Conigliaro Seeks Acquittal or New Trial

By Walter F. Roche Jr.

A part owner of the drug company blamed for a deadly 2012 outbreak is seeking an acquittal or a new trial charging that highly prejudicial evidence and even a comment from the presiding judge made it impossible for confused jurors to conclude he conspired to defraud the U.S. Food and Drug Administration.
In two filings in U.S. District Court in Boston, Mass. the attorney for Gregory Conigliaro argued that prosecutors never should have been allowed to state that their client "made millions of dollars" from the New England Compounding Center, the now defunct firm blamed for the fungal meningitis outbreak.
Conigliaro and four others were convicted late last year on racketeering, mail fraud and conspiracy charges following a more than two month trial. The charges stem from a two year probe of the outbreak that took the lives of more than 100 patients.
Daniel Rabinowitz, Conigliaro's lawyer, stated that among the prejudicial evidence unfairly allowed during the trial was testimony relating to a nearby recycling facility that Conigliaro owns. He wrote that evidence should not have been allowed should not have been allowed because prosecutors failed to present any evidence that the recycling business was the source of deadly fungi that made its way into drugs that NECC was selling.
The filing cites a comment made during the trial by U.S. District Judge Richard G. Stearns regarding the recycling evidence as "unduly prejudicial."
"I have a different view," Stearns said following a comment by Conigliaro's defense team challenging the relevance of the recycling business.
The two memoranda come as the date for a hearing on the acquittal motion is approaching. Another defendant, Sharon Carter last week filed a similar acquittal motion. A Feb. 26 hearing date has been set for oral arguments on the acquittal requests.
Conigliaro and Carter's lawyers, taking a cue from Stearns, centered their arguments on the claim that it was a legal impossibility for the two to conspire to defraud the FDA, because the government agency did not have clear legal authority to regulate drug compounders like NECC.
Citing trial and Congressional testimony along with FDA documents, Rabinowitz wrote that "the uncontroverted evidence at trial showed it was legally impossible to determine whether a business was a manufacturer or a compounding pharmacy.
Prosecutors and government witnesses charged that NECC was actually acting as a manufacturer but disguised itself as a compounding pharmacy to avoid stricter regulation by the FDA.
Noting that the U.S. Supreme Court struck down a law that did set a distinction between manufacturers and compounders, Rabinowitz argued it was not possible for the court to find the FDA had been defrauded of its regulatory ability and cited the testimony of Dr. Janet Woodcock of the FDA and former FDA Commissioner Margaret Hamburg.
The filing also states that Conigliaro should have been granted a separate trial because much of the evidence against the four co-defendants had nothing to do with the single conspiracy charge against Conigliaro.
The result, the filing continues was "weeks and weeks of testimony" that was completely irrelevant to the single charge against Conigliaro.
Rabinowitz also argued that Stearns should not have allowed testimony by pharmacy regulators from nine states, who were called as prosecution witnesses against Conigliaro.
"The evidence at trial was legally insufficient for any rational trier of fact to conclude that the government proved beyond a reasonable doubt that Mr. Conigliaro intended to defraud the FDA," the filing concludes.

NECC Defendant Wants Jury Overturned

By Walter F. Roche Jr.

One of the defendants in the recent trial stemming from a deadly fungal meningitis is asking the the presiding judge to overturn the jury's guilty verdict on charges that she conspired to defraud the U.S. Food and Drug Administration.
In a 21-page motion filed today in U.S. District Court in Boston, Mass. lawyers for Sharon Carter said it was a legal impossibility for her to conspire to defraud the FDA of its legal authority because top agency officials themselves didn't think they had that authority to regulate state licensed drug compounders.
The argument was one that presiding U.S. District Judge Richard G. Stearns specifically urged defense attorneys to explore when he set the schedule for the acquittal motions. The same argument has been raised by lawyers for co-defendant Gregory Conigliaro, who is seeking acquittal.
Carter was one of five employees of the New England Compounding Center convicted late last year following a more than two month trial in Stearn's courtroom. The trial was the third stemming from the 2014 indictment of 14 NECC connected individuals who were charged following a two year probe of the deadly fungal meningitis outbreak caused by contaminated NECC drugs.
"The FDA did not believe that it possessed clear statutory or regulatory authority - or necessary tools - to oversee the compounders during the relevant time period," attorney Michael Pinneault wrote in the 21-page filing in support of an acquittal on the same conspiracy charge.
The motion cites testimony by Dr. Janet Woodcock during last year's trial and in congressional hearings. Former FDA Commissioner Margaret Hamburg's congressional testimony also was cited.
The filing notes that when the FDA was informed by Colorado regulators of NECC's illegal activity in that state, the FDA merely forwarded the information to Massachusetts regulators, effectively deferring jurisdiction.
The brief also argues that there was insufficient evidence presented by federal prosecutors to justify a conviction
"The evidence failed to prove that Ms. Carter knew of the existence of an agreement to deceive, obstruct and impede the FDA,"the filing states.
Prosecutors charged that NECC was actually acting as a drug manufacturer subject to strict FDA regulation, but disguised itself as a small family owned company subject only to state regulation.
"There was no testimony that Ms. Carter contributed to, or even knew about NECC's" communicators with regulators," the filing continues.
Noting that Carter's role at NECC involved supervising other workers in verifying orders for drugs, the brief states that that the evidence did not support the conclusion that Carter was even aware of a conspiracy to defraud the FDA.
Carter's brief cites the testimony of Robert Ronzio, the prosecution's star witness who testified that, "I didn't realize at the time what we were doing was illegal."
The jury's conviction, the filing concludes,"is contrary to the substantial weight of the evidence."
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Panel Rules for Disclosure of Jurors' Addresses

By Walter F. Roche Jr.

A three judge panel has reversed and vacated a ruling by the judge presiding over the NECC criminal cases in which he refused to provide the addresses of the 12 jurors who decided the case against Glenn Chin, who was convicted on racketeering and mail fraud charges.
In a 27-page ruling written by Judge David J. Barron the First Circuit Court of Appeals today vacated the order issued by U.S. District Court Judge Richard G. Stearns.
Citing a prior appeals court decision in a case brought by the Boston Globe, the court said Stearns failed to make a particularized finding that justified withholding the jurors' addresses.
The suit was filed by WBUR the public radio station owned by Boston University. WBUR had filed a request for the names home addresses of the jurors who decided the case against Chin.
Chin was a supervising pharmacist for the New England Compounding Center, the company blamed for a deadly 2012 fungal meningitis outbreak. The jurors cleared Chin on 25 counts of second degree murder, but convicted him on racketeering, mail fraud and conspiracy charges.
Stearns not only refused to provide the jurors addresses but refused to provide even the names of the jurors until Chin had been sentenced, which didn't occur until several weeks following the jury verdict
The appeals court said that before it could restrict access to jurors names and addresses a judge must first make "the kind of particularized findings that could justify either the non-disclosure of that information or the disclosure of it only with lawful conditions tailored to those findings."
In remanding the case back to the district court, the panel instructed Stearns "to follow the rule set forth in re. Globe and to unseal the jurors' names and addresses as WBUR requested."
The decision marks the second time a Stearns decision in the NECC cases has been reversed by an appeals court. Another appeals panel reversed Stearns decision to dismiss charges against three of the original 14 defendants. Two of those defendants, Kathy Chin and Michelle Thomas are scheduled to go to trial March 25.

NECC "Consultant" Gets Probation

By Walter F. Roche Jr.

A hospital pharmacy buyer who collected $355,000 to help channel business to a now defunct drug company was spared jail and placed on one year's probation today following a hearing in U.S. District Court in Boston, Mass.
U.S. District Judge Leo Sorokin, following the agreed recommendation of prosecutors and a defense lawyer, imposed the sentence on Claudio Pontoriero, who is still working as a pharmacy buyer, but for a different hospital.
He also imposed a $40,000 restitution order and a $100 special assessment.
Pontoriero, a registered pharmacy technician, had entered a guilty plea to a charge that he lied to federal agents in 2015 when he was asked why he had been paid the $355,000 by Ameridose,LLC.
Under the plea agreement Pontorieo acknowledged that the payments of $5,000 per month over six years were not for web site services but for using his position at the Massachusetts General Hospital to steer business to Ameridose and a sister company, the New England Compounding Center(NECC).
Both companies closed down in the aftermath of the outbreak.
Pontoriero's role came to light during the investigation of the 2012 fungal meningitis outbreak, a deadly public health crisis caused by contaminated steroids shipped by NECC to health providers across the country.
Both Pontoriero's former and current employers wrote letters of support for him. He is currently employed at the Spaulding Rehabilitation Hospital.
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NECC Pharmacists Under Investigation

By Walter F. Roche Jr.

A Massachusetts regulatory board has formally opened complaint investigations against four defendants who were convicted late last year on charges ranging from racketeering to mail fraud, all stemming from a federal probe of the 2012 fungal meningitis outbreak.
According to a spokeswoman for the Board of Pharmacy, the panel voted at a meeting last week to initiate investigations against the four defendants who were found guilty following a more than two month trial in U.S. District Court in Boston, Mass.
"The complaints serve to initiate investigations in which the board will gather relevant documentation and evidence," the spokeswoman said.
Those being investigated are Gene Svirskiy, Christopher Leary, Alla Stepanets and Sharon Carter.
All were employed at the now defunct New England Compounding Center, the company blamed for the outbreak which took the lives of more than 100 patients among 800 who were sickened.
Leary, Svirskiy and Stepanets are licensed pharmacists, while Carter is a registered pharmacy technician.
The board voted to take no action against Joseph Evanosky, who was acquitted of all charges in the recent trial.
The board spokeswoman said that any disciplinary action, would require a vote by the full board and the agency would be required to comply with the provisions of the state Administrative Procedures Act. That statute requires that the licensees facing discipline must be notified and given an opportunity to respond.
A fifth NECC defendant who was found guilty, Gregory Conigliaro, is not a licensed pharmacist, but could face action by the regulatory board overseeing real estate agents. Conigliaro, a licensed real estate salesman, was vice president and part owner of NECC.
The five were among 14 indicted in 2014 following a two year probe of the fungal meningitis outbreak.
Barry J. Cadden and Glenn Chin, both licensed pharmacists surrendered their licenses before they were indicted. Both are now serving jail terms following their conviction on racketeering and mail fraud charges.
Cadden was president and part owner of NECC while Chin was a supervising pharmacist.
During the recent trial lawyers for the defendants repeatedly cited the fact that their clients had retained their licenses despite the outbreak but testimony showed that the state pharmacy board delayed action at the request of federal prosecutors.
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Pharmacist in NECC Probe Seeks Probation

By Walter F. Roche Jr.

A pharmacist, who pleaded guilty to lying to federal investigators about his relationship with a now defunct drug company, is asking a federal judge not to give him a jail sentence but one year of probation and a $100 special assessment.
In an 11-page filing in U.S. District Court in Boston, Mass. the lawyer for Claudio Pontoriero said his client was guilty of only a one time lapse of judgment when he lied to federal agents about the payments he received from Ameridose, a now shuttered Westborough pharmaceutical company that came under scrutiny in the 2012 fungal meningitis outbreak. Pontoriero is scheduled to go before U.S. District Judge Leo Sorokin for sentencing Thursday.
Pontoriero, a pharmacy technician, entered a guilty plea to charges that he lied to federal agents about $355,000 in payments he received from Ameridose between 2006 and 2012. The payments were made in $5,000 monthly installments. He told agents that the payments were in return for consulting work related to the company's web site.
In fact, prosecutors charged, Pontoriero was being paid in return for his influence at Massachusetts General Hospital in winning business for Ameridose and a sister company, the New England Compounding Center. NECC has been named as the cause of the 2012 outbreak which sickened nearly 800 patients, killing more than 100 of them.
Pontoriero was a pharmacy buyer at Mass General. He is still a registered technician and is employed at Spaulding Rehabilitation Hospital.
In the filing this week, Pontotiero's lawyer, Joshua Ruby, wrote that his client was a dedicated husband who realized the seriousness of the charges filed against him. He noted federal prosecutors also agreed that Pontoriero should not be imprisoned.
Noting that two other NECC defendants, Douglas and Carla Conigliaro, were given only probation as a sentence after their guilty pleas, Ruby wrote that it would be a "grave injustice" for Pontoriero to be given a harsher sentence. He noted that the Conigliaros earned profits from NECC and were "personally involved in events leading up to the 2012 meningitis outbreak."
Attached to the filing were 23-pages of letters from supporters urging leniency for Pontoriero. Among those were Carlo DeMaria, the mayor of Everett.
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$21+ million Paid to 2012 Outbreak Victims

UPDATED 1/11/19

By Walter F. Roche Jr.

The Massachusetts Attorney General has now distributed more than $21.125 million to victims of the 2012 fungal meningitis outbreak from a $40 million allocation provided under a grant from the U.S Justice Department.
A spokeswoman for the agency said today that the grants were distributed to more than 600 victims who filled out applications by a Dec. 31 deadline.
The spokeswoman said the agency still will review and consider additional applications but all funds must be obligated by a Sept. 30 2019 deadline. Any amounts remaining by the deadline will go back to the federal government.
The funding was provided by the federal agency under a program established to give assistance to crime victims. The award came following a lobbying campaign spearheaded by U.S. Rep. Mike Bishop, a Michigan Republican whose district was particularly hard hit by the outbreak.
Latest figures from federal prosecutors show the outbreak, caused by drugs contaminated with deadly fungi sickened nearly 800 victims, including over 100 who died. In addition to Michigan, states hard hit by the outbreak include Indiana, Virginia and Tennessee.
The outbreak, with victims in some 20 states, was caused by contaminated drugs shipped from the now defunct New England Compounding Center in Framingham, Mass. Two officials of that company, Barry J. Cadden and Glenn A. Chin are now serving federal prison sentences following their conviction on racketeering, mail fraud and related charges. Cadden was president and part owner while Chin was a supervising pharmacist.
Late last year the same two were charged with 11 counts of second degree murder in papers filed in circuit court in Livingson County Michigan. They are scheduled to be arraigned March 1.
The new Michigan charges followed a lengthy probe by then Michigan Attorney General Bill Schuette, whose term expired earlier this month. His successor, Dana Nissel, is now involved in making arrangement for the two to be brought to Michigan for the arraignments
The Massachusetts attorney general already has extended the deadline for grant applicants several times, but a spokeswoman said applications submitted following the Dec. 31 deadline still will be reviewed but all funds must be obligated by the September deadline. The application is available at: https://www.mass.gov/mass-necc-program.
The award for most victims will be $25,000 but Healey aides say those who suffered a permanent impairment and the survivors of victims who died as a result of the outbreak can qualify for a second $25,000 grant. The impairment must be verified by a physician.
The spokeswoman for Attorney General Maura Healey said that the agency, working with federal prosecutors, has made multiple efforts to contact all possible claimants including sending letters emails and making phone calls. She said additional payments are slated to be mailed out next week.
The spokeswoman said her office will continue ongoing outreach and will review and make payments for as long as they are able to do so.
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NECC Defendants May Face License Loss

By Walter F. Roche Jr.

Five defendants convicted on federal charges stemming from the 2012 fungal meningitis outbreak could face a loss of their licenses or other disciplinary action from Massachusetts regulators as soon as this week.
Five of the six were found guilty last month following a nearly three month trial in U.S. District Court in Boston, Mass. Four of those five hold licenses or registration permits from the Mass. Board of Pharmacy.
An item on the board's agenda for Thursday lists the three who hold pharmacy licenses and a fourth who is registered as a pharmacy technician.
Meanwhile, Gregory Conigliaro, who was vice president and part owner of the company blamed for the deadly outbreak could face action on his Massachusetts real estate salesman's license. Conigliaro got the license in late 2014, just days before he was indicted.
Conigliaro did not hold a pharmacist's license or technician's registration. He was convicted on a single charge of conspiracy to defraud the U.S. Food and Drug Administration.
The four facing possible pharmacy board action are Gene Svirskiy, Christopher Leary, Alla Stepanets and Sharon Carter. Svirskiy, Leary and Stepanets are licensed pharmacists while Carter is a registered pharmacy technician.
Paul Kelly, Leary's attorney, said neither he or his client were informed of any proposed board action.
Joseph Evanosky's name also appears on the board agenda but he was acquitted of all charges. He holds a pharmacist license.
During the recent trial attorneys for the defendants repeatedly cited the fact that their clients still maintained their licenses and attempted to convince jurors that the board would have moved to revoke or suspend their licenses if they believed they were a threat to the public.
Prosecutors, however, indicated through testimony that the state board had withheld action pending the outcome of the federal trial.
A total of 14 people were indicted in late 2014 following a two year probe of the outbreak. Two, Barry J. Cadden and Glenn A. Chin are already serving prison terms following their conviction on racketeering and mail fraud charges. Cadden and Chin surrendered their pharmacist licenses. Two of the original 14 are scheduled to go on trial in March.
Federal officials say that some 793 patients were sickened and more than 100 died after injection with NECC steroids contaminated with deadly fungi.

NECC Defendants Face Michigan Arraignment

By Walter F. Roche Jr.

A Michigan Judge today set a tentative date for the arraignment of two former officials of the drug compounding company blamed for the deadly 2012 fungal meningitis outbreak that took an especially heavy toll in Livingston County Michigan.
According to Kelly Rossman-McKinney, spokeswoman for Michigan Attorney General Dana Nessel, Livingston County District Judge Shauna Murphy signed separate writs for the appearance of Barry J. Cadden and Glenn Chin to answer to charges of 11 counts of second degree murder.
The judge set a tentative March 1. arraignment date for the two.
Rossman-McKinney said the office of the attorney general is in the process of making all the necessary arrangements for the appearance of the defendants.
Cadden was president and part owner of the New England Compounding Center, which shipped thousands of vials of fungus tainted steroids to health facilities across the country. Cadden is serving a nine year sentence at the federal prison in Lorreto, PA. He was convicted on racketeering and mail fraud charges.
Chin, who was a supervising pharmacist at NECC, is serving an eight year sentence at a federal prison in Allenwood, PA. following his conviction on similar charges.
The outbreak killed more than 100 patients across the country and sickened 798.
Though Cadden and Chin were charged with 25 counts of racketeering second degree murder by federal prosecutors, two separate juries cleared them of those charges.
The Michigan charges filed late last year include eight of the Michigan deaths plus three others. At least 19 Michigan patients died in the outbreak. Those figures however, have not been updated since Oct. 30, 2015.
The new charges against Cadden and Chin were filed by former state Attorney General Bill Schuette, just before his term expired. He was barred from seeking another term.
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NECC Judge Grants Motions

By Walter F. Roche Jr.

A federal judge has eased the restrictions on one of the defendants awaiting sentencing on charges stemming from a 2012 fungal meningitis outbreak.
In a brief order issued today U.S. District Judge Richard G. Stearns approved a motion easing the restriction on Alla Stepanets, a former employee of the New England Compounding Center, the company blamed for the deadly outbreak.
Stepanets had petitioned to ease travel restrictions so that she can travel anywhere in the continental United States.
Stepanets was one of five person connected to NECC who were convicted on charges ranging from racketeering to mail fraud in a trial that ended early last month.
Stearns also approved Stepanets request that she be allowed to be in contact with her fellow defendants. In her motion seeking the easements, Stepanets said that while a ban on contacts before the trial might be justified to avoid collusion between the defendants, that danger was no longer present since the trial is over.
"The prohibition on travel is also unnecessary," Stepanets' motion stated, " adding that there was "no risk of flight and no other reason to maintain the domestic travel ban."
Stepanets lawyer, John H. Cunha Jr. noted his client was convicted only of misdemeanors.
Stearns also granted a motion sought by federal prosecutors to delay an upcoming hearing in the case from Feb. 20 to Feb. 26.
The convicted defendants have filed motions asking Stearns to overturn the jury's guilty verdicts.
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