Preterm infants fed cow’s milk-based baby formulas by Similac or Enfamil are more likely to develop necrotizing enterocolitis (NEC), a serious gastrointestinal illness that is seen mostly in premature babies. Shouse Law Group is helping parents bring claims against the manufacturers Abbott and Mead Johnson for failing to warn doctors and parents about the increased risk of NEC. We are pursuing the highest financial settlement allowable under the law.
In this article, our mass tort lawyers will discuss:
- 1. Which formulas are linked to NEC in premature babies?
- 2. What is NEC?
- 3. Does baby formula cause NEC?
- 4. What is the current state of the litigation?
- 5. How much money can I get?
- 6. Has the baby formula been recalled?
- 7. Other baby food-related lawsuits
1. Which formulas are linked to NEC in premature babies?
Cow’s milk-based formulas – such as Enfamil and Similac – make it more likely that premature babies will suffer from the bowel disease necrotizing enterocolitis (NEC). NEC typically develops in preemies being fed this formula when they are two-to-six weeks old.
Neonatal intensive care units (NICUs) often rely on cow-milk formula – which is high in calories – to provide preemies with nutrition and immune support and to help them gain weight. This formula is also used to supplement nutrition for breastfeeding preemies with latching difficulties.1
2. What is NEC?
NEC – short for necrotizing enterocolitis – is a gastrointestinal bacterial infection that largely affects premature babies. This life-threatening illness causes inflammation, tissue death of the intestines, and perforation of the wall of the intestines. Treatment includes antibiotics and possibly abdominal repair surgery.
Possible consequences of NEC – or the surgery to treat NEC – include:
- Peritonitis (an abdominal infection)
- Narrowing of the intestinal wall, called intestinal stricture
- Short bowel syndrome, which may cause malabsorption (and may require a bowel transplant)
- Neurodevelopmental problems
- Growth failure
- Death (if the NEC is not treated quickly)
Potential symptoms of NEC are:
- Not gaining weight
- Trouble eating
- Bloody diarrhea or dark stools
- Ileus (decreased sounds in the bowel)
- Yellow or green vomit
- Pain, redness, tenderness and/or swelling (distension) in the abdomen
- Low breathing, temperature, blood pressure (hypotension), and heart rate (bradycardia)
- Apnea (paused breathing)
- Lowered peripheral perfusion
Symptoms of advanced NEC include:
- Abdominal wall erythema
- Cardiovascular collapse2
3. Does baby formula cause NEC?
Scientific studies indicate that cow’s milk-based (“bovine”) formulas cause more incidents of NEC in preemies than donor breast milk. A study going back to 1990 that followed 926 preterm infants indicated that:
- Formula-fed preemies were six to ten times more likely to get NEC than preemies who were fed breast milk.
- Formula-fed premies were three times more likely to get NEC than preemies who received both breast milk and formula.3
In 2011, several hospitals concluded that NEC was less of a risk for very premature babies fed human donor milk than those fed cow milk.4 And in 2012, a policy statement by the American Academy of Pediatrics stated that preemies should receive only human milk due to NEC risks from bovine milk formula.5
4. What is the current state of the litigation?
Several parents have brought lawsuits against makers of cow’s milk-based baby formulas including Abbott Laboratories, Inc. (maker of Similac) and Mead Johnson & Company, LLC (maker of Enfamil) for causing their preterm babies to get sick or die from NEC. Common causes of action include:
- Strict liability for design defect (defective product)
- Strict liability for failure to warn
- Intentional misrepresentation
- Negligent misrepresentation
- Breach of warranty
- Wrongful death (if the infant died)
The strongest product liability lawsuit claim is probably “failure to warn” considering these cow’s milk-based formulas have no warning labels disclosing the NEC risks. Had there been an adequate warning on the products’ labels, neonatologists and pediatricians may have chosen human donor milk instead.6
It is expected that all the infant formula lawsuits against Abbott and Mead will join into MDLs, short for multi-district litigation. MDLs are a way to expedite litigation by having one federal judge make all the pretrial decisions. Eventually, a few cases will go to trial. How these bellwether trials turn out will then set the stage for settlement talks.
If the bellwether juries find for the plaintiffs and return big financial awards, then all the other plaintiffs in the MDL will have the upper hand in negotiations. In short, the more successful the bellwether trials, the higher the settlements for the remaining MDL plaintiffs.
(Note that many parents are also choosing to sue their medical providers for medical malpractice for feeding their preterm infants cow’s milk-based formula.)
5. How much money can I get?
The baby formula lawsuits against Abbott and Mead for causing NEC seek compensatory damages to cover medical bills, any other out-of-pocket costs, and pain and suffering. No price can be put on a baby’s life and well-being, so plaintiffs’ attorneys will be fighting for the largest settlement for financial compensation possible under the law.
6. Has the baby formula been recalled?
No. No bovine-based baby formula products have been recalled for their link to damaging intestinal tissues in pre-term infants.7
7. Other baby food-related lawsuits
There are a growing number of individual lawsuits and class action lawsuits against various manufacturers of baby food products for making food with dangerous levels of toxic elements. Parents are alleging that these baby food companies caused their child’s autism or brain damage. These lawsuits are largely in the U.S. District federal court for the Eastern District of New York.
A congressional report released on February 4, 2021, revealed that certain baby foods contain high levels of toxic heavy metals arsenic, lead, cadmium, and mercury. This subcommittee report says that according to the U.S. Food and Drug Administration (FDA), these four toxic heavy metals are dangerous – especially to babies. They can cause irreversible brain damage and other health problems.
The baby food manufacturers and baby food brand names listed in this congressional report include Beech-Nut Nutrition Company, Earth’s Best Organic (Hain Celestial Group Inc.), HappyBABY (Nurture, Inc.), Happy Family Organics (Nurture, Inc.), Gerber, Parent’s Choice (Perrigo), Plum Organics (Campbell Soup Company), and Sprout Organic Foods. Baby food maker Beach-Nut issued a voluntary recall of some of its infant rice cereals due to arsenic problems.8
- See Jocelyn Shulhan et al, Current Knowledge of Necrotizing Enterocolitis in Preterm Infants and the Impact of Different Types of Enteral Nutrition Products, Adv Nutr. (Jan, 2017). See Colaizy, T et al, Impact of Optimized Breastfeeding on the Costs of Necrotizing Enterocolitis in Extremely Low Birthweight Infants, Journal of Pediatrics, (2016). Other formulas with cow’s milk include Earth’s Best, Happy Baby, Go & Grow, Gerber, Parent’s Choice, Baby’s Only, Loulouka, Holle, Kendamil, Bobbie, and Lebenswert.
- See Necrotizing Enterocolitis, Children’s Hospital Los Angeles.
- Lucas A & Cole TJ (1990). Breast milk and neonatal necrotising enterocolitis. Lancet 336 (1990). See also Minekawa R, Takeda et al. (2004) Human breast milk suppresses the transcriptional regulation of IL-1beta-induced NF-kappaB signaling in human intestinal cells. Am J Physiol Cell Physiol. (November, 2004). See also Theresa JO., et al., Is Mother’s Own Milk Lactoferrin Intake Associated with Reduced Neonatal Sepsis, Necrotizing Enterocolitis and Death? Neonatology (February 2020).
- Formula-fed preemies at higher risk for dangerous GI condition than babies who get donor milk, Science Daily (May 1, 2011)(“Extremely premature babies fed human donor milk are less likely to develop the dangerous intestinal condition necrotizing enterocolitis than babies fed a standard premature infant formula derived from cow’s milk.”).
- Breastfeeding and the Use of Human Milk, Pediatrics (March 2012)(“Lower rates of sepsis and NEC indicate that human milk contributes to the development of the preterm infant’s immature host defense.”)
- See, e.g., Miller complaint and Dillard complaint in Madison County Circuit Court, VA.
- There have recently been baby formula recalls unrelated to the bovine formula-NEC issues: On August 8, 2021, the Able Group (HiPP, Holle, Bioland, Kendamil) recalled various products for having low iron levels in violation of FDA requirements. Some affected products with insufficient amount of iron include Hipp Comfort Milk Formula, Combiotic First Infant Milk Formula, HiPP Dutch Stage 1 Combiotic Infant Milk Formula, HiPP German Stage 1 Combiotic Infant Milk Formula, Holle Bio Stage PRE Organic Infant Milk Formula, and more. Babies fed these recalled products risk developing insufficient iron levels and iron deficiency anemia and other negative functional development outcomes. All lot codes have been recalled. These products were imported from Europe and purchased through the littlebundle website, not at retail stores like Walmart or Costco. Parents who used these products are encouraged to consult with their doctors to test whether their babies have enough iron. Able Groupe Recalling Products Labeled as Infant Formula Formulas Have Insufficient Iron Levels as Per Requirements for Infant Formula in The U.S., and Products Do Not Meet Other FDA Requirements, FDA (August 8, 2021). And on June 21, 2019, Perrigo recalled its Parent’s Choice Advantage Infant Formula Milk-Based Powder with Iron (lot number C26EVFV) for the potential presence of a foreign metal. Perrigo Issues Voluntary Recall For Parent’s Choice Advantage Infant Formula Milk-based Powder With Iron, Perrigo (June 21, 2019).
- U.S. House of Representatives, Subcommittee on Economic and Consumer Policy (February 4, 2021)(The FDA allows 10 parts per billion (ppb) of inorganic arsenic in drinking water. The EPA capped allowable mercury levels in drinking water at 2 ppb. Many popular baby foods contained dangerous levels of arsenic and mercury.). High levels of toxins found in more baby food brands, government report says, CBSNews (September 29, 2021). Beech-Nut Nutrition Company Issues a Voluntary Recall of One Lot of Beech-Nut Single Grain Rice Cereal and Also Decides to Exit the Rice Cereal Segment, FDA (June 8, 2021). Also, California Attorney General Xavier Becerra sued Graceleigh Inc. (Sammy’s Milk Free-Range Goat Milk Toddler Formula) and Nutraceutical Corp. (Peaceful Planet Toddler Supreme Formula) for having high levels of lead in their toddler formula. California v. Nutraceutical Corp., No. RG18907841 (Cal. Super. Ct., Alameda Cty., filed June 7, 2018). See also Healthy Babies Bright Futures.