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Infant Formula Lawsuit

What To Do If Your Premature Baby Developed Necrotizing Enterocolitis (NEC) After Being Fed Preterm Infant Formula

From the desk of:
Andy Bederman, Managing Attorney

To Families:

If your premature baby was fed infant formula and subsequently developed necrotizing enterocolitis (NEC) -- this may be one of the most important messages you will read.

Here is why...

A mounting amount of scientific literature is showing that infant formulas designed for preterm babies are linked to significantly higher rates of necrotizing enterocolitis (NEC) -- an extremely serious gastrointestinal inflammatory disease that often results in emergency surgeries and sadly has a 25-50% mortality rate in preterm infants.

Necrotizing enterocolitis (NEC) is a condition where the baby's intestines become highly inflamed, causing severe injury to the gut wall barrier. Necrosis (tissue death), or holes in the gut wall barrier can develop causing dangerous bacteria to "leak" out of the intestines -- often leaving doctors no choice but to perform emergency surgery in hopes to save the child.

While necrotizing enterocolitis (NEC) can occur in full-term infants, preterm infants are as much as five-times more likely to develop NEC... and doctors didn't always understand why.

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Necrotizing Enterocolitis (NEC)

New Research Shows Preterm Infant Formula Is Linked To Increased Risk of Necrotizing Enterocolitis (NEC)

New research is shining a spotlight on a likely culprit for increased prevalence of NEC in preterm babies...

Bovine milk-based infant formula.

In other words... infant formula that is based on cow's milk.

These cow's milk-based formulas are made by Similac® and Enfamil®. A few of the most common bovine milk-based preterm infant formulas are:

  • Similac Special Care
  • Enfamil NueroPro Enfacare

Many premature babies are unable to breastfeed after birth due to their inability to perform the "suck-swallow-breathe" rhythm -- mostly due to low coordination or insufficient energy. As such, preterm infants often begin feedings via intravenous delivery or enteral feeds of either, A) the mother's own human milk, B) human donor milk, or C) preterm infant formula.

Additionally, premature babies often require additional supplementation that human milk or standard formula cannot provide.

In these instances, doctors often recommended adding additional supplementation with what is called "fortifiers". While human milk fortifiers do exist, it was common for doctors to use fortifiers that come from bovine (cow) based milk.

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Similac and Enfamil Premature Infant Formula

Why Use Bovine Milk-Based Formulas At All In Preterm Infants?

While there are distinct benefits that human breast milk offers that cannot be replicated in infant formula, use of cow's milk-based formulas in hospital settings has been desirable for other reasons.

For one, cow's milk-based infant formulas are easy to find. They are easy for hospitals to procure and readily available for purchase.

Also, cow's milk-based infant formula is easy to store, since it is shelf-stable. Many human-milk based products require refrigeration which is more difficult for hospitals to manage.

And lastly, cow's milk-based infant formula is dramatically less expensive than human milk or human donor milk products. In fact, human milk is as much as 41x more expensive than cow's milk-based formula.

So what's the problem?

The problem is researchers have discovered that preterm babies that are fed bovine-based (ie. cow's-milk) infant formula are significantly more likely to develop necrotizing enterocolitis (NEC) than those fed human milk-based products.

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Doctor carrying baby away with NEC

A Preterm Baby's Gastrointestinal System Is Not Developed Enough To Safely Digest Cow-Based Milk Formula...

The infant's gastrointestinal system plays a critical role in the development of immunity and nutrition. The intestines contain an entire microbiota of bacteria that not only are needed to digest beneficial foods and nutrients, but also are needed to protect the baby from harmful foods and pathogens.

Because a premature infant's gestation period is shorter than normal, their body's systems are not as developed as full-term babies. And this is certainly the case with a preterm infant's gastrointestinal system.

In preterm phase, the stomach and intestines are still lacking many of the beneficial bacteria that are typically present at full-term.

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Leaky Gut

A "Leaky" Gut Barrier Is Common In Preterm Infants -- So Foods Need To Be As Safe As Possible

The underdevelopment of the gastrointestinal system in preterm infants is the reason why so many preterm infants have what doctors refer to as "leaky gut" -- where there is permeability of the gut lining which can cause the passage of toxins and bacteria into the baby's bloodstream.

The intestinal walls are literally our shield to any dangerous or harmful things that enter our body.

But in the case of preterm infants, many things that are deemed safe for a full-term infant would be considered harmful for them.

Unfortunately, Bovine milk-based infant formula appears to be one those harmful substances.

But why?

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Oligosaccharides, an Important Prebiotic Found In Human Milk, Completely Missing From Bovine-Based Formula

In nature, foods often come bundled with nutrients that serve to aide in the digestion of that food. Human breast milk is no different.

There are many beneficial components in human milk that naturally help a preterm infant breakdown and digest the nutrients contained within.

One of those beneficial components is oligosaccharides -- a critically important prebiotic that stimulates the growth of the highly beneficial probiotic, bifidobacteria.

Bifidobacteria species of probiotics are known as "good" bacteria, and can even be found on the shelves of your local grocery store or health food store sold as a supplement to those who wish support their own gut health.

The Bifidobacteria help digest and break down food, absorb nutrients into the baby's body and protects them from foreign or bad organisms that can cause serious illness.

The highly beneficial prebiotic Oligosaccharides, which stimulates the growth of these critical probiotics that aide in gut health, while present in human breast milk, is completely missing from bovine milk-based infant formula.

In fact, studies have been published that show simple supplementation of Oligosaccharides in preterm infants provided a significant improvement to intestinal tolerance to feeding (especially enternal feeding) in preterm infants.

Further, many recent studies are now suggesting that the absence of oligosaccharides in bovine milk-based infant formula may be the reason why necrotizing enterocolitis (NEC) is more prevalent in preterm babies.

They simply do not have the proper prebiotics and "good" bacteria to safely digest cow's milk-based formula.

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Milk Fat Globule Membrane (MFGM) -- A Miracle Component of Human Milk That Gets Destroyed In The Processing of Bovine Milk-Based Infant Formula

Another known problem with bovine milk-based infant formulas is that the processing of the formula strips out something called the, "milk fat globule membrane" (MFGM).

MFGM is another incredibly beneficial component that literally aids in the maturation and development of the preterm infant's gut -- helping to make the babies immunity and digestion stronger in the first 6-months of life.

The reason preterm formulas have such a difficult time maintaining or including MFGM is because it is extremely complex in structure and the biosynthesis of milk fat globule is costly.

Yet, we know it is a critical component to a preterm infant's health, maturation and immunity. And researchers have suggested that by feeding preterm infant formula, we may be increasing the prevalence of necrotizing enterocolitis (NEC) because of the absence of milk fat globule membrane (MFGM).

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Preterm Infant Formula Manufacturers Should Have Warned About The Increased Risks of Necrotizing Enterocolitis (NEC) With Bovine Milk-Based Products

For years, studies have shown an association between bovine milk-based preterm infant formula and the development of necrotizing enterocolitis (NEC).

So why didn't the manufacturers of these infant formulas warn both the doctors and parents of these known risks?

Why did they, instead, choose to continue manufacturing and marketing an infant formula that was based on cow's milk and missing critically important components?

We know a preterm baby's gastrointestinal system is both fragile and underdeveloped -- to the point where bovine-based formulations come with immense risks.

Those risks aren't small, either. As of today, doctors report a 25-50% mortality rate in babies that develop necrotizing enterocolitis (NEC).

And of those that develop NEC and survive, the majority will have life-long complications.

Should cow's milk-based formula really be marketed as a safe and effective feed regimen for preterm infants when there are numerous human milk-based options available that have a better safety profile and show higher efficacy?

Many in the medical community say no -- and have been sounding the alarms about bovine milk-based formulas for premature infants.

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These Children and Their Parents Deserved Better -- They Should Have Been Warned So Alternative Feeding Options Could Be Considered -- And the Health of the Child Be Prioritized

One of the main reasons, if not the primary reason, bovine milk-based infant formulas are used is cost.

It's dirt cheap for a hospital to buy and procure these bovine milk-based preterm infant formulas compared to the human milk alternatives.

But what is hidden in the "supposed" cost savings, is the astronomically high healthcare costs associated with treating necrotizing enterocolitis (NEC) -- which often requires NICU stays and surgery.

Severe NEC cases in preterm infants can easily cost over $300,000+.

And what parent wouldn't trade anything in the world to go back in time and to have been warned of the known risks associated with these bovine milk-based formulas -- knowing that NEC has a 25-50% mortality rate?

All parents want to have informed consent -- to at a minimum, be warned of all risks and be provided the opportunity to weigh the advantages of something versus the potential risks.

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What To Do If Your Premature Baby Developed Necrotizing Enterocolitis (NEC) After Being Fed Preterm Infant Formula

If your child suffered injury and/or death due to necrotizing enterocolitis (NEC) after being fed infant formula, please know there is help available.

And please know that you are not alone.

There are hundreds, if not thousands, of parents who have shared the same tragic loss and hardship. Our legal team understands what our clients have endured -- so it's our goal to always be an advocate for your family and all the other families who would do anything to turn back time and have been warned of these risks with bovine milk-based infant formula.

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Discover What Options Are Available To You
Get A Free Consultation Today

Our legal team is pursuing significant financial compensation on behalf of the families who have been affected by necrotizing enterocolitis (NEC) due to use of preterm infant formula.

We are currently accepting cases nationally -- from all 50 states.

For a limited time, our pharmaceutical attorneys are offering free and confidential legal consultations.

This is your opportunity to have a conversation with an experienced attorney who can answer all your questions and help you determine if you are eligible to pursue financial compensation.

Act Now Because There Is A Limited Window of Time To Pursue A Legal Case

There is a very small window of time for victims to seek financial compensation after an injury or death -- it is called the "statute of limitations" and the time window for pursuing a case is different in each state.

So please do not wait to speak to an attorney because you do not want to miss your opportunity to pursue an infant formula settlement or lawsuit.

Here is how to get started:

Fill out the free consultation form below and one of our attorneys will promptly call you to discuss your case.

This consultation is FREE. There is no-risk and no obligation. This is simply your opportunity to understand if you have a case and discover what your legal options are in terms of pursuing financial compensation.

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We look forward to speaking with you.

Sincerely,

Andy Bederman
Owner & Managing Attorney
Law Offices of Greenberg & Bederman, LLC

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