Continued from part 2 of our Texas drug defect attorneys’ series on the deadly outbreak
NECC, source of contaminated steroid, has been investigated before for violations
Texas drug defect attorneys note that The Boston Globe has been reporting on some of the past lapses at the NECC (New England Compounding Company). Tainted tinctures from the NECC of a steroid injected into the lower back for pain have been fingered as the source of the outbreak of the deadly fungal meningitis that has killed at least 7 people so far.
Both state and federal authorities have already investigated the NECC several times for previous lapses. In some cases, the lapse involves overstepping the proper role of a compounding pharmacy and actually “manufacturing” and marketing new drugs. In other cases, the investigations involved lapses in sterile procedures during production of drugs.
For example, one complaint against the NECC this year involved the potency of a “triple strength” eye medication. That complaint remains under investigation. Our Texas drug defect attorneys point out that three complaints from 2002 and 2003 involved the company’s preparation of methylprednisolone acetate, the tainted steroid at issue in the current deadly outbreak of a rare form of meningitis.
A 2004 inspection at the NECC found a number of problems at the Framingham, MA facility. The problems were detailed in a warning letter issued to the NECC by authorities in 2006.
Just how serious is a fungal meningitis infection?
Meningitis is a very serious, potentially fatal, inflammation of the protective membranes that cover your brain and spinal cord. The most common forms involve viral or bacterial infection. The current outbreak, however, has been linked to a much more rare form of fungal meningitis. The Texas drug defect attorneys at Denena & Points emphasize that the fungal form of meningitis, unlike the viral and bacterial forms, is not contagious.
At least two forms of fungus have so far been found in patients that have contracted the rare form of fungal meningitis. The two fungi, Aspergillus and Exserobilium, can be found in back yards. The latter form causes leaf spots, but also can cause sinus and skin infections in humans. Aspergillus can cause lung infections in those with HIV, cancer, and compromised immune systems.
Fungus can grow in drugs that are not stored properly and can contaminate the drugs through air contact. Our Texas drug defect attorneys caution that the NECC steroids at the source of the deadly fungal meningitis outbreak was prepared without preservatives that might usually tend to destroy the fungi.
What NECC products might contain the deadly fungal contamination?
In the interests of caution, health officials are telling health providers and patients to avoid all products manufactured by the NECC, particularly those 35 products that can be injected into the spine. These products include epidurals used to block the pain of childbirth, and surgical and saline solutions. Three steroids, betamethasone, dexamethasone, and traimcinolone, as well as the anesthetics lidocaine and bupivicaine, and the blood pressure drug clonidine are of particular concern.
Continue to part 4 to learn what to do if you might be affected by the tainted medication.