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 defective design and failing to warn doctors and parents about the increased risk of NEC on preemies. 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. What is the statute of limitations to sue?
- 7. Has the baby formula been recalled?
- 8. 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 (before 37 full weeks) 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
Similac products that contain cow’s milk ingredients include:
- Similac Alimentum
- Similac Alimentum Expert Care
- Similac Human Milk Fortifier
- Similac Human Milk Fortifier Concentrated Liquid
- Similac Human Milk Fortifier Hydrolyzed Protein- Concentrated Liquid
- Similac Human Milk Fortifier Powder
- Similac Liquid Protein Fortifier
- Similac NeoSure
- Similac Special Care
- Similac Special Care 20
- Similac Special Care 24
- Similac Special Care 24 High ProteinSimilac Special Care 30
Enfamil products that contain cow’s milk ingredients include:
- Enfamil 24 and DHA & ARA Supplement
- Enfamil Human Milk Fortifier Acidified Liquid
- Enfamil Human Milk Fortifier Powder
- Enfamil Human Milk Fortifier Liquid High Protein
- Enfamil Milk Fortifier Liquid Standard Protein
- Enfamil NeuroPro Enfacare
- Enfacare Powder
- Enfamil Premature 20 Cal
- Enfamil Premature 24 Cal
- Enfamil Premature 24 Cal/fl oz HP
- Enfamil Premature 30 Cal
The product name “Human Milk Fortifier” is misleading. A reasonable person might believe it contains human milk, but it does not.
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. NEC begins in the intestinal wall’s inner lining, and it affects the intestines’ thickness.
Treatment includes ceasing feedings (fasting), administering antibiotics and IV fluids and nutrition, draining abdominal fluids, nasogastric drainage, circulatory support, and possibly abdominal repair surgery. NEC – if caught and treated promptly – can be curable with no complications.
Possible consequences of NEC – or the surgery to treat NEC – include:
- Sepsis (from intestinal bacteria draining out into the abdominal cavity)
- 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)
- Holes in the intestines (causing waste to leak out)
- Neurodevelopmental problems
- Cerebral palsy
- Organ failure or damage caused by decreased oxygen supply
- Growth failure
- Liver failure (IFALD)
- Death (if the NEC is not treated quickly) up to 50% of the time
Potential symptoms of NEC are:
- Not gaining weight
- Trouble eating/feeding residuals
- 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)
- Metabolic acidosis
- Green fluid in the abdominal wall
- Apnea (paused breathing)
- Lowered peripheral perfusion
Symptoms of advanced NEC include:
- Abdominal wall erythema
- Cardiovascular collapse
NEC is diagnosed through:
- blood tests and cultures
- abdominal imaging (CT scans, PET scans, ultrasounds)
- blood gas level tests
- a physician’s clinical observations
Of the 480,000 preterm infants born every year in the United States, about 9,000 come down with NEC. And 90% of those NEC cases occur in preterm infants.
The four types of NEC are 1) classic NEC; 2) transfusion-associated NEC; 3) Atypical NEC; and 4) Term infant NEC. Most of the bovine formula-related cases involve “classic NEC.”
NEC can also develop as a result from being born with underdeveloped intestines or from oxygen deprivation during labor and delivery.2
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 In 2011, The U.S. Surgeon General said, “For vulnerable premature infants, formula feeding is associated with higher rates of necrotizing enterocolitis (NEC).” 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 product liability for design defect (defective product) because there was a reasonable alternative design
- 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 design defect. This is because the academic scholarship is clear that human milk increases the risk of NEC in preemies, yet Abbott and Mead continued to manufacture and sell it.
Abbott and Mead are sure to argue that the design defect claim is “preempted” by the Infant Formula Act because the FDA approved the formula for sale. But this is a losing argument according to past case law.
Plaintiffs’ attorneys are also pushing the “failure to warn” claim. These cow’s milk-based formulas have no warning labels disclosing the NEC risks. Abbott and Mead Johnson knew – or should have known – about the risks of bovine-based formulas on preemies, and they intentionally omitted adequate warnings.
With all of the scientific evidence linking human milk to NEC in preemies, they had an obligation to warn about their products’ hazards and dangers. Had there been an adequate warning on the products’ labels, neonatologists and pediatricians may have chosen human donor milk instead.6
Abbott and Mead are sure to argue that the “failure to warn” claim is defeated by the “learned intermediary doctrine” – which puts the onus on doctors to warn patients of risks. But this doctrine does not relieve Abbott and Mead of the duty to warn doctors themselves.
Furthermore, it was never an undue hardship for Abbott or Mead Johnson to add a warning label disclosing the NEC risks. Baby formula is regulated as a food, not a drug. So adding a warning would have been an easy process under the United States Federal Food, Drug, and Cosmetic Act (FDCA).
Multi-district litigations (MDL)
In 2022, all the infant formula lawsuits against Abbott and Mead are joining into an MDL, short for multi-district litigation, out of the Northern District of Illinois before Judge Rebecca Pallmeyer. Consolidating similar cases into an MDL is a way to expedite litigation by having one federal judge make all the pretrial discovery decisions. Eventually a few cases will go to trial, where juries will determine liability and the extent of any compensatory- and punitive damages. How these bellwether trials turn out will then set the stage for out-of-court global 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. And the defendants may be anxious to resolve these cases quickly to curb public relations damages.
(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. Several of these “med mal” verdicts and settlements have been in the low millions. Since juries tend to be less sympathetic to multi-billion-dollar Big Pharma companies than to physicians and their staff, hopefully any verdicts and settlements from the anticipated MDLs will be even higher.)
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 (including ongoing care), any other out-of-pocket costs, and pain and suffering.
No price can be put on a baby’s life and well-being – or on the emotional distress a child’s illness or death causes – so plaintiffs’ attorneys will be fighting for the largest settlement for financial compensation possible under the law. Depending on the extent of the baby’s injuries, we will be pursuing six- and seven-figure settlements for economic- and non-economic damages.
6. What is the statute of limitations to sue?
The statute of limitations to file a NEC baby formula lawsuit turns on several factors, including:
- the state the injury occurred in (the time limit to sue can be as short as one year after the injury);
- who is bringing the lawsuit (the parents, an estate, or the child – sometimes children have up to 21 years to sue);
- when the plaintiffs discovered the NEC (“discovery rule”); and
- any other facts that may toll (pause) the statute of limitations from running.
Therefore, anyone who believes they have grounds to sue should consult an attorney immediately. An attorney can determine the deadline to bring a legal action.
7. Has the baby formula been recalled?
No, not as of 2022. No bovine-based baby formula products have been recalled for their link to damaging intestinal tissues in pre-term infants.7
An alternative to cow milk formula is Prolacta, which includes a human milk-based fortifier that has been available for sale since 2006 and a ready-to-feed formula that has been available since 2014. Pasteurized human donor milk can be purchased through the Human Milk Banking Association of North America and the European Milk Bank Association.
An unrelated recall in 2021 involved the Able Group, which recalled its Kendamil, Bioland, Holle, and HiPP formulas for containing insufficient iron – and there was no warning to parents about the need to supplement with iron. In 2018, CVS pulled its Enfamil products after a tampering incident where the powdered formula had been replaced with flour. And in 2012, some babies developed Cronobacter sakazakii after taking Enfamil, but the FDA said there was no connection.8
8. Other baby food-related lawsuits
There are a growing number of individual lawsuits and traditional 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.9
On February 17, 2022, Abbott recalled Similac baby formulas manufactured at a Michigan facility due to reports of Cronobacter sakazakii bacteria and Salmonella. Abbott is also recalling Alimentum and EleCare baby formulas made at its Sturgis plant.10
- 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)(“Among ELBW infants, not being fed predominantly human milk is associated with an increased risk of NEC. Efforts to support milk production by mothers of ELBW infants may prevent infant deaths and reduce costs.”). 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. Brown JV, Walsh V, McGuire W, Formula versus maternal breast milk for feeding preterm or low birth weight infants, Cochrane, (July 8, 2020)(“Since another Cochrane Review showed that feeding with formula compared to donor breast milk increases the risk of serious gut problems in preterm or low birth weight infants, it is unlikely that families and clinicians would consider it acceptable to allocate an infant to receive formula as an alternative to maternal breast milk when it is available.”).
- See Necrotizing Enterocolitis, Children’s Hospital Los Angeles. Ginglen, J.G. & Butki, Necrotizing Enterocolitis (August 13, 2021). Necrotizing Enterocolits, NICHD – Eunice Kennedy Shriver National Institute of Child Health and Human Development. Necrotizing Enterocolitis (NEC), Cleveland Clinic. Necrotizing Enterocolitis, Children’s Hospital of 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.”). The Surgeon General’s Call to Action to Support Breastfeeding, Office of the Surgeon General (US); Centers for Disease Control and Prevention (US); Office on Women’s Health (US)(2011).
- Infant Formula Act of 1980. Russell Thornton, The learned intermediary doctrine and its effects on prescribing physicians, Proc (Bayl Univ Med Cent) (July 2003). See, e.g., Miller complaint and Dillard complaint in Madison County Circuit Court, VA. See also Crawford v. Mead Johnson & Company et al. (Florida Northern District Court (N.D. Fla), filed 12/9/2021, 1:21-cv-00201).
- 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).
- 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); Josh Hafner, CVS pulls Enfamil powdered baby formula from shelves after mom finds tampered product, USA Today (August 30, 2018); Enfamil Formula Recall 2021 & Tampering Issues: What You Need To Know, Motherhood Community (November 4, 2018); Enfamil infant formula cleared in kids’ bacterial infections, CBS News (January 3, 2012).
- 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.
- Abbott recalls certain Similac baby formula made at Michigan facility, Reuters (February 17, 2022). See also Mélissa Mialon, Paulo Serodio, Eric Crosbie, Nina Teicholz , Ashka Naik and Angela Carriedo, Conflicts of interest for members of the U.S. 2020 Dietary Guidelines Advisory Committee, Cambridge University Press (March 21, 2022)(Abbott and Mead are among the food companies with conflicts of interest with the U.S. Dietary Guidelines Advisory Committee).
- Amy B. Hair et al., Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk–Based Diet, Breastfeeding Medicine Vol. 11 No. 2 (2016)(“Extremely premature infants who received an exclusive HUM diet had a significantly lower incidence of NEC and mortality. The HUM group also had a reduction in late-onset sepsis, BPD, and ROP. This multicenter study further emphasizes the many benefits of an exclusive HUM diet, and demonstrates multiple improved outcomes after implementation of such a feeding protocol”).
- Diana Maffei, Richard J Schanler, Human milk is the feeding strategy to prevent necrotizing enterocolitis! Semin Perinatol (February, 2017)(“Infants who receive greater than 50% of mother’s own milk (MOM) in the 2 weeks after birth have a significantly decreased risk of NEC.”)
- Misty Good et. al, Evidence-based feeding strategies before and after the development of necrotizing enterocolitis, Expert Rev Clin Immunol (July, 2014)(“Necrotizing enterocolitis (N.E.C.) is a devastating disease of premature infants with significant morbidity and mortality. It is well established that the risk is increased by the administration of infant formula”).
- Bartosz Helfer et al., Conduct and reporting of formula milk trials: systematic review, British Medical Journal (October 14, 2021)(“The results show that formula trials lack independence or transparency, and published outcomes are biased by selective reporting.”).
- Arthur I. Eidelman, et al., Breastfeeding and the Use of Human Milk, Pediatrics (March 2012)(“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”).
- Richard J. Schanl, In time: human milk is the feeding strategy to prevent necrotizing enterocolitis, Pediatra (June, 2015)(“There is a 50% reduction in the rate of NEC and/or LOS and a shortened length of hospital stay among the ELBW infants receiving MOM at an average daily dose of more than 50 mL/kg compared to MOM + formula, or formula alone”).
- Diehl-Jones, William, et al., Human Milk Fortification Increases Bnip3 Expression Associated With Intestinal Cell Death In Vitro, Journal of Pediatric Gastroenterology and Nutrition (November, 2015)(“Our data support the hypothesis that HMF increases intestinal Bnip3 in vitro, and that the gene product triggers cell death. We suggest that misoprostol is a promising therapy, which may reduce intestinal cell death.”).
- 51 Donor Milk in the NICU: A Community Pediatrics Perspective, Pediatrics & Child Health (October 29, 2021)(“The data from our community NICU support the current literature that infants who receive formula are at increased risk for transfer for suspected NEC compared to those who receive PDHM.”) ,