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11/21 Update: Fungal Meningitis Outbreak

This update to our continued coverage of the Fungal Meningitis Outbreak deals with Ameridose inspections, a history of problems at NECC, and an update to the current CDC Case Numbers

FDA details contamination issues at Ameridose

Lab technician image from the CDC
The FDA and CDC continue to uncover disturbing findings as the Fungal Meningitis outbreak continues

This past Monday, the Food and Drug Administration (FDA) released a report documenting their findings of an inspection of Ameridose located in Westborough, Massachusetts.  Ameridose is the ‘sister company’ of the New England Compounding Center (NECC) where the tainted steroids that caused the fungal meningitis outbreak have been traced.  The report cited insect problems, bird infestations, leaking ceilings, non-sterile conditions and poor quality control. The FDA also reported that there had been 53 incidents of bacterial contamination that were found during testing of drugs that were not investigated.  Numerous samples of bacteria and mold had been isolated from manufacturing areas and no corrective actions were taken.

To make matters worse, there were also complaints of serious reactions with drugs felt due to excessive potency.  Complaints included over sedation (Fentanyl Patch) and hyperstimulation of the uterus resulting in fetal distress and maternal hemorrhage (drug not documented).  There were complaints of under potent drugs used to sedate children during surgery. A reply from Ameridose is pending however they have stated that they have had no instances of product contamination in its six year history and shipping of over 70 million units of product.  At this point no clinical infections have been linked to Ameridose.

Congressional hearings on NECC problems will be held this week.  Republican staffers released a report in advance of these hearings where they stated that problems at NECC had been going on since March of 2002.  The FDA learned in 2002 of two patients who developed septic shock after being given epidural steroids (betamethasone) and two patients who developed meningitis like symptoms after administration of methylprednisolone, compounded by NECC.  The report states that scientists at NECC resisted and lied to federal and state regulators who were attempting to force changes at the company.

It appears that the same problems that caused the 2012 fungal meningitis outbreak were present and identified 10 years prior and no action was taken. The finger-pointing in Washington has already started.  Questions include, why was the FDA recommendation to suspend operations in 2002 not acted on, and why did the state of Massachusetts or their Health Department not take action?

The Center for Disease Control has stated that the meningitis risk is waning, but is not gone.  It may take six weeks or longer after an injection is given for an infection to be diagnosed.

Center for Disease Control (CDC) – Update on Case Numbers
As of November 10, 2012 here are the counts.

State

Total

Joint

Deaths

Florida (FL)

23

0

3

Georgia (GA)

1

0

0

Idaho (ID)

1

0

0

Illinois (IL)

2

0

0

Indiana (IN)

52

0

4

Maryland (MD)

23

0

1

Michigan (MI)

128

6

8

Minnesota (MN)

11

0

0

New Hampshire (NH)

13

4

0

New Jersey (NJ)

27

0

0

New York (NY)

1

0

0

North Carolina (NC)

3

0

1

Ohio (OH)**

15

0

0

Pennsylvania (PA)

1

0

0

Rhode Island (RI)

3

0

0

South Carolina (SC)

1

0

0

Tennessee (TN)

81

0

13

Texas (TX)

2

0

0

Virginia (VA)

50

0

2

TOTALS

438*

10

32

 *428 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus 10 peripheral joint infections (e.g., knee, hip, shoulder, elbow). No deaths have been associated with peripheral joint infections.  Case counts by state are based on the state where the procedure was performed, not the state of residence.

We will continue to update you as more information comes to light. If you or a family member has been infected with a fungus from an epidural or intra-articular injection you should consult an attorney to know your rights.  The attorneys at Michles & Booth are prepared to help you.  Please call (850) 438-4848 or out of area call (800) 436-3606.

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