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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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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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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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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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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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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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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