 77 who died during the outbreak. Payments to three survivors of one of those victims will total some $450,000.
Five beneficiaries of the second victim will share a little over $360,000.
Zobel also heard from lawyers for victims and the operators of a Maryland clinic. Eight cases against the Box Hill Clinic are still in Zobel's court, while some 20 others are being litigated in Maryland courts.
Zobel urged both sides to make an effort at mediating a settlement of the federal cases. A Maryland judge already had ordered mediation in the cases being heard in Harford County. However, Zobel said there would be no point in her ordering mediation if the clinic lawyers were set on taking the cases to trial.
"There's nothing the court can do right now," Zobel said.
Also presented during the session was a status report on payments to outbreak victims from a separate fund established under the bankruptcy of NECC.
Michael Fencer, the lawyer representing the trustee, said 2,018 claims have been approved and some $77.7 million has been disbursed. According to the report from Lynne Riley victims can expect a second payment during the summer.

2,018 Outbreak Victims Approved for Payments

By Walter F. Roche Jr.

A court appointed trustee has reported that 2,018 victims of the 2012 fungal meningitis outbreak have had the claims approved and some $77.7 million has been disbursed thus far.
The report by Lynne Riley was filed today in U.S.District Court in Boston, Mass. a day ahead of a status conference scheduled for Thursday before U.S. District Judge Rya Zobel.
According to Riley's five-page report a total of 1,810 checks have been distributed including 206 to victims owed money from separate funds established for claims against clinics that reached a settlement agreement.
Riley reported that she expects that victims whose claims have been approved should expect to receive a second payment of approximately the same amount as the first over the summer.
Riley's report states that 311 claims were "fully denied" and 21 were found to be invalid. Two claims were withdrawn.
She said that 128 appeals have been processed by a federal judge. An additional 18 claims could still be appealed.
The funds being distributed were generated in the bankruptcy of the New England Compounding Center, the company blamed for the outbreak. Some $47.5 million came from owners and officers of NECC and additional funds came from companies providing services to the drug compounder.
Zobel has been presiding over hundreds of victims' cases stemming from the outbreak that sickened some 778 patients in  20 states. Seventy-seven of them died.
Contact: wfrochejr999@gmail.com

Chin NECC Trial Delayed Til August

By Walter F. Roche Jr.

The trial of the second defendant in the criminal case stemming from a deadly 2012 fungal meningitis outbreak is being delayed by four months and opening arguments in the case against Glenn Chin have been set for Aug. 14.
U.S. District Judge Richard G. Stearns issued a brief order today setting the trial date and also disclosing that he will be setting time limits on both sides to present their cases.
Chin's trial had been anticipated to begin in April following the recent conclusion last week in the trial of the other main defendant, Barry J. Cadden.
Both Cadden and Chin were charged with racketeering, mail fraud and 25 counts of second degree murder following a two year probe of a fungal meningitis outbreak that sickened 778 patients, killing 77 of them.
A 12 member jury convicted Cadden of rackecteering and mail fraud but acquitted him on the second degree murder charges. Cadden was a part owner and president of the New England Compounding Center, the company blamed for the outbreak.
Chin, who faces identical charges, was a supervising pharmacist at NECC.
In his brief order, Stearns stated that an additional order setting time limits on the upcoming trial would issue "in due course."
Both prosecutors and Chin's attorneys have submitted proposals on limiting the testimony.
The judge moved to limit testimony as the Cadden trial inched its way through his court over a nine week period. Most of that time was consumed by the prosecution case, while Cadden's defense covered barely two days.
Under Stearns order jury selection will begin Aug. 11.
Stearns order does not make clear what will happen with the cases against seven other NECC defendants who also had been slated for an April trial.  Those include Scott Connelly who was working as a pharmacy technician at NECC even though he had voluntarily given up his registration following a state Board of Pharmacy investigation.
Contact: wfrochejr999@gmail.com

Prosecutors' Time Limit Response Under Seal

By Walter F. Roche Jr.

Federal prosecutors have filed their response to a judge's order aimed at setting time limits on the case against the second major defendant in the criminal case stemming from a deadly fungal meningitis outbreak.
The government response to the order from U.S. District Judge Richard G. Stearns in the case against Glenn A. Chin was filed late last week under seal, which means it is not available for public review.
The filing comes just after the case of Barry J. Cadden came to a close with the jury convicting him on racketeering and mail fraud but acquitting him on 25 counts of second degree murder.
Cadden was the pharmacist in charge and part owner of the New England Compounding Center, the company blamed for the 2012 outbreak. Chin was a supervising pharmacist at NECC and oversaw operations in the clean room where fungus laden vials of a spinal steroid were prepared.
Chin faces the same charges as Cadden did, racketeering, mail fraud and second degree murder.
Stearns issued the order in February aimed at limiting the length of the Chin trial in the midst of the Cadden trial, which Stearns described as the longest case in the history of the courthouse. It opened in 1988.
Citing the lengthy case, federal prosecutors sought and obtained an extension from Stearns on the deadline for filing their trial shortening proposal.
In his  six-page February order Stearns wrote that time limits improve "the quality of jury comprehension" and enable the court "to efficiently manage its docket."
He also expressed concern about the effect on jurors of "mega trials," trials that are measured in months rather than days.
Initially Chin and Cadden were set to be tried at the same time, but as the trial date approached, Cadden's lawyers disclosed that a major part of their defense would be to blame Chin. They did so frequently in the trial that just ended.
Contact: wfrochejr999@gmail.com

Majority of Jurors Voted Guilty on Murder Charges

By Walter F. Roche Jr.

BOSTON, Mass. - The official tally sheets for the jurors in the murder and racketeering trial of Barry J. Cadden shows the majority voted for a guilty finding for deaths in four states.
Though a unanimous vote was required for a conviction eight jurors voted for a guilty finding on second degree murder in cases from Michigan and Tennessee, while four voted not guilty.
In the Indiana cases the vote was 9-3 in favor of a guilty finding. The vote for a guilty finding was 7-5 on the Maryland cases.
In the Virginia cases the vote was 3 for guilty and 9 not guilty. In the Florida and North Carolina cases the vote was 12-0 for a not guilty verdict.
As explained in the 50-page jury instructions the jury had to consider the specific state laws in deciding their votes on the second degree murder charges. Virginia, Florida and North Carolina statutes had stricter standards for reaching a guilty finding.
Here are the 25 second degree murder cases in the indictment.

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

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

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

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

Virginia: Kathy Sinclair (1/19/13), Douglas Wingate (9/18/12)

Florida: Godwin Mitchell (3/18/13)

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

Cadden Cleared on Murder Charges, Convicted of Racketeering, Mail Fraud

By Walter F. Roche Jr.

BOSTON, Mass.- A federal jury today convicted a former drug company executive on charges of racketeering and multiple counts of mail fraud but acquitted him of the most serious charges, 25 counts of second degree murder.
The jury, which began deliberations late last week, found Barry J. Cadden, 50, guilty of shipping out drugs that were untested, allowing an unlicensed pharmacy technician to prepare drugs and shipping misbranded drugs in interstate commerce with false patient names.
In addition to the murder charges they found him not guilty of conspiracy to defraud the United States and for shipping expired drugs.
Overall he was convicted on 58 of the 96 counts in the original indictment.
Acting U.S. Attorney William Weinreb said Cadden could face up to 20 years on each of 52 charges of mail fraud. U.S. District Judge Richard G. Stearns set June 21 for sentencing. A conviction on the murder charges could have brought a life sentence
Weinreb said Cadden was responsible for "the largest public health crisis in U.S. history caused by a pharmaceutical."
Though Cadden was only charged for 25 deaths, his company, the now shuttered New England Compounding Center, was blamed for 77 deaths among some 778 patients who were sickened.
Bruce Singal, Cadden's lawyer, said avoiding conviction on the murder charges "was our main priority."
He said it was unjust for the murder charges to have been brought in the first place, adding that the jury had vindicated his client by rejecting those charges. He said he plans to file an appeal of the convictions.
Living victims of the outbreak had mixed reactions to the verdict, many expressing gratitude to prosecutors but disappointment with the not guilty verdict on the murder counts.
The family of Donald McDavid, who died following his injection with an NECC steroid at a Crossville, Tenn. clinic issued a statement commending federal prosecutors for their work on the case. Cadden had been charged in McDavid's death.
"We live with Don's loss every day. We take some comfort in knowing Mr. Cadden will be held accountable for his actions..No matter how long Mr. Cadden spends in prison, it will never bring Don back," the family said.
Jona Angst, a Michigan victim, said she was disappointed in the verdict.
"The victims wanted the murder charges," she said. "We deserve our justice. The dead deserve justice." 
Mark Chalos, a Nashville attorney who represents victims, said that while victims could take some solace in the conviction, "Mr. Cadden's scheme would not have succeeded without the greed and recklessness of the corporations that bought his products on the cheap and injected them into patients."
The verdict came after what Stearns called the longest trial in the history of the 29-year-old courthouse. Opening arguments were delivered on Jan. 19 and testimony from more than 60 witnesses stretched over some two and a half months
Cadden was one of 14 persons affiliated with NECC indicted by a federal grand jury in late 2014 following a more than two year investigation.
Prosecutors charged Cadden with playing Russian Roulette with the lives of unsuspecting patients and cited multiple records showing a history of  problems  in maintaining the safety and sterility of NECC's products.
Cadden's lawyers insisted he had no reason to believe, based on more than a decade of operation, that the 17,000 vials of methylprednisolone shipped out by NECC between May and September of 2012 were anything but safe and sterile.
Cadden, who had entered not guilty pleas to all 96 counts against him, did not testify in his own defense and his lawyers rested their case after only two days of testimony from a handful of witnesses.
The case against Cadden included extensive internal NECC documents, including Cadden's own emails and the videotapes of his sales training sessions. Prosecution witnesses included several former employees of NECC and an affiliated sales company including a former sales manager, Rob Ronzio, who testified under the terms of a plea deal.
Under that agreement Ronzio pleaded guilty to a single count of conspiracy to defraud the federal government.
As the trial dragged on from mid-January through February and in to March, Stearns made repeated attempts to move the trial along, at one point telling one of Cadden's lawyers, "You seem to have run out of things to say."
Before that he ruled that prosecutors could not present further testimony from outbreak victims or their survivors because of its prejudicial impact.
In addition to Ronzio and Cadden, two others named in the 2012 indictment entered guilty pleas to vastly reduced charges, two had all charges dismissed. The remainder are expected to go on trial shortly. The next case, according to court filings will be the charges against Glenn Chin, NECC's supervising pharmacist, who also faces multiple second degree murder charges.
Weinreb would not comment when asked what effect the Cadden verdict might have on the case against Chin. He said the trial was slated to begin next month.
Stearns already has issued orders seeking to set limits on the length of the Chin trial.
The 2012 outbreak first became public in early October of 2012, but trial testimony showed that the alarm had already been sounded days earlier after NECC clients began complaining about patients becoming ill and evidence of contamination in vials of NECC's products.
It became public shortly after a physician at the Vanderbilt University Medical Center reported to the Tennessee Health Department that a patient, who had recently had a spinal injection, was suffering from a very rare form of meningitis, one caused by a fungus called aspergillus fumagatus.
During the trial federal prosecutors attempted to show that Cadden delayed in sounding the alarm. Ronzio testified that Cadden "knew right away it was us."
Cadden's attorneys countered with a tape recording of a call Cadden made to a clinic with a warning that the drugs were being recalled.
"We consider this an emergency," he said in a voice mail left at the clinic.
Prosecutors played videotaped training sessions Cadden held with sales staffers in which he bragged about staving off state and federal regulators.
"They don't want to deal with us. They don't know what they are looking at," Cadden said, adding that he "educated" the state investigators.
"When complaints come in from other states, the board says, 'Just go away.'" Cadden told the sales traineed
Among the former NECC amployees to testify was Joseph Connolly, whose brother Scott was among those indicted. He testified that despite the promises made to customers NECC did not do the proper testing on its products. He said his brother had given up his registration as a pharmacy technician following a state investigation and shouldn't have been working in one of NECC's clean rooms.
According to other testimony Scott Connolly used Cadden's sign in and initials to authenticate his work at NECC.
Cadden was found guilty on the charges relating to Scott Connolly.
Annette Robinson, who was in charge of quality control for NECC, testified that when she brought sterility concerns, including presence of mold in and around the clean rooms, to Cadden's attention, nothing happened.

Jurors Question Could Jeopardize 40 Charges

By Walter F. Roche Jr.

BOSTON, Mass.-Jurors deliberating the racketeering and murder charges against a former drug company president raised a question today that could negatively impact up to 40 of the 96 counts pending against the defendant.
The  question was one of several raised by the 12 member jury as they completed the second full day considering the racketeering and second degree murder charges against Barry J. Cadden who served as president and pharmacist in charge for the now defunct New England Compounding Center.
Cadden was charged following a two year investigation of the 2012 fungal meningitis outbreak caused by fungus laden steroids shipped fron NECC's Framingham, Mass. headquarters.
The jurors sent a written question to U.S. District Judge Richard G. Stearns asking whether they could find Cadden guilty of violations of the federal Food Drug and Cosmetic Act, if they did not find that he did so willfully, meaning he intended to defraud and mislead.
The question arose from the instructions jurors were given and a check list they must complete on each of the charges.
Stearns said that because of the instructions and the check list the jurors could not find Cadden guilty of the violations unless they also concluded that he did so willfully.
If there is no intent to defraud or mislead, Stearns said, then you must find Mr. Cadden innocent.
 "That's not the way the instructions read," said Assistant U.S. Attorney George Varghese.
of Stearns' conclusion.
Varghese noted that the check list given to jurors has separate columns for a finding of guilt and a finding of intent and the law still provides for violations to be charged without specific intent..
"It's too late to change the instructions," Stearns replied.
Bruce Singal, Cadden's attorney, quickly signaled his agreement with Stearns.
Stearns said the jurors would be told that they must find Cadden willfully violated the law to also find him guilty of violating the act.
The counts in question charge Cadden with a variety of violations of the Food, Drug and Cosmetic Act, including mislabeling drugs and shipping drugs across state lines that he knew were prepared under insanitary conditions. The list includes vials of methylprednisolone acetate shipped by NECC to clinics in Tennessee, Michigan and Indiana.
Earlier in the days the jurors  asked for additional information on exhibits that were presented during the nearly three month trial, including information on the test results on drugs produced by NECC.
Singal objected to the jurors being presented a separate binder containing test results, because that binder had never been formally introduced as evidence.
Stearns assured him three times that the disputed binder was not in the jury room.
At the very end of the session jurors sent another request for a list of certificates of analysis on NECC drugs that were introduced during the trial.
Assistant U.S. Attorney Amanda Strachan said she would provide a list informing the jurors of the exhibit numbers for the certificates.
The jurors will reconvene tomorrow at 8 a.m.
Contact: wfrochejr999@gmail.com

Maryland Outbreak Cases Move Toward Trial

By Walter F. Roche Jr.

BOSTON, Mass.- Cases brought by victims of the fungal meningitis outbreak against a Maryland pain clinic are moving forward and lawyers for both sides have agreed on two of the cases that should be tried first and serve as templates for the remainder.
 Competing lists were submitted this week in U.S. District Court and the final decision on which cases will go first and serve as so-called bellwethers will come from U.S. District Judge Rya Zobel, who is presiding over remaining civil cases stemming from the 2012 fungal meningitis outbreak.
Lawyers for both the Box Hill Clinic in Abingdon Md. and the victims submitted four names each, two among victims who died and two for victims who survived. The initial cases, called bellwethers, are supposed to serve as templates for the resolution of the remaining cases.
On both lists were Bahman Karshi, who died and Belinda Dreisch who survived.
On the list of survivors submitted by victims' lawyers were Dreisch and Angela Farthing. In addition to Karshi, the plaintiff lawyers submitted the name of Meghan Handy as its second deceased victim candidate.
Karshi's son testified recently in the criminal trial of Barry Cadden, the one time president of the company blamed for the 2012 outbreak. He said his father, who lived in California, got the injection at the Abingdon clinic while visiting him.
Also testifying at Cadden's trial was Ritu Bhambhani, who operates the pain clinic. She was one of several professionals of pain clinics where outbreak victims were injected brought here to testify for federal prosecutors.
She testified that when Cadden called her to inform her that a recall had been initiated, he assured her that there was nothing to worry about and the recall was initiated out of an excess of caution after a doctor noticed some discoloration in a single vial of methylprednisolone acetate.
Farthing, a guidance counselor, was one of a group of outbreak victims who were invited to attend Cadden's trial at government expense. The victims were brought in for a week at a time to watch the proceedings.
Other cases recommended by attorneys for Box Hill were Evelyn Bowman, who did not survive the outbreak, and Teresa Davis, who did.
Meanwhile jurors considering the racketeering and second degree murder charges against Cadden are scheduled to resume deliberations tomorrow (Monday) morning.
Contact: wfrochejr999@gmail.com

Cadden Jurors Wrap Up First Day

By Walter F. Roche Jr.

BOSTON, Mass.- Jurors considering the murder and racketeering charges against a former drug company adjourned shortly after 2 p.m. today, but not before asking for clarification on a critical issue.
In a brief session before U.S. District Judge Richard G. Stearns the jury considering the case against Barry J. Cadden asked questions indicating they are grappling with a decision on whether Cadden's actions could be considered second degree murder or negligence.
Stearns told them negligent conduct is failing to act as a prudent person would under the circumstances.
"What would a prudent man do under the same circumstances," he said.
He said there was a higher threshold for second degree murder in which a person acts in a way that he or she knows is likely to cause death or serious injury.
Cadden, the former president of the now defunct New England Compounding Center has been charged with racketeering and 25 counts of second degree murder. If the jury were to decide Cadden was negligent that would not meet the requirements for a racketeering charge.
Additional racketeering charges, however, would remain.
The jurors will resume their deliberations Monday morning.
Cadden is the first to go to trial in charges stemming from the 2012 fungal meningitis outbreak

Cadden Murder Case Goes to Jury

By Walter F. Roche Jr.

BOSTON, Mass--Charging that the former part owner of a now defunct drug company was playing a game of Russian Roulette with the lives of unsuspecting patients, federal prosecutors today asked a 12 member jury to convict him on charges of racketeering and 25 counts of second degree murder.
The final arguments in the case of Barry Cadden, 50, lasted several hours and came at the end of testimony in a trial that is approaching the three month mark.
Cadden was the president and pharmacist in charge at the New England Compounding Center, which has been blamed for a deadly 2012 fungal meningitis outbreak that sickened 778 patients in 20 states, killing 77 of them.
Cadden's lawyer, Bruce Singal, told the jurors that while the outbreak was a horrible tragedy, federal investigators were never able to point to a single act Cadden performed to cause the outbreak.
"Barry Cadden didn't murder any of those people. It is not a murder case," Singal said, calling the murder charges prosecutorial overreach.
Following some 90 minutes of instructions by U.S. District Judge Richard G. Stearns, the jurors met briefly in an organizational session and will begin formal deliberations at 8 a.m. tomorrow.
Assistant U.S. Attorney Amanda Strachan said that Cadden ignored multiple warning signs that things at the Framingham, Mass. company were "going off the rail" and that he showed a willful disregard for the patients being injected with NECC drugs.
"He deliberately broke the rules. He knew those drugs could kill," Strachan said. "He ignored the red flashing lights."
Using Cadden's own words from his emails and videotaped sales training sessions, Strachan said that NECC's own data showed multiple sterility problems requiring remediation in 37 out of 38 weeks in NECC's final year of operation.
She charged that under Cadden's leadership and direction NECC compounded drugs beyond their use date sending outdated and mislabeled products to health facilities in New York, Illinois and Nevada. Despite mold being found in clean rooms for compounding sterile drugs, Strachan said Cadden did nothing.
Despite promising physicians and hospitals that its drugs were prepared under strict sterility standards, Strachan said that was just one of many false promises by NECC.
"He didn't follow the rules. He knew people could die," Strachan said. "That is murder in the second degree."
Noting a series of last minute Cadden emails about tests not being performed, Strachan said,"He waited for people to die to do something."
Assistant U.S. Attorney George Varghese said Cadden was "playing a game of Russian Roulette... spinning the cylinder and pulling the trigger" by sending out vial after vial of drugs without promised testing.
"It was inevitable," he said of the deadly outbreak.
Singal argued that NECC had shipped out 859,125 vials of similar steroids between 2006 and 2012 without any problems and Cadden had no reason to expect otherwise.
He charged that prosecutors played on the emotions of jurors by eliciting testimony about the deaths of victims and introducing extraneous evidence. As part of that effort Singal said prosecutors presented evidence of issues that weren't even contested.
"The basic core of a murder charge is that the defendant did something," Singal said, yet prosecutors were unable to identify a single act that Cadden committed that led to the outbreak.
"Barry Cadden did nothing to cause these people to die."
As he has throughout the trial Singal pointed the blame on codefendant Glenn Chin, who was a supervisory pharmacist.
"It was Glenn Chin who was in charge of the clean room," Singal said, referring to the room where the deadly vials of methylprednisolone acetate were prepared.
Chin, who is facing identical second degree murder charges is expected to go on trial when Cadden's case is completed.

Prosecutors Get More Time on Time Limits

By Walter F. Roche Jr.

BOSTON, Mass.- Federal prosecutors have won an extension until March 24 to submit a proposal to set time limits on the upcoming trial of Glenn Chin, the second defendant to face a jury  on charges stemming from a federal probe of a fatal fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns approved the extension this week. Assistant U.S. Attorney George Varghese had cited the ongoing trial of co-defendant Barry J. Cadden, as the reason an extension was needed.
Closing arguments are set for tomorrow in the Cadden trial. Testimony in the case stretched over two months.
Chin, like Cadden, is facing charges of racketeering and 25 counts of second degree murder.
Both were indicted following a two year investigation of the 2012 fungal meningitis outbreak. Cadden was president and part owner of the New England Compounding Center, the company blamed for the outbreak. Chin was a supervising pharmacist at NECC.
Stearns, who has made numerous attempts to move the Cadden trial toward completion, issued an order late last month calling on Chin's lawyers and prosecutors to propose time limits.
 In the six-page order Stearns wrote that time limits improve "the quality of jury comprehension" and enable the court "to efficiently manage its docket."
He also expressed concern about the effect on jurors of "mega trials," trials that are measured in months rather than days.
Contact: wfrochejr999@gmail.com

Jury to Finally Get Cadden Case

By Walter F. Roche Jr.

BOSTON, Mass.- After more than two months of testimony jurors Thursday will get the chance to decide the fate of Barry Cadden, the 50-year-old former drug company president, who prosecutors have charged in the deaths of 25 patients.
Lawyers for Cadden and prosecutors have  been given 90 minutes each to present final arguments. The judge will give final instructions and deliberations will begin.
U.S. District Judge Richard G. Stearns told lawyers for both sides that the jury decision on some of the most serious charges won't necessarily be the last word.
He said he would let the jury take "the first pass" at charges that Cadden and others at the New England Compounding Center conspired to defraud the U.S. Food and Drug Administration. He said, based on the testimony, he was not certain what the FDA was defrauded of.
If the jury were to find Cadden guilty of that charge, Stearns, as his "first pass" comment indicates, could overrule them.
He also indicated there maybe issues with the second degree murder charges Cadden is facing. He said in some jurisdictions, recklessness alone is not sufficient to convict on a charge of second degree murder. He also mentioned a federal appeals court decision on that issue but did not elaborate.
Cadden's lawyers have consistently argued that the murder charges are an overreach.
The opening arguments came more than two months ago with prosecutors showing the jury pictures of the victims, the 25 who died after being injected with fungus tainted methylprednisolone acetate shipped from NECC to more than 20 states.
Despite the lengthy trial, the testimony has left many questions about the deadly outbreak unanswered. The jury was never told that the outbreak actually killed three times more victims or that a total of 778 patients were sickened.
And unbeknownst to the jurors many of those victims or their survivors were sitting in the courtroom as the trial proceeded. The U.S. Attorneys office invited victims to spend up to a week each to watch the trial at government expense.
They came from Michigan, Indiana, Pennsylvania, Tennessee and Virginia.
Among the unanswered questions is the case of Alice Machowiak, an 88-year old victim from South Bend, Ind.  According to the records and testimony Machowiak was injected at the South Bend Clinic on Sept. 6, 2012 and Oct. 1, 2012. She died on Dec. 12, 2012.
Machowiak's second injection came four days after witnesses have testified Cadden had contacted all the clinics to warn them there might be a problem with NECC's methylprednisolone acetate.
In fact an employee of the Indiana clinic testified that she got a call from Cadden on Sept. 21 and immediately quarantined all of NECC's methylprednisolone acetate. Cadden's lawyers have denied he made a call on Sept. 21, but they have acknowledged that on Sept. 26 Cadden made a series of calls to clinics telling them there were problems with the steroid.
Another victim, Donald McDavid, according to court records, was injected at a Crossville, Tenn. clinic on Sept. 26, the same day Cadden was up all night making those calls. McDavid, according to the indictment, also was injected on Aug. 29, 2012. He died on Nov. 4.

 Charged Deaths

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

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

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

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

Virginia: Kathy Sinclair (1/19/13), Douglas Wingate (9/18/12)

Florida: Godwin Mitchell (3/18/13)

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

Judge Questions Charges In Cadden Case

By Walter F. Roche Jr.

BOSTON, Mass.- The federal judge presiding over the the first criminal trial stemming from a deadly fungal meningitis outbreak said today that he will let the jury have the "first pass," but he expressed strong doubts about some of the more serious charges against a former drug company president.
"It's hard for me to see what the FDA (U.S. Food and Drug Administration) was defrauded of," said U.S. District Judge Richard G. Stearns., adding "I'll let the jury have the first pass."
He also said he would let the jury decide on the 25 counts of second degree murder facing Barry J. Cadden, but noted that some court rulings have concluded that recklessness alone is "not sufficient" to establish a case of second degree murder.
"This case is going to the jury anyway," he said.
Stearns comments came after the 15 jurors hearing the case had been sent home until Wednesday, when they will hear final arguments. Stearns said each side will have a total of 90 minutes.
In questioning the charges that Cadden and other employees of the New England Compounding Center conspired to defraud the FDA, Stearns cited the congressional testimony of former FDA Commissioner Margaret Hamburg.
Her testimony was read into the record last week by one of the attorneys representing Cadden.
At a 2012 hearing called by a House committee in response to the fungal meningitis outbreak,  Hamburg said, "The law is not clear on this,"  adding that there were "significant gaps in our authority." She also cited a court ruling striking down a law related to compounding.
The charges against Cadden, which also include racketeering and mail fraud, stem from a two year grand jury probe of the 2012 fungal meningitis outbreak which sickened some 778 patients across the country, killing 77 of them. Of the 14 originally indicted, charges have been dismissed against two and two others pleaded guilty to vastly reduced charges.
Cadden, who did not testify in his own defense, was president and part owner of the New England Compounding Center, the company blamed for the outbreak. His lawyers have conceded that spinal steroids shipped from NECC caused the deaths and illnesses.
The judge's comments come more than two months after the jury was selected in early January. Since then dozens of witnesses have been called to give hours of testimony in daily sessions starting at 9 a.m. and ending at 1 p.m.
Prior to Stearns' comments Bruce Singal, Cadden's lawyer had argued for acquittal contending that the problems at NECC cited by prosecutors did "not rise to the level necessary" to prove second degree murder.
"Something went horribly, tragically wrong," Singal conceded but said prosecutors had failed to connect the deaths to any specific deficiency. He said NECC had previously shipped some 800,000 vials of the same type of steroids without incident.
Calling the second degree murder charges "a gross overreach and a gross miscarriage of justice," Singal said no reasonable prosecutor would have brought such charges in the seven states where the 25 victims died.
Assistant U.S. Attorney George Varghese, however, said Cadden had been "extraordinarily reckless" by shipping drugs that hadn't been tested and that he knew would be injected into the spinal columns of patients.
Stating that Cadden's actions were equivalent to shooting into a crowd, Varghese said, "That's murder."
He said Cadden "didn't do what he was supposed to do" and he knew there was a likelihood of harm to patients.
Prior to their dismissal, jurors also heard testimony from a former employee of NECC's
sales affiliate who said his review of telephone records showed there were no calls from NECC to an Indiana clinic on Sept. 21, 2012.
A prosecution witness earlier testified Cadden did call her that day and informed her there might be a problem with a recent shipment of spinal steroids. The recall of those spinal steroids was instituted five days later.
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Key Timing Data Challenged in Cadden Trial

By Walter F. Roche Jr.

BOSTON Mass.- Using an FBI agent as one of their witnesses, lawyers for a former drug company executive facing second degree murder charges today attacked key timing issues in the case presented by prosecutors.
Called as a witness by lawyers for Barry J. Cadden, FBI Agent Philip Sliney acknowledged that a key prosecution witness, the head of sales for the now defunct New England Compounding Center, wasn't sure just when Cadden said,"It's us. It's over."
Sliney said Rob Ronzio, who testified against Cadden under a plea agreement, wasn't sure whether Cadden made the comment on Sept. 26 or Sept. 27, 2012.
Cadden is facing charges of racketeering and 25 counts of second degree murder for his role in the 2012 fungal meningitis outbreak which took the lives of 77 patients. Cadden's lawyers have conceded that NECC steroids caused the outbreak.
The date Cadden first learned of the emerging outbreak is critical, as his lawyer Bruce Singal  pointed out today.
Prosecutors have pointed to an apparent five day delay between the time Cadden first learned there might be a serious problem with one of NECC's key products and the institution of a recall of thousands of vials that turned out to be contaminated with a deadly fungus.
Cadden's lawyers also presented evidence challenging the timing testimony of an employee of a South Bend, Ind. pain clinic.
Wendy Huffman testified that she spoke with  Cadden in a phone call on Sept. 21, 2012 and he told her there might be a problem with a shipment of vials of methylprednisolone acetate.
Communications company officials, who had gathered the clinic's phone records, testified today that there were no calls to or from the clinic to a number in the 508 area code on Sept. 21, 2012.
On cross examination, prosecutors questioned whether the telephone records were complete.
Sliney, the FBI agent, was asked to review notes he made from interviews with Ronzio before the Cadden trial began nearly ten weeks ago.
"He (Ronzio) was clearly struggling with the date," Sliney said. "He wasn't sure. I felt he wasn't sure of it."
Ronzio also stated under questioning that Cadden knew from the time of the first reports of a problem at a Nashville, Tenn. clinic that it was an NECC product that was to blame. Tennessee health officials at first thought there might be other causes for several patients being taken ill.
In addition to the phone records, Cadden's lawyers read extensively from the transcript of a 2012 congressional hearing in which then FDA Commissioner Margaret Hamburg was being questioned about her agency's regulation of compounding pharmacies like NECC.
The hearing was called in response to the fungal meningitis outbreak. Hamburg told members of a House committee that court rulings striking down a key statute had made regulation difficult.
"The law is not clear on this," Hamburg testified, adding that there were "significant gaps in our authority."
Cadden's lawyers also read to the jury emails, memos and correspondence from federal officials in which the difficulty in regulating compounders was detailed.
One of the charges against Cadden is that he defrauded the FDA.
Another witness for Cadden, Stephen O'Neill, head of an Ashland, Mass. testing company, said his twice a year tests of NECC's clean rooms found no evidence of excess particulates. He said rooms met and exceeded industry standards.
U.S. District Judge Richard G. Stearns told the 15 jurors hearing the case that final witnesses would be called Monday and final arguments, depending on the weather, will come on Tuesday.

Physician Says Prescriptions Are Fake

By Walter F. Roche Jr.

BOSTON Mass.-The chief medical officer at a major local hospital testified today that he never signed or approved several prescriptions that the head of a drug compounding firm submitted to state regulators in response to a 2012 complaint.
Testifying in in U.S. District Court in the second degree murder trial of Barry J. Cadden, Dr. Sunil Eappen also said that several other prescriptions submitted by the New England Compounding Center could not have been written by the doctors named on the forms because they would not be using the drug being dispensed.
Eappen,  an anesthesiologist from the Massachusetts Eye and Ear Infirmary (MEEI) was the final prosecution witness in a trial that began nearly two months ago. Lawyers for Cadden later introduced their first witness and there were indications the case could finally go to the jury next week after two additional days of testimony.
Cadden has been charged with defrauding the U.S. Food and Drug Administration, racketeering and 25 counts of second degree murder.
 Shown prescriptions for a large volume of an eye numbing agent, Eappen said they weren't his and he never approved them despite the fact that his name was listed on the forms as the prescribing physician.
Shown prescriptions signed by other MEEI physcians, Eappen said the doctors named would never have had a need for an eye numbing agent because of their specialties. One of them does nose jobs, while another is a plastic surgeon, Eappen said. A third doctor, whose name was on an NECC prescription, does cochlear implants.
Under questioning by Assistant U.S. Attorney George Varghese, Eappen recounted how MEEI filed a formal complaint against NECC with Massachusetts Pharmacy Board in 2012 after doses of that same eye numbing drug proved ineffective, with both patients and their doctors registering complaints.
"We just wanted to make sure it wasn't a trend" Eappen said when asked why it was reported to the state.
Eappen said doses of the eye numbing drug were eventually found to have only 25 percent of the prescribed key ingredient, lidocaine.
His testimony about the false prescriptions follows Wednesday's statements by a former employee of NECC's sales arm. Beth Reynolds related how she and another employee, under Cadden's direction, created some 300 prescriptions to make it appear that NECC had complied with a state law mandating the use of patient specific prescriptions.
Eappen said the numbing agent is used for eye surgeries. In addition to blocking pain, it keeps the eyeball still. He said it is injected into the tissue beneath the eyeball. At MEEI, he said,  those injections are administered between 6,000 and 7,000 times a year.
He said MEEI initially had the numbing agent prepared daily by staff anesthesiologists, but then shifted the duty to the in-house pharmacy. He said they eventually turned to NECC because the Framingham company offered a version with fewer risks of infection and a 30 day shelf life.
Also testifying about the eye blocking incident was William E. Frisch Jr., an investigator for the state Pharmacy Board, who was assigned to look into the MEEI complaint.
He said he sent a letter to Cadden with a series of specific questions about the preparation of the drug and general information on NECC's operations including a list of licensed pharmacists and registered pharmacy technicians.
Among the items requested were copies of the patient specific prescriptions for the eye numbing drug from the lot which triggered the complaint.
"We wanted to make sure there were prescriptions," he said.
He said the response including the prescription copies were sent to the board on June 14, 2012 in a letter signed by Cadden.
After Assistant U.S. Attorney Amanda Strachan announced the prosecution had completed its case, Stephen O'Neill, the head of an Ashland environmental monitoring company, was called as Cadden's first witness.
Under questioning by Bruce Singal, O'Neill said his firm, Scientific Air Analysis had been doing testing twice a year for NECC since the compounding firm opened in the late 90s. The company specializes in clean room inspection and monitoring, according to its web site.
Shown the results of the last test conducted on June 22, 2012, O'Neill said the sampling for particulates in the primary clean room showed it exceeded the requirements set by the U.S. Pharmacopeia and the International Standards Association.
His testimony will resume Friday.
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Cadden Seeks Acquittal on All Charges

By Walter F. Roche Jr.

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

By Walter F. Roche Jr.

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

Cadden Learned Sept. 21 of First Victims

By Walter F. Roche Jr.

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

By Walter F. Roche Jr.

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

By Walter F. Roche Jr.

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

CDC Shows Brain Destruction Caused by Fungus

By Walter F. Roche Jr.

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

Prosecution Witness Grilled and Scolded

By Walter F. Roche Jr.

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