NECC Defendant Lost Physician Licenses

By Walter F. Roche Jr.

One of the convicted defendants in the criminal case stemming from the 2012 fungal meningitis outbreak has been forced to forego his right to practice medicine in two states.
Records of the Massachusetts Board of Medicine show the agency acted in 2019 to bar Douglas A. Conigliaro, 60, from ever renewing his physician's license.
The action came even though Conigliaro's Massachusetts license had expired in 1993 and was never renewed.
The action in Massachusetts led to a complaint from the Florida Medical Board because Conigliaro failed to report the disciplinary action in Massachusetts to Florida. Rules in that state require licensed physicians to report adverse actions in other states within 30 days.
Though Conigliaro was represented by counsel in the Florida case he ultimately surendered his license and agreed to never again apply for licensure in the state as a physician.
The action by the two boards came after Conigliaro and his wife pleaded guilty to a single count of making multiple structured withdrawals under $10,000 from a bank account to avoid their actions being reported to the federal government.
He was fined $55,000 and given two years probation. He was also forced to forfeit about $120,000, the total of the structured withdrawals from a Massachusetts bank.
Conigliaro was president of Medical Sales Management, which acted as the sales agent for the New England Compounding Center, the company blamed for the deadly 2012 fungal meningitis outbreak.
His wife Carla was the majority owner of NECC.
The Massachusetts medical board cited the fact that Conigliaro was convicted of a crime "which reaonably calls into question his ability to practice medicine."
The board also said Conigliaro had engaged in conduct that could "undermine public confidence in the medical profession."
"The overall nature of the respondent's deceit goes beyond mere greed in its scope," the board's order states.
The lawyer who represented Conigliaro before the board did not respond to a request for comment on the case or from Conigliaro himself.
A graduate of the Boston University Medical School, Conigliaro was licensed in Massachusetts on Nov. 18, 1987.
Florida records show Conigliaro was fined $10,000 in 2002 following an investigation of his handling of a patient who was paralyzed when he attempted to place a morphine pump in her spine. The licensing board cited him for improperly handling the procedure, not recording a proper history of the patient and having illegible records.
The board also placed a "letter of concern" in his licensing record.
He attempted to place the pump after a series of spinal injections failed to provide the 64-year-old woman with any lasting relief. She died two years after the surgery.
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Conigliaro, Carter Face Oct. 6 Bail Hearing

By Walter F. Roche Jr.

With their convictions on conspiracy charges restored, two former officials of a rogue drug compounding company have been ordered to appear at a bail hearing next week.
In an order issued today U.S. District Judge Richard G. Stearns set an Oct. 6 date for Gregory Conigliaro and Sharon Carter to appear before Magistrate Judge Jennifer C. Boal to determine what bail should be set prior to their formal sentencing.
In a ruling issued yesterday a three judge panel of the First Circuit Court of Appeals overruled Stearns and reinstated the unanimous jury findings of guilty. The two were charged with conspiring to defraud the U.S. Food and Drug Administration.
Conigliaro was vice president and part owner of the now defunct New England Compounding Center, the company blamed for a 2012 fungal meningitis outbreak that ultimately killed more than 100 patients. Carter was NECC's director of operations.
Stearns had ruled the two couldn't have defrauded the FDA because agency officials did not believe they had clear authority over state licensed drug compounders.
The appeals court, however, said that regardless of the confusion at the FDA, federal law did give them authority over pharmacies like NECC. The decision, written By Judge David J. Barron, cited "documentary evidence" of actions taken by by both Carter and Conigliaro involving them in the conspiracy to deceive regulators.
The charges against Carter and Conigliaro were not related to the deadly fungal meningitis outbreak caused by fungus laden steroids shipped by NECC to dozens of health providers across the country.
The appeals court decision overruling Stearns comes after prior rulings by the same court overturning Stearns decisions in the same case.
The panel ruled that Stearns had overlooked enhancements in setting the sentences for Barry Cadden and Glenn Chin, two codefendants who were among 14 persons affiliated with NECC who were indicted in late 2014. Stearns acknowledged in a re-sentencing hearing that the appeals court had concluded he was "too lenient" in setting the original sentences.
The appeals court in a separate ruling concluded that Stearns erred in acquitting two other NECC defendants, Kathy Chin and Michelle Thomas, of related charges. Both were eventually convicted.
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Convictions of Key NECC Defendants Reinstated

By Walter F. Roche Jr.

In a stunning reversal a federal appeals court has reinstated the convictions of two key figures in the 2012 fungal meningitis outbreak, concluding that the two did indeed conspire to defraud the U.S. Food and Drug Administration.
In a 61-page decision handed down today the court rejected the conclusion of U.S. District Court Judge Richard G. Stearns that it was legally impossible to defraud the FDA because the agency doubted its own authority to regulate state licensed drug compounders.
The Boston ruling sends the cases against Gregory Conigliaro and Sharon Carter back to Stearns to determine a sentence. Stearn's June 6, 2019 ruling had overturned the unanimous jury conclusion that the two that were guilty.
The court also sent back to Stearns for further inquiry the defendants claim for a new trial.
Conigliaro was vice president and part owner of the New England Compounding Center, the company that shipped thousands of vials of a contaminated steroid to health care providers across the country. Carter was NECC's director of operations.
The two had argued that because the FDA was unsure of its authority to regulate drug compounders, it was impossible for the defendants to conspire to defraud the FDA of the authority, it wasn't even sure it had.
Stearns, in fact, had suggested to the defense lawyers,that the legal impossibility argument was the one that most interested him.
The appeals court, however, looked to the underlying statute, the Food Drug and Cosmetic Act and concluded that whether or not the FDA chose to regulate compounders, the law gave the agency the authority to do so.
Stating that it did not understand the district court's reasoning, the ruling concludes that "the district court erred as the government contends."
The panel also rejected the argument that the jury's guilty verdict deprived the defendants of legally required fair notice.
"There is no due process based bar to the defendants being convicted," the ruling states.
The panel cited internal emails and other documentary evidence in which Carter instructed sales staff on the procedure to be followed when orders were placed without patient specific prescriptions as legally required. She told sales staff that the patient names must ressemble real names.
The names listed on NECC records included Ted Bundy and Barney Fife, the panel noted. It states that Conigliaro told federal regulators that NECC was a small family owned compounding pharmacy.
Also cited was the testimony of Robert Ronzio, NECC's national sales director, who already entered a guilty plea to the conspiracy charge.
"The district court's judgments of acquittal must be reversed," the ruling concludes.
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Michigan Outbreak Hearing Canceled

A status conference on the second degree murder charges against two former pharmacists was canceled today, apparently because the Michigan Supreme Court has yet to rule on appeals from the two defendants.
Called off was a 10 a.m. session before Livingston County Judge Michael Hatty on the 11 second degree murder charges against Barry J. Cadden and Glenn Chin.
Both defendants have asked the Supreme Court to effectively throw out the charges. The two were employed by the New England Compounding Center which shipped thousands of contaminated vials of steroids to health providers across the country.
Chin was a supervising pharmacist in the clean room where the fungus riddled drugs were prepared.Cadden was president and part owner of NECC.
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MI Prosecutor Under Review... Retires

By Walter F. Roche Jr.

A lead prosecutor in the case against two former pharmacists charged with second degree murder has abruptly retired even as he remains under scrutiny for allegations that he failed to disclose exculpatory evidence in an unrelated case.
A spokeswoman for the Michigan Attorney General's office said today that Assistant Attorney General Gregory Townsend retired on July 12.
The retirement came as the Oakland County prosecutor was reviewing allegations that Townsend, while working in the Oakland County prosecutor's office, failed to disclose information regarding witnesses in the arson trial of Juwan Deering.
Subsequently Oakland County prosecutor Karen McDonald, citing possible ethical violations, announced that the charges against Deering would be dropped. Deering was convicted on arson murder charges and has served 14 years of a life sentence.
Townsend was the lead attorney in the prosecution of Barry J. Cadden and Glenn A. Chin, the former Massachusetts pharmacists charged with 11 counts of second degree murder. In the appeals cases Assistant Attorney General Erik R. Jenkins has been prosecuting the cases.
In disclosing Townsend's departure, spokeswoman Lynsey Mukomel, said that an ongoing exhaustive review of Townsend's cases in the attorney general's office had thus far found no cause for concern.
"We take Prosecutor McDonald’s findings seriously, as we did when she first announced the Special Prosecutor's review in May," Mukomel wrote in an email statement.
She said that when the charges surfaced, Townsend was reassigned from his docket while the office conducted a detailed audit of his cases.
At that time, Assistant Attorney General Townsend was reassigned from his docket for the purpose of performing a comprehensive audit of his work. AAG Townsend retired from the Department July 12.
"While the audit remains ongoing, the department's exhaustive review of his cases has not identified any that pose a concern," she said, adding that "the Department remains committed to its due diligence and will be contacting defense counsel in cases identified as deserving additional scrutiny.
"No additional details will be released at this time given that process continues," she concluded.
Townsend appeared in district court and circuit court pursuing the charges against Chin and Cadden which stem from the 2012 fungal meningitis outbreak caused by contaminated drugs shipped from the Massachusetts drug compounding center where they both worked.
The disclosure comes as a status conference on the murder charges is scheduled for Friday before Judge Michael Hatty.
The session, if it is held, is not expected to result in any major action since Chin and Cadden both have appeals pending before the Michigan Supreme Court. The appeals seek to overturn the ruling by lower courts that there was sufficient evidence for the second degree murder charges to be heard by a jury.
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Compounded Drug Recall

TOPIC: Compounded Products Intended to be Sterile by Greenpark Compounding Pharmacy: CDER Alert - FDA Alerts Patients and Health Care Professionals Not to Use AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: FDA is alerting patients and health care professionals not to use compounded products intended to be sterile, produced and distributed nationwide by Prescription Labs Inc. doing business as Greenpark Compounding Pharmacy due to lack of sterility assurance. Administration of non-sterile products intended to be sterile may result in serious and potentially life-threatening infections or death. FDA investigators recently inspected Greenpark Compounding Pharmacy’s facility during July and August 2021 and observed conditions which could cause the compounded drugs to be contaminated or otherwise pose risks to patients. For more information about this alert, click on the red button "Read Alert" below. BACKGROUND: On August 18 and August 31, 2021, the compounder initiated a recall of several lots of a compounded ophthalmic drug. On September 2, 2021, FDA recommended Greenpark Compounding Pharmacy expand its recall to all unexpired compounded drugs intended to be sterile and stop sterile production until it implements adequate corrective actions. FDA is not aware of any adverse reactions associated with the use of compounded drugs from Greenpark Compounding Pharmacy. RECOMMENDATION/S: Health care professionals and patients should immediately check their medical supplies, quarantine any products marketed as sterile from Greenpark Compounding Pharmacy, and not administer or provide them to patients. Patients who have received compounded drugs produced by Greenpark Compounding Pharmacy and have concerns should contact their health care professional. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Read Alert Button feed

Cadden, Chin MI Criminal Hearing Set

By Walter F. Roche Jr.

A status hearing has been scheduled for Sept. 24 in the criminal homicide case against two former Massachusetts pharmacists, but it is unlikely the case will progress substantially due to pending appeals.
Barry J. Cadden and Glen Chin have been charged with 11 counts of second degree murder for their roles in the 2012 fungal meningitis outbreak.
The status coinference before Judge Michael P. Hatty comes as both Cadden and Chin have filed appeals in the Michigan Supreme Court seeking to have the charges effectively wiped out.
Cadden and Chin's lawyers have argued that there was insufficient evidence to justify binding the two over for a trial by jury.
Attorneys for the Michigan Attorney Generals have countered by charging that the two are responsible for the deaths caused by a contaminated steroid injected into the joints and spines of unsuspecting patients.
Hatty and the state Court of Appeals already have ruled against both appeals.
Cadden was president and part owner of the New England Compounding Center, the defunct company that shipped the fungi laden drugs to Michigan and some 20 other states.
Chinn was the supervising pharmacist in the NECC clean room where the deadly preservative free methylprednisolone acetate was produced.
The two already have been convicted on racketeering, conspiracy and related charges in federal court in Boston. Cadden is serving a 14.5 year sentence while Chin is serving an 10.5 year sentence.
Two federal juries, however, declined to convict the two on racketeering murder charges.
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Nine Years and Still Hurting

By Walter F. Roche Jr.

They all report pain, sometimes unbearable pain.
Many report feelings of isolation and difficulty in comprehension.
Nearly all have been dropped by their doctors and have difficulty getting a physician willing to treat them.
Ironically many still have serious after effects from the powerful medications used to keep them alive.
They are all victims of the 2012 fungal meningitis outbreak and nine years later the suffering endures.
Though in many cases the harm had been inflicted months earlier, the "totally avoidable" medical tragedy began to unfold in the Fall of 2012. Tennessee was the first state to report a rare case of fungal meningitis in mid-September.
Though it would take weeks, months and years for the full details to emerge, the cause of the outbreak, which ultimately sickened nearly 800 and killed over 100 of them, was deadly fungi that contaminated a steroid prescribed to kill painful spinal and joint pain.
Describing her extreme pain, Joan Peay, a Tennessee victim, said, "If I try to stifle a yawn, the pain is so bad I could almost pass out."
Peay, who suffered two bouts of fungal meningitis following injections of contaminated methylprednisolone acetate, said the pain in her back, side and neck gets worse at night forcing her to use "a long heat pack" that she warms in a microwave.
But pain is not the worst after effect. Difficulty in comprehension she says leaves her feeling isolated.
"Whatever controls comprehension was damaged with the huge swelling that occurred in my head," she said, adding that if someone talks too fast or too softly, "I have no idea what they are saying. I frequently feel left out because of that. It is an isolated feeling."
A feeling shared by others.
"My short term memory is gone," said Justine Miller, a Michigan victim who also reported heart and non-alcoholic liver disease.
Dawn Elliott, an Indiana victim, said she and other patients at the facility where she was injected were summarily dropped by the clinic and she has had continuing difficulty in finding a physician willing to deal with her serious pain.
"I ended up walking out," she said after describing her last heated encounter with one physician. "Now I have no pain doctor."
"I was seeing a pain doctor but after a short period of time, she cut off my pain meds and referred me to physical therapy," said Nancy Dargan.
Dargan said back in 2012 she was initially supposed to get a spinal injection but because of severe pain the doctor decided to inject her in the hip.
She had an immediate severe reaction and ended up making multiple trips to the hospital. vorinconazole.
"I had trouble remembering things, my thought processes were a mess..I had hystrionics, was hallucinating and talking to people who weren't there," she recalled.
Jack Pavlekovich, who was injected in Indiana, said his health has been going downhill and he needs a walker to ambulate.
"I have constant back pain," he said. Pavlekovich, however, says he no longer has any trouble getting medical care. That's because he left Indiana and moved to Wisconsin.
"I've had no problem at all," he said.
Rita Begin Geisler says her current condition makes it difficult to even take a walk.
"I am so bad now that I can’t even walk around the block with my dog and husband without moaning and groaning in pain," she said, adding that she likes to read and, thankfully, has no pain when sitting.
Elliott, Pavlekovich and other Indiana victims have yet to see a dime from suits against the clinics where they were injected. And in Michigan Justine Miller says she has been waiting almost four months for a payment she was already awarded.
Yet Miller, like many other outbreak victims, continues to live in pain.
"I live in severe pain with my back and legs and sometimes cannot dress myself without my husband’s help," she said.
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