Similac lawsuits claim that the cow’s milk-based baby formula is causing preterm infants to develop the gastrointestinal illness necrotizing enterocolitis (NEC). Shouse Law Group is suing Similac formula manufacturer Abbott for failing to warn physicians and parents about the NEC risks in preemies. Our baby formula lawsuits are seeking the biggest financial settlements available under the law.
In this article, our mass tort attorneys discuss:
- 1. Does Similac cause NEC?
- 2. What is necrotizing enterocolitis?
- 3. Has Similac been recalled?
- 4. What is the current state of the lawsuits?
- 5. How much money can I expect?
- 6. Who makes Similac?
1. Does Similac cause NEC?
According to scientific studies, premature infants fed bovine-based baby formula such as Similac (or Enfamil baby formula) are more likely to come down with the bowel disease necrotizing enterocolitis (NEC). This typically occurs in two-to-six-week-old preemies.
One study going back decades that followed more than 900 preterm infants showed that:
- Formula-fed preterm babies were six to ten times more likely to develop NEC than preterm infants who were given breast milk.
- Formula-fed preterm babies were three times more likely to develop NEC than preterm infants who were fed both breast milk and formula.1
In 2011, a group of hospitals deduced that very premature babies given human donor breast milk were less at risk for NEC than those given cow milk formula.2 Then in 2012, the medical professionals representing the American Academy of Pediatrics proclaimed that premature babies should be fed only human milk because cow milk formula carried too great of a NEC risk.3
2. What is necrotizing enterocolitis?
Necrotizing enterocolitis (NEC) is a gastrointestinal bacterial infection that occurs largely in preterm babies. NEC causes inflammation that may lead to tissue death in the intestines. NEC is treated by antibiotics and – if necessary – abdominal repair surgery.
NEC may lead to serious health problems and complications, such as sepsis, intestinal strictures, perforation of intestinal tissue, development problems, and possibly death. Symptoms of NEC may include:
- Trouble eating and gaining weight
- Diarrhea with blood or dark stools
- Vomit that is yellow or green
- Distended abdomen
- Lowered heart rate and blood pressure
- Shock (in advanced cases)4
3. Has Similac been recalled?
No. Similac infant formula products remain on the market despite the increased risk of NEC. The Food and Drug Administration (FDA) has not recalled Similac. And Abbott has not voluntarily recalled Similac.
Popular Similac products include Similac Special Care, Similar NeoSure, Similac Pro-Advance, and Similac Pro-Sensitive. In cases where preemies do not develop NEC, Similac is an efficient way to provide babies calories – especially if they have trouble breastfeeding.
4. What is the current state of the lawsuits?
Litigation is very new. Every week brings new lawsuits against Similac maker Abbott Laboratories, Inc. for allegedly causing babies to develop NEC. Typical causes of action in these lawsuits are:
- Strict product liability for design defect (“defective product”)
- Strict liability for failure to warn (the Similac labels and product information still do not disclose NEC risks)
- Intentional misrepresentation
- Negligent misrepresentation
- Breach of warranty
- Wrongful death lawsuits (if the infant passed away)5
It is likely that all these product liability lawsuits against Abbott will consolidate into a MDL – short for multi-district litigation – in a U.S. District Court. MDLs are a way to expedite the pretrial and settlement process. They are similar to class action lawsuits, except that the cases in an MDL remain separate. (It is also likely an MDL will form against the Enfamil maker Mead Johnson & Company to consolidate the Enfamil lawsuits.)
Parents are also bringing state- and federal court medical malpractice lawsuit claims against hospitals whose NICUs (neonatal intensive care unit) fed their babies Similac.
5. How much money can I expect?
The necrotizing enterocolitis lawsuits against Similac baby formula maker Abbott are seeking compensatory damages for medical bills, out-of-pocket costs, and pain and suffering. Considering that NEC can cause infants to die or sustain lifelong injuries, plaintiffs’ attorneys are fighting for as much money as possible.
6. Who makes Similac?
Similac products are manufactured by the American health care company Abbott, headquartered in Abbot Park, Illinois. Abbott Nutrition also makes Pedialyte, Ensure, and Glucerna. Similac was originally made by Ross Laboratories, which merged with Abbott in 1964.
According to Abbott financial reports, Abbott sold more than a billion dollars worth of Similac in 2019.6
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- 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 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.
- See, e.g., Miller complaint and Dillard complaint in Madison County Circuit Court, VA.
- Abbott 2020 Annual Report. Typical ingredients in non-gmo Similac products according to Similac.com are Beta-Carotene, Lutein, Chloride, Taurine, Choline Chloride, L-Carnitine, Potassium Chloride, Vitamin A Palmitate, in, Thiamine Chloride and Nucleotides.