NEC, Similac Recall, & Baby Formula Lawsuit

In what is a parent’s worst nightmare, countless families across the country have recently discovered that feeding their premature or underweight baby formula — formula that’s been advertised to be safe and not harmful to newborns — has in fact led to a dramatic increase in the risk for a serious bowel infection. Called necrotizing enterocolitis, or NEC for short, this condition can commonly develop in newborns, especially those born prematurely or significantly underweight. Only recently has it been discovered that feeding a baby formula based on artificial or cow’s milk can dramatically increase the risk of infants developing NEC.

If your baby has suffered or, tragically, passed on due to an NEC infection after ingesting baby formula, you may be eligible to seek compensation for your losses and the suffering of your child. You may also be eligible for similar damages if your baby has suffered an infection of Cronobacter or another pathogen after consuming contaminated formula. An attorney can help you file a baby formula lawsuit seeking to recover 100% of the financial expenses for medical treatments and other losses, as well as compensation for the suffering of your family and your young child.

The Personal Injury Lawyers ™ have represented thousands of clients each year, and we have helped them secure millions through settlements and court awards. Our only goal is to maximize the damages that you are able to recover from your family’s devastating medical crisis.

You can speak to a baby formula lawsuit attorney during a free, confidential case review to learn more about your legal options and the types of damages you may be eligible to claim. Take our free eligibility quiz to see if your case qualifies.

What Is the Basis of a NEC Baby Formula Lawsuit?

Lawsuits filed in relation to the development of NEC after baby formula consumption are based primarily on the fact that formula manufacturers failed to warn parents of the high risks of feeding non-human milk to certain newborns, including those born prematurely and those with a significantly lower-than-average birth weight.

A “failure to warn” claim can be filed in cases where the company had actual knowledge — or reasonably should have known — about a severe risk, yet did nothing to communicate this risk to its customers. Claims filed on the basis of strict liability can hold manufacturers accountable even in the absence of actual knowledge of the risks, provided that the claimant can prove that the product was used as intended and posed an unreasonable health and safety risk to the general public.

In regards to the current NEC lawsuit wave, the claim is that Abbott, the manufacturer of formula products under brand names like Similac and Enfamil, produced products exclusively for the consumption of newborns and other babies likely to fall into high-risk groups. Yet, the company did nothing to warn or advise parents on the risks of developing NEC. These products were even used in hospitals and other care facilities, including with high-risk babies in NICUs.

What Must Be Proven for a Parent to Claim Damages From an Infant Formula Company?

To claim damages under a strict liability doctrine, a parent must prove the following:

  • They purchased a formula product or were provided with one
  • They used the product as directed
  • Use of the product led to NEC, or another medical condition that posed significant risk to the life and well-being of their baby
  • The harm inflicted upon the baby led to damages
  • The product posed an unreasonable risk of harm to the baby, and others in the general public

For jurisdictions that do not have a strict liability statute, the claimant may also need to prove that the company knew, or should have known, about the risks their product posed, yet failed to warn the public about them.

What Damages Are Available in a Dangerous or Contaminated Formula Lawsuit?

The exact damages received through a settlement or court award will vary according to the unique details of each case. However, claimants can expect to seek damages in some or all of the following categories:

  • Costs of medical treatment in connection with an infection or other adverse event caused by dangerous and contaminated formula, including NICU stays, surgery, specialist treatments, and other care made necessary by the adverse event
  • Projected costs of future treatment, including all care needed for a baby that is disabled by or will acquire a chronic condition because of the harm inflicted by the formula
  • Lost wages experienced by the parents, particularly in connection with work missed or benefits used because of health emergencies, the need to attend appointments, etc. In some cases, the child may be eligible for restitution of wages they would have earned throughout their lifetime had they not encountered a medical crisis in infancy.
  • Pain and suffering of the parents and the child
  • Funeral and burial expenses for fatal cases
  • Punitive damages, which must be awarded by a jury, and which are only provided in cases of extreme disregard for the safety of consumers

Your attorney will help you assess all damages you have suffered and seek the maximum amount of compensation available under the law. They can also help you decide on the most appropriate jurisdiction in which to file your case, giving it the highest chances of success and of recovering all of the losses you have experienced.

Importantly, parents of children who have suffered (or passed on) from a bout of NEC have several years after the date of the incident to file their claim. The statute of limitations varies depending on the jurisdiction where the case is filed, but a typical period is 2 – 4 years from the date the condition was first discovered. This time limit is one major reason why it’s critical to reach out to an experienced attorney to get moving on the process of your case as soon as possible.

Why Does Formula Cause NEC?

NEC is a relatively rare, but extremely serious, medical condition that primarily affects newborns. Babies born prematurely or underweight are at particular risk for the illness. It begins with substantial inflammation in large intestine or colon. The inflamed tissue becomes so swollen that it can trigger the death of other cells in the vicinity. The baby must then have surgery or other treatments to address the spread of infection and avoid the intrusion of gut bacteria into the rest of the body.

A review of available literature shows that, while NEC affects just 5 – 12% of low birth weight infants, a range of 20 – 40% of cases have been shown to require an emergency surgery. Further, NEC was fatal to 25 – 50% of the infected population in studied groups. The same review also concluded that providing babies with cow-based milk products, as opposed to human-based, resulted in a higher risk of developing NEC for high-risk infants.

A 2019 concluded that the risk of developing NEC for prematurely born or low-weight infants was nearly twice as high when they were fed artificial or cow-based formula.

What’s important in these studies is that the risk is higher, regardless of the manufacturing process or the chemical composition of the final product. If it contains cow’s milk or other artificial milks, the child is at a higher risk of developing NEC. Manufacturers had an obligation to determine that this was the case and to warn the public so that they could make an informed decision, yet they did not.

However, there have also been cases where baby formula was contaminated with bacteria, leading to an outbreak of NEC in certain care facilities.

Was the Formula Recall in 2023 Related to NEC?

Parents may be confused about the spate of product recalls that have been issued, beginning with Abbott products recalled starting in 2022. These recalls aren’t directly related to the development of NEC in infants that consumed the recalled formula, although it is possible that some babies did develop NEC afterward. Rather, the recalls were issued because Abbot’s products had been found to have been contaminated by Cronobacter sakazakii.

The Minnesota Health Department was the first to have reported a Cronobacter infection, one that occurred in St. Louis County. Because the illness is rare in infants, it was suspected that the formula they had consumed had been somehow contaminated with the pathogen. An inspection of Abbott’s infant formula manufacturing facility in Sturgis, Michigan uncovered multiple instances of Cronobacter on plant equipment and within the products being manufactured. Abbott then initiated a historically large voluntary recall, pulling Similac, Alimentum, and EleCare products from shelves all across America.

Since the discovery of Cronobacter contamination at Abbott’s facility in 2022 and the corresponding Similac recall, the FDA discovered contamination in three more companies’ facilities: ByHeart, Reckitt/Mead Johnson, and Perrigo, the latter of which manufactures the widely recognized Gerber line of infant formulas. FDA inspections also uncovered significant health and safety violations at several plants, including water leaks, cracks in drying systems, and other substandard conditions that could lead to a dramatically increased risk of contamination.

Reckitt/Mead Johnson also discovered Cronobacter contamination in finished products, leading to a voluntary recall in February 2023. Perrigo similarly found contaminated batches and issued recalls in March 2023.

Parents of babies infected by Cronobacter should look up the manufacturer of their infant formula to determine if infection could have occurred.

Brand Name Products Affected by Infant Formula Recalls and Product Contamination

There is a broad range of products that have been recalled because of Cronobacter contamination or because of similar health and safety concerns. Some of the most notable product brands include:

  • Similac
  • Gerber
  • Enfamil
  • Pediasure
  • Avacare
  • Kendamil
  • Parent’s Choice
  • Earth’s Best
  • Baby’s Only
  • Happy Baby
  • Loulouka
  • Holle
  • Lebenswert
  • Bobbie

Products With a High Risk of NEC

All baby formula products that contain cow’s milk or other non-human milk components present an elevated risk of NEC for low-weight and preterm newborns. Similac and Enfamil products, in particular, have been named as high-risk because of their wide distribution and use in healthcare facilities, including NICUs and specialty facilities that tend to babies with very low birth weight and other pressing health concerns.

What to Do If You Suspect Your Baby Has Been Infected by Dangerous or Contaminated Formula

First, know the signs of NEC and Cronobacter infection, and then report to your doctor or neonatologist for immediate evaluation and care.

Symptoms of NEC in infants include:

  • Abdominal swelling
  • Bloody stool
  • Green discharge from the anus or mouth
  • Slow breathing
  • Lethargy
  • Difficulty feeding
  • Rapid changes in temperature

Symptoms of Cronobacter in infants include:

  • Fever
  • Reduced feeding
  • Low energy
  • Excessive crying or upset behaviors
  • Seizures

Report any concerns to a doctor immediately. Discontinue use of any formulas or other products suspected to have been contaminated. Do not discard these products, but ensure that they will not be used by others. Save any proof of purchase or receipts.

Get a full diagnosis from your doctor, and then reach out to The Personal Injury Lawyers ™. Our personal injury attorneys will help you determine your legal options for seeking repayment for your medical bills and other damages related to your baby’s condition. Your child should not have to suffer because the cynicism and carelessness of a multi-billion dollar corporation. We will do everything we can to help your case succeed and to hold those responsible accountable for every cent of losses they have inflicted.

Reach out to the Personal Injury Law Firm That Wants to Fight for You and Your Baby

The Personal Injury Lawyers ™ believes in the ability of every client to find justice through the legal system. We know that corporations like Abbott have substantial legal resources, but so do we. We are prepared to help you take on products manufacturers and, where appropriate, retailers and distributors of harmful products.

Let us help you handle your case and find every bit of evidence available to support your claims. You have enough to worry about with your new family member.

We are also available in cases where your baby was affected by NEC or infected by contaminated formula in the past. Our services are provided on a contingency basis, with no up-front fee, and no charges at all if we are unable to secure a settlement or award for you.

Learn how to stand up for your legal rights and help ensure the financial security of your child during a free, confidential case review with no obligation. Schedule your free case evaluation today when you call (312) 999-9990 or contact us online.


The Personal Injury Lawyers ™
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Chicago, IL 60601