Thursday, September 29, 2016
$40 Million Approved for Meningitis Outbreak Victims
By Walter F. Roche Jr.
The U.S. Department of Justice has approved a $40 million grant request that will go into a fund to benefit victims of the 2012 fungal meningitis outbreak and victims can begin applying to the Massachusetts Attorney General whose office is administering the fund.
Information on the grant approval and the application procedure were disclosed Thursday in separate announcements.
U.S. Rep. Mike Bishop, a Michigan Republican, whose district was particularly hard hit in the outbreak disclosed that the application for the $40 million had been approved. The grant will go to the Massachusetts Attorney General's office which had applied for the funds.
Chloe Gotsis, a spokeswoman for the Attorney General said a special division will be set up to handle grant applications.
To be eligible victims must either be on an official victims' list compiled by the Federal Bureau of Investigation or the U.S. Attorney's office in Boston, Mass. which conducted the criminal investigation of the outbreak.
Gotsis said her office will not be making separate eligibility determinations
Applicants can fill out the needed forms online at the Attorney General's office.
( learn how to apply for compensation at this link)
"I am grateful for the work of the DOJ and my House colleagues in our fight for justice," Bishop said in announcing the approval.
"These families have gone through unimaginable heartache losing loved ones, caring for the sick and facing financial uncertainty for the last four years," Bishop added.
The $40 million will come from a national fund for victims of crimes, which is comprised of fines and assessments on defendants sued or prosecuted by DOJ.
Fifteen of the 19 Michigan victims of the outbreak who died, lived in Bishop's district. Nationwide 77 patients died out of the 778 who were sickened.
Contact: wfrochejr999@gmail.com
Wednesday, September 28, 2016
Attorney Outbreak Suit Expenses Listed
Expenses being sought by attorneys in the settlement of the 2012 fungal meningitis outbreak total just under $900,000 and include meal and lodging expenses totaling some $237,998.
Details of the expense reimbursements being sought were included in filings for legal fees totaling more than $12.4 million that were filed this week in U.S. District Court in Boston, Mass.
The filings show that requested expense reimbursements actually topped $1 million but were then reduced downward by $192,494.16.
Airfare requested totaled $212,11.76, that total run up as lawyers traveled from around the country to court sessions in Boston, Mass.
The top expense category was fees paid for professional services, such as accounting or testing, which totaled $431,206.46
Here is a list of expenses finally approved versus amounts requested in three categories:
Firm Approved Requested Meals Requested Lodging Requested Air Fare
Andrews Thornton $43,631.41 $687.03 $22,362.41 $47,416.11
Bransetter Stranch $174,237.70 $28,915.72 $42,053.48 $50,096.75
Clayton $4,121.53 $31.99 $1,263.44 $2,826.19
Cohen Placitella $0.00 $0.00 $0.00 $0.00
Crandall Law $89,676.06 $4,850.79 $24,914.15 $22,492.70
Ellis & Rapacki $62,645.51 $326.25 $1,568.70 $2,091.40
Fay $5,000 $0.00 $0.00 $0.00
Federman $77.04 $0.00 $0.00 $0.00
Galligan $20,064.44 $0.00 $14,576.49 $0.00
Hagens $84,610.11 $6,317.72 $5,277.99 $8,902.20
JJS * $53,804.47 $2,099.91 $1,528.70 $4,701.35
LHCB * $169,071 $18,922.71 $31,591.22 $35,732.54
Leader Nolan $39,519.12 $679.21 $4,013.59 $5,936.58
Lipton $37,272.95 $2,121.28 $3,651.78 $11,572.58
Miller Law $40,638.17 $329.93 $2,100.02 $2,602.70
Oliver Law $5,278.96 $648.88 $233.66 $812.88
Shef $5,000 $0.00 $0.00 $0.00
SMBB * $2440.01 $29 $1,779.11 $632
M. Wright $32,772.50 $1,083.16 $11,409.21 $1,861.79
Zamora $29,309.04 $0.00 $2,594.13 $3,467.60
*JJS Janet Jenner and Suggs
*LHCB Leiff Cabreser
*SMBB Saltz Mongeluzzi
Judge Approves First Outbreak Payments to Victims' Survivors
By Walter F. Roche Jr.
U.S. District Judge Rya Zobel today approved the first two awards to come before her for the survivors of patients who died in the 2012 fungal meningitis outbreak caused by a Massachusetts drug compounder.
Zobel's approval came during a session in her Boston, Mass. courtroom, on petitions submitted by the the attorney representing both families. Her approval was necessary under Virginia's wrongful death statute.
The three survivors of one victim will share $169,651.92, while the three survivors of the second victim will share $469,964.49.
The payments are coming from funds totaling some $210 million amassed in the aftermath of the outbreak caused by fungus tainted steroids shipped to health providers across the country by the New England Compounding Center.
About $120 million of the total came from settlements in NECC's bankruptcy and additional funding came from settlements with health care providers who injected patients with the fungus laden steroids.
The total award in one case approved today by Zobel was for $805,622.88 with 40 percent going to attorney J. Scott Sexton, $12,182 going to legal and other expenses, leaving $156,654.83 going to each of the three beneficiaries.
In the second case the total award was $290,786.77, with attorneys fees totaling $116,314.71, other expenses $4,801.18, leaving $169,651.92 to be split between the three survivors in shares of $56,550.54 each. The victim in the case died in October of 2012.
Both victims were injected with methylprednisolone acetate from NECC and administered at Insight Health, which is contributing $40 million of the $210 million total.
Additional payments could come at a later date from the NECC bankruptcy settlement.
Other payments, not requiring court approval, are being made by the attorney appointed as trustee of the payment funds, Lynne Riley. She has stated that checks began to be mailed some two to three weeks ago.
The outbreak sickened 778 patients, killing 77 of them.
Contact: wfrochejr999@gmail.com
Tuesday, September 27, 2016
Lawyers Seek $12.4 Million in Fees, Expenses
By Walter F. Roche Jr.
A team of lawyers that litigated and negotiated for a multimillion settlement in the wake of a deadly fungal meningitis are asking a federal judge to approve nearly $12.5 million in fees and expenses or 8 percent of the total recovery.
In a massive filing today in U.S. District Court in Boston, Mass., the panel of lawyers said the fees were justified and that all parties would be receiving less than they originally sought.
Calling the results of their efforts "quite extraordinary," the filing by lead attorney Thomas Sobol recounted the long history of the outbreak beginning with the discovery in the Fall of 2012 that a deadly fungal meningitis outbreak was spreading across the country.
The fees, if approved, will come out of a national recovery fund now estimated at $130.1 million, but could grow to an estimated $157.35 million.
The fees sought in the petition are intended for services that benefited all those seeking claims and is called a "common benefit fund." The fees are in addition to fees victims will be obligated to pay their individual attorneys.
According to the filings fees paid to individual lawyers under the proposal range from $275 to $550 an hour. The largest single allocation, $2.6 million in fees and expenses would go to Sobol's firm, Hagens,Berman Sobol and Shapiro
Sobol noted in the filing that it is not expected that any of the fees will be approved until near the end of the calendar year and after victims of the outbreak receive their initial payments from the national settlement fund.
Checks for individual claims have now begun to trickle in to lawyers across the country. Nashville attorney William Leader said today his firm has now received the first check for one of its clients.
Sobol noted that an 8 percent fee already had won initial approval from U.S. District Judge Rya Zobel who has been presiding over 379 of cases stemming from the outbreak blamed on fungus laden steroids shipped from the now defunct New England Compounding Center in Framingham, Mass.
"All counsel are receiving less than their reported or allocated lodestar," the petition states, noting that original fee requests totaled $14.7 million, rather than the $12.4 million being submitted for approval.
Acknowledging that the total fund was "Insufficient to fully compensate claimants given the enormity of the wrongs committed here," Sobol acknowledged that some firms "may not be happy with our suggestions. These are compromises."
"If there is dissent it will be only by a few firms," Sobol wrote.
Objections must be filed by Oct. 24.
According to the filing the major allocations for fees and expenses will go to the following law firms:
Hagens Berman Sobol and Shapiro 8,645 hours $2,610,662
Branstetters Stranch and Jennings 3,899 hours $1,509,843
Crandall and Katt 1,760 hours $898,997
Janet Jenner and Suggs $1,075,737
Lief Cabraser Heiman and Bernstein $1,023,554
Lipton Law $534,602
Orlando Firm LLC $572,557
Andrews and Thornton $474,051
Cohen Placitella and Roth $417,883
Ellis and Rapacki $1,608,813
Collins Gilbert Wright and Carter $153,855
Leader, Bulso and Norton $221,073
Kinnard Clayton $81,506
Miller Law Firm $646,299
Riley Williams and Piatt $121,186
Saltz Mongeluzzi $113,283
Sommers Schwartz $125,365
Lawyers Seek $12.4 Million in Fees, Expenses
By Walter F. Roche Jr.
A team of lawyers that litigated and negotiated for a multimillion settlement in the wake of a deadly fungal meningitis are asking a federal judge to approve nearly $12.5 million in fees and expenses or 8 percent of the total recovery.
In a massive filing today in U.S. District Court in Boston, Mass., the panel of lawyers said the fees were justified and that all parties would be receiving less than they originally sought.
Calling the results of their efforts "quite extraordinary," the filing by lead attorney Thomas Sobol recounted the long history of the outbreak beginning with the discovery in the Fall of 2012 that a deadly fungal meningitis outbreak was spreading across the country.
The fees, if approved, will come out of a national recovery fund now estimated at $130.1 million, but could grow to an estimated $157.35 million.
The fees sought in the petition are intended for services that benefited all those seeking claims and is called a "common benefit fund." The fees are in addition to fees victims will be obligated to pay their individual attorneys.
According to the filings fees paid to individual lawyers under the proposal range from $275 to $550 an hour.
Sobol noted in the filing that it is not expected that any of the fees will be approved until near the end of the calendar year and after victims of the outbreak receive their initial payments from the national settlement fund.
Checks for individual claims have now begun to trickle in to lawyers across the country. Nashville attorney William Leader said today his firm has now received the first check for one of its clients.
Sobol noted that an 8 percent fee already had won initial approval from U.S. District Judge Rya Zobel who has been presiding over 379 of cases stemming from the outbreak blamed on fungus laden steroids shipped from the now defunct New England Compounding Center in Framingham, Mass.
"All counsel are receiving less than their reported or allocated lodestar," the petition states, noting that original fee requests totaled $14.7 million, rather than the $12.4 million being submitted for approval.
Acknowledging that the total fund was "Insufficient to fully compensate claimants given the enormity of the wrongs committed here," Sobol acknowledged that some firms "may not be happy with our suggestions. These are compromises."
"If there is dissent it will be only by a few firms," Sobol wrote.
Objections must be filed by Oct. 24.
According to the filing the major allocations will go to the following law firms:
Hagens Berman Sobol and Shapiro 8,645 hours
Branstetters Stranch and Jennings 3,899 hours
Crandall and Katt 1,760 hours
Janet Jenner and Suggs
Lief Cabraser Heiman and Bernstein
Lipton Law
Orland Firm LLC
Andrews and Thornton
Cohen Placiteller and Roth
Ellis and Rapacki
Judge Upholds NECC Conspiracy Charges
By Walter F. Roche Jr.
A federal judge in Boston, Mass. has denied a motion to dismiss conspiracy charges against several of the criminal defendants in the case against former owners and employees of the company blamed for a deadly fungal meningitis outbreak.
In an 11-page decision, U.S. District Judge Richard Stearns said the indictment issued by a grand jury in late 2013 contained sufficient information to allow the defendants to attempt to rebut the charges.
The motion was filed in behalf of Barry Cadden, Gregory Conigliaro, Alla Stepanets, Sharon Carter and Robert Ronzio, all tied to the New England Compounding Center, the company blamed for the 2012 fungal meningitis outbreak.
The challenged section of the indictment charged the defendants with engaging in a conspiracy to defraud the U.S. Food and Drug Administration by inducing "regulatory authorities, including the FDA, into believing that NECC was doing busines as a compounding pharmacy when in fact it was in the business of manufacturing drugs."
Stearns said that based on the law and existing precedents the government did not have to show the fraud was financial.
"Count Three clearly satisfies the pleading requirements," Stearns wrote, noting that the indictment included allegations that NECC submitted false names and made other efforts to obstruct a state investigation of their operations.
Cadden, a founder and part owner of the defunct Framingham, Mass, company is scheduled to go on trial in January along with chief pharmacist Glenn Chin. The other defendants face a March 2017 trial date.
Charges against Cadden and Chin include 25 counts of second degree murder.
The outbreak, caused by fungus laden steroids from NECC, sickened 778 patients across the country, killing 77 of them.
Contact: wfrochejr999@gmail.com
Thursday, September 22, 2016
Massive Sterile Drug Recall in Progress
Wells Pharmacy Network Issues Voluntary Nationwide Recall of Sterile Products due to Concern for Lack of Sterility Assurance
For Immediate Release
September 20, 2016
Contact
Announcement
Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening.
The recalled products were used for a variety of indications. NO VIAL OR PORTION OF ANY LOT OF THESE MEDICATIONS HAS BEEN FOUND TO BE NON STERILE. All recalled products have a label that includes the name Wells Pharmacy Network, logo, drug name, and expiration date. If unsure, Customers can call the pharmacy to determine if their product is on the list. To date, no adverse events have been reported.
WPN takes the utmost care to ensure patient safety. All patients and providers that received any sterile compounded products prepared between February 22, 2016 and September 14, 2016, and that remain within expiry, should take the following actions:
- Discontinue use of the products;
- Quarantine any unused product until further instructions are received on how to return the product; and
- Contact WPN at the Quality hotline at (800) 794-2360 Monday through Friday, between 9:00 am and 6:00 pm EST or email at WPNQuality@wellsrx.com to discuss the return of any unused sterile product.
Adverse reactions or quality problems experienced with the use of these products in humans or animals may be reported to FDA in the following ways:
- For adverse
events in Humans please use 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
- 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
Again, WPN’s primary concern is your safety and WPN is taking this action out of an abundance of caution. Thank you for your support.
List of products to be recalled:
| Drug | Lot # | Animal Type |
|---|---|---|
| TESTOSTERONE CYPIONATE IN SESAME OIL (1ML) 200MG/ML INJECTABLE | 03282016@10 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE | 03282016@16 | Human |
| ULTRA-TEST 250 (CYP 80%/PROP 20%) 250MG/ML INJECTABLE | 03282016@22 | Human |
| TESTOSTERONE ENANTHATE-GRAPESEED OIL 200MG/ML INJECTABLE | 03282016@3 | Human |
| TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE | 03282016@6 | Human |
| QUAD3 (2ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE | 03292016@12 | Human |
| PHENYLEPHRINE HCL - (5ML) 1MG/ML (0.1%) INJECTABLE | 03292016@3 | Human |
| MIC COMBO - STANDARD (30ML) 15MG/50MG/100MG/ML INJECTABLE | 03292016@5 | Human |
| NICOTINAMIDE ADENINE DINUCLEOTIDE (NADH) - LYOPHILIZED (P.F.) 100MG INJECTABLE | 03302016@13 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE | 03302016@4 | Human |
| ULTRA-TEST 200 (8ML) GRAPESEED OIL (CYP 90%/PROP 10%) 200MG/ML INJECTABLE | 03302016@5 | Human |
| TESTOSTERONE ENANTHATE-GRAPESEED OIL 200MG/ML INJECTABLE | 03302016@6 | Human |
| METHIONINE/INOSITOL/CHOLINE/CHROMIUM+B12(M) - 10ML 25MG/50MG/50MG/25MCG/1MG/ML INJECTABLE | 03302016@8 | Human |
| METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML) 15MG/30MG/30MG/85MG/20MG/ML INJECTABLE | 03302016@9 | Human |
| CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL | 03312016@1 | Human |
| ALPROSTADIL - (5ML) 20MCG/ML INJECTABLE | 03312016@6 | Human |
| TRIMIX - (10ML) 30MG / 2MG / 20MCG INJECTABLE | 03312016@7 | Human |
| QUAD2 (5ML) 9MG/1MG/10MCG/0.1MG/ML INJECTABLE | 03312016@8 | Human |
| TESTOSTERONE CYPIONATE IN SESAME OIL (10ML) 210MG/ML INJECTABLE | 03312016@9 | Human |
| TESTOSTERONE CYPIONATE/ZINC SULFATE IN GRAPESEED 200MG/200MCG/ML INJECTABLE | 04012016@2 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (3ML) 200MG/ML INJECTABLE | 04012016@4 | Human |
| BIMIX - (5ML) 30MG/1MG INJECTABLE | 04012016@7 | Human |
| TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE | 04012016@9 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE | 04042016@10 | Human |
| TESTOSTERONE PROPIONATE 100MG/ML INJECTABLE | 04042016@2 | Human |
| TRIMIX WITH ATROPINE (2ML) 30MG/3MG/150MCG/0.2MG/ML INJECTABLE | 04042016@22 | Human |
| CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL | 04042016@30 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 200MG/ML INJECTABLE | 04042016@7 | Human |
| METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE | 04052016@1 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 50MG/ML INJECTABLE | 04052016@4 | Human |
| METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE | 04052016@5 | Human |
| MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE | 04062016@106 | Human |
| SERMORELIN ACETATE/GHRP (2) 6MG/4.5MG KIT | 04062016@170 | Human |
| LEUCINE/ISOLEUCINE/VALINE 10MG/10MG/5MG/ML INJECTABLE | 04062016@3 | Human |
| SODIUM BICARBONATE, MDV 8.4% INJECTABLE | 04062016@4 | Human |
| METHYLCOBALAMIN - 10ML 1,000MCG/ML INJECTABLE | 04062016@5 | Human |
| HISTRELIN ACETATE, LYOPHILIZED 5.5MG INJECTABLE | 04062016@6 | Vet |
| CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL | 04062016@7 | Human |
| TRI1 - NR (2ML) 3.6MG/0.4MG/0.04MG INJECTABLE | 04072016@10 | Human |
| TRIMIX - (10ML) 30MG / 1MG / 10MCG INJECTABLE | 04072016@13 | Human |
| METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML) 15MG/30MG/30MG/85MG/20MG/ML INJECTABLE | 04072016@15 | Human |
| SERMORELIN ACETATE/GHRP (2) & (6) 9MG/9MG/9MG KIT | 04072016@19 | Human |
| QUAD4 (2ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE | 04072016@8 | Human |
| TESTOSTERONE CYPIONATE IN SESAME OIL (1ML) 200MG/ML INJECTABLE | 04072016@85 | Human |
| METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE | 04082016@3 | Human |
| METHIONINE/INOSITOL/CHOLINE/B-COMP/(M)/CHROMIUM/CARNITINE 20MG/40MG/50MG/25MCG/25MG/ML INJECTABLE | 04082016@4 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE | 04082016@6 | Human |
| PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE | 04082016@7 | Vet |
| QUAD3 (5ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE | 04112016@10 | Human |
| TRIMIX WITH ATROPINE (10ML) 30MG/3MG/150MCG/0.2MG/ML INJECTABLE | 04112016@13 | Human |
| NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE | 04112016@16 | Human |
| VITAMIN D3 IN SESAME OIL (5ML) 100,000 IU/ML INJECTABLE | 04112016@23 | Human |
| TRIMIX / ATROPINE (10ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE | 04112016@6 | Human |
| TRI2 - NR (5ML) 30MG/3MG/0.3MG INJECTABLE | 04112016@8 | Human |
| TESTOSTERONE CYPIONATE/ANASTROZOLE 200MG/1MG/ML INJECTABLE | 04122016@1 | Human |
| QUAD1 (2ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE | 04122016@17 | Human |
| TRIMIX (10ML) 30MG/3MG/100MCG INJECTABLE | 04122016@18 | Human |
| TRI1 - NR (5ML) 3.6MG/0.4MG/0.04MG INJECTABLE | 04122016@19 | Human |
| TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE | 04122016@2 | Human |
| TRI-TEST 200 (CEP) 200MG/ML INJECTABLE | 04122016@4 | Human |
| MIC COMBO - STANDARD (30ML) 15MG/50MG/100MG/ML INJECTABLE | 04122016@76 | Human |
| TESTOSTERONE ENANTHATE-GRAPESEED OIL 200MG/ML INJECTABLE | 04132016@1 | Human |
| TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE | 04132016@14 | Human |
| INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE | 04132016@32 | Human |
| DMSO W/LIDOCAINE 50%/0.5% SOLUTION | 04132016@69 | Human |
| TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE | 04132016@8 | Human |
| CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 3,500 UNIT VIAL VIAL | 04132016@91 | Human |
| CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 20,000 UNIT VIAL VIAL | 04132016@96 | Human |
| MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC | 04142016@107 | Human |
| METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE | 04142016@112 | Human |
| QUAD1 (2ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE | 04142016@14 | Human |
| QUAD1 (5ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE | 04142016@15 | Human |
| QUAD4 (5ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE | 04142016@16 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE | 04142016@2 | Human |
| SERMORELIN ACETATE 28MG KIT | 04142016@28 | Human |
| CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 6,000 UNIT VIAL VIAL | 04142016@34 | Human |
| SERMORELIN ACETATE 15MG KIT | 04142016@43 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 20MG/ML INJECTABLE | 04142016@5 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 100MG/ML INJECTABLE | 04142016@7 | Human |
| SERMORELIN ACETATE/GHRP (2) 9MG/3MG KIT | 04152016@149 | Human |
| ULTRA-TEST 200 - (10ML VIAL) 200MG/ML INJECTABLE | 04152016@2 | Human |
| SERMORELIN ACETATE/GHRP (2) 9MG/9MG KIT | 04152016@21 | Human |
| METHYLCOBALAMIN 5,000MCG/ML INJECTABLE | 04152016@3 | Human |
| METHIONINE/INOSITOL/CHOLINE/CHROMIUM+B12(M) - 10ML 25MG/50MG/50MG/25MCG/1MG/ML INJECTABLE | 04152016@5 | Human |
| MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE | 04182016@10 | Human |
| TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE | 04182016@33 | Human |
| METHIONINE/INO |
Friday, September 16, 2016
Filings Show Net Amounts to Virginia Victims
By Walter F. Roche Jr.
Net awards to the families of two Virginia victims who died in the 2012 fungal meningitis outbreak range from a little under $170,000 to a little over $470,000, according to petitions filed in U.S. District Court in Boston, Mass.
The awards along with attorneys fees, legal expenses and repayments to the federal Medicare program provide the very first public disclosure of the distribution of some $200 million set aside in a trust fund for the victims of the outbreak that sickened 778 patients across the country, killing 77 of them.
The disclosure comes as the hundreds of victims and their survivors have waited precisely four years since the outbreak became public without getting any compensation. Those include 113 patients or their survivors who were treated at a Nashville, Tenn. clinic.
A master settlement agreement of suits against that clinic is reportedly imminent, but there were no court filings on that matter as a Friday deadline passed.
The two Virginia petitions seek court approval of the distributions to the victims' families and various expenses including 40 percent in legal fees.
The disclosures are being made under the requirements of Virginia's wrongful death act.
In the first of the two cases, the beneficiaries of the victim are to be awarded $685,445.95 from a settlement with Insight Health, the facility where the victim was injected with a fungus laden steroid, methylprednisolone acetate. Another $120,176.93 will come from the bankruptcy settlement of the New England Compounding Center, the now shuttered company that produced the tainted steroid.
From that total of $805,622.88, $322,249.15 or 40 percent will go to the family attorney, J. Scott Sexton and his law firm.
Legal expenses totaled $12,037 and Medicare accepted reimbursement of $145.76 on the $249.15 it had paid for the victim's care.
The three beneficiaries, according to the filing, will be awarded $156,654.83 each.
The petition states that there may be additional awards and expenses at a later date.
In the second petition, the three beneficiaries stand to collect a total of $169,651.92 or $56,550.64 apiece. The victim died in October of 2012
The total award was $290,786.77, the petition states with $210,885.35 coming from Insight Health and $79,901.42 coming from the NECC bankruptcy. Attorneys fees total $116,314.71 and expenses were $4,801.18. The victim was not covered by the Medicare program, the filing states.
The Insight awards come from a $40 million settlement with the health firm, while the NECC bankruptcy payments come from $120 million recovered in the bankruptcy.
Contact: wfrochejr999@gmail.com
Cadden Says Civil Testimony, Data Will Clear Him of Charges
By Walter F. Roche Jr.
The lead defendant in the criminal case stemming from a deadly fungal meningitis outbreak says that evidence already gathered in a related civil case will clear him of all charges, including 25 counts of second degree murder.
In a six-page filing in U.S. District Court in Boston, Mass. Cadden's attorney said the evidence in that civil case "makes clear that he (Cadden) is not guilty of the criminal charges against him."
The filing was made in response to a charge by federal prosecutors that Cadden was attempting to do "an end run" around the rules that govern federal criminal cases.
Without access to the civil case records, Cadden's motion states, he and his lawyer will be left in an "impossible position" of having evidence of his innocence but being unable to present it.
Cadden is seeking access to and permission to use a repository of documents, deposition transcripts and thousands of page of other evidence gathered in an ongoing civil trial stemming from the 2012 fungal meningitis outbreak.
The motion states that Cadden, because he was originally a defendant in that case, already has access to many of the records he is now seeking to use in his defense in the criminal case scheduled for trial on Jan. 5, 2017.
"He already has most of the information, he simply seeks permission to use it to defend himself against murder charges," the filing by attorney Michelle Peirce states.
Peirce is requesting that U.S. District Judge Rya Zobel hold a court hearing to hear arguments on the request.
"Neither he nor his counsel can 'unring the bell' and forget about or ignore the information generated during the MDL (civil case)," the filing states.
As an example of the "exculpatory evidence," the filing cites transcripts that "demonstrate the pivotal role that the New England Compounding Center's cleaning consultant, Unifirst, played in contaminating NECC's cleaning rooms, leading to Unifirst's $30.5 million settlement."
The filing disputes claims that Cadden's access to the civil case data was improper and labels as a"red herring" claims that Cadden, if his motion were approved, would have access to confidential patient information on outbreak victims.
Stating that the patient data is in a separate repository, the filing states Cadden's request "raises absolutely no issues of patient privacy."
Concluding that the charges against Cadden demonstrate "unprecedented overreaching" by prosecutors, the filing concludes that it would be "counter-intuitive and unjust" to bar Cadden from using the civil trial information.
Contact: wfrochejr999@gmail.com
Tuesday, September 13, 2016
Plaintiffs Oppose Cadden Motion
By Walter F. Roche Jr.
The lead attorney for plaintiffs in the civil suits stemming from the fungal meningitis outbreak has joined with federal prosecutors in opposing a move by the primary defendant in a related criminal case to gain access to thousands of documents amassed by lawyers for outbreak victims.
Thomas Sobol, one of the attorneys representing victims of the 2012 outbreak, wrote that since Barry Cadden has been released from the civil case he should not be allowed access to the civil litigation records.
"We agree with the government that Mr. Cadden has not shown a need to access these civil litigation materials," Sobol wrote.
Cadden's lawyers filed the request to have access to the repository of documents amassed in the three-year-old civil case to use in his defense against charges, including 25 counts of second degree murder, pending against him.
Cadden is scheduled to go on trial along with codefendant Glenn Chin on Jan. 5, 2017.
Both the criminal and civil litigation stem from the 2012 fungal meningitis outbreak caused by the New England Compounding Center. The now defunct company sent thousands of vials of fungus laden steroids to health facilities across the country.
In a filing last week federal prosecutors charged that Cadden's request was an attempt to do an end run around the rules of civil procedure governing criminal trials.
In his request to access the civil files, Cadden's attorney wrote, "He (Cadden) seeks to use the materials he already possesses as well as other material added to the repository more recently to defend himself," the motion states.
Contact: wfrochejr999@gmail.com
Friday, September 9, 2016
Extension Sought in St. Thomas Negotiations
By Walter F. Roche Jr.
Negotiators seeking a resolution to some 110 lawsuits against a Nashville, Tenn. clinic missed a court imposed deadline today and are asking the presiding judge for another week to work out final details.
In a motion filed late today in U.S. District Court in Boston, Mass., attorneys for the Saint Thomas Outpatient Neurosurgical Center and related parties asked U.S. District Judge Rya Zobel to extend the deadline to Sept. 16.
Zobel had set today as the deadline for the parties to finalize a master settlement agreement and the language of individual releases to resolve some 110 claims by victims of the 2012 fungal meningitis outbreak.
Stating that "the material terms of this settlement have been agreed to for some time," the motion states that additional time is needed to resolve how liens from the federal Medicare program and other insurers will be handled.
"The parties have exchanged multiple drafts of the master settlement agreement and continue to resolve any remaining differences," the motion by attorney Marcy Greer states.
The Saint Thomas clinic is half owned by the Saint Thomas Network and Nashville's Howell Allen Clinic.
The claims come from patients or their survivors who were injected with a spinal steroid that was supposed to be sterile but was instead laden with fungus, according to state and federal regulators.
The steroids were shipped to the Nashville clinic and dozens of other health facilities across the country by the now defunct New England Compounding Center in Framingham, Mass.
Contact: wfrochejr999@gmail.com
First Checks Mailed to Outbreak Victims
By Walter F. Roche Jr.
The first checks have gone out to victims of the 2012 fungal meningitis outbreak and more will now follow due to an agreement with the U.S. Justice Department.
Lynne Riley, the trustee of the vctims' fund, said today that the first checks were mailed out a week and a half ago.
More checks will follow as the U.S. Justice Department has finally given its approval to an agreement on how much victims will have to pay to reimburse the Medicare program for the costs it incurred for treatment of the victims.
The payments come as the fourth anniversary of the outbreak approaches. The outbreak first came to public attention in mid-September of 2012 when a Vanderbilt University Medical Center physician notified Tennessee Health Department officials of the death of one of her patients from a rare fungal infection.
About $120 million of a $210 million trust fund will eventually be going to more than a thousand victims of the deadly outbreak caused by fungus infested injectable steroid drugs shipped to health facilities across the country.
The fund was created in the bankruptcy of the New England Compounding Center, the now defunct Framingham, Mass. firm blamed for the outbreak.
Under a court approved system, victims will be paid depending on the severity of their illnesses along with other factors including the length of hospitalization and treatment with anti-fungal drugs.
Under the agreement just approved by the U.S. Justice Department, victims will have amounts ranging from 10.5 to 21.5 percent deducted from their payments to reimburse the Medicare program.
The initial payments will be about half of the total amount victims can expect to receive. Final payments will come at a later date after all the administrative and other costs have been deducted.
The $210 million fund includes payments from the owners of NECC, insurance companies and other entities that provided services to NECC.
The $210 million also includes money earmarked only for those victims treated at specific clinics that have reached a settlement in ongoing litigation in U.S. District Court in Boston, Mass.
Those amounts range from $3.5 million earmarked for victims treated at a North Carolina clinic to $40 million for those treated at a Virginia health care provider.
The victims were injected with fungus laden preservative free methylprednisolone acetate shipped from the NECC facility.
Wednesday, September 7, 2016
Prosecutors Charge Cadden With End Run
By Walter F. Roche Jr.
Federal prosecutors are charging that a primary defendant in the fungal meningitis outbreak case is trying to do an end run around established rules for criminal proceedings to gain access to thousands of pages of protected documents in a separate civil case.
In a filing in U.S. District Court in Boston, Mass., two assistant U.S. Attorneys said that Barry Cadden, the top pharmacist and part owner of a defunct drug compounding firm, should not be allowed to pore through thousands of documents compiled in separate civil litigation stemming from the deadly 2012 outbreak.
Cadden's lawyers had filed a motion recently seeking access to the records of the civil cases, stating that they were necessary to prepare for his criminal trial scheduled for Jan. 5, 2017.
Cadden, who was part owner of the New England Compounding Center in Framingham, Mass. is facing a 97 count indictment charging him with crimes ranging from mail and wire fraud to racketeering to 25 counts of second degree murder.
The filing by Assistant U.S. Attorneys George Varghese and Amanda Strachan charges that Cadden is attempting to use the civil discovery process of the (civil litigation) as an end run around the federal rules of criminal procedure applicable to his criminal case."
Noting that a federal judge previously turned down his request to access some of the documents, prosecutors also argued that giving Cadden the requested access would give him an unfair advantage over the 11 remaining codefendants in the case.
"There is no legal or factual basis for providing such an advantage to a single criminal defendant," the filing states.
Prosecutors also charged that even after he was dismissed from the civil cases, Cadden "continued to attend depositions, for the sole purpose of gleaning information for use in his criminal case."
At issue are documents that include the medical records of hundreds of victims of the 2012 fungal meningitis outbreak that have been amassed by attorneys for outbreak victims.
Stating that Cadden's defense team already has been provided over 12 million pages of records, prosecutors said Cadden himself has produced no documents for the repository that contains "records and documents far beyond the scope of the criminal trial."
Cadden also has filed a motion in his criminal case seeking disclosure of the instructions that were given to the grand jurors who eventually indicted him.
Contact: wfrochejr999@gmail.com
Judge Sets Deadline for Saint Thomas Settlement
By Walter F. Roche Jr.
A federal judge today set a Friday deadline for finalization of a master settlement agreement between victims of the 2012 fungal meningitis outbreak and the Nashville, Tenn. clinic where over 100 of those victims were injected with fungus ridden spinal steroids.
U.S. District Judge Rya Zobel issued the one-page order after being told that both sides had agreed to setting a deadline.
Her order also requires both sides to agree on the language of a release document which victims will be asked to sign if they agree with the settlement.
No details of the agreement have been made public though attorneys have testified in hearings in Zobel's Boston, Mass courtroom that an agreement in principle had been reached between lawyers representing the victims and the Saint Thomas Outpatient Neurosurgical Center and related parties.
Settlements in cases against other health facilities sued in the aftermath of the outbreak have ranged as high as $40 million.
Saint Thomas officials have declined to discuss the terms, but they did state in a recent bond prospectus that the settlement would not have an adverse impact on the Saint Thomas entities.
At an August hearing attorneys told Zobel that an agreement had been reached but said paperwork had delayed finalization.
Nashville attorney William Leader, citing lengthy delays, recently asked Zobel to set a deadline.
The agreement is expected to resolve about 110 suits filed in behalf of patients who were injected with fungus laden methylprednisolone acetate at the Nashville clinic.
The 2012 outbreak, state and federal regulators have concluded, was caused by steroids shipped from the now defunct New England Compounding Center in Framingham, Mass.
A total of 778 patients were sickened in the outbreak and 77 of them died.
Among those deaths were several Nashville patients including Thomas Rybinski of Smyrna, Tenn. and Diane Reed of Nashville. Suits by their relatives are among those to be settled under the agreement.
Reed was the sole caretaker of her husband Wayne, who suffers from Lou Gehrig's disease.
Contact: wfrochejr999@gmail.com
Tuesday, September 6, 2016
Mass AG Applying for Victims Compensation Funds
By Walter F. Roche Jr.
Officials of the Massachusetts Attorney General's office say they are in the process of applying for some $40 million in federal funds that will eventually be available for victims of the 2012 fungal meningitis outbreak.
In an email response to questions, an agency spokeswoman said today that a formal application to the U.S. Justice Department was in the works.
The money was set aside recently by DOJ following a lobbying effort headed up by U.S. Rep. Mike Bishop, a Michigan Republican. Bishop's district was particularly hard hit in the outbreak that sickened some 778 patients across the country, killing 77 of them.
The attorney general's staff said that once the application is submitted and approved, a director will be hired to oversee the program and to begin processing payments to individual victims.
The exact process for distributing the grants is still being developed, but victims can contact the Mass. Attorney Generals Victim Compensation and Assistance Division to ensure that they will be notified of any requirements or developments.
Under the program victims can seek up to $50,000 apiece, although most are expected to get less than that amount
The $40 million was only set aside after the Justice Department and the federal Office of Management and Budget agreed that victims of the fungal meningitis outbreak met the requirements of the program.
The funding comes from penalties and assessments imposed on parties convicted of violating federal laws.
Here is contact information for the office:
Office of the Attorney General
Victim Compensation & Assistance Division
One Ashburton Place, 19th floor
Boston, MA 02108-1698
(617) 727-2200 ext. 2160
(617) 742-6262 fax
Here is a link to the program's web page.
Here is a link to that office:
http://www.mass.gov/ago/public-safety/resources-for-victims/victims-of-violent-crime/victim-compensation.html
What I can tell you on background
(not for direct quotation but for paraphrasing and attribution to me as a
spokeswoman or to the office) is that we are in the process of applying
for the funds. Once we do that, we will be able to hire a program
director and staff to begin the process of getting
victims compensated.
Link to Info on Massachusetts Crime Victims Compensation Program
Officials of the U.S. Department of Justice say that payments to victims
of the 2012 fungal meningitis outbreak will be made under Massachusetts
Crime Victims Compensation Program.
Here is a link to the site for that program which includes links for an application form and other needed information.
According to federal officials the maximum amount of compensation under Massachusetts law is $50,000 but most will probably get less than that based on the severity of their illness. Exact guidelines have not been announced.
http://www.mass.gov/ago/public-safety/resources-for-victims/victims-of-violent-crime/victim-compensation.html
Here is a link to the site for that program which includes links for an application form and other needed information.
According to federal officials the maximum amount of compensation under Massachusetts law is $50,000 but most will probably get less than that based on the severity of their illness. Exact guidelines have not been announced.
http://www.mass.gov/ago/public-safety/resources-for-victims/victims-of-violent-crime/victim-compensation.html
Thursday, July 7, 2016
Outbreak Victims Could Get $50,000 Each
By Walter F. Roche Jr.
Though most will get less, victims of the 2012 fungal meningitis outbreak could be eligible for payments of up to $50,000 apiece under a federally funded victims compensation fund, now that a dispute over the fund's use has been resolved.
The funding stream finally opened up Thursday following an intensive lobbying campaign spearheaded by victims of the outbreak and members of congress led by U.S. Rep. Mike Bishop, a Michigan Republican whose district counted 15 lives lost in the deadly outbreak.
U.S. Justice Department officials confirmed Thursday that they agreed to free up as much as $40 million for outbreak victims. The money will come from a fund maintained by DOJ's Office for Victims of Crimes from fines, penalties and assessments imposed upon defendants convicted of federal crimes.
According to DOJ officials the money will be channeled through Massachusetts's Attorney General Maura Healey's office. The state agency must first formally apply to DOJ for the funds, agency officials said.
It will be up to Healey's office to determine eligibility standards for the awards, according to those familiar with the program. Justice Department officials said they would be working closely with Healey's staff to implement the awards program.
Healey did not immediately respond to a request for comment.
Under Massachusetts law victims may be eligible to receive a maximum of $50,000 if they suffered "catastrophic injuries," which is defined as an injury that creates a permanent impairment.
The decision to free up the money came after a review of the history of the outbreak which sickened 778 patients in 20 states, killing 77 of them.
State and federal regulators concluded that the outbreak was caused by fungus loaded steroids (methylprednisolone acetate) shipped to hospitals and clinics across the country by the now defunct New England Compounding Center.
According to the U.S. Centers for Disease Control and Prevention the NECC case is the largest public health crisis caused by a drug in the country's history.
Fourteen owners and employees of NECC were indicted on charges ranging from racketeering and second degree murder to mail and wire fraud following a lengthy federal grand jury investigation. All have entered not guilty pleas and none have gone to trial.
As Bishop noted in announcing the fund allotment, most victims have yet to receive any compensation even though the outbreak occurred nearly four years ago.
Although $200 million has been placed in a fund created under the NECC bankruptcy, none of that money has yet gone to victims. In addition victims still face claims from the Medicare program and insurance companies for reimbursement of health care costs previously paid.
Attorneys contacted Thursday said it was unclear whether similar claims could be lodged against any awards from the victims' compensation fund.
Victims expressed elation yesterday when they learned DOJ had allotted the $40 million.
"It's nice to know our voices were heard. Hopefully this will come to fruition," wrote one of the victims.
"Since I heard this I can't stop crying! A true voice for the victims has finally been heard! Amen and hallelujah!" wrote Jona Angst, another victim.
Contact: wfrochejr999@gmail.com
Monday, September 5, 2016
Another Outbreak Anniversary .... With No Relief
By Walter F. Roche Jr.
James J. Nagle, a North Carolina victim of the 2012 fungal meningitis outbreak is 83 and he's just hoping to see his share of a victims' trust fund before he dies.
Jose Ramos of New Jersey fears that by the time he gets his share it will be all eaten up by lawyers fees and the Medicare program.
From New Jersey to Michigan to Tennessee, Virginia and Florida victims of the outbreak, or in some cases their survivors, are still waiting for even a penny in payments four years after the deadly outbreak that sickened 778 patients in 20 states, killing 77 of them.
Though some victims already had died weeks before that date, it was on Sept. 18, 2012 that the first alarm was sounded by a Vanderbilt University Medical Center physician who, puzzled by the case of an elderly patient stricken with meningitis, had ordered additional lab tests.
Dr. April Pettit notified Tennessee Health Department officials of her findings and soon the public alarm was sounded.
Ultimately the outbreak was traced to a rogue drug compounding firm in a Boston, Mass. suburb where thousands of vials of fungus riddled sterile steroids had been prepared and shipped to health providers across the country.
Reams of legal filings later, victims have gone from anger to despair and back to anger again as they await promised payments from a bankruptcy and a series of court settlements.
Earlier this year victims were told payments would be made in July, then August and still now they wait even as many are still suffering both from the fungal meningitis but also the after effects of toxic anti-fungal drugs.
"I feel they are just prolonging (it) so that the victims will be hurting so bad for money that they will jump on what ever offer comes our way," said Jose Ramos, a New Jersey victim.
Ramos has payments due him both from the compounding firm's bankruptcy settlement, but also the New Jersey based clinic where he got his injection.
Though Ramos said has been notified that he is eligible for a little over $400,000 in payments, "after lawyer fees and Medicare I'm gonna end up with change. Right now I have no words that can explain the pain I'm in everyday. I've been out of work since this has happened to me."
Ramos, like other victims who were on the federal Medicare program, have learned that the federal government now wants its share of any settlement as reimbursement for the money Medicare paid for his treatment.
"I just want my life back the way it was," Ramos said.
William Briggs of Michigan, whose wife Phyllis was a victim, said that she is finally getting back in some ways to where she was before getting the shots of tainted methylprednisolone acetate. But she walks with a cane and can't go more than 100 yards at a time. She also has memory problems.
"We are very frustrated and downright angry at the constant delays in receiving any financial award. It is also apparent that any financial assistance is being reduced with delays, insurance reimbursement and increasing legal fees," Briggs wrote in an email response to questions.
"Enough is enough," Briggs added. "We, as most others that have been affected, are not getting any younger. Most (victims) that we know are in their 70's or 80's."
Briggs said he also has been frustrated in efforts to find out about a crime victims program through the Massachusetts Attorney General's office which is supposed to be targeted to outbreak victims.
"We have called, but have not heard a word (back) regarding the Victims Compensation Fund, Briggs said, adding that he feared any grant from that source will also "be delayed and reduced in the process."
Kathy Pugh, whose mother Evelyn Bates-March is a Michigan victim, has spearheaded efforts to get assistance for all victims from that crime victims program administered through the states by the U.S. Justice Department.
Pugh says it is "unbelievable" that four years after the outbreak "not a penny has gone to the victims."
She said that her mother's health has deteriorated "month by month,"after surgery and six months on dangerous antifungal medication.
"She is unable to care for her self and is in pain 24/7. She can't understand how Medicare (CMS) can take money away from the victims when they are receiving so little."
Brenda Bansale, another Michigan victim, suffered for months from the after effects of her spinal injection and a subsequent infection and an incision that refused to heal.
She said she suffers mood swings and severe depression as just one continuing after effect.
But Bansale says despite all that and the long wait for any recompense, "It hasn't all been bad. Being sick has actually helped me put things in perspective and realize that life is too short to spend it being angry at people."
Instead she said she has been speaking up and advocating for all the outbreak victims with government agencies and the general public.
But for most victims, the passing of another year has brought no solace.
Nagle, the North Carolina victim, said it makes no sense that even though the clinic where he was treated has already agreed to a settlement, he and other victims can't get any of that money, some $3.5 million.
"I'm 83-years-old and would hope to receive payment before I pass," he said.
Contact: wfrochejr999@gmail.com
James J. Nagle, a North Carolina victim of the 2012 fungal meningitis outbreak is 83 and he's just hoping to see his share of a victims' trust fund before he dies.
Jose Ramos of New Jersey fears that by the time he gets his share it will be all eaten up by lawyers fees and the Medicare program.
From New Jersey to Michigan to Tennessee, Virginia and Florida victims of the outbreak, or in some cases their survivors, are still waiting for even a penny in payments four years after the deadly outbreak that sickened 778 patients in 20 states, killing 77 of them.
Though some victims already had died weeks before that date, it was on Sept. 18, 2012 that the first alarm was sounded by a Vanderbilt University Medical Center physician who, puzzled by the case of an elderly patient stricken with meningitis, had ordered additional lab tests.
Dr. April Pettit notified Tennessee Health Department officials of her findings and soon the public alarm was sounded.
Ultimately the outbreak was traced to a rogue drug compounding firm in a Boston, Mass. suburb where thousands of vials of fungus riddled sterile steroids had been prepared and shipped to health providers across the country.
Reams of legal filings later, victims have gone from anger to despair and back to anger again as they await promised payments from a bankruptcy and a series of court settlements.
Earlier this year victims were told payments would be made in July, then August and still now they wait even as many are still suffering both from the fungal meningitis but also the after effects of toxic anti-fungal drugs.
"I feel they are just prolonging (it) so that the victims will be hurting so bad for money that they will jump on what ever offer comes our way," said Jose Ramos, a New Jersey victim.
Ramos has payments due him both from the compounding firm's bankruptcy settlement, but also the New Jersey based clinic where he got his injection.
Though Ramos said has been notified that he is eligible for a little over $400,000 in payments, "after lawyer fees and Medicare I'm gonna end up with change. Right now I have no words that can explain the pain I'm in everyday. I've been out of work since this has happened to me."
Ramos, like other victims who were on the federal Medicare program, have learned that the federal government now wants its share of any settlement as reimbursement for the money Medicare paid for his treatment.
"I just want my life back the way it was," Ramos said.
William Briggs of Michigan, whose wife Phyllis was a victim, said that she is finally getting back in some ways to where she was before getting the shots of tainted methylprednisolone acetate. But she walks with a cane and can't go more than 100 yards at a time. She also has memory problems.
"We are very frustrated and downright angry at the constant delays in receiving any financial award. It is also apparent that any financial assistance is being reduced with delays, insurance reimbursement and increasing legal fees," Briggs wrote in an email response to questions.
"Enough is enough," Briggs added. "We, as most others that have been affected, are not getting any younger. Most (victims) that we know are in their 70's or 80's."
Briggs said he also has been frustrated in efforts to find out about a crime victims program through the Massachusetts Attorney General's office which is supposed to be targeted to outbreak victims.
"We have called, but have not heard a word (back) regarding the Victims Compensation Fund, Briggs said, adding that he feared any grant from that source will also "be delayed and reduced in the process."
Kathy Pugh, whose mother Evelyn Bates-March is a Michigan victim, has spearheaded efforts to get assistance for all victims from that crime victims program administered through the states by the U.S. Justice Department.
Pugh says it is "unbelievable" that four years after the outbreak "not a penny has gone to the victims."
She said that her mother's health has deteriorated "month by month,"after surgery and six months on dangerous antifungal medication.
"She is unable to care for her self and is in pain 24/7. She can't understand how Medicare (CMS) can take money away from the victims when they are receiving so little."
Brenda Bansale, another Michigan victim, suffered for months from the after effects of her spinal injection and a subsequent infection and an incision that refused to heal.
She said she suffers mood swings and severe depression as just one continuing after effect.
But Bansale says despite all that and the long wait for any recompense, "It hasn't all been bad. Being sick has actually helped me put things in perspective and realize that life is too short to spend it being angry at people."
Instead she said she has been speaking up and advocating for all the outbreak victims with government agencies and the general public.
But for most victims, the passing of another year has brought no solace.
Nagle, the North Carolina victim, said it makes no sense that even though the clinic where he was treated has already agreed to a settlement, he and other victims can't get any of that money, some $3.5 million.
"I'm 83-years-old and would hope to receive payment before I pass," he said.
Contact: wfrochejr999@gmail.com
Saturday, September 3, 2016
NECC Defendants Want Grand Jury Instructions
By Walter F. Roche Jr.
Charging that it was highly likely that grand jurors were misled, the two main defendants in the New England Compounding Center criminal case are asking a federal judge to force prosecutors to disclose the instructions given to those jurors during secret 2014 proceedings.
"There is a substantial likelihood and a grave danger that the grand jury based its decision on inaccurate and misleading instructions," the attorneys for Barry Cadden and Glenn Chin stated in a motion filed this week in U.S. District Court in Boston, Mass.
They are asking U.S. District Judge Richard Stearns to force federal prosecutors to disclose the instructions they gave to the grand jury that charged Cadden and Chin with 25 counts of second degree murder, along with racketeering and mail fraud charges. Cadden was an NECC owner and chief pharmacist while Chin was a supervising pharmacist for the defunct Framingham, Mass. firm.
The motion is the second attempt by defense lawyers to attack a key element in the case, the use of a private industry standard as a measuring stick for the operation of a company producing sterile drugs for human use.
The defense lawyers are charging that the grand jury may have been led to believe that violating the industry standard was the equivalent of violating a federal criminal law.
According to the motion and an accompanying 11-page brief all but 16 of the 97 counts against Cadden hinge on the sterility standard set by the U.S. Pharmacopeia.
The motion acknowledges that Stearns already has denied a dismissal motion based on the same issue, but they noted that Stearns said in his ruling that the jurors in the actual trial would not be shown the challenged wording in the indictment.
The indictment states that the USP standards "were meant to prevent harm, including death to patients that could result from the non-sterility of drugs."
That wording, the memorandum states, could easily lead a grand juror to believe that violating the USP standard was the same as violating federal law.
Chin and Cadden, who are set to go on trial Jan. 5, were among 14 owners or employees of NECC indicted by a federal grand jury in late 2014 stemming from the investigation of a deadly fungal meningitis outbreak that eventually killed 77 of the 778 patients sickened.
State and federal regulators concluded that it was fungus laden sterile drugs shipped from NECC's in 2012 that cause the deadly outbreak.
Cadden and Chin will be tried separately, 10 others are scheduled for trial on April 12, 2017. Two have pled guilty to substantially reduced charges and face sentencing before Stearns in November.
The filing by Chin and Cadden comes on the fourth anniversary of the first public disclosure of the outbreak following the death of patients treated at a Nashville, Tenn. clinic.
In their motion this week, lawyers Bruce Singal for Cadden and Stephen Weymouth for Chin, said that if the judge decided not to give them a copy of the grand jury instructions then, as an alternative, he could review them himself.
"The defendants would suffer severe prejudice if forced to defend a charge that was not properly reviewed by the grand jury," the memo concludes.
Contact: wfrochejr999@gmail.com
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