There is strong evidence that baby formulas made from cow milk, such as Similac and Enfamil, increase the risk of a dangerous digestive disease called necrotizing enterocolitis (NEC) for all newborns, particularly for babies born preterm.
Yet, the respective companies that make Similac and Enfamil have yet to place appropriate warning labels on their product packaging, likely contributing to thousands of NEC cases among prematurely born infants.
This blog entry provides both legal and medical information about NEC. Q&As include:
What is necrotizing enterocolitis (NEC)?
What does the term “necrotizing enterocolitis” mean?
What is the link between infant formula and necrotizing enterocolitis (NEC)?
What are the symptoms of necrotizing enterocolitis (NEC)?
What are the different kinds of necrotizing enterocolitis (NEC)?
How is necrotizing enterocolitis (NEC) treated?
What is the survival rate for babies diagnosed with necrotizing enterocolitis (NEC)?
Who manufactures Similac and Enfamil?
What is the history and status of lawsuits concerning necrotizing enterocolitis (NEC)?
To what damages can be recovered relative to necrotizing enterocolitis (NEC) and baby formula?
Is there a statute of limitations for NEC baby formula lawsuits?
Should you file an NEC baby formula claim or lawsuit?
How do you file a NEC baby formula claim or lawsuit?
How much does it cost to hire a NEC baby formula lawyer?
1. What is necrotizing enterocolitis (NEC)?
Necrotizing enterocolitis (NEC) is a serious gastrointestinal problem that inflames intestinal tissue, causing it to die (see source). The disease primarily affects premature infants, probably because their intestinal mucus membranes are not as fully developed as that of a full-term baby, and are therefore more fragile (see source).
NEC is mild in some infants. But in more serious cases, the inflammation can cause a perforation to develop in the premature infant’s intestine through which bacteria can enter the abdomen or bloodstream, causing a life-threatening infection.
The disease usually develops within two to six weeks after birth (see source).
2. What does the term “necrotizing enterocolitis” mean?
This term is quite literal. And once you break the word down, it can help you understand the nature of the disease. That said:
Entero is a combining form signifying something to do with the intestine.
Colitis is inflammation of the lining of the colon.
Thus, necrotizing enterocolitis is an inflammation that causes the death of the inner linings of both the small intestine and the colon.
3. What is the link between infant formula and necrotizing enterocolitis (NEC)?
Scientific research and clinical studies have shown that Similac, Enfamil, and other infant formulas made from cow milk significantly elevate the risk of NEC in premature infants. Two examples:
A 2009 study assessed the health benefits of feeding premature infants a diet composed entirely of human milk compared to one containing both human and cow milk. Results demonstrated that premature babies who were entirely fed human milk were 90 percent less likely to require NEC surgery compared to those who had cow milk added to their diets.
A 2017 article published by the American Society for Nutrition reviewed two trials that compared the effect of infant formula made from cow milk compared to that made from human milk for infants with severely low birthweights (between 17.5 and 44 oz). Both trials found that an entirely human milk diet resulted in a much lower incidence of NEC.
4. What are the symptoms of necrotizing enterocolitis (NEC)?
NEC typically occurs in premature babies between three and 12 days after being born. However, late onset might occur several weeks after birth. NEC symptoms affect each baby differently. They might include:
Swollen, red, or tender belly
Gastroparesis (food remaining in the stomach longer than expected)
Diarrhea and/or dark or bloody stools
Inactivity or lethargy
Low or unstable body temperature
Green vomit (containing bile)
Bradycardia (slowed heart rate)
Hypotension (low blood pressure) (see source)
5. What are the different kinds of necrotizing enterocolitis (NEC)?
There are four main types of NEC. They are classified by what causes the disease and when its symptoms begin. These are (source):
Classic NEC. This is the most common type of NEC and the focus of this blog entry. It affects premature babies, occurring three to six weeks after birth. Usually, the infant is stable and doing well. Then, symptoms suddenly appear.
Atypical NCE. So-called because, rarely, a newborn will develop NEC in the first week of life or before the first feeding.
Transfusion-associated. About 33 percent of preterm newborns develop NEC within three days of receiving blood transfusions for anemia.
6. How is necrotizing enterocolitis (NEC) treated?
The first step in treating NEC is the cessation of all feedings. Instead, to keep the intestines empty, a tube is routed through the mouth and into the infant’s stomach to provide needed nourishment. Antibiotics are administered to fight bacterial infection. Blood tests and abdomen x-rays are regularly performed.
Surgery might be required in severe NEC cases, either by opening the baby’s abdomen to remove dead portions of the intestine (i.e., laparotomy), or less invasively, by placing a soft rubber drain into the abdomen to allow damaged material to exit (i.e. peritoneal drainage).
Unfortunately, babies who only undergo peritoneal drainage might nonetheless require laparotomy hours or days later. Those who survive NEC often endure lifelong nutritional and neurological complications. And in the most severe cases, where all of the intestine is dead, NEC is fatal (see source).
7. What is the survival rate for babies diagnosed with necrotizing enterocolitis (NEC)?
The survival rate for children diagnosed with NEC has not significantly improved since the initial description of the disease some 60 years ago, despite significantly improved neonatal care. Sadly, over seven thousand babies are affected by NEC each year in the U.S alone, with a death rate as high as 50 percent. In fact, NEC is currently the leading cause of infant death in the U.S. (see source).
8. Who manufactures Similac and Enfamil?
Similac is manufactured by Abbott Laboratories Inc, and Enfamil by Mead Johnson Nutrition Company, LLC. It is virtually inconceivable that both companies have been unaware of the burgeoning scientific evidence that links cow-milk baby formulas to increased risk of NEC in premature infants.
However, both companies apparently chose not to place an appropriate warning label on their product packaging, something that is relatively easy to do under the U.S. Federal Food, Drug, and Cosmetic Act. This raises the ugly question, were both companies wantonly putting sales before the health of premature infants?
9. What is the history and status of lawsuits concerning necrotizing enterocolitis (NEC)?
The first cow-milk formula lawsuits concerning NEC were medical malpractice claims aimed at healthcare providers. These lawsuits typically alleged that plaintiffs were unable to give informed consent about feeding their infants with cow-milk formula because healthcare providers failed to warn them of the elevated risk of NEC. In response, healthcare providers argued that they were not negligent, because the cow-milk formula manufacturers effectively kept them in the dark about NEC risks.
While some plaintiffs continue to pursue individual medical malpractice claims against healthcare providers and hospitals, a growing number of them are targeting the manufacturers of these cow-milk formulas, particularly Abbott Laboratories and Mead Johnson.
These lawsuits make multiple accusations. However, the fundamental assertion across all of them is that the manufacturers of Similac and Enfamil knew of the increased NEC risk posed by their products, particularly for preterm babies, yet they callously avoided placing appropriate warning labels on their product packaging, lest they lose sales.
Galindo lawyers have been analyzing these NEC lawsuits in all 50 states as they unfold, so that every Galindo NEC baby formula lawyer is highly knowledgeable and qualified to help families whose premature babies are suffering, suffered, or died from NEC subsequent to being fed Similac and/or Enfamil.
10. To what kinds of compensation might parents be entitled relative to necrotizing enterocolitis (NEC) and cow-milk baby formula?
When your infant is injured by NEC, both you and your newborn suffer harm. You can pursue your damage claims either within your child’s claim or lawsuit, or you can file a separate claim or lawsuit. The possible kinds of compensation you can realize are:
Cost of medical care. This is compensation for any past, ongoing, or future medical bills related to NEC.
Pain and suffering. This is compensation not only for physical pain, but also for mental suffering such as emotional distress, loss of enjoyment of life, fear, anger, anxiety, and other negative effects.
Lost income and diminished earning capacity. E.g., you might ask for compensation for lost income if you took time off from work to care for your NEC-affected child. Or, if your child faces a permanent NEC‑related disability, you can sue for his or her lost future earnings.
Loss of Consortium. You might be able to win compensation for the loss of the intangible benefits that rearing a healthy child would provide your family. E.g., caring, nurturing, affection, etc. Whereas loss-of-consortium damages have historically been only available to spouses, an increasing number of states now allow parents to recover them when a child is seriously injured or disabled.
Wrongful death and survival actions. Should your baby die, this is compensation for damages such as funeral and burial costs, your baby’s pain and suffering prior to death, medical costs prior to death, and other losses.
11. Is there a statute of limitations for NEC baby formula lawsuits?
This is a complicated question because different states have various deadlines for filing personal injury lawsuits, and some states might have special deadlines for certain kinds of product liability litigation. Also, the deadline to sue for a child (which can be up to 21 years) is usually longer than for a parent.
Some NEC infant formula lawsuits might have an extended statute of limitations for trial discovery. This is because these suits allege that the lack of appropriate warnings prevented parents from knowing the relationship between cow-milk baby formula and NEC until only recently.
Nonetheless, there could be a relatively brief window for filing a claim. So, if you are considering bringing forward a baby formula claim or lawsuit, you should consult with a NEC formula lawyer today to fully understand your rights—even if you are just thinking about it at this point.
12. Should you file an NEC baby formula claim or lawsuit?
You might be understandably equivocal about filing a NEC baby formula claim or lawsuit because it is not in your nature—you might say—to “sue people” or otherwise be litigious. After all, Abbott Laboratories and Mead Johnson have been selling cow-milk based infant formula for decades, and the great majority of full-term babies who lack access to human milk do well with it.
In fact, perhaps adding to your reluctance, you might have other children who “did okay” with Similac and Enfamil. Maybe even you were fed it as a child. But these are precisely the reasons that Abbott Laboratories and Mead Johnson should be brought to task and held responsible. Consider:
The failure to warn parents about the risk of NEC to their babies due to cow milk—whether full term or premature—is a terrible example of corporate greed and negligence.
A package warning would have had little effect on sales from parents and medical caretakers of full-term babies: the lion’s share of the business. Americans are quite accustomed to manufacturers’ warnings about the possible serious side effects that their medicines might have in very rare instances, “including death.” They leave it to their physicians to help them weigh the risk/benefit ratio for themselves and their children; and it is virtually always in favor of taking the medicine.
Contrarily, yes, sales to parents and medical caretakers of premature infants would have taken a substantial hit. But as a percentage of total sales, this would be small. One has to wonder how someone in marketing did not notice that the amount of goodwill (and consequent brand loyalty) the warning label would foster was better public relations than abetting “the leading cause of infant death in the U.S.”
In sum, these companies took cynical advantage of your trust in them, hiding the dangers of their product to your premature baby, solely to protect a ridiculously small portion of their profits. Morally, you could call this a callous disregard for life.
Do not let them get away with it.
13. How do you file a NEC baby formula claim or lawsuit?
Galindo Law NEC baby formula lawyers are currently seeking to confer (at no cost) with the families or guardians of premature infants who have contracted NEC after being fed Similac or Enfamil formula. As things are unfolding, there is an excellent chance that you will be empowered to seek compensation from Abbott Laboratories or Mead Johnson if your premature baby was harmed by cow‑milk infant formula.
14. How much does it cost to hire a NEC baby formula lawyer?
Galindo Law does not charge any upfront or out-of-pocket fees. We are only paid a percentage of the settlement we are able to secure for you. So by working with Galindo Law, you incur zero financial risk.
Remember, when it comes to a NEC baby formula claim, you are not asking for charity. You deserve to be adequately compensated for your and your child’s losses.
Or, if you prefer, email us.
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