Parents are filing lawsuits against baby formula manufacturers after their infants developed a serious condition called necrotizing enterocolitis (NEC). NEC affects mainly preterm babies and can cause serious consequences or be fatal. Parents of children with NEC are taking legal action against the makers of Enfamil, Similac, and other formula brands. These lawsuits allege that cow’s-milk-based formulas caused their infants to develop NEC.
NEC lawsuits have been consolidated into a multidistrict litigation. This group lawsuit has been joined by thousands of parents who want to hold baby formula manufacturers liable for the injuries their formulas caused. These lawsuits accuse Abbott Laboratories, Reckitt Benckiser, and other manufacturers of not properly disclosing the potentially dangerous side effects of cow’s milk-based infant formula.
Parents whose babies experienced necrotizing enterocolitis (NEC) after being fed cow’s milk-based formula say they were not properly warned about this dangerous side effect by baby formula manufacturers. After developing NEC, many infants became severely sick or passed away. In an effort to gain compensation for these unimaginable losses, parents are filing necrotizing enterocolitis baby formula lawsuits.
NEC Baby Formula Lawsuit Updates
May 15, 2025: Arizona Parents File NEC Lawsuit Against Abbott After Death of Newborn
Two parents in Arizona have sued Abbott Laboratories, which manufactures Similac. Marina and Shen Seiken’s premature baby, K.S., was given Similac Special Care formula. K.S. developed necrotizing enterocolitis and sepsis and underwent aggressive treatments for several days after eating Similac. Sadly, K.S. died in the hospital. Marina and Shen filed a lawsuit against Abbott to hold it accountable for not warning parents about the dangers of Similac products.
May 5, 2025: First Bellwether Trial in NEC Lawsuit Dismissed, But Expert Witnesses and MDL Move Forward
The judge overseeing the NEC baby formula lawsuits has dismissed the first bellwether trial in the multidistrict litigation (MDL). Bellwether trials are “test trials” that establish facts for the case and often predict how future lawsuits in a group litigation will be decided. U.S. District Judge Rebecca Pallmeyer dismissed the lawsuit of RaiLee Mar, whose infant child died of necrotizing enterocolitis (NEC) after consuming formula made by Abbott. Judge Pallmeyer said Mar’s attorneys did not make a strong enough case to support the lawsuit moving forward. The judge said Mar’s attorneys failed to show that Abbot’s failure to warn doctors or families about NEC and formula usage caused the child’s death. Similarly, the judge said Mar’s attorneys failed to show there was a reasonable alternative way for the formula to be made. Although this is difficult news for Mar and her family, Judge Pallmeyer said the expert witnesses for the plaintiff would be allowed to testify in future trials. There are more than 700 cases in this MDL, so being able to retain expert witnesses is positive news for many plaintiffs. Parents can still file lawsuits on behalf of infants diagnosed with NEC. Many attorneys remain optimistic about the future of this litigation.
May 1, 2025: Parents File Lawsuit Over Child Who Developed NEC After Consuming Similac
Parents in Arizona have filed a lawsuit against Abbott Laboratories after their child, T.G.Z., developed necrotizing enterocolitis (NEC). T.G.Z. was fed Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid (Similac Human Milk Fortifier) made by Abbott. Although T.G.Z. survived, the infant sustained severe and lifelong injuries. The lawsuit, filed by Plaintiffs Melanie and Jennifer Gibson-Zuverink, alleges that the Similac cow-milk-based nutritional supplement is what led their child to develop NEC. They are seeking a number of damages related to their child’s injuries.
April 18, 2025: Nearly 700 Cases Ongoing in Federal NEC Baby Formula MDL
As of April 1, 2025, there are 683 active lawsuits in the federal litigation against Abbott Laboratories, Reckitt Benckiser, and other baby formula manufacturers. In these cases, plaintiffs—parents of preterm babies who got sick or died—accuse baby formula manufacturers of failing to warn medical providers and parents of the risks of giving their baby cow’s milk-based formula. Parents and their legal teams point to a body of medical research showing that premature babies who are fed cow’s milk-based formula have a significantly higher chance of developing necrotizing enterocolitis. The baby formula manufacturers deny liability, and the lawsuits against them are ongoing.
March 14, 2025: Judge Orders a New Trial in Baby Formula Lawsuit Against Abbott and Reckitt
Kaine Whitfield’s family will get to re-try their baby formula lawsuit. In 2024, Abbott and Reckitt won a verdict in their favor in a lawsuit claiming cow’s milk-based formula manufactured by these companies caused Kaine to develop necrotizing enterocolitis. The family appealed the verdict, claiming Abbott’s attorneys did not follow the trial judge’s instructions about what was and was not appropriate to say to the jury. The appeals judge agreed with Chance’s family and sent the case back for a new trial.
July 26, 2024: Missouri Jury Requires Baby Formula Maker Abbott Laboratories To Pay $495 Million in Necrotizing Enterocolitis Case
Margo Gill’s daughter, Robynn, developed necrotizing enterocolitis shortly after being given Abbott’s Similac baby formula while in an intensive care unit. While Margo’s daughter survived the severe illness, which has a very high mortality rate, she has a lifelong disability from it. Margo’s attorneys believe Abbott was aware of the risks, which have been studied since the 1990s, but failed to pass this knowledge onto parents and their care teams. A jury ruled in favor of the family, and Abbott will have to pay the family $95 million and pay $400 million in punitive damages.
March 15, 2024: Mead Johnson (Reckitt Benckiser) To Pay $60 Million to Illinois Family of Baby Who Died from Formula-Induced Necrotizing Enterocolitis
The family of Chance Dean, who was born prematurely and died due to complications from necrotizing enterocolitis, won their jury trial in Illinois. They credited Mead Johnson’s (part of Reckitt Benckiser) baby formula, Enfamil, for causing Chance to develop necrotizing enterocolitis. Lawyers representing Chance’s family cited multiple studies showing cow’s milk-based formula, like Enfamil, increases a premature baby’s risk of having necrotizing enterocolitis. An Illinois jury awarded Chance’s family $60 million in compensatory damages.
July 6, 2022: Study Shows Abbott’s Similac SpecialCare Baby Formula Increases Risk of Intestinal Diseases in Preterm Babies
A research article published in Frontiers of Pediatrics discovered that some baby food formulas have a higher risk profile for a preterm baby’s gut health than others. Specifically, the authors noted that Abbott Laboratories’ Similac SpecialCare resulted in a higher rate of intestinal injuries, such as necrotizing enterocolitis, compared to breast milk or other baby formulas. Of note, the researchers said, “[T]he use of formula in preterm infants is not benign, as formula feeding is an important risk factor for NEC.”
About the NEC Baby Formula Lawsuit:
Types of NEC (Necrotizing Enterocolitis)
How Does Baby Formula Cause NEC?
What Are the NEC Infant Formula Claims?
What Are NEC Baby Formula Symptoms?
Studies Link NEC to Cow’s Milk-Based Formula
Who Can File a NEC Baby Formula Lawsuit?
How to File a NEC Baby Formula Lawsuit
NEC Baby Formula Lawsuit Statute of Limitations
NEC Baby Formula Lawsuit Payout and Settlement Amounts
King Law Is Accepting NEC Baby Formula Cases
What Is NEC In Babies?
Necrotizing enterocolitis occurs when a baby’s intestines become inflamed, leading to an infection that can cause tissue death or breakage in the intestinal wall. Necrotizing enterocolitis can harm a baby’s colon and intestine, and cause sepsis (an improper reaction to infection). A baby with necrotizing enterocolitis (NEC) has a 10 to 50% chance of surviving this condition. However, almost all babies who experience perforation, peritonitis, and sepsis from NEC pass away.
All babies can potentially get necrotizing enterocolitis. However, babies who are born premature or who have a low birth weight have a higher chance of developing the condition. About 1 in 1,000 premature babies develop NEC. Babies with very low birth weight (VLBW) have a 7% chance of developing NEC. Infants can recover from NEC, especially if it is diagnosed early.
NEC and Baby Formula
A growing body of research suggests baby infant formulas like Similac and Enfamil, which are both cow’s milk-based, increase a baby’s risk of developing NEC. Cow-milk-based formulas may lead to inflammation and be harder for infants to break down in their intestines. Babies with low birth weight who consume infant formula are much more likely to develop NEC.
Types of NEC (Necrotizing Enterocolitis)
There are several different types of necrotizing enterocolitis (NEC), each of which has various symptoms and outcomes. Doctors classify forms of necrotizing enterocolitis based on their severity and potential cause. Triggers of necrotizing enterocolitis include being fed baby formula, a lack of oxygen, an underdeveloped intestine, and different viral or bacterial infections.
Classic NEC
Classic necrotizing enterocolitis (NEC) is the most common type of NEC in preterm babies (babies born before 28 weeks of pregnancy). Typically, a baby will develop this condition two to six weeks after being born.
Atypical NEC (Term NEC)
Atypical or term necrotizing enterocolitis impacts infants who were born around their due date. Babies with atypical necrotizing enterocolitis may have coexisting conditions, like a heart condition, sepsis, or asphyxia (lack of oxygen). Symptoms may surface within a week after a full-term baby is born. Fewer than 10% of infants diagnosed with NEC are considered full-term.
Transfusion-Associated NEC
Transfusion-associated necrotizing enterocolitis occurs within 48 hours of when a baby receives a blood transfusion. Some believe that the timing of when a baby eats before or after receiving a transfusion may play a role in whether they develop necrotizing enterocolitis.
Spontaneous Intestinal Perforation (SIP)
The symptoms of necrotizing enterocolitis are similar to spontaneous intestinal perforation, which occurs when a baby has a tear in their intestines. A spontaneous intestinal perforation can become infected and cause inflammation. Babies who were born with a low birth weight have a better chance of surviving spontaneous intestinal perforation than they do necrotizing enterocolitis.
How Does Baby Formula Cause NEC?
Cow’s milk-based baby formula can increase a premature baby’s chance of getting necrotizing enterocolitis (NEC) for several reasons. Formula, as opposed to breast milk, has a higher risk of disrupting the baby’s gut health. Additionally, cow’s milk can encourage inflammation of the gut, which can lead to an infection that can cause necrotizing enterocolitis.
Immature Digestive System and Inflammatory Response
When an infant is born, their gut (digestive tract) is not fully developed yet, especially if they are preterm or have a low birth weight. Because of this, their system has a hard time digesting food and battling infections. Cow’s milk-based formula has a host of processed ingredients that are difficult for the infant’s system to break down and use. As a result, the gut (intestines) can become inflamed and infected, which can lead to necrotizing enterocolitis.
Disruption of Gut Bacteria (Microbiome)
The bacteria in cow’s milk-based formula are much different than those in breast milk. Breast milk has protective and healthy bacteria in terms of the types and quantity. This supports a baby’s gut microbiome—the variety of bacteria in their gut—so it grows stronger and protects the baby’s system.
In contrast, cow’s milk-based formula contains different bacteria and lacks the same protective bacteria that human milk does. Because of this, a preterm baby’s system may grow too much of one type of bacteria, resulting in an infection that includes inflammation that tears the intestines or colon.
Lack of Protective Antibodies and Nutrients
Human milk contains a host of protective antibodies—cells used to fight off an infection—and nutrients that are essential for a baby to grow stronger and stay healthy. Babies depend on this boost from their mother’s milk to encourage healthy bacteria in their gut and the antibodies they need to reduce inflammation.
Cow’s milk-based formula does not have the same antibody or nutritional profile as breast milk, which puts some babies at risk. Their systems may not have the tools they need to keep infections away and protect themselves against necrotizing enterocolitis (NEC).
Increased Gut Permeability
Preterm babies who are fed formula have a higher chance of developing a leaky gut because their system does not have the bacteria it needs to strengthen their intestinal walls. So, their bodies cannot consistently keep bacteria from getting into their bloodstream. This increases the chance of infection, such as sepsis, and inflammation, which are risk factors for necrotizing enterocolitis.
Osmolality and Digestion Issues
Osmolality is how concentrated a liquid is; in other words, its water-to-ingredients ratio. If the formula has a high concentration (osmolality) level, it can disrupt a baby’s gut functions and take water from other parts of their body. Then, the rest of their gut and organs, like their kidneys, can become inflamed and infected, opening the door to necrotizing enterocolitis. The mother’s breast milk, in contrast, has a balanced osmolality and is less likely to have a dangerous concentration level.
Which Formulas Cause NEC?
Potentially, any baby formula can cause necrotizing enterocolitis. However, there are specific manufacturers whose formulas have been linked to an increased risk of this condition. For example, in 2024, Abbott Laboratories paid a $495 million verdict because its specialty Similac formula caused a preterm infant girl to develop necrotizing enterocolitis and permanent brain damage.
Similac (Abbott Laboratories)
Abbott has faced penalties in recent years because babies are getting hurt or dying due to complications from NEF after being fed Similac formulas. In particular, the following Similac products are some of the culprits:
- Similac Advance
- Similac Alimentum
- Similac Human Milk Fortifier
- Similac NeoSure
- Similac Special Care
Studies have found that some of these Similac formulas have an increased risk of harming pre-term babies, especially if the babies are not given enough breast milk. Some of these formulas are explicitly marketed towards pre-term and vulnerable babies, putting them at greater risk of harm or death.
Enfamil (Mead Johnson/Reckitt Benckiser)
Reckitt Benckiser’s Enfamil has also been accused of causing babies to develop necrotizing enterocolitis (NEC). Here are some of the Enfamil formulas at issue:
- Enfamil 24 Cal
- Enfamil Human Milk Fortifier
- Enfamil NeuroPro EnfaCare
- Enfamil Premature
In 2024, an Illinois jury awarded $60 to a family who sued Reckitt Benckiser after their infant drank Enfamil and died because of necrotizing enterocolitis. The family accused Reckitt Benckiser of not warning the public about the increased risk of babies developing necrotizing enterocolitis. The Illinois jury agreed with the family.
What Are the NEC Infant Formula Claims?
The parents of prematurely born babies are suing infant formula manufacturers whose products are linked to NEC and infant injuries and death. Some of the claims being brought against the manufacturers include failure to warn, misrepresenting the research about their products, and negligent or misleading marketing.
Allegation #1: Failure to Warn
One of the claims being made against formula manufacturers is that they did not warn the doctors, parents, or hospitals that their formulas increased the risks of premature infants developing necrotizing enterocolitis (NEC). Many believe the manufacturers had access to internal data and research about these risks, but they did not alert the public about these warnings. Instead, manufacturers like Abbott and Reckitt continued to encourage people to feed these cow’s milk-based formulas to premature babies.
Allegation #2: Defective Product Design
Parents and others also believe cow’s milk-based formulas are inherently dangerous for one of the populations they are marketed for—premature babies. Studies show that the ingredients and lack of protective bacteria and antibodies in formula can harm a baby’s gut health and drive necrotizing enterocolitis. Even still, the manufacturers specifically marketed these products as safe and preferable alternatives to breast milk for preterm babies, which research shows is untrue.
Allegation #3: Negligent Marketing
Many are speaking out against what they say were misleading and negligent marketing practices by the baby formula companies. For years, companies like Abbott have insisted that their products are safe, specialized, and even preferred alternatives to breast milk. They have claimed their special formulas can help preterm babies get the kick-start they would typically get from their mother’s milk. However, reports reveal that these messages were misleading and inaccurate, putting many preterm babies at risk without their parents’ knowledge.
Allegation #4: Breach of Warranty
Parents and others also accuse baby formula manufacturers of breaching their warranties (promises) to the public. Baby formula labels and marketing suggest the formulations are safe and healthy for preterm infants. However, time-tested research shows this is not entirely true. For example, a study showed a three to 10 times higher risk of infants developing necrotizing enterocolitis when they have just formula or a blend of formula and breast milk compared to those fed breast milk alone.
Allegation #5: Scientific Misrepresentation
Parents and others have evidence that formula manufacturers dismissed or downplayed research linking formula to necrotizing enterocolitis (NEC) in preterm infants. For example, a study revealed that only a small percentage of extremely premature babies developed necrotizing enterocolitis if they were exclusively fed human milk. Legal advocates and parents believe the manufacturers misrepresented the science on breastfeeding versus formula feeds, and they believe this misrepresentation constitutes fraud or negligence.
What Are NEC Baby Formula Symptoms?
The symptoms of necrotizing enterocolitis may appear rapidly, and they are most likely to show up within the first six weeks of a baby’s life. Typically, these symptoms arise after a baby is fed cow’s milk-based formulas or fortifiers, such as those offered by the Similac and Enfamil brands. Symptoms may seem mild at first, but the baby’s health can rapidly deteriorate. Because of this, it is essential for parents and medical providers to recognize and respond to necrotizing enterocolitis early on.
Gastrointestinal Symptoms
The most common symptoms of necrotizing enterocolitis are gastrointestinal symptoms. These symptoms might include the following:
- A swollen, bloating, stiff, or discolored belly
- Refusing to eat or not being able to keep food down
- Bloody, runny, or dark stool
- Discolored vomit (usually, green or yellow)
- Pain in the belly (baby cries when someone touches their belly)
The symptoms may appear without warning and can progress rapidly, especially with continued feeding of the problematic formula.
Behavioral and Physical Changes in Infants
A baby with necrotizing enterocolitis may also experience changes in their behavior and appearance. For example, an infant with necrotizing enterocolitis may show the following signs:
- Appear tired or have a marked decrease in activity
- Little to no bowel movements
- Increased irritability (crying or fussing more than usual)
- Noticeable temperature changes (like rapidly becoming too hot, then too cold)
- The intestines may become visible through the baby’s skin
The baby may also experience breathing issues or problems with moving blood throughout their body. Because premature babies are most at risk for developing necrotizing enterocolitis, these changes can be especially taxing on the baby’s underdeveloped systems.
Severe Side Effects and Symptoms
Babies with necrotizing enterocolitis may also experience the following severe or advanced symptoms:
- Irregular and sporadic breathing
- Low heart rate
- Drop in blood pressure
- Discoloration of the belly
- Sepsis or shock (e.g., cold limbs, rapid breathing, and weak pulse)
Severe symptoms of necrotizing enterocolitis can become life-threatening, so it is essential to act quickly when a baby starts to show these signs.
Studies Link NEC to Cow’s Milk-Based Formula
The scientific awareness about the dangers of feeding infants and preterm babies non-human milk continues to increase. Since the 1990s, research has shown that premature babies who are fed strictly breast milk or donor milk have an extremely low chance of developing necrotizing enterocolitis. Many more studies have now confirmed these findings, and baby formula companies are under fire for potentially misleading the public about the risks of their products.
AAP Review Found Formula Increased Risk of NEC Almost Threefold
In 2022, the American Academy of Pediatrics published a review of the current understanding of health outcomes for babies fed formula versus their mothers’ milk. There were over 89,000 infants involved in the final review of 42 qualifying studies.
The research revealed that premature babies who were fed formula were 2.99 times more likely to develop necrotizing enterocolitis versus their peers who were fed only their mother’s breast milk. These findings highlight the need for increased transparency about how food choice affects premature babies’ outcomes.
Johns Hopkins Research Shows Breastfed Preemies Have Lower Rates of Developing NEC
A Johns Hopkins research study also found that premature babies are much less likely to develop necrotizing enterocolitis if they are fed donor breast milk instead of infant formula milk. The study looked at the outcomes for 53 extremely premature babies.
29 infants were fed exclusively breast milk, and only one of these infants developed necrotizing enterocolitis. The condition did not become severe, and the baby made a full recovery without needing surgery. In contrast, 24 babies had been fed formula, five of them developed necrotizing enterocolitis, and four of the ones who developed necrotizing enterocolitis required surgery. The researchers concluded that these findings justified a shift in protocols to feed extremely premature babies exclusively breast milk rather than formula.
Nature Pediatric Research Study Shows Increased Risk of NEC in Cow-Based Formulas
A 2011 Nature Pediatric research study also found that premature infants fed a cow’s milk-based formula had an increased chance of necrotizing enterocolitis and sepsis compared to their peers who were fed breast milk. The results from this publication are supportive of many other studies showing poor outcomes for premature babies who are given cow’s milk-based formula. Breastfeeding and breast milk (even if it is donor human milk) remain the safest feeding option for preterm babies.
Who Can File a NEC Baby Formula Lawsuit?
Parents whose babies developed necrotizing enterocolitis may qualify to file a lawsuit against baby formula manufacturers if their child:
- Child was born on or after 1/1/2006 and born prematurely
- Child was given formula or milk fortifier with cow’s milk as an ingredient
- Child was diagnosed with one or more of the following:
- Necrotizing enterocolitis (NEC)
- Short bowel syndrome (SBS) as a result of surgery to treat infection
- A gastrointestinal issue requiring surgery to treat an infection or remove any intestines
It is common for parents not to know their child was given cow’s milk-based formula while at the hospital. Additionally, medical providers do not always understand or explain to parents the risks of providing a pre-term baby cow’s milk-based formula. If you think you may meet these eligibility criteria, contact an attorney as soon as possible to protect your legal rights and receive guidance on tracking down this information.
How to File a NEC Baby Formula Lawsuit
Suing the baby formula manufacturers because of the pain and trauma you, your baby, and your family have gone through may bring you validation and compensation you need to begin healing. Here are some of the steps involved in filing a claim because your baby was fed formula and developed necrotizing enterocolitis:
- Step 1: You have a consultation with an attorney and discover if you and your family have a claim against a baby formula manufacturer.
- Step 2: You hire an attorney to help you write and file the complaint and other legal documents.
- Step 3: Your lawyer requests information from the baby formula manufacturers and develops a strong legal case.
- Step 4: Your attorney negotiates a settlement with the company that made the dangerous baby formula.
- Step 5: You receive a settlement or go to trial to seek a full and fair verdict for your damages.
King Law has the resources to help you with the steps involved in suing a baby formula manufacturer for harming your infant. We are available to provide a free case review and assist you with the entire legal process.
NEC Baby Formula Lawsuit Statute of Limitations
The statute of limitations (filing deadlines) for filing necrotizing enterocolitis lawsuits against baby formula manufacturers depend on several factors. States have their own rules about when people need to file different types of claims. And, many states have exceptions when the victim is under 18. A qualified attorney is best-positioned to help you understand what your deadlines are in your situation.
NEC Baby Formula Lawsuit Payout and Settlement Amounts
Individual settlements for necrotizing enterocolitis may reach $45,000 to $600,000 or more in some successful cases. How much someone receives is decided on a case-by-case basis, and it depends on factors like the baby’s medical care costs, the severity of their necrotizing enterocolitis, and the long-term consequences of the condition.
King Law Is Accepting NEC Baby Formula Cases
King Law is accepting baby formula cases where an infant developed necrotizing enterocolitis (NEC) after being fed cow’s milk-based baby products. Our legal team can gather information about your case and arrange an appointment with an experienced lawyer.
We do not charge our clients any up-front legal fees to handle their lawsuits. Instead, we only get paid if we win your case for you.
Contact a NEC Baby Formula Lawyer Today
If your baby was given cow’s milk-based formula and developed necrotizing enterocolitis or short bowel syndrome, you may be entitled to compensation from the baby formula manufacturers. Our law firm can fight for you and your family in a lawsuit against those who are responsible for what happened to your child.
King Law provides personalized recommendations and a customized legal strategy to its clients. We are available to take your call and help you take this next step. Reach out to us today by calling (585) 496-2648 to seek the compensation you may be entitled to.