In the last week, the fungal meningitis outbreak has claimed four more lives, bringing the count of fatalities to 23. More than 300 people are now sick as a result of a batch of contaminated steroid injections. As we discussed last week, these steroids need to remain sterile at all points during production. Because the steroids cannot contain preservatives, they are very vulnerable to contamination from outside sources.
Massachusetts officials investigated the facility responsible for the injections-the New England Compounding Center. These officials reported initial findings this week, pointing to an increased likelihood that NECC’s failure to comply with sterilization procedures led to the outbreak. If this is the case, NECC could be liable for selling a defective product.
Perhaps the most concerning finding was that NECC shipped this batch of steroids without even waiting for the results of a final sterility test. This suggests that it was much more interested in selling the steroids than ensuring patient safety. Investigators also said that NECC did not do enough to sterilize its products. One expert said that it did not sterilize them long enough to satisfy even the minimum standards for sterility.
Other concerns focused on the physical condition in which NECC maintained its sterile manufacturing area. Filthy floor mats lay just outside the doors and a leaking piece of equipment left a pool of standing water inside the sterile room.
Any of these findings taken alone could point to a major shortcoming on the part of NECC. All of them together, along with more facts that could yet come to light, probably suggest that NECC’s operations could be responsible for this fatal outbreak.
Source: New York Times, “Sterility Found Lacking at Drug Site in Outbreak,” Abby Goodnough, Oct. 23, 2012