Tuesday, February 28, 2017

Expert: NECC Failed to Meet Testing, Sterility Standards

By Walter F. Roche Jr.

BOSTON, Mass. A pharmaceutical expert witness says the New England Compounding Center failed repeatedly in multiple categories to meet standards for the production of sterile drugs, thus putting patients at grave risk.
Eric S. Kastango, a pharmacist who was hired by federal prosecutors to assist in the investigation of the 2012 fungal meningitis outbreak, said, "The testing was not being done. Every time a lot was done, each and everyone should have been tested."
He said that when drugs that are not sterile are injected into the body they can cause "devastating harm and death can occur."
Kastango was one of two new witnesses to testify today in the racketeering and second degree murder trial of Barry J. Cadden, the one time president and part owner of the now defunct NECC.
The outbreak sickened 778 patients. Seventy eight died.
The 15 jurors also heard from the head of the California drug company that sold NECC a chemical used in a cancer treatment drug. He said the chemical purchased by NECC in 2005 expired in 2007 even though NECC used it and shipped it to healthcare providers in 2012.
Thomas N. Tyner, vice president of Spectrum Chemical, said his company had never authorized an extension in the expiration date for methotrexate, the chemical purchased by NECC.
He said there was only one option in 2012, "Throw it out."
Kastango, who was on the witness stand for most of the session, said he was hired by prosecutors at a rate of $225 an hour and billed for 100 hours in his efforts to investigate NECC and the outbreak. He said he was being paid $350 an hour for his court testimony.
Under questioning by Assistant U.S. Attorney George Varghese, Kastango said he had visited NECC's Framingham heaquarters, examined company records, interviewed NECC employees and reviewed transcripts of the NECC grand jury.
From everything from autoclaving to sterility testing to maintaining sanitary conditions to temperature and humidity control, Kastango said NECC failed to meet the industry standards for the compounding of sterile drugs.
"They did not use validated procedures," he said.
On autoclaving Kastango said the industry standard set by the nonprofit U.S. Pharmacopeia called for
placing the drug in the autoclave for 20 to 60 minutes at 121 degrees.
But NECC was only auto-claving for 15 minutes or as low as 12 minutes, and that included no so-called ramp up time, the five minutes needed for the autoclave to reach the desired temperature.
"There was no evidence they did any testing to make sure it was properly auto-claved," he said, adding that the company also failed to use bio-indicators, another testing method to ensure sterilization.
He was also critical of NECC's practice of auto-claving drugs, like the spinal steroid blamed for the outbreak, in bulk. He said NECC stored the bulk material in beakers, leaving the opportunity for later contamination.
Kastango said NECC's sterility testing was not done consistently or correctly and when they did send out drugs for outside testing, they sent an insufficient amount. Instead of the single vial sent to an Oklahoma firm, NECC should have sent four or 20 depending on the size of the lot.
As for the use of outdated ingredients by NECC, Kastango quipped, "When in doubt, throw it out."
Varghese showed jurors and Kastango an email Cadden sent to an NECC employee regarding a testing procedure.
"What you are seeing is what we are not currently doing but should be doing," Cadden wrote. "We are not covering these things all the time in the current testing method."
Asked to comment on the email, Kastango said, "Cadden knew they weren't doing the testing correctly."
Kastango said NECC failed to comply with a number of other elements in the industry standard including a written procedure for notifying physicians and patients in the event an adverse test result came back on a drug already shipped.
He said they were using alcohol to wipe down the clean room even though it was not effective for combating fungus.
He said NECC in some categories was actually doing more testing than was recommended in industry standards, but when tests showed action levels had been exceeded, "They basically ignored that for weeks on end."
Under cross examination by Cadden's attorney Bruce Singal, showed materials from a training session Kastango hmself had conducted that included a recommendation to autoclave drugs from only 12 to 30 minutes.
Showing more of those materials, Singal asked if co-defendant Glenn Chin and not Barry Cadden, was responsible for determining clean room standards such as the length of time for auto-claving sterile drugs. Cross examination continues Wednesday.

Monday, February 27, 2017

Details Disclosed on 20 Fatal Outbreak Victims

By Walter F. Roche Jr.

BOSTON, Mass. - Case by case a health official today went through the names, causes of death and and other details of 20 of the patients from seven states who died in the 2012 fungal meningitis outbreak.
 Ann Burgess, who holds a Ph.D. in nursing, cited the deaths of victims from Michigan, Tennesseee, Indiana, Maryland, Virginia, North Carolina and Florida in testimony in U.S. District Court. Burgess was a prosecution witness in the case of Barry J. Cadden.
Cadden has been on trial for over a month on charges of racketeering and 25 counts of second degree murder, along with mail fraud.
In nearly all of the cases, Burgess cited fungal meningitis as the direct or secondary cause of the deaths.
The death certificate for Diana Reed, 56, of Nashville listed "fungal meningitis" as the cause. She had three injections in August and September of 2012, Burgess testified. She died on Oct. 3.
The death certificate for Thomas Rybinski of Smyrna listed "complications of aspergillus meningitis" as the cause.
As each case was detailed, jurors were shown a photo of that victim.
Pauline Burema, an Indiana victim, was 89 when she died  in 2012. "Injected with tainted steroid," records of her case state.
Godwin Mitchell, 88, died March 18, 2013 after being injected with "a tainted steroid" at a Virginia clinic, Burgess said.
Prosecutors have presented other evidence on the deaths in the indictment not included in Burgess testimony.
The jury also heard testimony from an investigator from the U.S. Food and Drug Administration about the shipment of three lots of fungus laden methylprednisolone from Cadden's company, the New England Compounding Center, to health facilities including the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn.
Joseph Ridgley said the Nashville clinic got four shipments between June and early September of 2012. The cost of the orders, all for 500 vials, ranged from $3,270 to $3,430 vials.
Similar details were provided for shipments to Michigan Pain Specialists and an Indiana clinic, two other sites where victims were injected.
Under questioning by prosecutors, Ridgley matched a list  NECC drugs with some of the charges that have been leveled against Cadden. The drugs included some that did not have the required potency and others in which the ingredients had gone past their expiration date.
He also testified about drugs compounded by co-defendant Scott Connolly who was not registered as a pharmacy technician, as required under Massachuetts law.
The FDA investgator said Connolly compounded a drug called cardioplegia which was shipped to a Las Vegas hospital before test results came back. He said Connolly signed company records using Cadden's initials.
Ridgley also testified about a long list of other NECC drugs that did not meet specifications but are not included in the indictment.
Asked if any of those drugs caused any harm, Ridgely responded "I'm not aware of any."
FBI Agent Philip Sliney presented a chart showing NECC drugs that did not contain the required ingredients including a drug used in eye surgery that was shipped to the Massachusetts Eye and Ear Infirmary.
Another drug that didn't meet specifcations was shipped to a Tavares, Fl clinic, he said. Both of those cases were included in the indictment, he testified.
Under cross examination, Bruce Singal, Cadden's lawyer questioned how Cadden could be charged with a felony because an NECC clean room worker didn't put enough ingredients in a drug. He also noted that the long list Sliney presented included multiple entries for the same drug, an antibiotic.
His cross examination will continue Tuesday.
Contact: wfrochejr999@gmail.com

Named Victims and Dates of Death

Michigan: Karina Baxter (9/23/12), Paula Brent (11/17/12), Gayle Gipson (10/26/12), Donna Kruzich (10/8/12), Lynn Lapierre  10/17/12), Mary Pletti (8/23/12), Sally Roe (10/18/12), Emma Todd

Tennessee: Marie Hester (11/1/12), Eddie Lovelace (9/17/12), Donald McDavid (11/4/12), Diana Reed (10/3/12) , Thomas Rybinski (9/29/12), Carol Wetton (4/16/13), Earline Williams (10/15/12)

Indiana: Pauline Burema (10/10/12), Kathy Dillon (11/5/12), Alice Machowiak (12/10/12)

Maryland: Bahman Kashi (1/28/13), Brenda Rozek (9/16/12), Edna Young (12/31/12)

Virginia: Kathy Sinclair (1/19/13), Douglas Wingate (9/18/12)

Florida: Godwin Mitchell (3/18/13)

North Carolina: Elwina Shaw (10/19/12)

Friday, February 24, 2017

More NECC Drugs Found Contaminated

By Walter F. Roche Jr.

BOSTON, Mass. - A parade of microbiologists from the U.S. Food and Drug Administration detailed today how they found contaminants in a variety of drugs produced by the now defunct New England Compounding Center.
Testifying in U.S. District Court the scientists from New York, Denver and San Francisco described in brief detail how they tested the drugs, some collected at NECC's Framingham offices along with others from Tennessee, Florida and West Virginia.
The drugs found contaminated included the spinal steroid blamed for dozens of death, but also other drugs not previously identified such as triamcinolone, betamethasone and cardioplegia.
At the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn. 78 vials of methylprednisolone acetate were collected.
Haydee Romero from FDA's New York office, said 28 of the vials contained yeast, while 20 had two different kinds of mold.
NECC vials found at the Specialty Surgery Center in Crossville, Tenn. also were contaminated.
Romero also tested 25 vials that were collected directly at NECC. All 25 were contaminated with yeast or mold.
The testimony came in the case of NECC's one time president and part owner, Barry J. Cadden. He has entered not guilty pleas to charges of racketeering and second degree murder. The murder charges stem from the death of 25 of some 78 patients who died after being injected with fungus ridden steroids from NECC.
In other testimony Stacey Degamo, an FDA investigator, testified that while they found several varieties of fungus when they inspected NECC in October of 2012, they did not find either of the two specific fungi, aspergillus fumigatus and exserohilum rostratum found in victims of the 2012 outbreak.
Other microbiologists to testify under questioning from Assistant John Claud, a U.S. Justice Department attorney, included Patricia Stanke from FDA's Denver office. She said one of 10 vials of betamethasone she tested had a bluish mold, which turned dark grey with aging.
Henry Lau from FDA's San Francisco office said he also tested betamethasone produced by NECC. Five vials were found to have bacteria, which he said could be "very harmful."
He also tested triaminclone and three vials showed the presence of bacteria, bacillus lentus.
A third drug he said he tested was cardioplegea, a drug used to stop the heart from beating during surgery. He said three vials contained bacteria.
On cross examination Lau said that he became aware that some of the drugs collected from NECC went missing, but he said he didn't know whether they were ever found.
The vials that turned out to be tainted came from health facilities in Florida, West Virginia and Kentucky

Thursday, February 23, 2017

FDA: NECC Steroids Not Properly Sterilized

By Walter F. Roche Jr.

BOSTON, Mass.-An investigator from the U.S Food and Drug Administration testified today that the fungus ridden steroids shipped from a now defunct compounding firm had been sterilized for less than half the recommended time.
Testifying in U.S. District Court Stacey Degarmo said that records she reviewed at the New England Compounding Center in 2012 showed the steroids were placed in an autoclave for only 15 minutes. She said with the volume of drugs being treated the manual for the autoclave called for 31 minutes in autoclave.
She said NECC didn't even follow its own instructions, which called for 20 minutes inside the autoclave at a temperature of 121 degrees.
Degarmo, the lead FDA investigator assigned to the 2012 fungal meningitis outbreak was testifying for the prosecution in the second degree murder trial of Barry J. Cadden. He was one of 14 people connected to NECC who were charged in a 2014 indictment.
The indictment followed a two year probe of the 2012 fungal meningitis outbreak, which sickened 778 patients, killing 78 of them.
The FDA investigator said she asked NECC for validation that a 15 minute treatment in the autoclave was adequate but she never got a response. She said her review of NECC records showed that the practice of sterilizing the steroid, methylprednisolone acetate, for only 15 minutes dated back to 2009.
Another problem area, she said, was the fact that NECC was testing its steroids in bulk, not the individual vials later shipped to health care providers. She said the records showed NECC had shipped out vials before the sterility tests came back.
Degarmo said that one of the first things she noticed when she got to NECC was a big pile of deteriorating mattresses piled up near the building. She said heavy equipment was being operated in the area creating a cloud of dust and particulates.
"All this was flying around," she said.
She said that set of  "red flags" because she had learned that one of the seven outbreak victims in Nashville, Tenn. had been diagnosed with aspergillus fumagatus, which grows in the soil.
Degarmo said that she also performed environmental sampling tests when she arrived at NECC's Framingham, Mass. facility on Oct. 1, 2012.
She said 11 of 41 samples tested positive for mold, bacteria or both. Yeast was also detected in key areas including the air conditioning and heating unit atop the brick structure.
The 11 positive findings for mold or bacteria included specimens from  a pass through from the clean room to the warehouse or packing area, inside the glove of a glove box used to prepare sterile drugs, on a mat at the entrance to the clean room and around a boiler sitting in a pool of leaking water.
The FDA investigator said she also learned that when NECC prepared lots of the steroid only one sample was sent out to an independent laboratory to test for sterility. She called that "inadequate."
Under questioning by Assistant U.S. Attorney George Varghese, Degarmo said that when they examined vials of the steroid that had not been shipped out before a quarantine was imposed some had "clearly visible black mold."
She said 12 of 45 vials examined had visible mold.
At that point in time, she testified Cadden "still didn't believe there was a problem with the NECC product."
She also said she got conflicting information when she asked Cadden if NECC was compounding the drugs from sterile or non-sterile components.
Under cross examination by Bruce Singal, Cadden's lead attorney, Degarmo was questioned repeatedly about why the agency waited several days after learning about the outbreak before sending a team to NECC.
Citing internal FDA emails and documents, Singal asked why the FDA was worried about whether it had the legal authority to join an investigation already begun by the Massachusetts Board of Pharmacy.
Degarmo said she was aware that the FDA's authority over compounding pharmacies had been challenged in the past, but it was not a major factor. She said the agency clearly had the authority to investigate any cases involving adulterated drugs.
She said her team accompanied the team from the Mass. Pharmacy Board on the initial inspection because that agency had clearer authority to order NECC to produce records in the event the company refused to do so.
Singal, however, noted that FDA still hadn't acted even after it learned that seven patients in Nashville, Tenn. had been stricken with an additional case reported in North Carolina.

Wednesday, February 22, 2017

Judge Seeks Limits on Next NECC Trial

By Walter F. Roche Jr.

With the current trial winding up its eighth week with no end in sight, the federal judge presiding over the criminal trials stemming from the 2012 fungal meningitis outbreak is moving to limit the length of the next scheduled case.
In a six-page order issued this week U.S. District Judge Richard G. Stearns has instructed lawyers for the defendant, Glenn Chin, and federal prosecutors to submit proposed time limits for the jury trial.
The action comes as the case against Barry J. Cadden is approaching a third month and the prosecution has yet to wrap up its side of the case.
The charges against Chin mirror those against Cadden, racketeering and 25 counts of second degree murder among other charges.
They were among 14 people connected to the New England Compounding Center indicted following a lengthy probe of the 2012 fungal meningitis outbreak. Two of the 14 have pleaded guilty to lesser charges. Two others have had all charges dismissed.
Cadden was president and part owner of NECC. Chin was a supervising pharmacist.
The remaining defendants are slated to go on trial after the Chin case is completed.
In the order issued by Stearns he cited the advantages of setting such limits and noted there are precedents for such a process.
"It enables the court to efficiently manage its docket" and "improves the quality of jury comprehension," Stearns wrote.
Stearns wrote that he had additional concerns about "the phenomenon of mega-trials, that is trials, the duration of which are measured in months not days."
He also expressed concern of the effect on jurors in trials that "consume an inordinate amount of the court's time and focus."
The outbreak, caused by fungus riddled drugs shipped by NECC to health care providers across the country, sickened 778 people and killed 78 of them.

FDA Raced to Find Outbreak Cause

By Walter F. Roche Jr.

A microbiologist for the U.S. Food and Drug Administration testified that he had never seen sterile drugs as contaminated as the ones he rushed to analyze in October of 2012 from the New England Compounding Center.
"I've never seen a sterile product so contaminated," Philip F. Istafanos told jurors.
He said samples of NECC drugs were shuttled from Massachusetts to FDA's National Research Laboratory in Jamaica, New York on Oct. 3 where he and others worked into the night to begin a detailed analysis.
Because of the urgency, the FDA official said staff from New York met counterparts from Massachusetts at the halfway point to collect the samples.
Istafanos was testifying for the prosecution in the trial of Barry J. Cadden, the one time president and part owner of NECC. He has been charged with racketeering and 25 counts of second degree murder. The outbreak sickened some 778 patients across the country, killing 78 of them.
Istefanos said nearly 100 vials of drugs from NECC were brought to his laboratory followed by more than two dozen swabs taken from key locations in NECC's Framingham, Mass. headquarters.
The samples arrived on Oct. 3, just as a formal announcement of the fungal meningitis outbreak was becoming public.
He said a first look at the vials of methylprednisolone acetate showed nine had visible black spots and he removed the stringy mass from one vial to examine it.
"I took out the black material and put it under a microscope," he said, adding that he had never seen anything like what he found in the vials.
He described black threadlike material bundling together, some of which clung to the sides and bottom of vials.
He said half of the samples were sent to the U.S. Centers for Disease Control and Prevention and analysis of the remaining vials began with testing of the dust cover to exclude it as the source of the fungus.
He said they then began testing the actual drugs using three different media or growth agents, instead of the usual two.
Though the full process normally takes 14 days, Istafanos said,"It was urgent. We needed a faster result."
He said they began examining the samples and began to see results in four or five days when a blackish mold became visible. In addition to the mold, analysis showed the presence of yeast, which Istafanos described as a "very unlikely" combination.
"It was contaminated, very contaminated, very bad," he said.
He said 49 of the 50 samples had yeast and mold and one had only yeast.
He said as a control they replicated the testing process with substances known to be sterile. Those produced no growth.
Describing blackish and white-ish mold found in the NECC drugs, Istafanos said, "This is a sterile drug. It should have nothing in it."
He said 11 of the environmental sample swabs also tested positive.
Earlier in the day Roger Edwards, a forensic accountant hired by the FDA, testified that Cadden and his wife collected $19.5 million in salary and profits from NECC between 1998 and the company closing in October of 2012.
Each owned 17.5 percent of the company. Barry Cadden collected $10.9 million in salary and profits while Lisa Cadden collected over $8.6 million.
A third witness, FDA investigator Kristina Donohue, testified about inspections of NECC she conducted in 2002 and 2003. She said the agency had received complaints that even though it was only licensed as a pharmacy, NECC was acting like a drug manufacturer, which would make it subject to stricter FDA regulation.
On her first visit in 2002 she said she observed a beaker of betamethasone covered with tin foil. Calling it "problematic," Donohue said the situation raised concerns about sterility. She said they also noted NECC was not doing end product testing and there were concerns about expiration dates of some products.
She said that when she returned in 2003, the physical size of the NECC operation had doubled and staff had jumped from eight to 12.
She said Cadden told her NECC was issuing drugs only with patient-specific prescriptions, as required by law. She said staff from the Massachusetts Board of Pharmacy accompanied her on the NECC visits because that board licensed the company.
At that point, Donohue said, the FDA considered NECC to be acting as a pharmacy, subject to state regulation and not the stricter FDA standard for drug manufacturers.
Contact: wfrochejr999@gmail.com

Tuesday, February 21, 2017

Accountant Cites $32.4 Million NECC Revenue

By Walter F. Roche Jr.

A forensic auditor testified today that the New England Compounding Center's revenues soared in its final ten months of operation hitting $32.4 million and pushing the company's total sales since its inception in 1998 to $153 million.
Roger Edwards, a forensic accountant, was called as a prosecution witness in the trial of NECC's one time president and part owner Barry J. Cadden. Cadden has been charged with racketeering and 25 counts of second degree murder following a grand jury probe of the deadly 2012 fungal meningitis outbreak.
In other testimony Tuesday, Cadden's attorney Michelle Peirce continued to sharply question a key prosecution witness, NECC's quality control manager, Annette Robinson.
Robinson acknowledged in a later exchange with prosecutors that she testified before the grand jury investigating NECC under a grant of immunity and she had legal counsel at the time. Robinson was not charged in the 2014 indictment.
Edwards testified that he had examined the books of NECC and at first the now defunct company had the appearance of a small family business. That changed in 2007 when there was a dramatic increase  in revenues.
He said there was another "significant" jump in 2012 when revenues hit  a record $32.4 million, even though the company was only in business for a little over nine months. NECC shutdown in early October after the outbreak became public.
Edwards also will be testifying later this week on a report he compiled showing Barry Cadden and his wife, Lisa, collected $18 million in profits from NECC from the 1998 startup till the 2012 closure. The accountant's report lists payments of $8.5 million to Lisa Cadden and $9.5 million to Barry Cadden between 1998 and October of 2012.
The cross examination of Robinson took most of the Tuesday session as Peirce repeatedly questioned apparent differences between the witness's statements in court last week and testimony she gave before the grand jury and in interviews with federal investigators.
Peirce focused on Robinson's statement about the fact that bioindicators were not being used when drugs were being sterilized in an autoclave. Robinson testified last week that Cadden told her in 2012 that they should have been using bioindcators all along.
Peirce cited Robinson's grand jury testimony in which she said Cadden "may have" made that statement.
Peirce also asked Robinson about how many times she had been questioned by federal officials and whether she was discussing her upcoming testimony with prosecutors during a break in the day's court session.
U.S. District Judge Richard G. Stearns cut off that line of questioning.
"I'm sure nothing untoward happened," he said.
Robinson testified earlier that when she was about to be questioned by officials from the U.S. Food and Drug Administration in 2012, Gregory Conigliaro, an NECC part owner, told her to just tell the truth.
Asked if Cadden hadn't said the same thing, Robinson agreed that may have happened.
Peirce also challenged Robinson's statement that she notified Cadden whenever test results from an independent testing firm showed any NECC drugs were out of specifications or when she discovered mold in the clean rooms.
"I would go in and say, 'Barry there is a lot of mold,'"Robinson responded. "I went to him when I thought there was a problem."
Several of Peirce's questions related to Robinson's admission that she thought she might have caused the outbreak because she mishandled a glove box while collecting environmental monitoring samples.
"Did you clean it," Peirce asked.
"No," Robinson responded.
She also acknowledged she did not report the incident at the time it occurred.

Friday, February 17, 2017

Former NECC Official Thought She Caused Outbreak

By Walter F. Roche Jr.

The quality control manager at the New England Compounding Center said she had to leave the office in 2012 when she broke down because she mistakenly thought she was the cause of a deepening fungal meningitis outbreak with a mounting death toll.
"Oh my God people are dying," Annette Robinson recalled thinking. "I actually felt I had caused this."
Robinson was testifying Friday for the second day in the trial of Barry Cadden, the former president and part owner of now defunct NECC. Cadden, a Wrentham, Mass. resident, has been charged with racketeering and 25 counts of second degree murder,
Robinson, who also testified that Cadden ordered her to falsify multiple NECC drug mixing records, said she thought she might have caused the outbreak when she did some surface testing on NECC equipment. That equipment, a glove box, was used in making the steroid ultimately blamed for the 2012 fungal meningitis outbreak which took the lives of 78 patients across the country.
Robinson said she had been called into work by Cadden to help with the recall of the thousands of vials methylprednisolone acetate, the cause of the outbreak.
"I couldn't do it anymore," Robinson said and then burst into tears. "I went home. Everyone was looking at me."
Robinson, who a day earlier testified that Cadden did nothing when she reported that mold and bacteria had turned up in a clean room used for making sterile drugs, underwent extensive cross examination by Cadden attorney Michelle Peirce.
Peirce repeatedly challenged Robinson's Thursday testimony on several key points including the assertion that Cadden did nothing when informed of adverse test results both from within NECC and an outside testing laboratory.
Showing Robinson a report on one drug that was found out of specification, Peirce said, "You didn't remember seeing it, did you?"
Flustered Robinson responded,"I don't remember anything, You're answering my questions for me. Barry does know about them," she said, adding that she always sent the adverse test results to Cadden.
In earlier questioning by Assistant U.S. Attorney Amanda Strachan, Robinson recounted how Cadden called her into his office and told her to alter on records of media fills, chemicals mixed for microbiological testing.
She said he instructed her to cross out the name of the employee who actually performed the task and put his initials in its place.
"It took a few hours," she said.
Some of the records altered dated back to 2008.
She said the task was assigned at the same time Cadden wanted to eliminate any"paper trail" showing that an unlicensed technician, Scott Connolly, had been working in the NECC clean room.
"My heart sank," Robinson said. "He asked me to do something that was wrong, but I did it because he was my boss."
Connolly is a codefendant in the case and is scheduled for trial in April.
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Thursday, February 16, 2017

Caddens NECC Earnings Hit $18 Million

By Walter F. Roche Jr.

The jury hearing the second degree murder trial of Barry J. Cadden will be able to hear a forensic accountant's report showing Cadden and his wife Lisa collected $18.1 million in profits from a now defunct Framingham drug compounding company.
In a brief ruling issued today U.S. District Judge Richard G. Stearns denied a motion by Cadden's attorneys to limit the accountant's presentation to the amount earned by the defendant alone.
Cadden's lawyers had argued that Lisa Cadden's earnings from the company were separate and use of the combined figure would be prejudicial.
Prosecutors countered by pointing out both Lisa and Barry's share of NECC profits went into the same bank account.
Cadden has been charged with racketeering and 25 counts of second degree murder as a result of a two year probe of the 2012 fungal meningitis outbreak which was caused by fungus tainted drugs shipped from NECC.
The accountant's report lists payments of $8.5 million to Lisa Cadden and $9.5 million to Barry Cadden between 1998 and October of 2012 when the company shut down.
Stearns did rule earlier that prosecutors could not make references to Barry Cadden's overall wealth, a point noted by Cadden's lawyers in the recent motion seeking to strike references to Lisa Cadden's earnings.
The outbreak sickened 778 patients and 76 of them died. Cadden, however, has only been charged in 25 of those deaths and the judge has barred the use of the higher figures.
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NECC's Quality Control Officer Says Test Results Ignored

By Walter F. Roche Jr.

In a soft voice and answering dozens of questions with one word: no, the woman who headed a drug compounding company's quality control program delivered devastating testimony in the second degree murder trial of the president of that now defunct company.
Annette Robinson, who said she had no formal quality control training, told the jury hearing the case against Barry J. Cadden that she took the job in 2007 and remained there until the New England Compounding Center was shut down in the wake of the deadly fungal meningitis outbreak it caused.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Robinson said, "No," when asked if NECC followed a series of Standing Operating Procedures that were supposed to govern drug compounding at the Framingham, Mass. facility.
And though SOPs were supposed to be reviewed and revised annually, Robinson said she couldn't get Cadden to work on the SOPs on sterile compounding he was assigned.
"He never did them," Robinson said.
Robinson's former boss is on trial on charges of racketeering and second degree murder. He was indicted following a two year investigation of a deadly 2012 fungal meningitis outbreak caused by steroids, methylprednisolone acetate, shipped from NECC to 22 states across the country.
Robinson said that when she pushed Cadden's codefendant, Glenn Chin for his SOP reviews his answer was brief.
"F--- the SOPs," she said Chin responded.
On everything from the use of cleaning solutions, to performing daily environmental monitoring checks in clean rooms, Robinson said standards were not followed
She said flies and hair were found in the clean rooms and recurring cracks in the clean room floor where temperatures soared to 100 degrees due to failing air conditioning.
When she told Cadden about the cracks, she said he told her it could wait.
She said the air conditioning was shut down on nights and weekends and she had to be shown how to turn on the system when clean room work was done on weekends.
Asked if the facility's prescribed temperature and humidity limits were observed, she said no.
Robinson said she was assigned to send samples from lots of NECC drugs to an independent testing laboratory. She said only two samples were sent for each lot, no matter its size.
Asked if NECC ever shipped drugs that hadn't been tested or before test results were obtained, she said yes.
And when labels of the sample and the accompanying paperwork didn't match, the sample would be relabeled, she said.
Though she was in charge of quality control, Robinson said No, when asked if she was familiar with the U.S. Pharmacopeia, the standard mandated by state and federal regulators.
She said when environmental monitoring and other tests showed the presence of mold or bacteria little or nothing was done about it.
"Mold is bad," she said when asked if those test results concerned her.
Robinson said that when the results of another air monitoring test on a hood in the clean room kept coming back at a level requiring remedial action, Cadden instructed her to simply change the allowable level by a factor of three.
Strachan also questioned Robinson about a series of laboratory finding that showed NECC products were not sterile after a 14 day incubation period or did not meet specifications.
She said Cadden in some cases would order her to tell the testing laboratory not to do any further testing.
Asked whether negative test results prompted any remedial action, such as increased cleaning, Robinson answered with a string of NOs.
Strachan led Robinson through a series of test results showing the presence of mold or bacteria starting in the first quarter of 2012 all the way through the third quarter. She said she told Cadden but nothing was done.
Mold was found in a shelf where methylprednisolone acetate was stored, Robinson said.
Strachan then showed Robinson Quality Assurance reports that NECC sent to its customers on a quarterly basis. Asked if the information showing 100 per cent compliance was correct, Robinson once again said No.
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Wednesday, February 15, 2017

Investigator Details Unraveling of Deadly Outbreak

By Walter F. Roche Jr.

An investigator for the Massachusetts Pharmacy Board said that when he finally took a close look at the vials of steroids in a Framingham, Mass. drug company he knew something was very wrong.
Samuel Penta testified that he saw filaments and black spots in the containers of methylprednisolone acetate at the New England Compounding Center. He said he didn't know at first what it was but knew it shouldn't be there and certainly not injected into someone's spine.
"What we saw were visible contaminants," Penta said. "We just knew it shouldn't be there."
Penta was called as a prosecution witness in the trial of Barry J. Cadden, the one time NECC president and chief pharmacist. He has been charged with racketeering and 25 counts of second degree murder in the death of 25 patients, including seven from Tennessee.
The deadly 2012 fungal meningitis outbreak federal and state regulators have concluded was caused by fungus riddled spinal steroids produced by NECC. In fact Cadden's lawyers have conceded that NECC products caused the outbreak.
Penta said he first got word of a possible outbreak on Sept. 24 and the next day participated in a conference call with officials of the Tennessee and Massachusetts health departments, the U.S. Centers for Disease Control and Prevention, the U.S. Food and Drug Administration and NECC.
He said the Tennessee cases were the first to signal an impending outbreak, though they later learned there was an earlier case in North Carolina.
But it wasn't until Oct. 3, Penta testified, when the FDA was able to test a vial and found fungus.
Penta said that the Tennessee cases were "a likely cluster" and attention at first centered on three possible sources: the steroid, a dye used in injecting patients and lidocaine, a painkiller.
He said when his boss first contacted NECC, Cadden told him that the steroids had been tested for sterility and "they didn't believe it was their product."
Nonetheless James Coffey, then Penta's boss, ordered NECC to quarantine all products until further notice.
He said when he made a visit to NECC the next day he was hit with "the distinct odor of bleach" as soon as Gregory Conigliaro, NECC's vice president, let him in the door.
"We took a walking tour of the facility," he said adding that he was surprised at the volume of drug products being processed.
"It was massive. It was manufacturing not compounding," Penta said under questioning from Assistant U.S.Attorney George Varghese. "It was well beyond compounding."
"They were cleaning inside the clean room, wiping down with alcohol," he said. Later he was shown a photo of the clean room and said signs of contaminants on a hood used for sterilizing drugs were visible through a window outside the room.
He was shown a picture of a boiler with a pool of water at its base and said it was located within the NECC facility.
Penta said that when they took a walk around the outside of the NECC building they discovered a mattress recycling operation only 100 yards from the drug compounding area. (The mattress recycling business was run by the Conigliaro family)
Penta said that when he did finally get a chance to inspect a vial of the methylprednisolone acetate, "We saw floaters and black spots," he said, adding that powder was gathered at the bottom of the vial and was sticking to the side. "You could see there was some defect in the product."
Under questioning from Michelle Peirce, one of Cadden's lawyers, Penta acknowledged that Cadden and Conigliaro were cooperative and responsive to his requests for data, but said he never did get requested information about drug expiration dates.
He also acknowledged that NECC underwent a successful inspection in 2011 after some renovations were completed.
Responding to a question from Peirce, Penta agreed that research was conducted by regulators to determine if NECC could be forced to provide samples.
"We had to have a plan in case he said no," Penta said.
Penta was also asked if Dr. Marion Kainer, a Tennessee Public Health official, was among the people participating in the Sept. 25 conference call. He said he didn't know.
Kainer, who played a major role in handling the Tennessee outbreak, has been listed as a possible prosecution witness.
Contact: wfrochejr999@gmail.com

Tuesday, February 14, 2017

Cadden Emails Detail Prelude to Outbreak

By Walter F. Roche Jr.

It was only after his company had shipped thousands of fungus contaminated vials of steroids that the head of a Massachusetts drug compounding firm sent out a series of emails to his staff telling them to stop fudging "and clean up all our processes."
 "No more fudging. No more BS. We must clean up all of our processes," Barry Cadden wrote in one email.
The emails were read into the record by a federal agent Tuesday as the second degree murder trial of Barry Cadden entered another week.
Cadden was indicted following a federal grand jury probe of the 2012 fungal meningitis outbreak. The outbreak was caused by drugs shipped from Cadden's company, the now defunct New England Compounding Center. Cadden is charged with racketeering and 25 counts of second degree murder.
U.S. Department of Defense Investigator Sara Albert also read emails in which Cadden approved the use of outdated drugs, relabeling drugs to change their expiration dates and discussed the employment of a pharmacy technician who had lost his license.
In another email he discussed a "fungal bloom" discovered at the company's Framingham, Mass facility. Another discusses a problem with mice getting into a restricted area.
In one email Cadden wrote, "Bottom line is we cannot get caught with our pants down to our ankles."
In another email he wrote,"Just relabel the old stuff."
In a 2012 email he discussed using drugs that had expired in 2007.
In an Aug. 7, 2012 email Cadden wrote that something had to be done about an employee, Scott Connolly, who was working as a pharmacy technician in a clean room even though he had given up his license.
"We need to get Scott out of that room. It can't continue on beyond today," Cadden wrote.
In an email exchange with a staffer, Cadden warned of a need to eliminate a "huge wave" of backlogged orders.
"We need to plan for this. We will need to extend hours," the email states.
On cross examination by Cadden's lawyer, Bruce Singal, Albert read from a series of emails in which Cadden admonished sales staffers for not getting the names of patients who were being treated with NECC drugs.
"All names must be real names. No Micky Mouse or Donald Duck," he wrote in one email.
A second prosecution witness, Samuel Penta, an investigator for the Massachusetts Pharmacy Board testified about two advisory letters sent to NECC due to complaints that Cadden himself was attempting to sell drugs without patient specific prescriptions as required under Massachusetts law. The complaints had come from South Dakota, Wisconsin and Iowa.


Sunday, February 12, 2017

Monday Cadden Session Canceled

 Due to the ongoing storm, Monday's session in the trial of Barry Cadden has been canceled, as were Thursday and Friday sessions.

Wednesday, February 8, 2017

Checks Mailed to 1,313 Outbreak Victims

By Walter F. Roche Jr.

Initial checks from a national trust fund have been mailed to 1,313 victims of the 2012 fungal meningitis outbreak, according to a report filed today in U.S. District Court in Boston, Mass.
The report by Lynne F. Riley, the trustee of the victims' fund, also states that a total of 2,005 claims by victims have been fully or partially approved. A total of 310 claims have been denied.
She said payments issued thus far total $51.9 million.
The national fund, with an estimated value of $130 million to $157 million, was amassed in the bankruptcy case of the New England Compounding Center, the Framingham, Mass. firm blamed for the deadly outbreak. 
Riley reported that an additional 134 checks have been issued to some of the same victims who were treated at certain clinics that have reached separate settlements.
The report was filed as U.S. District Judge Rya W. Zobel held a monthly status conference on the civil litigation stemming from the outbreak which sickened 778 patients, killing 76 of them.
Michael Fencer, who represents Riley in the case, said that 127 appeals have been decided and only one remains pending.
He said that 12 claims have been held up due to a dispute with Tennessee Blue Cross. Another 30 have been delayed pending an agreement with another insurance carrier.
Fredric Ellis, an attorney representing outbreak victims, told Zobel it will be at least another three months before the trustee will be able to send out the second set of checks to victims. The checks currently being issued represent about half of the total each victim is expected to receive.
During the hearing Chris Tardio, attorney for the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn., said his client wants the details of a settlement agreement with the more than 100 patients who sued the facility kept secret.
Gerard Stranch, representing the victims, indicated agreement with the request and Zobel said she would approve the request to seal the record, which includes the amount of the settlement. It has been reported to be in excess of $20 million.
On another issue Stranch and Tardio argued over a motion by the Specialty Surgery Center in Crossville, Tenn. to assess part of the blame for the outbreak on the U.S. Food and Drug Administration and the Massachusetts Board of Pharmacy.
Tardio said that both agencies had notice that NECC was operating outside of the law but they did not step in.
He said both agencies were notified by the Colorado Board of Pharmacy that NECC was selling drugs in that state without complying with the law.
"They dropped the ball," Tardio said of the two government agencies.
Stranch said there was not a single case in any state in which a defendant was able to reduce its liability by shifting the blame to parties not even involved in the case.
Zobel said she would issue a ruling on the matter.
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Tuesday, February 7, 2017

Judge Denies Cadden Motion on Key Phone Call

By Walter F. Roche Jr.

The judge presiding over the second degree murder trial of a former drug compounding executive has swiftly rejected a motion to strike from the record the testimony of a key prosecution witness.
In a one page order issued today U.S. District Judge Richard G. Stearns denied a motion to strike from the record the testimony of an official from an Indiana clinic who told jurors that Barry Cadden called her on  Sept. 21, 2012 to let her know there might be a problem with steroids shipped from his company, the New England Compounding Center.
Wendy Huffman testified that the call was made five days before NECC initiated a voluntary nationwide recall of over 10,000 vials of methylprednisolone acetate.
Stearns said "whether Ms. Huffman is mistaken in her recollection of the day of her September 2012 conversation with the defendant is a matter of (hotly) disputed fact that the jury can decide.
Attorneys for Cadden, who is on trial on racketeering and second degree murder charges, had cited telephone records showing the only call to the Indiana clinic on that date from NECC's area code came from a woman making an appointment for a friend.
Cadden's lawyers said Huffman's testimony was highly prejudicial and could leave jurors with the impression that Cadden was a "cold blooded killer" by letting additional patients get injected with a tainted drugs for another five days.
They charged that prosecutors knew or should have known that Huffman's testimony was false.
Stearns, however, said the defense could present its evidence to the jury so that they could decide.
"While the court recognizes that the evidence is conflicting, it is not prepared to draw an inference of bad faith on the part of the government from an adversarial disagreement over the interpretation of facts or the credibility of witness testimony."
Stearns also rejected the request by Cadden's lawyers that prosecutors be required to report to defense lawyers on their routine meetings with witnesses prior to testimony.
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Key NECC Phone Call Disputed

By Walter F. Roche Jr.

A former drug company executive on trial for second degree murder has charged that a key 2012 phone call to an Indiana pain clinic never happened despite detailed testimony from a prosecution witness.
Lawyers for Barry J. Cadden say their client never made a call to the South Bend  clinic on Sept. 21, 2012 and federal prosecutors knew or should have known that the testimony of a manager at that clinic was false.
Stating that the testimony last week made Cadden look like a "cold blooded killer, Michelle Peirce, one of Cadden's lawyers, asked U.S. District Judge Richard G. Stearns to instruct the jury that the call to Wendy Huffman at the South Bend Clinic never happened.
In the 18-page motion, Peirce said that records subpoenaed for Cadden's defense showed that only one phone call was made from the NECC area code to the clinic on Sept. 21 and that was from a woman setting up an appointment for a girl friend.
Huffman had testified that she got a call from Cadden on Sept. 21 five days before NECC issued a voluntary recall of its spinal steroid, methylprednisolone acetate.
The filing comes as Cadden's trial is in its fourth week. He has been charged with racketeering and 25 counts of second degree murder for his role in the deadly 2012 fungal meningitis outbreak, which killed some 76 patients across the country.
Cadden was part owner and president of the New England Compounding Center, the Framingham, Mass. company that shipped fungus contaminated steroids to health facilities across the country.
Calling the action by prosecutors "inexcusable," Peirce's motion states that the testimony falsely left jurors with the impression that Cadden knew there was a problem with the steroids on Sept. 21, but did nothing to warn its customers until Sept. 26, when a recall was issued. By that time several more victims had been injected with the tainted steroids.
"The government ignored - and deliberately declined to obtain a review- irrefutable evidence (telephone records) - that fully disprove Huffman's memory," the motion states.
The motion does not name the woman who did call the clinic on Sept. 21 from the 508 area code, but said, "she will confirm that neither she nor her former girl friend has any connection to Cadden, NECC or their affiliates."
The motion charges that information about the phone call was provided to the U.S. Attorney the night before Huffman's testimony, but prosecutors went ahead and presented "potentially devastating - and wrong- testimony to the jury."
The motion asks Stearns to hold a separate hearing on the issue.
Contact: wfrochejr999@gmail.com

Monday, February 6, 2017

Judge Rules Out Further Victims' Testimony

 By Walter F. Roche Jr.

In a major setback to prosecutors, the judge presiding over the second degree murder trial of Barry J. Cadden has ruled that no further victims of the 2012 fungal meningitis outbreak will be allowed to testify.
In a five-page ruling U.S. District Judge Richard G. Stearns sitting in Boston, Mass. granted a motion by Cadden's attorneys to block further further testimony by victims or their survivors.
Stating that while prosecutors have thus far been "delicate" in the presentation of victims' evidence, Stearns wrote that "the emotional impact on the jurors has been visible to the court" particularly when the testimony "has turned inevitably (and understandably) to a description of the suffering of the victim prior to death."
The ruling may also block plans by prosecutors to present autopsy testimony on the 25 victims named in the second degree murder charges against Cadden.
In a second decision, Stearns ruled that Cadden's lawyers can present as evidence emails from Cadden prior to 2012 that show the former drug company president did have concerns about the quality and safety of drugs being produced by the New England Compounding Center. Previously he had ruled that any emails prior to 2012, the year of the outbreak, could not be presented to the jury.
Both decisions come in Cadden's trial on racketeering and second degree murder charges. He is the first to go to trial in a 2014 grand jury indictment stemming from a federal probe of the outbreak that took the lives of 76 patients across the country. Cadden's company, NECC, has been blamed for the outbreak caused by fungus laden steroids.
In the decision on victim witnesses, Stearns noted that testimony on three victims already has taken place, including the Friday testimony of a Maryland physician whose father was an outbreak victim.
"Family witness victim description testimony has now reached (the Rule 403) tipping point," Stearns wrote. "No further testimony in this vein will therefore be permitted."
Citing a U.S. Supreme Court ruling by then Chief Justice William Rehnquist, Stearns said that  "evidence that is unduly prejudicial renders the trial fundamentally unfair."
He added that court rules provide that evidence "even though relevant may be excluded if its probative value is substantially outweighed by a danger of unfair prejudice, confusing the issues or misleading the jury."
Noting that prosecutors had argued that victim witness laws in five states, including Tennessee, Michigan and Indiana, allowed such testimony, Stearns concluded that only the law in Maryland was "mildly on point."
"In sum the government has not offered convincing support for an all inclusive introduction of victim description evidence."
Stearns did leave the door open for prosecutors to propose exceptions "in cases in which the government can demonstrate that the witness is competent to testify to an issue pertinent to the defendant's legal guilt."
In a footnote Stearns indicated that his ruling also would apply to testimony from medical examiners on the autopsies performed on victims. The government list of possible witnesses includes medical examiners from Tennessee and Maryland.
"This has particular relevance in light of the government's intention to offer autopsy evidence in each of the victims' cases, much of which in the court's experience is certain to be gruesome," Stearns wrote referring to unduly prejudicial evidence.
In the second ruling, Stearns ruled that while prosecutors can use several emails Cadden sent or received, Cadden's lawyers will be allowed to present emails prior to 2012 in which Cadden expressed concern that NECC meet state and federal guidelines on sterility.
He also granted Cadden's motion to exclude some emails, including one with "joking banter" about the use of cocaine at a company party.
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Friday, February 3, 2017

Cadden Trial Brings Back Victim's Anger

By Walter F. Roche Jr.

Ronda Burns, a victim of the 2012 fungal meningitis outbreak, says she has gone through a series of emotions over the more than four years since she was sickened; depression, despair, frustration and anger.
It is that last emotion, anger, that has emerged as she has followed the developments in a Boston, Mass. courtroom.
Barry J. Cadden, the one time president of a booming drug compounding company, is on trial on charges of racketeering and 25 counts of second degree murder. Cadden's now defunct company, the New England Compounding Center, produced the fungus riddled drugs that sickened Ronda and more than 700 others. It killed 76.
Burns was one of 153 Tennessee victims of the outbreak. Sixteen of them died. The outbreak first came to light when a Smyrna patient who had been injected with a contaminated steroid at the Saint Thomas Outpatient Neurosurgical Center died with a diagnosis of fungal meningitis.
Cadden's trial will be followed by trials for nine others charged by a grand jury that investigated the deadly outbreak.
For Burns the ongoing murder trial of the president of the company that caused her illness has brought back the anger.
"I want them to suffer like we did," she said of the defendants.
 An activist among the hundreds of living outbreak victims, she started a secret page for 50 other victims to share their stories and emotions.
"It helps us to be able to talk to each other. I feel like I had to start something good for the survivors," Burns said.
The Castalian Springs, Tenn. resident said her back problems first surfaced when she was a junior in high school and went to a chiropractor for treatment of whiplash. Problems resurfaced every few years and she developed sciatica after getting a spinal block in the delivery of her first child in 1992.
It recurred in 2010 and she was diagnosed with arthritis.
"I had arthritis in my spine and it was eating my neck and lumbar discs pretty badly," she said.
She declined a spinal fusion but two years later the sciatica came back with a vengeance.
"It was worse this time. The pain was really bad, " Burns said.
When nothing seemed to help she agreed to have steroid injections, the first on Aug. 17, 2012.
Almost immediately after the shot, she said the pain was worse than ever.
"The pain was horrid," she said.
When she called the doctor, he told her to come in for another injection on Aug.30.
She would later learn that both shots came from lots of fungus laden lots of methylprednisolone acetate from NECC.
She said she was in constant pain and bedridden for most of September and October, when she finally went to the emergency room at the Saint Thomas Hospital.
"It looked like a war zone. Patients were everywhere. They were in the hallway and it was a scary site," she recalled.
After waiting several hours she underwent a lumbar puncture which turned out negative so she was sent home.
She returned two days later and was sent home again.
She said she did not get a final diagnosis of fungal meningitis until early January, 2013 after undergoing an MRI.
"I knew I had it the whole time. I had enough medical training and that voice inside my head kept telling me so," Burns said.
With the diagnosis, Burns began treatment with a powerful antifungal drug with devastating side effects.
"After taking the antifungal (Voriconizole) for two weeks, I couldn't raise my head off the pillow. I felt like I was dying. I actually wanted to die several times during the nine months on that drug," she said.
"I had all the side effects. Nausea was awfully bad. My nails peeled, skin red all the time. I could not be in the sun. I was a hermit for all the nine months," she said. 
Still later an abscess was discovered in her spine requiring surgery.
Though improved, Burns still suffers from other after effects of the meningitis and the toxic drugs used to cure it. There's the condition called arachnoiditis and drug induced neuropathy in her feet.
"I try to be happy with the good days. Thank God that I  have some good ones. I will never forget what I have been through."
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NECC Shipped Long Expired Cancer Drug

By Walter F. Roche Jr.

BOSTON, Mass.-Federal prosecutors presented evidence today indicating a now defunct Massachusetts drug compounding firm shipped a cancer treatment drug to an Illinois hospital even though the drug's main ingredient had expired five years earlier.
 Kandie Dino, the pharmacy manager at the Decatur Hospital said she ordered the methotrexate on Feb. 7, 2012 from the New England Compounding Center and it was delivered five days later.
She was shown a large jar of methotraxate that had been seized from NECC's Framingham, Mass. offices in 2012.
Her testimony came in the trial of NECC's one time president Barry J. Cadden, who has been charged with racketeering and second degree murder.
Dino said that when she contacted the NECC sales representative to order the drug, "he told me I needed to talk to Barry Cadden."
She said she complied and contacted Cadden to make the request.
Reading from the jar seized from NECC, she said the expiration date was in 2007, but when the drug was delivered to her hospital the methotrexate had an August 2012 expiration date.
"We received the product," she said under questioning from Assistant U.S. Attorney George Varghese.
Asked if she would have accepted the drug if she had known about the expiration date, Dino said, "Expiration dates are very important."
She said that depending on their ingredients expired drugs could be either stronger or weaker than originally indicated. If you open a bottle of aspirin and get a vinegar smell, it means the aspirin has begun to decompose and is no longer its original strength, she said.
"Expired products are not to be used," she said, adding that there was nothing you could do to an expired drug to make it right again.
She said the hospital paid $1,750 for multiple vials of the drug plus a $20 shipping fee. She said the 300-bed hospital had been purchasing drugs from NECC for several years.
A patient needed the drug to continue chemotherapy and the hospital's supply was running out, she said.
Also testifying was Kiumarce Kashi, a Baltimore, Md. physician whose father was injected with a fungus tainted NECC steroid in 2012.
He said his father got the injection at an Abingdon, Md. clinic while he was visiting from his home in California.
He said his father became ill soon after his return to Sacramento, Calif. He rushed to his bedside at a local hospital and convinced the doctor treating his father to do a lumbar puncture. The test showed evidence of fungal meningitis.
He said he had his father transferred to a larger hospital,and while he rallied briefly, he was soon in a trance like state and died on Jan. 20, 2013.
The session ended early after a juror became ill and the judge called a recess until Monday morning.
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Thursday, February 2, 2017

Witnesses: Cadden Gave No Hint of Imminent Outbreak

By Walter F. Roche Jr.

BOSTON, Mass. - Officials from two health care facilities testified today that they spoke with Barry J. Cadden as a national fungal meningitis outbreak was unfolding but he gave no hint of an impending crisis.
A Maryland physician, who already had lost one patient, said Cadden assured her "there was nothing to worry about" despite the fact that a recall of some NECC drugs already had been initiated.
Cadden, the one time president and owner of the New England Compounding Center, is on trial for racketeering and 25 counts of second degree murder. His trial in U.S. District Court is ending its third week.
Dr. Ritu Bhambhani, who runs the Box Hill clinic in Abingdon, Md. testified that Cadden told her that another doctor had stated that he saw particulate matter in a vial of NECC's methylprednisolone acetate.
"Oh it's nothing to be concerned about," Bhambhani said Cadden told her. She said he assured her there was no cause for concern and that the recall was initiated just to be extra cautious.
Cadden is charged in the deaths of three Box Hill patients, Bahman Kashi, Brenda Rozek and Edna Young. A fourth Box Hill patient died, but is not named in the indictment.
Marcy Grow-Dorman, a manager of the OSMC clinic in Elkhart, Ind. said she had two telephone conversations with Cadden in late September after two clinic doctors reported observing particulates in vials of steroids from NECC.
She said Cadden told her he was not aware of any problem and that he would get back to her. She said she called him back the same day, Sept. 24, 2012, to offer to send him the two suspect vials.
She said she never heard back from him.
Asked by prosecutors if Cadden said anything about sicknesses in other states or offered any other information, Grow-Dorman said, "No, he did not."
She said some 468 patients had been injected with NECC steroids from the suspect lots. She said 58 were sickened and nine died.
She said that the clinic "lost valuable time" in contacting patients due to the lack of information.
"Had we known (sooner) that would have been extremely helpful," she said. "We lost time, valuable time."
She also said she thought that Cadden knew something about the impending outbreak when she called him but he didn't tell her.
U.S. District Judge Richard G. Stearns later told the jury that Grow-Dorman's comments about the effect of delays in getting patients care was "probably beyond the expertise of the witness."
Stearns also gave jurors a summary of the charges in the case after  some jurors expressed confusion over exactly what Cadden has been charged with.
Cadden has been charged in the deaths of two OSMC patients, Pauline Burema and Kathy Dillon.
Prosecutors in earlier court sessions have presented evidence that NECC in the same late September time period asked an outside testing firm to conduct fungal testing on some of its products.
Also testifying was Kiumarce Kashi, whose father was a Box Hill patient and died. Kashi, who is a physician himself, said his father had chronic back problems, and decided to get a spinal injection while visiting with him in Maryland.
"He did have some relief," Kashi said, adding that his father then returned to his home in Sacramento, Calif. He was soon hospitalized and by the time he arrived his father had suffered a stroke and was in the intensive care unit.
"In this day and age, it is hard to imagine how this could happen," Kashi said in a session with reporters following the hearing.
Kashi is one of eight victims or their survivors who have filed civil suits against Box Hill.
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Wednesday, February 1, 2017

Cadden E-mails Cite Pubic Hair in Clean Room

By Walter F. Roche Jr.

BOSTON, Mass. - The defendant in the ongoing fungal meningitis criminal case wants a judge to bar the use by prosecutors of "highly prejudicial" emails that mention finding pubic hair in a clean room and include "joking banter" about using cocaine at a holiday party.
In a motion filed Tuesday in U.S. District Court, Cadden's lawyers asked that 33 of 63 emails be excluded from presentation to the jury hearing his second degree murder case.
The motion states that the 33 emails "are extremely prejudicial as they repeatedly reference and describe pubic hairs found in the clean room and other purported grooming issues."
The motion also argues that some of the emails are too old and are not relevant to the time in 2012 when the deadly fungal meningitis outbreak surfaced. The outbreak, caused by fungus contaminated steroids from NECC caused the death of 76 patients in 20 states.
Cadden's lawyers noted that U.S. District Judge Richard G. Stearns already blocked the use of other dated emails.
In addition to the pubic hair email, the motion cites other emails in which NECC officials joked about the use of cocaine.
The emails contain "unfairly prejudicial banter about using cocaine at a holiday party," the 10-page motion states.
Another set of emails gives "the false impression that Mr. Cadden was aware that mice were present in the clean room.
Another email cited by Cadden includes a reference to an NECC pharmacy technician, Scott Connolly, who was working without a license. Scott Connolly is a co-defendant in the case and his trial is scheduled for April.
"This situation is exactly why Scott (Connolly) must be swapped into a less dangerous position. We would be f------ if this was a cardio med," the email states.
The motion also challenges the plan by prosecutors to have the emails read into the record by U.S. Food and Drug Administration Agent Sara Albert, thus depriving the defense of an opportunity to cross examine a witness with direct knowledge of the emails.
Overall, the motion concludes, the 33 emails are "replete with unfairly prejudicial statements that are often irrelevant and misleading...(T)he unfair prejudice to Mr. Cadden if these emails are admitted is insurmountable."
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NECC Fungus Bloomed in Petri Dish

By Walter F. Roche Jr.

BOSTON, Mass. When a microbiologist saw the blooming fungus from a sample steroid from the New England Compounding Center she was so surprised she took out her camera and took a picture of it.
Eleven separate fungi were blooming on her petri dish.
Tiffany Hyde from the Analytic Research Laboratories recounted the discovery of the fungus from an NECC steroid in testimony today in the murder trial of Barry J. Cadden, the former president and part owner of NECC.
Cadden is the first to go on trial on charges stemming from the 2012 fungal meningitis outbreak which state and federal regulators say was caused by fungus loaded methylprednisolone acetate shipped by NECC to health providers in 20 states.
First detected in Tennessee, the outbreak sickened 778 patients, killing 76 of them.
"It's very uncommon to see a growth like this," Hyde testified, as her 2012 picture was displayed on monitors in the courtroom.
 Her report described "a large cotton like ball covered covered in product... white filamentous raised fungal colonies with with blackish green center."
ARL, based in Oklahoma was the company NECC hired to test its steroids and other drugs produced at its Framingham, Mass. headquarters.
Under questioning by prosecutors, Hyde acknowledged that her company had sent reports to NECC attesting to the sterility of its methylprednisolone acetate. But that was before the outbreak became public and NECC for the first time asked for fungal testing to be done.
Though it has not been mentioned in the ongoing trial, court records show ARL agreed to pay $6.1 million into a fund for victims of the outbreak. Dozens of victims sued ARL charging that the company had certified that the NECC steroids were sterile though they were later found to be riddled with fungus.
Hyde was questioned about a series of tests performed by ARL that showed other NECC drugs were not sterile.
They included a potassium chloride solution and an antibiotic solution, polymyxin-bacitracin.
Hyde said that when she notified NECC of one of those results she was told not to perform any further tests because NECC would discard the entire lot.
In a two-hour afternoon session, Michele Peirce, one of Cadden's lawyers, repeatedly challenged another ARL employee, Jimmy Means, about entries on a list he had compiled of drug tests ARL had performed to check on the potency of NECC drugs. He said the list included cases in which the drugs were found to be too potent or too weak.
Peirce questioned the testing methods used by ARL and cited several instances in which ARL issued conflicting test results on drug samples from the same lot.
Following the testimony U.S. District Judge Richard G. Stearns said he had questions about whether 27 of the items should be included on the list and presented to the jury. He asked for briefs from both sides on the issue.
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