Friday, October 20, 2017

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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Thursday, October 19, 2017

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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Wednesday, October 18, 2017

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.
Thetekoff  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."

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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




Tuesday, October 17, 2017

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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Monday, October 16, 2017

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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Thursday, October 12, 2017

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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