Enfamil lawsuits are legal claims against Mead Johnson Nutrition for defective design and failing to warn consumers that its baby formula can cause preterm infants to develop necrotizing enterocolitis (NEC).
NEC is a serious gastrointestinal illness that can result in lifelong complications and even death.
- 1. Does Enfamil cause NEC?
- 2. What is necrotizing enterocolitis?
- 3. Has Enfamil been recalled?
- 4. What is the status of the lawsuits?
- 5. How big will the settlements be?
- 6. Who makes Enfamil?
1. Does Enfamil cause NEC?
Science indicates that premature babies – before 37 full weeks – fed cow’s milk-based baby formula such as Enfamil (or Similac) are more likely to get necrotizing enterocolitis (NEC), usually at two-to-six weeks. One study which followed more than 900 preemies showed that:
- Formula-fed premature babies were six to ten times more likely to come down with NEC than preterm infants who drank breast milk.
- Formula-fed premature babies were three times more likely to come down with NEC than preterm infants who drank both breast milk and formula.1
In 2011, various hospitals proclaimed that very premature infants fed human donor breast milk were at a lesser risk for NEC than very premature infants fed bovine milk formula.2
Also in 2011, the U.S. Surgeon General said, “For vulnerable premature infants, formula feeding is associated with higher rates of necrotizing enterocolitis (NEC).”
The following year, the American Academy of Pediatrics announced that premature babies should be given only human milk.3
2. What is necrotizing enterocolitis?
Necrotizing enterocolitis (NEC) is a serious gastrointestinal bacterial condition that is largely seen in preterm infants. NEC causes inflammation and potentially intestinal tissue death. Doctors fight it with antibiotics and – if necessary – surgery.
NEC may result in severe complications, such as:
- intestinal strictures,
- bowel perforation,
- development delays,
- short bowel syndrome,
- cerebral palsy, and
- possibly death.
Symptoms of NEC can include such health problems as:
- Difficulty eating and gaining weight
- Diarrhea with blood or dark-colored stools
- Vomit that is tinged yellow or green
- Distended abdominal cavity
- Reduced heart rate and blood pressure
- Shock (in advanced cases)
- Liver disease (IFALD)
Of the 480,000 preterm infants born in the U.S. annually, about 9,000 develop cases of NEC. And 90% of those cases occur in preemies; 10% occur in full-term infants.
The four types of NEC are the following: 1) classic NEC; 2) transfusion-associated NEC; 3) Atypical NEC; and 4) Term infant NEC. The majority of the bovine formula-related cases involve “classic NEC.”4
3. Has Enfamil been recalled?
No. The Food and Drug Administration (FDA) has not recalled Enfamil baby formula even though its packaging omits any warning label about an increased risk of NEC cases. Enfamil infant formula products including Premature, NeuroPro and Human Milk Fortifier remain for sale today.
An alternative to Enfamil is Prolacta, a human milk-based fortifier that has been available since 2006 and a ready-to-feed formula that has been available since 2014. Pasteurized human donor milk is available through the:
4. What is the status of the lawsuits?
Currently there are dozens of lawsuits against Enfamil maker Mead Johnson & Company (as well as Similac Special Care maker Abbott Laboratories, Inc.) in Illinois – where both companies are headquartered.
The lawsuits claim that the cow’s milk-based formula caused preemies to get NEC. Thousands more lawsuits are expected.
Typical causes of action in these necrotizing enterocolitis lawsuits are:
- Strict product liability (“defective product”)
- Failure to warn (all the Enfamil’s label says is not to microwave the formula)
- Intentional misrepresentation
- Negligent misrepresentation
- Breach of warranty
- Wrongful death lawsuits (if the baby passed away)
All the lawsuits against Mead Johnson are being joined into a MDL – which stands for multi-district litigation – out of the Northern District of Illinois before Judge Rebecca Pallmeyer. The MDL number is 3026.
MDLs help to speed up pretrial and settlement procedures. But unlike class-action lawsuits, the cases in an MDL stay separate.
Note that some parents are also filing medical malpractice lawsuits against health care providers and hospitals where NICU (neonatal intensive care unit) nurses gave the babies Enfamil.
4.1. How is Mead defending itself?
Mead is expected to hide behind these two defenses:
- The lawsuits are preempted by federal law under the Infant Formula Act (IFA): Since the FDA approved Enfamil, there can be no viable defective design claim.
- Mead had no duty to warn about Enfamil’s risk; instead, pediatricians (“learned intermediaries”) had the duty to warn.5
Based on prior lawsuits, plaintiffs’ counsel believe these defenses have zero merit.
5. How big will the settlements be?
Plaintiffs’ lawyers in the 2022 infant formula lawsuits are seeking the largest settlements possible to cover these compensatory damages:
- medical expenses
- other out-of-pocket costs
- pain and suffering (often the largest expense)
- funeral expenses (if the baby passed away)
Shouse Law Group is seeking settlements in the hundreds of thousands or millions of dollars, depending on the child’s injury.
6. Who makes Enfamil?
Enfamil has been made by the American health care company and formula manufacturer Mead Johnson & Company since the 1950s. Mead Johnson Nutrition Company was bought by Reckitt Benckiser in 2017.
Currently, there are nearly 20 Enfamil baby formula products – including EnfaCare – geared towards newborns. Mead Johnson is incorporated in Delaware and has its principal place of business in Illinois, although Mead claims its PPB is actually in Indiana.6
Note that there has also been a shortage of Enfamil in recent months.7
Has your preterm infant suffered NEC after being fed Enfamil products? Our injury lawyers offer consultations and case evaluations to you and your loved ones about seeking financial compensation.
Use our contact form or call our baby formula lawyers toll-free for a case review. Our phone number for bringing 2022 Enfamil NEC lawsuits and Similac baby formula NEC lawsuits is 877-504-7750. There is a statute of limitations to file a lawsuit, so call now.
- 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).
- See Necrotizing Enterocolitis, Children’s Hospital Los Angeles. 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. Neonatal Necrotizing Enterocolitis, Semin Pediatr Surg (May 2008).
- See, e.g., Miller complaint and Dillard complaint in Madison County Circuit Court, VA. Other lawsuits have been filed in the Middle District of Louisiana, the Middle District of Florida, the Northern District of Florida, and the Central District of California. Russell Thornton, The learned intermediary doctrine and its effects on prescribing physicians, Proc (Bayl Univ Med Cent) (July 2003). Infant Formula Act of 1980.
- See also Primavera Capital Acquires Greater China Business of Mead Johnson from Reckitt Benckiser Group, PR Newswire (June 5, 2021).
- Ben Popken, Baby formula supply issues send parents scrambling, NBC News (February 18, 2022).