The fungal meningitis outbreak continued this week as the number of reported cases rose to more than 300, including some here in Ohio. At least 24 people have died in 17 states. Health authorities are now reporting the first findings from an inspection of the compounding pharmacy that is apparently responsible for the outbreak.
Since the findings indicate significant sterility failures on the part of the pharmacy, this new information suggests that the company will be liable for wrongful death.
Because the steroid involved in this outbreak cannot contain preservatives, it is crucially important for it to stay in a completely sterile environment during production. The slightest exposure to contaminants-like the fungal spores that cause meningitis-can lead to this kind of dangerous infection.
However, Massachusetts authorities report that the New England Compounding Center was not exactly careful about sterilization procedures. The company shipped part of the contaminated batch of steroids without even waiting for the results of a sterility test. Apparently, a leaking boiler tank in the sterile manufacturing area allowed a pool of standing water to accumulate in the room. Standing water is very vulnerable to many kinds of bacterial and fungal contaminants.
The investigators also reported problems with equipment maintenance and dirty floor mats just outside the supposedly sterile area.
While the investigators did not conclusively say what went wrong, all of these findings point to big problems for NECC. It looks more and more likely that the company put sales before safety. If so, NECC will likely be liable for causing this fatal fungal meningitis outbreak.
Source: ABC News, “Meningitis Outbreak: Pharmacy Inspection Reveals Drug-Safety Lapses,” Katie Moisse, Oct. 24, 2012