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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No Witnesses as Defense Rests in Outbreak Trial.

By Walter F. Roche Jr.

BOSTON- Without calling a single witness, lawyers for a man facing 25 counts of second degree murder rested their case today even as prosecutors introduced evidence that hundreds of additional non-sterile drugs were shipped by a drug compounding company to dozens of health facilities.
Glenn Chin's lawyers rested their case after reading from the transcript of the prosecution's closing argument in the recent federal trial of Barry J. Cadden, a codefendant. Cadden was president and a stockholder in the New England Compounding Center, the company that employed Chin as a supervising pharmacist.
Cadden was found guilty of racketeering and mail fraud charges but acquitted of second degree murder. He is serving a nine year prison sentence. Chin is facing the same racketeering, second degree murder and mail fraud charges
In the four paragraph excerpt read by Chin's attorney, Stephen Weymouth, prosecutors stated that the New England Compounding Center was "Barry's baby" and that he was the "master conductor" controlling all aspects of the company operations.
They have also argued that Chin was just an employee doing as Cadden instructed.
Weymouth also read from an email Cadden sent to a prospective customer in which he stated that he started the company and made every important decision on a daily basis.
Closing arguments by federal prosecutors and Chin's lawyer are scheduled for Friday to be followed by instructions from U.S. District Judge Richard G. Stearns. The jury is expected to begin deliberations on Monday.
Weymouth's announcement that the defense was resting followed testimony by a special agent for the U.S. Food and Drug Administration that NECC had shipped additional nonsterile  and outdated drugs to dozens of health care facilities. Those shipments are over and above those included in the indictment of Cadden and Chin.
Joseph Ridgley, the FDA investigator, detailed a long list of  "allegedly nonsterile" drugs that turned up in the NECC investigation.
 He said those contaminated sterile drugs were in addition to multiple shipments of the three contaminated lots of methylprednisolone acetate that went to facilities not listed in the indictment. State and federal officials say the three lots, loaded with deadly fungus, caused the outbreak that sickened 778 patients, killing at least 76 of them.
Prosecutors displayed FDA test reports on some of those drugs nonsterile. Other reports showing contamination were performed by a private testing company on contract to NECC.
He said the list covered nine-pages and was compiled from NECC and bank records.
Health facilities receiving the tainted drugs ranged from a medical center in Albany, N.Y. to a hospital in Belleville, Ill. to a physician and an eye clinic, both in Knoxville, Tenn.
Expired drugs not included in the indictment were sold to physicians in Quincy, Mass. and Victoria, Tenn., and a medical practice in Dickson, Tenn, records show.
Outdated or unsanitary drugs included under the indictment include shipments to Florida, Nevada and New York.
After the outbreak became public in 2012, all of NECC's unused drugs were recalled.
Ridgley also provided a list of drugs compounded by an unregistered NECC pharmacy technician, Scott Connolly, that are not included in the indictment. Connolly is also a defendant in the case and is expected to go on trial with the six other remaining defendants after Chin's trial has ended.
Drugs compounded by Connolly were shipped to facilities in Nashville and Clarksville, Tenn., the 
records show.
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Jurors Get Details on Outbreak Deaths

By Walter F. Roche Jr.

BOSTON - Case by case, picture by picture jurors hearing the second degree murder trial of Glenn Chin were shown pictures of the 25 victims named in the indictment charging him with second degree murder.
Ann Burgess, a registered nurse specializing in forensics, read from the autopsies and death certificates for each of the victims. Many of the documents listed contaminated steroid injections as a cause. Some also named the deadly fungus, exserohilum rostratum.
Chin, whose case could go to the jury by the end of the week, has been charged with racketeering, and mail fraud in addition to the 25 counts of second degree murder.
The charges stem from a two year federal grand jury probe of the deadly fungal meningitis outbreak caused by steroids Chin compounded at the now defunct New England Compounding Center.
There were eight victims from Michigan, seven from Tennessee, three each from Indiana and Maryland, two from Virginia and one each from North Carolina and Florida.
Prosecutors began questioning their last witness Wednesday, a criminal investigator from the U.S. Food and Drug Administration. Chin's lawyer Stephen Weymouth said he only plans to call two witnesses, one of them another FDA investigator whose testimony is likely to be brief.
Closing arguments could come before the weekend leaving only the instructions from U.S. District Judge Richard G. Stearns to the jury before deliberations can begin.
Burgess said Diana Reed, 56, a Nashville, Tenn. victim had been injected three times with methylprednisolone acetate from NECC. The records showed the injections were administered at the Saint Thomas Outpatient Neurosurgical Center on Aug, 21, Sept. 4 and Sept. 18. She died on Oct. 3, 2012, leaving behind her husband who suffers from Lou Gehrig's Disease.
Thomas Rybinski, the victim whose case first signaled the oncoming outbreak, died of "complications of aspergillus meningitis" after receiving a single injection at the same Nashville clinic, the jury learned.
Donald McDavid, 67, died after two injections at a Crossville, Tenn. clinic. His original death certificate listed "pending further study" as the cause. It was later amended to list an aneurysm and exserohilum as the cause.
In other testimony, one of Chin's lawyers, Robert Sheketoff, cross examined a key prosecution witness, Eric Kastango. Kastango had testified Tuesday that NECC and Chin had test results showing multiple problems in the clean room where sterile drugs were prepared, but then did nothing to remediate the problems.
Sheketoff questioned whether Kastango's testimony was influenced by the fact that prosecutors had hired him as a consultant during the NECC investigation.
"Do you have a bias because one side has paid you?" Sheketoff asked.
No, said Kastango, who earlier testified he was paid about $30,000.
Shetekoff  repeatedly questioned whether it was Chin or his boss, Barry Cadden, who made all the decisions at NECC.
"He (Chin) was the supervisor of the clean room," Kastango responded, adding that it was Chin's responsibility to read the industry rules for the operation of a clean room.
Asked if Cadden, NECC's president, was concerned about following the rules for a compounding pharmacy, Kastango said, "He (Cadden) was concerned about the bottom line."
Cadden, who was indicted along with Chin and 12 others, already has begun serving a nine year federal prison sentence after being found guilty of racketeering and mail fraud charges. He was acquitted on the second degree murder charges.
Thetakoff also asked whether Chin and "everyone in that clean room" should have quit their jobs because of all the violations.
"Absolutely," Kastango responded, "all should have quit."

---------------------
TENNESSEE VICTIMS

Marie Hester, 78, died Nov. 1, 2012
Eddie Lovelace, 78, died Nov. 2, 2012
Donald McDavid, 67, died Nov. 4, 2012
Diana Reed, 56, died Oct. 3, 2012
Thomas Rybinski, 55, died Sept. 29, 2012
Carol Wetton, 71, April 14, 2013
Earline Williams, 72, died Oct. 15, 2012



MICHIGAN DEATHS

Karina Baxter
Paula Brent
Gail Gipson
Donna Kruzich
Lyn Laperriere
Mary Plettl
Sally Roe
Emma Todd

INDIANA DEATHS

Pauline Burema
Kathy Dillon
Alice Machowiak

MARYLAND DEATHS

Bahman Kashi
Brenda Rozek
Edna Young

VIRGINIA DEATHS

Kathy Sinclair
Douglas Wingate

FLORIDA DEATH

Godwin Mitchell

NORTH CAROLINA DEATH

Elwina Shaw

Warning Signs Ignored as Outbreak Approached

By Walter F. Roche Jr.

BOSTON-A sterility expert testified today that a drug compounding company and its supervising pharmacist failed repeatedly to conduct proper tests on its products and ignored industry standards mandated by state boards of pharmacies.
 Answering repeatedly with "Absolutely not" or "No, they did not," Eric Kastango detailed failures by the New England Compounding Center and its supervising pharmacist, Glenn Chin, to adequately prepare and test drugs that would be injected into the bodies of unsuspecting patients.
Hired by federal prosecutors to assist in the investigation leading up to Chin's 2014 indictment, Kastango said NECC shipped drugs without proper tests or with no testing at all. Even when tests showed a need for immediate action, nothing was done.
Kastango said Chin did not properly sterilize hundreds of vials of methylprednisolone acetate that were shipped to health facilities across the country. State and federal regulators have concluded that those vials, loaded with fungus and injected into the spines and joints of patients, caused a nationwide outbreak of fungal meningitis that sickened 778 patients, killing 76 of them.
Kastango said that NECC's own records showed the methylprednisolone acetate was supposed to be placed in an autoclave for 20 minutes, yet NECC's records showed Chin generally removed the steroids after only 15 minutes.
In addition he said Chin failed to use biological indicators needed to ensure the steroids were sterile.
And, Kastango said, Chin should have been adding an additional eight to 11 minutes in each autoclave cycle to ensure that the large volume of liquid had reached the 121 degree mark needed to achieve sterility.
Kastango, who said he was paid about $30,000, for his consulting work for federal prosecutors, said it was critical that the types of drugs Chin was preparing be sterile because they were being injected into patients' bodies.
"Once you inject something, you can't get it back," he said.
Under questioning by Assistant U.S. Attorney George Varghese, Kastango described promotional material from NECC in which the company called its operations "state of the art" and fully compliant with the minimum standards set by the U.S. Pharmacopiea.
"They said they were the best," he said.
Asked by Varghese if indeed NECC was in compliance with those standards, Kastango said, "No they were not."
Kastango testified that while the industry standards did not have the force of law, state pharmacy boards, including Massachusetts, have made compliance mandatory.
Varghese also led Kastango through emails gathered in the investigation including a chain in which Chin described what he did after discovering that a key ingredient was missing from a beaker of a drug. The email showed that instead of discarding the deficient bottle, he mixed it with three other containers of the same drug that had the proper ingredients.
The result, Kastango said, was that all the containers were deficient, including one shipped to a Massachusetts hospital.
Other deficiencies Kastango said included failure to conduct end product testing, using outdated chemicals, falsely labeling drugs and failure to have the proper number of vials sent out for independent testing.
Varghese also introduced emails from Chin's then boss Barry Cadden.
In one Cadden acknowledged required testing was not being done.
"What you are not seeing is what we are not currently doing, but should be doing," Cadden wrote referring to a sterility test.
Cadden is now serving a nine year sentence following his March conviction on racketeering and mail fraud charges. That same email was entered as an exhibit in Cadden's trial.
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CDC Raced to Find Quick Outbreak Test

By Walter F. Roche Jr.

BOSTON- With the death toll mounting and quick treatment essential,  a federal health official said her agency had to come up with a new and speedier test to determine what was causing patients to contract fungal meningitis.
Mary Brandt, head of the myotic diseases branch of the U.S. Centers for Disease Control and Prevention, testified Monday in the racketeering and second degree murder trial of pharmacist Glenn Chin. The charges stem from a two-year probe of the 2012 fungal meningitis outbreak which first surfaced in Tennessee.
Under questioning by Assistant U.S. Attorney George Varghese, Brandt went through a list of victims, starting with Thomas Rybinski of Smyrna, who became the so-called index or lead case.
Brandt said that the existing tests either took too long or were not precise enough to quickly identify the fungus causing the outbreak.
She said without rapid diagnosis victims would be showing up at emergency rooms with the staffers having no idea of the real cause or the best treatment.
"Strokes would kill patients before the cause would be realized," she said.
The test developed, called Real Time PCR, enabled a quicker identification of the fungus contained in specimens of tissue and liquid extracted from victims being delivered to CDC's Atlanta laboratories.
Brandt said her unit also tested and matched vials of the suspect steroid, methylprednisolone acetate, gathered from Chin's employer, the New England Compounding Center and health facilities around the country.
Stating that it was critical to precisely identify the fungus, Brandt said the results showed that the predominant fungus turned out to be exserohilum rostratum, while tests on specimens from Rybinski contained a different fungus, aspergillus fumigatus.
She testified that subsequent tests on other NECC products showed a variety of different fungi and bacteria.
"It's very unusual to see such a diverse group of organisms," she said.
Brandt said the CDC had little to no experience with treatment of the dominant fungus so they quickly assembled a panel of experts to come up with treatment plans.
"We stopped all work in the bureau for three months," she said, referring to multiple teams set up to address the crisis. "Everybody had a job."
She said some 1,000 specimens were tested including spinal fluid and brain and spinal tissue extracted from victims.
She said the fungus appeared as long strands "which are very difficult to capture." The analysis was made more difficult because some of the patients were already being treated with anti-fungal medications which destroyed some of the evidence.
She said the new Real Time PCR test improved
from 10 per cent to 50 per cent the number of cases being correctly diagnosed.
Other victims cited in Brandt's testimony included Diana Reed and Marie Hester of Nashville along with victims from Indiana and Michigan. Chin, whose initials appeared on the vials put in evidence, has been charged with second degree murder in 25 of those deaths.
 Under cross examination by Chin's lawyer, Stephen Weymouth, Brandt acknowledged that there were NECC vials, 41 in fact, that contained no evidence of fungus. Weymouth challenged the prosecution's contention that a lot of steroids produced in May were contaminated.
Weymouth also noted that the new "Real Time" test has not received formal approval from the U.S. Food and Drug Administration.
But another prosecution witness, Dr. Sudha Chaturvedi, said tests done under her supervision at the New York State Health Department showed at least one NECC vial from the May lot was contaminated with the suspect fungus. Calling the results "devastating," she said tests on other NECC steroids showed they were heavily contaminated with another fungus.
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Deadline Extended for Outbreak Victim Grants

By Walter F. Roche Jr.

The deadline for victims of the fungal meningitis outbreak to apply for grants of up to $25,000 has been extended to March and officials say there is no longer any fear that any grants may have to be paid back.
The changes were disclosed by U.S. Rep. Mike Bishop who led efforts to get $40 million allocated to outbreak victims.
The new filing deadline is March 1, 2018. Originally there was a Dec. 15, 2017 cutoff.
Bishop also said that he has received assurances that victims will not be required to pay back any grants if they eventually collect under insurance policies.
According to Bishop, the Massachusetts Attorney sought and obtained a waiver from a state law that would have automatically triggered a pay back requirement.
"By doing so, they removed the distribution of funds from their state law and thus have removed any concerns about potentially needing to pay these funds back at a later date," Bishop's office said in a statement.
"This will give victims and families, many of whom still struggle with day-to-day finances much needed peace of mind ... that the money they are receiving is actually theirs," the statement continued.
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Information about applying for compensation

·         The Massachusetts Attorney General’s office is currently establishing a process through which claims will be disbursed. To be eligible for these funds, victims must apply by March 1, 2018 (please note, that date has changed from the previous deadline of December 15, 2017). After the applicant’s case is verified, they will be eligible to receive a direct payment of $25,000, with the option to submit additional documentation to receive compensation beyond that amount.

Eligible victims have received a Victim Identification Number from the FBI. If you believe you or a loved one was harmed by a contaminated injection from the New England Compounding Center (NECC) in the fall of 2012, please contact Congressman Bishop’s D.C. office at 202-225-4872 for more information.

Potentially Deadly Bacteria Found in NECC Drugs

By Walter F. Roche Jr.

BOSTON-Microbiologists from the U.S. Food and Drug Administration testified today that they found mold, yeast and bacteria, some of it potentially deadly, in several drugs shipped from a Massachusetts drug compounder.
The FDA scientists, testifying in the trial of one-time supervising pharmacist Glenn Chin, said that a variety of bacteria were found in multiple drugs shipped by the New England Compounding Center to health facilities from Massachusetts to Florida and Washington.
Chin has been charged with racketeering and second degree murder for his role in the 2012 fungal meningitis outbreak which eventually sickened some 778 patients, killing 76 of them.
Henry Lau, from FDA's San Francisco office, said that his tests of cardioplegia that had been shipped by NECC to Brigham and Women's Hospital in 2012 contained the bacteria brevibacillus choshinensis.
Asked about the possible effects of that bacteria should it be injected in a patient, Lau answered with a single word: "Deadly."
Forty seven bags of the drug used to stop the heart during surgery, had been shipped to the Boston hospital, according to an exhibit displayed for jurors.
The testimony from Lau and other FDA officials showed that contamination at NECC was not limited to the steroid, methylprednisolone acetate, the drug blamed for the deadly fungal meningitis outbreak.
Lau said an NECC steroid, triamcinolone, was found to have three different bacteria, some of them harmful. He said testing of 10 vials of betamethasone shipped to an Indiana clinic showed five had bacteria that would be harmful to patients with a compromised immune system.
Stephen Yarmouth, one of Chin's lawyers, countered by questioning another FDA microbiolgist in the same California office about test results that showed possible contamination in the clean room at the same office.
Jonathan Yenovkian, Lau's colleague, said that growth, indicating the presence of some contamination, was discovered in the FDA's San Francisco clean room, but despite several tests said, the exact identity of the organism could not be determined.
"We did our best," Yenovkian said, adding "It was viable. It grew."
He said there was no evidence it affected the tests performed on NECC drugs.
Yenovkian said that betamethasone NECC had sold to an Orlando outpatient surgery center had two different bacteria and samples of the same steroid shipped to a Kentucky clinic contained potentially harmful bacteria.
Haydee Romero, who works in a New York FDA laboratory, said that she tested 78 vials of the methylprednisolone acetate that had been shipped to the Saint Thomas Outpatient Neurosurgery Center in Nashville.
She said tests showed 48 vials were contaminated, with 28 showing yeast and 19 with mold. She said there was so much mold in one sample that it was growing off the plate used to conduct the test.
She said tests on 25 vials of the same drug sent to another clinic showed all were contaminated.
"It is unusual to get so much growth from a single drop," she said noting only a single drop of a drug is used to conduct the sterility test.
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Critical Minutes Lost in Outbreak Probe

By Walter F. Roche Jr.

BOSTON -As critical minutes passed, top state and federal investigators trying to find the source of a deadly and growing fungal meningitis outbreak sat in their cars hiding behind a drug store awaiting a signal they could continue their probe.
That was the testimony Wednesday from an official of the U.S. Food and Drug Administration as federal prosecutors moved toward wrapping up their case against a pharmacist employed by the drug compounding firm blamed for the 2012 outbreak that took the lives of 76 patients..
In a related development U.S. District Judge Richard G. Stearns denied a motion to dismiss filed by three other defendants in the same case.
Stearns ruled the three will have to stand trial at a later date on conspiracy charges.
They were indicted in late 2014 at the same time as Glenn Chin, who was a supervising pharmacist at the New England Compounding Center in Framingham, Mass. He has been charged with racketeering and second degree murder.
In the Chin case FDA micro-biologist Almaris Alonso testified that she and other state and federal investigators sat for an entire day on Oct. 3, 2012 awaiting word on when and if they could continue their investigation inside the New England Compounding Center.
She said that during Oct. 3 U.S. Marshals were in NECC's building apparently executing search warrants. She said both state and federal investigators in her group eventually went back to their offices and did not return to the company until the next day. She said negotiations apparently were also going on over whether NECC would surrender its pharmacy license.
Alonso's revelation came in response to questions posed by Chin's attorney, Stephen Weymouth, who asked why the FDA team only collected a limited number of samples.
"We didn't have enough time," Alonso said. "We had to go. We had to do an inventory."
She said the team, which included investigators from the Massachusetts Pharmacy Board, had only 24 hours to get samples collected at NECC back to FDA testing laboratories.
Asked why she didn't go back on Oct. 5, Alonso said she was under orders to wrap things up by Oct. 4.
Alonso also said that Annette Robinson, who headed NECC's quality control efforts, had no training in micro-biology and didn't follow up when insanitary conditions were found.
In other testimony, Philip Istafanos, another FDA microbiologist, said that samples from NECC, which were delivered in person to his laboratory in New York, were "highly contaminated."
He said the vials of methylprednisolone acetate contained both bacteria and mold. Several also turned up evidence of yeast.
He said he performed the analysis on the very first vials and described how black filaments could be seen in nine vials even without the aid of a microscope.
He described seeing clumps of the black filament bunching together. Describing the initial findings as "very significant," Istafanos said it showed there was excessive mold growth in the samples.
A lab report on one of those initial samples shown to jurors states, "Blackish/whitish mold and yeast like cells detected."
The FDA scientist said that about half of those original vials were kept by the FDA and the rest were sent to the U.S. Centers for Disease Control and Prevention for testing. Two were turned over to the state Pharmacy Board.
Stearns in his ruling on the dismissal motion filed by three of Chin's co-defendants, concluded that the argument raised by the three-- that the charge that they conspired to defraud the FDA was a legal impossibility - was not applicable.
The motion was filed in behalf of Gregory Conigliaro, an NECC officer and stockholder, and Alla Stepanets and Sharon Carter, NECC employees.
"Had the FDA known what the alleged conspirators were up to, it might have imposed more stringent safety standards," Stearns wrote.
"The court has no choice but to put the matter down for trial," Stearns concluded.
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Mold Found at NECC After 2 Day Cleaning

By Walter F. Roche Jr.

BOSTON- A microbiolgist from the U.S. Food and Drug Administration said she was surprised to still find nearly a dozen mold growths in the clean room of a drug compounding company even after the facility had undergone two days of cleaning.
Testifying at the racketeetering and second degree murder trial of Glenn Chin, Almaris Alonzo said she found evidence of mold in nearly a dozen locations in her examination of the area where sterile drugs were being compounded. There was "a high level of contamination," she said.
Chin was charged following a two year probe of the 2012 fungal meningitis outbreak which took the lives of 76 patients in 20 states. More than 700 others were sickened after being injected with spinal steroids loaded with fungus.
Chin was a supervising pharmacist at the New England Compounding Center, the company blamed by state and federal regulators for the outbreak. Opening arguments in the case were delivered on Sept. 19 and the case is expected to go to the jury next week.
Alonzo said she saw a evidence of a likely source for mold even before entering the clean room where thousands of vials of methylprednisolone acetate were prepared. Pooled water was found near a boiler and grass was evident on the sticky mats NECC cleanroom workers walked over on their way into the drug preparation area.
"Mold loves to eat grass," Alonzo said, adding that standing water was a perfect place for mold to take hold.
She said some of the grass from the sticky mat was likely dragged into the clean room. She described the general condition of the room and some of its equipment as "very dirty."
She said the goal for her and the other investigators was to isolate the microbes causing a growing number of victims to become ill. She said the original case was a victim from Tennessee who suffered fungal meningitis from an organism called aspergillus fumigatus. He died.
She said some of the grass on the sticky mat likely was dragged into the clean room itself.
Remaining members of the jury - two were absent Tuesday - were shown pictures of Alonzo and other investigators examining the clean room wearing gas masks. Also shown in the pictures was Chin, who was a supervising pharmacist at NECC overseeing the clean rooms.
Alonzo said the on-site inspection took place in early October, just as the growing outbreak was becoming public. Under questioning by Assistant U.S. Attorney George Varghese, the FDA scientist said that the in-house cleaning, while far from thorough, actually made the job of investigators more difficult.
"It would have been a more useful result," she said if the area had been left alone.
She said that when she questioned Annette Robinson, who was in charge of NECC's environmental monitoring, she learned that NECC was using a medium intended to show growth of bacteria but not the medium to best show mold growth.
She said that Robinson also told her that when contamination was found, it was never investigated nor was remedial action taken.
In other testimony, Robert Sheketoff, one of Chin's lawyers, challenged an FDA investigator, Stacey Degarmo, who had testified that NECC was sterilizing drugs for only 15 minutes when 20 minutes was recommended by the manufacturer.
Sheketoff had her read from internal NECC documents that had listed 15 minutes as the standard for some time.
But on redirect by Varghese, Degarmo repeated that 20 minutes in the autoclave at 121 degrees was the minimum necessary to achieve sterility.
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NECC Drugs Verified Before Sterilization

By Walter F. Roche Jr.,

BOSTON- A U.S. Food and Drug Administration official said today the company responsible for a nationwide outbreak certified its drugs were sterile before they had been sterilized.
Testifying in U.S. District Court as a prosecution witness Stacey Degarmo, the lead FDA investigator in the probe of the 2012 outbreak said Glenn Chin's verification of the steroid blamed for the outbreak was dated a day before records show the drug was placed in an autoclave to ensure sterility.
The statement came in the 14th day of the trial of Chin, who was a supervising pharmacist at the now defunct New England Compounding Center. Chin is facing racketeering, second degree murder and mail fraud charges.
U.S. District Judge Richard G. Stearns disclosed at the end of the Friday session that the trial was running some three weeks ahead of schedule and the case could be going to the jury the week after next. That would be in sharp contrast to the 10-week trial of co-defendant Barry J. Cadden, who already is serving a nine year prison sentence,
Cadden, who was NECC's president and part owner, was convicted of racketeering and mail fraud, but cleared of second degree murder charges.
Degarmo also testified at length about NECC's use of an autoclave, in violation of its own standard operating procedures. She said Chin, who was in charge of the clean room where the methylprednisolone acetate was compounded, told her the drug was sterilized in large beakers for only 15 minutes instead of the 20 minutes listed in the company records.
She said Chin told her NECC changed to 15 minutes after the purchase of a new autoclave. Degarmo said that changing the autoclave would not justify a reduced treatment time.
In addition she said NECC failed to include the time needed to being the large beakers of steroid to the the desired temperature. She estimated that as a result the beakers may only have been sterilized at the proper temperature for four minutes.
She also said Chin acknowledged NECC was not using biological indicators to assure sterilization had been achieved
In other testimony, Samuel Penta of the Massachusetts Board of Pharmacy described how surprised he was to see the size and scope of NECC's operations. He said it was nothing like anything he had seen at any drug compounder licensed by the state.
Stating that they knew they would need help, Penta said the state board turned to the FDA and agents for both agencies began a series of visits to the Framingham, Mass. facility.
Penta acknowledged there was confusion as the outbreak developed in late September 2012 over whether state or federal officials had jurisdiction.
The 2012 outbreak sickened some 778 patients in 20 states. Seventy-six died.
Testimony continues Tuesday.
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Prosecution Witness Hammered at Chin Trial

By Walter F. Roche Jr.

BOSTON-The head of quality control at a defunct drug compounding firm said that the company president sent a completely falsified report to state regulators even as a deadly fungal meningitis outbreak caused by the company was unfolding.
Testifying at the racketeering and second degree murder trial of supervising pharmacist Glenn A. Chin, the witness, Annette Robinson, said the report purporting to show nearly perfect scores on environmental tests was falsified and that despite her position she was never even shown the document before it was sent the Massachusetts Board of Pharmacy.
During questioning by Assistant U.S. Attorney Amanda Strachan, Robinson said she was warned by a fellow worker at the New England Compounding Center not to tell Chin that she had inadvertently touched something she shouldn't have in a clean or sterile room where injectable drugs were being prepared.
"He'll throw you under the bus," Robinson said she was told.
Robinson subsequently underwent more than an hour of cross examination by one of Chin's lawyers, who asked if she didn't have a personal grudge against Chin. Robinson said she didn't know, couldn't remember or didn't understand many of Robert L. Sheketoff's questions.
Robinson's testimony, which spanned two days, comes in the racketeering, conspiracy and second degree murder trial of Chin, 49. He was one of 14 charged following a two-year probe of the 2012 fungal meningitis outbreak, which took the lives of 76 patients in 20 states. Co-defendant Barry Cadden already is serving a nine-year prison sentence following his March conviction on racketeering, conspiracy and mail fraud charges.
It was Cadden, Robinson testified, who sent the false report to the Massachusetts board on the results of environmental testing at NECC's facilities.
Under cross examination Sheketoff zeroed in on Robinson's earlier testimony that Chin was present when Cadden said that there was a test that the company should have been performing all along but hadn't"
When Robinson said Chin was "probably there," Sheketoff asked what probably means.
"I don't know if he was there or not," she responded.
He also questioned her about the fact that she was testifying under a grant of immunity and that she had a lawyer representing her when she was first questioned by federal prosecutors.
Robinson later stated that the lawyer was provided by NECC and Cadden.
As she did at Cadden's trial, Robinson wept while testifying that she feared that she might have caused the outbreak because she had inadvertently touched a piece of equipment in the clean room where sterile drugs were prepared.
"Why didn't you just clean it? Why didn't you tell anyone?" he asked.
Sheketoff also questioned why Cadden would have ever hired her for the quality control position when she had no background or training for the job.
"He thought that I could do it," she responded.
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NECC Official Told F-Off on Tests

By Walter F. Roche Jr.

BOSTON- The woman who was the sole quality control official at a now defunct drug company said she was told to F-off when she raised questions about the failure to conduct periodic tests on the competency of employees compounding sterile drugs intended for human injection.
Annette Robinson, testifying today at the racketeering and second degree murder trial of Glenn Chin, said it was Chin who sent her an e-mail with that message not once but twice in the weeks and months leading up to a deadly fungal meningitis outbreak caused by drugs produced at the New England Compounding Center.
She said she had emailed Chin, NECC's supervising pharmacist, expressing concerns that the staffers had not even read the mandated procedures for conducting the tests known as media fills.
Another email entered into the record by federal prosecutors was a message Chin sent to an official of a sterilizing device manufacturer showing that he was unsure of how long drugs had to be placed in an autoclave to assure sterility.
The email, sent from Chin's personal computer, was dated Oct. 12, 2012, over a week after the outbreak had become public and even as victim deaths were mounting. Prosecutors have charged that Chin failed to place steroid drugs in an autoclave long enough to kill any contaminants.
Robinson was also a witness against NECC's president and part owner, Barry J. Cadden, who is now serving a nine-year sentence following conviction on racketeering, conspiracy and mail fraud charges. He was acquitted on the 25 second degree murder charges that Chin still faces.
Chin, Cadden and 12 others were indicted in 2014 following a two year federal probe of the deadly fungal meningitis outbreak caused by fungus loaded steroids shipped from NECC to health facilities across the country. The outbreak sickened 778 patients, killing 76 of them.
Robinson, who said she had no formal training or previous experience in environmental monitoring, said she was given the quality control job when another employee left. She said her predecessor described the duties including conducting environmental monitoring in NECC's clean rooms, sending products out for testing and making sure staffers read the Standard Operating Procedures for compounding various drugs.
She said that when her environmental tests showed evidence of fungus or bacteria, nothing was done about it. One hot spot, she said, was in the area where methylprednisolone acetate was being prepared. That drug, federal regulators have concluded, caused the outbreak
Robinson said she also learned that employees were apparently not performing daily and monthly cleaning assignments. In fact she said she found out workers waited till the end of the month and affixed their initials to a cleaning log sheet.
She said she did have a conversation  with Chin because the forms were not being filled out on a daily basis.
"They weren't being done," she said.
She said she saw insects in the clean rooms and other locations in the Framingham, Mass. facility. She also said hair was frequently found in the same two rooms.
When Cadden raised concerns about the hair droppings, Chin replied in an email, "Yes there are a lot of hairy zoo animals in the room."
Robinson said that she only sent out two samples of drug batches for testing at an outside laboratory though she later learned that more samples were required for a valid result. She said that when she raised the issue with Chin, he told her her he didn't want to waste the vials.
She said some drugs were also sent out before sterility test results were received and in some cases the tests were never performed.
As for her relationship with Chin, Robinson said, "Sometimes he was nice" but he also could be hurtful. The hurtful "happened more and more" as NECC raced to an October 2012 shutdown, she said.
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Judge Pleased With Pace of Chin Trial

By Walter F. Roche Jr.

BOSTON - The federal judge presiding over the racketeering and second degree murder trial of the former supervising pharmacist at a company blamed for a deadly meningitis outbreak said Tuesday that he was pleased with the pace of the trial and it might end sooner than he had predicted.
U.S. District Judge Richard G. Stearns told jurors just before he dismissed them for the day that he was pleased with the way the trial was proceeding.
He praised lawyers for moving the case along and told jurors that his original estimate - that the trial would last six to seven weeks - might be revised.
Under his original prediction the trial could go into early November but a revised estimate could bring the case to an end late this month.
Stearns comments to the 12 jurors and three alternates followed by a day comments he made to the attorneys on the case after the jurors had gone home. On Monday he praised the attorneys, particularly prosecutors, for the way they have been presenting the case.
In the earlier trial of co-defendant Barry J. Cadden, Stearns, during a bench conference was critical of the way the case was being presented. He told the attorneys both he and jurors were frustrated by the repetitious presentation, according to a transcript released after the 10 week trial had ended.
Prior to opening arguments in the Chin case, Stearns imposed time limits on both the prosecution and defense teams.
Cadden and Chin were among 14 indicted in late 2014 following a two year federal probe of the 2012 fungal meningitis outbreak. Cadden was given a nine-year prison sentence following his conviction of racketeering and mail fraud charges.
Cadden was the president and part owner of the New England Compounding Center, while Chin was a supervising pharmacist. NECC shipped thousands of vials of contaminated drugs to health facilities across the country sickening 778 patients, including 76 who died.
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NC Witness Details Mother's Outbreak Death

 

By Walter F. Roche Jr.

BOSTON-The daughter of an outbreak victim whose death first alerted health officials to the fact that a growing public health tragedy was not limited to Tennessee, says her mother hoped her death would help others to survive.
 Anna Allred testified for the prosecution in the racketeering and 2nd degree murder trial of Glenn Chin, who was a supervising pharmacist at the company blamed for the outbreak.
Alfred's mother, Elwina Shaw, was the first outbreak victim to be stricken who had not been injected with a fungus laden steroid  at a Nashville clinic. Until her death in October of 2012, all the victims had been treated at the Saint Thomas Outpatient Neurosurgical Center.
Allred said her mother knew she would not survive but agreed to forego any treatment with pain or other medications which might make it more difficult for health professionals to figure out exactly what was sickening and killing a growing number of victims.
She said her mother became the 11th outbreak victim to die. That total would eventually climb to 76. They were among 778 patients sickened after being injected with methylprednisolone acetate from the now defunct New England Compounding Center.
"She insisted  they do a spinal tap," Allred said, adding that her mother "became sick almost immediately" after getting the third in a series of injections at a High Point, N.C. pain clinic.
While the third shot made her sick, the first two provided no relief, Allred said.
She said the spinal tap showed a "very milky" spinal fluid, an indication of a severe infection.
One of her mother's last requests, Allred said,  was that an autopsy be performed in hopes that the results would help the other victims.
In other testimony Tuesday, a 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, which "likes blood vessels," attacked them, 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 Donna Kruzich, Karina Baxter and Lyn LaPerriere. Chin has been charged with second degree murder in theirs and 22 other outbreak deaths.
Also testifying was a former NECC clean room worker, Derek Carvalho, who said that one of his fellow workers was acting as a registered pharmacy technician even though his registration had been revoked. He said the technician used the name and password of then NECC President Barry Cadden to sign into the company computer system.
Cadden is serving a nine year prison sentence following his conviction on racketeering and mail fraud charges.
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Cadden Email Warned: "People Can Die"

By Walter F. Roche Jr.

BOSTON -Just months before a deadly outbreak swept across the country, the head of a drug compounding firm warned his supervising pharmacist that practices at their company were "a disaster waiting to happen. People can die."
The 2012 email from Barry J. Cadden to Glenn A. Chin was introduced into evidence today as Chin's federal trial on racketeering and second degree murder charges entered its third week.
U.S. Department of Defense Special Agent Sara Albert testified that the June 21 email along with more than a dozen others had been recovered from the records of the New England Compounding Center, where Cadden served as president. Some were also recovered from Chin's personal email.
She testified that other emails covered such topics as shipping drugs before testing, relabeling drugs to make it appear they had been tested, using expired ingredients and and shipping drugs that had never been tested at all.
Both Cadden and Chin were indicted along with a dozen others following a two year probe of the fungal meningitis outbreak which sickened 778 patients in more than 20 states. Seventy six of them died.
Cadden whose 10-week trial on similar racketeering and fraud charges ended in late March, already is serving a nine year prison sentence. He was acquitted on the second degree murder charges.
Albert also testified about a Chin resume retrieved during the investigation in which he claimed to be a supervising pharmacist at NECC since at least 2009. Chin's lawyers had challenged the assertion that he held that title.
In one email exchange Albert read to the jury, Chin informed Cadden that it was too late to give an employee another chance because he already had fired him.
 "Too late. I just canned his ass," Chin wrote.
In a July 25, 2012 email, Cadden stated that there were tests that "we are not currently doing, but should be doing."
In the June 21 email and others Cadden expressed concerns about practices in NECC's two clean rooms where sterile injectable drugs were prepared under Chin's supervision.
In a 2011 email, which also was introduced in Cadden's trial, Cadden warned, "We can't get caught with our pants around our ankles...Ever."
"We can't do what you are currently doing any more. No exceptions," Cadden wrote in another email to Chin.
In other testimony a Michigan pain doctor described how the outbreak unfolded at the clinics where he had administered injections of NECC's methylprednisolone acetate into the spines and joints of patients.
 Dr. Edward Washabaugh of Michigan Pain Specialists described how one victim was stricken just after arriving in London and had to be sent back home. By the time she arrived she had suffered a devastating stroke Washabaugh said.
Even worse were the side effects of powerful antifungal medications victims were forced to take, he said. He said the overall impact caused patients to die from heart attacks and other seemingly unrelated ailments.
He said 19 of the clinics patiens died. Five of them were his.
Anita Baxter, the daughter of a Michigan victim, said her mother suffered a massive stroke and doctors said she was clinically dead.
"It was horrible" she said recalling the scene in her mother's last hours.
Her mother had told her, "I don't want to be a vegetable," so she agreed to end life support. She said her mother had also directed that her body be donated for medical research and, as a result, the cause of her death was eventually determined.
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