Nevada Drug Compounder In Recall

Well Care Compounding Pharmacy Issues Voluntary Statewide Recall of All Sterile Compounded Products Due to Lack Of Assurance if Sterility Concerns

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For Immediate Release

May 17, 2016

Contact

Consumers

Well Care Compounding Pharmacy
  info@mywellcarepharmacy.com 
 (702) 553-2575

Announcement

Well Care Compounding Pharmacy, Las Vegas, Nevada is performing a voluntary statewide recall in Nevada on all unexpired sterile compounded products due to the Food and Drug Administration’s (FDA) concern over lack of sterility assurance. The recall impacts all sterile compounded products distributed between 01/01/2016-04/29/2016.

Administration of a sterile drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death.

All recalled products have a label that includes the name Well Care Compounding Pharmacy, logo, drug name, and expiration date. If unsure, Customers can call the pharmacy to determine the expiration date.

We have not received any reports of adverse effects or injuries to date. We are conducting this recall after an inspection conducted by the FDA. Customers that have any recalled products should immediately stop using it and contact the pharmacy to arrange for the return of any unused product.

Well Care Compounding Pharmacy takes the utmost care to ensure patient safety and performing this voluntary recall. Customers with questions regarding this recall can call the pharmacy by phone (702) 553-2575 Monday through Friday 9am – 6pm PST or email at info@mywellcarepharmacy.com.

Adverse reactions or quality problems experiences with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

1. Complete and submit the report online: www.fda.gov/medwatch/report.htm
2. 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

For reporting animal adverse drug events, please follow the link to the FORM FDA 1932a found at:http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

Well Care Compounding Pharmacy regrets any inconvenience and disruption due to this recall on its customers, however, the safety of customers are the primary concern.

This recall is being conducted with the knowledge of the Food and Drug Administration.

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Judge Rules Racketeering Charges Stand in NECC Case

By Walter F. Roche Jr.

In a key ruling a federal judge has rejected an attempt to have racketeering charges dismissed against owners and employees of the company blamed for a deadly 2012 fungal meningitis outbreak.
In an 8-page decision U.S. District Judge Richard Stearns concluded that the defendants will have to face the racketeering charges when the case comes to trial this fall.
While acknowledging that the theory of prosecutors in bringing the charges was somewhat novel, Stearns concluded it was not without precedent.
  "I agree with the government that the indictment passes muster," Stearns wrote in the case pending in U.S. District Court in Boston, Mass.
The decision comes in a massive indictment stemming from the 2012 fatal fungal meningitis outbreak that sickened 778 patients, killing 76 of them.
The 131-count indictment charges two of the defendants, Barry Cadden and Glenn Chin, with 25 counts of second degree murder. In addition to the racketeering charges, all 14 defendants face mail and wire fraud charges.
The defendants had sought to have 92 of the charges dismissed.
Lawyers for the defendants had challenged the legality of the racketeering charges because they hinged on sterility standards set by a non-government agency, the United States Pharmacopeia Convention.
Some legal commentators had labeled the indictment "an unprecedented approach to regulatory violations."
Cadden was part owner of the New England Compounding Center, the firm blamed for the 2012 fungal meningitis outbreak and Chin was the chief pharmacist. The defunct company shipped thousands of vials of fungus infested methylprednisolone acetate to health care providers across the country.
The tainted drugs, which were supposed to be sterile, were injected into the spines and joints of thousands of patients in at least 20 states.
In his decision, Stearns said he agreed with the argument of defendants that prosecutors should be barred from claiming the U. S. Pharmacopeia standards had the force of law, but noted that prosecutors had stated they did not intend to do so.
"The defendants are not charged with violating the USP but rather are charged with perpetrating a scheme to defraud customers based on misrepresenting NECC's compliance with the USP," the ruling concludes.
Still pending before Stearns is a motion to dismiss the second degree murder charges.
Contact:wfrochejr999@gmail.com

Grants To Meningitis Outbreak Victims in Jeopardy

By Walter F. Roche Jr.

A proposal that could put $25,000 into the hands of victims of the 2012 fungal meningitis outbreak has been approved by one federal agency only to be rejected by another.
Under the proposal victims of the outbreak could get some $25,000 each from a crime victims fund overseen by the U.S. Department of Justice.
But while DOJ officials had agreed to the proposal, officials of the U.S. Office of Management and Budget have nixed the idea, apparently due to budgetary concerns.
As a result a Michigan congressman is leading an effort to lobby other members of congress and OMB to reverse the decision.
U.S. Rep. Mike Bishop's staff has been calling on victims of the deadly outbreak to contact their representatives in Congress voicing support for his effort to get OMB to drop its opposition to use of the DOJ victims compensation fund.
The effort comes as victims are still awaiting a share of a $200 million trust fund created under the bankruptcy of the New England Compounding Center, the defunct firm blamed for the outbreak.
Fungus infested steroids shipped by NECC to health care providers across the country sickened 778 patients, killing 76 of them.
Owners and employees of NECC have entered not guilty pleas to charges ranging from second degree murder to mail and wire fraud in connection with the outbreak. A trial is scheduled to begin later this year.
Fredric Ellis, a Boston attorney who has been negotiating with DOJ in behalf of victims in a separate but related issue said in an email response to questions that he did not have any information on the crime victims fund issue.
Ellis has been involved in discussions with DOJ on how much officials of the federal Medicare and Medicaid programs will seek to recover from awards victims receive from the NECC trust fund.
Victims, many from Michigan, have been contacting not only local congress members, but also emailing President Obama.
The emails cite not only the victims compensation fund issue but also a decision by Health and Human Services Secretary Sylvia Burwell to deny a request for a blanket exemption from Medicare and Medicaid for recovery of any money from the $200 million NECC trust fund.
One of the emails to Obama states," Please, please have your administration do the right and moral thing and reverse their decisions."
Contact: wfrochejr999@gmail.com

Another PharMEDium Recall

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

PharMEDium Issues Voluntary Nationwide Recall Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl) Due to the Presence of Glass Particulate Matter

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For Immediate Release

May 5, 2016

Contact

Consumers

Thomas Rasnic
 847-457-2256

Announcement

Lake Forest, IL PharMEDium Services, LLC is voluntarily recalling the codes/lots of sterile preparations compounded with a single recalled lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl) to the hospital level. Fresenius Kabi recalled the specific lot at issue due to identification of particulate matter characterized as glass during reserve sample inspection. The list of affected codes/lots can be found on PharMEDium’s website at http://www.pharmedium.com/.
Fresenius Kabi indicated in its recall notice that the presence of glass particulate matter in solution, if undetected and administered via the epidural route, could block drug administration, delaying therapy. If the particulate is able to pass through the catheter and enter the body, this could result in local inflammation, mechanical disruption of tissue or cause an immune response to the particulate. PharMEDium Services has not received any reports of adverse events to date related to the Fresenius Kabi recall.
The drug products affected by this recall are indicated for the production of local or regional anesthesia or analgesia for surgery procedures, diagnostic and therapeutic procedures and for obstetrical procedures. The affected codes are contained in the attached list including lot number and expiration dates. The product was distributed to hospital customers and acute surgery centers in the United States.
PharMEDium Services has contracted with Inmar Pharmaceutical Services to coordinate this recall. Inmar will send notification via electronic mail to all affected customers, request an accounting of remaining units, quarantine the affected products and ensure the destruction of products.
Hospital pharmacies or acute surgery centers that have one or more of the products referenced in this notice should immediately remove from all points of use and quarantine in accordance with applicable hospital policy. Hospital pharmacies or acute surgery centers that may have shared these products with other hospitals should contact those hospitals that received the products.
Hospital or health care providers with questions regarding this recall can contact PharMEDium Services by calling 847-457-2244 or quality1@pharmedium.com Monday through Friday, 8:00 AM to 5:00 PM, Central Standard Time. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
P10799 Rev 1 (B)

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Charges Fly in Meningitis Court Filings

By Walter F. Roche Jr.

Saint Thomas Health of Nashville,Tenn. and related entities are asking a judge to dismiss most of the most serious claims against them in some 100 suits, contending they had no control over the clinic in which they held a 50 percent ownership interest.
In a series of filings in U.S. District Court in Boston, lawyers for Saint Thomas state that neither the health care nonprofit nor its employees "had any role in causing the contamination" that sickened over 100 Tennessee patients and killed 13 of them.
The health care firm's filings have triggered a sharp response from lawyers for victims of the 2012 fungal meningitis outbreak caused by fungus tainted spinal steroids injected in patients at Nashville's Saint Thomas Outpatient Neurosurgical Center.
"The record contains documents and testimony indicating that the Saint Thomas entities could and did exercise control over the Saint Thomas clinic," the rebuttal states, adding that Saint Thomas breached its duty by allowing the clinic to operate "below the required standard of care."
The Saint Thomas motion to erase liability claims, if granted, would likely have a substantial impact on the amount, if any, local victims can collect from trials scheduled to begin this summer.
In a recent filing with state regulators in Alabama for an upcoming bond issue, Saint Thomas' parent company, Ascension Health, in fact appeared to assume the motion would be granted and its liabilities sharply limited.
"The Tennessee Plaintiffs," the filing states," allege only vicarious liability against the Saint Thomas entities and the Ascension entities, where applicable, for the actions of Saint Thomas Outpatient Neurosurgical Center, Howell Allen Clinic and their employees."
The disclosure states that Ascension's management "does not believe this matter, if decided adversely to the defendants, would have a material adverse impact on the System's financial position or the results of operations as a whole."
In fact, as the court filings show, the motion to dismiss the liability claims is still pending before U.S. District Judge Rya Zobel.
In its 22-page memorandum seeking dismissal of the claims, the Saint Thomas entities contend that employees of the Howell Allen Clinic, the co-owner of the neurosurgical center, ran the outpatient center and were responsible for the decision to purchase steroids from the New England Compounding Center, the firm blamed for the 2012 meningitis outbreak.
"The Saint Thomas entities did not have any right of control over the operation of the (neurosurgical center) or the Howell Allen employees who ran it," the memo states, adding that all the patients treated at the clinic had been referred by Howell Allen doctors.
As a result, they concluded, "actual agency and direct liability claims should be dismissed."
The 27-page brief filed for plaintiffs by Nashville attorney Mark Chalos, cites internal Saint Thomas emails and deposition testimony to challenge the health care firms claims of non-involvement.
Quoted was an email from then Saint Thomas President Michael Schatzlein to Howell Allen which states,"You may be assured no one from Saint Thomas has referred to (the neurosurgical center) as an unaffiliated clinic."
Calling the Saint Thomas entities and the clinic "an indistinguishable tangle of related entities," the brief notes that it was Saint Thomas personnel who were assigned to contact patients after the outbreak became public in the Fall of 2012.
The brief also cites testimony showing that the chief pharmacist at Saint Thomas had ordered all pharmacy staff not to purchase drugs from any drug compounders and even contacted state drug regulators expressing concern about the legality of NECC's promise to deliver compounded drugs without patient-specific prescriptions.
While the ban was put in place at Saint Thomas non-profit entities, the filing states, the for profit neurosurgical center half owned by a Saint Thomas entity, purchased the tainted drugs from NECC.
In a reply to that brief, Saint Thomas attorney Sarah P. Kelly, charged that the Schatzlein email had been taken out of context and "facts doom" the direct liability claims.

Saint Thomas' Parent Predicts Little Impact From Meningitis Suits

By Walter F. Roche Jr.

Officials of the parent company of Saint Thomas Health in Nashville, Tenn. have informed bond holders that they do not expect some 100 pending suits over a deadly fungal meningitis outbreak to have a substantial adverse financial impact, even if the cases are lost.
The disclosure about the potential financial impact of the lawsuits was included in a $73 million bond prospectus just filed by Ascension Health with regulatory authorities in Alabama.
"At this time," the disclosure states, "management of Ascension does not believe this matter, if decided adversely to the defendants, would have a material adverse impact on the System's financial position or the results of operations as a whole."
One of defendants referred to in the filing is the Saint Thomas Outpatient Neurosurgical Center, the clinic where most of the Tennessee victims of the fatal 2012 fungal meningitis outbreak were injected with fungus tainted spinal steroids.
The outpatient clinic is 50 per cent owned by the Saint Thomas Network, which is named as a defendant in a number of the some 100 pending suits. 
As the prospectus discloses several other Saint Thomas entities are also named as defendants. And while a federal judge did dismiss the claims against Ascension Health, the claims against the clinic and the Saint Thomas entities are proceeding towards trials scheduled to begin in mid-July.
"The Saint Thomas entities are in the process of concluding discovery in the (MDL) litigation," the bond document states.
The filing is apparently the first public disclosure of the predicted impact of the litigation.
 "The Tennessee Plaintiffs," the disclosure continues," allege only vicarious liability against the Saint Thomas entities and the Ascension entities, where applicable, for the actions of Saint Thomas Outpatient Neurosurgical Center, Howell Allen Clinic and their employees."
Howell Allen is the 50 per cent owner of the outpatient neurosurgical center.
As the filing recounts, the suits, first filed in federal court in Tennessee, have been merged before U.S. District Judge Rya Zobel in federal court in Boston, Mass.
Zobel ruled recently that the victims of the outbreak could not pursue product liability claims against the neurosurgical center and the related parties. Lawyers for victims have asked Zobel to reconsider that decision
Zobel has set a mid-July date to begin the first trial involving a claim by Tennessee victim Jane Wray. Two other so-called bell-wether cases are scheduled for August and September.
Contact:wfrochejr999@gmail.com

Death Toll From Outbreak Still Climbing

By Walter F. Roche Jr.

It was more than three years after he first became sickened when 48-year-old Daniel Lindenberg passed away in Evansville, Ind. on March 7.
Lindenberg, according to his wife Carolyn, never fully recovered from the fungal meningitis that struck him in 2012 along with the after effects of the powerful antifungal medicines taken to combat it.
Lindenberg already had been counted as one of the 778 victims of the outbreak, but now his widow says she has been in touch with health officials to have his death added to the 76 known fatalities.
Although the U.S. Centers for Disease Control and Prevention lists 753 victims and 64 deaths from the outbreak, federal investigators later boosted that total as a result of a lengthy criminal probe.
Indiana, according to the CDC, had 93 victims, 11 of them died.
Attorneys familiar with the outbreak have long felt that there are still other victims, both dead and alive, that would boost the totals even higher.
Some of the now known cases only were identified after victims bodies were exhumed and autopsied.
One such case was that of a Kentucky judge, Eddie C. Lovelace, whose death was at first attributed to a stroke. An autopsy performed after exhumation however, showed it was fungus tainted steroids from a Massachusetts firm that caused his death.
In another case, Gokulbhai Patel's name was added to the victim's list only after his family filed suit in late 2013. The Nashville resident had died of fungal meningitis on Jan. 13, 2013.
Lindenberg said she is "trying to get my Danny's death included in the official death toll number."
She said in an email response to questions that fungal meningitis was listed on her husband's death certificate as the official cause of death.
Daniel Lindenberg was also one of a growing group of victims who made contact with other victims through social media outlets including blogs, sharing pains and even occasional laughs.
One of those other victims recently paid tribute to Lindenberg on his memorial page.
"You were a bright star in the outbreak and made me laugh so many times when I thought I couldn't go on. You are already missed," the victim wrote.
"It helps to know you are no longer in pain."
Before his death Lindenberg, who reported suffering severe pain, multiple seizures and hallucinations from antifungal drugs,  told a reporter in 2013 about his concern for fellow victims.
"There are people out there suffering. They're losing their jobs, their houses and their lives," Lindenberg said.
Besides his wife Lindenberg left a son, a daughter and three grandchildren
Contact: wfrochejr999@gmail.com