More than 10% of premature infants who develop necrotizing enterocolitis (NEC) don’t survive. Those who do often face a lifetime of medical complications—short bowel syndrome, developmental delays, and repeated surgeries, to name a few.
Parents are filing lawsuits claiming cow’s milk-based formulas like Similac and Enfamil put their preemies at unnecessary risk. The accusation is that these companies knew the dangers but didn’t provide clear warnings. Now, families are holding them accountable.
At LitigationConnect, our network of lawyers works with families whose infants were harmed by NEC. Call (833) 552-7274 today or contact us online. We’ll connect you with a vetted attorney who knows the ins and outs of these cases and will help you take the next step.
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Allegations Against Formula Manufacturers
At the core, these lawsuits argue that the companies made a choice: prioritize sales over safety. And that choice had devastating consequences for premature infants and their families.
Failure to Warn
The primary allegation is straightforward—failure to warn. Families claim these companies knew about the heightened risk their cow's milk-based formulas posed to premature infants, yet they didn’t provide clear, specific warnings to doctors or parents.
In legal terms, it falls under failure to warn liability, which is part of product liability law. Under Illinois law, where many of these cases have been filed (735 ILCS 5/2-621), a manufacturer has a duty to inform users of risks that are not obvious and could lead to harm. When a product like baby formula is marketed for vulnerable infants—especially those in neonatal intensive care units (NICUs)—the threshold for that duty skyrockets.
Parents allege that the labels on Similac and Enfamil products didn’t say anything about the increased risk of necrotizing enterocolitis. No warnings. No advisories. Nothing to suggest their decision to use formula instead of donor milk or breast milk might lead to a life-threatening diagnosis. That omission, according to plaintiffs, was not an accident. It was a calculated decision.
Misrepresentation
Then there’s the issue of how these formulas were marketed. Lawsuits claim that Abbott and Mead Johnson actively promoted their products as safe, healthy options for premature infants—sometimes even as superior alternatives to breast milk.
Consider the typical marketing language: “clinically proven,” “supports growth,” “recommended by doctors.” None of these statements, families argue, addressed the elephant in the room—that multiple studies had found a connection between cow’s milk-based formula and NEC in preterm babies. Instead, the messaging gave parents and hospitals a false sense of security.
False advertising and misrepresentation in Illinois are covered under the Illinois Consumer Fraud and Deceptive Business Practices Act (815 ILCS 505/). Plaintiffs argue that Abbott and Mead Johnson’s promotional materials misled both consumers and healthcare professionals. According to these claims, the companies presented their products in a way that obscured the risks, leaving decision-makers without the full picture.
- Direct-to-consumer ads: Brochures, websites, and social media campaigns targeted at new parents.
- Healthcare professional materials: Educational packets and seminars aimed at neonatologists and NICU nurses.
- Hospital partnerships: Agreements that provided bulk supply deals to hospitals, reinforcing trust in the product.
Scientific Evidence and Manufacturer Responses
Every claim made in the NEC baby formula cases rests on a foundation of scientific studies, medical literature, and expert testimony.
Studies on NEC Risk
The connection between NEC and cow’s milk-based formula isn’t a recent discovery. Medical researchers have published studies for decades examining the risks associated with feeding premature infants anything other than human breast milk.
- A 1990 study published in The Lancet was among the first to report a significant association between formula feeding and NEC in preterm infants. The researchers found that babies fed formula had a six to ten times higher risk of developing NEC compared to those who received breast milk.
- In 2012, the American Academy of Pediatrics issued a policy statement recommending human milk—either maternal or donor—as the standard nutrition for preterm infants, citing the reduced risk of NEC as a major factor.
- A meta-analysis published in 2020 concluded that preterm infants fed formula were substantially more likely to develop NEC than those fed human milk. The numbers weren’t subtle: formula-fed infants faced a risk increase of up to 50%.
The science points in one direction. Cow’s milk-based formulas introduce proteins that premature infants struggle to digest, potentially triggering inflammation and bacterial overgrowth in the gut. NEC follows—a rapid, destructive process where intestinal tissue dies, and infection spreads. In severe cases, it leads to sepsis, multiple organ failure, and death.
Manufacturer Stance
Abbott Laboratories and Mead Johnson aren’t standing still. Both companies have pushed back hard against the allegations, arguing that the science doesn’t prove causation. They claim the existing studies show correlation but fall short of demonstrating that their specific formulas cause NEC. And in the courtroom, correlation isn’t always enough.
Both companies cite the complex nature of NEC. They argue that premature infants face multiple risk factors—low birth weight, oxygen deprivation, immature immune systems—and that formula is just one piece of a larger puzzle. Abbott’s official stance, according to statements filed in court, is that Similac products “provide safe and necessary nutrition” for premature infants. Mead Johnson makes similar claims about its Enfamil products.
They also point to regulatory approval. Both Similac and Enfamil meet the standards set by the U.S. Food and Drug Administration (FDA) for infant nutrition. Manufacturers argue that FDA oversight confirms the safety of their products when used as directed.
In recent trials, defense attorneys have leaned heavily on these arguments. They’ve introduced expert testimony to challenge plaintiffs’ medical experts, citing studies that show no statistically significant link between their formulas and NEC when other factors are controlled.
Still, juries haven’t always bought it. Recall that earlier verdicts found the manufacturers liable for failing to warn and misrepresenting the safety of their products. The question isn’t whether NEC exists without formula feeding. It’s whether companies knew—or reasonably should have known—that cow’s milk-based formulas increased the risk and whether they failed to warn consumers about that risk.
Legal Proceedings and Multidistrict Litigation (MDL)
The NEC baby formula lawsuits have turned into a sprawling litigation campaign, with plaintiffs pushing on multiple fronts to hold Abbott Laboratories and Mead Johnson accountable. Two main battlefields have emerged: the federal MDL and various state courts.
MDL Formation
In April 2022, the Judicial Panel on Multidistrict Litigation (JPML) created MDL No. 3026, consolidating dozens of NEC baby formula lawsuits into a single federal court in the Northern District of Illinois. Judge Rebecca R. Pallmeyer oversees the pretrial process. The purpose was to speed things up and avoid conflicting rulings while hundreds of similar cases move through the system.
An MDL isn’t a class action. Each plaintiff keeps their own lawsuit. But by consolidating pretrial discovery and motions, MDLs reduce duplicative efforts and give both sides a chance to test the strength of their cases through bellwether trials. If juries return big verdicts in those early test cases, it puts pressure on the defendants to settle the remaining claims. If they don’t, the defendants gain leverage.
This process falls under 28 U.S. Code § 1407, which allows for centralization when cases involve common factual issues. Here, the common thread is the allegation that cow’s milk-based formulas caused NEC in premature infants, and that the manufacturers failed to warn about the risk.
State Court Actions
While the MDL moves forward in federal court, Abbott and Mead Johnson are also busy defending lawsuits in state courts. Illinois and Missouri have seen a surge of cases. Not only are these states home to the defendants (Abbott is headquartered in Illinois, Mead Johnson has a strong presence in Missouri), but state laws there offer procedural advantages for plaintiffs.
In Illinois, plaintiffs rely on the Illinois Code of Civil Procedure (735 ILCS 5/) to bring product liability and wrongful death claims. These cases argue that Abbott and Mead Johnson sold defective products, failed to warn of known risks, and caused avoidable deaths and injuries.
In Missouri, cases proceed under Missouri Revised Statutes Chapter 537. Plaintiffs argue similar theories of product liability, negligence, and wrongful death, alleging that the formula products were unreasonably dangerous for their intended use—feeding premature infants.
The state court cases don’t wait for the MDL to finish. Some of them have already gone to trial. Jury verdicts in state courts, particularly when they award millions—or hundreds of millions—in damages, influence the federal litigation and future settlement talks.
Recent Verdicts and Legal Developments
As the NEC baby formula lawsuits move through courts nationwide, the outcomes are piling up—and they’re anything but predictable. Some juries have handed down staggering awards, while others have left families without compensation. The legal landscape shifts with every verdict, and manufacturers Abbott and Mead Johnson are feeling the pressure.
March 2024 Verdict – Illinois Jury Awards $60 Million
The first major crack in the defense came in March 2024. An Illinois jury awarded $60 million to the mother of an infant who died after developing NEC. The baby had been fed Enfamil formula while in the neonatal intensive care unit.
The plaintiff’s attorneys argued that Mead Johnson failed to warn hospitals and parents about the risks of NEC linked to its cow’s milk-based formula. They pointed to internal company documents that allegedly showed knowledge of the increased risk but no steps taken to address it publicly. The jury found that failure amounted to negligence and awarded both compensatory and punitive damages.
In Illinois, punitive damages are typically capped in personal injury cases. But in product liability claims involving willful and wanton conduct—such as knowingly withholding risk information—juries have more leeway under 735 ILCS 5/2-1115.05. The jury’s decision in this case reflected their belief that the company’s conduct warranted a financial penalty beyond compensatory damages.
August 2024 Verdict – St. Louis Jury Awards $495 Million
The second major blow landed five months later. A St. Louis jury awarded $495 million to a family whose premature infant developed NEC after being fed Similac formula in a Missouri hospital.
The plaintiff’s legal team successfully argued that Abbott Laboratories had aggressively marketed Similac as safe for premature infants despite knowing about the NEC risks. They presented expert testimony on medical studies linking cow’s milk-based formulas to NEC, and the jury found Abbott liable for both strict product liability and negligent misrepresentation.
Missouri’s Revised Statutes Chapter 510 allow for punitive damages if the defendant “intentionally harmed the plaintiff without just cause or acted with a deliberate and flagrant disregard for the safety of others.” The $495 million verdict included a significant punitive damages award, signaling the jury’s conclusion that Abbott’s behavior went far beyond ordinary negligence.
November 2024 – Defense Verdict in Missouri
The tide turned briefly in November 2024. In a separate Missouri trial, a jury sided with Abbott and Mead Johnson, finding no liability for the infant’s NEC diagnosis and death. Defense attorneys argued that the science around NEC remains unsettled, and they presented evidence that the infant had multiple risk factors unrelated to formula feeding.
The verdict surprised many observers. Plaintiffs’ lawyers alleged misconduct during the trial, claiming the defense withheld key documents during discovery. These allegations didn’t sway the jury, but they set the stage for further legal maneuvering.
March 2025 – Retrial Ordered
The controversy surrounding the November 2024 defense verdict escalated when a Missouri judge vacated the ruling in March 2025. The judge cited concerns about withheld evidence, granting the plaintiffs’ motion for a retrial.
Under Missouri Rules of Civil Procedure Rule 75, a court can set aside a judgment if there’s evidence of fraud, misconduct, or other irregularities that affected the fairness of the trial. The decision to grant a new trial reignited the fight and sent a clear message: procedural fairness matters, and courts will enforce it.
This retrial is scheduled for late 2025 and will be closely watched by both sides. The outcome may influence future settlements and jury decisions, as both plaintiffs and defendants recalibrate their strategies based on these legal twists and turns.
Hold Formula Companies Accountable. Start Today.
Every lawsuit sends a message: profits don’t come before people. Parents trusted these companies to provide safe nutrition for their most vulnerable newborns. Instead, they were handed risks no one warned them about. Now it’s their turn to fight back.
At LitigationConnect, our network of lawyers works with families ready to take action. Call (833) 552-7274 today or contact us online. We’ll connect you with a vetted attorney who knows how to hold these manufacturers responsible—and who won’t back down.