Baby Formula Necrotizing Enterocolitis (NEC) Lawsuit
For over thirty (30) years the manufacturers of baby formula have known or should have known, that their products could cause necrotizing enterocolitis. Unfortunately, they have failed to warn doctors and the public of the potentially deadly risks associated with their baby formula(s).
- As early as 1990 (over 30 years ago), a study on 926 preterm infants found that NEC was six to ten times more common in formula-fed babies. (LANCET “Breast milk and neonatal necrotising enterocolitis”)
- In 2016, a study of 1,587 infants was published in the scientific medical journal Breastfeeding Medicine. This study found that extremely premature infants who received an exclusive human milk–based diet had a significantly lower incidence of NEC and mortality. (Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk–Based Diet)
- The Journal of Pediatrics published a study in 2010, that established when premature babies were fed an exclusive diet of mother’s milk, donor milk, and human milk fortifier, these babies were 90% less likely to develop surgical NEC. (An Exclusively Human Milk-Based Diet Is Associated with a Lower Rate of Necrotising Enterocolitis than a Death of Human Milk and Bovine Milk-Based Products)
- The U.S. Surgeon General published a report in 2011 stating, “For vulnerable premature infants, formula feeding is associated with higher rates of necrotizing enterocolitis (NEC)” In the same report, the Surgeon General concluded that premature infants who are not breastfed are 138% more likely to develop NEC. (The Surgeon General’s Call to Action to Support Breastfeeding)
- In 2021 The Official Journal of The American Academy of Pediatrics published a study that included the following … “Meta-analyses of 4 randomized clinical trials performed over the period 1983 to 2005 support the conclusion that feeding preterm infants human milk is associated with a significant reduction (58%) in the incidence of necrotizing enterocolitis (NEC). A more recent study of preterm infants fed an exclusive human milk diet compared with those fed human milk supplemented with cow-milk-based infant formula products noted a 77% reduction in NEC. One case of NEC could be prevented if 10 infants received an exclusive human milk diet, and 1 case of NEC requiring surgery or resulting in death could be prevented if 8 infants received an exclusive human milk diet.” (Breastfeeding and the Use of Human Milk)
- In a study published in 2014, it was reported: “Necrotizing enterocolitis (NEC) is a devastating disease of premature infants and is associated with significant morbidity and mortality. While the pathogenesis of NEC remains incompletely understood, it is well established that the risk is increased by the administration of infant formula and decreased by the administration of breast milk.” (Evidence-based feeding strategies before and after the development of necrotizing enterocolitis)
- A 2015 study stated in part, “There is a 50% reduction in the rate of NEC and/or LOS and a shortened length of hospital stay among the extremely low birth weight infants receiving MOM [mother’s own milk]…” (In time: human milk is the feeding strategy to prevent necrotizing enterocolitis)
- A paper was published in 2017 that compared two Randomized Clinical Trials. The paper found, “both trials found that an exclusive [Human Milk] diet results in a lower incidence of NEC. The paper also concluded that the use of DHM or bovine milk-based formula significantly increased the risk of NEC. (Current Knowledge of Necrotizing Enterocolitis in Preterm Infants and the Impact of Different Types of Enteral Nutrition Products)
What is Claimed in Necrotizing Enterocolitis Lawsuits?
The science shows the dangers of cow’s milk-based formula products in causing NEC and death in premature infants, yet the manufacturers of Similac and Enfamil baby formulas have done nothing to change their product, packaging, guidelines, instructions, and/or warnings.
The warnings and instructions on their baby formula products are broad and vague. The manufacturer never warns that Similac or Enfamil can significantly increase the risk of NEC and death.
Despite knowing that its product significantly increases the risk of NEC and death, the manufacturers of these baby formulas have deliberately chosen to omit a specific warning of NEC or death and deliberately failed to provide any detailed instructions or guidance on how to avoid NEC or death when feeding Similac or Enfamil to an infant.
Abbott Laboratories, Inc. manufactures, designs, formulates prepares, tests, provides instructions, markets, labels, packages, places into the stream of commerce in all fifty states, and sells premature infant formula including Similac.
The various premature infant formula products made by Abbott Laboratories, Inc. include the following:
- Similac Special Care
- Similac Human Milk Fortifier
- Similac NeoSure
- Similac Alimentum
- Similac Alimentum Expert Care
- Similac Human Milk Fortifier Concentrated Liquid
- Similac Human Milk Fortifer Hydrolyzed Protein Concentrated Liquid
- Similac Human Milk Fortifier Powder
- Similac Liquid Protein Fortifier
- Similac Special Care 20
- Similac Special Care 24
- Similac Special Care 24 High Protein
- Similac Special Care 30
Mead Johnson & Company, LLC and/or Mead Johnson Nutrition Company manufactures, designs, formulates, prepares, tests, provides instructions, markets, labels, packages, places into the stream of commerce in all fifty states, and sells premature infant formula products including Enfamil.
The various premature infant formula products made by Mead include the following:
- Enfacare Powder
- Enfamil Human Milk Fortifier Liquid High Protein
- Enfamil Milk Fortifier Liquid Standard Protein
- Enfamil NeuroPro Enfacare
- Enfamil Premature 20 Cal
- Enfamil Premature 24 Cal
- Enfamil Premature 24 Cal/fl oz HP
- Enfamil Premature 30 Cal
- Enfamil Human Milk Fortifier Acidified Liquid
- Enfamil Human Milk Fortifier Powder
- Enfamil 24 and DHA & ARA Supplement
What is Necrotizing Enterocolitis (NEC)?
Necrotizing enterocolitis (NEC) is a serious gastrointestinal disease that affects approximately 1-1,000 premature babies. NEC is very rarely seen in full-term babies coming in at approximately 1-10,000 births.
NEC mostly affects the infant’s intestine. NEC causes the wall of the intestine to be attacked by bacteria that subsequently cause an infection that can ultimately lead to inflammation and the destruction of the wall of the bowel.
The destruction of the bowel wall may sometimes cause a perforation of the intestine that causes leakage of stool into the abdominal cavity causing additional infection and sometimes, unfortunately, death.
Babies Are Natural Born Fighters! Hopeful Prognosis?
According to the Children’s Hospital Los Angeles, “Most infants who develop NEC recover fully and do not have further feeding problems. In some cases, scarring and narrowing of the bowel may develop and can lead to future intestinal obstruction or blockage. Another residual problem may be malabsorption (the inability of the bowel to absorb nutrients normally). This is more common in children who require surgery for NEC and lose a large segment of intestine. Still, there are some infants who lose so much intestine from the infection that they do not have enough intestine left to survive. These infants may end up requiring a bowel transplant to survive.”
If your infant was diagnosed with NEC, you should review the following article published by the NEC Society: 10 Things to Know When Your Baby is Diagnosed with NEC.
Bereavement Help & NEC Support Group
If you have recently lost a baby, we urge you to seek emotional support and help through whatever means is appropriate to your personal beliefs. There are many online support groups available specifically for parents and family members who have lost a baby to NEC.
One such group is called The NEC Society. Here is a direct link to an article they published titled, “10 Things for Bereaved Parents to Know”. The NEC Society also hosts a community support group.
Baby Formula Recall
In February 2022, Abbott Nutrition agreed to recall powdered formula products Similac, Alimentum, and EleCare produced at its facility in Sturgis, Michigan. According to the Food and Drug Administration (FDA), those products had been linked to at least five illnesses in infants: four babies who contracted Cronobacter sakazakii, a bacteria that can cause meningitis, and one who was exposed to Salmonella Newport. To date, this investigation has been associated with illnesses in Minnesota, Ohio and Texas. Two of the infants in those initial reports died.
A subsequent FDA inspection found Cronobacter on surfaces and a lack of quality control in the Abbott facility, leading to a halt in production and its temporary closure.
Symptoms and Treatment of Cronobacter sakazakii Infection
Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.
According to the CDC:
“Cronobacter infections are treated with antibiotics. Infants suspected of having sepsis or meningitis should be hospitalized and given empiric antibiotics immediately. Once Cronobacter has been diagnosed, antimicrobial susceptibility testing should be performed because multidrug-resistant strains have been reported. This testing can help medical providers choose the best antibiotic.”
Additional information can be found in the U.S. Centers For Disease Control & Prevention (CDC) notice: Cronobacter & Salmonella Illnesses Linked to Baby Infant Formula
Symptoms and Treatment of Salmonella Newport
Salmonella are a group of bacteria that can cause gastrointestinal illness and fever called salmonellosis. Most people with salmonellosis develop diarrhea, fever and abdominal cramps. More severe cases of salmonellosis may include a high fever, aches, headaches, lethargy, a rash, blood in the urine or stool, and in some cases, may become fatal.
According to the Mayo Clinic:
“Because salmonella infection can cause dehydration, treatment focuses on replacing lost fluids and electrolytes — minerals that balance the amount of water in the body. If dehydration is severe, emergency room care or hospitalization may be needed so that fluids can be delivered directly into a vein (intravenous).”
Johnson//Becker, PLLC Attorney Appointed Co-Lead in Baby Formula Lawsuit
In a multidistrict litigation/class action lawsuit against Abbott Nutrition, Johnson//Becker attorney Stacy Hauer has been named co-lead counsel for the plaintiffs. The lawsuit is expected to include hundreds of plaintiffs across numerous states.
Questions About a Baby Formula Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review.
The lawyers at Johnson//Becker are pursuing litigation against on behalf of families affected by baby formula. If your infant has been sickened by baby formula, you should be aware that you may be entitled to holding the manufactures of the defective baby formula accountable by filing a lawsuit.
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