Cow’s Milk Based Formula Can Harm Premature Babies

The multi-billion-dollar baby formula market is growing every year. Still, 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. The products are still on the shelves and heavily marketed. But parents are given no warning.

About 80% of formulas are based on cow’s milk, though they are usually modified in some way. Some are fortified with iron. Formulas are treated to make them more digestible for infants and mixed with additives and substitutes – sometimes to make them better, sometimes cheaper. 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) or related illnesses and consumed formula as a prematurely-born infant. Call us at 1-866-900-7078 for a free evaluation of your circumstances.

What Is NEC and How Does It Harm Babies?
What Is the Link Between Baby Formulas and NEC?
Giant Multinational Companies May Be Putting Infants at Risk
What Can I Do if My Child or I Have Suffered NEC or Its Long-Term Effects?

What Is Necrotizing Enterocolitis and How Does It Harm Babies?

Necrotizing enterocolitis, or NEC, is an infection of the walls of an infant’s intestine by bacteria that can inflame and ultimately destroy them. The destruction of these walls leads to perforation of the bowel and allows stool to spill into the infant’s abdomen. The infections that happen as a result can easily result in death.

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.

What Are the Symptoms of Necrotic Enterocolitis (NEC)?

There is a raft of 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 newborns and especially those born prematurely, 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 giving their child 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 Necrotizing Enterocolitis (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.

A Wider View Calls Corporate Motives Into Question

Other indicators show that some of these companies may not be as focused on helping children grow as much as helping their profit margins increase. There is plenty of industry pressure to resist regulation.

Meanwhile, the Center for Food Safety and the International Center for Technology Assessment have filed a petition urging the FDA to ban specific toxic nanomaterials from formulas sold in the U.S. – particles already banned in Europe. Prompted by a 2016 Arizona State University study, the petition claims the nanomaterials are toxic, chemically reactive, and capable of penetrating biological membranes.

Given the industry’s focus on cow’s milk as a base for its formula, ostensibly because of its low cost, there is clear motivation to cut costs and push profits. Regardless of the brand, consult a lawyer if your child has suffered the effects of NEC or its consequences after consuming cow’s milk based formula.

What Can I Do if My Child or I Have Suffered from Necrotizing Enterocolitis and Its Long-Term Effects?

There is no way to know how many children and families have suffered harm from NEC caused by formula. While each case is different, some qualifying characteristics apply.

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 cow’s milk-based formula or fortifier.

If you meet these criteria, you may be entitled to 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

We urge you to act as soon as possible. Call us at 1-866-900-7078 or contact us online right away. Either way, you’ll be communicating with a real person who wants to help you. Don’t wait. Tell them you mean business.

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.