(PRWEB) October 11, 2012
Cleveland, Ohio, law firm Spangenberg Shibley & Liber LLP is investigating personal injury and wrongful death claims on behalf of individuals who suffered serious illness, a stroke, or died after developing fungal meningitis following an epidural steroid injection for back pain. “[A]ll infected patients received preservative-free methylprednisolone acetate from among the three lots voluntarily recalled by the New England Compounding Center in Framingham, Massachusetts, on September 25th,” Dr. Benjamin Park reported during a Centers for Disease Control- and FDA-hosted teleconference last Thursday. On Saturday, the New York Times reported that some of the infected patients have suffered a stroke.
What is the Drug Involved in the NECC Fungal Meningitis Outbreak?
According to WebMD, healthcare professionals often inject patients with an epidural steroid to treat pain that is caused when an inflamed spinal disc touches the nerve root. A person may develop fungal meningitis when a fungus is introduced directly into the central nervous system, the CDC reported on its website.
Last month, the Tennessee Department of Health notified the CDC about a patient who acquired meningitis nearly three weeks after being injected with an epidural steroid, the CDC stated during last week’s teleconference. Someone in another state became infected with the disease a week later. When the FDA investigated, it found fungus in an unopened vial of methylprednisolone acetate that it collected from NECC, stated the agency’s director of the office of compliance for the Center of Drug Evaluation and Research.
“Foreign material could easily be seen floating in other vials found at the company,” FDA officials said, according to an October 5 Boston.com article.
Since then, the CDC has reported that fungus has been found in specimens taken from nine patients, NBC News writer JoNel Aleccia reported on Monday.
As of October 8, over 105 people have fallen ill with meningitis symptoms, and eight have died, Aleccia wrote. CBS News reported that 13,000 Americans may have been injected with the contaminated steroid, which was shipped to 76 providers in 23 states.
NECC, a compounding pharmacy, has shut down operations and surrendered its pharmacy registration to the Massachusetts Board of Registration and Pharmacy.
It has been investigated several times, two of which were due to complaints the FDA received ten years ago with regard to NECC’s preparation of the steroid in question, Boston Globe writers Matt Rocheleau and Travis Andersen wrote on Sunday. Both the state and the FDA investigated NECC for lapses in maintaining sterile conditions in its two-story brick building, Massachusetts health officials reportedly told the Globe.
“Compounding pharmacies usually make drugs to order, and the steroids suspected of causing the infections did not contain preservatives that can keep fungi and bacteria from growing,” NBC News reported.
In 2007, the FDA issued a warning stating that compounded drugs “are not FDA-approved,” the Wall Street Journal noted in its article “Outbreak Spurs Calls for New Controls.”
About Spangenberg Shibley & Liber
Spangenberg Shibley & Liber handles a broad range of defective drug, defective medical device, personal injury, wrongful death, and medical malpractice cases. The firm also litigates a variety of property damage and insurance coverage cases. For more information about the firm, please contact marketing manager Miranda Miller at 216.696.3232 or visit http://www.spanglaw.com.