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Premature Baby Formula NEC Lawsuit​

Parents of premature infants already have enough to worry about. Babies born prematurely are at greater risk of health complications. Parents should be able to trust that what they’re feeding their newborn babies is safe and healthy, even if they can’t or don’t want to breastfeed. Certain baby formulas that use cow’s milk have been linked to an increased risk of necrotizing enterocolitis in babies that are born prematurely or that are underweight.

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Parents want to make sure they’re doing what’s best for their children. New parents especially may stress over how to take care of their babies, worrying about everything from their baby’s health to what to feed the baby. Parents should be able to trust that what they feed their baby, whether it’s breastmilk or formula, is safe and healthy for their child. Instead, some new parents may have to worry about an increased risk of necrotizing enterocolitis in their vulnerable infant.

Formula based on cow’s milk has been linked to an increased risk of an underweight or premature baby developing NEC (necrotizing enterocolitis). If your infant developed NEC as a result of consuming cow’s milk-based baby formula, you may be eligible for compensation. Contact Farah & Farah for a free consultation to determine if you have a case. You won’t have to pay a dime unless your case is successful.

a doctor feeding a baby

What Is Baby Formula?

Baby formula, also called infant formula, is any manufactured milk that has been designed for the consumption of children under the age of twelve months. Usually, baby formula is made from cow’s milk and then altered so that it more closely resembles breastmilk. Some baby formulas are based on soy milk instead. Any baby formula is designed so that it can take the place of breastmilk entirely, should the parents decide not to breastfeed their baby. However, it can also be used to supplement breastfeeding as necessary.

Type of Baby Formula

There are three different types of baby formula:

  • Cow milk-based formula
  • Soy milk-based formula
  • Protein hydrolysate formula

Cow’s milk-based baby formula is the most common type of baby formula, but sometimes a baby is allergic or otherwise intolerant to cow’s milk. Soy milk is a common replacement for cow’s milk, but the protein hydrolysate formula is available for those who are allergic or intolerant to both cow’s milk formula and soy milk formula.

Baby formula can come ready-to-use, in concentrate liquid form, or as a powder. Ready-to-use formula is the most convenient because it doesn’t need to be mixed with water before being given to the baby, but it’s also the most expensive of the available options.

Who Should Use Baby Formula?

Baby formula is designed for babies under the age of 12 months. Whether or not to breastfeed is a big decision for many parents. Many think that breastfeeding is best, but not every parent is able to breastfeed or even wants to. Baby formula can be a good replacement for breast milk because it’s made from milk and supplemented with nutrients that a baby needs. Any parent who is either not breastfeeding at all or needs to supplement breastfeeding can use baby formula.

What Is Baby Formula Made From?

While milk is a major ingredient in infant formula, it isn’t not the only ingredient. Baby formula is meant to be either a replacement for or a supplement to breast milk, which means that it has to include the nutrients that babies need. In addition to the source of protein (cow’s milk, soy milk, or protein hydrolysate), there’s also a fat source, which is typically a vegetable oil blend, lactose, a mix of vitamins and minerals, and sometimes other ingredients as well, depending on who manufactured the formula.

Who Manufactures Baby Formula?

Some popular manufacturers of baby formula include:

  • Baby’s Only
  • Bobbie
  • Earth’s Best
  • Enfamil
  • Gerber
  • Go & Grow
  • Happy Baby
  • Holle
  • Kendamil
  • Lebenswert
  • Loulouka
  • Parent’s Choice
  • Similac

Many of these brands are offered at hospitals to new parents who need or want them after the baby is born.

What Is a Premature Birth?

A premature birth is any that occurs three weeks or more from the estimated due date. This means that a premature birth is one that happens during the 36th week of pregnancy or before. Premature delivery can be dangerous because babies haven’t had as much time to develop within the womb. It’s possible for preemies to develop serious medical conditions and many have to spend time in the NICU, or neonatal intensive care unit, under the careful supervision of doctors and nurses.

Preemie Newborn

Symptoms of Premature Birth

As a result of being born prematurely, infants may experience the following symptoms:

  • Baby’s Only
  • Bobbie
  • Earth’s Best
  • Enfamil
  • Gerber
  • Go & Grow
  • Happy Baby
  • Holle
  • Kendamil
  • Lebenswert
  • Loulouka
  • Parent’s Choice
  • Similac

Risk Factors of Premature Birth

There are certain risk factors that can increase the risk of a premature birth occurring:

  • Previous premature delivery
  • Multiple births (twins, triplets, etc.)
  • Getting pregnant again less than six months after giving birth
  • In vitro fertilization
  • Smoking
  • Drug use
  • Certain infections
  • Uterus, placenta, or cervix problems
  • High blood pressure
  • Diabetes
  • Several abortions or miscarriages
  • Being overweight or underweight
  • Stressful events in life
  • Physical injury
  • Trauma

Complications of Premature Birth

Premature birth can result in complications for the premature baby. These can be both short-term and longer-term.

Short-term complications include problems with:

  • Brain
  • Heart
  • Breathing
  • Temperature control
  • Gastrointestinal system, including necrotizing enterocolitis (NEC)
  • Blood
  • Immune system
  • Metabolism

Long-term complications:

  • Cerebral palsy
  • Impaired learning
  • Vision issues
  • Dental issues
  • Hearing difficulties
  • Behavioral problems
  • Psychological issues
  • Chronic health problems

What Is NEC?

NEC stands for necrotizing enterocolitis. NEC affects premature infants’ intestines and can be very serious or even fatal if it isn’t treated. Usually, preemies who develop NEC do so within the first two weeks after they’re born. In NEC, bacteria invade the premature baby’s intestinal wall and can cause cracks within the intestines. Germs and bacteria can then leak into the baby’s abdomen.

Causes of NEC

It’s not known exactly what causes NEC. Premature babies are more susceptible because their intestines and lungs are weaker and less mature than those of full-term babies. This increases the risk of all kinds of health problems, not just NEC. There’s a reason why premature infants often require more medical care and observation than full-term babies. Premies can’t break down food as well, their bodies can’t move oxygen and blood around as well, and they also have a harder time fighting infections.

Risks Factors of NEC

NEC is fortunately very rare, with only one premature baby out of every 2,000-4,000 born suffering from it. Technically, NEC can happen to any premature baby. However, there are some risk factors that can increase a premature baby’s chances of developing NEC, including:

  • Weighing under 3.25 pounds
  • Existing gastrointestinal issues
  • Difficult delivery
  • Too many red blood cells
  • Receiving a blood transfusion
  • Serious illness
  • Lower levels of oxygen
  • Consuming formula (either orally or via tube)

Symptoms of NEC

The symptoms of NEC can be different depending on the infant. However, there are some common symptoms that doctors and parents should be on the lookout for.

The following symptoms can develop during the first two weeks after a premature baby’s birth:

  • Swollen stomach
  • Bloated stomach
  • Feedings don’t move through the intestines, instead staying in the stomach
  • Green stomach fluid
  • Bloody poop
  • Sluggishness
  • Low heart rate
  • Difficulty breathing

If you notice any of these symptoms in your newborn, especially if the baby is premature or is underweight, you should contact your doctor immediately. Many normal stomach conditions or medical issues can produce similar symptoms. However, due to the serious risk that comes with developing NEC, it’s important to keep an eye out for any symptoms that could be linked to the condition. If NEC isn’t treated, it could result in death.

How NEC Is Diagnosed

Doctors diagnose necrotizing enterocolitis in premature infants by taking X-rays of the baby’s stomach as well as running blood tests. All of this is usually done in the NICU (neonatal intensive care unit). The blood tests look for a low white blood cell count, which is a sign of NEC. It’s also a sign that your baby might have difficulty fighting off infections of any kind. If your baby has NEC, the X-rays will show air bubbles or gas located in the intestinal walls. Another way to look for NEC is to put a needle into the baby’s stomach. If fluid starts to leak out of the stomach, that can be a sign that there’s a hole in the baby’s intestinal wall, a sign of NEC.

NEC Treatments

There are a variety of different treatment options available to your doctor. Which ones are best suited to treat an infant depend on the severity of the NEC infection and also how premature the baby is. The treatment options can include:

  • IV fluids
  • Stopping feedings
  • Antibiotics
  • Draining fluids through a nose tube
  • Isolation from other babies to prevent the spread of NEC
  • Regular X-rays to monitor progress
  • Extra oxygen
  • Breathing machine

In severe cases, surgery may be necessary. Surgery is typically only necessary if there’s a hole in the baby’s intestine or if that baby doesn’t recover within five to seven days. Surgery would generally involve repairing a hole in the intestinal wall or removing dead tissue or tissue that is likely to develop a hole.

Recovery from NEC

Fortunately, most babies who develop NEC recover. For some, however, the bowels may have scar tissue or the bowels may be narrowed. In the most severe cases, babies who had to undergo surgery to remove sections of the bowels or intestines may require a bowel transplant because they won’t be able to process food normally.

Preventing NEC

There isn’t currently any way to 100% prevent NEC from occurring. Because of the link between cow’s milk-based baby formula and NEC, however, many NICU departments in hospitals use donor breast milk instead of formula for premature infants instead of using formula in order to reduce the risk of NEC.

Baby Formula Ties to NEC

Studies have found a link between cow’s milk-based baby formula and NEC, or necrotizing enterocolitis, in premature babies and babies that are underweight. For the study, the researchers compared the medical records of newborn babies who were given pasteurized donor human milk to the records of newborns who were given cow’s milk-based formula. For the purposes of the study, the newborn babies whose medical records were studied were of the same age and the same birth weight.

The study found that a higher percentage of newborn babies who drank the cow’s milk-based formula ended up needing tertiary care in the NICU, particularly for suspected NEC, than the newborn babies who drank pasteurized donor human milk. 8.9 percent of the babies who drank the formula needed additional care, compared to the 3.1 percent of those who drank the PDHM.

How Does Formula Increase the Risk of NEC?

It’s unknown exactly how cow’s milk-based formula increases the risk of NEC developing in premature or underweight infants. However, some researchers believe that the cow’s milk can encourage the growth of bacteria that can damage a premature infant’s gastrointestinal system. Because a premature baby is less developed than a full-term baby, they’re less able to fight off infection and inflammation. Human breast milk can help to add protections against both of those things. Thus, many studies found that donor breast milk resulted in a lower risk of a preemie developing NEC than if they drank formula that had cow’s milk in it.

Baby Formula Lawsuits

Some baby formula manufacturers are now facing lawsuits from parents of premature newborns. The plaintiffs claim that the manufacturers of the baby formula didn’t adequately warn of the risks of their infant developing NEC. Mead Johnson & Company and Abbott Laboratories are two of the companies being sued over a failure to warn of the risks of NEC from their Enfamil and Similac baby formulas. A wrongful death lawsuit that was filed in California names those two companies over the death of an infant due to NEC. The lawsuit also claims that despite the numerous studies linking baby formula to NEC in premature and underweight infants, Mead Johnson & company and Abbott Laboratories, Inc. have not changed the product itself to reflect the findings of the study. Nor have they made any changes to the packaging to include instructions or warnings about the risks in premature babies.

Should I Consider a Baby Formula Lawsuit?

If you had a baby prematurely and your infant was fed certain Similac or Enfamil baby formulas at the hospital and developed necrotizing enterocolitis (NEC), cronobacter sakazakii, salmonella, or severe gastrointestinal issues and a qualifying injury as a result, you may have a case against the manufacturers of that baby formula.

You may be eligible for a lawsuit against the company that manufactured the formula if your baby was fed any of the following products:

  • Enfamil Formula
  • Enfamil Milk Fortifier
  • Similac Formula
  • Similac Milk Fortifier
  • Alimentum
  • EleCare
The Farah and Farah team

Farah & Farah is committed to holding companies accountable for their actions. If a baby formula manufacturer’s failure to adequately warn parents of the risks of cow’s milk-based baby formula products in premature infants has resulted in your baby developing NEC, which can cause serious health problems or even death, then you may have a case against the company. Contact us today for a free consultation. You won’t have to pay anything unless your case is successful.


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