Wednesday, September 30, 2015

Deadline Looms For Meningitis Outbreak Victims

By Walter F. Roche Jr.

Victims of the 2012 fungal meningitis outbreak have only till Friday to submit detailed data to back up their claims to some $200 million in a trust fund amassed in a lengthy bankruptcy case.
The deadline, which was set by U.S. Bankruptcy Judge Henry J. Boroff, requires those claims to actually be in the hands of court officials by the Friday deadline.
The claimants are victims of the 2012 fungal meningitis outbreak which sickened 778 patients across the country, killing 76 of them. Some $50 million in the trust fund money came from the owners of the defunct New England Compounding Center, the Massachusetts firm blamed by regulators for the outbreak.
Several attorneys representing victims of the outbreak who were contacted this week reported that all the paperwork for their clients had been submitted.
But some of the victims also have filed for extensions on the Friday deadline. They include a North Carolina woman, Carolyn Wilson, who doesn't have an attorney.
She, like several other so-called pro-se claimants, have been getting an assist from two Boston University Law School students, who were recruited for the task by one of their professors, Kevin Outterson.
Lewis Osterman, who has just begun his second year at the law school, said he and a colleague, Kristen Rogerson, spent the summer assisting some two dozen victims in putting together the needed paperwork.
Among the items required, he noted, are medical records showing that the victim does indeed fall into one of the authorized categories.
Under a plan approved by the court, victims will be awarded points based upon a variety of factors including the severity of the illness they suffered after being injected with fungus infused steroids shipped from NECC.
Osterman said most of the victims he assisted were in "Category Six." Victims in that category were injected with the tainted steroid but did not suffer spinal meningitis. They did, however, suffer some ill effects such as headaches and dizziness.
He said a smaller number fell into "Category 7." Those victims did get injected with the fungus laden steroid but had no ill effects.
Osterman said that while he knows what category the victims he assisted fall into, he doesn't know how much, if anything, they will get from the trust fund.
"No one knows," he said. "It's really hard to say."
Osterman, a Colorado resident, said the victim from North Carolina also needed assistance signing a waiver under the federal Health Insurance Portability and Accountability Act, known as HIPAA.
He said that while the forms and process were quite complicated, many of those victims he dealt with, had done everything correctly.
"They just needed a reassurance that everything was okay," he said.

Thursday, September 24, 2015

Recall of Sterile Compounded Drugs

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

US Compounding, Inc. Issues Voluntary Nationwide Recall of All Sterile Compounded Products

800-718-3588 x254
501-327-1222 x254
FOR IMMEDIATE RELEASE – September 21, 2015 – Conway, AK – US Compounding, Inc. ("USC") is voluntarily recalling all lots of sterile products aseptically compounded and packaged by USC and that remain within expiry due to the Food and Drug Administration's ("FDA")_ concern over a lack of sterility assurance. The sterile products were distributed nationwide to patients, providers, hospitals, or clinics between March 14, 2015 and September 9, 2015. The recall does not pertain to any non-sterile compounded medications prepared by USC.
If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk. As USC takes the utmost care to ensure patient safety and out of an abundance of caution, then, USC is asking all patients and providers that received sterile compounded products from USC between March 14, 2015 and September 9, 2015, and that remain within expiry, to take the following actions:
  1. Discontinue use of the products;
  2. Quarantine any unused product until further instructions are received on how to return the product; and
  3. Contact USC at 800-718-3588 x254 or 501-327-1222 x254 from the hours of 8:30AM-5:00PM central time Monday-Friday, or e-mail at to discuss the return of any unused sterile compounded products.
Customers with questions regarding this recall can contact USC at 800-718-3588 x254 or 501-327-1222 x254 from the hours of 8:30AM-5:00PM central time Monday-Friday, or e-mail at Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Providers who have dispensed any sterile product distributed by USC to a patient(s) for use outside of the provider's office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall.
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.
This recall is being conducted with the knowledge of and at the request of the FDA.
Again, USC's primary concern is your safety and USC is taking this action out of an abundance of caution. Thank you for your support.
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Wednesday, September 23, 2015

Further Cuts Sought In NECC's Trustee Fees

By Walter F. Roche Jr.

The trustee in the New England Compounding Pharmacy bankruptcy case is not entitled to a $2.5 million commission and his total payments should be reduced to $1.43 million, according to attorneys for the victims of a 2012 fungal meningitis outbreak.
In a 37-page filing in U.S. Bankruptcy Court in Massachusetts, the outbreak victims lawyers said the trustee, Paul D. Moore, "is not entitled to, and the law does not provide" for such a commission.
The filing is the latest development in the bankruptcy of NECC, the firm blamed for the 2012 fungal meningitis outbreak, which sickened 778 patients across the country, killing 76 of them.
The request for a further reduction in Moore's requested fee follows the filing of an agreement between Moore and the U.S. Trustee reducing his originally requested fee by $2 million to $3.75 million.
But the victims' lawyers argued that the cut did not go far enough and the fee should be cut by another $2.32 million.
"While Mr. Moore's work has been exemplary, this is not the case to make new law and further reduce the already insufficient amounts available to NECC's victims," attorney Thomas Sobol wrote in the motion.
According to the brief, Moore's payment rate under the proposed compromise would compute to $2,162 an hour.
Sobol and his colleagues also noted that $4.3 million in additional payments have been requested by Moore's law firm, Duane Morris. The firm's billing includes $1.43 million for work done by Moore himself.
Even if his fee were reduced to the requested level, the filing states,  Moore and his law firm would get a total of $5.733 million "and will be among the highest paid attorneys and firms representing victims' interest in the NECC litigation."
Backing the claim for a further reduction, the filing cites numerous other cases in which the courts in the First Circuit have turned back bonus or commission payment requests.
"The trustee did an admirable job to maximize the benefit to NECC's victims," the filing states, adding that Moore "kept a vigilant eye on costs.
But, Sobol noted, other attorneys were involved in the effort to amass a total of a little over $210 million to pay victims and creditors.
"The settlements were accomplished by multiple players devoting thousands of hours of work, not by Mr. Moore alone," the filing states.
U.S. Bankruptcy Judge Henry J. Boroff, the presiding judge in the case, has set an Oct. 30 deadline for further objections to a total of $15 million in legal and other expenses pending before the court. A hearing on the fee requests has been set for Nov. 10 in federal court in Worcester, Mass.

Thursday, September 17, 2015

NECC Trustee Chops Fee Request Amid Protests

By Walter F. Roche Jr.

The trustee who oversaw the bankruptcy of the New England Compounding Center has agreed to a $2 million or 34.8 percent cut in his requested fees, even as creditors in the case are calling his original request excessive and unreasonable.
Filings in U.S. Bankruptcy Court in Massachusetts show Paul D. Moore, who served as NECC's trustee, reached an agreement with U.S. Trustee William K. Harrington to reduce his fees in the three-year-old case from $5.75 million to $3.75 million.
According to the filing the reduced fee for Moore and smaller reductions by other parties seeking payments was the result of recently completed negotiations.
On the same day that agreement was announced, creditors in the case filed an objection to Moore's original fee request charging that it, if approved, would amount to an hourly payment of $3,320, compared to Moore's normal hourly fee of a little over $600.
"This is excessive," the creditor's attorney William Baldiga wrote in the objection, adding that it would amount to "a windfall."
Conceding that Moore's work on the bankruptcy was "important and beneficial," Baldiga added, " he (Moore) was by no means the only party to drive the result. Trustee is seeking the maximum possible commission for himself."
In addition to his own fee request, Moore's law firm, Duane Morris, has asked for just under $4.3 million in fees and $63,601.10 in expenses. No reduction in those amounts have been offered.
In the filing by Moore and the U.S. Trustee, they also disclosed an agreement to cut payments by a little over $10,000 requested by two other firms involved in the case.
William Baldiga, the attorney for the creditors, did not respond to a request for comment on Moore's fee reduction.
The Moore fee cut agreement is not the first to be disclosed. Previously a Florida attorney disclosed he had agreed to cut his fee request by nearly $1 million.
Prior to those reductions, fee requests in the case totaled some $17 million.
Payments of the claims, if approved by Boroff, will come from a $200 million trust fund created under the NECC liquidation plan. Victims will be paid from the remaining funds after the expenses are paid.
NECC has been blamed for the 2012 fungal meningitis outbreak that killed 76 patients across the country. An additional 702 patients were sickened.
The fees are scheduled to be argued in November before U.S. Judge Henry J. Boroff.

Outbreak Anniversary Brings Mixed Results

By Walter F. Roche Jr.

It was  three years ago this week when a Nashville, Tenn physician raised the first alarm in what became one of the worst outbreaks in U.S. history, eventually sickening 778 patients and killing 76 of them.
The outbreak of fungal meningitis, fueled by fungus laden medications injected into the spines and joints of unsuspecting patients across the country, triggered a lengthy criminal investigation leading to the indictment of 14 people, two charged with 25 counts of second degree murder.
It prompted congressional hearings and, eventually, a change in the federal law governing drug companies compounding drugs for sterile use.
The culprit, the New England Compounding Center of Framingham, Mass., ended up in bankruptcy court even as the death toll was climbing. A liquidation plan for that company has produced a $200 million fund that could, by the end of this year, provide some long sought financial relief to victims and their survivors.
In addition to the change in federal law, several states have enacted new statutes or imposed new regulations to prevent a recurrence.
Officials of the U.S. Food and Drug Administration, meanwhile, cite stepped up enforcement in the wake of the outbreak.
Lyndsey Meyer, an FDA spokeswoman, said that some 250 inspections of drug compounders have been conducted in the past three years resulting in 55 warning letters. Three compounders have entered into consent agreements and one pleaded guilty to a misdemeanor criminal violation.
She also cited the 131 count NECC indictment.
Calling FDA's oversight of compounding pharmacies "vigorous," she said the FDA "continues to pursue regulatory actions as appropriate, to protect the public from adulterated and misbranded compounded drugs."
But  FDA's actions and the new law itself have left some wondering whether there has been any real improvement in the regulation of drug compounders.
Dr. Michael Carome of Public Citizen, who serves on an advisory committee created by the new law says the law itself was a step backwards.
"It (the new law) created a new category of companies, called outsourcing facilities, that are allowed to mass produce standardized drug products without seeking FDA pre-market approval, particularly during drug shortages. This legalized what previously was illegal drug manufacturing," Carome wrote in an email response to questions.
Citing the high percentage of outsourcers found in violation during initial inspections, Carome said those results "indicate that many facilities engaged in the production of sterile drugs are not complying with the requirement intended to ensure that products are sterile. This obviously poses a significant threat to patient health."
David Miller, who heads the International Association of Compounding Pharmacists, says he has his own concerns about the new law and the way the FDA is interpreting and enforcing it.
He said pharmacists are getting "completely contradictory" directives from the FDA and state pharmacy boards on key issues including the compounding of various  drugs, including oncology medications, for advance use in a physician's office.
Some states, he said, have expressly approved that practice, while the FDA has taken an opposite stance.
"It's an incredibly muddy situation" Miller said, citing laws in Maryland, Michigan and North Carolina.
Meyer, the FDA spokeswoman, said while the law does allow pharmacists to apply for exemptions, the statute still requires that pharmacists have a patient specific prescription for compounding drugs.
Miller said there have been "a ton of state law changes" in the wake of the outbreak.
 "It provided a jolt to the state boards of pharmacy," he said, citing increased training for inspectors. "It's very clear the real success has been at the state level. The boards have taken a more assertive role," he said, adding that generally states move much more quickly than the federal government in response to regulatory issues.
For the living victims of the outbreak, aside from waiting for the outcome of lengthy legal processes, many remain recovering from the outbreak and still suffering from the chronic pain that led them to allow a physician to inject steroids in their spines and joints in the first place.
"Physically, I'm no better.  I hurt all the time, 24/7/365," said Dennis O'Brien of Cookeville.   "But, my attitude and outlook must remain positive  or I'd fall into a rabbit hole."

Wednesday, September 16, 2015

Deadline Extended for Objections To Meningitis Fees

By Walter F. Roche Jr.

A federal bankruptcy judge has extended the time interested parties can file objections to more than $15 million in legal and related expenses being sought in the bankruptcy case of a defunct drug compounding firm.
U.S. Judge Henry J. Boroff moved the deadline for filing objections from Sept. 16 to Oct. 30 at the request of attorneys involved in the case.
A hearing on any objections also has been pushed back to Nov. 10 at 2:30 p.m. The hearing will be held in federal court in Worcester, Mass.
In recent filings in the case, attorneys told Boroff they were "currently discussing a consensual resolution" of the pending fee requests.
The fees would come out of a $200 million trust fund established to compensate victims of the 2012 fungal meningitis outbreak. NECC has been blamed for the fatal outbreak.
The fee requests include fees and expenses incurred by the trustee in the bankruptcy and his law firm.

Tuesday, September 15, 2015

Outbreak Victims Face Insurance Payback Demands

By Walter F. Roche Jr.

When Ray Sharer, a victim of the 2012 fungal meningitis outbreak, opened a letter from his insurance company recently he got an unpleasant surprise.
The letter informed him that if he ever gets any money from the parties blamed for the outbreak that put him in a hospital for eight weeks, the insurance company will be coming after him to recover the money it paid for his care.
Sharer, as he soon found out, is not alone. Dozens of other victims of the deadly outbreak have been getting similar notices, even as they still try to recover from the lingering effects of a crippling disease. Its a legal process called subrogation.
The notices come as the third anniversary of the outbreak approaches. It was in early October of 2012 when state and federal officials first announced that a deadly fungal meningitis outbreak was spreading across the country.
Eventually federal and state health officials concluded  that thousands of vials of fungus laden steroids shipped from a Massachusetts drug compounding firm had caused the deadly outbreak.
The latest available figures from federal officials shows the outbreak sickened 778 patients, killing 76 of them.
"I have been left with the permanent loss of my urinary tract, with having to catheterize myself and problems with my bowel tract.  In addition, I have lost feeling in my feet and have problems with my balance," Sharer said.
Sharer, like many other living outbreak victims, has been following the developments in Massachusetts courtrooms, where a slowly moving judicial process is playing out. Earlier this year they learned that  some recompense might finally be available from the settlement of the bankruptcy case of the New England Compounding Center, the company responsible for the fungus tainted drugs.
The trustee in that case, Paul Moore, has expressed hope that payments from a $200 million trust fund, can begin to flow to victims before the end of 2015.
That ray of hope however, is now being dimmed by that 11-letter word, subrogation.
"I talked to several others who also got notice. People don't expect this," Sharer said.
While many victims were surprised to learn that insurance companies would be demanding a piece of any winnings, others, like Dennis O'Brien, another Tennessee victim, were not.
O'Brien, a Cookeville resident, said he knew that his insurance company would be trying to recoup its payments made for his care.
Nashville attorney Gerard Stranch said efforts to get insurance companies or the federal Medicare program to limit or drop any subrogation claims have so far been unsuccessful
"It is an unfortunate aspect of our current legal system that victims are going to have to pay back large sums of money to their insurance carriers and Medicare when they were not made whole by the settlement," said Stranch, who represents several victims.
He said he and other attorneys for victims have asked Medicare to waive any claims, but the agency has "not agreed to any reduction, let alone a complete reduction."
Sharer, who gets his Medicare coverage through HealthSpring, has responded to the company notice by sending dozens of letters to public officials expressing outrage.
"The purpose of this letter is to put you on notice of this matter. I feel that your office should be reviewing same to see if we can get relief from this preposterous position being taken by the various health insurance companies.  So many of us are suffering tremendously, not only from our medical conditions, but also financially," the letter states.
HealthSpring and officials did not respond to requests for comment on subrogation efforts. Medicare officials said that by law they are required to seek reimbursement.
"Statute requires Medicare to recover its conditional payments once primary payment responsibility has been demonstrated through a settlement, judgment, award, or other payment," a Medicare spokesman said.
Carol Snyder, a New Mexico resident, who lost her mother, Pauline Burema, in the outbreak, said she was aware that Medicare would be seeking reimbursement.
Burema was 89 and suffering from chronic back pain when she began getting shots at an Indiana clinic.
She had put off additional back surgery and agreed to get the steroid shots for interim relief, Snyder recalled in a recent interview.
After the first shot in August she was already feeling sick. And then things got worse.
Snyder said she tried to reach her mother repeatedly by phone after that last shot on Oct. 1 and got no answer.
"So I called my brother. He found her on the bathroom floor. She had probably been there for a day. She was rushed to the hospital. They thought it was a stroke," Snyder continued.
 As her mother's condition worsened, the CDC made the first public announcement of the outbreak.
She said that ultimately she suffered seven strokes and died on Oct. 10.
 "It was a horrible, horrible death. She looked so miserable," Snyder said.
Now Snyder says her one goal is to be in the courtroom for the criminal trial of the owners and employees of the NECC.
That trial is scheduled for April, 2016.
"If I could just be there. I would like to be there to speak for her. She was 89 and wanted to live to be 100," Snyder said. "She probably would have."

Monday, September 14, 2015

Tennessee Health Officials Provide Outbreak Victims List

By Walter F. Roche Jr.

Acting under a federal judge's order, Tennessee Health Department officials have turned over the official list of Tennessee victims of the 2012 fungal meningitis outbreak to officials overseeing claims filed for a share of a $200 million trust fund.
Release of the list was authorized last week in a three-page order issued by U.S. District Judge Rya W. Zobel following a hearing on a series of civil suits stemming from the outbreak.
Woody McMillin, spokesman for the Tennessee health agency said late Monday that the list had been provided as ordered. 
Under Zobel's order the list will be used by the national settlement administrator, who is handling claims for the trust fund, and an appeals administrator, who will process appeals of those initial awards.
Noting that the records contain personal health information protected under the federal Health Insurance Portability and Accountability Act, Zobel ordered that the protected information cannot be released to any other parties.
Under the qualified protective order the settlement administrator and the appeals administrator will have access to the list "for the sole purpose of facilitating the claims resolution process."
The $200 million trust fund was created as part of a liquidation plan approved in U.S. Bankruptcy Court. The funding came from the owners of the drug compounding company blamed for the 2012 outbreak, related parties and insurance companies.
State and federal regulators named the New England Compounding Center as the source of fungus tainted drugs that caused the outbreak.
Tennessee and federal health officials have reported that 153 Tennessee patients were sickened in the outbreak. Sixteen of them died.
According to the U.S. Centers for Disease Control and Prevention 751 patients were sickened nationwide and 64 died.
Subsequent to the CDC count, federal prosecutors reported additional illnesses and deaths pushing the total of patients sickened to 778 and deaths to 76. The location of those additional illnesses and deaths, however, have never been disclosed.

Thursday, September 10, 2015

Judge Approves Order on Names of Tennessee Meningitis Victims

By Walter F. Roche Jr.

A federal judge has approved an order that will permit lawyers for victims of the 2012 fungal meningitis outbreak to get the official list of victims from the Tennessee Health Department.
U.S. District Judge Rya W. Zobel signed the order late Thursday following a hearing in which plaintiffs' attorneys promised to "clean up"  the language of the protective order that would allow the state to provide such a list.
 Zobel had questioned the wording of the original request, noting that the Tennessee Health Department was  not currently a party to the case before her.
The exchange with Nashville attorney Ben Gestel came during a 50 minute status conference in the hundreds of cases merged before Zobel.
Gastel said following the hearing that he already had filed an amended version of the request. Her approval quickly followed.
All the cases before Zobel stem from the 2012 outbreak of fungal meningitis that sickened 778 patients across the country killing 76 of them.
According to the official count of the U.S. Centers for Disease Control and Prevention, 153 Tennessee patients were sickened by fungus laden steroids and 16 of them died. The steroids were shipped to health facilities across the country by the now defunct New England Compounding Center in Framingham, Mass.
Mark Chalos, also a Nashville attorney, gave Zobel a rundown of other cases from the outbreak that are now in state courts across the country.
In Michigan, he reported, 120 plaintiffs' cases were proceeding as a class action against one clinic and those cases could go to trial late next month. There are 311 claims against Michigan Pain Specialists and 120 cases in Indiana courts.
Chalos said there were a smaller number of cases in Maryland where cases must first be assessed by a panel before actual filing in court.
Chalos also reported that plaintiffs and defendants in the Tennessee cases have come up with a list of 15 possible cases that would serve as so-called bellweather trials. Eight cases were proposed by plaintiffs and eight by defendants. One case was on both lists.
Chris Tardio, one of the attorneys for the Tennessee clinics, told Zobel that depositions have been scheduled for some former employees of NECC, but officials of the U.S. Attorneys office had requested a hold on those sessions.
Zobel asked Tardio to file a response to the U.S. Attorney's motion and promised she would act on it before the depositions are scheduled.

Sterile Drug Recall

Medistat RX Sterile Drug Products: Recall - Possible Contamination

AUDIENCE: Health Professional, Patient
ISSUE: FDA alerted health care professionals and patients of a voluntary recall of all non-expired drug products produced for sterile use and distributed nationwide by Medistat RX, LLC, in Foley, Alabama, due to possible contamination. During an ongoing inspection, FDA investigators and Alabama state inspectors observed significant deficiencies that raise concerns about Medistat’s ability to assure the sterility of drug products that it produced. The recalled products were distributed between November 1, 2014, and September 3, 2015. 
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
BACKGROUND: FDA has received reports of several adverse events that are potentially associated with drug products made by Medistat. Medistat voluntarily ceased sterile compounding operations on September 1, 2015. FDA previously inspected Medistat in September 2014 and issued a Form FDA 483.
RECOMMENDATION: Health care professionals should immediately check their medical supplies, quarantine any drug products marketed as sterile from Medistat, and not administer them to patients. Patients who have received any drug products produced by Medistat and have concerns should contact their health care professional.
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:
  • Download form 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
Read the MedWatch safety alert, including a link to the Medistat RX alert, at:

You are encouraged to report all serious

Thursday, September 3, 2015

Meningitis Attorney Slashes Fee Request by Nearly $1 million

By Walter F. Roche Jr.

One of the attorneys seeking reimbursement from the bankruptcy of a defunct drug compounding firm has slashed his fee request by nearly $1 million.
In a petition filed this week in U.S. Bankruptcy Court in Massachusetts, Florida attorney Melvin Wright and his Orlando law firm, Colling, Gilbert, Wright and Carter, reduced the claim for services and expenses from $1.35 million to $411,780.59.
Overall attorneys and other professionals involved in the bankruptcy of the New England Compounding Center have filed for claims of about $17 million.
A Sept. 30 hearing has been scheduled to consider those claims.
In the filing Wright's law firm said the reduction included a substantial cut in his typical hourly fee, removing all fees for the services of paralegals and waiving certain other costs.
Wright's fees were included in an overall $3 million fee request for attorneys representing unsecured creditors in the bankruptcy. With his reduction, the total for the unsecured creditors attorneys drops to $2.1 million.
The unsecured creditors include victims of the 2012 fungal meningitis outbreak caused by fungus tainted drugs shipped by NECC all over the country. Wright represents Kathleen Distler of Ocala, whose husband, Charles, died in the outbreak.
The outbreak sickened 778 patients, killing 78 of them.
Owners and former employees of NECC have been charged in a criminal indictment with multiple charges including second degree murder. They have all entered not guilty pleas and are scheduled to go on trial in April of next year.
Victims and some NECC creditors will share in an estimated $200-$215 million fund established during the bankruptcy.