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.
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
|
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
From The New England Journal of Medicine
....
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.
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.
List of Healthcare Facilities that Received Lots of Methylprednisolone Acetate (PF) Recalled from New England Compounding Center on September 26, 2012
| Facility Name | Phone Number | City | State |
|---|---|---|---|
| California | |||
| CYPRESS SURGERY CENTER | 559-740-4094 | VISALIA | CA |
| ENCINO OUTPATIENT SURGICENTER | 818-986-1037 | ENCINO | CA |
| UKIAH VALLEY MEDICAL CENTER | 707-463-7345 | UKIAH | CA |
| UNIVERSAL PAIN MANAGEMENT | 661-267-6876 x166 | PALMDALE | CA |
| Connecticut | |||
| INTERVENTIONAL SPINE AND SPORTS MED | 203-598-7246 | MIDDLEBURY | CT |
| Florida | |||
| FLORIDA PAIN CLINIC | 352-237-5906 | OCALA | FL |
| INTERVENTIONAL REHABILITATION CENTER | 850-484-8800 | PENSACOLA | FL |
| MARION PAIN MANAGEMENT CENTER | 352-622-1845 | OCALA | FL |
| NORTH COUNTY SURGICENTER | 561-626-6446 | PALM BEACH GARDENS | FL |
| ORLANDO CENTER FOR OUTPATIENT SURGERY | 407-426-8331 | ORLANDO | FL |
| PAIN CONSULTANTS OF WEST FLORIDA | 850-494-0000 | PENSACOLA | FL |
| SURGERY CENTER OF OCALA | 352-237-5906 | OCALA | FL |
| SURGICAL PARK CENTER | 305-271-9100 x226 | MIAMI | FL |
| Georgia | |||
| FORSYTH STREET AMBULATORY SURGURY CENTER | 478-749-1610 | MACON | GA |
| Idaho | |||
| PAIN SPECIALISTS OF IDAHO | 208-522-7246 | IDAHO FALLS | ID |
| WALTER KNOX MEMORIAL HOSPITAL | 208-365-3561 x3342 | EMMETT | ID |
| Illinois | |||
| APAC CENTERS FOR PAIN MANAGEMENT | 708-483-7007 | WESTCHESTER | IL |
| APAC CENTERS FOR PAIN MANAGEMENT | 773-935-2760 | CHICAGO | IL |
| THOREK MEMORIAL HOSPITAL | 773-975-6734 | CHICAGO | IL |
| Indiana | |||
| AMBULATORY CARE CENTER LLC | 812-475-1800 | EVANSVILLE | IN |
| FORT WAYNE PHYSICAL MEDICINE | 260-436-9337 | FORT WAYNE | IN |
| OSMC OUTPATIENT SURGERY CENTER | 574-266-4173 | ELKHART | IN |
| SOUTH BEND CLINIC | 574-237-9372 | SOUTH BEND | IN |
| UNION HOSPITAL | 812-238-4964 | TERRE HAUTE | IN |
| WELLSPRING | 812-376-0700 | COLUMBUS | IN |
| Maryland | |||
| BALTIMORE PAIN MANAGEMENT | 410-682-5040 | BALTIMORE | MD |
| BERLIN INTERVENTIONAL PAIN MANAGEMENT | 410-641-3759 | BERLIN | MD |
| BOX HILL SURGERY CENTER | 410-877-8141 | ABINGDON | MD |
| GREENSPRING SURGERY CENTER | 410-653-0077 | BALTIMORE | MD |
| HARFORD COUNTY ASC, LLC | 410-538-7000 | EDGEWOOD | MD |
| PAIN MEDICINE SPECIALISTS | 410-825-6945 | TOWSON | MD |
| SURGCENTER OF BEL AIR | 410-638-5523 | BEL AIR | MD |
| Michigan | |||
| MICHIGAN NEUROSURGICAL INSTITUTE | 810-606-7112 | GRAND BLANC | MI |
| MICHIGAN PAIN SPECIALISTS | 734-995-7246 | BRIGHTON | MI |
| NEUROMUSCULAR & REHABILITATION | 231-935-0860 | TRAVERSE CITY | MI |
| SOUTHEAST MICHIGAN SURGICAL HOSPITAL | 586-427-1000 | WARREN | MI |
| Minnesota | |||
| MAPS-EDINA MEDICAL PAIN CLINIC | 763-537-6000 | MINNEAPOLIS | MN |
| MAPS-MEDICAL ADVANCED PAIN | 763-537-6000 | FRIDLEY | MN |
| MEDICAL ADVANCED PAIN SPECIALISTS | 763-537-6000 x238 | SHAKOPEE | MN |
| MEDICAL ADVANCED PAIN SPECIALISTS. | 763-537-6000 | MAPLE GROVE | MN |
| MINNESOTA SURGERY CENTER | 763-767-7139 | EDINA | MN |
| MINNESOTA SURGERY CENTER- | 763-537-6000 | MAPLE GROVE | MN |
| North Carolina | |||
| HIGH POINT SURGERY | 336-878-6048 | HIGH POINT | NC |
| NORTH CAROLINA ORTHOPAEDIC CLINIC | 919-403-5148 | DURHAM | NC |
| SURGERY CENTER OF WILSON | 252-237-5649 | WILSON | NC |
| New Hampshire | |||
| DR. O'CONNELL'S PAIN CARE CENTER | 603-335-5070 | MERRIMACK | NH |
| DR. O'CONNELL'S PAIN CARE CENTERS, INC | 603-692-3166 | SOMERSWORTH | NH |
| New Jersey | |||
| CENTRAL JERSEY ORTHOPEDICS SPECIALISTS PC | 908-561-2122 | SOUTH PLAINFIELD | NJ |
| EDISON SURGICAL CENTER | 732-452-0123 | EDISON | NJ |
| IF PAIN ASSOCIATES / ISAIAH FLORENCE | 201-287-1100 | TEANECK | NJ |
| PREMIER ORTHOPEDICS SURG. ASSOC., LLC | 856-690-1750 | VINELAND | NJ |
| COMPREHENSIVE PAIN MANAGEMENT | 973-796-5216 | SPARTA | NJ |
| SOUTH JERSEY HEALTH CARE | 856-363-1558 | ELMER | NJ |
| SOUTH JERSEY HEALTHCARE | 856-641-7557 | VINELAND | NJ |
| Nevada | |||
| SAHARA SURGERY CENTER | 702-362-7874 | LAS VEGAS | NV |
| New York | |||
| BUTANI, SUNIL H., PHYSICIAN PC | 516-747-5042 | MINEOLA | NY |
| OBOSA MEDICAL SERVICES | 914-530-2323 | MOUNT VERNON | NY |
| ROCHESTER BRAIN AND SPINE | 585-334-5560 | ROCHESTER | NY |
| Ohio | |||
| BKC PAIN SPECIALISTS, LLC | 740-387-7246 | MARION | OH |
| CINCINNATI PAIN MANAGEMENT | 513-891-0022 | CINCINNATI | OH |
| MARION PAIN CLINIC | 740-375-0200 | MARION | OH |
| ORTHO-SPINE REHABILITATION CENTER, INC. | 614-793-8817 | DUBLIN | OH |
| Pennsylvania | |||
| ALLEGHENY PAIN MANAGEMENT | 814-940-2000 | ALTOONA | PA |
| SOUTH HILLS PAIN & REHAB ASSOCIATES | 412-469-7722 | JEFFERSON HILLS | PA |
| Rhode Island | |||
| NEW ENGLAND ANESTHESIOLOGY (NEA) | 401-490-7530 | WARWICK | RI |
| OCEAN STATE PAIN MANAGEMENT | 401-766-7700 | WOONSOCKET | RI |
| OCEAN STATE PAIN MANAGEMENT | 401-884-6070 | EAST GREENWICH | RI |
| South Carolina | |||
| INTERVENE MD | 843-216-4844 | MOUNT PLEASANT | SC |
| Tennessee | |||
| PCA PAIN CARE CENTER | 865-835-5196 | OAK RIDGE | TN |
| SPECIALTY SURGERY CENTER | 931-484-2500 x125 | CROSSVILLE | TN |
| ST. THOMAS OUTPATIENT NEUROSURGICAL | 615-341-3425 | NASHVILLE | TN |
| Texas | |||
| DALLAS BACK PAIN MANAGEMENT | 214-445-5077 | DALLAS | TX |
| HARRIS METHODIST SOUTHLAKE CENTER | 817-748-8778 | SOUTHLAKE | TX |
| Virginia | |||
| INSIGHT IMAGING-ROANOKE | 540-581-0882 | ROANOKE | VA |
| NEW RIVER VALLEY SURGERY CENTER | 540-639-5888 | CHRISTIANSBURG | VA |
| West Virginia | |||
| PARS INTERVENTIONAL PAIN | 304-865-7277 | PARKERSBURG | WV |
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.
