Enfamil Formula Lawsuit - Necrotizing Enterocolitis (NEC)

According to the CDC, about 10% of all babies born in the United States each year are considered preterm (born before 37 weeks gestation). Preterm babies can develop myriad health issues, many of which are linked to low birth weight. Some preterm babies struggle to get the nutrition they need because they are unable to breastfeed. , Many baby formula products have been developed to help preterm babies grow, including Enfamil. Sadly, a clear link between some cow’s milk-based formulas, including several in the Enfamil range, and the gastrointestinal disease necrotizing enterocolitis (NEC). A series of lawsuits have been filed against Mead Johnson & Company, the parent company of Enfamil, alleging that Enfamil producers knew the risks associated with their product and did nothing to warn families of preterm babies and healthcare professionals of the potential danger.

Studies linking NEC and products like Enfamil go back several decades. In 1990, the results of an important study were published in The Lancet (one of the world’s most important medical journals), showing that NEC was up to 10 times more common in formula-fed preterm babies than in those fed breastmilk. Several other studies carried out since then have reinforced the link between cow’s milk-based formulas and NEC. It’s impossible that Mead Johnson, the parent company of Enfamil, did not know about these studies. 

Experts don’t know exactly what causes NEC, although they can cite some theories and risk factors. It has been proven that preterm babies are much more likely to get NEC when fed Enfamil and similar products. The basis of the Enfamil lawsuits charge that Mead Johnson did not do enough to warn families, nor make any effort to mitigate the risk of NEC in preterm babies feeding on Enfamil products. 

NEC can be a devastating disease, attacking a baby’s intestinal tissues, sometimes leading to death. Bereaved families, and those who have seen their children injured by Enfamil, are seeking justice. Hundreds of Enfamil NEC lawsuits have been filed in American courts in recent years. It’s not too late to join the lawsuits against Mead Johnson. If your baby has been harmed by Enfamil, you can contact an Enfamil lawyer to start your claim for compensation.

April 1, 2025

Longitudinal fecal microbiota and volatile metabolomics preceding necrotizing enterocolitis in preterm infants.

February 1, 2025

Digging deeper into necrotizing enterocolitis: bridging clinical, microbial, and molecular perspectives.

• January 1, 2025 - Necrotizing Enterocolitis Treatment & Management
• December 1, 2024 - Hundreds of lawsuits allege Abbott Laboratories' formula for premature infants made babies sick. But is the formula to blame?
• November 1, 2024 - Closings Start Wednesday In Bellwether NEC Baby Formula Trial.
• October 1, 2024 - Trial Over Alleged Baby Formula Health Risks Begins Monday In Missouri.
• August 1, 2024 - Nutrition companies, parents clash in court over cause of infant intestinal disease. The companies say no published study's ever concluded their products cause NEC.
• July 1, 2024 - FDA Warning on Probiotics for Prevention of NEC Causes Shift in Care
• June 1, 2024 - Reckitt unit hit with $60 million verdict in Enfamil baby formula case in IL.
• May 1, 2024 - Minnesota mom claims baby formulas have a hidden risk. Hundreds of parents are suing, claiming formula makers failed to warn that premature infants fed cow's milk formulas were at higher risk for NEC, a devastating illness.
• April 1, 2024 - Mead Johnson, baby formula manufacturer, ordered to pay $60M to parents after they were found liable for putting preemies at increased deadly disease risk.
• March 1, 2024 - Why nationwide lawsuit alleging formula causes deadly disease in preemies is heading to Illinois.
• February 1, 2024 - Detecting NEC quickly saves premature babies.
• January 1, 2024 - Mead Johnson Nutrition Recalls Certain Batches Of Nutramigen Infant Formula Powder Due To A Possible Health Risk
• November 1, 2023 - FDA issues warnings about preterm infants probiotics.
• October 1, 2023 - Baby formula concerns rise - Companies including Perrigo, Byheart, and Reckitt/Mead Johnson are being investigated after the Food and Drug Administration revealed results from recent inspections.
• July 25, 2023 - UPMC Children's Hospital study looks to save pre-term babies through antibodies in breast milk.
• July 1, 2023 - Recall of 145000 cans Enfamil Prosobee Infant Formula.
• June 1, 2023 - FTC investigates Abbott and Baby Formula Makers for possible collusion.
• May 1, 2023 - FDA recalled contaminated Enfamil baby formula months after it was recalled.
• April 1, 2023 - Over 140,000 cans of Enfamil infant formula recalled over contamination fears.
• March 1, 2023 - Six counts are being brought against Enfamil's manufacturer. The plaintiff claims that Enfamil Premature formula contributed to her baby's premature death.
• February 1, 2023 - DHS recommends Enfamil AR as a replacement to Similac for Spit Up. Enfamil AR requires a medical request form, as it is not a contract formula.
• January 1, 2023 - Walmart and two major retailers have taken Enfamil packages from thousands of stores, along with other popular brands of infant formula, after a Missouri child who had ingested the product contracted a rare bacterial disease.
• December 1, 2022 - Enforcement Discretion to Manufacturers to Increase Enfamil Infant Formula Supplies.
• November 16, 2022 - Enfamil baby formula hard to find again in St. Louis region because of shortages.
• August 14, 2022 - Parents in search of baby formula as shortage continues. Mead Johnson’s Global Manufacturing Director Art Pike said: "We are now feeding 50% of America’s babies with Enfamil, including 211,000 more babies than before the shortage".
• August 1, 2022 - Enfamil formula safe for full term infants.
• July 1, 2022 - U.S. continues to import baby formula in from overseas amid shortage. A quick search for baby formula on U.S. stores' apps shows an inventory of select Enfamil, Similac & Gerber U.S. brand baby formula is still out of stock or low.
• June 1, 2022 - In May 2022 we have received over 45 inquiries on our site from parents of babies with NEC who fed their babies problematic Enfamil formula (39%) listed on this page and other formulas Similac (48%), the other 13% were Gerber, Earths Best or another cows milk-based formula.
• May 1, 2022 - In April 2022 we have received over 50 inquiries on our site from parents of babies with NEC who fed their babies problematic Enfamil formula (33%) listed on this page and other formulas Similac (38%), the other 29% were Gerber, Earths Best or another cows milk-based formula.
• April 1, 2022 - In March 2022 we have received over 71 inquiries on our site from parents of babies with NEC who fed their babies problematic Enfamil formula (31%) listed on this page and other formulas Similac(39%), the other 30% were Gerber, Earths Best or another cows milk-based formula.
• March 1, 2022 - Last month we have received over 240 inquiries on our site from parents of babies with NEC who fed their babies problematic Enfamil formula (30%) listed on this page and other formulas Similac(40%), the other 30% were Gerber, Earths Best or another cows milk-based formula.
• February 1, 2022 - U.S. National Library of Medicine - Osmolality of commonly used oral medications in the NICU.

While the first lawsuits against Mead Johnson were filed over two years ago, it’s important to stress that the Enfamil lawsuits are still considered in their early stages. We are still at the stage where Enfamil baby formula law firms are asking families to come forward and take action against Mead Johnson. The research showing a link between Enfamil and NEC is clear. Several thousand preterm babies are diagnosed with NEC each year, and it is more than probable that a large number of NEC-diagnosed babies were fed Enfamil products.

We should point out that Enfamil is not the only brand cited for NEC dangers in the preterm baby formula lawsuits. Similac, owned by Abbot Laboratories, also has several cow’s milk-based formulas in its product line that have been linked to NEC in preterm babies. There is overlap between the Enfamil and Similac lawsuits, as it is likely that many preterm babies with NEC were fed on both Similac and Enfamil products. Not all Similac and Enfamil products are listed in the NEC lawsuits. The focus is on specific cow’s milk-based baby formula designed to help preterm babies with low birth weight who can’t breastfeed or can’t get the required nutrition from breastfeeding. These products include Enfamil Human Milk Fortifier, Enfamil Powder, Similac Special Care, Similac Special Care High Protein, Similac NeoSure, and Similac Alimentum. If you are worried about feeding your baby Similac or Enfamil products, please contact your pediatrician for advice.

Many parents have reported side effects when feeding their babies Enfamil products. Enfamil baby formula side effects can include – but aren’t limited to:

• Stomach pain, cramps, nausea, vomiting
• Constipation, diarrhea, black stool
• Congestion, wheezing, cough
• Low blood pressure, lethargy

Some of these symptoms may be signs of necrotizing enterocolitis. NEC symptoms include stomach pain & bloatedness, vomiting (green or yellow in color), lethargy, and lack of weight gain. However, it’s important not to panic or make any assumptions should your child be unwell and suffering from these symptoms. As in all cases when caring for a child, whether you are worried about NEC or the side effects of baby formula or any other issue, contact your baby’s doctor for further advice.

On April 1, 2023, over 140,000 cans of Enfamil infant formula were recalled due to contamination fears.

Enfamil products linked to NEC include:

• Enfacare Powder
• Enfamil 24 and DHA & ARA Supplement
• Enfamil Human Milk Fortifier Acidified Liquid
• Enfamil Human Milk Fortifier Liquid High Protein
• Enfamil Human Milk Fortifier Powder
• 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

There are several factors to consider when estimating the Enfamil settlement payout for families affected by NEC. Some of the lawsuits against Johnson Mead allege wrongful death, whereas others focus on injuries. It will also be important for prosecutors to establish what Mead Johnson knew about the Enfamil dangers with regards to NEC, and whether the company wilfully covered it up. If it is proven that Mead Johnson acted unlawfully, thereby causing death and serious injury in babies, the company could be forced to pay huge amounts in Enfamil settlements to affected families. 

Mead Johnson may settle out of court, agreeing to pay compensation to families in the Enfamil lawsuits before it goes to trial. At this stage, it is difficult to put a figure on how much you can get from an Enfamil lawsuit settlement payout.

The short answer is that the Enfamil cases are neither a class action nor mass tort lawsuit – yet. Class actions and mass torts combine many lawsuits into a single case. However, class-action lawsuits usually deal with consumer issues with the exact same grievance against a company or individual. The Enfamil preterm NEC lawsuits are more complicated, with claimants filing the lawsuits for a range of reasons, including wrongful death and serious injury caused by Enfamil. 

That, combined with the huge number of cases against Mead Johnson from across the country, means it is likely that Enfamil cases will be consolidated into multidistrict litigation (MDL). An MDL is a type of mass tort lawsuit that allows for evidence sharing, legal proceedings, judges’ opinions, etc., to be shared across a single case. However, it differs from a class action suit as each claimant is judged individually when it comes to outcomes and compensation payouts.

Why is Enfamil being sued?

The makers of Enfamil, Mead Johnson & Company, as well as other producers of cow’s milk-based formulas, are being sued due to the link between these products and necrotizing enterocolitis (NEC). The Enfamil lawsuits allege that Johnson Mead knew about this link, yet it was negligent in failing to warn doctors and families about the NEC risks.

Is there a recall on Enfamil?

No. There has not yet been an Enfamil baby formula recall. It is possible that there will be a recall of Enfamil by the FDA if more evidence comes to light about its link with causing NEC in preterm babies.

Is Enfamil toxic?

There are some claims that Enfamil baby formula is toxic. Certain Enfamil products – not all of them – have been linked to the potentially devastating disease NEC in preterm babies.

Does Enfamil cause NEC?

While numerous studies have been conducted on products like Enfamil and NEC, we cannot say unequivocally that Enfamil causes NEC. However, it is clear from these studies that preterm babies who are fed Enfamil products are more likely to get NEC. More evidence linking NEC and Enfamil could come to light with the conclusion of the Enfamil lawsuits.

Who makes Enfamil baby formula?

Enfamil is produced and manufactured by Mead Johnson & Company, sometimes known as Mead Johnson Nutrition, or simply Mead Johnson. The company has a range of nutritional products, including baby formulas in the Enfamil range.