Hundreds of families are seeking justice and compensation against Abbott Laboratories and Mead Johnson, makers of Similac and Enfamil, respectively. They claim the infant formula makers failed to warn parents and healthcare providers about the potential risks associated with their cow's milk-based formulas.
Specifically, premature infants across the United States have developed necrotizing enterocolitis (NEC), a devastating and potentially life-threatening gastrointestinal condition, after consuming these products. If your premature infant developed NEC after receiving baby formula in the hospital, you may recover compensation through an NEC baby formula lawsuit.
This isn't just a legal battle—it's a fight for the most vulnerable among us. Families are demanding answers, accountability, and justice for the unimaginable suffering their tiny fighters have endured. As the lawsuits unfold, they reveal a web of questions about product safety, corporate responsibility, and the true cost of cutting corners when it comes to infant health.
If your premature infant developed NEC after consuming baby formula, it's crucial to consult an experienced attorney. A skilled lawyer can evaluate your case, help you understand your legal options, and guide you through the complex process of seeking compensation for your child's injuries and your family's losses. Reach out to an NEC baby formula lawsuit lawyer.
What Is Necrotizing Enterocolitis?
Necrotizing enterocolitis is a severe gastrointestinal condition that primarily affects premature infants, typically those born before 37 weeks of gestation.
This distressing disease usually manifests within a few days to weeks after birth and occurs when bacteria invade the wall of the intestines. In more severe cases, the intestinal tissue becomes inflamed and can perforate, allowing bacteria and other substances to leak into the abdominal cavity or bloodstream.
The diagnosis of NEC is particularly frightening for parents of premature infants, given the vulnerability of these tiny patients. Treatment for NEC is intensive and often involves stopping all regular feedings, administering nutrients intravenously, and inserting a nasogastric tube to suction fluids from the stomach.
Antibiotics are given to combat the infection, and frequent X-rays are performed to monitor the disease's progression.
In many cases, additional supportive care, such as extra oxygen or mechanical ventilation, may be required. While necessary, these life-saving interventions can significantly affect the crucial bonding time between parents and their newborns.
While many cases of NEC can be resolved with medical management, severe instances may require more drastic measures. Approximately 30% of babies diagnosed with NEC need surgery to remove damaged portions of the intestines. The condition can kill babies, with a mortality rate of 20-30%. Among survivors, about half face long-term complications.
NEC Complications
While some infants who develop NEC recover fully with proper treatment, many survivors face significant long-term health challenges. These complications can harm a child's growth, development, and quality of life.
Common long-term complications of NEC include:
- Short bowel syndrome: This condition occurs when a significant portion of the intestine has been removed due to NEC, leading to malabsorption issues and nutritional deficiencies.
- Poor growth and malnutrition: Damage to the intestines can impair nutrient absorption, potentially resulting in stunted growth and ongoing nutritional challenges.
- Parenteral nutrition-associated cholestasis and liver dysfunction: Extended reliance on intravenous feeding can lead to liver problems, including cholestasis (reduced bile flow).
- Metabolic bone disease: Nutritional deficiencies and other factors related to NEC and its treatment can affect bone development and strength.
- Recurrent sepsis or severe infections: Damage to the intestinal barrier can increase vulnerability to future infections.
- Neurocognitive impairment: The physiological stress of NEC and associated treatments may contribute to developmental delays or cognitive issues.
For families dealing with these challenges, ongoing medical care, specialized nutritional support, and developmental interventions may be necessary.
Types of NEC
NEC can manifest in different forms, varying in severity and presentation. Generally, it's classified into three main categories:
Medical NEC
This is the most common and least severe form of NEC. It can often be managed with conservative medical treatment without the need for surgical intervention. Symptoms may include abdominal distension, feeding intolerance, and bloody stools. Treatment typically involves stopping oral feedings, administering antibiotics, and providing supportive care.
Surgical NEC
In more severe cases, surgical intervention becomes necessary. This occurs when there is evidence of intestinal perforation or the condition fails to improve with medical management alone. Surgical NEC often requires the removal of damaged portions of the intestine and may result in more long-term complications.
Atypical NEC
This less common form of NEC can occur in full-term or premature infants outside the typical time frame for NEC onset. It may be associated with other conditions, such as congenital heart defects or viral infections.
Additionally, some medical professionals further categorize NEC based on its progression:
- Stage I (Suspected NEC): Mild symptoms and non-specific signs.
- Stage II (Definite NEC): Clear radiographic evidence of NEC, often with pneumatosis intestinalis.
- Stage III (Advanced NEC): Severe NEC with systemic illness, often requiring surgical intervention.
Regardless of the type or stage, all forms of NEC are serious and require prompt medical attention.
NEC and Baby Formula. What is the Connection?
Scientific research has long examined the link between cow's milk-based baby formulas and necrotizing enterocolitis (NEC) in premature infants. Numerous studies have consistently shown that premature babies fed cow's milk-based formulas face a significantly higher risk of developing NEC compared to babies fed human breast milk.
A landmark study published in The Lancet in 1990 found that premature infants fed cow's milk-based formulas were 6 to 10 times more likely to develop NEC than babies exclusively fed breast milk.
Even babies receiving cow's milk-based formula as a supplement to breast milk showed a threefold increase in NEC risk. More recent research has further solidified this connection.
A meta-analysis of six studies involving 869 preterm infants, published in Advances in Nutrition in 2017, revealed a staggering 362% increased risk of NEC in infants fed cow's milk-based formula compared to those fed human breast milk.
The scientific evidence supporting this connection is so strong that in 2011, the U.S. Surgeon General issued a Call to Action supporting breastfeeding, specifically noting that formula feeding is associated with higher rates of NEC in vulnerable premature infants.
A 2020 study in Breastfeeding Medicine further emphasized this link, finding that premature babies fed cow's milk-derived formula had a 4.2-fold increased risk of NEC and a 5.1-fold increased risk of NEC surgery or death.
Despite this well-established body of evidence, manufacturers of popular cow's milk-based formulas like Enfamil and Similac have failed to adequately warn parents and healthcare professionals about the increased NEC risks their products pose to premature infants. This failure to warn forms the basis of many lawsuits against these companies, as families seek accountability for the harm caused to their vulnerable newborns.
Which Babies Are at Risk for NEC?
While necrotizing enterocolitis can affect any infant, certain groups are at significantly higher risk. Understanding these risk factors is crucial for parents and healthcare providers in managing the care of vulnerable newborns.
Premature infants are by far the most susceptible to NEC. Of the approximately 480,000 babies born prematurely (before 37 weeks gestation) each year in the United States, about 9,000 develop NEC.
The risk increases dramatically with lower birth weights and earlier gestational ages:
- Very-low-birthweight infants: Babies weighing less than 3.3 pounds (1.5 kg) are at the highest risk. The American Society of Nutrition reports that 5-12% of these infants develop NEC.
- Extremely low birth weight: For infants weighing less than 4.5 pounds (2 kg), the risk is even higher, with approximately 80% developing the disease.
- Degree of prematurity: The more premature the baby, the greater the risk. This correlation is likely due to the underdevelopment of the intestinal tract in these infants.
While prematurity is the most significant risk factor, with 90% of NEC cases occurring in premature infants, full-term and near-term babies are not entirely exempt from the risk.
Factors that may increase NEC risk in these infants include:
- Congenital heart defects
- Gastrointestinal abnormalities
- Polycythemia (high red blood cell count)
- Exposure to certain medications
The outcomes for babies who develop NEC can be severe. Among very-low-birthweight infants with NEC, 20-40% require surgery, and the mortality rate ranges from 25-50%.
Given these statistics, it's clear why premature infants fed formula made with cow's milk have become a serious concern. The increased risk of NEC associated with these formulas, particularly in already vulnerable premature babies, forms the basis of many current lawsuits against formula manufacturers. If your child developed NEC from premature infant formula or another form of cow's milk formula, contact Lawsuits.com to discuss your NEC baby formula case.
What Baby Formulas Are Affected?
NEC is linked to baby formulas and human milk fortifiers derived from cow's milk.
The two most common baby formula brands include:
Enfamil Baby Formula by Mead Johnson & Company
Baby formulas and human milk fortifiers derived from Cow's Milk include:
- Enfamil Human Milk Fortifier Acidified Liquid
- Enfamil Human Milk Fortifier Powder
- Enfacare Powder
- Enfamil Human Milk Fortifier Liquid High Protein
- Enfamil Milk Fortifier Liquid Standard Protein
- Enfamil NeuroPro Enfacare
- Enfamil Premature 20 Cal
- Enfamil Premature 24 Cal
- Enfamil Premature 24 Cal/fl oz HP
- Enfamil Premature 30 Cal
- Enfamil 24 and DHA & ARA Supplement
Similac Baby Formula by Abbott Laboratories
Infant formulas & human milk fortifiers derived from Cow's Milk include:
- Similac Alimentum
- Similac Alimentum Expert Care
- Similac Human Milk Fortifier
- Similac Human Milk Fortifier Concentrated Liquid
- Similac Human Milk Fortifier Hydrolyzed Protein- Concentrated Liquid
- Similac Human Milk Fortifier Powder
- Similac Liquid Protein Fortifier
- Similac NeoSure
- Similac Special Care
- Similac Special Care 20
- Similac Special Care 24
- Similac Special Care 24 High Protein
- Similac Special Care 30
Why Are People Filing NEC Infant Formula Lawsuits?
Parents are filing infant formula NEC lawsuits against major baby formula manufacturers, particularly Mead Johnson (maker of Enfamil) and Abbott Laboratories (maker of Similac), for failing to warn about the risks associated with their cow's milk-based formulas.
Despite decades of scientific research linking these formulas to an increased risk of necrotizing enterocolitis in premature infants, these companies have not included warnings on their products to alert parents or healthcare professionals about this potentially life-threatening condition.
The lawsuits allege that by withholding this crucial information, these companies have put vulnerable premature infants at unnecessary risk. Many families have endured significant financial losses due to extensive medical treatments, as well as profound emotional distress from watching their babies suffer or, in tragic cases, die from NEC.
Through these legal actions, parents are not only seeking compensation for their losses but also aiming to raise awareness about the potential dangers of cow's milk-based Enfamil premature infant formula or Similac formula for premature infants, hoping to prevent other families from experiencing similar tragedies.
What Is the Status of the NEC Baby Formula Lawsuits?
At Lawsuits.com, we strive to keep you informed about pending litigation so you understand your rights and options. Return to this page often for the most recent litigation updates related to the NEC baby formula multidistrict litigation.
May 1, 2025 - MDL Bellwether Trial Could Accelerate Settlement Talks
As of last month, there are 683 active lawsuits pending in the NEC Baby Formula multidistrict litigation (MDL 3026), centralized before Judge Rebecca Pallmeyer in the Northern District of Illinois. In addition, another 600 to 700 cases are proceeding through various state court systems, particularly in Illinois, Missouri, and Pennsylvania.
While the litigation has grown, it remains relatively streamlined compared to larger mass torts like the Johnson & Johnson Talcum Powder MDL, which now exceeds 58,000 pending claims. With a more manageable number of cases, the NEC baby formula MDL offers a more straightforward path to conducting bellwether trials, assessing damages, and negotiating global settlements. Legal experts note that, given the severity of the injuries alleged, individual settlement payouts in NEC cases may be higher than those typically seen in other mass torts.
Attention is now focused on the upcoming first federal bellwether trial, set for May 5, 2025, in Mar v. Abbott Laboratories. Although new case filings have slowed in recent weeks, many attorneys expect a surge of new claims once a jury verdict is reached, particularly if plaintiffs secure another win.
Recent verdicts strongly favor plaintiffs. Missouri and Illinois juries have already returned awards of $495 million and $60 million, respectively, in NEC-related cases. Moreover, the only defense verdict so far has been overturned due to trial misconduct, giving plaintiffs an undefeated record in NEC trials to date.
With settlement discussions quietly progressing, the results of the upcoming bellwether trial could have a significant impact on shaping future negotiations and determining how juries evaluate the link between cow’s milk-based infant formulas and the risk of necrotizing enterocolitis (NEC).
General NEC Baby Food Litigation Review
Since research unveiled the link between NEC and infant formula, parents of babies who developed NEC have filed lawsuits against Abbott and Mead Johnson in District Courts across the country.
While many cases were pending in state courts around the country, on April 8, 2022, the Judicial Panel on Multidistrict Litigation consolidated all federal lawsuits into an NEC Baby Formula multidistrict litigation (MDL 3026) in the Northern District of Illinois under Judge Rebecca Pallmeyer for coordinated discovery and pretrial proceedings. The purpose of the MDL is to organize federal lawsuits filed by families alleging that cow’s milk-based infant formulas—such as Similac and Enfamil—caused premature infants to develop necrotizing enterocolitis (NEC), a serious and potentially fatal intestinal disease.
Plaintiffs claim that manufacturers, including Abbott Laboratories and Mead Johnson & Company, failed to adequately warn doctors and parents about the heightened risks of NEC in premature babies fed their products.
Since then, the litigation has steadily built momentum. Discovery battles, expert witness preparation, and early bellwether selections helped shape the course of the MDL. By early 2025, the number of pending federal cases had grown to 683, with hundreds more active in state courts. Early state court trials resulted in substantial plaintiff verdicts, strengthening claims across the broader litigation.
With the first federal bellwether trial scheduled for May 5, 2025, the MDL is now entering a pivotal phase, with potential settlement talks gaining traction in the background.
Do I Qualify for an NEC Baby Formula Lawsuit?
You may file an NEC baby formula lawsuit if your situation meets the following criteria:
- Your baby was born prematurely (less than 37 weeks of gestation).
- Your infant was fed cow's milk-based Enfamil and/or Similac infant formula or human milk fortifier before being diagnosed with NEC.
- Your baby was diagnosed with necrotizing enterocolitis (NEC).
- Your child suffered at least one of the following complications:
- Intestinal perforation
- Scarring or strictures in the intestines
- Cerebral Palsy
- Neurological damage
- Sepsis
- Required resection surgery
- Death
If these conditions apply to your situation, you may have grounds for a lawsuit against the baby formula makers. Consult an experienced attorney who handles these cases to evaluate the specifics of your claim and guide you through the legal process.
Discuss Your Case with Experienced NEC Baby Formula Lawyers
If your premature baby developed necrotizing enterocolitis after being fed cow's milk formula, you may be entitled to compensation for the physical, emotional, and financial toll this devastating condition has taken on your family.
An experienced NEC baby formula lawyer knowledgeable in NEC baby formula lawsuits can help you in several ways:
- Evaluate your case to determine if you have grounds for a lawsuit
- Gather and analyze medical records and other relevant evidence
- Navigate the complex legal process on your behalf
- Negotiate with formula manufacturers and their legal teams
- Represent your interests in court if a settlement cannot be reached
- Ensure you receive fair compensation for medical expenses, lost wages, and pain and suffering
Don't face this challenging situation alone. Contact a qualified attorney today at 888-984-6195 or through the online form to discuss your case and explore your legal options. Your family deserves justice, and your actions could help prevent other premature infants from suffering similar harm in the future.