Pharmakon Compound Drug Recall

Pharmakon Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Compounded Products Due to FDA Concern of Lack of Sterility Assurance

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For Immediate Release

April 19, 2016

Contact

Consumers

Pharmakon Pharmaceuticals, Inc.
 888-660-6715

Media

David F. McNamar
  dfmcnamar@mcnamarlaw.com

Announcement

Pharmakon Pharmaceuticals, Inc. is voluntarily recalling all lots of sterile products aseptically compounded and packaged by Pharmakon Pharmaceuticals, Inc. that remain within expiry due to the Food and Drug Administration’s (FDA) concern over a lack of sterility assurance and other quality issues. Administration of a sterile drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death. To date, Pharmakon Pharmaceuticals, Inc. has not received any reports of adverse effects or injuries.
These compounded sterile products are used for a variety of indications and are packaged in bags, syringes and cad cassettes. All recalled products have a label that includes the Pharmakon Pharmaceuticals, Inc. name, address and expiration date. The sterile products were distributed nationwide to hospitals between March 4, 2016 and April 15, 2016.
As Pharmakon Pharmaceuticals, Inc. takes the utmost care to ensure patient safety and out of an abundance of caution, then, Pharmakon Pharmaceuticals, Inc. is notifying its customers that received sterile compounded products via email and is arranging for return of all recalled products. All hospitals that received sterile compounded products from Pharmakon Pharmaceuticals, Inc. between March 4, 2016 and April 15, 2106 and that remain within expiry, to take the following actions:

1. Discontinue use of the products
2. Quarantine any unused product
3. Contact Pharmakon Pharmaceuticals, Inc. at 888-660-6715 x251 from the hours of 8:30am 5:00pm Eastern Standard Time Monday-Friday to discuss the return of any unused sterile compounded products

Customers with questions can contact Pharmakon Pharmaceuticals, Inc. by phone 888-660-6715 Monday-Friday, 8:00am to 5:00pm Eastern Standard Time, or email at contactmfg@pharmakonrx.net
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
• Voluntary Product Recall List: https://pharmakonmfg.net/pr/

This recall is being conducted with the knowledge of and at the request of the U.S. Food and Drug Administration.
Again, Pharmakon Pharmaceuticals, Inc.’s primary concern is your safety and Pharmakon Pharmaceuticals, Inc. is taking this action out of an abundance of caution. Thank you for your support.

###

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Page Last Updated: 04/19/2016
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FDA

Lien Waivers Were Granted in 9/11 Claims

By Walter F. Roche Jr.

Officials of the federal Centers for Medicare and Medicaid Services have confirmed that lien waivers were granted for some victims and first responders from the 9/11 terrorist attacks, thus sparing them from having to repay the government for millions of dollars in medical bills.
Tony Salters, a spokesman for CMS, acknowledged the granting of 9/11 waivers in an email response Monday to a series of questions.
He wrote that waivers were granted for "first responders and other victims related to the September 11, 2001, terrorist attacks on the World Trade Center in New York City."
He said the waivers can be authorized on a discretionary basis under a provision of the Social Security Act which gives the Secretary of Health and Human Services the authority to grant waivers "in the best interests" of the program.
The waivers can be for all or a portion of the amounts sought by the agency for reimbursement of medical costs it paid for Medicare and Medicaid recipients.
Such a waiver already has been denied to victims of the 2012 fungal meningitis outbreak which sickened 778 patients across the country, killing 76 of them.
In response to a request from four members of Congress, HHS Secretary Sylvia Burwell early this year denied the waiver request, just days after it was submitted. The four members of Congress, including U.S. Sen. Lamar Alexander, a Tennessee Republican, had noted in their request that a waiver had been granted for 9/11 victims.
Salters said that notwithstanding the waiver denial negotiations over Medicare liens for the outbreak victims were ongoing with the agency represented in those talks by the U.S. Justice Department.
In a hearing last week in federal court in Boston, Fredric Ellis, who has been representing victims in those negotiations, reported substantial progress.
At issue is how much from a $200 million trust fund will actually go to victims of the outbreak and how much will go to the federal government and private insurance companies.
Some victims have argued that the federal government is in part responsible for the outbreak since federal regulators failed to shutdown the Massachusetts drug compounding firm that shipped fungus tainted drugs across the country. As a result, they argue, the federal government should waive any reimbursement claims
The now defunct New England Compounding Center was cited repeatedly by state and federal regulators  but allowed to keep operating until shortly after the deadly outbreak became public.
The trust fund was generated during the subsequent NECC bankruptcy with contributions from NECC's owners, insurance companies and other related parties. 
Salters said that absent a waiver, federal law requires CMS to seek reimbursement. 
"We understand that many NECC settlement recipients who are Medicare beneficiaries are concerned about their settlements. Medicare routinely works to make sure that, in similar situations, people with Medicare benefits are able to keep a portion of their settlement," he wrote.  
Contact:wfrochejr999@gmail.com 
 

Meningitis Trial Dates Set; First Payments Possible in June-July

By Walter F. Roche Jr.

A federal judge has set a mid-July date for the first trial in the cases brought by Tennessee victims of a fungal meningitis outbreak against the Nashville clinic where they were injected with fungus laden spinal steroids.
In a 45-minute session in her Boston, Mass. courtroom U.S. District Judge Rya Zobel said the trial in the first case would begin around July 15 to be followed by a second trial a month later.
The first case will be the claim of Jane Wray, who was sickened following a steroid injection on Aug. 31, 2012.
In the same session, Zobel was told that, depending on ongoing negotiations, some victims of the outbreak could get initial payments in early June or July from a $200 million trust fund.
The action came amid arguments between lawyers for the victims of the 2012 outbreak and the lawyer for the Saint Thomas Outpatient Neurosurgical Center, the Nashville clinic where many of the victims were injected.
C.J. Gideon, representing the clinic and related parties, urged Zobel not to reverse her prior decision to dismiss claims made under Tennessee's product liability law.
"You were right the first time," Gideon said.
Mark Chalos, one of the attorneys representing victims, said that Zobel could allow the liability claims to go forward in the upcoming trials and let the juries make a decision.
At issue is  a recent ruling in which Zobel concluded that Tennessee's medical liability law precluded claims made under the state's product liability statute. Victims' lawyers have appealed that decision and asked Zobel to reconsider.
Chalos, however, noted that the issue of which law should apply has not yet been ruled on by a federal appellate court or the Tennessee Supreme Court.
"We believe the two statutes can be read in harmony," Chalos argued.
Gideon, however, said the two statutes were "completely irreconcilable" and "inextricably at odds with each other."
Zobel asked both sides to submit further written arguments.
The judge then questioned lawyers about when victims might actually get paid from a $200 million trust fund established in the bankruptcy case of the New England Compounding Center, the company blamed for producing the fungus tainted methylprednisolone acetate.
Frederic Ellis, who has been handling negotiations with federal officials, reported that "significant progress" had been made recently in an attempt to reach a settlement.
At issue is how much the Medicare and Medicaid programs will get from the proposed settlement to reimburse the costs the programs paid for the medical care of the victims. Federal officials already have rejected a request to waive any such claims
Ellis said the median age of the victims was 64 and many were on Medicare when they were sickened.
He said it was possible that payments to some victims whose claims have not been disputed could be made as soon as June or July. There are some 1,200 claims in that category. He cautioned, however, that the negotiations are still ongoing and the outcome is far from certain.
Kristen Johnson, another attorney for victims, noted that the initial payments will not be for the full  amount that victims are entitled to and the final payments will come at a later date, after all claims have been processed.
Ellis said talks also have been progressing with major insurance companies which are also are seeking reimbursement for costs of victims' medical care they have underwritten.
Contact: wfrochejr999@gmail.com

Dead Pilot Fixated on Taylor Swift

By Walter F. Roche Jr.


The pilot who crashed his plane on a fog bound Nashville, Tenn. runway in 2013 was drunk and fixated on Taylor Swift, perhaps explaining his fatal and unauthorized flight from Canada to mid-Tennessee.
A report from the National Transportation Safety Board concludes that Michael Callan, 45, of Windsor Canada crashed his rented plane while attempting to land in dense fog.
"Contributing to the accident was the pilot’s mental state, his impairment due to alcohol, and his decision to operate the airplane from Canada to the United States without the owner’s permission and without proper clearances for the flight," the brief report concludes. 
The Oct. 29, 2013 crash occurred in the early morning, but the wreckage on a Nashville International Airport runway was not discovered till hours late.
Callan's body was found among the charred and scattered remnants of the Cessna 172R aircraft, the pilot had rented from a Windsor flying club.
"This pilot was not supposed to be in the United States flying to Tennessee," an NTSB record states.
The NTSB investigation noted that Callan had apparently circled the airport for some two hours before making his final fatal approach. He had taken off from Windsor some nine hours earlier on a flight that was supposed to end on Pelee Island on Lake Erie within the Canadian border.
Noting that Callan was not qualified to make an instrument landing, the report states, "the pilot was unaware of the IFR (instrument only) conditions in Nashville until he arrived in the area and that, because he was not instrument rated, he was unable to safely land the airplane with no visual contact with the runway."
Callan's mysterious trip drew widespread attention when officials disclosed that he had listed Taylor Swift as his emergency contact person.
Records gathered by NTSB investigators show that Callan had named Swift on his application to the Windsor Flying Club, the organization that rented him the plane. Swift has stated through her publicist that she did not know Callan.
"He (Callan) had developed a significant interest in a celebrity who lived in Nashville," the NTSB report noted, adding that he also had "a history of repeated convictions for criminal activity."
 "Although the medical records did not include a specific psychiatric diagnosis, the pilot’s prior criminal actions and impulsive behavior are consistent with antisocial personality disorder, which likely led to his impetuous decision to fly to Nashville," the NTSB states.
The report cites an August 2012 mental health evaluation of Callan in which "he reported that he had developed a significant interest in a celebrity and had written several letters to her. According to the mental health evaluator, the letters 'have the flavor of stalking.' The celebrity of interest resided in Nashville, Tennessee at the time of the accident."
"Toxicological testing of the pilot’s blood revealed significantly elevated levels of ethanol, indicating that the pilot ingested alcohol before the accident. The alcohol likely further impaired the pilot’s judgment and his ability to fly the airplane safely in IFR (instrument only) conditions," the report adds.
An autopsy conducted by Tennessee authorities following the crash found that Callan's blood alcohol level was .081 percent, over the .080 percent Tennessee legal limit to drive a car. Federal regulations set a  .04 percent limit for aircaft operators.
The NTSB examination of the wreckage "found no mechanical malfunctions or failures that would have precluded normal operation."
Contact: wfrochejr999@gmail.com 
 

Notices Sent to All Meningitis Claimants

By Walter F. Roche Jr.

Initial notification letters have now been mailed to the thousands of patients or their survivors who have filed claims in the bankruptcy case stemming from the 2012 fungal meningitis outbreak.
Fredric Ellis, a Massachusetts attorney representing victims, said Friday that all claimants should have received at least one letter from the court appointed administrator overseeing a $200 million trust fund established in the bankruptcy of the New England Compounding Center.
He said those notices include those whose claims were awarded in full, partial awards and those whose claims were denied.
More than 3,000 claims were filed during the bankruptcy of the Framingham, Mass. firm blamed for the 2012 outbreak that killed 76 patients, the drug firm blamed for the outbreak. Most, though not all of the claims, were filed by victims.
If there are persons who filed claims and haven't received at least one letter, Ellis said those individuals should contact the administrator or their own attorney. Contact information for the administrator is listed on the settlement website (www.neccsettlement.com).
Ellis also said the initial set of appeals filed under the plan have been resolved, but others are still in process and still others have yet to be filed. Claimants generally have 90 days after their notification to file an appeal.
Another key issue - reimbursement claims by the federal government and insurance companies -  remains to be resolved. Ellis said negotiations with the U.S. Centers for Medicare and Medicaid Services and major private insurers are ongoing. He declined to provide any details.
Those claims could vastly reduce, or even eliminate in some cases, any awards going to the victims.
Contact: wfrochejr999@gmail.com)