NEC Infant Formula Recall Lawsuit

The lawyers at Rueb Stoller Daniel law firm are representing parents of babies who were fed Enfamil or Similac formula and subsequently developed necrotizing enterocolitis in NEC infant formula recall lawsuits. If your family has suffered the horrible consequences of NEC, you have our sympathy, and we are ready to fight for your family to see the formula manufacturers are held responsible.

Often, premature babies are small and lack enough body fat, making it difficult for them to manage the suck, swallow and breathe coordination required for breastfeeding. This means they need another source of nutrition to provide the extra minerals and calories that they need. This is precisely why advanced infant formulas are manufactured.

Premature children have enough problems. Feeding your premature baby with infant formula should be a safe practice and not pose additional risks to such fragile infants. Unfortunately, studies have revealed that infant formulas made from cow milk put premature babies at an increased risk for a debilitating condition known as necrotizing enterocolitis (NEC).

A diagnosis of NEC (necrotizing enterocolitis) is not something any baby should be forced to endure. Children with NEC may need one or multiple surgeries to help them survive the symptoms, or they may not survive at all.

There exists reasonable evidence that manufacturers of formulas made explicitly for premature babies, namely Similac and Enfamil, were aware of the dangers and failed to advise health care providers or parents of premature babies about the potential risks.

If your family has suffered the devastating effects of NEC, contact our infant formula attorneys today at 1-866-CALL-RSD for a free case review. You may qualify for a NEC Lawsuit, we will get the justice and compensation you deserve.

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NEC Infant Formula Updates

June 2024:  Following two months of higher-than-average new case volumes, the NEC infant formula MDL saw a slight decrease in May, with only 18 new cases added, bringing the total pending cases to 514.

The first NEC baby formula test trial in the MDL is scheduled for May 5, 2025.

Additionally, a new lawsuit was filed on Friday. It alleges that a prematurely born infant at Rose Medical Center in Denver, Colorado, developed severe health complications after being fed cow’s milk-based products, including Enfamil Premature Infant Formula and Enfamil Human Milk Fortifier, shortly after birth on June 19, 2002.

May 2024: In April, forty-three new cases were added to the NEC preterm infant formula MDL, marking the second consecutive month of higher-than-average case volume. This brings the total number of pending cases to 496.

Many plaintiffs’ lawyers have been naming both defendants reflexively in NEC lawsuits. To address this, the MDL judge has issued a new case management order targeting the involvement of Mead Johnson & Company. The order stipulates that Mead Johnson should only be named in cases where there is clear evidence that the infant consumed their manufactured or distributed products, encouraging more precise identification of defendants.

April 2024: In the last month, the NEC preterm infant formula class action Multi-District Litigation (MDL) experienced a significant spike, registering 50 new cases—the largest monthly increase since the MDL began. The total pending cases have risen to 453, up from 342 at the start of the year.

March 2024: In a groundbreaking verdict from an Illinois state court, a jury awarded $60 million to the plaintiffs in a lawsuit involving Mead Johnson over its cow’s milk-based formula for premature infants. The lawsuit claimed that Mead Johnson failed to provide sufficient warnings about the risk of NEC (necrotizing enterocolitis), which led to the death of a child.

This case marks the first NEC failure-to-warn lawsuit to reach trial, setting a precedent in the ongoing litigation. Despite the plaintiffs’ lawyers initially seeking $25 million, the jury’s decision to award $60 million underscores the severity of the case and signals a major shift in awareness and accountability in similar legal actions.

March 2024: The NEC pre-term infant formula Multi-District Litigation (MDL) now encompasses a total of 405 active cases. This follows the addition of 16 new cases filed last month.

What Infant Formulas Increase the Risk of NEC?

Welcoming a newborn into this world should be a time of extreme excitement, joy, and enthusiasm. However, when a baby comes into this world prematurely, this joyous event may also be filled with fear, stress, and worry.

NEC (necrotizing enterocolitis) occurs in approximately 10% of all preemies born 37 weeks or earlier. And after numerous scientific and clinical studies, we now know that cow milk-based baby formulas – such as Enfamil and Similac – significantly increase the risk of premature babies developing necrotizing enterocolitis.

Yet, for years, there has been no warning on Enfamil or Similac infant formulas that their products might increase the risk of premature babies developing NEC.

A study conducted back in 1990 and published in The Lancet found that formula-fed premature infants were 6 to 10 times more likely to develop NEC.

Another study published in the Journal of Pediatrics revealed similar results and found that premature babies fed with human milk-based formulas or breast milk were 90% less likely to develop NEC compared to those fed with cow milk-based formulas.

Another study conducted by Cochrane in 2019 revealed that a premature infant on a cow milk-based infant formula diet had seven times higher rates of developing NEC.

What Infant Formula Companies Are Being Sued?

The product liability lawyers at Rueb Stoller Daniel are evaluating lawsuits against Abbot Laboratories Inc. (maker of Similac) and Mead Johnson Nutrition (makers of Enfamil).

Similac Lawsuit

The product liability lawyers at Rueb Stoller Daniel are evaluating NEC lawsuit against Abbot Laboratories Inc. (maker of Similac) for premature infants who developed NEC. The cow milk-based products for Similac include:

  • Similac Special Care 20
  • Similac Special Care 24
  • Similac Special Care 30
  • Similac NeoSure
  • Similac Liquid Protein Fortifier
  • Similac Alimentum Expert Care
  • Similac Special Care 24 High Protein

Enfamil Baby Formula Lawsuit

Our dedicated baby formula lawyers are also evaluating product liability claims against Mead Johnson Nutrition (makers of Enfamil) for parents who have babies with NEC. Specific cow milk-based Enfamil products include:

  • Enfamil NeuroPro EnfaCare Infant Formula
  • Enfamil 24 Cal Infant Formula
  • Enfamil Premature Infant Formula 24 Call with Iron
  • Enfamil Premature Infant Formula 24 Cal High Protein
  • Enfamil Premature Infant Formula 30 Cal with Iron

Why Are They Being Sued?

While numerous studies indicate the increased risk of NEC in premature infants on a cow milk-based formula, manufacturers of infant formulas failed to alert healthcare providers, parents, and consumers to the potentially debilitating consequences of nourishing premature babies with these formulas.

The claims against Abbot and Mead (the makers of Similac and Enfamil, respectively) allege that they were well aware of the scientific studies and evidence establishing that their cow milk-based infant formulas significantly increased the risk of NEC in preemies but defectively designed their infant formulas and failed to warn parents that their products increase the risk of NEC in infants.

Additionally, claims assert that Enfamil and Similac aggressively marketed their infant formulas as being equivalent to human breast milk while being fully aware of the increased risk of developing NEC in preterm babies.

Potential causes of action in claims against Similac and Enfamil in an infant formula NEC lawsuit include:

  • Negligence
  • Strict product liability (defective product)
  • Breach of warranty
  • Intentional misrepresentation
  • Failure to warn
  • Wrongful death (of a baby who passed away)

NEC infant formula recall lawsuit concept, formula in bottle

Contact us today at 1-866-CALL-RSD to start the claims process.

What Is Necrotizing Enterocolitis?

Necrotizing enterocolitis, also known as NEC, is a serious gastrointestinal/digestive disease that primarily occurs in premature babies – affecting 5-10% of premature infants. The risk of developing the disease increases the lower the infant’s birth weight is and the earlier they are born.

The disease can cause inflammation, destruction, and infection to intestinal tissue, causing rapid intestinal tissue decay and eventually killing the infant’s intestinal walls (necrosis).

Necrotizing enterocolitis is extremely dangerous to infants and has a mortality rate ranging from 10% to more than 50% in babies who weigh less than 1500 g.


There is no single consistent cause of NEC. In most cases, the real cause is not known. But experts in the health industry believe the following things might play a role:

  • Formula feeding (cow milk-based formula-fed babies are at higher risk)
  • Injury to the intestinal lining
  • A premature or underdeveloped intestine
  • Excess blood or oxygen flow to the intestine at birth or later
  • Significant bacterial growth in the intestine that erodes the intestinal wall
  • Bacterial or viral infection of the intestine


An infant with necrotizing enterocolitis may have the following symptoms:

  • Constipation
  • Apnea (pauses in breathing)
  • Trouble feeding
  • A red, swollen, or tender belly
  • Diarrhea and/or bloody or dark stool
  • Green vomit
  • An unstable or low body temperature
  • Slowed heart rate
  • Hypertension
  • Food staying in stomach too long

The symptoms of necrotizing enterocolitis can vary from infant to infant and can be similar to those caused by other digestive problems.


In infants with NEC, prompt diagnosis and treatment are vital and can prevent permanent damage and potentially save the child’s life. To diagnose necrotizing enterocolitis, a doctor may do the following:

  • Perform an abdominal X-ray to assess intestinal damage. The presence of abnormal gas patterns in the X-ray can be used to confirm an NEC diagnosis.
  • Gently feel the baby’s stomach to check for tenderness, pain, and swelling
  • Test stool to check for blood in the stool
  • Insert a needle in the infant’s belly to withdraw fluid see whether there’s intestinal fluid leaking indicating a hole in the intestine


After the diagnosis of NEC, treatment begins immediately. Treatment may involve:

  • Antibiotic treatment
  • Discontinuing oral feedings and using IV to provide nutrients
  • Oxygen support if the infant has difficulty breathing
  • Surgery to remove damaged or dead tissue and repair the intestine

Nurse holding sick baby, NEC infant formula lawsuit concept

How Do I Know If My Baby Has Been Affected?

While most infants who develop NEC recover fully after treatment and do not have further intestinal or feeding issues, if diagnosis and treatment are delayed, the baby can suffer permanent damage with severe long-term consequences and is also at risk of death.

Even a mild case of NEC can threaten the life of your newborn, so you want to make sure you detect the signs early. Watch out for the following signs to know if your child has been affected:

  • Abdominal swelling and pain
  • Diarrhea with bloody stool
  • Lethargy
  • Lack of weight gain and refusing to eat
  • Yellow or green vomit
  • Changes in blood pressure, heart rate, body temp, and breathing

How Can a Lawyer Help?

No parent should ever worry that the medicine, toys, and food they are giving their baby will affect their health or kill them. This is especially true for parents already dealing with a sick, fragile, and at-risk infant.

If your preterm baby suffered injuries, complications, or died because of NEC caused by Similac or Enfamil infant formula, you need the help of experienced lawyers who understand what it takes to hold the negligent party accountable.

Our skilled and compassionate NEC lawsuit lawyers are ready to fight for you and your baby. We are perfectly placed to fight on your behalf and help you recover fair compensation for the following cases:

Product Liability Action Against the Formula Manufacturer

Manufacturers of Enfamil and Similac have known the potential harm associated with cow milk-based infant formula for years. Yet, they failed to include any warning in their labeling. Our team of dedicated product liability lawyers is ready to go against these corporations responsible and fight for the fair compensation you deserve.

Medical Malpractice Suit Against a Hospital or Doctor

When it comes to NEC, prompt diagnosis and treatment are crucial and could be what saves your baby’s life. If your baby’s NEC was the result of a doctor’s or hospital’s negligence, you might be eligible to file a medical malpractice claim. The Rueb Stoller Daniel lawyers can help determine all liable parties and guide you through the claim process.

Find Out If You Qualify to File an NEC Lawsuit

If your child has suffered NEC or necrotizing enterocolitis after being fed Similac or Enfamil infant formula, we want to hear from you. Although no compensation can reverse the damage, it can hold the accountable party responsible and offset the financial burden of the situation.

It can be stressful and even next to impossible to fight large corporations on your own. But together with our experienced infant formula lawyers, we can! In the most difficult moment of your life, you deserve the best legal representation, and Rueb Stoller Daniel has your back.

Contact our law firm at 1-866-CALL-RSD to get started with a free case evaluation.