by: Edward B. Mulligan V, Attorney
The United States witnessed the largest outbreak of health-care associated infection in history last year. Methylprednisolone acetate (MPA) injections produced by the New England Compounding Center (NECC) and shipped to pain clinics and hospitals were later found to contain E. rostratum and A. fumigatus and are blamed for causing hundreds of people to become sick, and in some cases, die. To date, the CDC has received 751 reports of confirmed fungal meningitis and other infections associated with the outbreak as well as 64 reports of death. One CDC report estimates that as many as 13,000 people have been exposed to the contaminated steroid injections linked to the outbreak.
Fungal meningitis is an inflammation of the membranes that cover the brain and spinal cord and is typically contracted when fungus enters the bloodstream or is introduced directly into the central nervous system. It is very rare and it is not contagious. Symptoms include severe headache, neck stiffness, fever, and light sensitivity. If left untreated, fungal meningitis can lead to death. Diagnosis of meningitis requires a blood sample and/or spinal tap, a procedure where a physician inserts a needle into the spinal cord to take a sample of the fluid for testing. Spinal taps are extremely painful and risky. A negative spinal tap does not always result in a free-and-clear diagnosis. Some illnesses may take a while to develop and may not show up during an initial test. As a result, many patients must endure months of anxiety and painful testing procedures before they can be cleared.
The treatment of fungal meningitis can be long term– lasting several months or years depending on the patient– and invasive. For example, high-dose antifungal medications administered through an IV are necessary to treat infected patients. These treatments can cause side effects including nausea, diarrhea, and fever. Some antifungal treatments can also cause serious damage to the kidneys. Some of the patients who contracted fungal meningitis as a result of this outbreak were interviewed by CBS’ 60 Minutes and talked about their initial fear when the news was released and the pain they have endured throughout their treatment after diagnosis was confirmed.
Recently, the CDC issued two reports concluding that the initial response by public health care officials and healthcare professionals to affected patients was crucial in reducing the severity of the outbreak and mortality rate associated with it.
Even with this rapid response, however, many patients still contracted fungal meningitis and other infections and still suffer today. Sadly, this response also did not prevent the death of more than 60 people. The recent CDC report also states that while many of these affected patients have completed antifungal therapies, relapses of infection are still possible. In some cases, antifungal treatments have merely stabilized or provided only slight symptom improvement to infected patients. Further monitoring will be required even after symptoms have subsided.
To study the long-term impacts of this outbreak, the CDC has also contracted the University of Alabama at Birmingham to monitor people who were infected by this outbreak. The study is scheduled to run through 2015. The agency hopes to gain a better understanding of appropriate treatment time, best treatment options, and relapse rates.
Hundreds of patients who were exposed to these contaminated methylprednisolone acetate injections and suffered injuries have filed or plan to file claims against the NECC compounding facility and other affiliated companies and individuals. These lawsuits are currently pending in the United States District Court and Bankruptcy Court for the District of Massachusetts.
The Bankruptcy Court has established a fast-approaching claim deadline for those who received contaminated shots. As a result, anyone who received a contaminated injection and wishes to file a claim against the NECC compounding facility must file specific documentation required by the court quickly in order to preserve their claim against NECC.