October 10, 2012 - U.S. health officials have estimated that as many as 13,000 people may have been exposed to contaminated lots of a popular corticosteroid pain reliever that has been linked to a rare form of fungal meningitis. So far, the fungal meningitis outbreak has killed at least 12 people and sickened more than 120 in 10 states around the county. Fourteen new cases of fungal meningitis and one new death have been reported since yesterday.
Michael E. Schmidt, Managing Partner of Schmidt & Clark, LLP, has noticed an alarming number of inquiries to the firm related to fungal meningitis. Mr. Schmidt stated, "Our firm has substantial expertise in the area of product liability litigation. As a result, we have recently received a number of inquiries from patients who were treated with recalled steroid medications and subsequently diagnosed with fungal meningitis."
According to the U.S. Food & Drug Administration (FDA), the outbreak has been linked to Methylprednisolone Acetate, a widely-prescribed steroid pain reliever that was processed by the New England Compounding Center (NECC) in Framingham, Mass. A sealed vial of the drug was found to be contaminated by a fungus. In response to the outbreak, NECC has recalled ALL lots of Methylprednisolone Acetate, as well as all other drugs the company handles. Click here for a complete list of facilities that received the tainted medications.
"If patients are concerned, they should contact their physician to find out if they received a medicine from one of these lots," said Dr. Benjamin Park of the CDC, adding that most of the cases occurred in older patients with healthy immune systems.
The potentially contaminated steroids were distributed to at least 76 facilities in 23 states, and as many as 13,000 patients may have been injected with the drug. As of October 10, 2012, the CDC offered the following state-by-state breakdown of cases:
Florida - 4 cases
Indiana - 12 cases
Maryland - 8 cases, including 1 death
Michigan - 25 cases, including 3 deaths
Minnesota - 3 cases
New Jersey - 1 case
North Carolina - 2 cases
Ohio - 1 case
Tennessee - 39 cases, including 6 deaths
Virginia - 24 cases, including 1 death
Click here to view a CDC map of states affected by the outbreak.
Also known as Cryptococcus neoformans, fungal meningitis is a rare disease characterized by inflammation of the lining that surrounds the brain and spinal cord. This reaction is caused by fungal contamination, and can be life-threatening, even if treated in a timely manner. Telltale signs of the disease may be difficult to detect, given the fact that symptoms may be subtle and indicative of any number of other conditions. Symptoms of fungal meningitis may include:
-
headache
-
nausea
-
vomiting
-
stiff neck or neck pain
-
sleepiness
-
confusion
-
photophobia (sensitivity to light)
-
altered mental state
It is important to note that this particular variety of fungal meningitis is non-communicable, which means that there is no threat of the disease being transferred from person to person. Treatment is typically administered via high-dose antifungal injection, which requires a hospital visit. Patients who develop hydrocephalus (water in the brain) as a result of their illness may require a shunt procedure to drain the buildup of fluid. Sadly, even with swift and effective medical treatment, fungal meningitis is a tenacious disease that may lead to significant neurological damage or even death.
The potentially contaminated steroid injections were administered between July and September 2012. The CDC has cautioned that the incubation period for this type of fungal meningitis may be significantly longer than originally suspected. What was initially reported to be a period of up to one month between the time of injection and manifestation of symptoms has now been extended to three months or even longer.
"FDA is in the process of further identifying the fungal contaminate," said Dr. Ilisa Bernstein, acting director of the FDA's Center for Drug Evaluation and Research Office of Compliance. "Our investigation into the source of this outbreak is still ongoing."
The controversy surrounding the contaminated Methylprednisolone Acetate has called attention to the highly unregulated practices of so-called ‘pharmacy compounders,’ facilities that take drug ingredients and package them into custom dosages for specific clients. Like other compounding pharmacies, NECC’s products are not subject to the same degree of FDA regulation as large pharmaceutical companies. The issue with the contaminated steroid is not the first time NECC has been in trouble for shoddy drug manufacturing practices. In 2006, the FDA warned the company about processing procedures that had the potential to contaminate another drug it handled. NECC has voluntarily shut down all operations until the investigation into the source of the contamination can be completed.
Michael E. Schmidt is recognized as one of Americaʼs most passionate, accomplished and skilled trial lawyers. His law firm, Schmidt & Clark, LLP, is currently accepting fungal meningitis lawsuits in all 50 states and offers a free confidential case evaluation. To learn more about this topic and to see if you qualify to participate in a meningitis lawsuit, please visit his website: http://www.fungalmeningitislawsuit.org/
