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CDC and FDA Investigate Multi-State Meningitis Outbreak

Concern regarding the origination of a recent meningitis outbreak has witnessed a collaborative effort by both the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Accordingly, these regulatory agencies are currently coordinating a multi-state investigation of fungal meningitis among patients who received an epidural steroid injection. While having yet to determine the source of the outbreak, officials believe the main suspect is an injectable steroid produced and distributed by New England Compounding Center (NECC) in Framingham, Massachusetts.

Concern regarding the current outbreak began on September 21, 2012, when the CDC was notified by the Tennessee Department of Health of a patient with the onset of meningitis. According to the report, the onset of meningitis came approximately 19 days after the patients had received an epidural steroid injection at a Tennessee ambulatory surgery center (ASC). Initial tests of the patient’s blood were negative. However, subsequent testing revealed that Aspergillus fumigatus was isolated from the cerebral spinal fluid by fungal culture.

On September 28, investigators identified another case outside of Tennessee, possibly indicating contamination of a widely distributed medication. As of October 4, a total of 35 cases in the following states, five of which have resulted in fatal circumstances, have been identified with a clinical picture consistent with fungal infection:

  • Florida (2 cases)
  • Indiana (1 case)
  • Tennessee (25 cases, including 3 deaths)
  • Maryland (2 cases,including 1 death)
  • North Carolina (1 case)
  • Virginia (4 cases, including 1 death)

According to an FDA Statement, the product believed to be responsible for this meningitis outbreak is a preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid produced and distributed by New England Compounding Center (NECC) in Framingham, Massachusetts. The CDC’s interim data show that all infected patients received injection with this product. As of Oct 3, 2012, NECC has voluntarily shut down.

Meningitis refers to inflammation of the protective membranes covering the brain and spinal cord known as the meninges. The inflammation is usually caused by an infection frequently with a bacteria or virus, but meningitis can also be caused by less common pathogens such as fungi. The severity of illness and the treatment for meningitis differ depending on the cause. Thus, it is important to know the specific cause of meningitis.

Fungal meningitis occurs when the protective membranes that cover the brain and spinal cord are infected with a fungus. Fungal meningitis can develop after a fungus spreads through the bloodstream from somewhere else in the body, as a result of the fungus being introduced directly into the central nervous system, or by direct extension from an infected body site next to the central nervous system.

Symptoms of fungal meningitis are similar to symptoms of other forms of meningitis, however they often appear more gradually and can be very mild at first. In addition to typical meningitis symptoms, like headache, fever, nausea, and stiffness of the neck, people with fungal meningitis may also experience confusion, dizziness, and discomfort from bright lights. Patients might just have one or two of these symptoms. However, if the condition is allowed to progress, it may become fatal.

Do I Have a Meningitis Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in meningitis lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been diagnosed with meningitis following a a steroid injection, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

Categories: Product Liability
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