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In 2012, a fungal meningitis outbreak occurred in the United States after a compounding pharmacy sent contaminated vials of an epidural steroid to 23 states and 75 facilities.
New England Compounding Center (NECC), held to lesser standards than typical drug companies by the FDA, sent three lots (about 17,000 vials) of preservative-free methylprednisolone acetate, which were then recalled on September 26, 2012. The U.S. Centers for Disease Control and Prevention estimated 14,000 were exposed, and since that point, 730 cases of illness and 64 deaths resulted.
Lawsuits concerning the contamination and development of fungal meningitis have since been filed and consolidated into multi-district litigation in the U.S. District Court for the District of Massachusetts.
How the Outbreak May Have Occurred
Compounding pharmacies like NECC develop specialty drugs for patients requiring customized prescriptions. Smaller lots of a particular medication or substance get developed and then shipped to medical facility. This particular steroid had been created to reduce back pain and was also injected into the ankle, shoulder, or knee.
Government regulators tracing this contaminated shipment back to NECC eventually found black mold (exserohilum rostratum) in the vials, dirty equipment in the facility, and a contaminated “clean” room, and determined the drugs had not been tested before being shipped.
Some patients given the contaminated MPA developed fungal meningitis – a condition that may take one to three weeks to become apparent – or localized infections at the injection site, which could have been in the spinal or paraspinal area, knee, shoulder, or ankle. Other conditions related to fungal meningitis further surfaced, including strokes, osteomyelitis, and an abscess near the injection area.
In general, severe inflammation of the brain and spinal cord’s lining characterizes fungal meningitis. Medical professionals treating a patient give a high dosage of an antifungal medication intravenously, but patients may still experience permanent nerve damage.
Individuals exposed to this outbreak were given injections after May 21, 2012 and have been said to display a combination of the following symptoms: sensitivity to light, slurred speech, fever, new or worsening headache, stiff neck, numbness or weakness in parts of the body, and redness or swelling near the injection site. This particular form of fungal meningitis is not contagious and was not spread to others who didn’t receive the injections.
Although this particular incident occurred in 2012, NECC had contamination issues dating back to 2006.
Legal Issues
After other medications went under scrutiny, including triamcinolone acetonide and cardioplegic solution, NECC since stopped operation as of October 2012 and filed for bankruptcy not long after. As a result, filing lawsuits against the manufacturer – common for dangerous drugs and product liability cases – has turned into a challenge for lawyers representing clients with fungal meningitis claims.
However, other related companies have since been named defendants in these legal battles: other businesses owned by NECC’s founders and healthcare providers who gave the injections. As of 2013, a judge has frozen $20 million of NECC’s profits.
Patients and family members pursuing such cases often seek compensation for personal injuries, lost future wages, emotional distress, medical expenses, and punitive damages. For the latter of this group, other compounding pharmacies have come under scrutiny, with states increasing oversight and demanding greater responsibility.
This instance turned into one of the largest cases of drug contamination in recent history, with its ramifications leading to several deaths, permanent disability, or lengthy, costly hospital stays. Patients expect medical professionals and drug companies to fully test and sterilize medications before they’re sent out to the public, and those behind such negligent practices need to be held accountable.
