Parents of babies that suffered from necrotizing enterocolitis (NEC) after feeding Similac and Enfamil formulas are filing lawsuits against the manufacturers of the products. These products, manufactured by Abbott Laboratories and Mead Johnson & Company, contain cow milk which increases the risk of infection in preterm babies. NEC is a potentially fatal condition that causes the inflammation and death of intestinal tissues of preterm babies. These lawsuits allege that Abbott Laboratories, manufacturers of Similac, and Mead Johnson & Co. Enfamil manufacturers, knew of the risk of their products to premature babies but didn’t include warning labels or guide physicians on the product use.

You might be liable for compensation if your baby suffered NEC after feeding from any of these formulas. Contact a product liability attorney before the expiry of the legal timeline for filing claims. This post provides all the information about necrotizing enterocolitis baby formula lawsuits.

Necrotizing Enterocolitis Lawsuit Eligibility

Contact our NEC attorneys if your preterm baby suffers from necrotizing enterocolitis after feeding on Similac or Enfamil infant formula. The infant might have undergone surgery to correct the problem or died. Our attorneys will review your NEC lawsuit and guide you through the next steps of action.

Eligibility criteria:

  • Infant born prematurely
  • Used Similac or Enfamil formula
  • Diagnosed with necrotizing enterocolitis
  • Here are the updates and progress of the NEC baby formula lawsuit:
  • Consolidation motion

Over 2021, 33 infant formula NEC lawsuits were filed in Illinois state court against Abbott Laboratories and Mead Johnson, headquartered in Chicago. Due to this increasing number of cases, the plaintiffs’ lawyers filed a motion to the Supreme Court of Illinois to consolidate the cases before a single judge for a coordinated pretrial. The motion was filed in December 2021, and it sought to have the MDL in Madison County, which had 31 NEC infant formula lawsuits. Consolidation would benefit all parties involved, and if the lawsuits are successful, it would clear the way for a global NEC settlement.

All the parties were in support of a class action lawsuit. However, the only contention was whether it would be held in Connecticut or Illinois. In their petition, Abbott and Mead Johnson requested the MDL in Connecticut while the NEC plaintiffs favored the Northern District of Illinois, Abbot’s headquarters. 

The Supreme Court of Illnois had previously consolidated 20 NEC formula cases which were pending in the Illnois State courts to a mini-MDL NEC class action lawsuit in Circuit Court for Madison County under Judge Dennis Ruth. Abbot, is seeking to have this mini-MDL transferred from Madison County to either Lake County or Cook County (Chicago), based on forum nonconveniens. 

In April 2022, the JPML issued a transfer order to consolidate all pending federal NEC infant formula lawsuits into a mass tort MDL- Abbott Laboratories et al., Preterm Infant Nutrition Products Liab. Lit. (MDL No. 3026). The NEC formula MDL is under the Northern District of Illinois Chief Judge, Judge Rebecca R. Pallmeyer. All new NEC infant formula lawsuits in federal courts will now be transferred to the MD in Illinois.

In July 2022, judge Pallmeyer directed new plaintiffs to file NEC formula lawsuits against Abbot and Meadson Johnson in the MDL-3026. Meadson tried to oppose this directive but failed. 

The medical community has supported the plaintiff’s views of the infant formula. In 2022, the American Academy of Pediatrics (AAP) published a statement advising parents to give breast milk and only use infant formula as a last resort. They also discouraged the marketing of baby formula products in maternity wards.

Nanomaterials ban in infant formula

In February 2022, two consumer protection groups petitioned the FDA to ban nanomaterial additives in infant formula. The petition targeted infant formula manufacturers Abbot and Mead Johnson, the major infant formula manufacturers. Studies have shown that nanomaterials are likely toxic to infants and can easily penetrate their vulnerable biological membranes. 

A study carried out at Arizona State University discovered nanomaterial in infant formula from Similac, Well Beginnings, Enfamil, and Gerber. Nanomaterials contained in these products include nano-hydroxyapatite, nano-titanium dioxide, and nano-silicon dioxide, and are used for whitening, flow enhancing, and anticaking properties. Titanium dioxide was banned as a food additive in bulk and nona in the EU after scientists raised concerns about genotoxicity. Due to its health risks, the use of nano-hydroxyapatite in cosmetics has also been banned by European Commission’s Scientific Committee on Consumer Safety.

Similac recall

In February 2022, the FDA announced a substantial recall of powdered Similac formula products manufactured in the Abbot  Sturgis, Michigan facility. The products were suspected of having a deadly cronobacter contamination, leading to four infants’ hospitalization. 

Bellwether trials 

In August 2022, the NEC infant formula class action (Judge Pallmeyer) drafted the process for selecting the 12 bellwether cases. The lawyers on both sides would submit a list of four NEC lawsuits that could be fully prepared for trial and involve both or either defendant. The court would also randomly pick four. After selection, the cases would go through the usual pretrial discovery process, interrogatories, and depositions. After discovery, the defense and defendants will each pick two cases out of the 12 for the initial bellwether trials. The bellwether trials would then be held 12 weeks apart, alternating cases selected by the involved parties.

As of April 2023, the 12 bellwether cases in the NEC formula MDL were going through case-specific fact discovery. This process helps provide both sides with more information on the cases, and it involves pretrial discovery, depositions of facts, witnesses, and doctors. Once it is completed, the trials can be held in 2024.

The NEC infant formula class action MDL judge is expected to schedule a science day. This day allows both sides in the litigation to make presentations to educate the court on the pertinent scientific evidence. 

29 NEC cases involving hospitals in Pennsylvania state court

In November 2022, the motion filed by plaintiffs in the 29 pending NEC infant formula MDL cases to remand their cases to Pennsylvania state court was approved. These cases involved product liability claims against two defendants: the formula manufacturers and local hospitals that fed the formula to the infants. The cases were subject to remand because they included local hospitals as defendants. Thus, they did not meet the requirement for diversity jurisdiction in federal courts.

The involved Similac or Enfamil infant formula products include:

  • Enfamil by Mead Johnson & Company
  • Enfamil 24 Cal Infant Formula
  • Enfamil NeoPro EnfaCare Infant Formula
  • Enfamil Premature Infant Formula 20 Cal with Iron
  • Enfamil Human Milk Fortifier
  • Enfamil Premature Infant Formula 30 Cal with Iron
  • Enfamil Premature Infant Formula 24 Cal High Protein
  • Enfamil Premature Infant Formula 24 Cal with Iron
  • Similac by Abbott Laboratories 
  • Similac Liquid Protein Fortifier
  • Similac NeoSure
  • Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid
  • Similac Alimentum Expert Care
  • Similac Human Milk Fortifier
  • Similac Special Care 24 High Protein
  • Similac Special Care 20
  • Similac Special Care 24
  • Similac Special Care 30
  • NEC for preterm babies

Necrotizing enterocolitis is a common intestinal tract disease in which the intestine lining tissue becomes inflamed, dies, and can slough off. It affects preterm infants, underweight infants, or those already sick. The disease usually begins within the first two or three weeks after birth, often before the infant leaves the hospital.  

Preterm infants are vulnerable to many morbidities and mortalities due to their underdeveloped cardiac, immune, respiratory, and gastrointestinal systems. These collectively increase the risk of necrotizing enterocolitis, a serious gut disease. NEC affects 5 to 12 percent of very low birth weight babies. 20 to 40 percent of NEC cases result in surgery, and 25 to 50 percent of NEC infants die. When surgery is required, the treatment can cost approximately $300,000. Even those who survive NEC will likely grow slowly and suffer from other long-term side effects, including gastrointestinal and neurodevelopmental issues.

Many factors are believed to contribute to NEC, although the cause is not fully understood. Nutrition is believed to contribute to NEC on set and progression. Studies have shown that cow milk or bovine milk-based infant formulas increase the risk of NEC in preterm infants more than human milk. It is still unknown why human milk is linked to a lower risk of NEC, but some studies suggest it could have something to do with bacteria in cow milk.

In some cases, babies fed exclusively on human milk also develop NEC. Researchers are considering using semi-elemental or elemental formulas, which could be safer for preterm infants. These formulas are easy to digest and absorb and can make perfect nutritional interventions without risking NEC. 

Symptoms of NEC include:

  • metabolic acidosis
  • abdominal distention
  • green fluid in the abdominal wall
  • feeding residuals
  • feeding intolerance
  • jaundice appearance
  • an increase or decrease in stools
  • decreased bowel sounds
  • lethargy
  • bradycardia (slow heart rate).
  • acidosis
  • trouble breathing

Studies Linking NEC to Cow Milk Formula

Necrotizing enterocolitis occurs from bacteria from the cow’s milk in the formula that infects an infant’s intestinal walls. Some studies indicate that mother’s milk is protective against sepsis, as it contains bioactive elements that help in bactericidal and immune-modulating activities

Cow milk is used in fortifiers added to breast milk to boost its nutritional value. Over the years, cow-milk-based formula and fortifiers have been given to preterm babies. However, physicians and researchers began noticing a link between cow-based formula/fortifiers and NEC. Also, malpractice attorneys have filed malpractice lawsuits against physicians feeding preterm babies with cow-milk-based formula due to the known risk of NEC. The doctors have always responded that they didn’t know any link between these formulas and NEC. 

Studies carried out in 1990 on 926 preterm babies and published in the Lancet Journal indicated that babies fed formula were six to ten times more likely to develop necrotizing enterocolitis than those given breast milk. Other literature suggests that premature infants fed cow-milk-based formula or fortifier are up to ten times more likely to develop NEC. 

A WHO review published in 2006 found that feeding preterm infants of any gestation with breast milk reduced the risk of infection and NEC. 

According to 2010 findings published in the Journal of Pediatrics, children fed with breast milk and breast milk fortifiers were 90% less likely to develop NEC compared to those given the traditional bovine milk formula.

According to the 2014 Expert Review of Clinical Immunology, a review of the established scientific evidence shows higher rates of NEC in infants fed formula than breast milk.

A 2015 Portuguese study indicated a 50% reduced NEC risk for children fed with breast milk.

Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet, a 2016 Breastfeeding Medicine study of over 1,500 newborns found a lower NEC incidence in infants who received breast milk exclusively.

According to a 2019 Cochrane study of over 1,900 premature infants, those given cow-milk-based formulas and NEC. 

Studies published in The American Academy of Pediatrics Journal in 2021 showed that premature infants given human breast milk only had a 77% reduced risk of NEC.

Pediatrics and Child Health study published in October 2021 indicates that breast milk reduces NEC risk for premature babies. According to the same findings, cow-milk formula and fortifiers for preterm infants increases the risk of developing NEC (three times more than normal/ breast milk) and slow their development. 

In the most recent study published in 2023, there is no significant difference in NEC for preterm infants fed human milk diet and those given bovine milk formula and fortifiers. According to this study, human milk products are the same as cow-milk-based formula, and preterm infants should be given breast milk to their mothers.

Long-term Neurological Injuries Associated with NEC

In 2020, 10.1% of children in the US were born prematurely before 37 weeks, and thousands of these babies developed NEC between two to three weeks after delivery. With prompt diagnosis and treatment, NEC can be cured, and the affected baby can lead a normal life. However, long-term neurological problems may arise from severe NEC, such as cerebral palsy. This can happen when the infection in the intestinal walls spreads to other body organs. 

According to some studies, 45% of NEC survivors will likely have cerebral palsy, cognitive, visual, hearing, and psychomotor impairment at 20 months. 20% of babies with NEC have cerebral palsy, 36% cognitive, 35% psychomotor, and 3% visual or hearing impairments. 

These neurological problems for NEC survivors persist with age. In some cases, those whose brains were affected are likely to have poor mental and psychomotor development at two years. The children may have cognitive deficits such as low IQ, poor attention and visual perception at school.

What are the expected NEC Infant Formula Settlement Amounts?

The settlement values will vary depending on the current needs of the affected child. Cases, where the children require ongoing care are likely to receive the highest compensation. Lifelong care, pain, and suffering injuries might be awarded millions of dollars. Also, cases of wrongful death of an infant are likely to receive the highest settlements. Based on the history of similar lawsuit settlements, we estimate that the first-tier payouts might range between $250,000 and $750,000. Where the child recovered after pain and suffering, the payouts can go as high as $400,000, with the least affected getting $50,000.

Contact a Necrotizing Enterocolitis Baby Formula Lawyer From Stephens & Stephens, LLC

An attorney from Stephens & Stephens, LLC can help. Our Necrotizing Enterocolitis baby formula mass tort attorneys can be reached when you call 1-800-548-4494 or fill out the contact form on our website.