Connolly Gets 2 Years Probation

By Walter F. Roche Jr.

A federal judge today sentenced a one time pharmacy technician to two years probation for his role at a now defunct drug compounding company that caused a deadly national outbreak of fungal meningitis.
U.S. District Judge Richard G. Stearns imposed the sentence on Scott Connolly in his Boston, Mass courtroom. Connolly had entered a guilty plea to 10 counts of mail fraud and could have faced a sentence of up to 33 months.
But Stearns followed the recommendation of federal prosecutors who stated that Connolly became a valuable prosecution witness and testified extensively against his former colleagues at the New England Compounding Center.
Connolly reached a plea agreement with the prosecution nearly a year ago under which they agreed to drop racketeering and related charges which could have brought a multi-year jail sentence.
The charges against Connolly stem from the fact that he was working as a pharmacy technician at NECC even though he had voluntarily surrendered his technician's certification as a result of a state investigation of unrelated charges.
Connolly was one of 14 people connected to NECC who were indicted following a two year probe of the 2012 fungal meningitis outbreak which sickened nearly 800 patients. Over 100 of them have died.
Connolly's attorney had argued for one year of probation, citing the assistance he provided to prosecutors.
While working for NECC, Connolly prepared dozens of vials of cardioplegia, a drug used to stop a patient's heart during open heart surgery. As his lawyer pointed out, there was no evidence that the drugs he prepared caused any patient harm.
Trial testimony showed that Connolly used NECC president Barry Cadden's sign on and password so regulators would not realize he was working as a technician. In addition Connolly would leave the clean room where he normally worked when state or federal regulators visited NECC's Framingham, Mass. facilities.
Of the 14 NECC related defendants who were indicted, only one has been cleared of charges. Cadden, who was president and part owner of NECC is serving a nine year sentence and supervising pharmacist Glenn Chin is serving an eight year sentence.
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NECC Defendant Seeks One Year Probation

By Walter F. Roche Jr.

A defendant and government witness is asking a federal judge to sentence him to just one year of probation for his role at the drug compounding company blamed for a deadly fungal meningitis outbreak.
In an 18-page filing in U.S. District Court in Boston, Mass. lawyers for Scott Connolly asked U.S. District Judge Richard G. Stearns to sentence him to one year of probation or half the sentence proposed by federal prosecutors.
Connolly is scheduled to be sentenced Wednesday for his conviction on 10 counts of mail fraud. He was one of 14 indicted in 2014 following a two year probe of the 2012 fungal meningitis outbreak. The charges against Connolly stem from the fact that he was working as a pharmacy technician at the New England Compounding Center even though he had surrendered his registration.
In the filing Connolly's lawyer, Raymond Sayeg, recounted Connolly's life from his youth in a Boston suburb to his work as a pharmacy technician at area hospitals including a Veterans Administration hospital.
Attached to the filing were letters of recommendation from his new employer, a Catholic priest and his mother and father.
As his lawyer acknowledged Connolly could face up to 33 months in prison, but added, "It is extremely unlikely that Connolly will re-offend or commit additional crimes in the future.
Citing Connolly's contrition and co-operation with federal prosecutors, the brief states that there was no evidence that the drugs Connolly helped produce caused any harm to patients. Nor did his actions enrich him since he was paid by the hour.
In a filing last week federal prosecutors also cited Connolly's cooperation and recommended that he be given a sentence of two years probation.
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Prosecutors Seek Probation for Key Witness

By Walter F. Roche Jr.

Citing his critical testimony and substantial cooperation, federal prosecutors are asking a federal judge to sentence a key witness in a drug compounding case to two years probation and no jail time for his guilty plea to 10 counts of mail fraud.
In a nine-page filing today in U.S. District Court in Boston, Mass. the prosecutors also disclosed that the defendant, Scott Connolly, began cooperating with federal investigators a full year before a grand jury indicted 14 people associated with the New England Compounding Center.
The indictment followed a two year probe of the 2012 fungal meningitis caused by NECC steroids loaded with deadly fungi.
Under federal guidelines, Connolly could face a sentence of up to 33 months, but Assistant U.S. Attorneys George Varghese and Amanda Strachan said Connolly's statements and testimony "were critical" in corroborating the evidence against other defendants.
They noted he testified extensively in multiple trials. His brother Joseph, also an NECC employee, was also a government witness. The brother was not charged.
Nonetheless they conceded that Connolly worked as a pharmacy technician at NECC for over two years even though he had surrendered his registration as a result of an incident at a prior employer. He was under investigation by the state Pharmacy Board at the time.
Citing the drug Connolly prepared, cardioplegia, prosecutors said the scheme he engaged in was "highly dangerous." The drug is used to stop a patient's heart during heart surgery and was shipped to medical facilities across the country.
In addition they noted Connolly used NECC president Barry Cadden's user name and password when signing into the company system to avoid detection. He also dropped his technician's duties when regulators appeared at NECC.
However, citing Connolly's "honest and truthful statements, prosecutors said, "In sum Connolly's cooperation has been substantial and directly led to the successful prosecutions in this case."
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UPDATED: Mass. Pharmacies Subject of Probe

UPDATED 7/12


By Walter F. Roche Jr.

Two Massachusetts pharmacies partially owned by a state official are the subject of an inquiry over the sale of products made from hemp.
The state official, Andrew Stein, is part owner of the Bird's Hill Compounding Pharmacy in Needham and Johnson's Wellness and Compounding Pharmacy in Waltham, Mass. Both stores advertise hemp products on their web sites. Stein is a member and current president of the Massachusetts Board of Registration in Pharmacy.
Asked about the hemp sales at the two pharmacies, Ann Scales, spokeswoman for the state Health Department, said the agency "has an open complaint on this matter and is looking into it. We will have no further comment until the issue is resolved."
"We are currently undertaking a comprehensive review of the CBD products that we stock to ensure that they are in full compliance with Massachusetts law and regulations," Stein said in an email response.
The disclosure of the inquiry comes shortly after officials of the state Agricultural Resources and Health Departments announced new restrictions on the use of hemp derived cannabis or cannabidiol in products intended for human consumption.
In the June 12 announcement the state officials said the use of CBG in any food product or in any product claiming a medicinal benefit was illegal in the state.
"The following products are NOT approved for sale in the Commonwealth pursuant to M.G.L. c. 128, Section 117(c) and are likewise prohibited for sale under FDA and DPH guidance: Any food product containing CBD; Any product containing CBD derived from hemp that makes therapeutic/medicinal claims," the June 12 notice states.
Among the products advertised on the Bird's Hill web site is a balm "infused with concentrated Gold Formula CBD. Harness your human potential with Plus CBD Oil Extra Strength Balm," the pharmacy web site states."Extra strength CBD Balm absorbs quickly into the skin, providing a soothing and moisturizing experience."
Stein and his partner also have posted items on facebook touting the benefits of CBD products.
Stein was appointed to the state regulatory board in the wake of the 2012 fungal meningitis outbreak, which was caused by a now defunct drug compounding company licensed by the Massachusetts board. The deadly outbreak triggered efforts at reform at both the state and local level.
The composition of the Massachusetts Pharmacy board was changed in 2014 and Stein, a compounding pharmacist, was one of the appointees.
Campaign finance reports show Stein has contributed $550 to the campaign committee of Gov. Charles D. Baker.

Ronzio Sentencing Canceled

By Walter F. Roche Jr.

The sentencing of the key government witness in the criminal probe of a deadly fungal meningitis outbreak has been postponed indefinitely while the government appeals the acquittal of another key figure in the case.
U.S. District Judge Richard G. Stearns, sitting in Boston, Mass., today granted a motion filed by federal prosecutors and the attorney for Robert Ronzio to cancel Ronzio's scheduled sentencing session on Aug. 7.
Ronzio was the national sales director for the New England Compounding Center, the company blamed for the 2012 outbreak. Under an agreement with federal prosecutors he pleaded guilty to conspiring to defraud the U.S. Food and Drug Administration along with officials of NECC.
Stearns acquitted NECC Vice President Gregory Conigliaro and NECC manager Sharon Carter of the same charges although they had both been convicted by unanimous jury votes.
Noting Stearns recent acquittal action, prosecutors and Ronzio's attorney, Peter Horstmann, asked that Ronzio's sentencing be delayed "until after conclusion of any appeal by the government." Stearns quickly granted the motion.
Federal prosecutors, Assistant U.S. Attorneys Amanda Strachan and George Varghese, already have filed initial notice of their intent to appeal Stearns' acquittals.
In approving the request Stearns ordered attorneys for both sides to notify the court when the appeal is decided.
The government appeal marks the second time prosecutors have challenged a decision by Stearns to clear defendants in the case. He granted acquittal motions for two of the 14 originally indicted but the decision was overturned by the First Circuit Court of Appeals.
The 14 were indicted following a two year probe of the 2012 fungal meningitis outbreak caused by fungus laden steroids produced by the now defunct NECC. Nearly 800 victims were sickened and more than 100 of them have died.
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Last Call on Victims Fund

Time is running out for victims of the 2012 fungal meningitis outbreak to file a claim from a $40 million victims' compensation fund being administered by the Massachusetts' Attorney General's office.
According to agency officials any money not committed by Sept. 30 will have to be returned to the U.S. Justice Department, the agency that allocated the money for the fund.
So far the Massachusetts agency has approved claims filed by 621 victims with a total value of $22 million. An earlier report had erroneously indicated 651 claims had been approved.
Victims who have not filed should contact the Attorney General's office as soon as possible at 617-573-5375 or toll free at 844-315-0339. The office can also be reached by email at NECCAssistance@mass.gov. An on line application form is no longer available.
The office expects to be sending out another round of payments within the next two weeks.
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Prosecutors File Appeal Notice on Acquittals

By Walter F. Roche Jr.

Federal prosecutors have filed a notice of appeal of the ruling by a federal judge reversing the unanimous guilty verdicts reached late last year in the case against a part owner of the drug compounding company blamed for the 2012 fungal meningitis outbreak.
In a notice filed today in U.S. District Court in Boston, Mass. Assistant U.S. Attorneys George Varghese and Amanda Strachan said they intend to appeal the acquittal order issued on June 11 by U.S. District Judge Richard G. Stearns. The notice is a first step before formally filing an appeal.
Stearns granted acquittal motions filed in behalf of Gregory Conigliaro, who was vice president and part owner of the now defunct New England Compounding Center, and Sharon Carter, an NECC operations manager. The two were convicted of conspiring to defraud the U.S. Food and Drug Administration.
They were among five defendants found guilty late last year following an eight week trial.
In the appeals lawyers for Conigliaro and Carter had argued that defrauding the FDA was a legal impossibility because at the time the federal agency did not believe it had clear jurisdiction over NECC, which was licensed by the state of Massachusetts. In fact Stearns himself had suggested that argument when he set a hearing date for the acquittal motions in a Dec. 18 order.
Conigliaro was vice president for regulatory affairs at NECC and prosecutors pointed to a letter he wrote to regulators contending that NECC was a small family owned pharmacy and not a drug manufacturer subject to FDA regulation.
Government witnesses, including a top official from the FDA, testified that NECC was in fact a drug manufacturer and should have been subject to stricter federal regulation.
The appeal notice is not the first by prosecutors in the NECC case. A prior ruling to acquit NECC defendants of criminal charges was reversed by the First Circuit Court of Appeals.
Conigliaro and Carter were among 14 indicted in 2014 following a two-year probe of the deadly 2012 fungal meningitis outbreak. Only one of the 14 has been acquitted and two are already serving federal prison terms.
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