Friday, June 22, 2018

Conigliaro Denied Scrap Metal License

By Walter F. Roche Jr,

The Framingham, Mass. city coucil has voted to deny a scrap metal dealers license to a company headed by one of the founders of a now defunct drug compounding company blamed for a deadly 2012 outbreak of fungal meningitis.
The council voted earlier this week to deny a license to Conigliaro Industries headed by Gregory Conigliaro who is set to go on trial this Fall for his role at the New England Compounding Center, the firm blamed for the outbreak which killed 76 patients in 20 states. More than 700 other patients were sickened after injection with fungus riddled methylprednisolone acetate.
During this week's meeting council members cited Conigliaro's role at NECC where he was a vice president and part owner.
The denial marked the second time the panel turned down the request from Conigliaro. In 2015 a similar request was denied.
At a hearing earlier this year council members and residents expressed concerns about the recycling operation run by Conigliaro's company.
The scrap metal license would have allowed Conigliaro to buy and sell scrap metals.
Conigliaro was one of 14 persons connected to NECC to be indicted in December of 2014 following a two year federal probe of the 2012 fungal meningitis outbreak.
Two of the defendants, Barry J. Cadden and Glenn A. Chin already are serving prison sentences following their conviction by separate juries on racketeering, mail fraud and related charges. They were both cleared of second degree murder charges.
In addition to Conigliaro the defendants in the October trial include nine others charged in the 2014 indictment. All were either employees of NECC or related companies.
State licensing records show Conigliaro was granted a real estate sales license shortly before his indictment.

Friday, June 15, 2018

New Outbreak Suit Filed

AGO — A patient is suing Advanced Pain & Anesthesia Consultants PC, which does business as APAC Centers for Pain Management, and physician Randolph Chang, citing alleged medical negligence.

Leslie Musselwhite filed a complaint June 5 in Cook County Circuit Court, alleging the defendants failed to properly perform a cervical epidural steroid injection (ESI) procedure.

According to the complaint, the plaintiff was administered the injection between June 28, 2012, and Sept. 7, 2012, allegedly resulting in fungal meningitis and causing Musselwhite permanent pain and rendering him disabled.

The plaintiff requests a trial by jury and seeks more than $50,000 plus costs. He is represented by Charles A. Hornewer of Hornewer Law Firm LLC in Chicago.

Cook County Circuit Court case number 2018-L-005820
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Thursday, June 14, 2018

Compounding Outbreak

FDA’s investigation into Guardian’s compounded triamcinolone-moxifloxacin drug product
Update: June 14, 2018

On July 28, 2017, FDA alerted health care professionals of adverse event reports concerning at least 43 patients who were administered intravitreal (eye) injections of a drug containing triamcinolone acetonide (steroid) and moxifloxacin (anti-infective) compounded by Guardian Pharmacy Services in Dallas, Texas. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. As part of its investigation into these adverse events, FDA collected and tested samples of Guardian’s product to identify and quantify the substances contained therein. FDA also prepared and tested in-house samples to assess the impact of autoclaving and sonication, which were used by Guardian during its compounding process, on the stability of the drug product. Below is a description of the test results and the agency’s analysis of those results.

For more information, please visit: Guardian's compounded triamcinolone-moxifloxacin investigation.

Tuesday, June 12, 2018

Owners Sought to Save Sister Drug Firm

By Walter F. Roche Jr.

Even as a federal investigation was heating up, the owners of a Massachusetts drug compounding firm launched a last ditch effort to save a sister firm also facing regulatory scrutiny.
Records in Massachusetts show the effort to rescue Ameridose included the hiring of a politically connected firm to lobby on the firm's behalf. Ameridose, now defunct, had the same shareholders as the New England Compounding Center, the company blamed for a deadly fungal meningitis outbreak.
The outbreak, which became public in October of 2012, ultimately sickened 778 patients, killing at least 76 of them.
Registering as a lobbyist on Ameridose's behalf in late 2012 was O'Neill and Associates, headed by Thomas P. O'Neill, 3rd, a former Massachusetts Lieutenant Governor and the son of longtime U.S. House Speaker Thomas P. O'Neill Jr.
Also registering as an Ameridose lobbyist was the Boston law firm of Donoghue Barrett and Singal.
Listed as the goal of that firm was "to reopen Ameridose to save several hundred jobs."
The firm's report also stated, "No salary paid directly to lobbyist by client."
In one of its filings, O'Neill and Associates listed its role as "Legislative and regulatory issues related to pharmacy compounding."
Like NECC, Ameridose shut down voluntarily shortly after the outbreak became public. The closure followed critical state and federal inspections of the Westborough, Mass. facility.
Both lobbying firms reported earning only $20,000 apiece in the unsuccessful effort to get Ameridose reopened.
Registered in late 2012 the two lobbying firms subsequently withdrew in the first half of 2013.
The Donohue Barrett Singal firm, however, would later surface as the attorneys for NECC's president Barry J. Cadden in a 2017 criminal trial.
Bruce Singal, the former executive director of the Massachusetts Consumers Council. was Cadden's lead attorney in a marathon trial. Cadden, 51, who is now serving a nine year federal prison sentence, was convicted of racketeering, conspiracy and mail fraud charges but cleared of second degree murder/racketeering charges.
Andrew Paven, an employee of O'Neill and Associates, said he recalled that the firm did register as a lobbyist for Ameridose, but their efforts soon came to naught.
"To be honest there wasn’t really anything we could do for them; that die was cast," Paven wrote in an email response to questions.
Members off O'Neill firm, Massachusetts lobbying records show, collected $1,791,699 for lobbying services in the same year from its other clients.
Massachusetts records show that former employees of Ameridose, along with other related firms, did qualify for emergency assistance for retraining.

Thursday, May 31, 2018

$12.75 Million Sent to Outbreak Victims

By Walter F. Roche Jr.

A little over 500 of the victims from a 2012 fungal meningitis outbreak have won approval for payment from a $40 million fund being administered by the office of Massachusetts Attorney General Maura Healey.
According to office spokeswoman Chloe Gotsis, thus far 371 checks totaling $12.75 million were sent out in two waves for applicants who were found eligible. The first set of checks went out in December of last year. A second wave went out in March.
Overall she said 538 of the 748 applicants have been approved for payment. Approximately 262 of those claimants have been paid in full.
She said a third wave is expected to go out this summer. She noted that applicants must submit their applications by a June 30 deadline. That deadline already has been extended twice.
The fund was obtained from a national fund maintained by the U.S. Justice Department.
Michigan Republican U.S. Rep. Mike Bishop led the efforts to get approval for the fund. His district was among the hardest hit.
The 2012 outbreak was cause by contaminated steroids manufactured by the now defunct New England Compounding Center which was located in Framingham, Mass. At least 76 victims died out of a total of 778 who were sickened.
Information on the application process can be found at

Monday, May 14, 2018

NECC Owner Denied Separate Trial

By Walter F. Roche Jr.

A bid to have a separate trial by a former part owner of a defunct drug compounding company has been denied in a brief order from a federal judge.
In the order U.S. District Judge Richard G. Stearns wrote that Gregory Conigliaro, one time vice president and part owner of the New England Compounding Center, will be tried along with nine other defendants beginning in early October.
That trial will come on the sixth anniversary of the deadly fungal meningitis outbreak caused by fungus riddled steroids shipped from NECC's Framingham, Mass. offices. Seventy six patients from 20 states died after being injected with NECC's drugs.
Conigliaro's lawyer had argued that Conigliaro, who faces a single conspiracy charge, would be unduly prejudiced by the evidence against co-dfendants facing multiple charges.
Stearns, however, concluded that instructions to jurors could avert any prejudice.
He also noted that he already has ruled that evidence of deaths and illnesses from the 2012 fungal meningitis outbreak cannot be used at the upcoming trial.
Stearns said he was confident his ruling would enable the jury to focus its attention "on the actual allegations that remain against the defendants."
He also cited the "cardinal principle" that the law favors the joint trial of defendants who are indicted together to "prevent inconsistent verdicts and to conserve judicial and prosecutorial resources."
Conigliaro was one of 14 indicted following a two year federal probe of the deadly outbreak. Two. of those defendants, Barry Cadden and Glenn Chin, are already serving lengthy prison sentences following their conviction on racketeering and conspiracy charges.

Monday, May 7, 2018

Judge Bars Testimony on Outbreak Deaths

By Walter F. Roche Jr.

In a major setback to prosecutors, a federal judge has ruled that testimony and evidence of deaths caused in a nationwide fungal meningitis outbreak can not be used in the upcoming trial of 10 defendants linked to the company blamed for the outbreak.
In a 17-page ruling issued today in Boston, Mass., U.S. District Judge Richard G. Stearns ruled that the evidence and testimony of deaths would be highly prejudicial to the ten defendants who have not been charged with causing any of the deaths or involvement in the production of the contaminated drug that killed 76 people.
As Stearns noted prosecutors already had agreed not to present autopsy reports or elicit testimony from the next of kin of deceased victims.
Instead they said testimony would be limited to a CDC official, Dr. Benjamin Park, who played a key role in the prior trials of Barry J. Cadden and Glenn Chin. Cadden was president and part owner of the New England Compounding Center while Chin was a supervising pharmacist for the company. Both are now serving lengthy prison terms.
But Stearns ruled that even within those limitations agreed to by prosecutors, the effect would be highly prejudicial.
"I am convinced that the proposed evidence of patients' deaths and injuries entails a substantial risk that jurors will decide the case 'on an improper basis rather than on the evidence presented," Stearns wrote.
In the decision Stearns struck down one by one the series of arguments put forward by Assistant U.S. Attorneys Amanda Strachan and George Varghese.
He faulted prosecutors for failing to distinguish between two separate racketeering enterprises alleged in the original 2014 indictment. One, he wrote, involved murder and grievous injury, while the other did not. In addition he noted that both Cadden and Chin were cleared by separate juries of the murder/racketeering charges.
Stearns also rejected the argument by prosecutors that evidence of the deaths was necessary as a scene-setting device.
"The need for this information is slight and the liklihood of misuse is great," Stearns wrote.
Calling one argument of prosecutors "unfathomable," Stearns noted that Park's testimony in the Cadden and Chin trials was particularly detailed.
Park, he wrote "is a convincing witness and by all accounts one of the true heroes that emerges in the tragic story of the
response to the fungal meningitis outbreak."
While acknowledging that some of Park's testimony would be relevant to the charges against the remaining defendants, Stearns said, "the evidentiary shards are impossible to isolate from his more dramatic description of mass-scale injury and death related to the the tainted methylpredniolone acetate."