"Scorched Earth Legal Tactics"

“Mother and Child,” Studio Shin-e-Do Kobe, Japan 19th century

“In cases brought by families harmed by Cronobacter, Abbott Nutrition brought ‘the resources and tactics of Big Law’ against ‘poor families and their overwhelmed lawyers,’ using aggressive tactics in a case that one judge called ‘the worst by a factor of 10.’ Following a ‘seven-year legal battle’ for one family whose infant suffered ‘debilitating brain damage,’ your company successfully sought a court order sealing trial testimony and evidence regarding Abbott’s testing and food safety protocols in its Sturgis, Michigan plant—seven years before consumption of unsafe formula resulted in the deaths of several infants and a nationwide infant formula shortage.” US Senator Elizabeth Warren’s letter sent to Abbott Laboratories dated October 12, 2022 https://www.warren.senate.gov/imo/media/doc/Abbott%20Nutrition%20Letter.pdf

How quickly a nation’s memory of the US infant formula contamination tragedy of 2022 fades into the background. Memory becomes faulty and the only thing people remember is that we had a infant formula shortage. The public forgets the why of the shortage; the deaths, the hospitalizations of infants who drank Abbott’s infant formula. Nor does the public remember that the number of infants affected by contaminated infant formula may never be known because at that time only one state (Minnesota) in the US was required to report Cronobacter cases. Since Abbott’s recall in 2022, there have been a number of infant formula recalls: ByHeart, Reckitt (Mead Johnson), Gerber Good Start now owned by Perrigo, and recently Nutricia for undeclared amino acid tyrosin. While the Nutricia recall does not involve bacterial contamination, it does show that infant formula has its risks. Politico had an article in March of this year discussing that lessons had not been learned regarding FDA recalls. https://www.politico.com/news/2023/03/27/fda-bacteria-infant-formula-recall-00088841

Another tragedy of the Mauri fires with 100’s of lives lost, inspires unaware organizations/non-profits to send pallets/cases of infant formula to a state that has some of the highest rates of breastfeeding in the US. How do parents fix infant formula with no electricity which means no refrigeration, water not easily available due in part to contamination, and lack of water makes cleaning bottlefeeding equipment very difficult? If the donations are powdered infant formula, are parents aware of the importance of boiling water at correct temperatures (158 degrees F. or 70 degrees C.) to avoid pathogens like Cronobacter sakazakii? Powdered infant formula is not sterile.

Senator Warren’s website states, “As early as 2003, Abbott representatives acknowledged that Cronobacter was ‘a little bit more ubiquitous’ in powdered infant formula than previous known. Despite an outbreak in 2011 and several lawsuits against Abbott alleging that its formula contained Cronobacter, information on the health threats failed to reach new parents, and Abbott continued to cut corners and operate under lax safety measures.” https://www.warren.senate.gov/imo/media/doc/Abbott%20Nutrition%20Letter.pdf

Depending on what research you read, infants who contract Cronobacter have a 40%-80% mortality rate. The bacterial infection causes sepsis, meningitis, and Necrotising Entercolitis (NEC) in babies, particularly premature and immunocompromised infants.

“NEC is a major cause of morbidity and death in preterm and other high-risk infants.” and,

“In exclusively formula-fed infants, the incidence (NEC) was 6-10 times more common than in those who received human milk exclusively. In those who received human milk and formula, it was three times more common than in the exclusively breastfed group.” Lawrence R et al., Ninth Edition Breastfeeding: A Guide for the Medical Profession, 2022, pg. 531-532.

I find it strange that the FDA and the CDC on their Cronobacter information websites directed at parents, only mention that Cronobacter causes sepsis and meningitis. While most research that I have read also includes NEC. A 2020 research paper by Chen et al. in J Med Microbiol’s first sentence in their abstract states, “Neonatal infection with Cronobacter sakazakii can cause severe intestinal damage and necrotizing enterocolitis (NEC).” https://pubmed.ncbi.nlm.nih.gov/32209170/

The CDC website on Emerging Infectious Diseases (on medical research) has a recent paper of 2023 entitles, “Fatal Necrotizing Enterocolitis in Neonate Caused by Cronobacter sakazakii Sequence Type 64 Strain of CRISPR Sublineage b,” by Zeng et al. The abstract states, “Cronobacter sakazakii is a major foodborne pathogen that is associated with outbreaks of life-threatening necrotizing enterocolitis, meningitis, and sepsis in neonates and infants.” https://wwwnc.cdc.gov/eid/article/29/9/23-0537_article

Meanwhile there are class action lawsuits against Abbott and Mead Johnson for their cow-milk based infant formulas that they implicate in NEC cases in infants. How much of these NEC class-action cases in babies are related to the ubiquitous pathogen called Cronobacter sakazakii? Who is asking that question, particularly when the FDA and CDC seem to have amnesia in regard to its association or cause of NEC? Is it possible that there are a hell of lot more infants damaged by this pathogen? https://www.lawsuit-information-center.com/nec-baby-formula-lawsuits.html

Both the CDC and the FDA have foundations that partner with corporations that donate to their organizations. While these US governmental bodies are not allowed to take money directly from corporations, their foundations through partnerships donate for programs run by the CDC or FDA. The CDC Foundation has a long list of partners who donate various amounts. Some of the top donors of $50,000 or more are the World Health Organization, Gates Foundation, American Type Culture Collection (ATCC), Booz Allen Hamilton (a consultant organization), Exon, Vanguard Charitable (Investment company charity). Then some small donations from $25-$999.00 are the following: AbbieVie Inc-a spin off company from Abbott Labs, Abbott Labs, Bristol Myers Squibb, Hero (infant formula company), Mead Johnson, Reckitt. Abbott Ireland donated between $10,000-$49,000, Pfizer, which at one time was an infant formula company donated from $1,000-$9,999. The website does not specify the amount but puts forth the monetary range of donations. https://www.cdcfoundation.org/FY2022/donors?group=corp

The FDA Foundation is called the Reagan-Udall Foundation. One foundation member of the BOD is Molly Fogarty who is employed by Nestlé. https://reaganudall.org/about-us/board-directors/molly-fogarty

Nestlé also appears to fund the Reagan-Udall Foundation as well as Bayer (infant formula company, besides being a drug company). PhRMA also funds the Regan-Udall Foundation. The Foundation’s website states that their purpose is to “modernize product development, accelerate innovation, and enhance product safety.”

From a political science perspective, corporations entangled with governmental agencies is part of the definition of fascism-a merger of state and corporate power. Every US governmental agency that I have seen has a foundation. So one gets the impression that is one way to pretend that corporations have no influence on governmental policy. This situation is not new, and has been ongoing since I started writing about it some 23 years ago. So many people are unaware that the Cronobacter contamination issue is not a new phenomena. The only reason this issue really came to the light of day in 2022 was because it created an infant formula shortage that impacted many, many parents. Some here in the USA do not realize that Abbott Labs is a multi-national corporation which sells its infant formula around the world. So the significance in the media is understated, minimized, and focused on a product shortage not focused on the bacterial contamination. Are other countries monitoring Cronobacter cases in infants under 1 year? Supposedly the US will be asking (requiring?-conflicting media reports on this) in 2024 that state health agencies report cases of Cronobacter sakazakii in babies under 1 year of age.

In a letter to the Lancet in 2004, Maaike Arts of UNICEF, comments to an article on “Enterobacter sakazakii (now called Cronobacter sakazakii) in factories and households.” She adds 2 recommendations:

“(1) enhancement of the promotion of and support of breastfeeding, and (2) inclusion of a warning on infant formulae and other breastmilk substitutes that the product might be contaminated by E. sakazakii and other micro-organisms.”

Maaike Arts was questioning why the research paper she was commenting about never mentioned these recommendations. Then she mentions that the research was supported by Nestlé Research Center, yet the authors declared no conflicts of interest. I am not particularly shocked by this 2004 revelation in The Lancet correspondence section. It is a very common situation now, and maybe it has always been a common situation. https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(04)16758-5.pdf

In October of 2007 in my first blog post to humanmilkpatentpending I wrote about the intrinsic contamination of e.sakazakii (now called Cronobacter). And over the years have written several articles/posts on this pathogen to my blog. It seems that Google no longer recognizes the existence of my blog. It still exists but seems to be difficult to find on Google. Rather sad that the internet has become this place where so many of us are muted by powerful interests in government who believe in censorship. https://vwmcclain.blogspot.com/2007/10/esakazakii-intrinsic-contamination.html

I find it revealing that the contamination of infant formula has created so little governmental interest in promoting exclusive breastfeeding. Is this hesitancy related to corporate interests and profit motives? When the FDA has on its BOD a woman actively employed by Nestlé, and this company appears to fund some programs at the FDA, one has to question whether infant safety and health is the driving force of our society or whether it is purely the profit motive?