Friday, September 28, 2018
Prosecutors Disclose Expert Witnesses
By Walter F. Roche Jr.
Federal prosecutors have issued new details on the expert witnesses they intend to call in the upcoming trial of six former employees of the drug compounding firm that caused a deadly national outbreak.
The filing in U.S. District Court in Boston, Mass. shows the upcoming October trial will repeat much of the evidence and testimony evoked in the trials of two other defendants, Barry Cadden and Glenn Chin, who are now serving prison terms.
"The expert disclosures the government provided to the remaining defendants is virtually identical to the disclosure provided to defendants Cadden and Chin before their trials,"the report by the two prosecuting attorneys states.
The witnesses include officials of the federal Food and Drug Administration and the U.S. Centers for Disease Control and Prevention, officials of a private testing laboratory and experts on the U.S. Pharmacopeia, the non-profit that sets standards for the drug industry and other health care providers.
The six scheduled to go on trial next month were all employees of the New England Compounding Center, the company blamed for the 2012 outbreak of fungal meningitis.
But unlike Chin and Cadden, none of the six has been charged in connection with the deaths of patient. Cadden and Chin were charged with second degree murder in 25 of the 76 deaths, but two separate juries cleared them of those charges.
They were convicted on racketeering, conspiracy and fraud charges. Cadden is serving a nine year sentence while Chin was given an eight year sentence.
The witness list includes Stacey Degarmo of the FDA, one of the first federal investigators to go to NECC's Framingham, Mass. offices, Eric Kastango, an expert on the U.S. Pharmocopeia, and Mary Brandt of the CDC. All three testified in the prior trials.
Listed as a possible witness was Janet Woodcock from the FDA. Woodcock didn't testify at the prior trials but her testimony from a congressional hearing was read into the record.
Still other include a New York state Health Department official, Sudha Charurvedi, who testified about testing done in her agency of an NECC product. Several FDA laboratory employees were listed. They testified at the prior trials on test results they conducted on NECC products.
In the filing today Assistant U.S. Attorneys Amanda Strachan and George Varghese cited the extensive record of prior testimony by the experts readily available in trial transcripts.
"No further disclosure is warranted or remotely necessary," the filing states.
The six face charges ranging from racketeering to conspiracy to defrauding the FDA.
The six facing trial are Gene Svirskiy, Christopher Leary, Joseph Evanosky, Sharon Carter, Alla Stepanets and Gregory Conigliaro,
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Tuesday, September 25, 2018
Two NECC Defendants Get Separate Trial
By Walter F. Roche Jr.
Two of the remaining defendants in the criminal case stemming from a deadly 2012 fungal meningitis outbreak will get a separate trial, under a ruling issued today by U.S. District Judge Richard G. Stearns.
Citing the high risk of prejudicial spillover, Stearns said Kathy Chin and Michelle Thomas will be tried on the first available date following the scheduled October trial of the six other defendants.
The order granting a separate trial was one of more than 30 orders issued by Stearns today in U.S. District Court in Boston, Mass. on pre-trial motions filed by lawyers for the remaining defendants.
The eight were among 14 indicted by a federal grand jury in late 2014 following a two year probe of the fungal meningitis outbreak. Some 778 patients were sickened and at least 76 died after being injected with fungus laden steroids. All of the remaining defendants were employees of the New England Compounding Center, the company that produced the drugs and caused the outbreak.
In his ruling today Stearns wrote that he had attempted "to devise a practical means of preventing spillover of hearsay evidence," but concluded that Chin and Thomas had to be split off from the other defendants.
Chin and Thomas, according to court filings, were assigned to look through orders about to be shipped out. Stearns had previously dismissed charges against the two, but his decision was overturned on appeal.
"Even assuming the risk of prejudice could be contained, which is doubtful, the court would be in the awkward position of reminding jurors that items of evidence are not to be considered against Chin and Thomas," the ruling states.
He added that doing that, aside from being disruptive, would also "exacerbate matters by calling excessive attention to these two defendants."
The decision means there will in the end be four trials stemming from the 2014 indictment. Co-defendants Barry Cadden already were convicted in separate trials. Glenn Chin is the spouse of Kathy Chin. Opening arguments for the six defendants is scheduled for Oct. 15.
Stearns said the Chin and Thomas trial will be scheduled when the October trial is completed.
In the ruling granting a separate trial Stearns said Kathy Chin and Thomas were "in the larger picture on the outer rim of the remote in terms of potential culpability."
In a series of other rulings Stearns granted some of the defendants motions to limit prosecutors but denied most.
Among those denied was a motion to require prosecutors to present some of their evidence ahead of time in a so-called proffer hearing.
"If ever there was a case where no benefit could be derived from such a hearing, it is this one," Stearns wrote. "There is nothing to be said that hasn't already been said and known to the defendants"
He also chided defense lawyers for a motion in which they asked the judge to bar prosecutors from using certain language that was used in the Cadden and Chin trials.
Stating that at best the motion was "a shot across the bow or at worst an attempt to portray the government's lawyers to the court in as unflattering light as possible," Stearns wrote that he expected "all counsel to conduct themselves according to the rules of the court and ordinary standards of civil discourse."
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Friday, September 21, 2018
NECC Prosecutors Strike Back
By Walter F. Roche Jr.
Charging that defense attorneys cherry picked a few sustained objections from two prior trials, federal prosecutors are asking a judge to reject a move to limit their questions and comments in the upcoming trial of eight former employees of the company blamed for a deadly fungal meningitis outbreak.
In two filings today in U.S. District Court in Boston, Mass. Assistant U.S. Attorneys George Varghese and Amanda Strachan asked U.S. District Richard G. Stearns to reject motions filed by attorneys for the defendants.
In those motions the defendants asked Stearns to rule in advance of the October trial to limit the conduct of the prosecution.
Strachan and Varghese also asked Stearns to reject the request to hold a hearing in advance of the trial in which prosecutors would be required to lay out the evidence of two conspiracy charges brought against some of the defendants.
Charging that such a proffer hearing would clash with prior rulings issued in the district, the filing charges that the co-conspirators are charged with producing drugs that were not sterile, not tested and "manufactured in dangerously filthy conditions."
The defendants in motions filed earlier this week also cited comments made by prosecutors in the trials of two co-defendants, Barry Cadden and Glenn Chin.
In the response Strachan and Varghese charged that defense attorneys "cherry picked a few examples' of sustained objections" and argued that"none of its direct examination practices were objectionable.
In other pre-trial filings, attorneys for Kathy Chin and and Michelle Thomas argued that they could not get fair trial if prosecutors are allowed to present evidence of injuries and death.
They stated that the two "had nothing to do" with the clean room where sterile drugs were prepared.
Similar arguments were made by attorneys for Gregory Conigliaro.
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Wednesday, September 19, 2018
Former Mass. Official on Witness List
By Walter F. Roche Jr.
The former director of the Massachusetts Pharmacy Board, who was fired in the midst of a deadly outbreak, may be testifying for one of the remaining defendants in the criminal case stemming from that same 2012 outbreak.
A witness list filed this week by lawyers for Gregory Conigliaro, includes James D. Coffey, who was director of the pharmacy board in 2012, but was fired after it was disclosed that he failed to act when he was informed that a Massachusetts licensed pharmacy had been found in violation by the Colorado licensing board.
That pharmacy was the New England Compounding Center, the company that state and federal regulators determined caused the deadly outbreak. Conigliaro was vice president and part owner of NECC.
Also on Conigliaro's witness list is Susan Manning, another former Massachusetts pharmacy board employee, who was placed on administrative leave at the same time. She was a board attorney.
The two failed to inform the pharmacy board when they were told by a Colorado official that NECC was selling drugs in that state without individual prescriptions as required in that state.
The Conigliaro witness list was one of more than a dozen filings this week by lawyers for Conigliaro and seven other defendants who will go on trial next month in U.S. District Court in Boston, Mass.
The eight are among 14 indicted following a two year probe of the deadly outbreak which sickened 778 patients in more than 20 states. Seventy-six of them died.
Other motions filed this week include a request that prosecutors be barred from mentioning that a recycling business was located right next door to the building where NECC prepared sterile drugs, including the injectable steroid contaminated with a deadly fungus.
In the motion the defendants' attorneys argued that federal prosecutors had tried unsuccessfully to infer that the recycling business was the source of the deadly fungus.
"Evidence of the recycling business is irrelevant and unfairly prejudicial,"the motion states.
Conigliaro's lawyer filed a separate motion asking U.S. District Judge Richard G. Stearns to bar prosecutors from using emails and other communications between their client and various boards of pharmacy across the country.
He argued that those communications were not relevant to the charge Conigliaro faces involving the U.S. Food and Drug Administration.
Conigliaro held the title of vice president for government regulation at NECC. In addition he was a part owner of NECC and owner of the adjacent recycling business.
Still other defense motions seek to bar prosecutors from the using "prejudicial language," which the lawyers charge were used by prosecutors in the trials of co-defendants Barry Cadden and Glenn Chin.
Cited were statements accusing Cadden of playing Russian Roulette with the lives of patients and testimony by a federal official comparing the 2012 outbreak with the Ebola outbreak.
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Monday, September 17, 2018
NECC Defendants Want "Outbreak" Ban
By Walter F. Roche Jr.
In the latest in a series of pre-emptive moves, the remaining defendants in the criminal case stemming from a deadly 2012 outbreak are asking a federal judge to ban the use of the word "outbreak" in their upcoming trial, citing the possibility of "extreme and irreversible undue prejudice."
The joint motion also asks U.S. District Court Judge Richard G. Stearns to "specifically enforce" his previous order barring prosecutors from making mention of "patient harm" from contaminated spinal steroids during the trial scheduled to begin with opening arguments on Oct. 15.
The eight-page motion asks Stearns to order the government "to instruct witnesses that such evidence has been excluded from the trial and is not be mentioned in front of the jury.
Specifically cited by the defendants is the possible testimony of Dr. John Culclasure of Nashville, who gave tearful testimony in the prior trials of two primary defendants in the case. Culclasure, whose name appears on the list of possible prosecution witnesses, injected dozens of his patients with fungus tainted methylprednisolone acetate at the Saint Thomas Outpatient Neurosurgical Center.
Also cited was the possible testimony of two officials of the U.S. Centers for Disease Control and Prevention, both of whom gave extensive testimony at the trials of Barry J. Cadden and Glenn Chin. Cadden, Chin and the eight remaining defendants were all affiliated with the New England Compounding Center, the company blamed for the 2012 outbreak which sickened 778 patients and killed 76 of them.
Stearns ruled previously that evidence of patient harm from the contaminated steroids could not be used in the upcoming trial.
Lawyers for the eight defendants have repeatedly stressed that none of their clients were involved in the production of the deadly steroids.
In the joint motion filed Monday, lawyers for the defendants pointed to dozens of exhibits that prosecutors have listed as possible evidence contain evidence of the deaths or the tainted steroids.
""This type of evidence is squarely prohibited by the court order," the motion concludes.
The motion is but the latest in a series by the defendants to limit the evidence and testimony prosecutors can utilize during the upcoming trial.
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Sunday, September 16, 2018
NECC Defendants Launch Barrage of Motions
By Walter F. Roche Jr.
With the start of a long awaited trial just weeks away, the eight remaining defendants in the case stemming from a deadly outbreak have launched a series of motions to limit what they contend would be highly prejudicial testimony and evidence against them.
The filings late last week contend that prosecutors intend to make the upcoming trial a replay of the prior trials of Glenn Chin and Barry Cadden, both of whom are now serving prison terms. Allowing prosecutors to do that, lawyers for the defendants contend, would be highly prejudicial
Cadden, Chin and the eight defendants were employees of the now defunct New England Compounding Center, the company at the heart of the 2012 fungal meningitis outbreak that killed 76 patients and sickened some 700 more.
One of the motions filed Friday asks U.S. District Judge Richard G. Stearns to order prosecutors to declare in advance of the October trial what evidence and testimony they intend to use in front of the jury to establish that six of the eight defendants were coconspirators.
Stating that the government must prove the existence of a conspiracy, the motion notes that the remaining defendants were not involved in the production of the drug, methylprednisolone acetate, that led to the death of dozens of patients.
"There is good reason to believe that the government will be unable to establish that any of the remaining defendants in fact intended to join Cadden and Chin in the alleged conspiracy," the joint filing states.
They argued that the just because they all were employees of NECC does not establish that they were part of a conspiracy.
The defendants, who are asking for a hearing on the issue, argue that allowing prosecutors to present their disputed evidence runs the serious risk of a mistrial.
Also filed late last week were a series of motions by Kathy Chin, the wife of Glenn Chin, who was an NECC employee and a licensed pharmacist. Chin was not charged with conspiracy. Her lawyer repeated charges in an earlier motion that prosecutors were attempting to bring in extensive evidence that has nothing to do with the four counts with which she has been charged.
Citing hundreds of pieces of evidence prosecutors have listed for possible use at trial, the motion states that Chin "has no way of knowing which of these the government may offer into evidence."
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Thursday, September 13, 2018
NECC Defendant Seeks to Limit Prosecutors
By Walter F. Roche Jr.
One of the remaining defendants in the criminal case stemming from a deadly outbreak is seeking to block federal prosecutors from holding her responsible for illegal acts of her co-workers at a drug compounding firm.
In a six-page motion filed in U.S. District Court in Boston, Mass. the lawyer for Kathy Chin said federal prosecutors have indicated they will make the argument that she should be held responsible for the acts of other because she was the only licensed pharmacist to check over pharmacy shipments from the New England Compounding Center.
"Ms. Chin's job was to check that drugs were being sent to the right facility,"the six-page motion filed by Joan M. Griffin states, adding she "had no responsibility for checking prescriptions or patient names."
Chin is the spouse of Glenn Chin who was a supervising pharmacist at NECC. He already is serving an eight year prison sentence following his conviction on racketeering and mail fraud charges.
Kathy Chin and seven other defendants are scheduled to go on trial Oct. 2. All were affiliated with NECC. She is charged with sending out prescription drugs without valid prescriptions, a requirement under Massachusetts law.
Charging that prosecutors are trying to make her responsible for the illegal acts of others because she was the only licensed pharmacist involved in shipping NECC's drug, the motion states, "Ms. Chin was a low level employee in the shipping department and had no supervisory role at the company.
"Kathy Chin cannot be held criminally responsible for alleged wrongdoing by her co-workers simply because she is a pharmacist," the motion concludes.
The 2012 fungal meningitis outbreak sickened 778 patients, killing 76 of them. Chin and her husband were among 14 indicted in 2014 following a two year federal probe of the outbreak.
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Wednesday, September 12, 2018
Judge Grants NECC Defendants More Challenges
By Walter F. Roche Jr.
A federal judge has granted the remaining defendants in the fungal meningitis outbreak additional peremptory challenges in their upcoming trial on racketeering, conspiracy and mail fraud charges.
U.S. District Judge Richard G. Stearns granted the motion filed jointly by the eight remaining defendants in a brief order Tuesday.
The action means the defendants will be able to disqualify up to 16 of the jurors when jury selection begins in October. Previously Stearns had limited the defendants to a total of 13 peremptory challenges.
His original order set the number of challenges for prosecutors at nine and that limit remains in place.
In their joint motion lawyers for the defendants had argued that additional challenges were justified because of the unique nature of the case.
The eight remaining defendants were among 14 indicted following a two year probe of the deadly 2012 fungal meningitis outbreak. All of the eight were affiliated with the New England Compounding Center, the company blamed for the outbreak.
Some 778 patients were sickened and 76 of them died after being injected with NECC steroids contaminated with a deadly fungus.
In addition to the eight set to go on trial, two of the 14 entered guilty pleas to reduced charges, one pleaded guilty to conspiracy charges but has yet to be sentenced. Another former NECC employee has pleaded guilty to charges stemming from the fact that he was acting as a pharmacy technician even though he had surrendered his license.
Glenn Chin, a supervising pharmacist and Barry Cadden, who was president and part owner, already are serving prison sentences following their convictions on racketeering, conspiracy and mail fraud charges.
The defendants motion seeking the additional challenges also cited the extensive publicity the case has received.
Contact: wfrochejr999@gmail.com
A federal judge has granted the remaining defendants in the fungal meningitis outbreak additional peremptory challenges in their upcoming trial on racketeering, conspiracy and mail fraud charges.
U.S. District Judge Richard G. Stearns granted the motion filed jointly by the eight remaining defendants in a brief order Tuesday.
The action means the defendants will be able to disqualify up to 16 of the jurors when jury selection begins in October. Previously Stearns had limited the defendants to a total of 13 peremptory challenges.
His original order set the number of challenges for prosecutors at nine and that limit remains in place.
In their joint motion lawyers for the defendants had argued that additional challenges were justified because of the unique nature of the case.
The eight remaining defendants were among 14 indicted following a two year probe of the deadly 2012 fungal meningitis outbreak. All of the eight were affiliated with the New England Compounding Center, the company blamed for the outbreak.
Some 778 patients were sickened and 76 of them died after being injected with NECC steroids contaminated with a deadly fungus.
In addition to the eight set to go on trial, two of the 14 entered guilty pleas to reduced charges, one pleaded guilty to conspiracy charges but has yet to be sentenced. Another former NECC employee has pleaded guilty to charges stemming from the fact that he was acting as a pharmacy technician even though he had surrendered his license.
Glenn Chin, a supervising pharmacist and Barry Cadden, who was president and part owner, already are serving prison sentences following their convictions on racketeering, conspiracy and mail fraud charges.
The defendants motion seeking the additional challenges also cited the extensive publicity the case has received.
Contact: wfrochejr999@gmail.com
Sunday, September 9, 2018
Texas Compounder Approved in Tennessee
By Walter F. Roche Jr.
The Tennessee Pharmacy Board has licensed a Texas pharmacy to issue sterile compounded and other prescription drugs in the state even though the company says it has suspended the production of sterile drugs while its facilities are upgraded.
Records from the state board show Surecare Specialty Pharmacy of El Paso, Texas was issued a pharmacy license in early July. But you won't find Surecare listed among the licensed pharmacies on the board's website. It was removed from the automated listing shortly after a request was submitted for a copy of the application.
Asked why the listing was removed, Shelley Walker, a spokeswoman for the state Health Department, said the action was taken under the state law creating the pharmacy panel. She declined to be more specific.
The unusual handling of the Texas drug compounding firm comes in a state where drug compounding has become controversial. It was a Massachusetts drug firm that compounded fungus laden steroids that took the lives of 15 Tennessee patients in a 2012 outbreak. Dozens more were sickened.
More recently an unnamed out-of-state drug compounder provided the Tennessee Corrections Department with the drug, Midazolam, needed to execute Billy Ray Irick on Aug. 9. Under state law the identity of that compounder has been kept secret.
Repeated calls and emails to Surecare and its majority owner Paul Galbiati went unanswered.
The Surecare web site lists sterile compounding as one of its services, but also states, "We
are currently updating our clean room facilities to meet changes in standards and regulations – at which time we will continue to offer sterile compounding for our patients."
According to the company's application, a predecessor firm, Sun City Compounding, was cited by the Texas Pharmacy Board for failing to disclose the fact that an officer had been convicted of a misdemeanor.
Surecare's Tennessee application lists Alexandra Abbas as the pharmacist in charge.
Abbas was also cited by the Texas board in 2017 for allowing an unlicensed technician to perform technician's duties. She was employed in a different pharmacy at the time.
Though Abbas was listed as the pharmacist-in-charge in the Tennessee application the company web site lists a different pharmacist in that position.
The application lists Galbiati as a 60 percent owner, 4AM Consulting with 30 percent, James A. Lyle at 5 percent and Ed Anderson with 5 percent. Neither Lyle or Anderson responded to requests for comment.
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FDA Proposes Eased Compounding Monitoring
By Walter F. Roche Jr.
The head of the U.S. Food and Drug Administration is proposing an easement in the oversight of drug compounders even as he acknowledges that current inspections have turned up evidence that the practices of some of those in the field "present serious public health risks."
Commissioner Scott Gottlieb, in an announcement issued late last week, said that a revised proposal for compounder regulation sets a higher threshold to trigger closer scrutiny of drug compounders who are shipping their products over state lines. Originally the FDA had proposed in 2015 that drug compounders shipping more than 30 percent of their products over state lines get greater scrutiny. The revised proposal sets a 50 percent threshold.
The new policy would effectively change the definition of an "inordinate amount" from 30 percent to 50 percent.
The new proposal is the FDA's latest effort to implement a 2013 law,the Drug Quality and Security Act. That law was passed in the wake of the 2012 fungal meningitis outbreak which sickened 778 patients across the country, killing 76 of them. The culprit was a Massachusetts drug compounder that was mass producing steroids and other drugs and shipping them across the country. Thousands of vials of methylprednisolone acetate contaminated with deadly fungi were shipped from the New England Compounding Center.
In his statement Gottlieb said the goal of the revision was "to collaborate with the states, so that, working together, we can have the greatest public health impact, while also maximizing our resources."
The new threshold would be included in memorandums of understanding between the FDA and state boards regulating pharmacies.
The original proposal prompted protests from state pharmacy boards and drug compounders who warned that the stricter regulation would lead to a shortage of needed drugs, thus hurting patients.
Traditionally local pharmacists compounded drugs to meet the needs of specific patients,such as a child who was allergic to one of the ingredients in a mass produced drug. As the 2012 outbreak demonstrated some of those local pharmacies had morphed into manufacturers, but were eluding the increased scrutiny required for manufacturers.
In his statement issued Friday, Gottlieb acknowledged that regulators continue to identify "insanitary conditions" at some drug compounding operations "that present a serious health risk." He said those include finding mold growth and animal hair in areas where sterile drugs were being prepared.
"Sometimes," he continued, "these involve situations where the compounders have already been warned to correct violations of law."
"This field is in need of vigilant oversight," Gottlieb said, adding that the goal of the new proposal was to "streamline our operations to expedite enforcement actions."
Gottlieb noted that there were increased risks when compounders ship their products over state lines.
"(I)t can be very difficult to gather information about possible adverse events associated with those drugs, connect them to the compounder and undertake coordinated action to address a potentially serious public health problem," he wrote.
Under the revised proposal state boards signing an MOU would agree to notify the FDA when they find drug compounders who, in any given month, ship more than 50 percent of their compounded prescriptions to out-of-state customers.
"States that enter into the MOU will investigate complaints and advise the FDA when they receive reports of serious adverse drug experiences or serious product quality issues, like drug contamination," Gottlieb said.
Michael Carome of Public Citizen, an advocacy group, noted that the revision still includes a provision requiring states that sign an MOU to notify the FDA within 3 business days of any complaint relating to a drug product compounded by a pharmacist or pharmacist and distributed outside the state involving a serious adverse drug experience or serious product quality issue.
In states where there is no MOU, the threshold for identifying out of state compounders would be 5 percent.
In his statement Gottlieb said his agency will also be issuing new policies relating to insanitary conditions that have been encountered in inspections of drug compounders. He noted that the revisions do not effect a new class of drug compounders who are licensed as mass producers under a provision of the new law.
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Tuesday, September 4, 2018
NECC Defendants Seek More Challenges
By Walter F. Roche Jr.
Lawyers for the remaining eight defendants in the probe of a deadly outbreak are asking a federal judge to give them three more peremptory challenges of jurors in their upcoming trial.
In a five-page filing today in U.S. District Court in Boston, Mass., lawyers for the defendants asked U.S. District Judge Richard G. Stearns to increase the number of peremptory challenges from 13 to 16.
Stearns last week in a pre-trial order granted prosecutors nine challenges and the eight defendants a combined total of 13.
Citing three factors, the defense attorneys said additional challenges should be allowed because of the unique characteristics of the case and "in the interests of justice."
The eight were among 14 indicted following a two year investigation of the fungal meningitis outbreak which has been described as the worst public health crisis ever to be caused by a prescription drug.
The outbreak sickened some 778 patients in 20 states, killing 76 of them.
All the defendants scheduled to go on trial in October were affiliated with the New England Compounding Center, the company that caused the outbreak by shipping out fungus infested drugs to unsuspecting health providers across the country. None of the eight has been charged with any of the deaths
In the motion the eight defendants cited the highly publicized nature of the case, the fact that charges against the defendants differ widely and the wide demographic disparity among the defendants as justification for additional juror challenges.
In a footnote the defendants also said they oppose a proposed summary of the case offered by Stearns in last week's order.
The charges range from racketeering to conspiracy to mail fraud. Jury selection is set to begin Oct. 2 and opening arguments are set for Oct. 15.
In addition to setting a pre-trial schedule, Stearns order sets limits on the amount of time prosecutors and defense attorneys can spend in presenting their cases. Both sides were allotted 60 hours, with cross examination to be included within those limits. The 60 minutes allocated to the defense must be divided up among the eight attorneys.
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Saturday, September 1, 2018
Judge Sets NECC Trial Schedule
By Walter F. Roche Jr.
A federal judge has set a time limit of 60 hours apiece for both defendants and prosecutors in the upcoming criminal trial of the remaining defendants in the racketeering and mail fraud case stemming from a deadly fungal meningitis outbreak.
In a four-page ruling dated Friday, U.S. District Judge Richard G. Stearns also set an Oct. 15 date for opening arguments in his Boston, Mass. courtroom.
The eight remaining defendants were among 14 indicted in late 2014 following a two year federal probe of the 2012 fungal meningitis outbreak that sickened some 778 patients in more than 20 states. Though 76 of those patients died, the remaining defendants have not been charged in any of those deaths.
All of the remaining defendants, however, were affiliated with the now defunct New England Compounding Center, the company blamed for the outbreak.
The October trial marks the second time in the case that Stearns has placed time limits on both the prosecution and defendants. He also set limits in the trial of codefendant and NECC supervising pharmacist Glenn Chin.
Stearns order states that jury selection will begin on Oct. 2 and 16 jurors will be selected before opening arguments. The government will be allowed nine challenges while the defendants will be allowed 13.
Stearns also asked both sides to propose a summary of the case to provide to jurors and offered one of his own. Both sides are also required to provide a proposed questionnaire for prospective jurors to fill out.
The order sets a 60 hour limit for the prosecution and 60 hours combined for the defendants. And the limits also apply to cross examination. If Stearns follows his past practice of limiting trial testimony to four hours per day, the trial could be over by the end of November.
The eight going on trial are Gene Svirskiy, Christopher Leary, Joseph Evanosky, Sharon Carter, Alla Stepanets, Gregory Conigliaro, Kathy Chin and Michelle Thomas.
As Stearns noted in his proposed summary six of the defendants were licensed pharmacists. Gregory Conigliaro was an officer and part owner of NECC while Sharon Carter was a pharmacy technician.
The indictment, Stearns summary states, charged the defendants with conspiring to commit fraud by knowingly marketing drugs that had been manufactured in non-sterile conditions.
Chin and NECC president Barry J. Cadden were convicted of racketeering and mail fraud charges in two separate trials. Both are now serving prison sentences. They were cleared of second degree murder charges.
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