NECC Award Letters Begin to Arrive

By Walter F. Roche Jr.

As promised, some victims of the 2012 fungal meningitis outbreak are beginning to receive notices that their claims have been approved.
The one-page letters from the National Settlement Administrator state the number of points the victim has been awarded and the estimated amount of an initial payment.
For instance, the survivors of a victim who died in the outbreak would be awarded 55 points and the estimated initial payment would be about $71,500.
The letters are going directly to claimants. For those who have an attorney involved in the claim, the lawyer will also get a copy.
The awards will come from a $200 million trust fund created under the bankruptcy of the New England Compounding Center, the Massachusetts firm blamed for the outbreak which sickened some 778 patients across the country, killing 76 of them.
"The initial payment," the letter states, "constitutes interim compensation. You may receive additional compensation after the claims process is completed and all appeals have been resolved."
Fredric Ellis, one of the attorneys on a plaintiffs' steering committee, said recently that the approval letters would be going to 1,350 victims or their survivors. Letters to those whose claims have been denied or reduced will be going out at a later date with an explanation of the appeals process.
As the letter explains, the approval does not mean that checks will be mailed immediately. Negotiations are still ongoing with officials of the Center for Medicare and Medicaid Services. CMS is attempting to recoup the amounts it paid for the medical care provided to  victims.
The letter states that efforts are aimed at obtaining a so-called global settlement. If that effort fails, each claim will have to be handled individually, a process that will take even longer.
The letter notes that some patients will also face liens from private insurance companies.
"If liens are required to be resolved on an individual basis, we will inform you and provide you with the name and contact information of a private lien resolution service who will work to resolve your liens if you so choose," the letter concludes.
Contact: wfrochejr999@gmail.com

NECC Criminal Trial Delayed Five Months

By Walter F. Roche Jr.

Amid a dispute over the review of thousands of internal emails, the trial of owners and employees of the defunct New England Compounding Center has been put off for five months till September of this year.
The delay came Wednesday in a status hearing on the criminal charges brought by a federal grand jury against former owners and employees of NECC, the Framingham, Mass. company blamed for a nationwide fungal meningitis outbreak that took the lives of 76 patients in 20 states.
U.S. District Judge Richard Stearns announced he would issue an order setting the new September date following a hearing in which attorneys for both sides presented arguments about the review of some 600,000 thousand pages of NECC internal emails which were seized in 2012 in a raid on the drug compounding firm's offices.
The trial had been scheduled to begin April 4 in Boston, Mass.
Christina Sterling, a spokeswoman for U.S. Attorney Carmen Ortiz, confirmed Wednesday that Stearns agreed to set an exact date for the trial in a coming order.
Federal prosecutors are appealing a magistrate judge's order that government screening teams quickly complete a review of the emails to determine if they contain privileged information. Defense lawyers also argued the emails could contain exculpatory information that would aid in the defense of their clients.
A federal grand jury handed up indictments of 14 former NECC employees and owners in December of 2014 with charges ranging from racketeering to mail and wire fraud to second degree murder.
State and federal regulators have concluded that NECC caused the 2012 fungal meningitis outbreak by shipping thousands of fungus riddled vials of steroid drugs earmarked for injection into the spines and joints of patients.
Overall some 778 patients were sickened, some suffering fatal strokes.
In separate legal proceedings a $200 million trust fund has been established for victims and some creditors of NECC.
Contact:wfrochejr999@gmail.com

New Notice at NECCSettlement.com

CLAIMS STATUS UPDATE (01/20/2016): Beginning this week, approximately 1350 determination letters will be sent out to Claimants (and their attorneys, if represented) granting approval of their claims in full. These determination letters will inform Claimants of the amount of the Points which have been allowed on their claims and the amount of the Initial Payments which will be made on their claims. It is expected that Claimants will receive a second payment after all claims are processed and any appeals from the Settlement Administrators’ final determinations have been resolved.
We do not yet know the timing of these Initial Payments as many claimants’ medical bills were paid by Medicare or private health insurance and these liens need to be resolved. For several months, the Plaintiffs Steering Committee has been in discussions with Medicare to resolve, on a global basis, all potential Medicare liens. Such a resolution would obviate the need to adhere to the Medicare reporting requirements for personal injury settlements and shorten the delay in making payments on approved claims. To date, no resolution has been achieved with Medicare. If no resolution is reached with Medicare, the Initial Payments will be delayed while Medicare reporting requirements are fulfilled and any resulting lien amounts are resolved on an individual basis. In the absence of a Medicare lien, there may also be a delay in making payments if there are private insurers that have asserted liens. If liens are required to be resolved on an individual basis, we will so notify claimants (and their counsel, if they are represented) and provide them with the name and contact information of a private lien resolution service who will work to resolve the lien(s), if the claimant so chooses.

Denial Letters Headed to Some 275 NECC Claimants

By Walter F. Roche Jr.

While some 1,350 victims of the 2012 fungal meningitis outbreak will be getting approval letters on their claims, some 275 other claimants will be getting notices that their claims have been denied in full.
According to Fredric Ellis, a Boston attorney representing victims, the denial letters are expected to be mailed during the week of Feb. 1. He added that those getting the denials will be given a chance to cure any deficiency or seek review under a separate category.
Those preliminary numbers come at the same time victims of the 2012 fatal outbreak are being told that before any distributions from a $200 million trust fund can be made, agreements must be reached with the U.S. Centers for Medicare and Medicaid Services and major insurance carriers who paid for victims medical care.
After the full denial letters are issued, Ellis said an estimated 450 letters will go out to victims who qualified for the basic distribution but who were denied upward adjustments for special circumstances.
Those claimants will also have an opportunity to appeal and cure any deficiencies.
Just when any funds will be distributed hinges on the negotiations with CMS and early indications for a quick resolution do not appear promising. According to sources familiar with the negotiations, the proposal from CMS could result in some victims losing more from their awards than the actual cost of their medical care.

A separate effort is underway to convince Health and Human Services Secretary Sylvia Burwell to simply waive any recovery payments. A letter from four U.S. Senators has been followed by similar letters from other members of congress.

Overall there were some 3,500 claims filed by patients who contend they were injected with fungus riddled injectable drugs produced by the defunct New England Compounding Center of Framingham, Mass.
The notices are the latest development in the aftermath of the 2012 fungal meningitis outbreak which sickened some 778 patients in more than 20 states, killing 76 of them.
The trust fund was established under a liquidation plan for NECC approved by a federal bankruptcy judge. Contributions to the fund came from NECC's former owners, insurance companies and other firms who provided services to NECC.
Awards to victims are based on the severity of their illnesses. Points, valued at a little under $1,300  apiece, will be allotted based on seven separate severity levels. Initial awards based on that $1,300 figure will be limited to about half of the total points each victim is entitled to. The balance will be paid at a later date.
Contact: wfrochejr999@gmail.com

Prosecutors Appeal Order on NECC Emails

By Walter F. Roche Jr.

Federal prosecutors are appealing a highly critical decision ordering them to complete a review of some 630,000 emails recovered from the defunct drug compounding firm blamed for a nationwide fungal meningitis outbreak.
The appeal, scheduled for a hearing next week, comes in the criminal case of the former owners and employees of the New England Compounding Center, the Framingham, Mass. firm which shipped thousands of fungus laden vials of an injectable steroid to health providers in more than 20 states.
In the six-page ruling now being appealed, Magistrate Judge Jennifer Boal strongly criticized federal prosecutors for failing to complete the review as ordered.
Citing the government's claim that it didn't have time to review the emails, Boal wrote, "this flies in the face of the government's characterization of the importance of this case as well as the number of agencies involved."
She noted that although the documents had been obtained under search warrants in 2012, government lawyers did not disclose until early November of last year that it had not completed the review and did not intend to do so.
Prosecutors had been ordered to review the emails to determine whether they contained any privileged information such as communications with attorneys. Some of those emails were then supposed to be turned over to lawyers for the defendants.
Boal in her decision flatly rejected claims by prosecutors that she lacked the authority to order the reviews be completed by a Dec. 10, 2015 deadline.
And, she added, that had the government wanted additional time it should have asked for it.
Instead, she wrote, "On December 3, 2015, approximately four months before the commencement of trial, the government announced that it was abandoning its longstanding discovery protocol in this case and foregoing review of the approximately 630,000 emails in its possession that were identified."
She noted that if there was any ambiguity in her order, it was effectively eliminated in a subsequent order from U.S. District Judge Richard G. Stearns. Stearns will hear arguments on the appeal Wednesday.
Boal also cited the argument of defense lawyers that they were entitled to the emails to find out if they contained any exculpatory evidence that would aid their clients.
As an example Stephen Weymouth, the attorney for defendant Glenn Chin, said that the emails could contain information showing that the defendants were concerned that outside consultants were not properly testing the drugs. Chin and former NECC owner Barry Cadden are facing the second degree murder charges.
In a brief supporting Boal's order, lawyers for the defendants charged that prosecutors' appeal was untimely and "the government indisputably failed to comply with its obligations."
 The 25-page defense brief also notes that prosecutors raised no objections to Boal's order in the 14-day period following its issuance.
The dispute comes as the scheduled April 4 trial date is fast approaching in the charges, ranging from second degree murder to  mail and wire fraud charges brought against 14 owners and employes of NECC.
State and federal regulators concluded that NECC shipped fungus ridden methylprednisolone acetate to health care providers in 2012. The drugs, which were supposed to be sterile, were injected into the spines and joints of thousands of patients.
The resulting fungal meningitis outbreak sickened 778 patients, killing 76 of them, federal court records show.
Contact: wfrochejr999@gmail.com

First Approval Letters Going to Outbreak Victims

By Walter F. Roche Jr.

Approval letters for some 1,350 victims of the deadly 2012 fungal meningitis outbreak will be going out in the mail this week and the claimants will learn for the first time what they are likely to receive as a preliminary award.
Fredric Ellis, a Boston lawyer representing victims, said the letters will include the number of points being awarded to each victim. He said the dollar value for each point will be slightly under $1,300.
The letters are the latest development in the aftermath of the 2012 fungal meningitis outbreak which sickened some 778 patients across the country, killing 76 of them.
The victims will be sharing in an estimated $200 million which was amassed in the bankruptcy of the New England Compounding Center, the company blamed for the outbreak. NECC shipped fungus laden steroids to health facilities where unsuspecting patients were then injected in spines and joints.
Ellis said just when victims can actually expect payments is not clear although he said it was possible it could happen in 90 days.
Ellis said the initial payments will be approximately one half of the amount victims can ultimately expect.
"We decided not to wait for everything to be resolved," Ellis said, adding that withholding half the money would provide a buffer. "This won't be the final payment."
Under the court approved allotment system (see below), victims will be awarded points based on the severity of their illnesses. For instance, the survivors of a victim who died in the outbreak would be awarded 55 points, while a patient who suffered fungal meningitis would be allotted 30 points.
Ellis said payments were being made in two installments because of a variety of factors, including the fact that some claims that were initially denied, could later be approved on appeal.
Yet another major factor is the ongoing negotiations with the federal government over how much of the awards will be earmarked to repay the Medicare program for the costs it incurred in paying for the medical care of victims.
Four U.S. senators have called on HHS Secretary Sylvia Burwell to waive any Medicare claims. So far there has been no response to their letter.

California Drug Compunder in Recall

Unexpired Sterile Human and Animal Compounded Products by Abbott's Compounding Pharmacy: Recall - Lack of Sterility Assurance

AUDIENCE: Patient, Pharmacy
ISSUE: Abbott's Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall. These include injectable medications, sterile solutions, eye drops, and eye ointments. All recalled products were distributed to patients, physician offices and clinics, and veterinarians within California.
All recalled products have a label that includes the Abbott's Compounding Pharmacy name and expiration date. If unsure, Customers can call the pharmacy to determine the expiration date. This recall impacts all sterile products distributed between 01/01/2015 and 01/14/2016.
BACKGROUND: The recall was issued after a series of onsite inspections by the FDA. Out of an abundance of caution, Abbott's Compounding Pharmacy is voluntarily recalling all sterile compounded products within expiry. If there is microbial contamination in products intended to be sterile, patients are at risk for serious and potentially life-threatening infections. To date, Abbott's Compounding Pharmacy has not received any reports of any adverse effects or injuries, and the recalled products were distributed exclusively within the state of California directly from its Berkeley, California pharmacy location.
RECOMMENDATION: Customers that have recalled product should immediately stop using it and contact the pharmacy to arrange for the return of unused product. Customers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products.
Customers with questions regarding this recall can contact Abbott's Compounding Pharmacy by phone Monday thru Friday, 9:00am to 5:00pm at (510) 548-8777, or email its media representative at tpark@capharmacylaw.com.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatc