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.
Contact: wfrochejr999@gmail.com
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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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.