As loved as a premature baby is, when a family brings one into the world, the baby comes with a slate of possible health issues. One is an acute need for extra nutrition to address medical needs, including dehydration, jaundice, weight loss, and low blood sugar.
To help the premature infant, many physicians recommend using baby formula, particularly if the mother is struggling to nurse. At least, for many premature infants, baby formula is a supplement to the mother’s contributions.
Unfortunately, several studies, and eyewitness accounts from parents, indicate that baby formula made from cow milk increases the chances of a premature infant contracting Necrotizing Enterocolitis (NEC).
If you have given your premature baby formula or if the hospital caring for your preemie fed them with cow milk-based formula, and they developed NEC, please continue reading about the pending NEC baby formula lawsuit to understand your legal options.
The attorneys at Stoy Law Group can help you move forward with your NEC lawsuit. Contact our team today.
What Is NEC?
NEC (Necrotizing Enterocolitis) is a potentially lethal gastrointestinal disorder that presents as intestinal injury or inflammation of the baby’s intestines. It can lead to necrosis, organ failure, and potentially death. It primarily sickens premature infants or newborns and presents as bowel tissue deterioration.
This weakens the intestine and can cause it to rupture. When that happens, the premature infant can experience:
- Blood Poisoning
- Loss of the body’s intestines
- Permanent blindness
- Cerebral Palsy
- Death
- Nerve damage
In most cases, an NEC baby experiences permanent, tragic injuries. At worst, an NEC premature infant can die.
What is NEC in Babies?
In a normal digestive tract, millions of bacteria live in the intestines and aid with digestion. The bacteria are called “normal flora.†Without them, food digestion and the extraction of nutrients would be much more difficult, if not impossible.
In an NEC newborn, normal flora, plus dangerous bacteria damage the intestine and cause a perforation. Often, this extends through the sides of the bowel, and the contents leak into the abdomen.
From there, bacteria can enter the premature infant’s blood, which can cause toxicity that leads to an infection. Necrotizing Enterocolitis causes several health problems and is life-threatening.
Major Negative Health Consequences with NEC
In addition, the damaged intestine can die and start to decompose. When that happens, in addition to any infection or infection side effects, surgery to remove the dead portion of the intestinal tissue becomes necessary.
If the premature infant only endured an infection or injured bowel, it would be bad enough. When you add NEC side effects and surgery to the equation, the situation becomes much severe. Bowel perforation surgery has a mortality rate exceeding 35% when performed on premature infants.
NEC Classifications
Healthcare providers break NEC cases down into specific, cause-based categories.
Classic
Classic NEC is the most common type. It most often affects infants born before 28 weeks in a normal pregnancy cycle. It usually occurs three to six weeks after birth and can develop and manifest exceptionally fast, usually with no warning or symptoms.
Transfusion-Associated
This type of NEC infection happens when an infant needs a blood transfusion to treat anemia. It also affects premature babies almost exclusively because their immune system is generally underdeveloped. About one in three preemies develop NEC within one week of getting a transfusion.
Atypical
This classification rarely happens, even among premature infants. The official definition is when an infant develops NEC within a week of birth or even before the baby’s first feeding.
Term Infant
In healthy full-term babies, developing NEC is exceptionally rare. Full-term babies, however, can develop NEC if they have underlying health issues, like a congenital disability. Congenital heart conditions, gastroschisis (when intestines are formed outside the body), and low oxygen levels at birth are examples of the types of defects that can cause infants to develop NEC. It is also rare.
Neonatal ICU (NICUs) Outbreaks
NICUs caring for premature babies can occasionally experience an NEC outbreak, although it is rare. It occurs most often when the unit or equipment becomes infected with bacteria, such as E. Coli. Usually, when an outbreak like this happens, several infants are infected.
NEC Preemie Symptoms
Symptoms relating to NEC vary widely from premature infant to premature infant. One reason NEC is difficult to diagnose is that many NEC symptoms mirror symptoms of other health issues. Often, NEC goes undetected until the premature infant has developed multiple symptoms and their short and long-term health is in jeopardy.
NEC baby formula symptoms include, but are not limited to:
- Temperature instability
- Slow heart rates
- Lower blood pressure
- Lack of appetite
- Distended belly
- Tender and swollen belly
- Lethargy
- Diarrhea and vomiting
- Breathing issues
NEC symptoms can occur singularly or in multiple.
Additionally, many parents wonder “Can NEC come back even after it is treated?”, and the answer is “yes†if the premature infant’s diet remains the same.
NEC Diagnosis
Because the symptoms mirror many different health issues, diagnosis is problematic and often is confirmed indirectly. An X-ray can reveal unusual gas patterns and their effects on the side of the body’s intestines. Blood tests are used to show high levels of bacteria, unusual blood cell counts, lactic acidosis, or low platelet counts (thrombocytopenia.)
The results of either test do not prove a diagnosis of the presence of NEC.
The difficulty in diagnosing NEC is partly why the disease can be so devastating. The process is to rule out simpler, less deadly issues first because treatments for NEC are invasive, complicated, and involve risk for the premature infant.
Standard NEC Treatment
There are a few approaches to treatment for NEC. The following is a summary.
Stop Feedings and Adopt a New Feeding Strategy
The first step is to remove the potential cause of the illness. That is not an admission that NEC infant formula claims are accurate, but it is an acknowledgment that trends between higher levels of NEC and the use of cow milk formula are clinically documented.
Relieve Gas
Insertion of tubes into the Premature infant’s stomach is the standard remedy for excessive gas. It is invasive, and one reason why ruling out other causes of symptoms resembling NEC symptoms is a priority.
Antibiotics
Another approach is to administer heavy doses of intravenous antibiotics. The goal is to arrest any bacteria growth as quickly as possible.
Intravenous Feedings
In addition, cow milk-based formula is discontinued, and the baby is fed intravenously.
Lab Work
The premature infant is monitored continuously. Part of the treatment may involve X-rays as well as blood tests or arterial blood gases analysis.
Elevated NEC Treatment
While all the above is the initial strategy, unfortunately, it does not always work. In some cases, an accelerated and more invasive procedure is required. This more invasive approach is adopted. Any severe damage done to the abdominal wall requires surgery.
Surgery, in this case, can include:
- Removal of dead tissue
- Colostomy
- Ileostomy
Any preliminary surgery can include part or all of that list.
In addition, a bowel reconnection will be required after some time, depending on what time the infection has been controlled and eradicated and the inflammation has healed.
NEC Prognosis
The prognosis of a premature infant afflicted with NEC varies. Several factors can determine the outcome and rate of healing:
- The premature infant’s immune system
- The point in time the NEC was discovered
- Whether surgery was needed
- How quickly treatment gained a foothold
- The degree of infection and/or toxicity
Unfortunately, NEC is a highly severe and dangerous disease. The mortality rate for premature infants that contract NEC is almost 40%.
The only treatment that will work is early diagnosis followed by aggressive measures such as intravenous antibiotics and abdominal tube insertion.
NEC is not a disease that will usually cure itself.
Can Babies Survive NEC?
There are health problems that babies that survive NEC or survive surgery are harnessed with for the rest of their lives. As mentioned, long-term problems include diseases like cerebral palsy, quality of life issues like damaged and missing intestines, and disabilities, including blindness.
Worse, a premature infant with NEC is not restricted to just one of those negative consequences. At least, a premature infant that develops NEC likely needs surgery to remove part of their intestine.
On top of the assumed risk associated with surgery, plus an injured or missing portion of one or both intestines, a premature infant can also develop one of those side effects.
In addition, just because a premature infant is treated and cured of NEC does not mean it cannot reoccur. If the feeding regimen of the premature infant remains the same, the likelihood NEC can return is at least as high as the likelihood the premature infant would catch it in the first place.
General Facts About Infection Rates
Just about every baby, 90% by some estimates, that develop NEC are born prematurely. Within that group, NEC affects certain premature infants more frequently and more seriously.
NEC cases show up most frequently in premature infants that fall into the following categories:
- Preemies born before week 37 of the pregnancy cycle
- Premature infants fed through a stomach tube
- Early babies that weigh less than 5.5 pounds at birth
The most significant risk of developing NEC is in premature infants that weigh less than two pounds.
Frequency of NEC
NEC occurs among premature infants so often it is considered “common.†Roughly 1 in 1,000 premature babies develop it.
Conversely, NEC rarely affects full-term infants. Only about one in 10,000 full-term infants develop NEC.
NEC Suspected Causes
There is no clinical verification that a specific formula causes NEC in premature infants. There are, however, observed links between cow milk-based formulas and NEC in premature babies. The occurrence of NEC in premature infants consuming cow milk-based formula versus premature infants that drink human milk is significant.
The occurrence of higher rates of NEC in premature infants that consume cow milk-based formula can be linked by default to specific manufacturers.
In one case, documented by researchers and medical staff at Johns Hopkins Medicine, only one developed NEC of 29 premature infants that received human-produced milk. Of premature infants that received formula cow milk-based formula, five of 24 babies developed NEC, four of whom needed surgery.
What is Clinically Proven?
What has been clinically observed is that there seems to be a link between premature infants that develop NEC that drink cow milk-based formula and a decrease in NEC occurrence among premature infants that consume human milk.
Additionally, premature infants that consume human milk exclusively have a far lower frequency of NEC occurrence and associated mortality. This is in comparison with the NEC occurrence and mortality rate of premature infants that are fed a diet containing cow milk products.
What That Means
Human breast milk is recognized as the hands-down healthier alternative for any newborn baby. This is even more so for premature infants because of their increased need for nutrition. Human breast milk promotes healthy organ and tissue development, brain development and strengthens internal systems like immunity.
While a mother’s breast milk is always the preferred option, human breast milk from anyone is an alternative if the mother cannot provide milk when a premature baby is born. Whether from the mother or a surrogate, the baby is fed human milk through a tube that runs through the mouth, nose, or stomach.
A Potentially Deadly Sequence
Cow milk-based formulas pose a risk to all infants, but mainly to premature infants. One reason for this is that a premature infant’s digestive tract cannot break down some of the proteins that are found in cow’s milk. Partially digested proteins allow toxins to build up and dangerous bacteria to cluster.
Compounding this threat is the fact that a premature infant’s intestinal wall cannot provide a suitable structural barrier to bacteria, both good and bad. What that means is that the premature infant is vulnerable to bacteria penetrating and eating away intestinal walls.
A third issue is that a premature infant’s digestive system is unable to keep dangerous bacteria out. This inability to filter bad bacteria and remove them adds to the problem of toxin and bacteria buildup and the weakness of either intestine.
Finally, a premature infant cannot secrete normal biochemical defenses, which would at least keep the bad bacteria at bay.
The entire sequence looks like this:
- A buildup of bacteria and toxins along with undigested proteins
- Lack of structural integrity to protect the intestine
- The inability of the infant to keep harmful bacteria out
- The inability of the infant to launch natural defenses against the onslaught
It is important to note that while the last three would be present no matter the scenario, the first risk is only present because of the cow milk-based formula.
Unsterile Formula
Adding to the overall risk posed by the cow milk-based proteins and natural vulnerabilities of the premature infant is the fact that most powder-based formulas are not sterile.
This opens the door for bacteria to piggyback on the formula and gain access to the premature infant. Once inside the premature infant’s intestinal tract, the inability to break down proteins from cow milk-based formula creates a natural food source for the bacteria.
From that point, it is only a matter of time before the premature infant succumbs to NEC unless some sort of intervention occurs.
The Role of Formula Makers
The trends regarding premature infants, cow milk-based formula, and NEC prevalence in premature infants are not in dispute. There is clinical and observed evidence that cow milk-based formula at least creates the environment for a “perfect storm†of toxicity to occur.
When that toxicity perforates through the intestine, the results are catastrophic, likely long-lasting, and deadly in the most severe cases.
What is disputed is the role cow milk-based formula makers play in contributing to the health risks of premature infants.
Additionally, two questions are relevant:
Did the makers of cow milk-based formula know about the risk to premature infants?
If not, given the clinically documented and observed trends, how could they not have known?
In the spotlight are the two leading manufacturers of cow milk-based formula, Abbot and Mead Johnson. Those manufacturers make Similac and Enfamil, respectively, two cow milk-based formula products.
Specifically, the following products are in question:
- Enfamil Human Milk Fortifier
- Enfacare Powder
- Similac Special Care
The NEC infant formula lawsuit alleges that both companies did know the risks and failed to warn consumers appropriately.
This does not preclude other cow milk-based formula products from being added to the lawsuit.
What Baby Formula Causes NEC?
The answer is not a matter of singling out a specific product. It is that all cow milk-based formulas at least increase the risk of NEC.
Additionally, all cow milk-based formulas help create the environment under which the bacteria that cause the perforated intestinal wall that leads to NEC can thrive.
More importantly, however, is the question of what either cow milk-based formula maker knew and when did they know it? Further, given the evidence of at least a link, how is it possible that both were not at least aware of the enhanced risk?
Finally, given the assertion that each should have known, why were consumers at least not warned about the suspected link between the formula and the occurrence of NEC?
Is There a Lawsuit Against Baby Formula Companies?
The answers to each of those questions help formulate a pattern of negligence by the manufacturers of cow milk-based formula.
The Negligence Argument
That negligence is a product of deliberate omission or an unbelievable ignorance regarding the risk the formula products in question posed to premature infants.
The plaintiffs in an NEC baby formula lawsuit allege that negligence led to unnecessary illness in premature infants that were fed cow milk-based formula.
In addition, the negligence also caused or contributed to lifelong or at least long-term physical health issues and attached mental and emotional health issues of the children sickened.
Finally, that negligence led to the deaths of premature infants that were
- Unable to fight off the NEC
- Diagnosed too late because the symptoms relating to NEC closely mirror the symptoms of multiple baby-related illnesses.
Involved Parties in NEC Lawsuits
The plaintiffs allege that the products in question lacked the proper warning for the following parties of the risk to premature infants:
- Physicians
- Medical providers
- Parents or guardians
The plaintiffs also allege that had those parties known of the risk, and they would not have used cow milk-based formula on any infants if it could be helped.
Further, they would not have used cow milk-based formula on any premature babies in any situation unless there was no other option.
Demands
Given all that, the baby food lawsuit demands:
- That premature infants that developed NEC symptoms and were given a cow milk formula diet should be compensated for medical costs to treat the NEC
- That babies that developed NEC baby formula symptoms and subsequently had long-term health problems because of it be compensated for the costs of treating the negative physical, mental, and emotional health issues
- That parents of babies that developed NEC baby formula symptoms that led to death or surgery and death be compensated for their loss as part of a wrongful death determination
Legal Case Logistics
As with any sizeable legal case, there are logistical challenges to ensure adequate representation to all that deserve it. This is why if your premature infant or child experienced NEC after being on a diet consisting of cow milk-based formula, you should contact Stoy Law Group which specializes in product liability and class action lawsuits.
The Suit Expands Beyond Victims
Additionally, even if your premature infant did not come down with NEC but was fed cow milk-based formula, you might have a legitimate reason to join this case. The two formula products maker’s alleged negligence extends beyond those who got sick, had long-term effects, or perished.
Any NEC class action lawsuit will cover those exposed to the negligence of the formula manufacturers as well as those exposed whose preemies became ill. Whether the manufacturers knew about the risk and said nothing or should have known about the risk, the exposure is the same regardless of whether a child was sickened because of ingesting the product.
While your situation may not apply to any NEC formula lawsuit, if your child was fed cow milk-based formula, it is worth discussing the matter with a competent attorney.
While compensation for those exposed to negligence or who suffered a child that developed NEC is the focus of the case, two other areas are addressed.
Adequate Warning to Caretakers
While it may not be a practical expectation that the manufacturers of cow milk-based formula would cease making it altogether, more and more explicit warnings on the product are needed at the very least.
It is one thing for a harried parent to overlook a warning. It is another for a physician or medical staff to serve a potentially deadly substance to a child because the warnings on the product are nonexistent or insufficient.
Manufacturers of cow milk-based formulas should increase and enlarge warnings to physicians, medical staff, and parents of the link between cow milk-based formulas and premature infants developing NEC. The product should be clearly labeled as a hazard to certain infants, and the risk should be clearly defined.
Better Packaging for Baby Forumulas
The fact that powdered, cow milk-based formulas are not sterile is also a significant cause of concern.
This expands the negligence argument far beyond just premature infants that develop NEC. It includes any newborns fed powdered, cow milk-based formula and particularly any premature infants provided the substance.
Again, adequate warning on formula packaging would provide an alert to physicians, nurses, other medical staff, and parents that formulas may not be safe.
Deadlines and Limitations for NEC Lawsuit
The deadline for any case is subject to state laws. Every US state has different deadlines for filing lawsuits. These are commonly referred to as “statute of limitations.â€
In civil cases, a statute of limitations is the timeline and deadline for which an aggrieved or injured party can file a lawsuit. The purpose of statute of limitations restrictions is to ensure due process for those accused of causing harm.
Additionally, many states have a “statute of repose.†This law restricts certain legal rights if a claim is not acted upon within a specific timeframe. Most often, statutes of repose affect what damages can be awarded if the defendant in a lawsuit is found guilty of the charge of the suit.
The smartest move to ensure you do not miss any deadlines if you have a legitimate claim in an NEC baby formula lawsuit is to get a free consultation from a qualified attorney.
Final Thoughts on NEC Lawsuit
NEC is an infection that can quickly sicken and even kill a premature infant. Compelling evidence suggests cow milk-based formula is to blame for creating the environment in which NEC can take hold.
If you have a premature infant that was sickened by NEC or was fed cow milk-based formula, contact the attorneys at the Stoy Law Group for a free consultation today.
