Research linking risks associated with cow’s milk-based baby formulas has been around for more than 30 years. A 1990 study published in The Lancet found that preterm infants exclusively fed formula developed a life-threatening disease called necrotizing enterocolitis at a rate of 600%-1000% higher than those fed breast milk. Even with this information available, companies like Abbott Labs and Med Johnson & Co continued to produce and sell formula products such as Similac and Enfamil to hospitals and the public.

An article published in the journal, Advanced Nutrition, in 2017 noted that ‘Several studies have indicated that bovine milk-based infant formulas lead to higher incidents of NEC in preterm infants than does human milk.” Recently, the Eunice Kennedy Shriver National Institute of Child Health and Human Development published a review noting evidence collected for a 2008 Seminar in Perinatology warned of an increased risk of preterm NEC. Their review also cited 2019 CDC statistics which listed NEC as one of the ten leading causes of infant mortality with 15%-40% of infants who contract NEC dying from the disease.

In January 2025 the Public Health Advocacy Institute (PHAI) filed a lawsuit against Abbott Labs over marketing practices and misleading parents and caregivers about the nutritional value of its toddler milks. This comes a year after the American Academy of Pediatrics also excoriated Abbott over what it described as “questionable marketing practices”.

FDA

October 2024 the FDA, CDC, and NIH released a joint statement noting evidence points to a lack of human formula, though not specifically formulas, as increased risk of NEC

MDL

MDL #3026: Northern District of Illinois, Judge Rebecca R. Pallmeyer

Litigation Update

The first trial in Illinois state court in March 0224 resulted in a $60 million verdict for the plaintiffs against Mead Johnson & Co. In July 2024, plaintiffs secured a massive $495 million verdict in another Illinois state court case, this time against Abbot Labs. An October 2024 state court trial ended in a defense verdict. First bellwether trial is scheduled to take place in May 2025.

Important Links

1. https://www.thelancet.com/journals/lancet/article/PII0140-6736(90)93304-8/fulltext
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC5227976/
3. https://publications.aap.org/aapnews/news/30429/FDA-CDC-NIH-Evidence-points-to-lack-of-human-milk?autologincheck=redirected
4. https://publications.aap.org/aapnews/news/30429/FDA-CDC-NIH-Evidence-points-to-lack-of-human-milk?autologincheck=redirected
5. https://www.reuters.com/legal/reckitt-unit-hit-with-60-million-verdict-enfamil-baby-formula-case-illinois-2024-03-14/
6. https://www.reuters.com/business/healthcare-pharmaceuticals/abbott-must-pay-95-million-premature-infant-formula-trial-jury-finds-2024-07-26/
7. https://www.cbsnews.com/news/abbott-laboratories-toddlers-milk-infant-formula-similac/

MDL Link

1. https://www.ilnd.uscourts.gov/Nextgen.aspx/mdl-details.aspx?Lbz1nwUsE4JWF/IQJN6GpA==

Case Management Orders