Tuesday, May 31, 2016

Settlement of Medicare Liens Not Uncommon

By Walter F. Roche Jr.

The settlement of millions of dollars in Medicare liens remains a major obstacle for victims of the 2012 fungal meningitis outbreak, but legal experts say such liens are routinely negotiated with federal officials by a widely accepted formula.
A review of past cases and legal journal articles shows a typical case with a $25,000 Medicare lien on a $50,000 settlement would be negotiated with the federal government getting a payment of $17,500 instead of the full $25,000. (See Excerpt Below)
Medicare and Medicaid liens on a $200 million trust fund established for outbreak victims have been the subject of ongoing negotiations between lawyers for victims of the outbreak and federal lawyers representing the Centers for Medicare and Medicaid Services.
Fredric Ellis, a Boston lawyer, who has been involved in negotiations for a master settlement in the meningitis cases recently told a federal judge that he expected those talks would end soon, though he did not predict whether they would end in success or failure.
Victims have been told they cannot get any payments from the trust fund until the liens are resolved.
In a hypothetical case cited by the Center for Medicare Advocacy, a claim for $100,000 was settled for $50,000 while Medicare claimed reimbursement for the $25,000 it paid in medical bills.
Under the hypothetical case, the Medicare claim would be reduced by an amount equal to the fee paid to the victim's lawyer, plus actual costs incurred in the case.
With a legal fee based on 30 per cent of the settlement, Medicare would reduce its fee to $17,500. The lawyer would get $15,000.
That would leave the victim $17,500 going to the victim, according to the advocacy group.
If the negotiations for a master settlement with CMS fail, legal experts say, it is likely that a process similar to the hypothetical case will be applied to the individual claims of the 2012 outbreak victims.
Ellis did tell U.S. District Judge Rya Zobel that he expected initial payments for some 1,200 victims would be made in July.
Contact: wfrochejr999@gmail.com

  Example From the Center for Medicare Advocacy

Example: Ben Beneficiary received a settlement of $50,000 following an accident. His medical expenses were $40,000, of which Medicare paid $25,000; his pain and suffering were valued at $10,000; lost wages were $20,000; and his permanent loss of limb was valued at $30,000.
Despite the fact that Ben's settlement was only 50% of his $100,000 damages, Medicare will demand recovery of its entire $25,000 outlay, reduced only by its proportionate share of the procurement costs. Assuming a 30% contingency fee arrangement, Medicare will claim $17,500, Beneficiary's personal injury attorney will receive a fee of $15,000, and Ben will receive only $17,500, leaving him with $82,500 in uncompensated losses.

Sunday, May 29, 2016

Meningitis Cases Put on Hold; Settlement Near?

By Walter F. Roche Jr.

A federal judge has abruptly put off scheduled trials and put other issues on an indefinite hold amid hints of a possible settlement for some Tennessee victims of the 2012 fungal meningitis outbreak.
In a two-page order issued Tuesday U.S. District Judge Rya W. Zobel called off so-called bellweather trials that had been scheduled to begin in mid-August.
The order also puts on hold several pre-trial matters that were expected to be acted upon in the coming weeks.
"The court will refrain from deciding ripe dispositive motions - this order supersedes any briefing schedule for both dispositive motions and unripe motions," the order states.
Lawyers involved in the cases said they were barred under confidentiality rules from discussing or commenting on what triggered the order.
Another recent court filing, however, hints at the possibility of a settlement.
The cases that had been scheduled for trial before Zobel were all brought in behalf of outbreak victims who were infected following treatment at the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn.
The motions put on hold by Zobel also involved claims by victims who were treated at the Nashville clinic.
Dozens of suits filed in behalf of the Nashville clinics' patients are currently pending before Zobel. A suit brought by Jane Wray had been scheduled to go to trial in mid-August.
Zobel ordered all parties in the cases to report back to her within 90 days.
Two other Tennessee clinics, including the Specialty Surgery Center in  Crossville, have been sued by outbreak clinics but it was not immediately clear whether those other clinic cases were included in a possible settlement. Zobel's order refers specifically to the Saint Thomas cases.
Still other outbreak cases before Zobel may be headed back to state and federal courts where they were originally filed. The judge has scheduled a hearing for next month to consider a proposal that would shift more than a dozen of those cases back to their home courts.
All the cases before Zobel stem from the 2012 fungal meningitis outbreak caused by a now defunct drug compounding firm. The company shipped thousands of vials of fungus tainted spinal steroids to medical facilities in more than 20 states.
The outbreak sickened 778 patients, killing 76 of them.
Contact: wfrochejr999@gmail.com

MDL NO. 13-02419-RWZ
ORDER May 24, 2016
ZOBEL, J. The Plaintiffs’ Steering Committee, the STOPNC defendants,1 and the St.
Thomas Entities2 have orally moved the court for relief from several impending deadlines. That motion is ALLOWED.
The bellwether trials already scheduled, Wray v. Ameridose, LLC, Temple v. Ameridose, LLC, and McElwee v. Ameridose, LLC, are continued in supersession of the court’s April 26, 2016 order (Docket # 2828). The court will refrain from deciding ripe dispositive motions—this order supersedes the court’s May 20, 2016 order (Docket # 2898), and suspends any briefing schedule for both unripe dispositive motions and unripe motions for leave to file such motions.
Saint Thomas Outpatient Neurosurgical Center, LLC, Howell Allen Clinic, P.C., Vaughan Allan,
1 Debra Schamberg, RN, and John Culclasure.
2 Thomas Health.
Saint Thomas West Hospital f/k/a St. Thomas Hospital, Saint Thomas Network, and Saint 1
Case 1:13-md-02419-RWZ    Document 2912    Filed 05/24/16    Page 2 of 2
The court will also refrain from deciding the following discovery motions: Motion in Limine to Exclude Reference to Michael O’Neal, O’Neal’s Pharmacy Consulting Services; and St. Thomas Neurosurgical’s Medical Executive Committee (Docket # 2608); Motion to Compel Completion of the Deposition of David Kessler, MD (Docket # 2763); Motion to Strike Matthew C. Lee as Case-Specific Expert (Docket # 2769); Motion to Quash Subpoenas and for Protective Order (Docket # 2815); Motion to Strike Mixon’s Supplemental Report (Docket # 2829).
Within 90 days, the parties shall file a status report with the court. The parties shall likewise notify the court immediately of any material deviation from their present positions.
May 24, 2016 DATE    RYA W. ZOBEL

Wednesday, May 25, 2016

Some Meningitis Suits May be Headed Back Home

By Walter F. Roche Jr.

More than 20 of the remaining civil suits stemming from the deadly 2012 fungal meningitis outbreak may be headed from a federal court in Boston back to the state and federal courts where they originated.
In papers filed Wednesday in U.S. District Court in Boston, lawyers for victims of the outbreak proposed that attorneys for the victims and defendants in some 28 cases be given deadlines for indicating whether they want to take their cases back to the state or federal court where the claims were first filed or continue litigation before U.S. District Court Judge Rya W. Zobel.
According to the proposed order, a majority of the attorneys involved in the cases already have indicated they would not object to a return to their home courts.
The proposal would not apply to suits filed against the Saint Thomas Outpatient Neurosurgical Center and the Howell Allen Clinic in Nashville, Tenn. or the Specialty Surgery Center in Crossville, Tenn.
The cases, which were consolidated in Boston some three years, ago stem from the fungal meningitis outbreak which sickened 778 patients across the country, killing 76 of them. The outbreak was traced to fungus infested vials of a spinal steroid produced by the now defunct New England Compounding Center.
The cases under consideration for remand involve clinics facing only one to four claims.
"The most prudent course of action," the filing states, "is to remand cases originally filed in state courts and transfer cases filed in federal court back to their home districts."
Under the proposal attorneys in 26 of the affected cases would be required to state their preferences by June 16. Zobel is scheduled to consider the issue at a June 22 hearing.
Lawyers for victims  treated at the Premier Orthopedics in Vineland, NJ and the Box Hill Surgery Center in Abingdon, MD. would have until July 16 to state their preferences. Those cases, according to the filing, are more advanced than the others.
The proposed partial unraveling of some of the fungal meningitis cases comes as  the scheduled start-up of so-called bellwether cases involving the Nashville clinic are nearing trial. The first case is now set for mid-August.
The filing states that some attorneys when first polled simply wanted more time to confer with their clients before committing to a remand.
In addition to the Box Hill and Premier cases, the defendants in the other 26 cases include Cincinnati Pain Management Consultants in Ohio, Encino Outpatient Surgery Center in California, OSMC Outpatient Surgery in Indiana, Ambulatory Care Center in Indiana, BKC Pain Specialists in Ohio, Ocean State Pain Management in Rhode Island and Sunrise Hospital and Medical Center in Las Vegas, Nev.

Thursday, May 19, 2016

Some Meningitis Payments Likely In July

By Walter F. Roche Jr.

A key effort to negotiate a master settlement on federal claims on a trust fund for victims of the 2012 fungal meningitis outbreak should be finally determined in the next week, a federal judge was told Thursday.
Fredric Ellis, a lawyer for some of the victims, told U.S. District Judge Rya Zobel in her Boston, Mass. courtroom that regardless of the outcome of those negotiations, some 1,200 victims should be receiving partial payments from the $200 million trust fund in July.
"Twelve hundred are ready to go," Ellis said in response to questions from Zobel.
The disclosure came in a one-hour status conference in hundreds of civil suits stemming from  the 2012 outbreak, which sickened 778 patients in more than 20 states, killing 76 of them.
Ellis said that the months long negotiations with officials of the federal Medicare and Medicaid programs over how much of the $200 million will go to reimburse those programs for victims' health care during the outbreak are coming to a head.
"We'll know in a week whether we'll have an agreement or not," Ellis said.
Without a master agreement, according to those familiar with the case, Medicare and Medicaid reimbursement claims will have to be decided on a case-by-case basis.
In other matters, the attorney for Nashville's Saint Thomas Network argued that the non-profit cannot be held liable directly or indirectly for claims against the Nashville clinic where victims of the outbreak were injected with fungus tainted spinal steroids.
Though the network is 50 per cent owner of the Saint Thomas Outpatient Neurosurgical Center, Marcy Greer said the network and related Saint Thomas entities had no control or responsibility over the purchase of drugs by the outpatient center.
She said the two key employees of the center, Dr. John Culclasure and Deborah Schamberg RN, were employees of the Howell Allen Clinic, which owns the other half of the neurosurgical center.
"There is really no basis for this (claim) whatsover," Greer said. "We cannot be held liable for anything Dr. Culclasure did."
Marc Chalos, representing Nashville victims, however, said the Saint Thomas entities had complete control and cited a provision in the operating agreement giving Saint Thomas veto power over clinic actions.
"In fact they did exercise control," Chalos said, citing deposition testimony of the former top Saint Thomas official Michael Schatzlein.
He noted that Saint Thomas ordered its non-profit entities not to use compounded drugs like those used in the clinic, but never issued the same edict to its for-profit entities.
In other developments, Keri L. Wintle, the attorney for Paul Moore, who served as trustee for the New England Compounding Center, reported that the owners of the defunct company have received tax refunds for the 2014 year, but refunds for other years are still awaited. NECC was the source of the tainted drugs causing the outbreak.
Those refunds could provide a significant boost to the amount available to victims, since they will be added to the $200 million trust fund, under the bankruptcy court settlement agreement. The amount of the 2014 refund, however, was not disclosed.
 Also discussed were the preparation for upcoming bellweather trials of three of the outbreak victims, scheduled to be held in Zobel's courtroom beginning in August. A July date start-up had been set originally for the cases filed in behalf of Jane Wray, Reba Temple and Basil McElwee. Temple died in the outbreak while Wray and McElwee survived.

Wednesday, May 18, 2016

Letter Seeks Reversal on Aid to Outbreak Victims

By Walter F. Roche Jr.

Eighteen U.S. House members have asked the Obama administration officials to reverse a decision by the Office of Management and Budget blocking aid of up to $25,000 apiece to victims of the deadly 2012 fungal meningitis outbreak.
The House members, led by Michigan Republican Micheal Bishop and including Tennessee Democrat Jim Cooper, are asking OMB Director Shaun Donovan to reverse a decision denying the outbreak victims grants from a federally funded crime victims fund.
The letter notes that victims of the outbreak have yet to receive any payments, although a separate $200 million trust fund has been created in a related federal bankruptcy case.
Calling the decision wrong in every sense of the word, the letter demands that the decision be reversed.
"Children have lost their mothers and fathers, parent have buried their sons and daughters and the lives of hundreds of families have been irretrievably altered," the letter states.
Bishop's district was one of the hardest hit in the outbreak blamed on a now defunct drug compounding company in Framingham, Mass. Tennessee was also among the hardest hit along with Indiana and Virginia
The outbreak killed 76 patients while sickening 778 in some 20 states. 
The proposal to use crime victims funds was apparently vetoed because administration officials felt the funds were meant for victims of terrorists acts.
The letter noted that two top officials of the company blamed for the outbreak have been charged with 25 counts of second degree murder.  The alleged actions do amount to  "mass violence," the letter states. "Any conclusion to the contrary is not consistent with the clear and unambiguous letter of the law."
If approved the grants would be in addition to any money awarded to victims from the NECC trust fund or in litigation against health providers who injected patients with fungus laden methylprednisolone acetate.

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

For Immediate Release

May 17, 2016



Well Care Compounding Pharmacy
(702) 553-2575


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.

Friday, May 13, 2016

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.

Tuesday, May 10, 2016

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

Monday, May 9, 2016

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

For Immediate Release

May 5, 2016



Thomas Rasnic


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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
P10799 Rev 1 (B)
Page Last Updated: 05/06/2016
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Friday, May 6, 2016

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.

Thursday, May 5, 2016

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.

Sunday, May 1, 2016

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