FDA Cites Continuing Deaths from Compounded Drugs

By Walter F. Roche Jr.

Citing multiple deaths and serious adverse events, two officials from the U.S. Food and Drug Administration say much more needs to be done to avoid a recurrence of a deadly 2012 fungal meningitis outbreak.
In an article published in the New England Journal of Medicine, Janet Woodcock and Julie Dohm noted it has been five years since the 2012 fungal meningitis which sickened 778 patients, killing 76 of them. The outbreak triggered passage of a new law in 2013.
Stating that more than 425 inspections have been conducted since the passage of the Drug Quality and Security Act, the report states that the FDA found during these inspections "problematic conditions during the vast majority of these inspections." There are currently 75 registered mass compounders.
"The FDA's experience in monitoring pharmacy compounding demonstrated the need for further improvement in compounding practices," the report states.
Cited were multiple violations turned up including dead insects found in compounding areas and visible mold on ceiling tiles and dog beds and dog hairs in close proximity to compounding areas.
According to the report the FDA has overseen the recall of 140 compounded drugs during the same six-year period.
Despite the new law the regulators noted that both before and after the outbreak small clusters of problems with compounded drugs have been reported.
Included in the report is a page-long list of events, some resulting in deaths that have been recorded since 2012. Citing "a steady stream of reports of serious adverse events, including deaths, the report notes that in July of this year 43 patients experienced diminished vision after treatment with a compounded drug.
In an August event two patients had severe sensitivity reactions to a compounded drug containing a substance not considered suitable for human consumption. One of those patients died.
In 2016 three infants were injected with a compounded morphine sulfate that had 25 times the labeled strength. And in 2013 bacterial bloodstream infections were reported for 15 patients, two of whom died.
The regulators noted that the adverse events they reported probably amounted to a small fraction of the actual number because most such events were not reported to the FDA.
Noting the outsourcing industry is in a state of rapid growth, the report states that it is critical that the efforts continue for compounders to meet Current Good Manufacturing Practice requirements.
"Five years after the tragic fungal meningitis outbreak is a good time to invigorate efforts to ensure that the compounded drugs given to patients...are made in facilities that are held to appropriate production standards," the report concludes.
Contact: wfrochejr999@gmail.com

Initial Checks Going to Outbreak Victims

By Walter F. Roche Jr.




Initial payments are in the mail for some victims of the 2012 fungal meningitis outbreak and a second payment is expected next year.
Interviews with victims and the attorneys representing victims show the payments from a $40 million victims compensation fund are being mailed out this week from the Massachusetts Attorney General's office, which is administering the payment program.
Those familiar with the program said the total payments could range from $25,000 to $50,000.
The funds were allocated to the Massachusetts Attorney General through the efforts of U.S. Rep. Mike Bishop, whose Michigan district was especially hard hit by the outbreak which sickened some 778 victims, killing 76 of them.
Bishop issued a statement applauding the efforts by Mass. Attorney General Maura Healey to begin distributing the grants.
"While no dollar amount will ever make these victims whole, I am happy to know that victims are finally getting some much needed additional financial help," Bishop said.
He noted that victims still have until March 1 to file a claim. The original December deadline was extended earlier this year.
The $40 million came from a U.S. Justice Department fund established to reimburse victims of serious crimes.
The president and a supervising pharmacist at the New England Compounding Center have been convicted of racketeering and mail fraud as a result of a federal grand jury probe of the outbreak.
Barry J. Cadden, NECC's president, already is serving a nine year prison term following his March conviction on 57 counts. Chin is scheduled for sentencing on Jan. 31.
NECC shipped fungus laden steroids to health providers across the country.
Contact" wfrochejr999@gmail.com

Info Needed for 67 Outbreak Victims to Get Checks

By Walter F. Roche Jr.




The trustee for a fund established to pay victims of a deadly 2012 fungal meningitis outbreak is asking a federal judge to order a California law firm to explain why it has failed to submit paperwork so that 67 victims can get paid.
In a two-page motion filed today in U.S. District Court in Boston, Mass., Lynne F. Riley, the trustee, asked U.S. District Judge Rya Zobel to order the law firm of Andrews Thornton Higgins and Razmara to explain why it has not submitted the needed information.
She states in the motion that there are a total of 142 victims whose checks cannot be released because information relating to liens or outstanding claims against those victims' payments hasn't been submitted.
According to the motion Andrews Thornton has not responded despite "a significant lapse of time" since the information was requested.
Riley reported previously that substantially all of the eligible victims had been paid. In a report to the court she said a total of $149.4 million has been distributed to a little more than 2,000 victims.
The victims' fund was created during the bankruptcy of the New England Compounding Center, the now defunct Framingham, Mass. firm blamed for the outbreak that took the lives of at least 76 patients.
Contact: wfrochejr999@gmail.com

Tennessee Outbreak Suits Formally Settled

By Walter F. Roche Jt.

Lawyers for Tennessee victims of the 2012 fungal meningitis outbreak have agreed to formally dismiss their claims under a confidential settlement with two Nashville clinics and related parties.
In papers filed this week in U.S. District Court in Boston, Mass. lawyers for the victims and the clinics said all but two of the 106 who filed claims have been paid under the settlement terms.
Only technical paperwork will be needed to finalize the last two claims.
Among the defendants in the cases were the Howell Allen Clinic and the Saint Thomas Outpatient Neurosurgical Center, both in Nashville. Lawyers for the clinics declined to comment.
A joint four-page petition seeks the approval of senior U.S. District Judge Rya Zobel for the dismissals. Suits brought by Tennessee victims and some 20 other states were merged in Zobel's court in late 2013.
"This fully and finally resolves all claims against all defendants in the cases listed in the consent order," the filing states.
The outbreak, federal and state regulators agree, was caused by fungus laden methylprednisolone acetate shipped from the New England Compounding Center to clinics across the country.
Complaints filed in subsequent cases showed most of Tennessee victims had sought treatment for spinal and related problems at the Howell Allen Clinic. There doctors prescribed injections of methylprednisolone acetate to be administered at the Saint Thomas Outpatient Neurosurgical Center.
That center was owned in equal shares by Saint Thomas Health and the Howell Allen Clinic.
In addition to the clinics defendants included the doctor who administered the shots and related firms. The petition would resolve the claims against all defendants.
Though all parties have declined to discuss the terms of the settlement it is believed to be in excess of $20 million.
The 2012 outbreak sickened some 778 patients nationwide, killing at least 76 of them.
In addition to payments from the Nashville clinic settlements, victims also were eligible to collect payments from a national settlement fund established in the NECC bankruptcy.
The trustee of that fund reported this week that payments totaling nearly $150 million have been paid to a little over 2,000 victims.
Contact: wfrochejr999@gmail.com

Trustee Reports $149.4 Million Going to Victims

By Walter F. Roche Jr.

A total of $149.4 million has been approved for payment to victims of the 2012 fungal meningitis outbreak, according to a report filed today in U.S. District Court in Boston, Mass.
Lynne F. Riley, who is in charge of overseeing the distributions, also reported that action has been taken on all 2,353 claims filed. All appeals have been resolved and payments to 2,026 have been fully or partially approved.
According to her four-page report, 284 claims were fully denied, 41 were determined to be invalid and two were withdrawn.
The funds stem from the bankruptcy of the New England Compounding Center, the now defunct Framingham, Mass. firm blamed for the outbreak. Funds are also being distributed through Riley from a settlement agreement with a Virginia clinic where victims were injected with fungus riddled methylprednisolone acetate.
Riley wrote that 237 initial checks have been distributed to victims who were injected at Insight Imaging, theVirginia firm that reached a settlement agreement. She reported that 165 of those Insight victims also received a second check.
Riley is not in charge of other clinic settlements including those reached with two Tennessee clinics where victims were injected with contaminated steroids. Payments from those settlements are being distributed separately.
The 2012 outbreak sickened at least 778 patients. Seventy-six of them died.
Riley also reported that the approved claims have also been submitted to federal and state agencies who can seek to recoup money they paid for the care of the victims.
Riley wrote that as of Friday, 1,884 victims have received a first check, while 1,857 of those have also received a second payment.
Checks for another 142 victims will be released once they or their attorneys submit needed documentation. She stated that 87 of that 142 have claims of less than $3,000.
Riley has indicated that a third smaller payment will be distributed at a later date after tax issues relating to NECC's owners are finally resolved.

Contact: wfrochejr999@gmail.com

Judge Re-affirms Restitution Delay

By Walter F. Roche Jr.

A federal judge has rejected a request that he consider immediately a proposal to award some $73.7 million to victims of the 2012 fungal meningitis outbreak.
In a brief order issued today, U.S.  District Judge Richard G. Stearns denied the reconsideration motion filed by the U.S. Attorney.
Stearns declined to reverse an earlier decision delaying action on the restitution order until the First Circuit Court of Appeals acts on an appeal of the conviction of Barry J. Cadden, the one time president of the drug compounding firm blamed for a deadly fungal meningitis outbreak.
While conceding that arguments could be made for both sides, Stearns wrote, "I am persuaded as a prudential matter, the wiser course is to stay restitution pending the resolution of the First Circuit appeal."
Assistant U.S. Attorneys George Varghese and Amanda Strachan had asked Stearns to reconsider his initial ruling on the issue.
Cadden's lawyers argued that precedent required that the matter be delayed.
Stearns noted that if the appeals court disagrees with his decision, the panel can remand the issue to his court.
"It is decidedly the First Circuit, as the higher court, that is now the boss," Stearns wrote.
Cadden already has begun serving a nine year prison sentence following his March conviction on racketeering and mail fraud charges.
wfrochejr999@gmail.com

NECC, Ameridose Profits Topped $200 Million

By Walter F. Roche Jr.

The company blamed for a deadly fungal meningitis outbreak and a closely related firm earned over $200 million in profits in the six year period preceding the 2012 outbreak, according to a filing in U.S. District Court in Boston, Mass.
The filing by the wife of the now jailed president of the defunct drug firms, shows that Barry and Lisa Cadden earned $72 million during that period from their 35 per cent ownership share in the New England Compounding Center and Ameridose.
Lisa Cadden disclosed the profit details in a 25-page motion filed in protest of a recently issued order from U.S. District Judge Richard G. Stearns. The Cadden's children also signed on to the motion which was filed by Bruce Singal, the same lawyer who represented Cadden in his recent criminal trial.
Lisa Cadden argues that because payments for a Wrentham home, along with adjoining properties, jewelry, an $89,220 sailboat, an $86,662 BMW and savings and investment accounts, came from a joint account, she retains ownership in all of those assets.
"Mrs. Cadden has legal right, title and interest in all of this property," the motion states in the request for Stearns to reverse his approval.
Also ordered seized was a $31,875 antique clock and jewelry purchased for $26,302.
Barry Cadden is now serving a nine-year federal prison term following his March conviction on racketeering, mail fraud and related charges.
NECC, the company Cadden helped found, filed for bankruptcy in late 2012. Ameridose, a related drug firm, was closed down by federal regulators and never reopened.
According to the filing Lisa Cadden earned $28 million from her 17.5 per cent share of Ameridose and $8 million from NECC. Barry Cadden had equal shares and profits.
The Caddens and other NECC owners did agree to pay a total of $47.5 million to a settlement fund that has been used to pay outbreak victims. That amount is likely to be increased because the NECC shareholders also agreed to put any tax refunds into the same fund.

Prosecutors Oppose Chin Acquittal Motion

By Walter F. Roche Jr.

Citing prior rulings in a parallel case, federal prosecutors are asking a federal judge to reject an acquittal plea from a pharmacist who played a key role at a drug compounding company that shipped thousands of vials of deadly fungus laden steroids.
In a 25-page filing in U.S. District Court in Boston, Mass. prosecutors said Glenn Chin's conviction on racketeering, conspiracy and mail fraud charges should stand and all five of his arguments for acquittal were without merit.
Chin, the government brief notes, was convicted on 77 counts following a five week trial. His sentencing is scheduled for Jan. 30 before U.S. District Judge Richard G. Stearns.
Assistant U.S. Attorneys Amanda Strachan and George Varghese noted that many of the arguments for acquittal  offered by Chin already have been rejected by Stearns in the case of co-defendant Barry J. Cadden. Cadden, who was president and part owner of the now defunct New England Compounding Center, is serving a nine year prison sentence in Pennsylvania.
Cadden and Chin were among 14 persons connected to NECC who were indicted in late 2014 following a two year probe of a deadly 2012 fungal meningitis outbreak that killed 76 patients and sickened 702 others.
"Chin, like Cadden before him, has presented no new arguments, nor cited any new case that calls into question the court's two prior rulings on this issue," the filing states.
Chin's lawyers had argued that the racketeering and conspiracy charges against him were too vague.
Charging that Chin was a manager of a criminal enterprise that sold "grossly substandard drugs" that were prepared in "filthy conditions."
"The evidence at trial showed Chin conspired with Cadden ... to operate NECC as a criminal enterprise. Chin, in his role as the supervising pharmacist of NECC's clean rooms, was part of that conspiracy," the brief states.
Cited was Cadden's role in using outdated drugs, shipping untested drugs and mislabeling drugs that hadn't been tested to make it appear that they had.
They noted evidence that under Chin's direction, drugs that were supposed to be placed in an autoclave for 20 minutes were only treated for 15 minutes.
They also noted the jury rejected Chin's claim that he was just following orders.
In a related development seven civil suits against a Maryland clinic where victims were injected with fungus laden NECC steroids were dismissed as the result of a settlement.'
Suits by outbreak victims against a Crossville, Tenn. clinic also have been settled and papers were filed this week to create a settlement fund for distribution to victims. Terms of the settlement with the Specialty Surgery Center were filed under seal.

Feds Move to Seize Cadden's House, Cash, Diamonds

By Walter F. Roche Jr.

Federal agents have executed preliminary forfeiture orders against more than a half dozen assets owned by the man now serving a nine year prison term for his role in a deadly 2012 fungal meningitis outbreak.
In filings today in U.S. District Court in Boston, Mass. the forfeiture orders were issued for the residence of Barry J. Cadden, along with jewelry, a "luxury clock or timepiece" purchased from an antique dealer and a sail boat purchased by the former drug company owner.
Cadden was convicted in late March on racketeering and mail fraud charges. He is now serving a nine year prison sentence in a federal prison in Pennsylvania.
U.S. District Judge Richard G. Stearns subsequently issued an order authorizing the forfeiture of Cadden's assets of $7.5 million.
In addition to Cadden's Wrentham, Mass. home the forfeiture orders apply to two adjacent properties, jewelry purchased by Cadden on Dec. 23, 2010 and Oct. 21, 2011 from DeScenza Diamonds, $1.4 million in a Lee Munder Wealth Planning account and $95,923 from a Middlesex Savings Bank account.
A total of eight preliminary forfeiture orders were filed. According to the filing, a copy of the seizure order was posted on Cadden's residence.
Cadden was president and part owner of the New England Compounding Center, the company blamed for the fungal meningitis outbreak which killed 76 patients across the country.
Contact: wfrochejr999@gmail.com