Prosecutors Push for Outbreak Restitution Order

By Walter F. Roche Jr.

Federal prosecutors are asking a judge to reverse a decision which could delay for months a decision on a $74 million restitution order to benefit victims of a deadly 2012 fungal meningitis outbreak.
In a seven-page motion filed today in U.S. District Court in Boston, Mass. Assistant U.S. Attorneys George Varghese and Amanda Strachan asked U.S. District Court Judge Richard G. Stearns to reverse himself and immediately consider the order which could bring financial relief to outbreak victims.
Stearns, in a decision issued Nov. 21, concluded that he could not consider the restitution because of pending appeals in the case of Barry J. Cadden. A decision on those appeals is not expected for months.
Cadden, who was president and part owner of the company blamed for the outbreak, was convicted in March on racketeering and mail fraud charges and is serving a nine-year federal prison sentence. Both his conviction and sentence are on appeal. Prosecutors have asked that Cadden be forced to make restitution of $73.7 million.
"The government submits that this court's jurisdiction is unaffected by Cadden's appeal from his conviction (or the government's appeal of his sentence)," the motion states.
While acknowledging that in many cases an appeal would delay such decision, the prosecutors cited two U.S. Supreme Court rulings to the contrary.
In addition they noted the federal Mandatory Victims Restitution Act of 1996 makes restitution "a mandatory component of sentencing for criminal offenses, including crimes for which Cadden has now been convicted."
They also noted a provision of the restitution statute that mandates restitution where an identifiable victim or victims have suffered a physical injury."
"The notice of appeal following the original judgment does not divest the sentencing court from resolving the restitution issue," the decision states.
Stearns already has issued an order requiring Cadden to forfeit $7.5 million in assets, including his BMW and Wrentham, Mass. home.
The 2012 fungal meningitis outbreak caused by fungus laden steroids sickened some 778 patients killing 76 of them.
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Chin Seeks Reversal and Acquittal

By Walter F. Roche Jr.

The pharmacist convicted of racketeering and mail fraud in the wake of a deadly fungal meningitis outbreak is asking a judge to throw out the jury verdict and acquit him of the charges.
In a nine-page filing in U.S. District Court in Boston, Mass., Glenn A. Chin said the fact that the jury found him not guilty on second degree murder charges undermines all the remaining racketeering and mail fraud charges.
"Without the second degree murder racketeering charges this case is even farther afield from RICO (racketeering) than where it started," the filing by Stephen J. Weymouth, Chin's attorney, states.
Adding that "constitutional concerns" were heightened by the "jury's acquittal" on 25 second degree murder charges, the motion states that Chin had no way of knowing that the conduct he was engaging in could lead to a racketeering charge.
"The RICO (racketeering) charge is unconstitutionally vague as to Chin on an alleged mail fraud scheme," the motion continues. "Chin was not - and could not have been - aware that the New England Compounding Center's (NECC's) compounding drugs, even if deficient, could amount to racketeering."
The motion states that restrictions have been set on similar charges "to prevent the government from targeting individuals based on personal bias or public pressure.. just as the government did here."
In addition, the motion states that the government presented no evidence, explicit or implicit, that Chin conspired with five of the codefendants.
As to the charge he conspired with co-defendant Barry J. Cadden, NECC's president, the motion states that Chin simply followed Cadden's instructions in order to keep his job.
"Throughout his employment Chin followed the directives and practices taught to him by Cadden. Cadden closely controlled the details of the operation," the brief states.
Finally the motion argues that any charges relating to one lot of drugs produced at NECC in May of 2012 should be tossed because the government never proved the lot was contaminated or that anyone was sickened from it.
The 2014 indictment of Chin and Cadden followed a two year grand jury probe of the 2012 fungal meningitis outbreak which sickened some 778 patients, killing 76 of them. The outbreak was blamed on vials of spinal steroids shipped by NECC while loaded with deadly fungi.
Cadden already is serving a nine-year prison sentence while Chin is scheduled for sentencing on Jan. 30 before U.S. District Judge Richard G. Stearns.
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Tennessee Outbreak Victim Passes

By Walter F. Roche Jr.

One of the earliest Tennessee victims of the deadly nationwide fungal meningitis outbreak has died just a little over five years after he was sickened by fungus laden steroids injected into his cervical spine.
Dennis O'Brien of Cookeville  died Nov. 16 in a local hospital days after he suffered a massive stroke.
A retired school teacher, O'Brien had turned to the injections seeking relief from chronic pain. He said in an interview that the injections actually did ease his pain. That was until August and September of 2012.
Court records show O'Brien was injected with methylprednisolone acetate from the New England Compounding Center on Aug. 17 and Sept. 14 of 2012. He was one of the more than 100 patients who got the injections at the Saint Thomas Outpatient Neurosurgical Center only to be taken ill. Several patients at the Nashville, Tenn clinic died.
It was on Oct. 2, 2012 when he went to the Saint Thomas emergency room suffering from a severe headache, vomiting and diarrhea. A test of his spinal fluid showed he was suffering from fungal meningitis. He was hospitalized for 10 days.
O'Brien and the other victims were treated with powerful anti-fungal drugs that often have severe side effects including hallucinations and vision problems.
In several interviews over the past five years O'Brien described the pain he continued to suffer from the after effects of the meningitis and the underlying neck problems that drove him to seek the injections in the first place.
In fact he had retired early from teaching due to his neck pain.
In interviews as he tried to spring back from the meningitis, O'Brien said he was forced to use a cane and was unable to do many of the tasks a 64-year-old would regularly perform.
"I'm a third of my former self," he said in one interview.
The outbreak caused by contaminated steroids from NECC eventually killed 76 patients out of the 778 who were sickened. More victims, O'Brien included, have died over the past few years, some of them also suffering strokes. Other victims also have reported ongoing ailments triggered, if not caused, by the meningitis.
In addition to his wife of nearly forty years, Kaye, O'Brien was survived by his mother, Marion O'Brien of Nashville, a daughter, Katie Little of Cookeville, a son Patrick of Rockvale, three sisters and a brother.
His wife said she and the family were grateful he would suffer no more pain.
"Dennis was ready to go on to heaven," she said.
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Prosecutors Reassert $73.7 Million Restitution Claim

By Walter F. Roche Jr.

Calling arguments by a former drug company executive absurd and nonsensical, federal prosecutors have reasserted their claim that Barry J. Cadden should pay $73.7 million in restitution to victims of a deadly fungal meningitis outbreak.
In a 13-page filing today in U.S. District Court in Boston, Mass. the U.S. Attorney charged that actions by Cadden were directly responsible for the deaths and injuries to some 352 identifiable victims.
Cadden is now serving a nine-year prison sentence following his March conviction on charges of racketeering, conspiracy and mail fraud. He already has been ordered to forfeit $7.5 million.
The filing by Assistant U.S. Attorneys Amanda Strachan and George Varghese also defends providing restitution to clinics that purchased drugs from the New England Compounding Center, the now defunct company Cadden headed. Their proposal also would bring restitution to insurance companies who paid some of the victims' medical expenses.
"The clinics endured substantial out-of-pocket losses as a result of Cadden's fraudulent schemes," they argued.
Most of the $73.7 million, however would go to patients sickened by NECC drugs. Some 778 patients were sickened and 76 of them died after being injected with fungus laden steroids produced by NECC.
"These patients were directly and proximately harmed by Cadden's criminal conduct," the filing states.
Cadden has argued that he was convicted for misrepresenting the processes utilized at NECC and not the quality of the company's drugs. His lawyers contend restitution should be limited to $5,377.60
"This statement is wrong and nonsensical," the prosecutors stated. "The quality of the drugs is the reason the production process mattered to customers."
Asserting  that Cadden was convicted on 27 separate fraud and racketeering charges, the prosecutors stated that if not for Cadden's "voluminous misrepresentations.. not a single victim would have been harmed."
They also rejected Cadden's claim that because there were so many victims suffering so many different injuries, no restitution could be calculated.

NECC Defendant Gets U.S. Paid Attorney

By Walter F. Roche Jr.

A federal magistrate judge has approved a request by a defendant in the criminal case stemming from a deadly fungal meningitis outbreak to have the federal government pick up the tab for the lawyer she hired to defend her.
In a four-page order issued today U.S. Magistrate Judge Jennifer Boal agreed that the government should pick up the tab for Sharon Carter's continued defense with her current attorney.
Carter is charged with racketeering conspiracy and conspiracy to defraud the U.S. Food and Drug Administration. She was one of 14 indicted in late 2014 following a two-year probe of the 2012 fungal meningitis outbreak.
Carter was director of operations for the New England Compounding Center, the company that shipped highly contaminated steroid drugs to dozens of health care facilities. The 2012 outbreak sickened 778 patients, killing 76 of them.
Under the decision Carter's current lawyer, Michael J. Pineault, can continue as her counsel even though he is not a member of a panel of lawyers selected to represent indigent defendants.
"The court finds that she (Carter) is financially unable to obtain counsel at this time," Boal wrote, adding that the defendant "has exhausted the personal assets available to fund her defense."
Though she noted that appointing a counsel not on the panel is only allowed in exceptional cases under the Criminal Justice Act, Pineault has been representing her for five years in a complex case.
"The court finds that exceptional circumstances are present in this case," the ruling states.
She added that Pineault's request that a colleague also be appointed to assist him should be resubmitted separately.
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Ronzio Sentencing Delayed Indefinitely

By Walter F. Roche Jr.


The sentencing of a key witness in the criminal probe of a deadly fungal meningitis outbreak has been delayed indefinitely under an agreement between his lawyers and federal prosecutors.
The two-page joint motion was filed today in U.S. District Court in Boston, Mass. Robert Ronzio's sentencing had been scheduled for Jan 31, 2018.
Ronzio, the head of sales for the New England Compounding Center, entered into a plea agreement with the U.S. Attorney's office on Dec. 19, 2016. He entered the plea to a single conspiracy count.
In the motion, prosecutors said Ronzio is expected to testify in the upcoming trial of seven co-defendants.
"His cooperation is not yet complete," the motion states, adding that his sentencing should be delayed until the final trial is completed.
Under his agreement Ronzio  admitted being involved in a conspiracy to defraud the U.S. Food and Drug Administration.
Ronzio already testified in the  trial of NECC's one time president Barry J. Cadden. The former pharmacist is serving a nine-year prison sentence in a federal prison in Pennsylvania.
Cadden and Ronzio were two of 14 persons connected to the defunct drug compounding firm named in a 2016 indictment. Seven of those defendants have yet to be tried on charges ranging from racketeering to mail fraud to violations of the federal Food Drug and Cosmetic Act.
Co-defendant Glenn Chin, who was a supervising pharmacist at NECC, was found guilty of racketeering and mail fraud charges but, like Cadden, he was cleared of 25 counts of second degree murder.
The 2012 outbreak, caused by fungus riddled steroids produced at NECC, took the lives of 76 patients.
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Seven NECC Defendants Now Face Trial

By Walter F. Roche Jr

With the trials of the two most prominent defendants now complete, seven more of the 14 indicted in the aftermath of a deadly national fungal meningitis outbreak are nearing a yet to be finally determined trial date in U.S. District Court in Boston, Mass.
One of those defendants, Sharon P. Carter, is asking the court to pick up the tab for her defense, according to papers filed last week. Carter, citing her depleting financial resources, is asking for the court, to allow her to continue with her existing attorney but with the federal government picking up the tab.
Carter also sought to have her personal financial records filed under seal with the court. U.S. District Court Judge Richard G. Stearns granted that motion but left it to Magistrate Judge Jennifer C. Boal to determine whether Carter qualifies for a court paid counsel.
Carter was the director of operations at the New England Compounding Center, the company blamed for the fungal meningitis outbreak.
The trial for Carter and the six other remaining defendants follows the convictions of Barry J. Cadden and Glenn Chin. Cadden, the president and part-owner of NECC already is serving a nine-year sentence following his conviction on racketeering, mail fraud and related charges. Chin's sentencing is set for Jan. 30.
Chin was also convicted of racketeering and mail fraud. Both Chin and Cadden avoided conviction on 25 counts of second degree murder connected to the racketeering charges.
Stearns had previously indicated that the trial for the remaining defendants would take place following the Cadden and Chin trials.
The others facing trial with Carter are Gene Svirskiy, a supervisor in one of the clean rooms where sterile drugs were prepared, Christopher Leary, who worked in a clean room, Joseph Evanosky, who also worked in a clean room, Scott M. Connolly, a one time pharmacy technician, Alla Stepanets, a licensed pharmacist, and Gregory A. Conigliaro, an NECC vice president, in charge of regulatory compliance.
Robert Ronzio, who was NECC's sales chief, has entered a guilty plea to conspiracy charges and awaits sentencing. Douglas and Carla Conigliaro entered guilty pleas to vastly reduced charges and were fined and placed on probation.
Stearns dismissed charges against two other NECC defendants, Kathy Chin and Michele Thomas. The dismissal is under appeal. He dismissed the same charges against Stepanets but she still faces a conspiracy charge.
The outbreak, caused by NECC steroids contaminated with deadly fungi sickened 778 patients, killing at least 76 of them.
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Chin Easement Requests Denied

By Walter F. Roche Jr.

A magistrate judge in Boston, Mass. has turned down a request to ease the restrictions imposed on a former druggist recently convicted on charges of racketeering, conspiracy and mail fraud.
Magistrate Judge Jennifer C. Boal turned down the request submitted in behalf of Glenn A. Chin, who is awaiting sentencing following his conviction last month.
Chin had asked that a requirement that he wear a location monitoring device be eliminted and that a limit on the hours he is allowed to leave his Canton, Mass. residence be lifted.
 Noting that Chin's recent conviction eliminated any presumption of innocence, Boal wrote that the sole justification offered by Chin for the easements was the need to get his personal affairs in order.
"His current curfew is 8 p.m to 6 a.m. on weekdays and 7 p.m. to 7 a.m. on weekends. This curfew allows Chin more than adequate time to place his personal affairs in order," Boal concluded.
The easement had been opposed by federal prosecutors who noted that Chin was originally placed under arrest as he was preparing to board a plane for China.
Chin has stated that he and his family were only headed to a family event and that he had a return ticket.
Chin was one of 14 persons indicted following a two year probe of the 2012 fungal meningitis outbreak which was caused by fungus laden steroids prepared by Chin at the now defunct New England Compounding Center. Seventy-six patients died in the outbreak while 778 were sickened.
Chin was charged with second degree murder in 25 of those deaths but the jury cleared him of those charges.
Codefendant Barry J. Cadden, who was convicted on similar charges, is serving a nine year prison sentence. Cadden was president and part owner of NECC while Chin was a supervising  pharmacist at the Framingham, Mass. company.
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Pain Compounded on 5th Anniversary of Outbreak

By Walter F. Roche Jr.

For Vicki Scott, a Virginia victim of the 2012 fungal meningitis outbreak, the pain continued even as the fifth anniversary of the outbreak's discovery quietly passed last month.
Scott, who at first had a difficult time getting officials to even acknowledge she was a victim, says she now has found it virtually impossible to find healthcare providers willing to treat her continuing ailments.
The Roanoke resident said she has been told she will have to move to another state to get needed care.
For Patricia Martin, a Nashville, Tenn. resident the pain is of a different sort. She lost her mother, Mary, to the outbreak..
"It's been five years since I was last with Mom. She left this earth not of her own accord but at the hands of a compounding pharmacy," Martin wrote in an email.
The toll of the outbreak at the anniversary date was itself compounded by the October verdict in the trial of Glenn Chin, the pharmacist who personally compounded the methylprednnisolone acetate badly contaminated with a deadly fungus.
While jurors in U.S. District Court in Boston, Mass. found Chin guilty of racketeering and mail fraud they cleared him of  25 counts of second degree murder. Victims, including several who witnessed parts of the trial, expressed anger and disappointment with the verdict.
They had the same emotions earlier this year when another federal jury cleared co-defendant Barry J. Cadden of the same 25 second degree murder counts. Cadden, like Chin, was convicted on racketeering and mail fraud charges and is already serving a nine-year prison sentence at a federal prison in Western Pennsylvania. Chin's sentencing is set for Jan. 30.
"I want to scream out about the wrong that was inflicted on her, the sad way she left this earth and the fact she deserved so much better," Martin wrote on Oct. 25, the anniversary of her mother's death.
Martin said she is very conscious of the fact that other victims of the outbreak who survived are now suffering from a variety of ailments, some caused by the fungal meningitis they contracted and others from the after effects of powerful anti-fungal drugs they were forced to tolerate.
Stating that she cannot imagine the pain living victims are enduring, Martin said, "Often I think I got off easy. Today I allow myself to feel the pain and disgust."
Scott is one for whom the physical pain continues.
"My health is terrible," Scott said in a recent interview.
She said when she finally was able to get an appointment with a specialist, it was canceled at the last minute.
"I am extremely ill and I'm being denied care," she said.
Other victims from Maryland to Indiana say they have confronted the same problem with physicians and other health care providers declining to treat them.

Scott said one physician told her that her condition was just "too complex" to handle.
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Compounded Drug Recall

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Prosecutors Oppose Easing Chin's Restrictions

By Walter F. Roche Jr.

Citing a series of "suspicious financial transactions," federal prosecutors are asking a judge to reject a request for an easement of restrictions on a former pharmacist just convicted of 77 counts in the aftermath of the probe of a deadly fungal meningitis outbreak.
In a motion filed Wednesday in U.S. District Court in Boston, Mass., Assistant U.S, Attorney George Varghese cited a series of financial transactions executed in recent months by Glenn A. Chin, the former supervising pharmacist for the company blamed for a deadly fungal meningitis outbreak.
Chin had requested that the judge presiding over his case lift an order that required him to wear a location monitor and remain under house arrest at his suburban Boston residence. In requesting the easement earlier this week, Chin's lawyers said they anticipated government lawyers would oppose the request.
"During his time on pretrial release, the government has continued to monitor Chin's activities, including a number of suspicious financial transactions," the motion states.
Cited in the seven-page motion are a series of withdrawals from Chin's retirement account that initially totaled $635.000.
Citing its previous charge that Chin was arrested the day before he and his family were set to leave the country, the government charged that Chin has spent $250,000 to purchase a sports utility vehicle, pay off a large credit card debt and to repay loans to relatives.
"It is unknown what Chin is doing with this additional cash, but these transaction appear to demonstrate a concerted effort to obtain significant available cash resources," the government motion states.
The motion notes that Chin was convicted on 77 counts by a federal jury following a trial that spanned nearly five weeks. As a result, the motion continues, Chin is likely to face a substantial federal prison sentence similar to the nine year sentence given to co-defendant Barry J. Cadden.
Cadden, who was convicted in late March already is serving that nine year sentence.
Citing a report by a government expert, the motion states that Chin's estimated net worth is $1.3 million
Prosecutors also challenged Chin's contention that easing his restrictions pending a Jan. 30 sentencing hearing would better enable him to place his personal affairs in order.
"This reason is specious," the motion states, adding that the Chin motion provides no explanation for why he can't place his affairs in order during the hours of 6 a.m. to 8 p.m., the time period he is now allowed to leave his Canton, Mass. residence.
"Given all the realities Chin faces, flight may now be more tempting to him than at any point since his arrest. This is not the time to relax his release conditions," the motion concludes.
Chin and Cadden were charged following a two year probe of the fungal meningitis outbreak which was caused by the company headed by Cadden, the New England Compounding Center. Chin, as a supervising pharmacist at NECC, reported to Cadden.
The outbreak sickened 778 patients, killing 76 of them.
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