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Babies born prematurely require extra nutrition to boost their development and growth. In hospitals and at home, many premature infants are fed with baby formula as a way of supplementing breast milk or replacing it altogether. Enfamil™ and Similac® are the two leading brands of infant formula. Parents do not expect their children’s health to be at risk from consuming these brands of formula, but mounting scientific evidence has shown that for premature infants, these cow’s milk-based formulas can contribute to a potentially serious condition requiring surgery, and in the worst case scenario, become fatal.
Mead Johnson & Abbott Laboratories may be held liable for their cow’s milk-based baby formula and milk fortifier products such as Enfamil™ and Similac®® which may increase the risk of premature and low-birth-weight babies developing a potentially fatal intestinal disease called necrotizing enterocolitis (NEC).
What is necrotizing enterocolitis (NEC)?
NEC is a serious intestinal disease that most commonly affects premature babies born before 32 weeks and under 3.25 lbs. It can also affect full-term babies with other health complications. If a baby has another gastrointestinal condition, or a higher than normal red blood cell count, they may develop NEC. It is the leading cause of death from gastrointestinal disease in premature babies.
NEC usually develops within two to four weeks after birth. When a baby develops NEC, inflammation or injury of the large or small intestine causes a hole in the intestinal wall, or necrosis (death) of intestinal tissue.
NEC can progress quickly from the first onset of symptoms to necrosis. When the intestines are perforated, bacteria enter the baby’s bloodstream or abdomen and cause a potentially lethal infection, called sepsis. Surgery is required to remove necrotic (dead) sections of the intestine.
The National Institute of Health reports that about 9,000 premature babies develop NEC out of the 480,000 born each year in the United States. Medical advances that help ensure the survival of babies with very low birth weight mean that more babies will actually be at risk of NEC.
NEC is fortunately a rare condition, affecting only one in 2,000 to 4,000 births, and only develops in 7% of premature babies. However, when contracted it can be extremely serious. NEC is one of the leading causes of illness and death for babies with very low birth weight, and results in death for 15-40% of premature infants diagnosed with it.
What Causes Premature Birth?
The majority of babies diagnosed with NEC are premature, which is defined as a baby born before 37 weeks of gestation. Premature birth puts the baby at risk for a number of health problems, as their immune systems, breathing and digestion are not yet fully developed. Doctors do not fully understand what causes babies to be born before they are full-term, but studies have identified a number of risk factors:
- Fewer than 12 months between pregnancies. This is especially risky if the mother has had a premature baby before.
- Experiencing high levels of stress during pregnancy
- An older (over 35) or younger (under 17) mother
- Health problems like diabetes or high blood pressure
- Overweight or underweight weight while pregnant
- Pregnancy with twins, triplets or more
- Problems with a previous pregnancy, such as early delivery or birth defect
- Complications with the uterus, cervix, or placenta
- Smoking, alcohol use, or drug use while pregnant
- Infections in the mother, specifically of the amniotic fluid or lower genital tract
- Physical injury or trauma to the mother
- Although the reasons are unclear, Black women are more likely to have a premature birth compared to white and Hispanic women.
All women should seek medical care when they become pregnant and avoid the risk factors they can control. This includes getting proper nutrition, maintaining a healthy weight, abstaining from smoking, alcohol and other drugs, and treating conditions like diabetes and high blood pressure. Taking these precautions will help establish the safest conditions for your pregnancy. However, despite best intentions, preterm births can happen unexpectedly and place the child at risk for necrotizing enterocolitis (NEC).
How can necrotizing enterocolitis (NEC) be prevented?
Doctors often promote the health benefits of breastfeeding. A medical study of 207 infants has shown that babies fed with human breast milk had a significantly lower incidence of NEC than babies who consumed a combination of breast milk and cow’s milk-based formula.
Many doctors have treated premature babies with antibiotics as a way of preventing infections. However, antibiotics can have a negative effect on healthy gut bacteria that can fight the invasive bacteria that causes NEC. Withholding use of antibiotics from premature infants can help prevent NEC.
What causes necrotizing enterocolitis (NEC)?
Doctors are unsure of the exact causes of NEC. Premature babies do not have fully developed circulatory and digestive systems. During a difficult delivery, a lack of oxygen may reduce blood flow to the intestine. This lowers the body’s defenses against infection and damage to the intestines.
Feeding by formula is also a risk factor. Some medical studies indicate that premature babies fed with cow’s milk-based formulas have a higher incidence of NEC than babies fed with breast milk, though the connection is not fully understood. Some experts theorize that the harmful effects of cow’s milk-based formula may be linked to underdeveloped mucous membranes in premature babies’ intestines, or the role of gut bacteria.
What are the symptoms of necrotizing enterocolitis (NEC)?
A baby with NEC may display the following symptoms:
- Difficulty feeding
- Changes in bowel movements (constipation, diarrhea, dark or bloody stools)
- Changes in body temperature, low blood pressure, and/or slowed heart rate
- Swelling, tenderness, or redness of the stomach area
- Slower digestion after feeding
- Vomiting (a green color indicates bile)
- Periodic pauses in breathing (apnea)
- Evidence of septic shock
How do doctors diagnose necrotizing enterocolitis (NEC)?
When a baby presents with the above symptoms, an x-ray is taken to identify an abnormal gas pattern, which looks like bubbles or streaks, in the walls of the intestine. A fluid sample taken from the abdomen can also confirm a diagnosis.
What is the treatment for necrotizing enterocolitis (NEC)?
As NEC is a potentially life-threatening condition, treatment begins immediately after diagnosis.
- Pausing feeding temporarily
- Insertion of IV to replace fluids and nutrition fluids for fluid replacement and nutrition
- Draining air and fluid from the stomach and intestine by inserting a tube through the nose and mouth
- A course of antibiotics for treating infection
- Multiple abdominal X-rays
- Surgical consultation. Surgery may be performed immediately if the situation is life-threatening.
- Frequent examinations monitor the baby’s progress. The abdomen is examined for swelling, and stools are checked for blood. Blood is drawn to test for bacteria and anemia.
Fortunately there are some new treatments in development for NEC. One is the use of probiotics, which are microorganisms (live bacteria and yeasts) in the gut that promote good health when ingested. Probiotics have been studied as a way to both reduce the risk of NEC and also to treat it. The “good bacteria” can counter the bacteria causing infection in the intestines, and prevent the build-up of nitric oxide, a gas that can destroy the intestinal wall.
What happens after treatment for necrotizing enterocolitis (NEC)?
When a baby responds well to treatment, intravenous feeding can end after 7 to 14 days, and regular feeding can begin. Breast milk is recommended for babies with NEC because it is more easily digested than formula, and it supports healthy gut bacteria and the immune system overall, which is less developed in premature babies. Donor milk from a milk bank may be sourced for women who are unable to breastfeed, or produce enough milk for regular feeding.
What happens if non-surgical treatment for NEC doesn’t work?
A baby who does not respond to treatment will need surgery. The surgeon will locate the hole in the intestine and remove any necrotic intestinal tissue. The remaining, healthy intestine is re-connected. If a large amount of intestinal tissue must be removed, the surgeon will perform an ostomy. An opening is created in the abdomen and the intestine connected, and waste leaves the body through it. The ostomy can be closed after 6 to 8 weeks when the intestine has healed.
Although most babies will make a full recovery from NEC and be able to feed normally, in some instances, there will be more lasting damage to the intestines. If there is scarring in the intestine, the baby may require further surgery to remove blockages. Some babies will have trouble absorbing nutrients after surgery, and may need intravenous feeding until the intestines are fully healed.
Studies About Necrotizing Enterocolitis (NEC) and Cow’s Milk-Based Formulas
Scientific evidence supports parents’ claims that their premature babies were harmed through cow’s milk-based formulas. Although cow’s milk-based fortifiers and formulas were originally believed to be safe, extensive scientific research has confirmed these products can cause NEC in low-weight and preterm babies. These studies are some highlights of research in this field over the past 30 years.
- As far back as 1990, studies have identified a possible link between cow’s milk-based formulas and NEC. A study published in The Lancet medical journal concluded that babies fed with cow’s-milk formula were 10 times more likely to develop the condition.
- A study published in 2009 in The Journal of Pediatrics concluded that very premature babies who were exclusively fed with their mother’s breast milk (or pasteurized donor breast milk) had significantly lower occurrence of NEC than babies whose diets included cow’s milk-based formula.
- The Expert Review of Clinical Immunology journal reported in 2014 that even though the causes of NEC in premature babies is not completely understood, cow’s milk-based formula feeding was a significant risk in developing the disease compared to breast milk feeding.
- The journal Breastfeeding Medicine, in 2016, published a study of 1,587 premature infants in Texas, Florida and California, and found that 16.7% of babies fed with cow’s milk-based formula suffered from NEC, while only 6.9% of babies developed the disease if they were fed with human breast milk.
- In 2018, in a systematic review of studies of breast milk feeding versus cow’s milk-based formula feeding in premature and low birth weight full-term babies, the Cochrane Group concluded that “feeding with formula compared to donor breast milk increases the risk of serious gut problems in preterm or low birth weight infants.”
- The British Medical Journal published a study in 2021 that was damning for cow’s milk-based formula manufacturers. The study concluded that companies across the board have not been transparent about the links between NEC in premature babies and the use of their products. The study also stated that these companies have funded biased and unreliable clinical product trials.
- Another study published in 2021 in the Canadian journal Paediatrics and Child Health reported that out of 247 premature babies, 8.9% of babies fed with cow’s milk-based formula had to be transferred to a neonatal intensive care unit with symptoms of NEC, compared to 3.1% of premature babies fed only with human breast milk. This study further supports the existing scientific literature that cow’s milk-based formulas are a significant risk factor in developing NEC.
The Reasons for NEC Baby Formula Lawsuits
Parents are suing baby formula manufacturers because they knew or should have known their products could cause necrotizing enterocolitis (NEC) in premature infants. Manufacturers have failed to warn parents and physicians about the risk.
This real-life case under litigation outlines the reasons for parents to bring a lawsuit against Abbot Laboratories, the manufacturer of Similac®, and Mead Johnson & Company, who manufactures Enfamil™ .
Richardson v. Abbot Laboratories and Mead Johnson & Company
In Richardson v. Abbot Laboratories and Mead Johnson & Company, filed in the United States District Court, Central California Western Division, the plaintiff is the mother of a premature infant who was diagnosed with NEC in the neonatal intensive care unit after being intravenously fed with cow’s milk-based Enfamil™ ™ and Similac®® formulas. The infant suffered from an abdomen instruction, blood in his stool, difficulty breathing, and neurological deterioration. The infant underwent surgery and one-third of the large and small intestines were removed.
The case alleges that both Abbot Laboratories and Mead Johnson & Company were aware of the risk of NEC associated with their formulas due to the evidence from scientific studies, but that there was no warning label on the formula packaging to inform consumers.
The complaint also points out that Abbot Laboratories had misleading labels on their products. In order to align with overwhelming scientific evidence that human breast milk has superior nutritional benefits for babies, Similac® products called “Human Milk Fortifier” were released into the market. The product name could lead consumers to believe that the products were derived from human breast milk, when in reality, they are cow’s milk-based formulas intended to supplement human breast milk. Therefore, these products also contributed to the risk of NEC.
The complaint alleges that both Abbot Laboratories and Mead Johnson & Company have intentionally misled consumers by promoting their cow’s milk-based products as:
- safe for babies, including premature and low birthweight babies,
- equally as nutritious and beneficial to babies’ health as breast milk, or even a superior substitute
- necessary for the growth and development of premature infants over breast milk or breast milk alone
- the primary choice of physicians
These marketing strategies have been employed in spite of knowing the risks of NEC.
The complaint also alleges that though Abbott products intended for premature infants now state a warning that they should be used under a doctor’s supervision, the older packaging is still widely available and could be misleading to consumers.
Overall, the case alleges that Abbott has not disclosed any warnings to consumers or to doctors about the risks associated between their products or NEC – including recommendation that hospitals inform parents of the risks of their cow milk-based formulas, and obtaining parental consent before they are fed to premature babies.
Additionally, Abbott has continued to use cow’s milk as the base of their products in spite of the known risks. The packaging does not even identify cow’s milk as an ingredient, using “nonfat milk” instead, which appears to be intentionally misleading to the consumer.
Baby Formula Lawsuits in Illinois State Courts
More than thirty lawsuits have been filed against Abbott Laboratories and Mead Johnson & Company in Illinois, where the companies are based. The complaints filed by parents claim that their premature babies were fed with Similac®, manufactured by Abbott Laboratories, or Enfamil™ , manufactured by Mead Johnson and Company, while they were in the hospital. Their babies developed NEC. Some required surgery, and several babies died as a result of the condition. The plaintiffs claim that the manufacturing companies ignored research evidence that their products were harmful to premature infants, and should have reformulated the products or warned consumers about the risks of NEC.
The defendants have denied the accusation that their products cause NEC and that since some babies who are fed only with breast milk develop the potentially life-threatening condition, it cannot be related to cow’s milk-based formula. The stance of these powerful corporations and their denial of responsibility means that experienced and expert legal representation is a must when filing a baby formula lawsuit. .
To sum up, the reasons that the manufacturers of Enfamil™ and Similac® can be legally liable for damages are:
- Product warnings and instructions were too broad and vague, failing to even mention the increased risk of NEC
- Despite knowing of the heightened NEC risk, defendants have made no changes to the formula, packaging, instructions, or warning labels and have continued to use cow’s milk as the foundation of their products, even though safer alternatives are available for preterm nutrition
- Defendants aggressively marketed their cow’s milk-based products as medically endorsed, equally safe, and nutritionally equivalent to human breast milk and targeted their ads to parents of premature infants
- Defendants have employed deceptive tactics to imply that the products are similar to or derived from breast milk when they really contain cow’s milk
Baby Formula and NEC Lawsuits: Settlements and Verdicts
Some of the financial losses incurred from premature babies who contract necrotizing enterocolitis from cow’s milk-based baby formula include:
- Medical expenses – Premature babies generally require time in the neonatal intensive care unit (NICU) until they finish developing and are strong enough to survive without medical assistance. NEC will extend this time in the NICU and possibly incur additional expenses from emergency surgery and further recovery time. Babies who have a bowel resection and require a stoma may need multiple surgeries.
- Lost income – Since premature babies have special medical needs, parents will need to be away from work longer and potentially lose income. If a child has lasting medical impairments, one parent may have to completely quit working to provide constant care.
By filing a baby formula lawsuit, parents may be receive compensation in the following ways:
NEC Lawsuit Settlements: A settlement is reached when the plaintiffs (parents and their legal team) and the defendants (the manufacturers of the baby formula) agree on an amount of financial compensation for the baby’s injuries. This usually happens before the case goes to trial.
NEC Verdicts: If a settlement agreement isn’t reached between the plaintiff and defendant, the case may proceed to trial, where a judge and jury can hear the claim and reach an outcome through a verdict.
Can I File an NEC Baby Formula Lawsuit?
Parents who have had a premature infant who suffered from necrotizing enterocolitis after being fed cow’s milk-based formula brands by Similac® or Enfamil™ can file a baby formula lawsuit and potentially be compensated.
These steps are helpful to provide evidence for your case:
- Find out if your baby was fed with Similac® or Enfamil™ while in the hospital. If you don’t know, your lawyer will be able to help.
- You may have fed your baby with a Similac® or Enfamil™ cow’s milk-based formula product after taking them home from the hospital. Keep any receipts, proof of purchase, packaging or boxes from the formula for evidence. Check to see if you have fed your child any of the following products.
These Enfamil™ products contain cow’s milk:
- Enfamil™ DHA-In-Sol
- Enfamil™ 24 Calorie Formula
- Enfamil™ Enspire™
- Enfamil™ Human Milk Fortifier Acidified Liquid
- Enfamil™ Human Milk Fortifier Powder (HCPM)
- Enfamil™ Liquid Human Milk Fortifier High Protein
- Enfamil™ Liquid Human Milk Fortifier Standard Protein
- Enfamil™ NeuroPro™ EnfaCare® Premature Baby Formula
- Enfamil™ NeuroPro™ Gentlease®
- Enfamil™ Nutramigen®
- Enfamil™ Premature 24 Cal
- Enfamil™ Premature 30 Cal
- Enfamil™ Premature Infant Iron Formula 20 Cal
- Enfamil™ Premature Infant Formula 24 Cal
- Enfamil™ Premature Infant Formula 30 Cal with Iron
These Similac® products contain cow’s milk:
- Similac® 360 Total Care®
- Similac® Alimentum®
- Similac® Expert Care® Alimentum®
- Similac® Human Milk Fortifier Concentrated Liquid
- Similac® Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid
- Similac® Human Milk Fortifier Powder
- Similac® Liquid Protein Fortifier
- Similac® NeoSure®
- Similac® Special Care®
- Similac® Special Care® 20
- Similac® Special Care® 24
- Similac® Special Care® 24 High Protein
- Similac® Special Care® 30
Premature births are very stressful and emotionally taxing times for families. If you have had a baby born prematurely, your number one priority is the health of your child and safeguarding them from any risks. The last thing a parent should have to be concerned about is their child developing a potentially life-threatening condition, needing surgery, and possibly losing their life because the neglect of a manufacturer of baby formula puts your child in danger.
If your child developed NEC after being fed cow’s milk-based baby formula products, contact Allan Berger & Associates today.
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