Friday, January 23, 2015

IG Finds Lack of Oversight in Hospital Use of Drug Compounders

By Walter F. Roche Jr.

More than two years after a nationwide outbreak of deadly fungal meningitis caused by a Massachusetts drug compounding firm, a federal audit has concluded federal regulators have not yet taken necessary steps to ensure adequate regulation of the industry.
In a 23-page report issued this week, the Inspector General for the Department of Health and Human Services found that surveyors, in most cases, don't even check to determine if drug compounding firms serving hospitals have registered with the U.S. Food and Drug Administration.
The report concludes that despite the outbreak which killed more than 64 patients across the country, agencies conducting hospital surveys have no plans to tight.en oversight. (A recent court filing states that the number of deaths has increased to 76)
"Despite outsourced compound injections' being responsible for the 2012 fungal meningitis outbreak, none of the oversight entities plan to change how their oversight addresses hospital contracts with standalone compounding pharmacies," the report states.
The 2012 outbreak has been blamed on the now defunct New England Compounding Center, a for-profit privately owned firm which supplied drugs that were supposed to be sterile to hundreds of hospitals and clinics from Massachusetts to California. Methylprednisolone acetate shipped by NECC was laden with fungus, sickening more than 750 patients. (778, according to a recent court filing)
The IG report focuses on those hospitals, some 80 per cent of those participating in the Medicare program, which contract with private firms to supply compounded drugs.
Officials of the Center for Medicare and Medicaid Services (CMS) did not dispute the findings and concurred with two recommended changes.
The report found that only one of five agencies conducting surveys for CMS reported that it always reviewed hospital contracts with so-called standalone pharmacies.
The report noted that such contract reviews could include determinations of whether the agreements included safety provisions such as appropriate recall, storage and testing requirements.
In another apparent lapse, the report found that surveyors for three of five review agencies did not check to determine whether the standalone pharmacies utilized by hospitals were registered with the FDA under the provisions of a new federal law enacted in the wake of the fungal meningitis outbreak.
 "Because most hospitals do not inspect the standalone pharmacies with which they contract, a satisfactory FDA inspection might be the only indicator of the conditions at a standalone pharmacy."
Other issues raised in the report include the training of surveyors in compounding pharmacy standards and in their ability to analyze supporting documents on hospital practices.
The IG recommended increased training for hospital surveyors and changing Medicare agreements with hospitals to cover standards for contracting with standalone compounding pharmacies.

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Thursday, January 8, 2015

Man Indicted in Drug Compounding Case Admitted Diverting Anti-fungal Drugs

By Walter F. Roche Jr.

One of the the 14 people indicted in the aftermath of a nationwide fungal meningitis outbreak gave up his pharmacy technician's license after admitting to stealing or diverting antifungal drugs from a former employer.
Records of the Massachusetts Board of Pharmacy show that Scott M. Connolly gave up his license in 2008 after getting caught sending 30 fluconazole tablets to an unidentified address in Missouri.
According to those records a contrite Connolly later wrote to the state agency calling his action "an extremely terrible error in judgment."
The drugs, valued at $432.14, are used to treat fungal infections, the same type of infection suffered by the victims of the 2012 outbreak.
According to the 131-count indictment made public last month, Connolly was working as a pharmacy technician for the New England Compounding Center, even though he had no license. The grand jury charged that Connolly used the username and password of his boss, Barry Cadden, to hide his role at NECC.
Prosecutors say that dozens of patients died and hundreds were sickened due to fungus infested sterile drugs shipped from NECC to health providers in more than 20 states.
Connolly was charged with racketeering and conspiracy for his role in one of NECC's clean rooms, the source of some of the contaminated or untested drugs.
Connolly, acting in violation of Massachsuetts' law, oversaw the preparation of a drug called cardioplegia, a drug used to temporarily stop the heart from beating during surgical procedures, the indictment charges. Two pending civil suits charge that NECC's cardioplegia was responsible for the deaths of two youths under treatment at a Las Vegas hospital.
The indictment lists cardioplegia doses shipped to hospitals in nine states, including Nevada, Florida and Massachusetts.
Connolly and the 13 others named in the 73-page indictment have entered not guilty pleas. Those include Cadden, who was a founder of NECC.
The records show a year after surrendering his license, Connolly wrote the panel to plead for reconsideration of his case.
"I know that what I did was wrong and can assure you it will never happen again," he wrote in a 2009 letter.
In the letter he told state regulators he was working for Ameridose, a sister company to NECC. He said he was involved in invoicing but wanted to return to a pharmacist technician's role.
The files indicate that the diversion came to light when the drugs were returned to his then employer, Bioscrip, because there was no one at the address to sign for them and the drugs were sent back to the company. Bioscrip then terminated Connolly and reported him to the state.
The files indicate the Connolly's plea for reconsideration was denied.
According to the indictment, despite the board's turndown, he went to work in the NECC cleanroom as a pharmacy technician.
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Wednesday, January 7, 2015

Meningitis Outbreak Death Toll Jumps to 76

By Walter F. Roche Jr.

The death toll in a 2012 fungal meningitis outbreak jumped by 12 to a total of 76, according to a massive filing in the criminal case against those blamed for the outbreak.
The new death toll numbers were included in an affidavit filed by federal agents to justify the seizure of additional assets from the owners of the New England Compounding Center, the now defunct firm blamed for the outbreak.
According to the filing, the number of victims of the outbreak continued to climb even after officials from the U.S. Centers for Disease Control and Prevention stopped updating the case count.
According to the affidavit the number of patients sickened also continued upward reaching 778, 27 higher than the last CDC count of 751.
"The CDC stopped updating its official count as of Oct. 31, 2013," Joseph Ridgley, a special agent for the U.S. Food and Drug Administration, wrote in one court filed affidavit.
"This investigation, however, revealed that the total number of infected patients increased and is approximately 778, of which 76 have died," he continued.
The new numbers were included in filings made by federal officials to justify the seizure of $18.3 million in assets held by NECC founder and stockholder Barry Cadden and co-owners Lisa and Douglas Conigliaro.
All three were named in a 131-count indictment handed up by a federal grand jury in Boston last month.
The three and 11 others - all owners or employees of NECC- were indicted on charges ranging from second degree murder to mail fraud. They all have entered not guilty pleas. No trial date has been set.
The affidavits totaling 128-pages, which were unsealed this week, detail how Cadden and the Conigliaros paid themselves millions of dollars which had been paid to NECC to provide a fungus tainted spinal steroid injected into the spines and joints of unsuspecting victims.
The 25 counts of second degree murder were lodged against Cadden, who was the chief pharmacist for NECC, and Glenn Chin, a supervisory pharmacist for the Framingham, Mass drug compounding firm.
Under the seizure order assets totaling $1.5 million were seized from Cadden while $16.8 million was seized from Douglas and Lisa Conigliaro.
The Conigliaros were charged in the indictment with violating a bankruptcy court order that had placed a freeze on the $16.8 million.
The owners of NECC already had agreed to contribute nearly $50 million to a $136 million fund to compensate victims of the outbreak. It was not immediately clear how much if any of the additional $18.3 million would be allotted to the victims' fund.
The victims' fund was created as part of the proposed settlement of NECC's bankruptcy case and is subject to approval by U.S. Bankruptcy Judge Henry Boroff.
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Tuesday, January 6, 2015

Feds Seize $18.3 Million from Drug Compounders

By Walter F. Roche Jr.

Federal officials have seized some $18.3 million in additional assets from the owners of a defunct Massachusetts drug compounding company blamed in the deaths of 64 patients.
Seizure orders, which were unsealed Tuesday, show that the funds were taken from the bank and investment accounts of members of the Cadden and Conigliaro families, owners of the defunct New England Compounding Center.
The funds are in addition to nearly $50 million from the two families under a settlement for a pending bankruptcy case. Overall some $136 million is expected to be available for victims of the 2012 fungal meningitis outbreak which sickened or killed 751 patients.
According to Boston U.S. Attorney Carmen Ortiz the seizures included $1.5 million from three accounts held by Barry J. Cadden, who  was indicted recently on charges of second degree murder in the deaths of 25 of the 64 victims.
Funds totaling $16.8 million held by Carla Conigliaro and her husband Douglas also were frozen.
In the recent indictment Carla and Douglas Conigliaro were charged with violating a bankruptcy court order freezing their assets.
The court records unsealed Tuesday charge that the Conigliaros transferred millions of dollars the same week NECC surrendered its state license and shortly before the company filed for bankruptcy.
The Conigliaros and Cadden were among 14 indicted by a federal grand jury in December following a more than two year investigation of the 2012 outbreak, which has been blamed on fungus tainted spinal steroids shipped by NECC to health care providers across the country.
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Tuesday, December 30, 2014

Prosecutors Say Outbreak Death Toll Tops Official Figure.

By Walter F. Roche Jr.

Federal prosecutors disclosed Tuesday that the death toll from a 2012 fungal meningitis outbreak exceeded the official figure of 64 set by the U.S. Centers for Disease Control and Prevention.
"We know the number is much higher," said Assistant U.S. Attorney Amanda Strachan, who also said the victims were not limited to patients injected with a spinal steroid, methylprednisolone acetate.
"Our investigation found a much higher number than that," Strachan said referring to the CDC case count.
Strachan and U.S. Attorney George P. Varghese, both working from the U.S. Attorney's office in Boston, Mass., made the disclosure in a conference call with victims of the outbreak or their survivors.
Though victims were allowed to listen in, they were not allowed to ask questions during the 25 minute session.
The official CDC count set the deaths at 64, with a total of 751 patients suffering illness or death.
In the 25 minute call, the two prosecutors stressed that they were aware that there were many more victims than the 25 specifically named in the 73-page 131 count indictment.
The indictment charges two persons, Barry Cadden and Glenn Chin with 25 counts of second degree murder. Cadden was part owner of the New England Compounding Center, the company blamed for the outbreak. Chin was the supervisory pharmacist.
Twelve other owners or employees of NECC were also charged in the indictment on charges ranging from racketeering, mail fraud, conspiracy to defrauding the U.S. government.
Strachan said Cadden and Chin were charged with the most serious crimes because they were the two most directly responsible for shipping fungus tainted drugs to doctors and healthcare facilities around the country.
She explained that to prove second degree murder prosecutors don't have to prove that the two intended to kill anyone, but that they acted "with wanton and willful disregard for human life."
Strachan said that by picking 25 specific cases, the prosecutors realized there were many more victims."
"You are all victims," she said.
She noted that records showed that in 37 out of 38 weeks in 2012, tests showed that there were not sterile conditions at NECC, but no action was taken despite state and federal requirements to do so.
The prosecutors noted that other non-sterile drugs were shipped out even though tests had shown they were contaminated
Strachan said that one of those charged, Scott Connelly, was overseeing preparation of a drug called cardioplegia, which is used to stop the heart beat during surgery.
Connolly was not licensed as a pharmacy technician and in fact had given up his license in 2009, she said.
Two pending suits in federal court charge that two children died in a Las Vegas hospital after being injected with cardioplegia shipped from NECC.
"It was not just about the methylprednisolone acetate," Strachan said.
Varghese warned the victims that it could be up to two years before all the charges are resolved, but said they would be advised of major developments. He also said that victims might be eligible for aid through victim assistance programs.
Varghese also outlined how two of those charged, Carla and Douglas Conigliaro, withdrew some $33.3 million from various accounts even though a freeze had been placed on them by a U.S. Bankruptcy judge.
A plan now under consideration in bankruptcy court would provide some $146 million for victims and creditors of NECC. Prosecutors stressed in the call Tuesday that the funds set aside in that settlement would not be affected by the criminal case and related forfeiture efforts.
"This does not affect the settlement," Varghese said.
Dozens of civil suits arising from the outbreak have been merged in federal court in Boston.
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Sunday, December 28, 2014

Meningitis Outbreak Victims Offered Explanation from Prosecutors

By Walter F. Roche Jr.

Victims of the 2012 fungal meningitis outbreak or their survivors are being offered a chance to listen to an official explanation of the recent indictment of 14 owners and employees of the Massachusetts company blamed for the fatal outbreak.
In a two-page letter sent to the victims or their survivors last week, U.S. Attorney Carmen Ortiz said prosecutors will offer the explanations in conference calls on Tuesday Dec. 30 and Tuesday Jan. 6, 2015. Both calls are scheduled for 2:30 p.m. (see call in information below).
In the letter, Ortiz described the indictments including the second degree murder charges against one of the NECC owners, Barry Cadden, and NECC's chief pharmacist, Glenn Chin.
"You are receiving this letter because you were identified as a victim or the designated contact person for a victims," the letter states.
According to federal officials 64 patients died and 751 were sickened after being injected with fungus tainted methylprednisolone acetate shipped from NECC's Framingham, Mass. headquarters.
Ortiz noted that to get a conviction of second degree murder, prosecutors don't have to prove that the defendants intended to kill the victims, "but rather that Cadden and Chin acted with extreme recklessness likely to cause death."
She also acknowledged that 25 murder counts represent a small fraction of the total number of victims.
She wrote that determining which cases to include was a "difficult decision" based on "numerous factors."
"Even if you or your loved one were not named in the indictment, you are still recognized as a victims," Ortiz wrote.
Other charges in the indictment include mail fraud, racketeering and conspiracy.
Victims will be able to listen in on the conference calls but will not be able to ask questions.

Call-In Information:
Tuesday Dec. 30, 2014 2:30 P.M. Eastern Time
Tuesday Jan. 6, 2015 2:30 p.m.

Call-In numbers 1-888-970-4169 toll free 1-212-547-0140  toll call
Pass Code 3586140


Named Victims
Michigan: Karina Baxter, Paula Brent, Gayle Gipson, Donna Kruzich, Lynn Laperriere, Mary Pletti,
Sally Roe, Emma Todd
Tennessee: Marie Hester, Eddie Lovelace, Donald McDavid, Diana Reed, Thomas Rybinski, Carol Wetton, Earline Williams
Indiana: Pauline Burema, Kathy Dillon, Alice Machowiak
Maryland: Bahman Kashi, Brenda Rozek, Edna Young
Virginia: Kathy Sinclair, Douglas Wingate
Florida: Godwin Mitchell
North Carolina: Elwina Shaw

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Thursday, December 25, 2014

Judge in Meningitis Cases Blocks Release of Trust Records

By Walter F. Roche Jr.

A magistrate judge has rejected a request by lawyers for Nashville area victims of a national fungal meningitis outbreak to force the disclosure of the details of a trust agreement related to the insurance coverage of the Saint Thomas Health.
The six-page order by Magistrate Judge Jennifer Boal, which already is being appealed, concludes that lawyers for the victims cannot force Saint Thomas Health to make details of the trust agreement available.
The issue was the subject of a Dec. 4 hearing in Boston.
Citing court rules, Boal wrote, "The court finds that the trust agreement is not discoverable."
The victims' lawyers contend that the information is needed to discover how much money might be available to reach a settlement in some 100 cases. They have accused the hospital parties of engaging in "a corporate shell game in an attempt to shield the Saint Thomas entities from the liability of its agent."
The victims were injected with a fungus laden steroid at the Saint Thomas Outpatient Neurosurgical Center, which is described in court filings as an agent of the Saint Thomas parties. Nationwide the outbreak took the lives of 64 patients and sickened 751.
In her ruling Boal concluded that "the trust appears to qualify as self insurance" and that the victims through their lawyers had "not sufficiently shown here how the trust documents are relevant to any claims or defenses in this action."
In an appeal now pending before U.S. District Judge Rya W. Zobel, Nashville attorney Mark Chalos wrote that Boal's decision was in error and the trust documents "are subject to mandatory disclosure."
"They are relevant to this action and will promote settlement and will help parties move this litigation to just, speedy and inexpensive solution,"the 18-page appeal states.
 "Disclosure is needed for the plaintiffs' steering committee to understand the terms of coverage," Chalos concluded, adding that the documents would help them determine "what may or may not be covered."
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