Friday, May 19, 2017

TN Clinics Seek Cadden, Ronzio, FDA Testimony


By Walter F. Roche Jr.

Charging that the testimony is critical to their defense, Tennessee clinics being sued in the fungal meningitis outbreak are asking a judge to either clarify or amend a prior order delaying depositions of defendants and witnesses in a parallel criminal case.
In a 17-page motion filed this week, the attorney for the clinics said that there was no longer any justification for delaying the depositions of Barry Cadden, Rob Ronzio and two others, along with officials of the U.S. Food and Drug Administration.
Citing the recent completion of the criminal trial of Cadden, the motion states that the time has now come for the depositions to proceed.
"The justification for staying these depositions are largely if not completely wiped out at this juncture," the filing by Chris Tardio states.
The motion was filed in behalf of Tennessee clinics in Crossville and Oak Ridge where patients were injected with fungus laden steroids shipped by NECC to health care providers in some 20 states. The 2012 outbreak sickened 778 patients and killed 76 of them.
Noting that Cadden was convicted by a jury on March 22 and Ronzio already has entered a guilty plea, the filing argues that key testimony is needed for the clinics to assert their claim that NECC was responsible for the deadly 2012 fungal meningitis outbreak.
In addition, the motion states that depositions from FDA agents are needed to show that the government agency acted recklessly by not taking action against NECC.
Stating that the FDA's involvement with NECC "spanned 10 eventful years," the motion adds, "There is no dispute that the FDA exercised some regulatory oversight of NECC."
As for Cadden and Ronzio, the clinic's lawyer acknowledged both are likely to invoke their constitutional right against self incrimination. Nonetheless the jurors in the civil case will be able to draw their own conclusions from their refusals to answer questions, the filing states.
In addition to Ronzio and Cadden, the clinics are asking U.S. District Judge Rya Zobel to allow the depositions of a former NECC employee, Joe Connolly and a salesman for NECC's sales arm, John Notarianni.
 Connolly was a key prosecution witness in Cadden's trial, detailing how NECC's operations disregarded concerns about safety and sterility and falsified records to make it appears drugs had been properly tested when they weren't.
Though Notarianni did not testify at the Cadden trial, the motion states that the former salesman has agreed to testify "substantively" about the assurances the NECC sales force gave to customers about the company's quality assurance.
Stating that "circumstances have changed," the motion concludes that delaying the depositions is no longer justified.
Though Cadden's trial ended with a conviction on 57 counts of racketeering and conspiracy, others charged in the two year outbreak investigation have yet to go on trial. Codefendant Glenn Chin's trial is scheduled for Sept. Others are scheduled for next year
,Contact: wfrochejr999@gmail.com

Tuesday, May 16, 2017

Denial of Cadden's New Trial Motion Urged


By Walter F. Roche Jr.

Stating that a federal jury "properly considered overwhelming evidence of his guilt," federal prosecutors today asked a judge to deny Barry Cadden's motion for a new trial on racketeering and mail fraud charges.
In a 48-page motion filed in U.S. District Court in Boston, Mass. federal prosecutors charged that all the arguments for a new trial already had been considered and denied either by presiding judge or the jury.
Cadden was convicted on March 22 following a 10-week trial on charges that Cadden's New England Compounding Center operated as a criminal enterprise.
He was cleared of 25 counts of second degree murder, although a majority of the jurors voted for a guilty verdict in all but four of the murder counts. A unanimous verdict was required for a conviction.
Cadden was one of 14 persons associated with NECC to be charged following a two year investigation of a deadly fungal meningitis outbreak that sickened 778 patients and killed 76 of them.
Cadden, in his motion for a new trial or acquittal, had argued that the inclusion of the murder counts prejudiced the jury.
"A majority of the jurors found Cadden guilty of 21 of 25 murders" including eight in Michigan and seven in Tennessee. The jury's verdict confirmed that racketeering acts were properly included," the filing states.
Denying Cadden's claim of "prejudicial spillover," prosecutors Amanda Strachan and George Varghese said that evidence of murders was "largely limited and tactfully presented" with no attempt to evoke emotional appeal.
"The jury properly considered overwhelming evidence of the defendant's guilt as to each of the 57 counts," the filing continues.
The prosecutors defended the inclusion of details of Cadden's actions and inactions in the days leading up to the first public announcement of the deadly outbreak in 2012.
Repeating the details of the timeline they noted that there was a several day delay from Sept. 20, when Cadden first learned of a problem with Tennessee patients becoming ill, and Sept. 26 when he began calling clinics telling them not to use NECC's spinal steroid.
 "Cadden didn't disclose people were getting sick. These were critical moments in an evolving national disaster," the brief states.
Accusing Cadden and his lawyers of sensationalism, the prosecutors charged that allegations of government misconduct in the handling a a binder of evidence was "untethered to any factual or legal foundation."
Stating that Cadden had "intimate knowledge and understanding of NECC's fraudulent compounding operations," they charged that Cadden knowingly and repeatedly violated the industry standards for compounding sterile drugs as set by the U.S. Pharmacopeia.
Recounting the testimony of witnesses from the U.S. Centers for Disease Control and Prevention, the filing states that Cadden had been warned a decade earlier that his testing procedures were flawed and too few samples were being tested.
They also defended the charges against Cadden stemming from the fact that an unlicensed technician was working for nearly two years in one of NECC's sterile drug compounding rooms. Emails, the filing states, showed Cadden had authorized the unlicensed individual to use his (Cadden's ) identification sign on so that there would be no records.
"There is next to nothing in the motion (for a new trial) that has not already been decided by this court and/or jury," the filing states, adding that Cadden actions led "to the largest public health crisis ever caused by a pharmaceutical drug."
Sentencing in Cadden's case is scheduled for June 29 before U.S. District Judge Richard G. Stearns.
Contact: wfrochejr999@gmail.com



Wednesday, May 10, 2017

Judge Orders Prosecutors to Produce Binder


By Walter F. Roche Jr.

A federal judge has ordered prosecutors to turn over a binder full of exhibits that has become a point of heated dispute in the aftermath of the criminal trial of a one time drug company executive.
In a two-page order dated Tuesday, U.S. District Judge Richard G. Stearns sitting in Boston, Mass. ordered federal prosecutors to turn over to him a binder full of exhibits and a PowerPoint presentation used in the recent trial of Barry J. Cadden.
Though Stearns had previously stated that he was certain the binder had not been provided to the jury during its deliberations, he said in his latest ruling that it was quite possible that the binder did find its way into the jury room.
"If there is any possibility (and now it appears that there is a real one)  that the binder was submitted to the jury, there is no reason that it should not be included in the trial record," Stearns wrote
The 12-member jury found Cadden guilty of 57 counts of racketeering and mail fraud but cleared him of 25 counts of second degree murder.
The dispute about the binder arose following the jury verdict when Cadden's lawyers filed a motion seeking either acquittal or a new trial. His lawyers also demanded that the binder be made part of the record for appeal purposes.
Stearns noted that federal prosecutors in responding to Cadden's motion on the binder disclosed that the binder was provided to the courtroom clerk "during the customary post-trial exhibit review, but that Cadden's counsel did not object to its inclusion in the jury materials."
In ordering prosecutors to turn over the binder, Stearns wrote, "there is no reason to keep secret something that was used (effectively in the court's judgment) in open court. Transparency is the best antidote for unwonted suspicion."
Cadden's lawyers have argued that the binder contained materials favorable to the prosecution case and did not include rebuttal material.
Stearns order requires prosecutors to turn over the binder by Friday. They also must file a copy of a PowerPoint presentation that was used by federal prosecutors in closing arguments.
Contact: wfrochejr999@gmail.com

IG Finds Some Flaws in VA Compounding


By Walter F. Roche Jr.

A review of drug compounding practices at Veterans Administration facilities showed that more than a quarter of those reviewed could not provide evidence that shelving and storage areas in sterile drug preparations area were cleaned at least once a month, the required standard.
In a 20-page report issued today,  the VA's Inspector General concluded that while there was generally high compliance with sterility and other standards at VA health facilities, there were about a half dozen areas needing improvement.
The report comes as national attention has been focused on the dangers of sterile drug compounding stemming from the recent criminal trial of the president and part owner of a now defunct Massachusetts drug compounding company.
A federal jury in Boston, Mass. recently convicted Barry J. Cadden on 57 counts of racketeering and mail fraud following a 10-week trial. Cadden headed the New England Compounding Center, the company blamed for the deadly 2012 fungal meningitis outbreak which took the lives of 76 patients across the country.
As VA officials pointed out in response to the audit, none of the deaths resulted from treatment at VA facilities, although several veterans were among the victims.
In the report, which covered 28 VA facilities where sterile drug compounding takes place, the IG found that in 26 percent there was no documented evidence that shelving and storage areas were cleaned at least once a month, as required under the national standard, the U.S. Pharmacopeia. At 11 percent of the facilities, the IG found that there was no documentation of daily cleaning of floors in so-called clean rooms where sterile drugs are compounded.
The report states that competency assessments for those compounding sterile drugs failed to include gloved fingertip sampling in 18 percent of some 267 employees reviewed. Written tests were not included for 20 percent of the employees and 15 percent of the assessments did not include"visual observation or hands on skills assessment of aseptic techniques."
The IG also found that at 24 facilities where high risk chemotherapy drugs were prepared, special protective gloves needed in such procedures were not available.
The IG noted that at some facilities the reporting requirements for so-called "near misses," cases in which patients could be at risk, were unclear. He recommended that guidance be provided by VA administrators to ensure that all near misses are being reported.
In its response, the VA agreed with the findings and submitted a timetable for achieving compliance.
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Tuesday, May 9, 2017

Status Report Requested on Outbreak Grants

By Walter F. Roche Jr,

A dozen members of Congress have called on the Massachusetts Attorney General for a status report on the processing of requests for grants from a $40 million fund earmarked for victims of the 2012 fungal meningitis outbreak.
The letter to Massachusetts Attorney General Maura Healey comes seven months after U.S. Rep. Mike Bishop, a Michigan Republican, was able to secure up to $40 million from a national victims fund for victims of the deadly outbreak.
A spokeswoman for Healey recently reported that some 400 applications had been submitted by victims, but no awards have yet been made. The deadline for submitting a claim is Dec. 16.
In the letter, the congress members asked Healey to respond to the request by May 17.
 "The victims - our constituents- continue to suffer as a result of the injections they received almost five years ago," the letter states. "This suffering need not be compounded by financial distress, but for far too many, their bills continue to go unpaid."
In addition to Bishop and several other Michigan members, those signing the letter include congress 
members from Indiana, Tennessee and  Minnesota.
Stating that "time is of the essence," the letter asks that Healey treat the request as a priority.
Interviews with victims show many have been hesitant to file a request because of language in the application indicating that any awards will eventually have to be paid back.
Aides to Bishop however, have stated that it is highly unlikely any grants will have to be paid back.
The 2012 outbreak was caused by fungus laden steroids injected into the spines and joints of victims. A total of 778 patients became ill, many with debilitating fungal meningitis. Seventy-six of those victims died.
The drugs were shipped from the now defunct New England Compounding Center, located in Framingham, Mass.
Recently a federal jury convicted one of the founders of NECC on 57 felony counts including racketeering and mail fraud. Barry J. Cadden is scheduled for sentencing on June 29.
Bishop's Michigan district was one of the hardest hit with some 200 patients sickened and 15 died as a result..
"We have a duty to continue fighting for the victims of this tragedy," Bishop said in announcing the letter.

Monday, May 8, 2017

Prosecutors Charge Acquittal Motion Patently False



By Walter F. Roche Jr.


Federal prosecutors are charging that the acquittal motion filed in behalf of a former drug company executive is based on "patently false and dishonest" allegations.
In a 48-page motion filed Monday in U.S. District Court in Boston, Mass., the U.S. Attorney asked the court to deny the motion for acquittal or a new trial for Barry J. Cadden, the president of a now defunct drug compounding firm.
Noting that a 12-member jury found Cadden guilty of 57 felony counts, including racketeering and mail fraud, the motion recounts detailed trial testimony in which witnesses describe the unsanitary conditions at the New England Compounding Center, the Framingham, Mass., the firm that Cadden headed.
Cadden, whose trial ended over a month ago, was one of 14 person indicted in late 2014 following a federal probe of the 2012 fungal meningitis outbreak which sickened some 778 patients killing 76 of them. State and federal regulators determined that the outbreak was caused by fungus laden drugs shipped by NECC.
While the jury found Cadden guilty of racketeering and mail fraud, they acquitted him of 25 counts of second degree murder.
In their motion federal prosecutors noted that while the second degree charges were not affirmed by all of the jurors, a majority did vote to convict him on 21 of the 25 murder counts.
Charging that trial testimony showed NECC manufactured drugs under "filthy conditions," the motion argues that the limited testimony on the second degree murder counts did not prejudice the jury, as Cadden had argued.
Stating that there was "no prejudicial spillover," prosecutors asserted that charges of prosecutorial misconduct were "patently false and dishonest."
In a separate motion prosecutors disputed Cadden's claim that prosecutors improperly presented jurors with a binder of drug tests and other evidence. They noted that the presiding judge, U.S. District Judge Richard G. Stearns, concluded that the binder was never given to jurors during their deliberations.
Assistant U.S. Attorneys George Varghese and Amanda Strachan said the binder was only used as a "pedagogical devise," during closing arguments. They also noted that Cadden's lawyers did not raise any objections when the binder was described to jurors.
The motion against acquittal cites detailed testimony during the trial about the fact that NECC routinely shipped drugs before they had been tested for sterility even though the company repeatedly assured customers that the drugs were quarantined until tests were completed.
Citing "a staggering amount of evidence" presented to jurors, the motion states that it was reasonable for the jurors to conclude that "Cadden operated NECC as a fraudulent enterprise on a massive- deadly scale."
Cadden is scheduled for sentencing on June 29.

Tuesday, May 2, 2017

Prosecutors Win Extension for Dismissal Motion Reply

A federal judge in Boston, Mass. has granted a motion filed by federal prosecutors for an extension of the deadline for filing a response to a dismissal motion filed by defendants in the criminal case stemming from a 2012 fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns approved the motion extending the filing deadline to May 12. The original deadline passed on Friday.y
The motion filed in behalf of Gregory Conigliaro seeks the dismissal of a charge of conspiring to defraud the U.S. Food and Drug Administration.
Conigliaro's motion was joined by two other defendants. Conigliaro's lawyers cited comments by Stearns himself during the recent trial of Barry J. Cadden. Stearns said during the final moments of Cadden's trial that he could not see what the FDA was deprived of.
Cadden was convicted on mail fraud and racketeering charges but cleared of second degree murder charges. Cadden faces sentencing on June 29.


Tuesday, April 25, 2017

Citing "Pure Legal Impossibility," NECC Defendants Seek Dismissal


By Walter F. Roche Jr.

Citing a comment by the presiding judge himself, three of the remaining defendants in the fungal meningitis probe, are asking for dismissal of a key conspiracy charge.
In motions filed this week in U.S. District Court in Boston, Mass., the group, headed by a part-owner of a defunct drug compounding company, is asking for dismissal of a charge that they conspired to defraud the U.S. Food and Drug Administration by evading regulation by that agency.
Gregory Conigliaro, who was a vice president of the New England Compounding Center, filed an 11-page memorandum contending that it was impossible for his firm to defraud the FDA because FDA officials didn't even believe at the time that they had clear jurisdiction over drug compounders.
Conigliaro is one of seven defendants charged with the conspiracy and a trial is expected in late Fall. In fact the conspiracy count is the only one Conigliaro has been charged with. Joining him in the motion to dismiss were defendants Alla Stepanets and Sharon Carter, former NECC employees.
Conigliaro's motion cites comments made by presiding U.S. District Judge Richard G. Stearns during the recent trial of NECC's president, Barry Cadden. Cadden was convicted on racketeering charges but cleared of 25 counts of second degree murder.
As the 10-week trial inched toward conclusion Stearns said it was hard to see just what it was that the FDA was defrauded of.
His comment followed the introduction by Cadden's lawyers of testimony by then FDA Commissioner Margaret Hamburg who told a congressional committee in 2012 that her agency did not believe it had clear legal authority to regulate compounders like NECC. She testified as the deadly fungal meningitis outbreak was still unfolding.
Conigliaro's motion also cites testimony by Janet Woodcock, then director of the Center for Drug Evaluation and Research, who expressed similar views.
The two regulators told congress that the FDA's authority over drug compounders was limited, unclear and contested.
Citing their comments, the motion states, "Thus it was impossible for the FDA to be defrauded in the manner the government has alleged."
Filed for Conigliaro by his attorney, Dan Rabinowitz, the memo adds, "Pure legal impossibility exists when actions which the defendant performs or sets in  motion, even if fully carried out, would not constitute a crime."
In addition to the lack of legal authority, the motion contends that there was no clear legal distinction at the time between drug compounders and drug manufacturers.
Prosecutors have charged that NECC, while licensed as a compounding pharmacy, was acting as a drug manufacturer and drug manufacturers were subject to direct FDA regulation.
The motion concludes by charging that the conspiracy to defraud charge "is entirely predicated on the faulty premise that the law drew a clear distinction between a compounding pharmacy and a manufacturer."
Contact: wfrochejr999@gmail.com





Monday, April 24, 2017

FDA, Mass. Board Can be Found at Fault for Outbreak


By Walter F. Roche Jr.

A federal judge has ruled that the U.S. Food and Drug Administration and a state pharmacy board can be found at fault for the 2012 fungal meningitis outbreak that took the lives of some 77 patients who had been injected with fungus contaminated drugs.
In a nine-page ruling issued today U.S. District Judge Rya Zobel concluded that lawyers for a Tennessee pain clinic had presented sufficient evidence in her Boston, Mass. courtroom for the claims that the two agencies acted recklessly to go forward.
Zobel denied a motion filed by attorneys for some 20 Tennessee victims of the outbreak to dismiss claims by the Specialty Surgery Center in Crossville, Tenn. that the government agencies could be found at fault for failure to take action against the New England Compounding Center, the maker of the deadly spinal steroids.
Citing a "special duty" provision of Tennessee's comparative fault law, Zobel concluded that the clinic's lawyers presented "sufficient assertions to state an affirmative defense of comparative fault" against the FDA and the Massachusetts Board of Pharmacy.
Under Tennessee law, Zobel's ruling could clear the way for any damages awarded against the surgery center to be reduced by the percentage of fault found by a jury against the FDA and the Massachusetts board. However, the two agencies, who are not parties to the suit, could not be forced to pay anything to victims.
Chris Tardio, one of the clinic lawyers, said the ruling means "we may present the jury with a full picture of how the meningitis outbreak occurred, including how it could have been prevented by those responsible for monitoring NECC's activities."
Noting that the ruling is only a preliminary one,  a victims' attorney expressed confidence in the ultimate outcome, adding "We are confident that once we present this to the court on a full factual record that the court will find that the governmental agencies were not reckless."
Zobel did dismiss parallel comparative fault claims against the Tennessee Health Department and the Tennessee Board of Pharmacy.
Zobel cited the claims by the surgery center lawyers that the FDA received numerous complaints that NECC was violating the FDA's guidance on drug compounding but "nevertheless failed to take any subsequent action to address the serious nature of the complaints which proximately caused the alleged injuries."
She noted that as early as 2002 the FDA was made aware of problems at NECC and four years later issued a warning letter but then failed to act.
"Defendants allege the FDA acted recklessly because it knew NECC had sterility and potency issues but failed to take any substantive action," the ruling states.
As for the Massachusetts board, Zobel cited evidence presented by the clinic's lawyers showing the the board "was aware of NECC's failure to comply with applicable state and federal law and manufacturing guidelines, failed to inform other state pharmacy boards of  of the threat to public health caused by NECC's non-public track record of regulatory noncompliance with state and federal law."
In a footnote Zobel noted the November 2012 congressional testimony of then Massachusetts Health Commissioner Lauren Smith that the state pharmacy board's failure to take decisive action against NECC in response to the 2006 complaints "has contributed to these tragic events."
Contact: wfrochejr999@gmail.com

Thursday, April 20, 2017

Final Victims' Payments Due By Summer


By Walter F. Roche Jr.

The second and final payments to victims of the 2012 fungal meningitis outbreak should come this summer and the underlying court case should be nearing final resolution by August.
That's what a federal judge was told yesterday by attorneys involved in the civil litigation stemming from the deadly 2012 fungal meningitis outbreak.
The checks due this summer will come from a fund established under the bankruptcy of the New England Compounding Center, the now defunct firm blamed for the outbreak.
U.S. District Judge Rya Zobel called the report "very encouraging" and asked Kristen Johnson, one of the lawyers for victims, to provide a written version of the verbal report.
"There's not that much left come August," Johnson said of the underlying case. "We're just about done with this MDL (litigation)."
She noted that there will be an additional fee allotment to attorneys who performed work done for the benefit of all of the victims. The second payment is expected to total about the same as the first, $6 million.
Ben Gastel, one of the attorneys for Tennessee victims of the outbreak, told Zobel checks from a settlement with the owners of a Nashville clinic, the Saint Thomas Outpatient Neurosurgical Center, should be going out next month. The exact terms of that settlement have never been made public, but it is believed to be in excess of $20 million.
Gastel said victims will be getting an initial check that is estimated at about 90 percent of what each victim will ultimately receive. He said a small reserve will be held back to cover any final expenses.
Meanwhile mediation is expected in cases brought against the Select Surgery Center in Crossville, Tenn. The same mediator used in the Nashville cases is handling those cases.
Zobel also got reports on efforts to settle or bring to trial cases against a Maryland clinic.
Zobel said she would contact a judge in Maryland who is handling the cases brought against the Box Hill Clinic in state courts to coordinate a schedule for the cases remaining in her court.
"I will not try to run him over,"Zobel said, but she made clear that she intends to keep the cases now before her in federal court.
She also agreed to rescind an order she issued April 7, setting four Box Hill cases for trial.
"I acknowledge I was wrong," she said, adding that she jumped the gun.

Tuesday, April 18, 2017

Notice to Blog Commenters

If your comments contain libelous and/or slanderous comments, they will not be published. While you are certainly entitled to your opinions, posting libelous/slanderous comments on a public blog can result in a lawsuit against me and you. And they will find out who you are.

Sunday, April 16, 2017

Seven NECC Defendants Seek November Trial


By Walter F. Roche Jr.

Seven remaining defendants in the federal criminal case stemming from the federal probe of a defunct Massachusetts drug compounding company are requesting a November date for their trial on fraud and conspiracy charges.
In a motion filed late last week, lawyers for the defendants who just had an April trial date canceled, said a November date would allow enough time for the completion of the scheduled trial of another codefendant, Glenn Chin, who has an August trial date.,
The Friday motion follows the recent completion of the trial of Barry Cadden, the former president and part owner of the New England Compounding Center, the Framingham, Mass. firm blamed for a deadly 2012 fungal meningitis outbreak.
Cadden was convicted of racketeering, conspiracy and mail fraud charges after a 10-week trial. The jury acquitted him on second degree murder charges.
Chin faces the same charges as did Cadden.
The motion filed by the seven remaining defendants opposes an open ended trial delay proposed by federal prosecutors. They proposed a delay until an appeals court rules on a prosecution motion to overturn a ruling by U.S. District Judge Richard G. Stearns dismissing several counts in the original 2014 NECC indictment.
The motion states a November date "would permit an interval period between the two cases and also provide a specific trial date that will assist with the scheduling complexities inherent in a multi-week multi-defendant trial.
The motion was filed in behalf of Gregory Conigliaro, Gene Svirsky, Christopher Leary, Joseph Evanosky, Scott Connolly, Sharon Carter and Alla Stepanets.
Contact: wfrochejr999@gmail.com

Thursday, April 13, 2017

Cadden Demands Jury Records Be Handed Over


By Walter F. Roche Jr.

The former drug company executive convicted on racketeering charges is asking a federal judge to order prosecutors to turn over copies of materials given to the jurors who found him guilty last month.
In an eight-page motion filed in U.S. District Court in Boston, Mass. lawyers for Barry J. Cadden charged that a binder full of test results on drugs produced by Cadden's company was improperly provided to the jury while it was deliberating.
The motion charges that the assistant U.S. Attorneys who prosecuted the case refused a request to provide a copy of the binder and a PowerPoint presentation that was provided to jurors just before they began their deliberations.
The motion follows Cadden's request to U.S. District Judge Richard G. Stearns to have the jury's guilty verdicts reversed or that he be granted a new trial.
Cadden was convicted on 58 counts of racketeering, conspiracy and mail fraud. The 12-member jury acquitted him on 25 counts of second degree murder.
Cadden was one of 14 people indicted following a lengthy federal probe of the 2012 fungal meningitis outbreak caused by drugs shipped from the New England Compounding Center. Cadden was president and part owner of NECC.
In the motion to compel, preserve and/or complete the trial record,"Cadden's attorneys said they were certain the binder had been given to jurors because it was among the materials returned after the jury finally adjourned.
"The government submitted a non-admitted binder to the jury," the motion states, adding that "it was only after the verdict that Cadden learned, as the government well knew, that the jury had the binder when it deliberated."
"Even now the government refuses to provide Cadden with a copy of that binder," the filing continues.
As the motion notes during the trial Stearns repeatedly assured Cadden's lawyers that the binder did not go the jurors,  even stating that he went into the jury room to make sure it wasn't there.
"The government had a duty to correct the court's misunderstanding, but instead allowed the error to continue," the motion adds.
Cadden's lawyers charged that through the use of the binder, prosecutors made a "surreptitious and successful" effort to provide jurors with a copy of a mycology report from the New York State Health Department  that was "highly prejudicial."
According to the motion the PowerPoint presentation included a compilation of test results that had never been provided to defense lawyers.
"The PowerPoint must be provided to clarify the record," the motion states, adding that the binder is also needed for Cadden to pursue his effort to have the charges overturned.
Contact: wfrochejr999@gmail.com

Tuesday, April 11, 2017

Cadden Charges Prosecutors Gave Jury Improper Evidence


By Walter F. Roche Jr.

Attorneys for a former drug company executive are charging that federal prosecutors somehow gave a secret binder to jurors that gave one-sided information and may have led to their client's conviction on racketeering, conspiracy and mail fraud charge.
The charges against the prosecution were included in a massive 64-page memorandum submitted to support a motion to either acquit Barry Cadden on all charges or grant him a new trial.
The 64-page memorandum also accuses federal prosecutors of attempting to mislead the jury by presenting evidence that they knew or should have known was false.
"The government presented misleading and factually incorrect evidence to manipulate the chronology to falsely show Cadden knew of a problem with the methylprednisolone acetate sooner than he did," the memo states.
The memo was filed to back Cadden's motion for acquittal on the 58 counts he was convicted on last month by a 12-person jury sitting in Boston, Mass.
Cadden, who is scheduled for sentencing on June 29, was convicted of racketeering, conspiracy and mail fraud following a 10-week trial. The charges stem from a federal probe of the 2012 fungal meningitis outbreak that sickened 778 patients across the country, killing 77 of them.
The memo charges that despite repeated assurances from U.S. District Judge Richard G. Stearns to the contrary, prosecutors improperly gave jurors a binder full of evidence against their client without providing evidence showing his innocence.
"There is no question the non-admitted binder was, in fact, submitted to the jury," the filing states.
They also charged that prosecutors presented jurors with a summary testing chart that had never been introduced as evidence and excluded rebuttal evidence presented in Cadden's defense.
Repeating arguments presented in the acquittal motion, Cadden's lawyers said prosecutors improperly influenced the jury by presenting "a sea of prejudicial evidence" about the deaths of 25 patients who died after being injected with steroids from the New England Compounding Center, a company headed and part owned by Cadden.
The jury acquitted Cadden on the second degree murder charges. Although a majority voted for conviction on most of those counts, a unanimous vote was needed.
Prosecutors, the memo charges, "presented evidence in the hope -ultimately futile-that it could inflame the jury to hook Cadden on at least one or more of the murder charges,"the filing continues.
"For 10 weeks the government paraded witnesses before the jury to testify about heart wrenching stories of death and suffering," .
Prosecutors, the memo continues, tried to leave jurors with the impression that Cadden delayed disclosure of the discovery that NECC drugs were laden with a deadly fungus.
Citing conflicting testimony about a phone call Cadden made to an Indiana clinic, his lawyers said the government knew from telephone records that the call couldn't have been made on the date a clinic employee testified she took the call.
It was "improper for the government to present evidence it knows is false," the memo states.
Cadden's legal team, headed by Bruce Singal, said prosecutors repeatedly tried to mislead the jury by presenting false and misleading testimony and evidence.
"Barely a day went by in this trial in which the government did not mislead the jury with distorted, incomplete or inaccurate evidence," the brief states.
The memo asserts that there was insufficient evidence to prove the racketeering and mail fraud charges despite the jurors unanimous votes.
As for the conspiracy, the memo charges that the government never proved there was an agreement between Cadden and any of the other defendants to break the law.
Contact: wfrochejr999@gmail,com

Cadden Seeks Acquittal or New Trial


By Walter F. Roche Jr.

The former head of a drug compounder blamed for a deadly fungal meningitis outbreak is asking for acquittal or a new trial on the racketeering and mail fraud charges on which he was recently convicted.
The motion charges that the government's "futile effort" to charge him with second degree murder, tainted and prejudiced the jury that convicted him.
The case was "tainted by the improper presentation of murders, death and suffering in support of charges that should not have been brought," the three-page motion states.
The 12 member Massachusetts jury convicted Cadden last month on 58 counts of racketeering, conspiracy and mail fraud, among other charges, but acquitted him on 25 counts of second degree murder.
Cadden was president and part owner of the now defunct New England Compounding Center, the Framingham, Mass. firm blamed for the 2012 fungal meningitis outbreak that sickened 778 patients in 20 states. Some 77 of those patients died.
In his motion Cadden said the tainted evidence need not even have been presented because his lawyers conceded from the outset that methylprednisolone acetate from NECC caused the deaths.
That evidence, the motion states, "would not have been admitted in a fraud case."
Charging that the prosecution's evidence was "inaccurate and misleading," the motion charges that it had "the cumulative impact of unfairly and irrevocably tainting the jury in its consideration of the non-murder charges."
The motion asks the presiding federal judge, Richard G. Stearns, to either acquit Cadden of the charges or grant a new trial on the non-murder charges.
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Monday, April 10, 2017

Nearly 400 Apply for Outbreak Grants

By Walter F. Roche Jr.

Nearly 400 applications have been filed with a Massachusetts agency for a grant from a victims' compensation program financed with a $40 million federal allotment earmarked for victims of a deadly fungal meningitis outbreak..
A spokeswoman in the Massachusetts Attorney General's office said the applications are under review and thus far no awards have been made. The state agency is working with the U.S. Attorney's office in Boston to verify the claims.
The $40 million was set aside by the U.S. Justice Department at the request of a Michigan congressman, U.S. Rep. Mike Bishop, whose district was especially hard hit by the 2012 outbreak.
The outbreak, which sickened some 778 patients in 20 states, was caused by fungus laden compounded drugs produced by a now defunct Framingham, Mass. company. Recently Barry J. Cadden, the former president and part owner of the New England Compounding Center was cleared of second degree murders charges but was convicted on 58 counts on charges includingf racketeering and mail fraud.
The spokeswoman said the deadline for filing claims is Dec. 16 of this year. The application form is available at  http://www.mass.gov/ago/public-safety/resources-for-victims/assistance-necc-victims.html
A project manager has been hired to oversee the program and additional staff are being hired, according to the spokeswoman.
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Friday, April 7, 2017

Four Maryland Outbreak Cases Go Forward


By Walter F. Roche Jr.

A federal judge in Massachusetts has given the go-ahead for four court cases brought by Maryland victims or survivors of deceased victims of the 2012 fungal meningitis outbreak to go forward.
In a brief order this week U.S. District Judge Rya Zobel picked the four cases - two filed by living victims and two by survivors of victims- to move forward for trial beginning in October.
The four cases were among eight selected by attorneys for the victims and for the Box Hill Surgery Center, one of a handful of Maryland clinics where victims of the deadly outbreak were injected with fungus laden methylprednisolone acetate.
The field will be further narrowed to two cases before the scheduled Oct. 30 trial date. The cases have been designated as so-called bellwethers, hopefully leading to templates for the settlement of other Maryland cases.
The two cases in which the victims died were filed by the survivors of John C. Millhausen and Brenda Rozek. Some details of Rozek's death became public during the recent criminal trial of Barry J. Cadden, the one time president of the defunct New England Compounding Center, the company blamed for the deadly outbreak.
Cadden was charged with second degree murder in Rozek's death, but the jury acquitted him of that and 24 other second degree murder charges. He was convicted on racketeering, conspiracy and mail fraud charges.
The owner of the surgery center, Ritu Bhambhani, was one of the prosecution witnesses at Cadden's recent trial.
The two other Maryland suits were filed by Belinda Dreisch and Teresa Davis. Both were injected twice, once in July and once in August of 2012, at the Box Hill Surgery Center in Abingdon, Md. They subsequently were sickened and hospitalized.
According to Zobel's order, one of the cases involving living victims will go to trial on the Oct. 30 date, to be followed by one of the death cases.
The owner of the surgery center, Ritu Bhambhani, was one of the prosecution witnesses at Cadden's recent trial.
Under Zobel's order, discovery, including depositions and gathering evidence, will proceed in all four of the designated cases.
Court filings show that some 778 patients across the country were sickened in the outbreak and 77 of them died. According to data compiled by the U.S. Centers for Disease Control and Prevention, 26 Maryland patients were sickened in the outbreak and three died.
The CDC, however, stopped counting a year after the outbreak. The subsequent criminal investigation turned up 12 additional cases across the country in which patients died.
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Thursday, April 6, 2017

Salt Lake Compounder Recalls Sterile Drugs

This information has recently been updated and is now available.


04/06/2017 03:05 PM EDT

Isomeric Pharmacy Solutions (“Isomeric”) is voluntarily recalling all lots of sterile products compounded and packaged by Isomeric and that remain within expiry to the hospital/user level because of the US Food and Drug Administration’s concerns of a lack of sterility assurance. These concerns were brought to Isomeric’s attention during a recent inspection by the US Food and Drug Administration. To date, Isomeric has not received any reports of adverse events related to this recall.

Cadden Sentencing Reset for June 29


By Walter F. Roche Jr.

The sentencing session for the lead defendant in the criminal case stemming from a deadly fungal meningitis outbreak has been pushed back to late June by U.S. District Judge Richard G. Stearns.
In an order issued this week Stearns set June 29 as the date for sentencing of Barry J. Cadden who was convicted on 58 counts of racketeering, conspiracy and mail fraud. The session had originally been set for June 21.
The jurors acquitted Cadden of 25 counts of second degree murder.
Stearns also issued an order officially canceling a pretrial hearing and an April 10 trial date for seven other defendants in the case. That delay had been expected.
The other lead defendant, Glenn Chin, is scheduled to go on trial Aug. 14. He faces the same charges as Cadden did.
Chin, Cadden and 12 others were indicted in late 2014 following a two year federal probe of the 2012 fungal meningitis outbreak which sickened some 778 patients, killing 77 of them. The outbreak was caused by fungus laden steroids shipped from the New England Compounding Center. Cadden was president and part-owner of the company.
Stearns order also calls for the U.S. Attorney to provide federal probation officials with the names of victims of the outbreak.
Many of the victims are expected to submit so-called victim impact statements. It is not clear whether any surviving victims will be allowed to testify at the June session. During Cadden's nine-week trial Stearns limited the number of victims allowed to testify.
The June 29 session is scheduled for 2:30 p.m. in Stearns' Boston, Mass. courtroom. He could face up to 20 years in prison on each of the mail fraud counts, but federal sentencing guidelines are likely to limit his actual sentence.
Of the 14 people originally indicted in the case, two have had all charges dismissed while two others entered guilty pleas to vastly reduced charges.

Tuesday, April 4, 2017

Mold, Fungus Cited In PA Hospital Deaths


By Walter F. Roche Jr.

Even as it is facing multiple law suits on the same issue, UPMC, the Pittsburgh, Pa. based health conglomerate, has been cited by state health officials for failure to maintain required controls in the handling of bed and other linens.
In a complaint investigation completed in February, UPMC's Shadyside hospital was cited for failure to maintain temperature and air pressure requirements in areas where clean and soiled linens are stored.
In addition the eight-page report cites the fact that clean linens were being transported past containers filled with soiled linens.
UPMC did not respond to a request for comment.
The report comes as UPMC is facing suits from the survivors of  patients who died after suffering fungal infections linked to bed linens. The UPMC's linen supplier is a co-defendant, Paris Healthcare, in some of those suits.
The inspection on Feb. 16-17 came following a complaint from an unidentified source.
"Based on a tour of the facility and staff interview, it was determined that the facility failed to maintain soiled and clean linens in properly ventilated and temperature controlled areas according to acceptable standards of practice, the report states.
The report notes that clean linen storage areas "are required to be maintained under positive pressure in relation to adjacent areas, have two total air changes an hour and temperature shall be controlled between 72 and 78 degrees fahrenheit."
The report states that an unidentified hospital employee acknowledged that the UPMC facilities did not comply with the required standards.
In a plan of correction filed by UPMC, hospital officials said that the needed permanent changes could not be completed before September. However they promised to implement an interim corrective action plan by June 7.
The interim plan includes steps to ensure that the area where clean linens are stored are under positive pressure. Automatic door closers will also be installed.
"The plans involve a significant change to the physical location of clean and soiled linens to ensure compliance with regulatory requirements," the report states.
In addition UPMC promised to implement an education plan to ensure employees are aware of the regulatory requirements.
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Thursday, March 30, 2017

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.




Wednesday, March 29, 2017

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

Tuesday, March 28, 2017

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.
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Sunday, March 26, 2017

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.
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Wednesday, March 22, 2017

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.







Monday, March 20, 2017

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



Sunday, March 19, 2017

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





Friday, March 17, 2017

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


Thursday, March 16, 2017

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.


Wednesday, March 15, 2017

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



Tuesday, March 14, 2017

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)



Monday, March 13, 2017

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.
Contact: wfroche@gmail.com








Friday, March 10, 2017

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.


Thursday, March 9, 2017

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.
Contact: wfrochejr999@gmail.com

Wednesday, March 8, 2017

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.
Contact: wfrochejr999@gmail.com