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(c) 2014 Jon L Gelman, All Rights Reserved.

Monday, October 22, 2012

Unintended Consequences - Spine Epidurals: Multistate Meningitis Outbreak

Note: This was the most actively read post of 2012. It has been updated with the current CDC case count information and reposted. 12/25/2012.

Workers' Compensation benefits generally are payable when a condition arises out of the employment including the consequences of medical treatment. Injured workers' who have suffered meningitis as a result of the consequences of an an epidural injection flowing from treatment from a compensable accident may be entitled to receive workers' compensation benefits for the infection. Additionally, there maybe a separate claim against the manufacturers or supplier of the tainted product.

Pharmaceutical products provided as a workers' compensation benefit have been the focus of national attention. Pricing and regulation of of pharmaceuticals have been an ongoing challenge to the delivery of adequate care to injured workers and the existence of product contamination will surely exacerbate the issue further.

See, Gelman, Jon L., The Complex World of Workers' Compensation and Pharmaceutical Benefits, New Jersey Law Journal, Vol. 206, p. 5, October 2011.


State
Total Case Counts
Meningitis (with or without other infection)*
Stroke without Lumbar Puncture only
Paraspinal/Spinal Infection only
Peripheral Joint Infection only
Paraspinal/Spinal + Peripheral Joint Infection
Deaths
TOTALS
620
367
8
218
26
1
39
Florida (FL)
25
20
3
2
0
0
3
Georgia (GA)
1
1
0
0
0
0
0
Idaho (ID)
1
1
0
0
0
0
0
Illinois (IL)
2
2
0
0
0
0
0
Indiana (IN)
68
47
1
20
0
0
7
Maryland (MD)
25
24
0
1
0
0
2
Michigan (MI)
223
64
1
137
20
1
10
Minnesota (MN)
12
10
0
2
0
0
0
North Carolina (NC)
5
3
0
2
0
0
1
New Hampshire (NH)
13
9
0
0
4
0
0
New Jersey (NJ)
43
39
0
4
0
0
0
New York (NY)
1
0
0
1
0
0
0
Ohio (OH)
19
16
0
3
0
0
0
Pennsylvania (PA)
1
1
0
0
0
0
0
Rhode Island (RI)
3
2
0
1
0
0
0
South Carolina (SC)
1
1
0
0
0
0
0
Tennessee (TN)
124
76
3
43
2
0
14
Texas (TX)
2
2
0
0
0
0
0
Virginia (VA)
51
49
0
2
0
0
2
* Some patients with meningitis had other infections diagnosed in addition; to date, all of these other infections have been paraspinal/spinal infections. The patient reported to have a peripheral joint infection and a spinal/paraspinal infection had both a joint injection and a spinal/paraspinal injection.
Case counts by state are based on the state where the procedure was performed, not the state of residence.



The US Centers for Disease Control (CDC) is coordinating a multistate investigation of meningitis among patients who received epidural steroid injections (medication injected into the spine). Several of these patients have had strokes related to the meningitis. In several patients, the meningitis was found to be caused by a fungus that is common in the environment but rarely causes meningitis.
Current Situation
  • About the Investigation

    • CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from two of the three implicated lots from NECC (Lot #06292012@26, BUD12/26/2012 and Lot #08102012@51, BUD 2/6/2013).  The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections.  Testing on the third implicated lot of methylprednisolone acetate and other NECC injectable medications continues.
    • As of October 22, 2012, a total of 54 patients have CDC laboratory-confirmed fungal meningitis. This form of fungal meningitis is not contagious. CDC’s laboratory has confirmedExserohilum rostratum in clinical specimens for all but two patients of these patients.  Of the other two patients, one has been found to be infected with Aspergillus fumigatus and one with Cladosporium. These fungi are common in the environment but were not a recognized cause of meningitis prior to this outbreak.
    • CDC continues to work with states to determine if there may be other fungal infections caused by exposure to NECC products beyond the three lots of preservative-free methylprednisolone acetate (80mg/ml) from NECC that were recalled on September 26, 2012. CDC does not have firm evidence that fungal infections have been caused by exposure to other NECC products.
    • CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from the three implicated lots of methylprednisolone and nearly 97% have now been contacted for further follow-up.
    • Patients and clinicians need to remain vigilant for onset of symptoms because fungal infectionscan be slow to develop. In this outbreak symptoms typically have appeared 1 to 4 weeks following injection, but it’s important to know that longer and shorter periods of time between injection and onset of symptoms have been reported. Therefore, patients and physicians need to closely watch for symptoms for at least several months following the injection. See updated Patient Guidance for more information, and contact your physician if you are concerned you may have become ill from your injection.
    • Information about the investigation and guidance for clinicians, including interim treatment guidelines, is available at  http://www.cdc.gov/hai/outbreaks/meningitis.html. CDC recommendations are subject to change as more information becomes available.

Total case count: 620 (Updated 12/17/12)
“All patients who may have received these medications need to be tracked down immediately. Patients can find the names of the clinics that used these medications on the CDC website,” said Benjamin Park, M.D., medical officer, Mycotic Diseases Branch, CDC. “It is possible that if patients with infection are identified soon and put on appropriate antifungal therapy, lives may be saved.”

Infected patients have developed a variety of symptoms approximately 1 to 4 weeks following their injection, including fever, new or worsening headache, nausea, and new neurological deficit (consistent with deep brain stroke). Some of these patients’ symptoms were very mild in nature. Cerebrospinal fluid obtained from these patients has shown findings consistent with meningitis.

On September 26, 2012, the New England Compounding Center voluntarily recalled the following lots of methylprednisolone acetate (PF) 80mg/ml:
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013

Physicians should immediately contact patients who have had an injection (e.g., spinal, joint) using any of the three lots of methylprednisolone acetate listed above to determine if they are having any symptoms. Although all cases detected to date occurred after injections with products from these three lots, out of an abundance of caution, CDC and the Food and Drug Administration (FDA) recommend that healthcare professionals cease use of any product produced by the New England Compounding Center until further information is available.

Patients who have had an epidural steroid injection since July 2012, and have any of the following symptoms, should talk to their doctor as soon as possible.
Worsening headache
Fever
Sensitivity to light
Stiff neck
New weakness or numbness in any part of your body
Slurred speech




Map of Healthcare Facilities that Received Three Recalled Lots* of Methylprednisolone Acetate (PF) from New England Compounding Center on September 26, 2012


See table for a complete list of health care facilities.

* Lot #05212012@68, BUD 11/17/2012; Lot #06292012@26, BUD 12/26/2012; Lot #08102012@51, BUD 2/6/2013
** All vials of methylprednisolone acetate that were sent to Nevada were recalled prior to use.
List of Healthcare Facilities that Received Lots of Methylprednisolone Acetate (PF) Recalled from New England Compounding Center on September 26, 2012
Facility NamePhone NumberCityState
California
CYPRESS SURGERY CENTER559-740-4094VISALIACA
ENCINO OUTPATIENT SURGICENTER818-986-1037ENCINO CA
UKIAH VALLEY MEDICAL CENTER707-463-7345UKIAHCA
UNIVERSAL PAIN MANAGEMENT661-267-6876 x166PALMDALECA
Connecticut
INTERVENTIONAL SPINE AND SPORTS MED203-598-7246MIDDLEBURYCT
Florida
FLORIDA PAIN CLINIC352-237-5906OCALAFL
INTERVENTIONAL REHABILITATION CENTER850-484-8800PENSACOLAFL
MARION PAIN MANAGEMENT CENTER352-622-1845OCALAFL
NORTH COUNTY SURGICENTER561-626-6446PALM BEACH GARDENSFL
ORLANDO CENTER FOR OUTPATIENT SURGERY407-426-8331ORLANDOFL
PAIN CONSULTANTS OF WEST FLORIDA850-494-0000PENSACOLAFL
SURGERY CENTER OF OCALA352-237-5906OCALAFL
SURGICAL PARK CENTER305-271-9100 x226MIAMIFL
Georgia
FORSYTH STREET AMBULATORY SURGURY CENTER478-749-1610MACONGA
Idaho
PAIN SPECIALISTS OF IDAHO208-522-7246IDAHO FALLSID
WALTER KNOX MEMORIAL HOSPITAL208-365-3561 x3342EMMETTID
Illinois
APAC CENTERS FOR PAIN MANAGEMENT708-483-7007WESTCHESTERIL
APAC CENTERS FOR PAIN MANAGEMENT773-935-2760CHICAGOIL
THOREK MEMORIAL HOSPITAL773-975-6734CHICAGOIL
Indiana
AMBULATORY CARE CENTER LLC812-475-1800EVANSVILLEIN
FORT WAYNE PHYSICAL MEDICINE260-436-9337FORT WAYNEIN
OSMC OUTPATIENT SURGERY CENTER574-266-4173ELKHARTIN
SOUTH BEND CLINIC574-237-9372SOUTH BENDIN
UNION HOSPITAL812-238-4964TERRE HAUTEIN
WELLSPRING812-376-0700COLUMBUSIN
Maryland
BALTIMORE PAIN MANAGEMENT410-682-5040BALTIMOREMD
BERLIN INTERVENTIONAL PAIN MANAGEMENT410-641-3759BERLINMD
BOX HILL SURGERY CENTER410-877-8141ABINGDONMD
GREENSPRING SURGERY CENTER410-653-0077BALTIMOREMD
HARFORD COUNTY ASC, LLC410-538-7000EDGEWOODMD
PAIN MEDICINE SPECIALISTS410-825-6945TOWSONMD
SURGCENTER OF BEL AIR410-638-5523BEL AIRMD
Michigan
MICHIGAN NEUROSURGICAL INSTITUTE810-606-7112GRAND BLANCMI
MICHIGAN PAIN SPECIALISTS734-995-7246BRIGHTONMI
NEUROMUSCULAR & REHABILITATION231-935-0860TRAVERSE CITYMI
SOUTHEAST MICHIGAN SURGICAL HOSPITAL586-427-1000WARRENMI
Minnesota
MAPS-EDINA MEDICAL PAIN CLINIC763-537-6000MINNEAPOLISMN
MAPS-MEDICAL ADVANCED PAIN763-537-6000FRIDLEYMN
MEDICAL ADVANCED PAIN SPECIALISTS763-537-6000 x238SHAKOPEEMN
MEDICAL ADVANCED PAIN SPECIALISTS.763-537-6000MAPLE GROVEMN
MINNESOTA SURGERY CENTER763-767-7139EDINAMN
MINNESOTA SURGERY CENTER-763-537-6000MAPLE GROVEMN
North Carolina
HIGH POINT SURGERY336-878-6048HIGH POINTNC
NORTH CAROLINA ORTHOPAEDIC CLINIC919-403-5148DURHAMNC
SURGERY CENTER OF WILSON252-237-5649WILSONNC
New Hampshire
DR. O'CONNELL'S PAIN CARE CENTER603-335-5070MERRIMACKNH
DR. O'CONNELL'S PAIN CARE CENTERS, INC603-692-3166SOMERSWORTHNH
New Jersey
CENTRAL JERSEY ORTHOPEDICS SPECIALISTS PC908-561-2122SOUTH PLAINFIELDNJ
EDISON SURGICAL CENTER732-452-0123EDISONNJ
IF PAIN ASSOCIATES / ISAIAH FLORENCE201-287-1100TEANECKNJ
PREMIER ORTHOPEDICS SURG. ASSOC., LLC856-690-1750VINELANDNJ
COMPREHENSIVE PAIN MANAGEMENT973-796-5216SPARTANJ
SOUTH JERSEY HEALTH CARE856-363-1558ELMERNJ
SOUTH JERSEY HEALTHCARE856-641-7557VINELANDNJ
Nevada
SAHARA SURGERY CENTER702-362-7874LAS VEGASNV
New York
BUTANI, SUNIL H., PHYSICIAN PC516-747-5042MINEOLANY
OBOSA MEDICAL SERVICES914-530-2323MOUNT VERNONNY
ROCHESTER BRAIN AND SPINE585-334-5560ROCHESTERNY
Ohio
BKC PAIN SPECIALISTS, LLC740-387-7246MARIONOH
CINCINNATI PAIN MANAGEMENT513-891-0022CINCINNATIOH
MARION PAIN CLINIC740-375-0200MARIONOH
ORTHO-SPINE REHABILITATION CENTER, INC.614-793-8817DUBLINOH
Pennsylvania
ALLEGHENY PAIN MANAGEMENT814-940-2000ALTOONAPA
SOUTH HILLS PAIN & REHAB ASSOCIATES412-469-7722JEFFERSON HILLSPA
Rhode Island
NEW ENGLAND ANESTHESIOLOGY (NEA)401-490-7530WARWICKRI
OCEAN STATE PAIN MANAGEMENT401-766-7700WOONSOCKETRI
OCEAN STATE PAIN MANAGEMENT401-884-6070EAST GREENWICHRI
South Carolina
INTERVENE MD843-216-4844MOUNT PLEASANTSC
Tennessee
PCA PAIN CARE CENTER865-835-5196OAK RIDGETN
SPECIALTY SURGERY CENTER931-484-2500 x125CROSSVILLETN
ST. THOMAS OUTPATIENT NEUROSURGICAL615-341-3425NASHVILLETN
Texas
DALLAS BACK PAIN MANAGEMENT214-445-5077DALLASTX
HARRIS METHODIST SOUTHLAKE CENTER817-748-8778SOUTHLAKETX
Virginia
INSIGHT IMAGING-ROANOKE540-581-0882ROANOKEVA
NEW RIVER VALLEY SURGERY CENTER540-639-5888CHRISTIANSBURGVA
West Virginia
PARS INTERVENTIONAL PAIN304-865-7277PARKERSBURGWV

From The New England Journal of Medicine

ORIGINAL ARTICLE

Brief Report: The Index Case for the Fungal Meningitis Outbreak in the United States

A.C. Pettit and Others

REVIEW ARTICLE

Current Concepts: Fungal Infections Associated with Contaminated Methylprednisolone Injections — Prelininary Report

C.A. Kauffman, P.G. Pappas, and T.F. Patterson

....
For over 3 decades the Law Offices of Jon L. Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered work related accident and injuries.