Cow’s Milk-Based Formula Can Harm Premature Babies: What to Know

The multi-billion-dollar baby formula market is growing every year even though science has warned us for decades about issues with its use in certain situations and the dire side effects it can cause in some infants – particularly those born prematurely. Still, manufacturers of cow’s milk-based formulas Similac (Abbott) and Enfamil (Mead Johnson) sell and market these formulas to hospitals – with no warning that they have been linked to severe diseases such as necrotic enterocolitis (NEC).

Cow’s milk-based formula is commonly used – one study posted on the National Library of Medicine website reported that 69% of children who were fed formula or regular milk consumed cow’s milk formula. For many infants, the formula is fine. For others, it can lead to life-altering medical problems or even death.

You may be entitled to compensation if your child has suffered from necrotic enterocolitis (NEC) after consuming formula as a prematurely-born infant in a neonatal intensive care unit (NICU). Call us at 1-866-900-7078 for a free evaluation of your circumstances.

What Is Necrotizing Enterocolitis and How Does It Harm Babies?

Necrotizing enterocolitis, or NEC, is a devastating and potentially fatal gastrointestinal disease that primarily affects premature infants. The condition occurs when tissue in the intestine becomes inflamed and begins to die, which can lead to intestinal perforation, life-threatening infection, and sepsis. NEC requires emergency surgical intervention in many cases, and survivors frequently suffer long-term complications including short bowel syndrome, developmental delays, and neurological impairment. The mortality rate for severe NEC can be as high as 50%.

While the exact cause of NEC is not precisely known, there is an established link to feeding a premature infant cow’s milk-based formula. Premature infants have immature lungs and intestines, making them more vulnerable to certain infections. And decades of published medical research have established a significant association between cow’s milk-based infant formula and the development of NEC in premature infants.

What Are the Symptoms of Necrotic Enterocolitis (NEC)?

There are many possible symptoms that may indicate necrotic enterocolitis. Initial symptoms can include:

• Nausea/Vomiting
• Diarrhea or a change in stool pattern
• Increased abdominal girth or distension
• Delayed emptying of the bowel
• Visible intestinal loops
• Palpable abdominal mass, abdominal tenderness, or both
• Ileus (temporary lack of muscle contractions in the intestines)
• Decreased bowel sounds
• Abdominal wall erythema (reddening of the skin or tissue, usually in advanced stages)
• Hematochezia (bloody stools)

Sufferers may also exhibit systemic signs of the infection, including:

• Apnea
• Lethargic behavior
• Decreased or low peripheral perfusion (to oversimplify, blood flow in the tissue)
• Cardiovascular distress or collapse
• Respiratory failure
• Shock
• Bleeding diathesis (the tendency to bleed or bruise easily)

When occurring in premature newborns, these symptoms can cause irrevocable harm to the child’s development and result in numerous complications and consequences that may last a lifetime.

That’s why NEC is a risk any parent should know about before allowing their child to be given milk-based formula.

What Are the Consequences of Necrotic Enterocolitis (NEC)?

According to a study found in the National Center for Biotechnology Information, several studies have indicated that bovine milk-based products – those made with cow’s milk – may increase the risk of NEC. The consequences of an NEC infection can include:

• Longer hospital stays
• Surgical intervention (in severe cases, which represent 20-40% of cases) including laparotomy, intestinal resection, and ostomy creation
• Short bowel syndrome and other surgical side-effects

Long-term health consequences can include:

• Feeding difficulties
• Gastrointestinal ostomies
• Failure to thrive
• Neurodevelopmental delays

If the scientific community has been pointing to possible links between formula and NEC in premature infants for more than 30 years – the initial published study was in 1990 – why have the companies making the product not placed a warning on it?

This failure to warn may have negatively impacted countless families.

What Is the Link Between Baby Formulas and NEC?

Many studies connect cow’s milk-based formula to a greater risk of necrotizing enterocolitis (NEC) in premature babies. As far back as 1990, a study published in The Lancet showed that NEC was six to ten times more likely to occur in babies exclusively fed with formula.

In 2011, Johns Hopkins published a study that showed premature infants given a standard premature infant formula developed NEC at an alarmingly higher rate and suffered more severe effects. Only one of the 29 infants (3%) in the study who received human milk developed NEC, and that child recovered without surgery. Five of the 24 infants fed with formula (20%) developed NEC, and four of those children required surgery.

Scientists in different studies found that between 3-5% of premature newborns given human milk develop NEC, while 17-21% of those given cow milk-based formulas develop the illness.

Another study published in Pediatrics and Child Health in October 2021 concluded that, compared to pasteurized donor human milk (PDHM), formula-fed neonates had better growth rates but were at increased risk of necrotizing enterocolitis (NEC) and feeding intolerance.

Formula makers also sponsor clinical trials, but in 2021, a study from the British Medical Journal debunked most of those trials:

“In this systematic evaluation of formula milk trials, we found an almost universal lack of transparency and evidence of selective reporting between and within trials. The widespread and increasing use of formula in children at a sensitive period of development emphasizes (sic) the importance of scientific rigor in this area of clinical investigation. Our findings suggest that recent formula trials lack that scientific rigor, and published outcomes are biased by selective reporting.”

The study found lack of transparency was complemented by favorable conclusions in more than 90% of the trials, pointing to an obvious industry bias.

Due to the decades of published medical research establishing a significant association between cow’s milk-based infant formula and the development of NEC in premature infants, plaintiffs allege that Abbott and Mead Johnson were aware of this body of research yet continued to market their products for use in NICUs without adequate warnings — prioritizing profit over the safety of the most vulnerable patients.

What Can I Do if My Child Has Suffered from NEC?

There is no way to know how many children and families have suffered harm from NEC caused by formula. While each case is different, you may be able to seek compensation if the following qualifying characteristics apply to your case:

First, your child must have been born on or after January 1, 2006.

Second, your child must have been born prematurely.

Third, your child must have been given Similac or Enfamil cow’s milk-based formula or fortifier while in the NICU.

If you meet these criteria, you may be entitled to significant compensation if your child:

• suffered NEC that led to a brain injury or developmental defect (cerebral palsy, HIE, etc.)
• had surgery to remove part of the bowel
• experienced intestinal perforation, scarring, or strictures in the intestine
• developed short bowel syndrome
• did not survive

The NEC Lawsuits Against Abbot and Lead Johnson

The NEC baby formula lawsuits against Mead Johnson and Abbott have been consolidated in Multi-District Litigation (MDL No. 3026) in the Northern District of Illinois. Multi-District Litigation is how the court system handles situations where large numbers of people are harmed by the same product. All of the cases are managed together by one federal judge, which keeps things efficient and consistent. Your case is still yours – you’re just part of a larger, coordinated effort to hold these companies accountable.

Types of Potential Compensation You Can Seek

Families who successfully pursue NEC-related claims may be entitled to compensation for the following types of expenses:

• past and future medical expenses
• costs of long-term care and therapy
• pain and suffering
• emotional distress
• loss of enjoyment of life
• and in cases of wrongful death, funeral expenses and loss of companionship

In cases where manufacturer conduct is found to be particularly egregious, punitive damages may also be .

We Can Help You Seek Justice – Free Case Evaluation

There are many cases alleging that Abbott and Mead Johnson knew their products carried a heightened risk of NEC in premature infants and failed to warn parents and healthcare providers. We can help you fight to hold them accountable.

If your child was diagnosed with NEC after being fed cow’s milk-based Similac or Enfamil formula in the NICU, we are here to help. We offer a free, no-obligation case evaluation to help you better understand your rights and options.

The Law Offices of James Scott Farrin has helped 78,000+ injured people pursue justice since 1997. We’ve generated more than $2 billion in total compensation for our clients during this time.¹ And we want to help you and your family, too.

We urge you to act as soon as possible. Call us at 1-866-900-7078 or contact us online. A real person is available to speak with you right now.

The Law Offices of James Scott Farrin consults with a national network of attorneys on product liability, defective drugs, and defective products cases in an attempt to provide the best representation we can for our clients. Depending on the details of your case, our firm may refer your matter to another law firm with which we associate. We will only do this if we believe it is in your best interests and if you agree.