LAWSUITS: NEC IN THE NICU

“One has to understand that to be born is to enter the world of microbes.”

and,

“If the newborn baby has only consumed colostrum, the dominant microbes belong to the bifidobacterium family and are accompanied by some coliform bacteria to which the baby is already adapted, since they come from the mother.  The newborn needs to be contaminated as early as possible by the domestic microbes that are satellites of its mother, and in this way be as well protected as possible in the event of an attack by more dangerous microbes.”  Michel Odent, “The Nature of Birth and Breastfeeding,” 1992 pg.72

 

NEC IN THE NICU (Neonatal Intensive Care Unit) LAWSUITS

“Similac and Enfamil products contain cow’s milk that has been hydrolyzed, or broken down, to remove certain proteins known to cause allergic reactions.  However, when given to premature or low birth weight babies, Similac and Enfamil may cause NEC [Necrotizing Enterocolitis] at much greater rates than is associated with babies fed breast milk, donor milk, or breast milk-based formula.” Saianitz & Kirk law firm  https://www.youhavealawyer.com/baby-formula-nec-lawsuit/

Recently, there has been a number of law firms on the internet who state that there are pursuing lawsuits against the manufacturers of Similac (Abbott Labs) and Enfamil (Mead Johnson).  They are looking for parents of premature infants who were fed these formulas in US hospitals and suffered health issues and/or death from NEC.  Currently, there is at least one case going through the courts and one settled court case from some years ago that I found on the internet.  There may be more cases, since a number of law firms around the country are advertising for parents whose premature babies were diagnosed with NEC to contact their lawyers.

WHAT IS NECROTIZING ENTEROCOLITIS (NEC)?   

“NEC is a condition characterized by variable injury or damage to the intestinal tract, causing death of intestinal tissue.  The condition most often occurs in premature newborns, but it may also occur in term or near-term babies.”  https://rarediseases.info.nih.gov/diseases/9767/necrotizing-enterocolitis

Ruth Lawrence, MD in her text book, “Breastfeeding:  A Guide for the Medical Profession 4^th edition  1994 (pg. 423) states,

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

And,

“In a large prospective multicentered study of 926 infants, 51 (5.5%) infants developed NEC.  Mortality was 26%.  In exclusively formula-fed infants, the incidence was 6 to 10 times more common than in those who received human milk exclusively.  In those who received human milk and formula, it was 3 times more common than in the exclusively breastfed group.”

I imagine that some people may be surprised to learn that the use of infant formula in preterm infants as well as some full-term infants is a risk for NEC.  Who would believe that infant formula is a risky product?  Some human milk researchers and patent holders have known the relationship between NEC and infant formula for years.  The infant formula industry has known of the problem for years, and some companies think the answer is adding genetically engineered human milk components.

The dissemination of this important information to the public has not been done.  Or at least I have not seen this information other than within breastfeeding advocacy organizations, human milk banks, medical professionals working in NICUs, and Prolacta Bioscience-a corporation that sells human milk-based infant formula to NICU’s.

A few months ago a friend of mine sent me a text about a law firm’s website on NEC lawsuits. The words, human milk-based infant formula had her questioning whether there was such a thing as human milk-based infant formula.  I replied yes, there is such a thing.  A company, Prolacta Bioscience manufactures a human milk-based infant formula for use in hospitals for premature babies.  They use donor milk from moms and those moms are compensated for their donation. Prolacta also sells a human milk fortifier called Humavant. They have a financial investment in promoting human milk/breast milk.  http://prolacta.asia/products/human-milk-fortifier

Prolacta Bioscience devotes a page on their website to the issue of NEC.  Is human milk-based infant formula equivalent to breast milk or breastfeeding?  According to their patents, it is manufactured by taking some human milk components apart (the fat is skimmed off), the donor milk is frozen and refrozen a number of times, human milk oligosaccharides are harvested from the milk, and then rearranged to form various formulas of different fat levels.  Then various vitamins and minerals are added as well as DHA/ARA (genetically engineered oils) added.  This makes the substance very different from donor milk (which in US is pasteurized).  No way does it compare to breastfeeding. http://prolacta.asia/parent/about-necrotizing-enterocolitis

 

I find it interesting that legal firms use these words on their website: breast milk, donor milk, or breast milk-based formula.  Nowhere is the word, breastfeeding.  The presumption seems to be that premature babies are not breastfed or at least not breastfed in hospitals.  Surprisingly or maybe not so surprisingly, the lawsuits are only about premature infants, despite the fact that full term infants are also at risk for NEC.

Breastfeeding is becoming not only a lost art but a word that seems to be disappearing from the medical and legal lexicon.  Instead, medical and legal institutions seem to only be aware of a substance, a product that needs legal protection. In a capitalistic society the needs of an industry outweigh the needs of the individual.  There is a power struggle between the financial and legal needs of the human milk industry versus the infant formula industry.  Breastfeeding, as usual, gets a backseat to the needs of these industries.  This society has lost the understanding that it is breastfeeding that needs the most medical and legal protection.

Premature babies can experience very painful touch by medical staff.  There are studies that it is now believed that pain in babies is far more stressful than for adults. The importance of human contact in which touch is gentle, and lovingly given should not be underestimated. Skin-to skin contact, breastfeeding de-stresses babies.  How many medically stable babies in US NICUs are given the opportunity to breastfeed?   All babies, not just premature babies benefit from skin-to-skin contact.  The skin-to-skin contact facilitates breastfeeding.  Separation of babies from their mothers increases stress in both the mothers and the babies. See, “Should Babies Sleep Alone?” https://www.biologicalpsychiatryjournal.com/article/S0006-3223(11)00639-1/fulltext

Are we being conditioned to believe that just giving a human milk product will decrease NEC in babies?  It seems we are already conditioned to easily accept  the separation of moms and babies as normal.  

A 1987 PATENT RELEVANT TO UNDERSTANDING NEC

Before I discuss the patents to treat or prevent NEC, I want to discuss a US patent filed in 1987 by Baylor College of Medicine.  It was entitled, “Lactoferrin as a dietary ingredient promoting the growth of the gastrointestinal tract.” (patent # 4977137) https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=4977137.PN.&OS=PN/4977137&RS=PN/4977137  

The patent states:

“A substantial growth of the intestines of newborn animals takes place in the first one to three days after birth.  For example in newborn pigs who are nursed by the mother, there is a substantial growth, approximately eight to ten inches of the intestines of the infant within the first few days after birth.  In a large number of human newborns who are not nursed by the mother but are placed on an infant’s formula, the growth of the gastrointestinal tract during the first few days may not occur, and, as a result, the infant is predisposed to chronic intractable diarrhea which must be managed for a period of three or more months at considerable expense and discomfort to the infant.”

The patent supposes that adding one human milk component, lactoferrin, will rectify the problem of a lack of growth of the gastrointestinal tract for babies that are not nursed.  The patent proposes to use either human or bovine lactoferrin as an additive to infant formula, treatment for short gut syndrome and diarrhea in infants.

If the research behind this patent is correct, then infant health and survival is dependent upon breastfeeding.  The belief by these researchers and many other researchers involved in infant nutrition is that many women will not or cannot breastfeed.  Thus, to safeguard infants from damaged guts created by the use of infant formula, science will add one human milk component in hopes that this component will solve the problem.  In this patent the inventors do admit that the lactoferrin used “should not be processed, such as pasteurization, which destroys the effectiveness.”  The problem with this statement is that infant formula must be made shelf stable for at least 18 months, which would require pasteurization.  Live substances like human milk components or probiotics that are pasteurized are not as effective.

Buford Nichols, patent co-inventor to the above patent, co-edited a book for Bristol-Myers Squibb/Mead Johnson Nutrition Symposia entitled, “Malnutrition in Chronic Diet-Associated infantile Diarrhea:  Diagnosis and Management,” in 1990.  https://www.findbookprices.com/author/Buford_L_Nichols

There is a long history of some researchers from Baylor College of Medicine being funded by Mead Johnson, now known as Reckitt. In 2021 Baylor thanks Mead Johnson/Reckitt on the website of Pediatric Academic Societies.                              https://www.pas-meeting.org/grant-supporters/

In 2019 a paper was published in Human Cell  by Ninkina et al. entitled, “Stem cells in human breast milk.” This paper states,”… exosomes purified from breast milk are able to promote intestinal epithelial cell growth in infants.” Exosomes are small particles that transfer DNA, RNA, and proteins to other cells.  This appears to confirm patent inventors (Nichols & McKee) observations from 1987 regarding the growth of the intestines in breastfed newborns.  Stem cells are important to medical researchers because they naturally generate new cells. This could be used in therapies for various cancers or other diseases. It also can be used in medical labs in the generation of cell lines. No infant formula delivers live cells that can generate stem cells. Infant formula is a sterilized product**(please read important correction) that is designed to have a shelf life of 18 months. The product is life-less because it is sterile.  Breastfeeding produces a substance that is full of life, and full of regenerative cells.  I have heard some mothers say that there is no difference between infant formula and breast milk.  Research by the infant formula industry in which they are trying to imitate breast milk components is indicative of a basic understanding that there is a huge difference between infant formula and breast milk.  https://link.springer.com/article/10.1007%2Fs13577-019-00251-7

PATENTS OWNED BY THE INFANT FORMULA INDUSTRY TO PREVENT NEC

This is a sample of some of the US patents that seek to address the problem of NEC in babies.

In 1997, Abbott Labs filed for a US patent (#6080787) called, “Methods for reducing the incidence of necrotizing enterocolitis.”  They determined that adding omega 6 and omega 3 oils plus egg yolk lipids would prevent NEC.  The patent states, “NEC is rare among infants fed only breastmilk.”  Susan E Carlson et al were co-inventors to this patent.  At this time there was much interest in adding DHA and ARA (omega 3 & 6) to infant formulas.  Martek Bioscience scientists were publishing many papers in various journals. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6080787.PN.&OS=PN/6080787&RS=PN/6080787

In 2011 Abbott Labs filed for a US patent (#8877812) entitled, “Methods for decreasing the incidence of necrotizing entercolitis, colic, and short bowel syndrome in an infant, toddler, or child.” Abbott Labs plans to use predigested fats which may include monoglycerides and/or fatty acid components as a preventative against NEC. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8877812.PN.&OS=PN/8877812&RS=PN/8877812

In 2012 Mead Johnson filed for a US patent (#8968722) called, “Milk-based nutritional compositions containing lactoferrin and uses thereof.”  The patent will add a prebiotic plus lactoferrin to prevent NEC. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8968722.PN.&OS=PN/8968722&RS=PN/8968722

 

In 2014 Nestec S.A. (Nestle) filed for a US patent (#10940158) called, “Compositions for use in the prevention or treatment of necrotizing enterocolitis in infants or young children born by C-section.”  The patent states, “It should be noted that, in the healthy vaginally-delivered breast-fed infant, Bifidobacteria form the basis of the microbiota for 60-90% of total bacteria in the infant gut.  Breast feeding also promotes intestinal barrier development which together with bifidobacteria domination leads to enhanced absorption and therefore utilization of ingested nutrition.” Nestle will use a mixture of Human Milk Oligosaccharides to prevent NEC. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=10940158.PN.&OS=PN/10940158&RS=PN/10940158

In 2015 Mead Johnson filed for a US patent (#9730969) entitled, “Nutritional compositions for promoting gut barrier function and ameliorating visceral pain.”  The patent would use a probiotic, Lactobacillus rhamnosus GG (LGG) in their formulas to prevent NEC and other intestinal issues. Remember that human milk researchers consider human milk to be a probiotic. (Researchers in Spain published a paper in the British Journal of Nutrition on probiotic bacteria derived from human milk specifically mentions the clinical trials of LGG used in infant formula that decreased the incidence of rotavirus and the duration of diarrhea). The patent describes the research of visceral pain in which they used Sprague-Dawley rats, and separated some mother rats from their babies in comparison to mother rats not separated from their babies.  The patent states, “Early life stress induced by maternal separation lowered threshold of pain perception in rats…”  Should we be surprised by this? We stress mother and infant mammals (including human) by separating them, but our society seems to ignore this reality.  https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9730969.PN.&OS=PN/9730969&RS=PN/9730969

In 2017 Abbott Labs filed for a US patent (#10471081) called, “Methods for decreasing the incidence of necrotizing enterocolitis in infants, toddlers, or children using human milk oligosaccharides.”  The patent makes several statements of importance, “Breast milk contains components that not only act as pathogen receptor analogues, but also activate immune factors by infant intestinal epithelial cells and/or associated immune cell populations to enhance development and maturation of the infant’s gastrointestinal and immune systems.”  And

“Not all infants, however, are in a position to receive human breast milk.”   https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=10471081.PN.&OS=PN/10471081&RS=PN/10471081

 

CONCLUSION

The infant formula industry has known for many years that NEC is a problem.  Over the years, the industry has patented various, genetically engineered human milk components to be added to their infant formula to prevent or treat NEC.  With increasing number of babies getting NEC, one has to question whether the industry can solve this serious health problem caused by their products. 

As for the lawsuits against two infant formula companies, I find it interesting that the word, breastfeeding, is missing.  Instead the focus is on breast milk, donor milk, and human milk-based infant formula as the answer to NEC.  Is human milk-based infant formula equivalent to donor milk?   The research on these very expensive human milk-based products is funded by Prolacta Bioscience.  Should we accept that research?  Are we creating a medical environment in which our priority has become a product rather than the action of breastfeeding? 

Copyright 2021 Valerie W. McClain

** This is an important correction.  While infant formula must be made sterile, manufacturers of infant formula cannot make powdered infant formula sterile.  Due to cases of Cronobacter and Salmonella in young infants causing hospitalizations and deaths, the recommendation from the WHO and the US CDC is that parents need to sterilize all feeding equipment and that water used to reconstitute the powdered formula should be at least 158F/70C degrees to inactivate pathogens. These infections can cause NEC.