Last Call on Victims Fund

Time is running out for victims of the 2012 fungal meningitis outbreak to file a claim from a $40 million victims' compensation fund being administered by the Massachusetts' Attorney General's office.
According to agency officials any money not committed by Sept. 30 will have to be returned to the U.S. Justice Department, the agency that allocated the money for the fund.
So far the Massachusetts agency has approved claims filed by 621 victims with a total value of $22 million. An earlier report had erroneously indicated 651 claims had been approved.
Victims who have not filed should contact the Attorney General's office as soon as possible at 617-573-5375 or toll free at 844-315-0339. The office can also be reached by email at NECCAssistance@mass.gov. An on line application form is no longer available.
The office expects to be sending out another round of payments within the next two weeks.
Contact: wfrochejr999@gmail.com

Prosecutors File Appeal Notice on Acquittals

By Walter F. Roche Jr.

Federal prosecutors have filed a notice of appeal of the ruling by a federal judge reversing the unanimous guilty verdicts reached late last year in the case against a part owner of the drug compounding company blamed for the 2012 fungal meningitis outbreak.
In a notice filed today in U.S. District Court in Boston, Mass. Assistant U.S. Attorneys George Varghese and Amanda Strachan said they intend to appeal the acquittal order issued on June 11 by U.S. District Judge Richard G. Stearns. The notice is a first step before formally filing an appeal.
Stearns granted acquittal motions filed in behalf of Gregory Conigliaro, who was vice president and part owner of the now defunct New England Compounding Center, and Sharon Carter, an NECC operations manager. The two were convicted of conspiring to defraud the U.S. Food and Drug Administration.
They were among five defendants found guilty late last year following an eight week trial.
In the appeals lawyers for Conigliaro and Carter had argued that defrauding the FDA was a legal impossibility because at the time the federal agency did not believe it had clear jurisdiction over NECC, which was licensed by the state of Massachusetts. In fact Stearns himself had suggested that argument when he set a hearing date for the acquittal motions in a Dec. 18 order.
Conigliaro was vice president for regulatory affairs at NECC and prosecutors pointed to a letter he wrote to regulators contending that NECC was a small family owned pharmacy and not a drug manufacturer subject to FDA regulation.
Government witnesses, including a top official from the FDA, testified that NECC was in fact a drug manufacturer and should have been subject to stricter federal regulation.
The appeal notice is not the first by prosecutors in the NECC case. A prior ruling to acquit NECC defendants of criminal charges was reversed by the First Circuit Court of Appeals.
Conigliaro and Carter were among 14 indicted in 2014 following a two-year probe of the deadly 2012 fungal meningitis outbreak. Only one of the 14 has been acquitted and two are already serving federal prison terms.
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Sterile Compounding Recall

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/rxq-compounding-llc-issues-voluntary-nationwide-recall-all-sterile-products-within-expiry-and?utm_campaign=RXQ%20Compounding%2C%20LLC%20Issues%20Voluntary%20Nationwide%20Recall%20of%20All%20Sterile%20Products%20within%20Expiry&utm_medium=email&utm_source=Eloqua

TDEC Approves US Nitrogen Chemical Shift

By Walter F. Roche Jr.

Tennessee officials have given their approval for a Greene County chemical plant to shift the chemicals being used to partially purify millions of gallons of water the company draws from the Nolichucky River.
In a one-page letter to US Nitrogen, Vojin Janjic said the company can go ahead with its plans, but he cautioned that two of the proposed treatment plans could actually worsen an algae problem the company has been trying to eliminate.
Janjic also wrote that the approval is conditional on the company maintaining the level of pollutants being sent back to the river to a so-called de minimis level.
US Nitrogen plant manager Dylan Charles had requested approval of four different treatment scenarios in a letter dated May 20. The request, however, was not posted on the TDEC web site until late last week.
"Increased levels of phosphates were observed in the facility's effluent holding pond, causing excessive algae growth,"
Janjic wrote, adding that an anti-scalant was the apparent source.
"We support all optimization processes that would result in reduction of discharged pollutants," Janjic continued.
"We approve the proposed alternative operating scenarios," Janjic added, stressing that the approval was conditional on any pollutants in the discharge to the river must remain below de minimis level.
"It is unclear, however," Janjic added how scenarios 3 and 4 would help with phosphorous loading and corresponding algae growth."
Citing tables submitted by US Nitrogen, Janjic said it appeared that in two of the four scenarios increase phosphate loading would actually increase.
US Nitrogen draws millions of gallons of water per week for use in the production of ammonium nitrate, but the company first treats the water at a treatment plant located on land owned by the local industrial development authority.

Some 60 Hospitals Used Unregistered Compounders

By Walter F. Roche Jr.

As many as 60 hospitals across the country have used unregistered drug compounders to purchase drugs without patient specific prescriptions posing a potential threat to public health, according to an audit report by the Inspector General in the U.S. Office of Health and Human Services.
The report, based on a questionnaire sent to 601 hospitals across the country, found that 11 percent admitted to purchasing non-patient specific drugs from compounders who had not registered with the U.S. Food and Drug Administration.
The report concludes that compounders not registered with the FDA "are not in compliance" with a federal law, the Drug Quality and Security Act, passed in the wake of the deadly 2012 fungal meningitis outbreak. Use of those compounders "could pose a public health threat," the report states.
To compile the report the agency contacted 300 hospitals with more than 50 beds, 300 with less than 50 beds and one that is itself registered as an outsourcer with the FDA. They reported a 94 percent response rate.
As the report noted, compounders registered as outsourcers are subject to stricter regulation, including compliance with provisions of the Food Drug and Cosmetic Act.
Of the 601 hospitals contacted 89 percent reported using only registered outsourcers for non-patient specific prescription drugs. Nine percent reported they used non registered compounders at least some of the time and two percent said they used unregistered compounders all the time.
The IG said it shared its findings with the FDA including the names of the unregistered compounders utilized by hospitals.
The urged the FDA to communicate with hospitals about the importance of obtaining non-patient specific drugs from registered compounders.
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Cadden, Chin Session Re-scheduled

A preliminary hearing in the case of two former pharmacists charged with second degree murder was re-scheduled today after lawyers for the two asked for additional time to review voluminous and complex evidence.
The hearing, known formally as a probable cause hearing conference, was reset for Sept.10 at 8 a.m.
Neither Barry Cadden or Glenn Chin, who are each charged with 11 counts of second degree murder, were present for the hearing.
Kelly Rossman McKinney, spokeswoman for Michigan Attorney General Dana Nessel said Cadden and Chin waived their rights to attend the Tuesday session or the Sept. 10 sessions.
A preliminary examination date has been scheduled for Nov. 14 and 15. Sessions are expected to last eight hours each day. Chin and Cadden are expected to attend those sessions.
Cadden and Chin already are serving federal prison terms for their involvement in the 2012 fungal meningitis outbreak. The outbreak was caused by fungus contaminated steroids produced by the New England Compounding Center, which was part owned by Cadden.
Chin was a supervising pharmacist at NECC in charge of the clean room where the contaminated steroids were produced. Both are serving their sentences at separate federal prisons in Pennsylvania. They were convicted on racketeering, conspiracy and mail fraud charges, but cleared of second degree racketeering murder charges.
(Michigan Court information provided by Donna and Ken Borton)

Cadden, Chin Face Michigan Hearing

By Walter F. Roche Jr.

A probable cause conference is scheduled this week in Howell Mich. on the 11 second degree murder charges against two Massachusetts pharmacists who already are serving federal prison sentences on racketeering, conspiracy and mail fraud charges.
The hearing is scheduled for 8 a.m. Tuesday before Livingston County Judge Shauna Murphy.
It is unclear whether the two defendants will be present. Records from the federal Bureau of Prisons show that as of today they are still in custody at separate federal prisons in Pennsylvania.
Cadden is serving a nine year sentence at the federal prison in Lorretto, PA. while Chin is serving an eight year sentence at Allenwood, PA.
The two were charged late last year with 11 counts of second degree murder in the deaths of Michigan patients who died after being injected with contaminated steroids produced by the New England Compounding Center, a now defunct drug company. Cadden was president and part owner of NECC, while Chin was a supervising pharmacist and worked in the clean room where the contaminated drugs were produced.
Under Michigan's court procedures a a probable cause conference is a a pre-trial session to set scheduling and other matters.
Cadden and Chin were charged with second degree murder in the federal criminal case, but they were cleared of those charges in two separate trials.
Contact: wfrochejr999@gmail.com

U.S. Attorney Reviewing NECC Ruling

By Walter F. Roche Jr.

Federal prosecutors say they are reviewing the 51-page decision acquitting two people charged with conspiracy in the wake of a 2012 fungal meningitis outbreak.
“We are reviewing the decision and, if appropriate, will seek to appeal Judge Stearns’ decision,” said U.S. Attorney Andrew Lelling in Boston, Mass. following the Friday decision by U.S. District Judge Richard G. Stearns.
Stearns overrruled jurors who had voted unanimously late last year to convict Gregory Conigliaro and Sharon Carter of conspiring to defraud the U.S. Food and Drug Administration. Conigliaro was vice president and part owner of the New England Compounding Center, the company blamed for the 2012 fungal meningitis outbreak which ultimately took the lives of more than 100 patients.
Carter, a pharmacy techncian, was a manager at NECC.
In his decision Stearns adopted the arguments put forth by lawyers for Conigliaro and Carter, who said it was impossible for the two to defraud the FDA because the FDA itself did not know whether it had authority over a state licensed firm like NECC.
During the trial of another NECC defendant Stearns had stated that it was hard to see how the FDA was defrauded.
If an appeal is filed it will be the second time his dismissal actions in the NECC case are challenged.
Prosecutors successfully appealed Stearns decision to dismiss charges against two NECC pharmacists. An appeals court later reinstated the charges and the two were ultimately convicted by a jury of multiple violations of the Food Drug and Cosmetic Act with intent to defraud. They are appealing the verdicts.

NECC Judge Overturns Unanimous Jury Verdicts

By Walter F. Roche Jr.

Overturning unanimous jury verdicts a federal judge today acquitted two defendants, including a part owner, of conspiracy charges for their roles at the company blamed for a deadly 2012 fungal meningitis outbreak.
In a 51-page ruling U.S. District Judge Richard G. Stearns sitting in Boston, Mass. acquitted Gregory Conigliaro and Sharon Carter of charges they conspired to defraud the U.S. Food and Drug Administration. Conigliaro was vice president and 10 per cent owner of the now defunct New England Compounding Center. Carter was a pharmacy technician and NECC's director of operations.
They were among 14 people indicted in late 2014 following a two year probe of the 2012 fungal meningitis outbreak, which ultimately took the lives of more than 100 patients in more than 20 states.
Prior to Stearn's ruling late Friday, only one of the defendants was acquitted.
Citing an argument he himself had suggested, Stearns cited testimony that at the time of the outbreak FDA officials did not believe they had clear authority over a state licensed entity like NECC.
"The defendants rights to fair notice and due process were violated," Stearns wrote.
Calling the arguments of federal prosecutors "worrisome," Stearns granted the motions for acquittal filed in behalf of Conigliaro and Carter.
"Ultimately resting criminal liability on such a shaky foundation raises legitimate concerns of constitutional due process," Stearns concluded.
Federal prosecutors had argued that regardless of the FDA's authority over state licensed drug compounders, NECC was acting as a drug manufacturer and was thus subject automatically to stricter FDA regulation. Cited specifically was an Oct. 1, 2004 letter from Conigliaro in which he described NECC as a "small scale family run" pharmacy.
Carter and Conigliaro were among five convicted late last year by unanimous jury verdicts delivered on Dec.14 of last year following an eight week jury trial.
The argument that it was a legal impossibility for the FDA to be defrauded of a power it did not know it had was at center stage at a February hearing in Stearns' courtroom. The argument was raised by Daniel Rabinowitz, Conigliaro's lawyer, and Michael Pineault representing Carter.
Stearns said at that hearing that he particularly liked Pineault's argument that while the FDA may have had the authority to regulate NECC, it chose not to do so.
In the ruling issued today, Stearns recounted the arguments raised by defense lawyers about the confusion within the FDA itself after the U.S. Supreme Court struck down, at least in part, a new statute which would have given the agency clear regulatory authority.
"Confusion created a regulatory lacuna in the borderland in which NECC progressively came to operate," Stearns wrote. "The picture emerges of an agency struggling to make sense of a regulatory scheme."
Carter and Conigliaro, he concluded, "could not have defrauded the FDA by interfering with the relevant functions because there were none to speak of."
Contact: wfrochejr999@gmail.com

Epidural Law Suit in Colorado

CASTLE ROCK, Colo. — A jury awarded a Castle Rock woman the second-largest medical negligence verdict in Colorado history on Thursday, an attorney said.
Robbin Smith received $14.9 million from The Surgery Center at Lone Tree after an injection caused her to be paralyzed from the waist down because of a spinal cord infarction.
Smith was 57 years old when she received an epidural steroid injection with the drug kenalog in September 2013 while she was a patient at the surgery center.
In 2011, the makers of kenalog received permission to include “Not for epidural use” as a warning on its label.
Smith’s attorney said the jury was shown examples of the bottles with the warning and that Smith and her husband Ed Smith were never informed of the changes before the injections.
Because of her injuries, Robbin Smith must receive around-the-clock assistance for the rest of her life.
“We hope this is a wake-up call for Ambulatory Surgery Centers and the people who run them,” Ed Smith said. “It’s one thing to say that patient safety is your first priority; it’s another thing to actually make it your top priority.”
“I’m grateful to the eight members of our jury in Douglas County who gave up two weeks of their lives to fully and fairly consider the evidence and return of verdict that finally provided justice for our deserving clients,” said the Smith’s attorney, Bruce Braley.
“This verdict won’t restore Robbin’s ability to walk. But it will give Robbin and Ed the chance to make the most of the life they now have.”

NECC Defendant Seeks Another Delay

By Walter F. Roche Jr.

The former vice president of a drug compounding company blamed for a deadly outbreak is seeking yet another delay in sentencing following his conviction on a charge of conspiring to defraud the U.S. Food and Drug Administration.
The lawyer for Gregory Conigliaro today filed a motion in U.S. District Court in Boston, Mass.to have his client's sentencing delayed until after Aug. 30. The current date, Aug. 5, was set following a prior motion to delay the original March sentencing date.
Daniel Rabinowitz, Conigliaro's lawyer, wrote in the filing that the further delay could obviate the need for any sentencing session since Conigliaro is awaiting a decision on a motion for acquittal or a new trial.
Conigliaro was one of five defendants convicted late last year following an eight week trial. All of the defendants had ties to the New England Compounding Center, the now shuttered drug compounding firm blamed for the 2012 fungal meningitis outbreak.
Conigliaro was charged with conspiring to defraud the FDA by pretending that NECC was a small family owned pharmacy and not a drug manufacturer.
Rabinowitz wrote that his motion to delay also seeks to force postponement of a conference Conigliaro is supposed to attend June 11 with the Probation Department. The session is needed so the agency can make a pre-sentence report in advance of the actual sentencing hearing.
Rabinowitz noted in his filing that federal prosecutors do not concur in the delay request.
In addition to Conigliaro four other NECC defendants are scheduled for sentencing in the coming weeks.
Kathy Chin is scheduled for Aug. 8 while Michelle Thomas is scheduled for the next day. They were convicted for violations of the Food Drug and Cosmetic Act.
Robert Ronzio, the one time NECC sales chief. is scheduled for an Aug. 7 sentencing on the same charge as Conigliaro. Ronzio pleaded guilty in a plea agreement with prosecutors. Scott Connolly, who pleaded guilty to mail fraud charges, is scheduled for sentencing on July 17.
In another development this week U.S. District Judge Richard G. Stearns approved a motion instructing the Probation Department to return to Christopher Leary his passport, which he was forced to surrender after he was charged in the case.
Leary, who was an NECC pharmacist, has been sentenced to eight months of home confinement following his conviction on mail fraud and related charges.

Prosecutors Oppose NECC RX Appeals

By Walter F. Roche Jr.

Charging that the defendants are raising arguments already rejected by judge and jury, federal prosecutors say the guilty verdicts against two pharmacists should stand and motions for a new trial must be rejected.
In a 22-page filing late Friday, Assistant U.S. Attorneys George Varghese and Amanda Strachan said the arguments raised by attorneys for Kathy Chin and Michele Thomas are flawed and without merit.
The two, former employees of the New England Compounding Center, were convicted after a four-day trial of multiple violations of the Food Drug and Cosmetic Act.
They were among 14 persons indicted in 2014 after a two year probe of a deadly fungal meningitis. Chin and Thomas, however, were not charged for producing the steroid that caused the outbreak but other drugs that were shipped to health providers in Georgia and Nebraska.
As the filing notes, evidence produced during the April trial showed the two filled prescriptions made out for obviously fake patients, including Filet O Fish and Chester Cheeto.
The jury found the names to be "patently fictitious," the prosecutors stated, adding that testimony from an official of the Mass. Board of Pharmacy showed state law required a patient specific prescription for every drug dispensed by a licensed pharmacist. And, they noted, both defendants were Massachusetts licensed pharmacists.
Rejecting arguments that some states allow pharmacists to dispense drugs in bulk for so-called office use, the brief asserts that no state authorizes pharmacists to issue drugs for fake patients.
"Chin and Thomas, acting as licensed pharmacists" performed the final verification before the drugs were packaged and shipped to customers, the prosecutors argued, adding that there was "ample evidence for the jury to conclude Chin and Thomas willingly dispensed drugs pursuant to fraudulent prescriptions."
The prosecutors noted that the jurors verdicts reached on May 2 were unanimous and the panel concluded the two violated federal law "with the intent to defraud or deceive.
Dismissing arguments that it was NECC part owner Barry Cadden who actually approved each of the fraudulent prescriptions, the prosecutors wrote, "Simply put these drugs could not have been dispensed without them (Chin and Thomas)."
(Cadden was found guilty of racketeering, conspiracy and is now serving a nine year prison sentence.)
In fact, the filing concludes, Chin and Thomas "played indispensable roles supporting and facilitating the fraudulent scheme.
Contact: wfrochejr999@gmail.com