If your premature infant fed on Similac or Enfamil baby formulas and suffered injuries or died from necrotizing enterocolitis (NEC), you have a right to seek justice. There is an ongoing mass tort against the manufacturers of these formulas for their failure to adequately warn consumers of the dangers of cow’s milk-based formulas, especially to preemie babies. Medical research confirms that cow’s milk-based formulas cause life-threatening neonatal conditions, including gastrointestinal problems like necrotizing enterocolitis.

The NEC baby formula lawsuits blame the makers of Similac and Enfamil for their negligence. These manufacturers knew or should have known about the possibility of preemie babies contracting NEC after consuming a cow’s milk-based formula. They are liable for damages because they gave no warning, therefore prioritizing their profit margins over the health and welfare of their consumers. A competent product liability lawyer can help you join other families in the class action against Similac by Abbott Laboratories or Enfamil by Mead Johnson.

Necrotizing Enterocolitis (NEC) Defined

Necrotizing enterocolitis is a bacterial intestinal infection that mainly affects premature infants. Often, the babies are more vulnerable to the disease during their first weeks of life, especially if they are fed a cow’s milk-based formula instead of breast milk.

NEC occurs when bacteria invade the intestines and inflame them to create cracks, gaps, and holes. These gaps allow germs to leak into the abdomen, causing a life-threatening infection. The lungs and intestines of preemie babies are weak, meaning their bodies cannot move blood and oxygen like full-term babies. Consequently, their digestive system has challenges breaking down food and fighting infection, a concern that triples the risk of developing NEC.

The symptoms of NEC include:

  • Bloated or swollen belly
  • Bloody poop
  • Greenish vomit
  • Lethargy and fever
  • Erratic blood pressure and breathing pattern changes
  • Loss of appetite
  • Low heart rate, lethargy, and sluggishness

NEC Treatment

Doctors can diagnose NEC using various procedures, including abdominal X-rays and blood tests. Unfortunately, the child has to remain in the neonatal intensive care unit for a while to have maximum chances of fighting the infection.

The ideal treatment approach will depend on a preemie baby's overall state of health. The treatment course can involve:

  • Stopping oral feeding and relying on IV fluids for hydration and nourishment
  • Aggressive antibiotic treatments
  • Removal of all fluid in the stomach via a tube inserted through the nose and into the stomach
  • Repeated x-rays to monitor the condition
  • Reliance on a breathing machine if the baby is too ill to breathe on its own
  • Isolation to prevent the possible spread of infection to other babies
  • Surgery to remove dead or ruptured intestinal tissues
  • Ostomy (connecting the intestine or bowel to an opening in the abdomen) in severe NEC cases

NEC Consequences

Although most infants who develop NEC recover fully, about 15 to 40% of premature patients succumb to the infection. The main reason behind the life-threatening nature of NEC is that an infection can cause sepsis, a potentially fatal blood infection.

Moreover, treatment can cause the narrowing and scarring of the bowel, increasing the risk of future blockage. Babies who undergo surgery and have substantial portions of the intestines removed will likely not absorb nutrients as effectively as other children. This could make a bowel transplant necessary to ensure the child lives a full and healthy life.

Why Do Preemie Babies Face A Greater Risk Of Developing NEC?

A fetus in the womb receives air from its mother’s blood through the ductus arteriosus. This is a blood vessel that connects the pulmonary artery and the aorta. The ductus arteriosus should close once the child is delivered.

Patent ductus arteriosus (PDA) arises when the ductus arteriosus fails to close as expected. Preemie infants are more susceptible to PDA, and the concern causes oxygenated blood to bypass the intestines and return to the lungs. Unfortunately, this also causes pulmonary edema when the blood vessels in the tiny lungs become overloaded.

So, how is this connected to necrotizing enterocolitis?

When a child is born prematurely or with low birth weight, Patent ductus arteriosus presents severe symptoms because the intestines are not fully matured. When a preemie consumes a cow’s milk-based formula, it causes accelerated deterioration of the bowel walls that already receive lower amounts of oxygen. This is what increases the risk of necrotizing enterocolitis.

The Connection between Cow’s Milk Based Formula and NEC in Premature Babies

Premature babies have unique nutritional needs. They require about 40% more protein, minerals, calories, and nutrients than full-term babies. The extra support from baby formulas is often essential during their first days of life. Irrespective of how hard a mother tries, her breast milk alone cannot satisfy the child's nutritional needs.

This is where fortified milk formulas come in handy. They provide the much-needed extra nutrients to ensure the proper growth and development of the baby. The products are also helpful when a preemie cannot physically breastfeed.

The Similac and Enfamil Problem

Baby formulas are fortified with higher concentrations of nutrients that ensure low-birth-weight and premature babies achieve the recommended feeding volumes. The problem emerges when these cow’s milk protein-based formulas are advertised as beneficial for premature babies.

Over the past three decades, numerous studies have shown that preemies have difficulty digesting cow’s milk-based formulas. The formulas also drastically increase the risk of contracting NEC, a condition that causes a bacterial septic overload in the intestines of premature babies. An infection bores holes in the tiny intestines causing bleeding, intestinal damage, and possible death. Unfortunately, this is something the makers of Similac and Enfamil know, yet they have conveniently failed to mention it on their product labels.

Lancet Study

In the U.S., 1 in every 2,000 full-term babies suffers from NEC. However, the concern is more prevalent among premature babies, and it affects roughly 10% of all preemies each year. Even though scientists are yet to unveil the actual cause of NEC, studies suggest that preemies fed on cow’s milk-based formulas like Similac and Enfamil are at greater risk of contracting the infection.

For decades, the link between NEC and cow’s milk-based formulas has been a well-known fact. The Lancet study published in 1990 confirmed that formula-fed preemies faced a ten times greater risk of developing NEC.

The Cochrane Study

Cochrane is an independent research group that mainly focuses on health care matters. In 2019, research dubbed the Cochrane study showed a detailed comparison of the outcomes of feeding preemies with cow’s milk-based formulas versus human milk. One of the critical facts unveiled by the study is the clear link between bovine-based products and NEC in premature infants.

Journal of Pediatrics Study

In 2000, the Journal of Pediatrics conducted a related study that further confirmed the 10% risk of developing NEC when infants are fed baby formula. The study showed that preemies exclusively breastfed or fed on human milk fortifiers faced a 90% reduced risk of developing NEC than infants fed on traditional baby formula.

The Journal of Pediatrics conducted two more studies published in 2013. Again, the findings confirmed the link between NEC and cow’s milk-based formulas.

British Medical Journal Study

On October 14, 2021, the British Medical Journal published a new study that further fuels the lawsuits against the manufacturers of Similac and Enfamil infant formulas. The studies suggest that Abbott Laboratories and Mead Johnson have funded unreliable and biased clinical product trials to water down the claims of thousands of parents whose premature babies developed NEC after consuming Similac or Enfamil. The formula trials lacked universal transparency and cannot downplay the link between NEC and cow’s milk-based formulas.

Other Relevant NEC Studies

  • In July 2014, an evidence-based clinical study on feeding strategies before and after contracting NEC established a link between the increased risk of developing the disease after administering infant formula. The condition has devastating health effects that can cause mortality.
  • The “Beyond Necrotizing Enterocolitis Prevention” –Breastfeeding Medicine published in 2016 and the “Human Milk Is The Feeding Strategy To Prevent Necrotizing Enterocolitis” – Semin Perinatol published in 2017 showed a lower risk of NEC when premature infants are fed exclusively on human milk. The studies also unveiled a reduced risk of sepsis and neurological conditions like BPD (Borderline Personality Disorder) and eye conditions like ROP (Retinopathy of Prematurity) when preemies feed exclusively on human milk. Generally, both studies emphasize the perks of human milk instead of fortified baby formulas.

Reasons the Manufactures of Similac and Enfamil Are Liable To Damages Caused By NEC

Similac by Abbott Laboratories Inc and Enfamil by  Mead Johnson Nutrition Company are billion-dollar companies that dominate the baby formula market in the United States. Both companies know or should have known about the scientific evidence linking cow’s milk-based formulas and the high risk of developing NEC in preemies. Unfortunately, neither Abbott nor Mead Johnson bothered to include this information on the product labels.

Thanks to the United States Federal Food, Drug, and Cosmetic Act (FFDCA), the process of changing warnings of product labels is dead simple. Arguably, the processes in place are much simpler than changing the warning labels on a drug.

This begs the question: why have Abbott and Mead Johnson opted to leave out the crucial warnings?

The main reason behind their negligence is yet to be unveiled. What is clear is that both companies continue to use stellar marketing gimmicks to pose their products as the best for the proper health and development of premature babies. Nowhere on their product labels have either company mentioned the devastatingly high risk of developing NEC for preemies fed on a cow’s milk-based formula.

It is easy to conclude that Abbott and Mead Johnson prioritize their profit margins over the welfare of their consumers. A clear warning of the risks of bovine-based formulas can quickly reduce their sales, leading to a significant cut on their annual profits.

NEC Lawsuits against Abbott and Mead Johnson Baby Formula Companies

There is an ongoing lawsuit filed by the parents of preemie infants who developed NEC after being fed with Similac or Enfamil baby formulas. The claims hold Abbott Laboratories Inc. and Mead Johnson Nutrition Company accountable for their negligence and failure to warn consumers of the link between NEC and cow’s milk-based formulas.

The product liability attorney will need to prove the following elements:

  • Duty — Abbott Laboratories Inc. and Mead Johnson Nutrition Company owed consumers of the baby formula a duty of care.
  • Breach — Even with knowledge about the high risk of preemie babies developing NEC after being fed on bovine formulas, these manufacturers failed to warn their consumers on their product labels. Hence, they violated the standard of care, causing the plaintiff’s injuries or death.
  • Cause in fact — Based on research conducted as early as 1990 (Lancet study), these companies knew or should have known about the link between NEC and Cow’s milk-based formulas. Numerous studies show a clear correlation between bovine baby formulas and Necrotizing Enterocolitis.
  • Proximate cause — If it were not for their failure to provide adequate warning, parents and caregivers would not have used these formulas. The affected preemies suffered injury or death due to Abbott’s and Mead Johnson’s failure to exercise their duty of care.
  • Harm — The premature babies fed on bovine formulas from these companies developed NEC and related health complications. These infants required medical procedures or died because of Abbott’s or Mead Johnson’s negligence.

Unfortunately, Abbott and Mead Johnson continue to advertise their baby formulas as safe and beneficial to babies, including those born prematurely. This does not water down the validity of the class-action lawsuit against the baby formula manufacturers.

So, are the lawsuits massive class actions?

The lawsuits against Abbott and Mead Johnson are not massive class actions because NEC is rare. Moreover, premature babies face the highest risk of developing the infection during the first two weeks of life. The number of victims is currently small, although this could change as more parents join the class action.

It is crucial to understand that the size of a class action has little or nothing to do with the settlement to expect. The court always considers the number of plaintiffs when deciding the befitting compensation to offer. Moreover, the victims of NEC caused by cow’s milk-based formulas suffer extreme injuries that warrant an extraordinary payout.

How Much Compensation to Expect

There is not much history about NEC baby formula lawsuits. However, it is possible to project the plaintiffs' potential settlement based on compensation awarded to NEC medical malpractice lawsuits victims. The victims of successful cases have received millions of dollars. Therefore, it is safe to anticipate the same kind of compensation payouts if the NEC baby formula lawsuits win.

Based on the overwhelming evidence against Similac and Enfamil lawsuits, these cases will potentially not go to trial. Instead, the baby formula manufacturers are likely to seek negotiations. Even in an out-of-court settlement, victims can expect a payout of at least $2 million per case. Of course, these are just the anticipated figures, meaning a payout could be more or less than $2 million.

Statute of Limitations for NEC Baby Formula Lawsuits

If your premature baby fed on Enfamil or Similac and suffered NEC, it is imperative to contact a product liability attorney right away. Note that you cannot file a claim once the statute of limitations for product liability expires.

The deadline for filing an NEC lawsuit depends on several factors, like when you suffered damage or when you discovered NEC damages caused by bovine-based baby formulas.

Generally, you have two years from when you suffered damages to file a case against Similac and Enfamil manufacturers. The law gives you a maximum of 3 years from when you discovered the damages caused by bovine-based baby formulas to file your claim. On the other hand, survivors of NEC inflicted by a cow’s milk-based formula have until they are 21 to file a lawsuit.

The best time to consult a skilled product liability attorney is now. The idea is to have your case reviewed in detail, and to understand your rights and legal options. Note that even if you have a strong case, you could lose your chance to seek a settlement if you fail to take advantage of the short window to file a claim.

Updates on the Ongoing NEC Class Action Lawsuit

By February 2021, there were 33 NEC baby formula lawsuits filed in Illinois, where the headquarters of both Abbott Laboratories Inc. and Mead Johnson Nutrition Company are situated. NEC lawyers filed a motion with the Illinois Supreme Court in December 2021 to have the 33 cases unified to form one MDL class action.

In January this year, the court granted Abbott and Mead Johnson extensions to respond to an MDL class-action request. There is a high likelihood that both companies will agree with combining the cases to facilitate a more efficient defense.

Illinois has a high chance of becoming the NEC baby formula lawsuit epicenter. There is growing momentum as tens of parents from all 50 states join the class action in 2022. One of the key reasons why Illinois is the best region to file the class action is that it allows attorneys from other jurisdictions to represent their plaintiffs in the state. Furthermore, because Abbott and Mead Johnson companies are based in Illinois, they have no grounds to object to filing a lawsuit within the jurisdiction.

The NEC baby formula class-action lawsuit is expected to begin this year. There is great anticipation that the involved baby formula manufacturers will provide a fair settlement to resolve NEC-related injuries and fatalities claims. This will also bring some changes to the product labels of Similac and Enfamil to protect other uninformed consumers from potential damages on preemie infants caused by cow’s milk-based formulas.

Arguments to Expect from Mead’s And Abbott’s Defense Teams

Families that have suffered damages because of Mead’s And Abbott’s failures to provide an adequate warning on their products can sue multiple parties within the bovine formula’s chain of distribution. However, suing the billion-dollar product manufacturers is the surest way to ensure you recover full damages. NEC baby formula attorneys are well prepared to tackle arguments Mead’s and Abbott’s defense teams will likely present.

These arguments include:

Preemption

A successful preemption defense can quickly force the court to dispose of a case. For instance, the manufacturer's defense team can argue that even though the FDA’s Changes Being Effected (CBE) regulations allow brand manufacturers to change product labels without prior FDA approval, not all labeling alterations can be made through the CBE. The move shifts the burden to the plaintiff to prove that the CBE was available to make the needful labeling changes.

Fortunately, the preemption argument has a history of not bearing the anticipated outcome.

Newly Acquired Information

FDA defines “newly acquired information” as data from clinical studies and other credible analyses that have not been submitted to the FDA in the past. This means that even clinical research findings conducted decades ago cannot be used unless the researchers presented the studies to the FDA.

Again, the presence of “clear evidence” in the NEC lawsuit is out of the question.

Cause of Damage

Mead’s And Abbott’s lawyers will likely argue that the actual cause of NEC is still unknown. Even preterm babies under exclusive breastfeeding can still develop NEC. A competent product liability lawyer will have to table strong, evidence-based arguments that demonstrate the clear link between cow’s milk-based formulas and the high risk of a preemie developing NEC.

Find A NEC Baby Formula Lawsuit Attorney Near Me

NEC is a life-threatening intestinal infection that causes devastating pain and suffering. Even preemies that survive after infection are at risk of suffering from long-term health concerns. If your premature baby developed necrotizing enterocolitis after consuming Similac or Enfamil formula, you should seek justice now. At Consumer Alert Now, we can help you file a lawsuit to help you recover compensation for the economic and non-economic damages suffered. Dial 800-511-0747 for a free consultation and no-obligation case evaluation. We accept cases from all 50 states!