New Michigan Victims in New Charges

By Walter F. Roche Jr.

Jennie Barth, an avid gardener who enjoyed an occasional trip to play the slots at area casinos, was 88 when she died on Jan. 13, 2013.
The Michigan resident was one of 19 state residents to die in the 2012 fungal meningitis outbreak and last week her death was added to the charges against two Massachusetts pharmacists charged with second degree murder.
In charges filed in Livingston County Circuit Court by outgoing Michigan Attorney General Bill Schuette, Barry J. Cadden and Glenn Chin were charged with 11 counts of second degree murder.
Cadden was the president and part owner and Chin a supervising pharmacist at the New England Compounding Center, the company blamed for the outbreak that caused over 100 deaths among 793 who were sickened.
Nine of the 11 victims named in the state complaint were also listed as second degree murder victims in the federal indictment of Cadden and Chin. Records of the Cadden trial show that eight of the 12 jurors voted to convict him under Michigan's criminal statutes. A unanimous verdict was required for conviction,
Barth, Patricia Malafouris and Ruth Madouse had not been previously named as Michigan victims.
Malafouris died Nov. 18, 2012, some two months before Barth, who died at the University of Michigan Hospital in Ann Arbor.
Ruth Madhouse, the third new victim died Dec. 30, records show.
The other victims named in the charges filed last week are Donna Kruzich, Paula Brent, Lyn Laperriere, Sally Roe, Mary Plettl, Gayle Gibson, Emma Todd and Karine Baxter. All were named as victims in the federal case.
Under Michigan law a second degree murder is one caused by a reckless disregard for human life. The law does not require that prosecutors show the death was premeditated.
Penny LaPerriere, the widow of Lyn, was one of those to testify for the prosecution in the federal case against Cadden. She said Cadden ruined her family.
“Who gave him the right to play God?” she asked.
At the Chin trial Michigan Medical Examiner, Dr. Jeffrey Jentzen, provided details on the autopsies performed on 11 victims who were injected at a local pain clinic. He described how the fungus, exserohelium rostratum, penetrated a protective layer of the spine and then traveled to the brains of victims.
Once in the brain, he said the fungus, attacked blood vessels, rupturing some and blocking others. The results were strokes and other brain damage. In some cases the spinal chord itself was damaged.
Jentzen walked jurors through the cases his office handled including Kruzich, Baxter and Lyn LaPerriere.
Similar testimony is likely when the new case comes to trial.
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Two NECC Pharmacists Charged in Michigan

By Walter F. Roche Jr.

Two pharmacist already serving federal jail terms have been charged with second degree murder in the deaths of 11 Michigan patients who died in the 2012 fungal meningitis outbreak.
Charged were Barry Cadden and Glenn Chin, who are now serving terms in separate prisons in Pennsylvania.
The pair had also been charged with eight of those murders in a 2014 federal indictment, but juries later cleared them of those charges. They were convicted, however, on racketeering and mail fraud charges.
In the Friday filing Chin and Cadden were charged in the deaths of Donna Kruzich; Paula Brent; Lyn Laperriere; Sally Roe; Mary Plettl; Gayle Gibson; Patricia Malafouris; Emma Todd; Jennie Barth; Ruth Madouse and Karine Baxter.
The deaths of Malafouris, Barth and Madoose were not included in the federal charges.
Chin is serving an eight year term at a federal prison in Allenwood, PA.,while Cadden is serving a nine year sentence in Loretto, PA
Chin was a supervising pharmacist at the New England Compounding Center, while Cadden was president and part owner. NECC has been blamed for shipping thousands of vials of fungus contaminated steroids to health facilities in 20 states, including Michigan.
Earlier this month a federal jury convicted five other NECC employees on racketeering and mail fraud charges. They are scheduled to be sentenced in March by U.S. District Judge Richard G. Stearns. The five were not charged with second degree murder and they were not involved in producing the deadly steroids.
The Michigan charges were brought Friday in Livingston Circuit Court by Attorney General Bill Schuette.
The 2012 outbreak sickened some 793 patients and more than 100 of them died. Michigan was among the hardest hit along with Virginia, Indiana and Tennessee.

Case Count in Outbreak Remains Elusive

By Walter F. Roche Jr.

Official government estimates of the number of patients who died from a 2012 fungal meningitis outbreak have jumped by 56 percent since the first figures were issued in 2013, but many feel the number should be even higher.
In a recent press release the U.S. Justice Department reported that" more than 100" victims of the outbreak had died among the 798 who were sickened by fungus laden steroids injected into their bodies.
That compares to the official count from the U.S. Centers for Disease Control and Prevention which reported in 2013 that 64 victims died among 753 who were sickened.
Court documents show that in 2014 investigators from the U.S. Food and Drug Administration had identified 76 deaths among 778 patients sickened by steroids from the New England Compounding Center.
Despite the disclosure officials of the U.S. Attorneys office in Boston, Mass.and the FDA have refused to provide any details about the additional deaths.
Asked to identify the states where additional outbreak deaths were discovered, a spokeswoman for the office said no further details could be provided.
The office also declined to provide the exact number of deaths among outbreak victims.
"FDA has no information to provide on this issue," said spokesman Jeremy Kahn, who referred questions back to federal prosecutors.
Many who have followed the outbreak's impact say that even the revised numbers understate the number of victims and deaths.
Terry Lewis, a Tennessee resident who has acted as an advocate for many of the outbreak victims said she knows there are victims who have not been included in the official counts.
In Tennessee more than 100 patients were sickened after being injected with contaminated NECC steroids. The CDC reported 16 deaths among Tennessee patients, but that figure has never been updated.
"I suspect there are likely a few people who died and, unfortunately the cause was never determined to be meningitis, especially if they had other serious conditions," said Bill Leader, a Nashville attorney who has represented outbreak victims and their survivors.
Mark Chalos, who also has represented outbreak victims said it was likely,"we will never have a full accounting of the casualties in this catastrophe."
The disclosure of the revised case count came following the two month trial of six former employees of NECC. The jury found five of the six guilty on charges ranging from racketeering to mail fraud and conspiracy. Two of those found guilty, Gregory Conigiliaro and Sharon Carter, have filed motions to have the verdicts overturned by U.S. District Judge Richard G. Stearns.
Stearns has set a Feb. 24 date for a hearing on the motions.
Conigliaro, an NECC vice president and part owner, was convicted on a charge of conspiracy to defraud the FDA. Carter was convicted on the same charge. A hearing on their motions is set for Feb. 20.
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Stage Set for NECC Verdict Reversals?

By Walter F. Roche Jr.

Setting the stage for possible reversals of unanimous guilty verdicts returned by a jury, a federal judge is asking lawyers for two of the defendants in the recent trial stemming from a deadly fungal meningitis outbreak to submit arguments that could clear their clients.
In a one-page order issued today in U.S. District Court in Boston, Mass. District Judge Richard G. Stearns set a Jan. 25 deadline for lawyers representing Gregory Conigliaro and Sharon Carter to submit briefs supporting a motion to reverse the guilty findings of a 12-person jury.
Conigliaro was the vice president and part owner of the New England Compounding Center, the company blamed for the 2012 outbreak that took the lives of dozens of patients across the country. Conigliaro was convicted on a charge of conspiracy to defraud the U.S.Food and Drug Administration.
In his order Stearns invited Conigliaro's lawyers to submit a brief focusing on the argument that it was a legal impossibility for the FDA to be defrauded because the agency itself was not sure it had jurisdiction over NECC.
Dan Rabinowitz, Conigliaro's lawyer, already has raised the same argument in motions filed before the two month trial that ended last week.
Stearns himself has questioned the FDA fraud charge in comments made during the trial of co-defendant Barry J. Cadden, who was NECC's president and part owner.
"It's hard for me to see what the FDA was defrauded of," Stearns said on March 13 of last year during the Cadden trial. Cadden was convicted on racketeering and mail fraud charges and is now serving a nine-year federal prison sentence.
Federal prosecutors have argued that the FDA had clear authority to act against NECC because the company was actually a drug manufacturer and not a small family owned pharmacy as Conigliaro had claimed.
During the trial Janet Woodcock, a top FDA official, said NECC was masquerading as a pharmacy to avoid stricter FDA scrutiny.
Stearns called on Carter's lawyer to submit a brief by the Jan. 25 deadline focusing on whether there was sufficient evidence to prove she was a participant in a conspiracy. Carter was NECC's director of operations, overseeing order processing, packaging and shipping personnel.'s job at NECC was to verify drug orders before they were shipped to doctors and health facilities.
Stearns's order invites "discussion on the issue of whether there is a sufficient factual basis to support her (Carter's) membership in the conspiracy to defraud the Food and Drug Administration as alleged in the indictment," the order states.
Stearns order sets a Feb. 15 deadline for the U.S. Attorney to respond to the defense briefs. A hearing with oral arguments will follow on Feb. 20.
Conigliaro and Carter were two of five former NECC employees to be found guilty by the jury last week. One defendant, Joseph Evanosky was found not guilty.
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Five Convicted In Compounding Case

By Walter F. Roche Jr.

Boston- A federal jury today convicted five defendants on racketeering and mail fraud charges stemming from the probe of a deadly fungal meningitis caused by contaminated drugs shipped from the company where they all worked.
The jury's decision came during its seventh day of deliberation in a trial that began just shy of two months ago.
U.S. District Judge Richard G. Stearns set March dates for sentencing.
One defendant, Joseph Evanosky, was cleared of all charges. His lawyer, Mark Pearlstein, said his client was "an innocent man who never should have been charged."
Gene Svirskiy, who worked in the clean room where sterile drugs were prepared, was convicted on racketeering and conspiracy charges.
NECC vice president and part owner Gregory Conigliaro was convicted on the charge of conspiring to defraud the U.S. Food and Drug Administration by representing NECC as a small family owned business thus avoiding stricter federal regulation. Defendant Sharon Carter was convicted on the same charge.
The other defendants, including Christopher Leary, were cleared of racketeering charges but convicted on mail fraud and violations of the Food Drug and Cosmetic Act.
Alla Stepanets, the sixth defendant, was convicted on charges of introducing misbranded drugs into interstate commerce.
Leary and Svirskiy could face sentences of up to 20 years, while the others convicted face up to five years.
All of the defendants were employees of the New England Compounding Center, a now defunct drug compounding firm located in Framingham, Mass. NECC shipped thousands of vials of a spinal steroid to health providers across the country.
The steroids were heavily contaminated with fungus and sickened nearly 800 patients in 20 states. At least 76 of them died.
The defendants convicted today were not involved in producing the deadly steroid known as methylprednisolone acetate, but other drugs, many of which prosecutors charged were contaminated, produced under unsanitary conditions, produced with expired chemicals or compounded by an unregistered pharmacy technician.
The drugs at issue in the trial were shipped to health facilities from California to Florida and included cardioplegia, a drug used to stop the heart during open heart surgery and an eye block use to numb and still the eye during cataract and other eye surgery. NECC shipped methotrexate, a drug used in cancer treatment, even though it had expired five years earlier.
The cardioplegia was compounded by co-defendant Scott Connolly, who had already entered a guilty plea to 10 counts of mail fraud. He worked at NECC as a pharmacy technician despite having surrendered his registration in the midst of an unrelated state pharmacy board investigation.
Connolly testified for the prosecution during the trial as did his brother Joseph, who also worked as a pharmacy technician at NECC.
The eye block was sent to the Massachusetts Eye and Ear Infirmary where it failed to numb the eyes of patients undergoing surgical procedures. Evidence introduced during the trial showed it only contained a fraction of the required lidocaine.
Barry Cadden, NECC's president and part owner, along with Supervisory Pharmacist Glenn Chin were convicted of racketeering and mail fraud charges in separate trials. Both are now serving sentences at separate federal prisons in Pennsylvania.
Two other defendants, Kathy Chin and Michelle Thomas,are scheduled to go on trial March 25, 2019.
The others indicted in late 2014 include Douglas Conigliaro and his wife Carla, who both pleaded guilty to vastly reduced charges. Robert Ronzio, NECC's sales chief, has pleaded guilty to a conspiracy charge and awaits sentencing. He testified for the prosecution in the current and prior NECC trials.

NECC Jurors Still Deliberating

Boston- Jurors hearing the racketeering case against former employees of a drug compounding firm completed another full day of deliberations Wednesday without reaching a verdict.
The 12 jurors left the federal courthouse at 4 p.m. They began deliberations last Wednesday. The current deliberations have now surpassed the time taken by jurors in the case of co-defendant Barry J. Cadden, whose case also included 25 racketeering charges of second degree murder. He was cleared of the murder charges but convicted on racketeering and mail fraud charges
On trial are six former employees of the New England Compounding Center. The Framingham company shut down for good in the Fall of 2012 even as hundreds of patients were suffering fungal meningitis and other illnesses caused by contaminated steroids from NECC.
The jurors began deliberations last week after closing arguments and instructions from U.S. District Judge Richard G. Stearns. The six face charges including racketeering, conspiracy, mail fraud and violations of the Food Drug and Cosmetic. The six and eight others were indicted in late 2014 following a two year probe of the outbreak which took the lives of 76 patients.
Two of the 14. including Cadden, already are serving prison terms. Two others have yet to be tried. Still two more have pleaded guilty and await sentencing.
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Another Day, No NECC Verdict

Boston--The jury pondering the fate of six former employees of a drug compounding company spent another day Tuesday without reaching a verdict.
The 12 jurors left the Moakley Court House shortly after 4 p.m. They began deliberations early last week and thus far have only asked for transcripts of the testimony of two key prosecution witnesses, Scott Connolly, a former pharmacy technician, and Eric Kastango, an expert witness and pharmacist.
The six are facing charges ranging from racketeering to conspiracy to mail fraud.

NECC Jury Ends 4th Day of Deliberations

By Walter F. Roche Jr.

Boston--The jury considering the criminal case against six former employees of a defunct drug compounding company adjourned at 4 p.m. today ending the fourth full day since the case was formally sent to them.
The defendants were employees of the New England Compounding Center, the company that caused a deadly nationwide fungal meningitis outbreak.
The six,including Gregory Conigliaro, an NECC vice president and part owner, have been charged with racketeering, conspiracy, mail fraud and violations of the Food Drug and Cosmetic Act.
They were indicted along with eight others following a two-year probe of the 2012 outbreak.
The jurors deliberate behind closed doors within the Moakley Federal Courthouse in the city's seaport district. They are visible, and then from a distance, only during lunch breaks.
Defendants, their lawyers and other interested parties spent the day wandering the courthouse hallways and visiting the second floor cafeteria. The jurors will deliver their verdicts in the seventh floor courtroom of U.S. District Judge Richard G. Stearns, who has presided over the trial which began with opening arguments on Oct. 15.
In the previous trials of co-defendants jurors deliberated by up to five days. Deliberations in the trial of Barry J. Cadden deliberated five days while deliberations in the trial of Glenn Chin lasted three days.
Cadden, NECC's president and part owner, is serving a nine-year prison sentence while Chin, an NECC supervising pharmacist, is serving an eight year term.

Jury Adjourns for the Weekend

Boston--The federal jury in the criminal case stemming from a deadly fungal meningitis outbreak adjourned at 4 p.m. and will return Monday to the U.S. District Court.
The panel did not return to the courtroom though attorneys for the six defendants remained on hand for the session.
The panel is considering charges against six former employees of the New England Compounding Center, the company blamed for the outbreak. The charges include racketeering, mail fraud and violation of the Food Drug and Cosmetic Act.
The jurors are working from a 24-page guide provided by U.S. District Judge Richard G. Stearns. The guide provides a listing of all the charges against each of the defendant and the votes the jurors must take to either find the defendants guilty or innocent.
The jurors were also provided with a 43-page copy of the instructions Stearns read to them earlier this week.
Those on trial are Gene Svirskiy, Christopher Leary, Joseph Evanosky, Sharon Carter, Alla Stepanets and Gregory Conigliaro.
They were among 14 indicted in late 2014 following a two year probe of the fungal meningitis outbreak.
Two of the 14, Barry J. Cadden and Glenn Chin, are now serving prison terms following their conviction on racketeering, conspiracy and mail fraud charges.
In other action this week, U.S. Justice Department officials acknowledged the payment of $369,000 by Cadden and his wife for property the family owns in North Kingston, R.I. The payment was part of the settlement of a forfeiture order against Barry Cadden. They will retain ownership in the seaside home in return for the payment.
Under the same agreement the Caddens must sell a multi-million dollar home in Wrentham, Mass. and turn a portion of the proceeds over to the federal government.
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Judge Bars Disclosure of Compounder's Profits

By Walter F. Roche Jr.

Boston--In a last minute reversal the judge presiding over the criminal trial of former employees of a drug company that caused a national public health crisis, barred federal prosecutors from telling jurors that one of the defendants, a part owner, earned some $20 million in profits in the six year preceding the 2012 fungal meningitis outbreak.
The order was issued earlier this week by U.S. District Judge Richard G. Stearns. He had earlier rejected a request by lawyers for Gregory Conigliaro to bar mention of how much Conigliaro, a vice president and part owner, collected from the New England Compounding Center and a related firm.
In the brief order this week granting the motion filed in Conigliaro's behalf, Stearns said he was granting the motion "There being no evidence Mr. Conigliaro stood to gain any financial advantage from NECC retaining its identity as a compounding pharmacy."
He added that government lawyers had not filed an opposition to the Conigliaro motion "suggesting anything to the contrary."
The profits came from the New England Compounding Center and a sister firm called Ameridose.
Records filed in related civil and criminal litigation show that Gregory Conigliaro made some $20 million in profits from NECC and a sister firm, Ameridose LLC, between 2006 and 2012, when both firms shutdown for good.
The closures came amid evidence that thousands of fungus contaminated vials of a spinal steroid had been shipped by NECC to health facilities across the country in 2012. Nearly 800 victims were sickened after being injected with the drug. Seventy-six of them died.
Meanwhile jurors Thursday completed their second full day of deliberations in the racketeering and mail fraud case stemming from a two-year probe of the outbreak.
Conigliaro and five other NECC employees are facing charges ranging from racketeering, to conspiracy and mail fraud.
Conigliaro faces a single charge of conspiring to defraud the U.S. Food and Drug Administration by portraying NECC as small family owned pharmacy licensed by the Massachusetts Board of Registration in Pharmacy.
While Stearns concluded there was no evidence that Conigliaro personally profited by remaining a state licensed pharmacy, several witnesses in the nearly two month trial testified that had NECC registered with the FDA as a drug manufacturer, it would have been required to meet higher and more extensive standards.
The witnesses stated that NECC was "masquerading" as a pharmacy to avoid stricter regulation.
The only hint jurors got of the income NECC generated came when federal prosecutors told jurors Conigliaro "made millions" from NECC.
Records from NECC's bankruptcy and a series of civil and criminal cases show that Gregory Conigliaro held a 10 percent interest in NECC and Ameridose. Court records show Barry Cadden, the NECC president, and his wife, who owned 35 percent of the two companies, earned $72 million during the same six year period.
A 10 percent stake would equal $20 million.
Dan Rabinowitz, Congiliaro's lawyer, had urged the judge to bar the disclosure of his client's income because "it would improperly taint the jury's ability to be fair."
Meanwhile the jurors in the case have now requested transcripts of the testimony of two prosecution witnesses in the case, Eric Kastango, a pharmacist and expert on sterile drug compounding, and Scott Connolly, a former NECC employee.
Kastango gave extensive testimony on his observations of the conditions at NECC's Framingham, Mass. and told jurors the company did not meet the standards required by a national code, known as the U.S. Pharmacopeia, for sterile drug compounders.
Connolly, who has already filed a guilty plea to 10 mail fraud charges, testified about how he worked as a pharmacy technician at NECC despite the fact that he had surrendered his registration to the state board in the midst of a separate investigation.
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NECC Jury Asks for Transcripts

By Walter F. Roche Jr.

Boston-- The jury hearing the racketeering trial of six former employees of a drug compounding company that shipped highly contaminated drugs across the country asked the presiding judge today provide a transcript of the testimony of a key prosecution witness.
The request for the testimony of Scott Connolly was quickly granted as jurors met for the first full day of deliberations on the case involving former employees of the now defunct New England Compounding Center.
Connolly, who already has entered a guilty plea to multiple mail fraud charges was working at NECC as a pharmacy technician even though he had surrendered his state registration in the midst of an investigation by the state Board of Pharmacy.
Connolly, whose brother also worked at NECC, was preparing a drug called cardioplegia, which is used to stop the heart from beating during open heart surgery.
At a brief hearing today lawyers for two of the defendants raised concerns that providing the transcript of just one witness might lead to that testimony getting too much attention.
U.S. District Judge Richard G. Stearns said his only concern was that the jury be provided with the full text, including direct testimony and cross examination.
The jurors ended their deliberations at 4 p.m. and will return tomorrow at 9 a.m.
The six defendants have been charged with racketeering, conspiracy, mail fraud and violation of the Food Drug and Cosmetic Act.
Scott Connolly in his testimony in late October told the jury he worked for NECC for some two years and the fact that he lacked needed registration was general knowledge among his colleagues. Those included three of the defendants, Gene Svirskiy, his direct boss, NECC Vice President Gregory Conigliaro and pharmacist Christopher Leary.
He testified that on about half a dozen occasions he was told to leave the clean room where he worked because regulators were on the premises.
"It was my understanding that regulators were coming and they wanted me out," he said.
He said he was told when he first went to work for the company that the clean room where sterile drugs were prepared would be a good place to hide him.
Connelly acknowledged he had reached a plea agreement with federal prosecutors that is contingent on his continued cooperation with prosecutors. His sentencing has been put on hold pending the completion of the ongoing case.
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NECC Criminal Case Goes to Jury

By Walter F. Roche Jr.

Boston--Federal prosecutors charged today that a Massachusetts drug compounder defrauded its customers and the federal government when it masqueraded for years as a local family owned pharmacy when it was really a drug manufacturer engaging repeatedly in dangerous practices.
The charges came in the closing arguments in the federal court trial of six former employees of the now defunct firm, the New England Compounding Center.
Attorneys for the defendants countered with claims that the company was operating in a regulatory "dead zone" and federal officials didn't even know at the time if they had jurisdiction over the company. They also stated that their clients never had any contact with the customers they are accused of defrauding.
The arguments were followed by instructions for the jury, which is expected to begin serious deliberations tomorrow.
The case stems from a two year probe of the 2012 fungal meningitis outbreak which took the lives of 76 patients including 16 from Tennessee. Presiding U.S. District Judge Richard G. Stearns noted that none of the six were involved in producing the specific drug, methylprednisolone acetate, that caused the outbreak.
Assistant U.S. Attorney Amanda Strachan told the jurors that the two defendants already convicted in the case "couldn't have done it alone. All six defendants made it possible."
Calling NECC "a fraudulent criminal enterprise, Strachan said that the company was "flying under the radar" of the U.S. Food and Drug Administration which licenses and inspects drug manufacturers.
She said NECC with the help of the six defendants shipped drugs made from expired and contaminated ingredients, mislabeled drugs and used fake patient names to escape the stricter FDA scrutiny.
She replayed for the jury a training tape made by the now convicted president and part owner of NECC Barry Cadden in which he bragged that inspectors from the Massachusetts Pharmacy Board didn't even know what they were looking at when they visited NECC's Framingham, Mass. facilities.
Cadden and NECC supervisory pharmacist Glenn Chin already are serving prison terms following their conviction on racketeering and mail fraud charges.
Strachan listed the crimes each of the six has been charged with committing including racketeering, conspiracy and mail fraud. They include shipping a cancer fighting drug that had expired years earlier and shipping subpotent drugs used in eye surgery.
She said defendant Gregory Conigliaro, an NECC vice president and part owner, played a central role in efforts to keep the company out of the grip of the FDA.
Attorneys for the defendants went through those same lists stating that their clients did nothing wrong.
Jeremy Sternberg, representing defendant Gene Svirskiy, said his client was a "decent, careful and quiet man" who had absolutely no contact with doctors and hospitals he is accused of defrauding. His client had no authority or control over his co-workers or of the physical condition of the workplace.
Paul V. Kelly said his client, Christopher Leary, was the youngest of the defendants and was often the target of locker room type pranks in the clean room where he worked.
There was no way, Kelly said, for Leary to be able to detect that a colleague had failed to put the required amount of an anesthetic in drugs shipped to a Boston clinic.
Mark Pearlstein, representing Joseph Evanosky, said his client worked by himself and there was no evidence to back up a charge that he was involved in mislabeling drugs through a process dubbed "botching the lots."
Dan Rabinowitz, Conigliaro's lawyer, said prosecutors were trying to put a square peg in a round hole with arguments that NECC should have been subject to FDA scrutiny. He noted that there was a four year gap between the time the federal agency was informed of allegations against NECC and when the federal agency responded.
Referring to "regulatory craziness," he said his client actually wanted to register NECC with the FDA.

NECC Sales Chief: "Didn't Realize It Was Illegal"

By Walter F. Roche Jr.

Boston --The prosecution's star witness testified today that at first he didn't think the drug compounding company he worked for was doing anything wrong. He said it was an official of a South Carolina hospital who told him that what they were doing was illegal.
The witness was Robert Ronzio, the one time sales director at the New England Compounding Center, the company blamed for a deadly 2012 fungal meningitis outbreak. Ronzio described the company's constant struggle to come up with patient names, a requirement under state law.
On trial in U.. District Court are six former employees of NECC charged with racketeering and mail fraud. The trial, which began in mid-October, will go to the jury Tuesday following closing arguments.
Ronzio, who already has entered a guilty plea to a charge of conspiring to defraud the U.S. Food and Drug Administration, was testifying under the terms of a plea agreement with federal prosecutors. The current trial marks the third time he has testified against former NECC employees and owners.
"I didn't realize that what we were doing was wrong at the time," Ronzio said.
He said that it was an official of a South Carolina hospital who first told him that NECC's practices for coming up with patient names were illegal.
He described how NECC would "backfill" patient names by using lists of prior patients on future orders.
Led through a series of company emails by Assistant U.S. Attorney George Varghese, Ronzio said the names were needed in case the Massachusetts Board of Pharmacy ever asked the company to produce them. Patient specific prescriptions were required under Massachusetts law for every dose of a drug the company sold.
He said that in some cases hospitals or other customers would come up with more names than needed. He said in yet other cases it turned out that the patients names provided were actually employees of the health facility placing the order.
He said that NECC would stop shipping drugs to customers in states like Oregon and Colorado, when regulators from those states raised issues about NECC's practices. He said that Tennessee was put in that category after a potential Oak Ridge customer raised questions about NECC's compliance with the law.
He said NECC President Barry Cadden would in some cases waive the patient name requirement but in at least one case later retracted it.
Ronzio also insisted that he never had any doubts about the quality of NECC's products and he believed the claims the company made to its customers about quality assurance practices.
Ronzio recounted one conversation with Cadden in which the company president bragged about how well NECC was doing and that the company fax machine had turned into his own personal ATM.
Under cross examination by attorneys for the six defendants, Ronzio acknowledged that it was Cadden, who is now serving a nine-year prison sentence, who ultimately decided about granting waivers to the patient name requirement.
He was also shown emails in which one defendant, Sharon Carter wrote that she was holding orders until she got needed patient names.
Under questioning by Dan Rabinowitz, the attorney for Gregory Conigliaro, Ronzio said that he and Conigliaro ended up taking over the task of contacting clients when a recall of contaminated products was underway in 2012.
He agreed that Conigliaro wanted Cadden kept away from regulators "because he was hysterical, crying and upset." Conigliaro was an NECC vice president and part owner.
Joseph Evanovsky's attorney noted that he was a fairly new employee and was involved in handling only 12 of the ingredients cited in the thick prosecution files.
The final witness was Joseph Ridgley, a special FDA agent, who amassed thousands of pages of documents to back up the individual charges in the original 2014 indictment.
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