Girardi | Keese

Fungal Meningitis Update: Investigators Report Sterility Problems

Less than a week after we last covered the national fungal meningitis outbreak, the death roll has risen to from 19 to 23 people and more than 300 other victims are sick from the contaminated steroids. Our recent post on the outbreak discussed how a sterilization failure could have contaminated the products and new information suggests that this may have indeed played a role.

If the New England Compounding Center did cause the outbreak by failing to properly sterilize its products, a series of wrongful death and product liability lawsuits could spring up across the country.

Massachusetts officials inspected the facility and its record, announcing Tuesday that they found serious concerns.

Here are some of the key findings from the investigators' new report:

· NECC apparently shipped part of the contaminated steroid batch to its customer clinics before it had even finished testing whether the batch was sterile.

· Documents showed that NECC did not even sterilize products for the minimum amount of time needed to make sure they were not contaminated.

· Parts of the facility were "visibly soiled with assorted debris," including floor mats located right outside a sterile area.

· A boiler tank inside the sterile area was leaking, resulting in a standing pool of water. Standing water is extremely vulnerable to contamination.

· NECC did not properly clean some equipment that was found in the compounding area.

These results suggest that NECC might have pushed its products to market without taking enough steps to make them sterile. If this is the case, NECC will probably face enormous liability for sickening and killing numerous victims.

Source: New York Times, "Sterility Found Lacking at Drug Site in Outbreak," Abby Goodnough, Oct. 23, 2012

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