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.
Contact: wallyroche@hotmail.com

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.
Contact: wfrochejr999@gmail.com

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.
Contact: wfrochejr999@gmail.com

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.
Contact: wfrochejr999@gmail.com

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.