Enterobacter sakazakii Outbreak Litigation
E. sakazakii, a gram-negative bacillus, is a rare cause of bloodstream and central nervous system infections. Although E. sakazakii can cause illness in all age groups, infants (children <1 year) are at most risk, with neonates and infants under two months at greatest risk. The groups of infants at greatest risk includes in particular pre-term infants, low-birth-weight (<2.5 kg) infants or immunocompromised infants. A growing number of reports have established powdered infant formula as a primary source and vehicle of infection. The FDA points out that powdered infant formulas are not commercially sterile products. Powdered milk-based infant formulas are heat-treated during processing, but unlike liquid formula products they are not subjected to high temperatures for sufficient time to make the final packaged product commercially sterile. In several investigations of outbreaks of E. sakazakii infection that occurred among neonates in neonatal intensive care units, investigators were able to show both statistical and microbiological association between infection and powdered infant formula consumption. Mortality rates from E. sakazakii infection have been reported to be as high as 50 percent or more, but this figure has declined to under 20 percent in recent years. Significant morbidity in the form of neurological deficits can result from infection, especially among those affected with bacterial meningitis and cerebritis.