Enfamil Formula Lawsuit - Necrotizing Enterocolitis (NEC)

Evidence from the CDC shows that around 10% of all babies born in the United States each year are considered preterm, i.e., born before 37 weeks of pregnancy have elapsed. As you might imagine, preterm babies can have a lot of health issues, many of which are linked to low birth weight. And one of the complications that can occur is the inability of the preterm baby to breastfeed. To help preterm babies get the nutrition they need, many baby formula products have been developed, including one widely used brand, Enfamil. However, studies have shown that there is 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 the makers of Enfamil, Mead Johnson & Company, alleging that the Enfamil producers knew about the risks associated with their product and NEC yet 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) that showed 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 that link between cow’s milk-based formulas and NEC, making it impossible for Mead Johnson not to have known about it. Experts don’t actually know what causes NEC, although they can cite some theories and risk factors. However, 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 charges 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 the baby’s intestinal tissues, sometimes leading to death. Bereaved families, and those who have seen their children injured by Enfamil, are seeking justice, with 100s of Enfamil NEC lawsuits filed in American courts over the last couple of years. Since this is the beginning of the legal claims against the manufacturer, it’s not too late to join the lawsuits against Mead Johnson. If your baby has been affected by Enfamil, you can contact an Enfamil lawyer to start your claim for compensation.

• 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. There are several reasons for this, not least due to the disruption in legal proceedings caused by the Covid-19 pandemic. However, we are still at the stage where Enfamil baby formula law firms are asking for families to come forward and join the action against Mead Johnson. We know that several thousand preterm babies get NEC each year, and it is more than probable that a large number of those babies were fed Enfamil products. As the link between Enfamil and NEC has been established, it is highly likely that hundreds, perhaps thousands, of families will be eligible to join the Enfamil lawsuits. 

We should point out that Enfamil is not the only brand cited for NEC dangers in the preterm baby formula lawsuits. Similac, a rival brand owned by Abbot Laboratories, also has several cow’s milk-based formulas in its range 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. We should also stress that 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 of Enfamil when feeding their babies these products. Reported Enfamil baby formula side effects can include – but isn’t limited to – the following:

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

Some of these symptoms could be a sign 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.

There has not yet been a recall of Enfamil carried out by the FDA, nor has there been a voluntary recall made by Mead Johnson. It is possible that there will be an Enfamil recall 2022 if more evidence links Enfamil products to NEC in preterm babies.

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. For example, 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. It is also possible that Mead Johnson settles 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 until we get more information from the lawyers.

The short answer is that the Enfamil cases are neither a class action nor mass tort lawsuit – yet. Class actions and mass torts are means of combining lawsuits into a single case for reasons of efficiency. However, class-actions usually deal with consumer issues with the exact same grievance against a company or individual. The Enfamil preterm NEC lawsuits are much more complicated, with claimants filing the lawsuits for a range of different reasons, including wrongful death and serious injury caused by Enfamil. That, combined with the huge number of cases against Mead Johnson from all over the country, means it is likely that Enfamil cases will be consolidated into a multidistrict litigation (MDL). An MDL is a type of mass tort that allows for evidence sharing, legal proceedings, judges’ opinions, etc., to be shared across a single case. However, it differs from a class action due to the fact that each claimant is judged individually when it comes to outcomes, including 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 is toxic, but that’s in the broadest sense of the word. We do know, however, that certain Enfamil products – not all of them – have been linked to causing 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 feeding on 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.