Baby Formula Lawsuit — What You Need To Know About NEC

In January 2020, numerous lawsuits were filed by parents against baby formula manufacturers Abbott Laboratories and Mead Johnson regarding their popular baby formula products. These were dubbed NEC lawsuits since it is alleged that certain lines of baby formulas produced by Abbott Laboratories and Mead Johnson have toxic effects on premature newborns. NEC-related lawsuits alleged that specific cow milk baby formulas manufactured by Abbott Laboratories and Mead Johnson had caused premature newborns or babies with low-birth weight to develop NEC or necrotizing enterocolitis. In addition, the lawsuits point out that Mead Johnson and Abbott Laboratories market their baby formulas as safe, failing to warn parents and medical professionals that their products can cause NEC, especially in premature babies.

What is NEC, and How Does it Affect Newborn Babies?

NEC or necrotizing enterocolitis is a severe type of gastrointestinal infection, and this is a life-threatening gastrointestinal disease that could affect a newborn child. Although any newborn baby could get NEC, premature babies and babies with low birth weight are at a greater risk of developing life-threatening complications due to NEC.

NEC is a severe disease that causes intestinal tissue death and is fatal. NEC develops because it causes a newborn’s large intestine to be damaged by inflammation. Specifically, it could potentially cause holes in the intestines, which allows the bacteria from the intestines to leak into a baby’s abdomen or blood. This severe complication could lead to infection, internal scarring, growth restriction, and even death.

Product liability claims can be based on the following legal theories: negligence, breach of warranty, or strict liability. As with any negligence claim, a claimant must allege the following elements:

  1. The defendant owed a duty of care to the claimant.
  2. The defendant breached their duty of care to the claimant.
  3. The claimant was harmed.
  4. The defendant’s breach of their duty of care caused the claimant harm or injuries.

A general breach of warranty pertains to an implied or expressed warranty or guarantee to the product’s consumer. An express warranty could be written or verbal associated with a product’s packaging, marketing, development, or even statements of its salespeople. At the same time, an implied warranty is automatically tied to the product to function as expected by the consumer.

Another legal theory under product liability claim is strict liability. This concept holds an entity liable for harm without having to prove intention or fault as long as the claimant can show that:

  1. The product was sold in the marketplace in an unreasonably dangerous condition;
  2. The unreasonably hazardous condition was present when the product left the manufacturer’s control, and
  3. The dangerous condition caused the claimant’s injuries.

Under negligence, Abbott Laboratories and Mead Johnson have a specific duty of care to their product consumers. Since their baby formulas are made explicitly for newborn babies, the manufacturers owe a duty of care to the vulnerable claimants of the NEC lawsuits. NEC lawsuits alleged that premature babies or babies with low-birth weight had suffered NEC and NEC-related complications, which are allegedly tied to the manufacturer’s baby formula products.

In addition, both manufacturers failed to warn or notify the consumers and medical professionals that newborns that consume their baby formulas could be at risk of developing NEC. 

In regards to warranty, it is alleged in NEC lawsuits that Abbott Laboratories and Mead Johnson market their baby formula products as safe for consumption to the consumers. Tied with the manufacturers’ lack of warning or notification of their products could potentially cause NEC to newborn infants, it can reasonably be construed that there are implied and expressed guarantees regarding the safeness of their product.

Regarding strict liability, the claimant does not need to allege that Abbott Laboratories and Mead Johnson intended to harm the consumers of their baby formula or that they are at fault. Instead, the lawsuit must allege the following:

  • The baby formula posed a danger to newborn babies, specifically premature babies and babies with low-birth weight; and
  • The baby formula posed a danger when the manufacturer shipped the products to their distributors; and
  • The NEC disease and related complications suffered by premature newborn babies or babies with low birth weight were caused by the baby formula manufactured by Abbott Laboratories and Mead Johnson.

What Baby Formulas Produced by Abbott Laboratories and Mead Johnson Nutrition Are Cited in NEC Lawsuits?

It is important to note that only baby formulas made from cow’s milk have been linked to NEC issues in premature babies; not all baby formulas made from cow’s milk in the market are included in NEC lawsuits.

The following specific baby formulas produced by Mead Johnson and Abbott Laboratories have been alleged in NEC lawsuits to have caused NEC issues to premature babies: 

  • Similac Special Care
  • Similac Human Milk Fortier
  • Similac Neosure
  • Similac Alimentum
  • Similac Alimentum Experct Care
  • Similac Human Milk Fortifier Concentrated Liquid
  • Similac Human Milk Fortifier Hydrolyzed Protein – Concentrated Liquid
  • Similac Liquid Protein Fortifier
  • Similac Special Care 20
  • Similac Special Care 30
  • Similac Special Care 24
  • Similac Special Care 24 High Protein
  • Invacare Powder
  • Enfamil Human Milk Fortifier Powder
  • Enfamil Human Milk Fortifier Acidified Liquid
  • Enfamil Human Milk Fortifier Liquid High Protein
  • Enfamil Human Milk Fortifier Liquid Standard Protein
  • Enfamil NeuroPro Enfacare
  • Enfamil Premature 20 Cal
  • Enfamil Premature 24 Cal
  • Enfamil Premature 24 Cal/fl. Oz HP
  • Enfamil 24 and DHA & ARA Supplement
  • Enfamil Premature 30 Cal

Have These Enfamil and Similac Baby Formulas Been Recalled?

Not all of them.

Interestingly, the line of Enfamil and Similac products alleged to have caused NEC in premature babies have not been recalled due to the NEC lawsuits. Instead, certain of the Enfamil and Similac baby formulas were recalled in February 2022 for potential bacterial infection, which has resulted in the death of two babies. These bacterial infection incidents are a completely separate issue from the NEC allegations.

Concerning the recall, the FDA released a preliminary inspection report in March 2022 that discovered Abbott Laboratories did not have a system of process control that would ensure infant formula does not become adulterated due to the presence of microorganisms.

The recall has caused a surmounting baby formula shortage in the United States. Despite the FDA receiving further reports that Abbott Laboratories’ baby formula could have led to the death of an infant due to bacterial contamination, the manufacturer has reopened at least one of the plants to have produced tainted baby formulas to help ease the shortage.

Who Are Eligible To File NEC Lawsuits Against the Baby Formula Manufacturers?

Parents and guardians of premature babies that have contracted NEC after being fed one of the baby formulas listed above can file NEC lawsuits against Abbott Laboratories or Mead Johnson on behalf of the baby.

Newborn babies that developed NEC could have been fed with the toxic baby formula either at home or after being discharged from the hospital. If a parent or guardian is unsure if their baby has been fed one of the baby formulas listed above while at the hospital, then they or their legal representation should reach out to the hospital and ask for verification.

To support any NEC-related lawsuit filed by a parent or guardian, keeping records of receipts, proof of purchase, or packaging of the baby formula fed to the child may be helpful. This documentation may be vital to the lawsuit as evidence.

Is There a Statute of Limitation To File a Claim?


Statute of limitation is the time limit set by the jurisdiction on when claimants are allowed to file their lawsuits. A lawsuit filed by the claimant after the set statute of limitation has passed will likely be opposed by the other party, and the court will likely dismiss the lawsuit. Each respective state sets its statute of limitation depending on whether the case is a criminal or civil lawsuit and the specific type of claim.

Statute of limitations generally starts from the date of the incident or when the claimant should have known the harm tied to the alleged action, which in this case is the baby formula. Since a lawsuit is connected to a specific deadline, filing a timely lawsuit to the appropriate court is essential.

Thus, it is crucial to speak with a reputable state-licensed product liability or personal injury attorney to provide vital information regarding filing an NEC lawsuit against Mead Johnson or Abbott Laboratories.

Legal Favor
Legal Favor

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  • FDA. FDA warns consumers not to use certain powdered infant formula produced in Abbott Nutrition’s facility in Sturgis, Michigan. U.S. Food and Drug Administration. Retrieved August 1, 2022, from https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-not-use-certain-powdered-infant-formula-produced-abbott-nutritions-facility
  • U.S. Food And Drug Administration (FDA). Food and Drug Administration. U.S. FDA. Retrieved August 1, 2022, from https://www.fda.gov/media/157073/download