Abbott Laboratories, Reckitt, and Mead Johnson & Company, LLC, baby formula manufacturers, now face necrotizing enterocolitis baby formula lawsuits for not adequately warning the public about the health complications related to their infant formulas, including Enfamil and Similac.
Preterm babies and babies born with low birth weights nationwide have developed a severe gastrointestinal condition called necrotizing enterocolitis (NEC) after feeding on Similac and Enfamil.
Parents of the affected infants are now seeking monetary compensation from the infant formula makers. The NEC infant formula lawsuits have been merged into an MDL (multidistrict litigation). Honorable Judge Rebecca Pallmeyer from the Northern District of Illinois oversees the NEC baby formula MDL.
Necrotizing enterocolitis can have a life-changing impact on the infants and their families. It can even cause irreversible health complications, like inflammation of the intestinal lining, causing tissue death and possible perforations in the bowel wall. These complications are severe and life-threatening, and they require long-term treatment, coping, and management. Thus, families of infants affected by these baby formulas must consult with an experienced product liability lawyer about filing an NEC lawsuit.
Overview of NEC Baby Formula Lawsuits: Causes and Claims
After 63 new NEC baby formula lawsuits were filed in February 2025–the highest monthly surge since the MDL began–lawsuit volume reduced in March 2025, and only 20 new cases were added. So far, there are 683 pending NEC baby formula MDL lawsuits.
Still, new cases keep coming in as parents hold infant formula manufacturers responsible for the complications related to their cow-based baby formulas. In the latest lawsuit on March 25, 2025, a family from Oklahoma is suing after their premature infant developed necrotizing enterocolitis after consuming Enfamil in the NICU (neonatal intensive care unit).
The case, filed in the NEC baby formula MDL in Illinois, points out the already-familiar allegations–Mead Johnson, Enfamil maker–knew for years that Enfamil drastically increased the risk of NEC in premature babies, yet it marketed it as safe and essential for the growth and development of babies. The plaintiff lays out the overwhelming scientific data linking baby formula to NEC and accuses Mead Johnson of not adequately warning doctors and parents while aggressively marketing its products to hospitals.
The premature infant developed severe health complications from necrotizing enterocolitis, requiring intensive medical treatments, and his parents are now seeking compensation for the lasting damage. This Enfamil necrotizing enterocolitis lawsuit adds to the growing number of lawsuits as more parents take legal action against Mead Johnson and Abbott Laboratories for their part in this devastating crisis.
Recent Verdicts and Settlements in NEC Formula Cases
There are no jury verdicts or approved settlements in the Illinois multi district litigation No. 3026, which contains primarily Enfamil and Similac claims. However, in March 2024, a state court lawsuit in Illinois awarded a plaintiff $60 million. In July 2024, another state court case in Missouri awarded a plaintiff $496 million. However, in October 2024, a jury in Missouri vindicated Abbott Laboratories and Mead Johnson & Company, LLC, the defendants in these lawsuits, rejecting that their baby formulas caused NEC in babies. The trial verdict was the defendant’s first win in NEC baby formula lawsuits.
Elizabeth Whitfield, a plaintiff, was seeking $6.2 billion. She argued that the cow-based infant formula had caused her son to get diagnosed with NEC after he consumed these products. Abbott Laboratories and Mead Johnson argued that their products provided essential nutrients to vulnerable babies, and no scientific data linked their products to NEC.
Some premature babies diagnosed with NEC get well after extensive treatment, whereas others develop lasting complications, and some even pass away.
The NEC baby formula lawsuits are being handled in state courts via an MDL, currently centralized in the Northern District of Illinois.
Contrary to class actions, each NEC lawsuit is assessed based on the damages the baby and their family suffered.
Key Developments in the NEC Baby Formula MDL
On March 15, 2025, Abbott Laboratories and Mead Johnson’s October win was overturned. A Missouri judge overturned the only jury verdict that Abbott and Mead Johnson had won, ruling that the defense attorneys violated court orders intentionally to mislead jurors. The judge found that the defense team falsely alleged the claimant wanted all baby formula banned, causing fear-based bias. Also, the defense team repeatedly introduced inadmissible evidence to mislead jurors and used inaccurate expert testimony and FDA arguments before court rulings.
This is a significant win for complainants and shows that judges won’t tolerate defense misconduct. Abbott Laboratories and Mead Johnson are now appealing the court order. Since the defendants have lost their only win, the momentum is on the complainants’ side.
With past NEC verdicts and settlement amounts totaling about $500 million, the pressure is mounting on the defense side to stop avoiding accountability and start warning the public about known NEC risks. The state court trials and verdicts also send a strong message about the impact of NEC linked to baby formula on the affected babies and their families. Further, it shows a strong desire by courts to hold the defendants accountable for their negligence.
Bellwether Trials: What to Expect in Upcoming NEC Cases
The first bellwether trials, also known as test trials, will start this year.
The cow-based baby formula MDL test case schedule is as follows:
- May 5, 2025: Mar vs. Abbott Laboratories
- August 11, 2025: K.B. vs Abbott Laboratories
- November 3, 2025: Brown vs. Abbott Laboratories
- February 2, 2026: Inman vs. Mead Johnson and Company, LLC, et al.
The plaintiffs and their attorneys hope for a global settlement before these trials start.
Scientific Evidence Linking Cow’s Milk Formula to NEC
Necrotizing enterocolitis is a dangerous intestinal disease marked by inflammation and damage to the gut wall lining that may cause necrosis (death of cells and tissues) and perforation of the gut. Severe cases of NEC can lead to surgery and even death.
Substantially high rates of NEC have occurred in preterm and premature babies with low birth weights who have consumed cow’s milk formula or fortifier products.
A 2009 study found that premature and preterm babies who consumed an exclusively human milk-based diet were 90% less likely to suffer from surgical NEC compared to preterm babies fed a diet that included some cow-based formula products.
Further, in 2011, many hospitals found that premature and preterm babies who consumed human milk-based products were less likely to develop the deadly NEC than infants fed cow-based baby formula. The Children’s Hospital of Los Angeles reports that NEC is one of the primary causes of gastrointestinal-connected morbidity and mortality in the NICU.
Babies with low birth weights and those born prematurely are more susceptible to necrotizing enterocolitis (NEC). The Eunice Kennedy Shriver National Institute of Child Health and Human Development reports that all newborn babies born prematurely or with low birth weights are more likely to get diagnosed with NEC. The more premature the baby or the smaller the infant, the more likely they are to get diagnosed with NEC.
Cow-based infant formulas are known to cause necrotizing enterocolitis (NEC). According to an article published in 2017 in the scientific journal Advanced Nutrition, many medical studies have found that bovine milk-based formulas result in a higher incidence of NEC in premature babies than human milk.
Thus, not only are cow-based infant formulas dangerous for infants, but they are also dangerous for premature babies or babies born with low birth weights. Sadly, these infants can’t be fed human milk. That means they fed on baby formula instead. In such cases, these infants shouldn’t be fed cow-based infant formulas but human donor breast milk instead.
Eligibility Criteria for Filing an NEC Baby Formula Lawsuit
You may be eligible to file a Similac or Enfamil claim if:
- Your premature infant developed NEC
- Your premature baby consumed cow-based baby formula
- Your baby was born prematurely or with a low birth weight
Your premature or preterm infant might have been fed Enfamil or Similac in the hospital. If unsure, your product liability attorney can help you get that information. Ensure you provide them with the name of the hospital where you gave birth and its location.
After your premature or preterm infant was discharged from the hospital, you might have fed them an Enfamil or Similac product. NEC infant formula attorneys advise parents to keep all receipts, proof of purchase, boxes, or packaging from the baby formula as evidence in their NEC baby formula lawsuit.
The Role of Failure to Warn in NEC Formula Litigation
Since baby formula makers, like Abbott and Mead Johnson & Company, LLC, knew for decades the risk of NEC related to their baby formulas, the NEC baby formula lawsuits against them primarily focus on their failure to warn. Product liability laws in the United States stipulate that product makers are legally mandated to warn the public of known and nonobvious risks linked to their products.
The danger of NEC among babies born with low weights and preterm infants undoubtedly falls in this category. Often, families have been informed that cow’s milk promotes growth and weight gain in infants–including by Abbott Laboratories and Mead Johnson & Company, LLC. Sometimes, that’s true. However, it’s not always the case, and, as shown by the scientific studies referenced above, cow-based baby formulas can cause severe, life-threatening complications for preterm and underweight infants.
Scientific research on this topic goes back to 1990. That’s when a study published in the journal Medical Science reported that in 926 preterm babies fed formula alongside breast milk, 5.5% developed NEC, while preterm babies who exclusively fed a formula-based diet were 6 to 10 times likely to be diagnosed with NEC and 3 times more likely than infants who fed cow’s milk formula and breast milk.
That scientific study was published more than 30 years ago, and still, baby formula makers aren’t adequately warning the public about the dangers of NEC related to baby formula products like Enfamil and Similac, which are commonly fed to preterm babies and infants born with low birth weights.
Sadly, at this point, it’s safe to assume that these companies aren’t warning the public about the potential severe and life-threatening complications associated with their baby formulas because they prioritize making profits over the health and vitality of infants. If baby formula manufacturers disclosed that their products might be fatal, parents and health providers would stop giving them to preterm babies and infants with low birth weights. That would cause significant revenue losses, and unfortunately, many companies care more about making profits than about the loss of life.
Settlement Amounts in NEC Lawsuits: Factors Affecting Compensation
Data from recent successful NEC lawsuits show that the average total award for an NEC baby formula lawsuit is $3.5 million. However, this doesn’t mean you’ll receive this exact amount when you file an NEC claim. Many factors often determine the amount of NEC formula lawsuit settlements you may be entitled to, including:
- Medical treatment and the severity of the injury your child suffered. The seriousness of NEC injury, total surgeries required, documented permanent health complications, and additional medical treatments are all vital in determining your settlement amount.
- Medical documents: Comprehensive medical records, compelling expert testimonies linking baby formula to NEC, clear timelines of when formula was administered, and verified hospital feeding protocol compliance also play a vital role in determining the amount you receive.
- Financial impact assessment: Combined past and current medical costs, total lost income while providing care to your child, and other family direct expenses all influence the amount awarded.
- Lawsuit classification and history: Individual NEC lawsuit merits vs. group litigation benefits, outcomes of similar lawsuits, current compensation patterns, and general evidence showing baby formula manufacturers’ responsibility are also crucial.
Further, the jury also plays a pivotal role in establishing how much the NEC formula lawsuit settlement amount you should receive. In addition, it’s imperative to note that your lawsuit might be worth more than the average settlement mentioned above, particularly if your baby sustained more severe injuries. For example, if the NEC complication causes permanent brain damage, the jury may award you a larger settlement due to the lasting impact of such a health complication.
Suppose your premature baby developed complications after feeding on baby formula. In that case, you need to talk with an experienced product liability lawyer as soon as possible to establish if you have valid grounds to pursue legal action against formula manufacturers.
Legal Strategies in NEC Baby Formula Cases
Building an effective NEC lawsuit demands proving clear causation between dangerous baby formulas and a premature baby’s or an underweight baby’s NEC diagnosis. This often involves coordinating product liability elements with possible medical malpractice aspects, especially when medical providers fail to recognize early warning signs.
Medical documentation must prove this connection, often via analysis that determines if misdiagnosis or delayed medical treatment contributed to the seriousness of the injury.
All that may seem complicated. However, hiring a skilled NEC baby formula attorney can help you through this complicated legal process.
A qualified NEC baby formula lawyer can:
- Review your unique circumstances and determine if pursuing an individual lawsuit or joining the existing NEC baby formula MDL is the best legal option.
- Establish a fair compensation amount based on your unique situation and similar lawsuits.
- Handle all communications with formula manufacturers and their attorneys.
- Meet strict statute of limitations or legal filing deadlines. Timing is vital in NEC lawsuits. Although most states allow two to three years from the date of complication discovery to file a product liability lawsuit, special regulations often apply to lawsuits involving babies. These exceptions might extend deadlines until the child is 18. However, families pursuing wrongful death or medical malpractice lawsuits usually face shorter time frames.
By waiting to file a claim you risk losing vital evidence and possibly missing opportunities to join the existing MDL. Thankfully, speaking with an experienced NEC infant formula attorney as soon as possible may help you maintain all options to recover compensation while the evidence remains fresh.
Manufacturer Responses to NEC Allegations
A fundamental issue in the NEC baby formula lawsuits is whether baby formula makers have to warn consumers directly about the potential dangers linked to their products. This issue focuses on corporate responsibility and public rights in neonatal care.
The manufacturers argue that since their formulas are used under doctor supervision, they should be treated like prescription drugs. In such instances, healthcare providers are often given warnings rather than consumers. That principle is called the “learned intermediary doctrine,” the foundation of their legal defense.
But this argument has been challenged in courts. In three lawsuits, courts have rejected the argument of the learned intermediary doctrine regarding baby formula. One judge rejected the reasoning behind this argument, saying that baby formula isn’t a recognized prescription drug or medical device.
That interpretation could have significant implications in the baby formula industry. If sustained, formula manufacturers will have to communicate potential dangers directly to consumers, possibly altering the dynamics of decision-making in neonatal care.
Future Outlook for NEC Baby Formula Litigation
More parents are still joining the NEC baby formula litigation as they discover the link between infant formula and NEC through their own traumatic experiences. Judges have established special procedures to manage these complicated lawsuits effectively and medical experts continue to strengthen the evidence connecting infant formula consumption to NEC diagnosis. Baby formula makers face mounting pressure to explain their failure to warn the public about the known dangers of their products.
Although some NEC infant formula trials and verdicts have resulted in wins for the defendants, many have validated the link between formula consumption and NEC in premature babies and babies born with low birth weights. These positive outcomes have encouraged more parents to file NEC lawsuits to seek justice for their affected children.
As litigation continues, it may facilitate changes in how formula manufacturers communicate known risks, how healthcare providers approach feeding protocols for premature and underweight babies, and how medical professionals balance formula with human milk in neonatal care. The outcomes of these NEC formula lawsuits could mark a crucial turning point in the ongoing efforts to reduce the incidence of NEC and improve outcomes for premature babies.
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