Judge Blocks FDA Depositions on Outbreak

By Walter F. Roche Jr.

A federal magistrate judge has ruled that a Rhode Island clinic cannot depose officials of the U.S. Food and Drug Administration in its efforts to defend against civil litigation stemming from the 2012 fungal meningitis outbreak.
In a seven-page ruling issued today in Boston, Mass., U.S. Magistrate Judge Jennifer C. Boal said lawyers for the Ocean State Pain Management "may not attempt an end run" of an earlier order by taking depositions of individual FDA employees.
Ocean State had also sought Boal's approval to depose other individual's involved in pending criminal action including former employees of the New England Compounding Center and its sales arm, Medical Sales Management.
Boal, however, reaffirmed a ban on depositions of the FDA, former NECC employee Joseph Connelly, MSM salesman John Notarrianni, now imprisoned former NECC President Barry J. Cadden and former NECC sales chief Robert Ronzio.
Boal concluded that a federal law does not prevent the court from staying the depositions because the action was sought by federal prosecutors. Injunctions are warranted, she added, to prevent state courts from interfering with a federal court's consideration of a case "so as to seriously impair the federal court's flexibility and authority to decide the case."
She did add that her order did not prevent Ocean State from deposing other NECC related witnesses "not specifically stayed by the court's prior order."
The Ocean State cases are just a few of hundreds filed in the wake of the meningitis outbreak that took the lives of 76 patients and sickened hundreds of others.
Just last week NECC's supervising pharmacist Glenn Chin was convicted on racketeering and mail fraud charges. He was cleared of second degree murder charges. His sentencing is set for Jan. 30. Co-defendant Barry J. Cadden already is serving a nine year prison sentence.
Still other related defendants are awaiting trial.
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Chin Wants Out of Monitor, Curfew

By Walter F. Roche Jr.

The ex-pharmacist just convicted on racketeering and mail fraud charges is asking a judge to lift his current curfew and remove the requirement that he wear a location monitor.
The lawyer for Glenn Chin today submitted the request asking for the current requirements to be lifted until Jan. 30 when Chin is scheduled to appear for a sentencing hearing.
Currently Chin must wear the monitor 24-7 and he is only allowed to leave his Canton, Mass.  residence between 6 a.m. and 8 p.m. on weekdays and from 7 a.m. to 7 p.m. on weekends.
Stating that "Mr. Chin has been in complete compliance with the pre-trial conditions of release during the pendency of this action," Stephen Weymouth wrote that Chin needed "to put his personal affairs in order.
"He will need to make arrangements for his family as well as for other aspects of his personal life," the two-page motion states.
The motion states that opposition is expected from the U.S. Attorney.
 Federal prosecutors are likely to cite the fact that Chin was originally arrested as he was about to board a plane for China. Chin's lawyers have countered that Chin was simply traveling to attend a family event and had already purchased a return flight ticket.
"It will be easier for Mr. Chin to properly discharge these duties and responsibilities if he was not wearing a location monitoring device and if he was not subject to a curfew," the motion continues.
In the event the judge declines that request, Chin is asking U.S. District Judge Richard G. Stearns to loosen the curfew hours so that he can leave his residence between 6 a.m. and 10 p.m. seven days a week.
In a related development Stearns has denied a request from lawyers for radio station WBUR that he promptly release the names and home addresses of the members of the jury that delivered the guilty verdicts this week.
Stearns said he would not release the addresses of the jurors but he would release the names of jurors after the Jan. 30 sentencing session if WBUR's lawyers submit an amended request.
Stearns took similar action on the same request following the conviction of co-defendant Barry J. Cadden.
"While the court supports the role of the media in maintaining an open judicial process, it will not release jurors' home addresses," Stearns wrote.
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Cadden to Forfeit $7.5 Million

By Walter F. Roche Jr.

BOSTON- A federal judge has approved an order authorizing the seizure of $7.5 million in assets from the former president and part owner of a drug compounding company blamed for a deadly fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns this week approved the order requested by prosecutors from the U.S. Justice Department.
Stearns' order approves the seizure of four properties owned by Cadden and his wife along with a boat, a BMW and funds in two accounts.
Under the order federal agents can auction off the three properties Cadden and his wife own in Wrentham, Mass. and an oceanside home in Rhode Island.
Cadden was convicted in March of mail fraud, racketeering and violations of the Food Drug and Cosmetic Act. He was cleared on 25 counts of second degree murder.
Yesterday Cadden's co-defendant, Glenn Chin was convicted and acquitted on parallel charges. He faces a Jan. 30, 2018 sentencing.
Cadden was the president of the New England Compounding Center and Chin was a supervising  pharmacist for the now defunct Framingham, Mass. firm.
In addition to the properties Stearns' order approved the seizure of jewelry and $95,923 in a bank account and $1.4 million in an investment account.
Assistant U.S. Attorneys Amanda Strachan and George Varghese also have asked Stearns to approve a $73 million restitution order. They have indicated they will attempt to have funds recovered go to victims of the 2012 outbreak. Stearns has yet to rule on that request and Cadden has asked for additional time to respond.
Cadden began serving a nine year federal prison sentence in August.
The outbreak sickened 780 patients killing 76 of them. The illnesses and deaths were caused by fungus contaminated methylprednisolone acetate produced by NECC.
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Chin Guilty on Racketeering, Cleared of Murder

By Walter F. Roche Jr.

BOSTON- The pharmacist who compounded steroids that eventually killed 76 patients was convicted on racketeering, mail fraud and multiple other charges today but cleared on 25 counts of second degree murder.
The verdict, following three full days of deliberations, was delivered shortly before 6 p.m. Wednesday. The clerk read through several dozen charges, announcing guilty in each instance.
Chin was convicted on charges including conspiracy,  43 counts of mail fraud and 30 counts of introducing adulterated drugs into interstate commerce.
The verdict follows nearly five weeks of testimony, some of it detailing the deaths of victims, many stricken with fungal meningitis after being injected with methylprednisolone acetate heavily contaminated fungus.
The outbreak first surfaced in Nashville in the Fall of 2012 when a Vanderbilt physician discovered her patient was suffering from an extremely rare form of fungal meningitis. That victim, Thomas Rybinski, was one of the first of 16 to die in Tennessee. Other hard hit states were Michigan, Indiana and Virginia.
"There is no celebration," said Stephen Yarmouth, Chin's attorney, who noted that but for the second degree murder counts and some racketeering charges, his client was found guilty of dozens of other charges."
"Chin is not responsible for the deaths," he said, adding that his client was remorseful.
Acting U.S. Attorney William Weinreb said,"Mr. Chin ran NECC's clean room operations with depraved disregard for human life."
Victims of the  outbreak expressed disappointment and anger, but not surprise at the verdict.
"What can I say, once again there is no justice for us and a slap on the hand for the bad guy," said Susan Edwards, a Minnesota victim of the outbreak.
"I am beyond saddened with what can be done to people today and it's okay," said Dawn Elliott, an Indiana victim.
Chin's verdict mirrors, though not precisely, the verdict against codefendant Barry J. Cadden, who like Chin was convicted on mail fraud and related charges but cleared of the same 25 second degree murder  counts. Cadden already has begun serving a nine-year prison sentence,
Both were charged in the deaths of victims from Tennessee, Virginia, Michigan, Indiana, Florida, North Carolina and Maryland.
The case was somewhat unusual in that both sides were given time limits to present their cases. The limits were imposed by Stearns in apparent reaction to the unusual length of the Cadden trial.
In Chin's case prosecutors presented a parade of witnesses testifying about the contamination found in NECC's drugs and the bacteria and fungus found in and around NECC's clean rooms where sterile drugs were being compounded, including the spinal steroid blamed for the outbreak.
Their testimony was augmented by former NECC employees, including the firm's sole quality control officer who testified that her warnings about contamination went totally unheeded.
 One former technician was highly critical of Chin's abilities and actions. That same witness told jurors his own brother was working under Chin in an NECC cleanroom even though he was no longer registered to do so.
Weymouth countered by stressing that the teams of microbiologists and investigators combing through NECC's facilities never found even a trace of the exact fungi that killed 76 patients. He said federal investigators inexplicably rushed their investigation dooming efforts to ever identify the actual cause.
Chin did not testify in his own defense nor did his lawyers present a single witness. Instead Weymouth read an excerpt from the prosecution's closing statement in the trial of co-defendant Barry J. Cadden. In it prosecutors said that NECC was "Cadden's baby" and that he was "the conductor" who controlled everything at the drug compounding firm.
In closing arguments as well as throughout the trial, Cadden's lawyers pointed to Cadden as the decisionmaker, even suggesting that Chin and the sole quality control officer were chosen for key roles not at all for competence but for their willingness to say yes.
Chin was indicted along with 13 others in late 2014 following a two year federal grand jury probe of the 2012 fungal meningitis outbreak which sickened at least 780 patients  in 13 states. Seventy-six of them died.  Two additional victims were recently added to the list of those made ill.
Cadden went on trial in January in a marathon case finally ending in late March. He was convicted of racketeering, mail fraud and violations of the Food Drug and Cosmetic Act. The jury acquitted him on the 25 counts of second degree murder.
Douglas and Carla Conigliaro pleaded guilty to vastly reduced charges relating to their handling of some of NECC's profits. They were given probation. Carla, who was NECC's majority stockholder was fined $4,500 and ordered to forfeit $4,600. Douglas was fined $55,000 and forfeited $119,647.
Chin's wife Kathy was one of two of the original 14 to have the charges dismissed. Charges were also dismissed against Michelle Thomas. The dismissal is on appeal.
Robert Ronzio, NECC's sales chief has entered a guilty plea to conspiracy charges but has yet to be sentenced.
Chin's sentencing is set for Jan. 30.
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Outbreak Jury Moving Towards Verdict?

By Walter F. Roche Jr.

BOSTON- Jurors gave the first hint they may be nearing a verdict in the racketeering trial of a druggist blamed for a deadly 2012 fungal meningitis outbreak.
The jurors asked U.S. District Judge Richard G. Stearns whether they could convict Glenn Chin on a racketeering charge if they unanimously agreed on just two of the so-called  68 predicate acts, which include 25 counts of second degree murder. U.S. District Judge Richard G. Stearns told them that the answer to that question was yes, but added that they also must consider the remaining 66 predicate criminal acts.
Stearns called the jurors into his seventh floor courtroom at mid-afternoon to answer their questions. The jurors have been deliberating since Monday in a trial that began in September.
Some observers were predicting, based on the questions posed, that a verdict could come as soon as tomorrow.
Stearns said that if the jurors could not vote unanimously on any of the remaining racketeering charges then no further action was required.  
In addition to second degree murder charges, the predicate acts include mail fraud and violations of the Food Drug and Cosmetics Act.
Chin was one of 14 indicted in late 2014 following a two year federal probe of the fungal meningitis outbreak caused by fungus laden steroids shipped from the New England Compounding Center, the now defunct firm that employed Chin as a supervising pharmacist.
The outbreak sickened 778 patients, killing 76 of them. Sixteen Tennessee patients were among the dead, while 153 were sickened.
After the brief courtroom session, Chin's lawyers speculated that the jurors may be split on the second degree murder charges. Co-defendant Barry J. Cadden was convicted on racketeering and mail fraud charges but cleared of the second degree murder charges. His trial began in January and did not end until late March.
Cadden, who is serving a nine year prison sentence, is appealing his conviction. His verdict was returned after a little more than three days of deliberation.
Earlier in the day jurors had asked for physical copies of exhibits detailing testing results inside NECC's clean rooms where the drugs that caused the outbreak were processed. One of the two binders requested was provided. The other had already been submitted in electronic form.
Chin faces other charges beyond those in the racketeering counts including violations of the Food Drug and Cosmetics Act, aiding and abetting, false and misleading labeling and mail fraud.

Chin Jury Deliberates for 1st Day

By Walter F. Roche Jr.

BOSTON-The jury considering the racketeering and second degree murder charges against one of the druggists blamed for a nationwide fungal meningitis outbreak completed its first full day of deliberations today without reaching a verdict.
Glenn A. Chin, who spent the day in a federal court house hallway waiting for news, is charged with racketeering, 25 counts of second degree murder and mail fraud. He was a supervising pharmacist at the New England Compounding Center, which produced fungus laden steroids that sickened 778 patients, killing 76 of them.
In a brief morning session before U.S. District Judge Richard G. Stearns, one of Chin's lawyers complained that Assistant U.S. Attorney George Varghese's closing argument left jurors with the impression that it was Chin who handed an autoclave manual to a federal investigator in October of 2012.
Stearns said he had reviewed the testimony of Stacey Degarmo, the investigator with the U.S. Food and Drug Administration, and concluded she did not say that Chin handed her the manual.
The manual has become an issue because it contained instructions on the length of time that items had to be placed in the autoclave to ensure sterilization. Prosecutors say Chin only left items in the autoclave for 15 minutes when up to 27 minutes were required.
The jury will resume deliberations Tuesday.
Chin's is the second major trial to occur since a federal grand jury issued an indictment of 14 persons connected with NECC.
Chin's boss, Barry J. Cadden, was found guilty of racketeering and mail fraud but cleared of the second degree murder charges. Three other defendants have entered guilty pleas while charges were dismissed against two others, including Chin's wife.
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Chin Case Goes to Jury

Friday, October 20, 2017

Chin Murder Case Goes to Jury

By Walter F Roche Jr.

BOSTON-.The lawyer for a former supervising pharmacist charged with 25 counts of second degree murder told a jury today that his client was not at all qualified for his job and couldn't supervise anyone.
 Delivering closing arguments for Glenn Chin, Stephen Weymouth also said that state and federal investigators mishandled the investigation of the deadly fungal meningitis outbreak Chin is accused of causing. As a result, he said the real cause of the outbreak will never be known.
Federal prosecutors, meanwhile, said Chin knew that the reckless way he was compounding steroids could result in deaths. The jury is scheduled to begin deliberations on Monday. In addition to second degree murder, Chin is charged with racketeering, mail fraud and violations of the Food Drug and Cosmetics Act.
Citing multiple action level alerts that something was wrong, Assistant U.S. Attorney Amanda Strachan said Chin "saw the flashing lights, but chose to ignore them."
"It was entirely preventable," said Strachan.
Even after people were dying, Strachan said Chin instructed his staff to clean up before state and federal investigators arrived.
The outbreak, caused by fungus loaded steroids, sickened some 778 patients in 13 states, killing 76 of them. State and federal regulators eventually concluded that thousands of contaminated vials of methylprednisolone acetate produced at the New England Compounding Center were the cause.
Weymouth, however, said that even as the outbreak unfolded, agents from the U.S. Food and Drug Administration rushed and botched their investigation.
"The FDA dropped the ball," he said."The government failed to proved how the methylprednisolone acetate became  contaminated."
Citing testimony during Chin's 21 day trial, Weymouth said the investigators didn't even take samples from the very area of the clean room where the steroids were compounded.
After the closing arguments, U.S. District Judge Richard G. Stearns read instructions to the jurors, telling them that they needed to vote on each count of the indictment and their decision, whether it be guilty or not guilty, must be unanimous.
That became an issue in the recent trial of Chin's co-defendant and former boss, Barry J. Cadden, who is now serving a nine year federal prison sentence. He was convicted of mail fraud and racketeering but acquitted on the same 25 second degree murder charges now facing Chin.
Records of the Cadden trial show that a majority of the jurors voted for conviction on some, but not all of the murder counts. The records do not show whether a unanimous vote for acquittal was ever recorded.
Weymouth in his closing remarks said that it was Cadden who oversaw every aspect of NECC's operations, including the clean rooms Chin was charged with supervising.
"Every decision was made by Barry Cadden," Weymouth said, adding that it was Cadden who taught Chin what little he knew about sterile compounding.
Calling his client a competent regular pharmacist, Weymouth said Chin "was not trained in sterilization" and had no training in that field whatsoever.
As for being put in charge, "he didn't no how to supervise anyone," said Weymouth.
Strachan said Chin chose to violate an oath he took when he became a pharmacist not to harm any patients.
She said records showed Chin repeatedly failed to adequately sterilize  steroids when he removed them from an autoclave after only 15 minutes. She said in some cases the steroids were "cooked" for only four minutes at the proper temperature and pressure. She said 27 minutes were required, based on a manual for the machine.
She cited records showing other drugs besides the methylprednisolone acetate proved to be contaminated with fungus and bacteria. His clean room, she said, was "a fungal zoo."
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