Enterobacter sakazakii, a gram-negative, rod-shaped bacterium, is a rare cause of invasive infection with high death rates in neonates and has been linked to powdered infant formulas and powdered human milk fortifiers. The Food and Agriculture Orgainzation of the United Nations has identified Enterobacter Sakazakii as an "organism of concern" and has conducted several studies and meetings involving the pathogen. Links to the reports of the FAO are located at the end of this article.
All powdered infant formulas, without exception, are not sterile and can contain a multitude of harmful bacteria—straight out of the package. Since the beginning of our initial investigation and research into powdered milk formulas and its deadly effect on neonates (and full term infants, we have learned), we have identified a number of cases involving premature and full-term infants who became ill after contracting sepsis and/or meningitis as a result of ingesting powdered infant formula products and powdered human milk fortifier formula products from various manufacturers. The instances of Esak contamination and outbreaks continue and are documented worldwide.
What is most alarming about this emerging health crisis is that formula manufacturers continue to produce the powdered formulas with full knowledge that the finished product is not sterile and may contain harmful or deadly bacteria. The manufacturers offer inadequate warnings regarding the non-sterile products even to hospitals and doctors.
Powdered infant formula and human milk fortifier can leave the manufacturers’ facilities laced with bacteria including salmonella, ecoli, and Enterobacter Sakazakii. Although E. sakazakii can cause illness in all age groups, infants 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 infants or immunocompromised infants. However, infants who are compromised for any other reason may also be at greater risk of E. sakazakii infection.
Most of the contaminants in powdered formulas can or may be killed by the operation of a full term, healthy immune system. Unfortunatley, very low birthweight or immunocompromised infants' immune systems are sometimes too weak to kill these bacteria. This explains why most documented Enterobacter Sakazakii infections involve neonates and immuno-compromised infants—their immune systems simply cannot eliminate all of the pathogens. However, as noted above, even full term infants have recently been the target of the deadly bacteria.
In April, 2002, the FDA sent a “Dear Doctor” letter to all health care professionals, the text of which is below (and can be found on the FDA website at the following link http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01146.html :
A quote from the letter states:
“As background information for health professionals, FDA wants to point 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…”
The tragic thing is, most health professionals are still unaware of the potentially deadly pathogens contained in these products. As a result, non-sterile powdered formula continues to be prescribed and fed to infants, despite the proven dangers.
The manufactures deny that their product is unsafe. However, Esak continues to harm and infect infants worldwide. In fact, powdered infant formula has been implicated in nearly all neonatal Enterobacter Sakazakii infections worldwide. Most infants who are infected with Esak die. The few that live must cope with a lifetime of severe brain damage, meningitis, and physical inability.
In light of the FDA’s continued and well documented failings in many food contamination cases, and the near daily reports of contamination of our food supply, this issue needs to be brought to the attention of parents everywhere. Parents, doctors, and healthcare givers must be informed as to the nature of these products before they are prescribed.
--Bill Pemerton is an attorney in Chattanooga, Tennessee at the law firm of Horton, Maddox and Anderson PLLC. In 2002, HMA was retained by the parents of an infant who was diagnosed with neonatal bacterial meningitis caused by Enterobacter Sakazakii. Since then, HMA attorneys have logged thousands of hours researching and investigating Enterobacter Sakazakii infections. If you have questions, you may contact the author at bpemerton@chattanooga-law.com.
http://www.who.int/foodsafety/publications/micro/mra6/en/
http://www.cdc.gov/mmwR/preview/mmwrhtml/mm5114a1.htm
http://jama.ama-assn.org/cgi/content/full/287/17/2204
http://www.fda.gov/oc/po/firmrecalls/meadjohnson03_02.html
http://www.fao.org/docrep/007/y5502e/y5502e07.htm
These articles are not legal advice and are not intended as legal advice. These articles are intended to provide only general, non-specific legal information. These articles are not intended to cover all the issues related to the topic discussed. The specific facts that apply to your matter may make the outcome different than would be anticipated by you. These articles are generally based on Tennessee and/or United States law. You should consult with an attorney familiar with the issues and the laws of your area or state. These articles do not create any attorney client relationship between you and Horton, Maddox & Anderson PLLC. The articles contained in this weblog are for informational purposes only and are not solicitations.
No comments:
Post a Comment