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 defective design and failing to warn physicians and parents about the NEC risks in preemies.
Our 2022 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 (before 37 full weeks) 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 Also in 2011, the U.S. Surgeon General stated, “For vulnerable premature infants, formula feeding is associated with higher rates of necrotizing enterocolitis (NEC).”
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 intestinal wall. NEC is treated by antibiotics and – if necessary – abdominal repair surgery on the decayed tissue.
NEC may lead to serious health problems and complications, such as sepsis from bacteria invading the bloodstream, intestinal strictures, perforation of intestinal tissue, development problems, cerebral palsy, 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, temperature, and blood pressure
- Halted breathing
- Shock (in advanced cases)
- Liver disease (IFALD)
There are four types of NEC: 1) classic NEC; 2) transfusion-associated NEC; 3) Atypical NEC; and 4) Term infant NEC. Most of the cow milk formula-related cases involve classic NEC. NEC cases range from mild to fatal.
Out of the 480,000 preemies born in the U.S. each year, about 9,000 get NEC. And 90% of these cases happen in preemies. It is the 10th leading cause of death for preemies and infants younger than one year.4
3. Has Similac been recalled?
Not as of 2022. 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 baby formula products include Similac Special Care, Similac NeoSure, Similac Pro-Advance Non-GMO, Similac Pro-Sensitive, Similac Alimentum, Similac Advance Powder DHA, and Similac Human Milk Fortifier (a misleading name because it contains no human milk). In cases where preemies do not develop NEC, Similac is an efficient way to provide babies calories – especially if they have trouble breastfeeding.
An alternative to Similac is Prolacta, a human milk-based fortifier that has been available for sale since 2006 and a ready-to-feed formula that has been for sale since 2014. Pasteurized human donor milk can also be obtained through the Human Milk Banking Association of North America and the European Milk Bank Association.
4. What is the current state of the lawsuits?
Litigation is very new. Every week of 2022 brings new baby formula NEC lawsuits against maker of Similac 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 warning labels and product information still do not disclose NEC risks, just that low birth weight infants are susceptible to GI problems)
- Intentional misrepresentation
- Negligent misrepresentation
- Breach of warranty
- Wrongful death lawsuits (if the infant passed away)5
All these negligence and product liability lawsuits against Abbott are being consolidated into an MDL – short for multi-district litigation – in the Northern District of Illinois before Judge Rebecca Pallmeyer. MDLs are a way to expedite the pretrial and settlement process.
MDLs are similar to class action lawsuits, except that the cases in an MDL remain separate. This MDL also includes Enfamil lawsuits against Enfamil NeuroPro maker Mead Johnson Nutrition.
Parents are also bringing state- and federal court medical malpractice lawsuit claims against providers and hospitals whose NICUs (neonatal intensive care unit) fed their babies Similac.
4.1. How is Abbott fighting back?
Plaintiffs’ attorneys expect Abbott (and Enfamil maker Mead Johnson & Company) to use the following two defenses:
- The lawsuits are preempted by federal law pursuant to the Infant Formula Act (IFA): Since the FDA approved Similac, it therefore cannot be defectively designed.
- Abbott had no duty to warn about Similac; instead, pediatricians (“learned intermediaries”) had the duty to warn.6
Based on past lawsuits, plaintiffs’ attorneys do not believe these defenses have merit.
5. How much money can I expect?
The 2022 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 financial compensation as possible, in the hundreds of thousands or millions of dollars.
6. Who makes Similac?
Similac products are manufactured by the American health care company Abbott, headquartered in Abbot Park, Illinois and with a principal place of business in Lake County, 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. Abbot is incorporated in Delaware.7
Abbott was well-aware that Similac – a cow’s milk-based formula – causes NEC in many preemies. The scientific evidence was established. Abbott’s knowing failure to warn doctors and consumers about the NEC risks indicates they put their own profits and marketability over the health of innocent, helpless infants.
Note that on February 17, 2022, Abbott recalled certain lots of Similac baby formula after complaints of Cronobacter sakazakii bacteria and Salmonella.8
Our personal injury lawyers offer free consultations and free case evaluations to you and your loved ones. Use our contact form or call us toll-free for a free case review. Our phone number for bringing Similac baby formula lawsuits is 877-504-7750.
- 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. Mortality in the United States, 2019, National Center for Health Statistics, CDC.
- See, e.g., Miller complaint and Dillard complaint in Madison County Circuit Court, VA. The first NEC lawsuit of 2022 is Shannon Hall, et al. v. Abbott Laboratories, 1:22-cv-00071, filed in the Northern District of Illinois. The Illinois Supreme Court is also considering whether to allow a possible class action lawsuit against both Abbott and Mead Johnson to go forward.
- 20 U.S.C. § 350a. Russell Thornton, The learned intermediary doctrine and its effects on prescribing physicians, Proc (Bayl Univ Med Cent) (July 2003). Infant Formula Act of 1980.
- 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.
- Abbott recalls certain Similac baby formula made at Michigan facility, Reuters (February 17, 2022).