Cow’s milk-based infant formulas and fortifiers primarily Similac (Abbott) and Enfamil
(Mead Johnson/Reckitt), have been linked in medical literature to Necrotizing
Enterocolitis (NEC) in premature infants. Families across the U.S. allege
manufacturers failed to warn that preemies fed bovine-based formulas face a
significantly higher NEC risk compared to those fed human milk.
Hundreds of lawsuits are pending nationwide. Federal cases are centralized in MDL No.
3026 (N.D. Illinois), with additional actions moving in state courts (e.g.,Illinois, Missouri, Pennsylvania). Plaintiffs say the companies knew of the NEC risk for decades yet continued to market their products for preterm use without adequate warnings.
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Defendants:
Abbott Laboratories (Similac), Mead Johnson/Reckitt (Enfamil), and, in some filings, hospitals/sales reps tied to promotion or use in NICUs.
Claims:
Failure to warn, negligent marketing/misrepresentation, design/manufacturing defect, breach of warranties alleging bovine-based formula substantially increases NEC risk in premature infants and caused catastrophic injuries or death.
Scientific Backing:
Decades of peer-reviewed research (e.g., Lancet 1990; Journal of Pediatrics; Cochrane 2019) associate cow’s milk-based feeding with significantly higher NEC incidence versus human milk. AAP guidance favors human milk for preemies; studies show donor human milk halves NEC compared to formula. Mechanistic evidence (e.g., TLR4-mediated inflammation in the premature gut) supports biological plausibility.
Current Status:
Federal cases consolidated in MDL-3026 (Judge Rebecca R. Pallmeyer). As of mid-2025, the docket includes 700+ cases, alongside active state-court proceedings. Early federal bellwether(s) saw mixed outcomes (including summary judgment in one case), while state juries returned major plaintiff verdicts ($60M IL; $495M MO); a Missouri defense verdict was later vacated for misconduct. Additional bellwethers and appeals are in motion.
September 2, 2025
Abbott CEO Robert Ford rejected settlement chatter on the Q2 call, defending Similac and stating that he would rather pull the product from the market than allow “lawyers in courtrooms” to override regulators and physicians, a tough stance that is common on earnings calls but often softens later in litigation history.
August 27, 2025
A Jacksonville family filed a lawsuit in MDL 3026 alleging that their premature infant, born at 27 weeks and weighing 1,000 grams, developed NEC after being fed Similac and Similac Human Milk Fortifier, with the complaint accusing Abbott of deceptive marketing that portrayed the products as safe alternatives to human milk.
August 23, 2025
The court partially excluded defense expert Dr. Larry Hedges after he admitted to using incorrect data that made formula appear safer than it is, while also noting flaws in other defense experts’ selective study choices, limiting the companies’ ability to rely on shaky science.
August 16, 2025
The second MDL bellwether trial was removed from the calendar just weeks before it was set to begin, highlighting delays in federal court while state courts continue to deliver large plaintiff verdicts including awards of $60 million and $495 million with the next federal trial now scheduled for November.
August 1, 2025
Judge Pallmeyer granted summary judgment to Abbott after striking the plaintiff’s expert testimony for not fitting the facts closely enough, preventing the second bellwether case from reaching trial and pushing more plaintiffs to consider filing in state courts.
July 21, 2025
Parents in New Jersey filed a lawsuit alleging their premature infant developed NEC after receiving bovine-based formula in a NICU, claiming both the hospital failed to obtain proper consent and the manufacturers promoted the products despite longstanding evidence of heightened risks.
July 12, 2025
The MDL court denied remand in six Pennsylvania cases, finding that plaintiffs had no real intent to pursue claims against local hospitals and deeming the joinder fraudulent, while certifying key questions for appeal to the Seventh Circuit.
July 8, 2025
Judge Pallmeyer remanded a Missouri case back to state court after finding that the inclusion of a local sales representative was not fraudulent joinder, allowing negligent misrepresentation claims to proceed under Missouri law.
July 7, 2025
The Judicial Panel on Multidistrict Litigation reported 744 pending NEC cases in the MDL, reflecting continued growth after the court’s Daubert ruling preserved key plaintiffs’ experts and kept the litigation on track toward bellwethers.
June 10, 2025
The NEC MDL rose to 740 cases, with 30 new filings in May, as plaintiffs gained confidence from favorable expert rulings and growing momentum in state courts, positioning the litigation for eventual settlement talks.
May 14, 2025
Judge Pallmeyer denied defense Daubert motions, allowing pediatric epidemiologist Dr. Logan Spector and neonatologist Dr. Jennifer Sucre to testify that cow’s milk-based formula significantly increases NEC risk, preserving plaintiffs’ core liability theory and defeating summary judgment.
April 28, 2025
There were approximately 360 cases pending in the federal MDL and another 600 to 700 in state courts, totaling about 1,000 nationwide, a relatively manageable caseload that makes organizing bellwether trials and settlement negotiations more feasible compared to other mass torts.
March 15, 2025
A Missouri judge vacated the only defense verdict in NEC litigation after finding repeated misconduct by Abbott and Mead Johnson, including misleading jurors and violating court orders, restoring plaintiffs’ string of victories.
February 11, 2025
Defendants moved for summary judgment across the MDL, arguing plaintiffs lacked admissible expert testimony on general causation, but plaintiffs pointed to prior state court verdicts and extensive research demonstrating the risks of cow’s milk-based formula.
January 26, 2025
Defendants sought to exclude neonatologist Dr. Jennifer Sucre, a leading Vanderbilt researcher, but plaintiffs emphasized her strong credentials and explained that ethical limits prevent direct human trials, making her testimony crucial to establishing biological plausibility.
January 24, 2025
The parties filed a joint status report in the MDL setting a streamlined briefing schedule for expert and dispositive motions, with the first bellwether trial, Mar v. Abbott, targeted for May 5, 2025.
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Potential compensation may include:
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If your premature baby developed NEC after Similac/Enfamil use, you may qualify
No fees unless you win. Attorneys typically work on a contingency basis.