Latest on Meningitis Outbreak
Written by Faith Anderson on January 4, 2013
Contaminated Steroid Recalled by NECC
Upon discovering the contamination of its medications, NECC recalled 17,000 vials of tainted steroid injections on September 26, before recalling all its drugs and shutting down the pharmacy on October 6. Unfortunately, at this point, approximately 14,000 potentially-tainted epidural injections had already been distributed to hospitals and pain centers across the country. Note that this is a much larger scale operation than is common among compounding pharmacies, and is actually not the capacity in which these pharmacies are intended to operate. Also, because compounding pharmacies like NECC are designed to mix prescriptions for specific special-need patients (not for widespread distribution), the pharmacies are not subject to U.S. Food and Drug Administration (FDA) regulations as other drug manufacturing companies are.
FDA Report Identifies Fungus, Bacteria in Pharmacy
Upon an investigation of the compounding pharmacy’s lab, the FDA found that one-quarter of the epidural injections in one bin contained “greenish black foreign matter,” according to the agency’s report. The FDA also identified several cleanrooms in the lab that contained mold or bacterial overgrowths. More specifically, the FDA report called the compounding pharmacy “an incubator of bacteria and fungus,” indicating that “the pharmacy knew this through monitoring results, and chose to do nothing.” UniFirst Corp apparently provided cleaning services to the compounding pharmacy’s Framingham, Massachusetts, lab once a month, and the company wrote the following regarding NECC’s accusations in its quarterly filing: “Based on its preliminary review of this matter, the company believes that NECC’s claims are without merit.”
Lawsuits Filed Over Fungal Meningitis From Tainted Steroid
According to UniFirst spokesperson Adam Soreoff, the company’s UniClean business cleaned portions of the compounding pharmacy’s cleanrooms to NECC’s specifications using NECC’s cleaning solutions. The company provided two technicians once a month for roughly an hour and a half. “UniClean was not in any way responsible for NECC’s day-to-day operations, its overall facility cleanliness, or the integrity of the products they produced,” Soreoff said. “Therefore, based on what we know, we believe any NECC claims against UniFirst or UniClean are unfounded and without merit.” As lawsuits filed against NECC for its contaminated steroid injection continue to grow, the compounding pharmacy is obviously on the lookout for someone else to take the blame. If you suffered from fungal meningitis, or if you lost a loved one to the disease, because of a tainted steroid injection, contact a knowledgeable lawyer today to discuss your legal options.