NEC Baby Formula Lawsuit

 

Our lawyers are handling Similac and Enfamil infant formula lawsuits for families whose premature babies suffered or died from necrotizing enterocolitis (NEC) after taking one of these formulas.

Medical research links cow milk-based infant formulas such as Similac and Enfamil to a dangerous neonatal medical condition known as necrotizing enterocolitis.  These newborn NEC formula lawsuits make a lot of allegations.  But at the core of it, are saying – The makers of these formulas knew of the risk of NEC and did nothing to warn families and give them a choice.

If your premature baby was diagnosed with NEC after being given Similac or Enfamil formula, you may be able to bring a product liability lawsuit against the formula company and receive financial compensation for your loss.

Our law firm is currently seeking new preemie baby formula lawsuits to represent families who have suffered as a result of this infant formula.  Our NEC formula lawyers are bringing lawsuits against the baby formula manufacturers.

You can call our baby formula lawyers today in all 50 states at 800-553-8082.  Time may be limited to bring an NEC lawsuit.  Do not let these companies avoid justice by hiding behind the statute of limitations.  Call our attorneys right now.


NEC Class Action Lawsuit Status Updates

I know many of you are already following the NEC baby formula lawsuit closely.  So before we get into the substance of these lawsuits, let me give you a quick update on the latest in the litigation. 

  • 5/23/22 NEC Update: The Formula NEC MDL (In re: Abbott Laboratories, et al., Preterm Infant Nutrition Prod. Liab. Lit.– MDL No. 3026) is formally underway in the Northern District of Illinois. Judge Rebecca Pallmeyer held her first status conference on May 19 and will make selections for the plaintiffs’ Lead Counsel, Liaison Counsel and leadership committee this week. As of May 16, a total of 52 active cases have been consolidated into the MDL. That number will likely triple over the next month.
  • 5/04/22 NEC Update:  These lawsuits are moving forward.  Our NEC baby formula lawyers are surprised by the number of parents we hear from every day interested in filing an NEC formula lawsuit.  Our attorneys are finding that the most viable lawsuits are the ones where the child is born after 2011.  The biggest problem our law firm is seeing with older claims is that finding the medical records can be a challenge.  The more recent cases are also better because the warning argument that parents and doctors should have been told of the risks gets stronger every year after 1990.  Still, our lawyers are reviewing necrotizing enterocolitis lawsuits as far back as 2001.  
  • 4/08/22 NEC Update:  The MDL Panel has certified a new MDL NEC baby formula class action lawsuit.  This means any NEC lawsuit filed in federal court will be transferred to Judge Rebecca Pallmeyer, a U.S. District Court Judge in Illinois. This development will help push these lawsuits out of second gear, pushing us towards a trial date that may push Abbott and Mead to offer reasonable settlement amounts for an NEC formula lawsuit.
  • 4/06/22 NEC Update: The Supreme Court of Illinois previously granted a request to consolidate a group of about 20 NEC formula cases pending in Illinois state courts before a single judge (Dennis Ruth) in the Circuit Court for Madison County. This effectively created a mini-MDL at the state court level. Now, however, Abbott is seeking to have the consolidated cases transferred from Madison County to either Cook County (Chicago) or Lake County, under the doctrine of forum non conveniens (inconvenient forum).  The reason the Illinois lawsuits matter is because lawsuits filed in Michigan, Ohio, Florida, or any other state might well find their way to Illinois state court.  So if you hire an NEC lawyer far away from Illinois, your baby formula lawsuit may end up in front of Judge Ruth in Madison County, Illinois.
  • 3/31/22 NEC Update:  A new study shows 95% of the U.S. Dietary Guidelines Advisory Committee had conflicting interests with the food and pharmaceutical industries.  Seven companies were singled out.  Were Abbott and Mead Johnson on the list?  Of course they were. This helps answer the question of how the baby formula manufacturers were able to get away with sweeping NEC under the rug for long. 
  • 3/6/22 NEC Update: After the Similac recall debacle, Americans are getting a closer look at how baby formula manufacturers put profits ahead of people – and how the FDA is not built to keep these companies in check.  This helps the NEC lawsuits because it shines a disturbing spotlight on how the sausage gets made and how federal regulators mind the store.  
  • 2/17/22 NEC Update:  The pressure on baby formula makers is growing.  In addition to NEC baby formula lawsuits, these companies now face a petition from consumer protection groups asking the FDA to prohibit the use of additives known as “nanomaterials” in their products. The petition urges the FDA to follow the lead of European regulators and ban nanomaterials from infant formula until their safety can be proven 
  • 2/14/22 NEC Update:  Last week, the manufacturer of Enfamil (Mead Johnson) joined Abbott in support of the request for an NEC baby formula class action lawsuit for all NEC claims in federal court.  This is a good development for plaintiffs who are hoping to avoid active litigation on their infant formula lawsuit. The big point of contention is which court will handle the MDL class action.  The defendants want U.S. District Court in Connecticut. Why?  Their motions did a poor job of explaining that.  Baby formula lawyers for victims prefer the Northern District of Illinois for obvious reasons: both Mead and Abbott are headquartered near Chicago.
  • 2/3/22 NEC Update:  Our NEC lawyers are still waiting to see if there will be a state court class-action lawsuit in Illinois as well. The Illinois Supreme Court has yet to rule. There may be two baby formula class actions pending in Illinois at one time: one in state court and the other in federal court. The formula defendants will likely consent to this class action just like then did the federal MDL. 
  • 1/27/22 NEC Update: The medical literature continues to support the contentions made by plaintiffs’ lawyers in the toxic infant formula NEC lawsuits.   This new article underscores the risk associated with NEC and cow milk.
  • 1/18/22 NEC Update: Abbott filed a petition with the JPML requesting that all NEC infant formula lawsuits be consolidated into a new MDL. Abbott requested that the MDL be created in the District of Connecticut and assigned to Hon. Stefan Underwood.

Baby Formulas Are Linked to NEC in Premature Babies

inflamed-bowel-300x169Babies born prematurely require extra nutrition to boost their development and growth.

Many premature infants, however, are not able to breastfeed feed. So they are generally given baby formula instead. Similac and Enfamil are the two leading brands of infant formula.

Cow Milk Problem

Most baby formulas, such as Similac and Enfamil, are made from cow milk with various nutrients and ingredients added to mimic human breast milk. Recent (and not so recent) scientific research has shown that cow-milk-based formulas such as Similac and Enfamil can make infants more likely to develop a dangerous neonatal digestive disease called necrotizing enterocolitis (NEC).

While making tons of money, the manufacturers of these infant formulas have conveniently ignored the science over the last 30 years.  That science shows that demonstrates cow milk formulas cause bacterial septic overload in the stomach of premature babies that can cut holes in their bowels and cause bleeding and infection.

What is NEC in Newborns?

NEC is a very serious bacterial infection that can develop in the gastrointestinal system of newborn infants. It primarily occurs in premature or underweight infants.

NEC can be extremely dangerous for newborns. When NEC occurs it causes inflammation of the intestinal tissue and rapid tissue decay. A perforation (hole) may form in the baby’s intestines causing bacteria to leak out into the abdomen.

NEC Treatment

NEC can be mild in some infants and extremely serious in others. The first step in the treatment of NEC is to stop all oral feedings and begin the baby on an aggressive course of antibiotics.

Nutrients will then be administered intravenously. If the infection is not stopped quickly enough, it may leave dead tissue in the baby’s intestines. If this occurs, surgery may be necessary to remove the dead intestinal tissue and repair any perforations.

NEC Is Life-Threatening

Even a mild case of NEC can be very dangerous and potentially life-threatening for a premature baby. Between 15-40% of premature infants with NEC die.  The main reason for this is that NEC can lead to a fatal blood infection called sepsis.

When NEC destroys the baby’s intestinal tissue, it allows bacteria to leak out of the intestine into the abdominal cavity.

This type of infection is called peritonitis and if not immediately and effectively treated, it will eventually allow the infection to enter the baby’s bloodstream and become sepsis.

  • Video on NEC lawsuit settlement amounts

NEC Consequences

Even when NEC is not fatal, it can cause other long-term or permanent complications and adverse health consequences. One of every 3 babies with NEC will develop intestinal strictures.

This is a narrowing of the intestine. Intestinal strictures can make it difficult for food to pass through and may require surgery to correct. If NEC results in surgical removal of intestinal tissue, it can cause short bowel syndrome and impact the baby’s development and growth.

NEC in Premature Infants Caused by Enfamil or Similac 

NEC only occurs in 1 out of every 2,000 full-term live births in the U.S. In premature births, however, the condition is much more common. NEC occurs in about 10% of all premature babies (born 37 weeks or earlier).

The exact cause of NEC is not fully understood, but there are many scientific and clinical studies definitively proving that cow-milk-based infant formulas, such as Similac and Enfamil, significantly increase the risk of a premature infant developing NEC.

But the risk of NEC with premature babies has long been clear.  For years, the American Academy of Pediatrics told us that human breast milk is the best path for preemies because of the risk of NEC from baby formula. Any newborn NEC baby formula lawsuit will focus on this medical literature and ask why Abbott and Mead did not give a warning.

Lancet Study

The first study suggesting a possible link between bovine baby formulas and NEC was first published in Lancet back in 1990 and found that formula-fed babies were 20 times more likely to develop NEC.

NEC and formula

Journal of Pediatrics Study

Ten years later, a study in the Journal of Pediatrics reached similar conclusions and found that infants fed with breast milk or human milk fortifiers were 90% less likely to develop NEC compared to those fed with traditional formula. 2 additional studies were published in 2013 which reached even more conclusive results about the link between NEC and bovine formulas.

New NEC British Medicine Study

A new study published on October 14, 2021, in the British Medical Journal will add new fuel to any necrotizing enterocolitis formula lawsuit.  The study suggests that the makers of infant formulas such as Similac and Enfamil have funded biased and unreliable clinical product trials. The researchers found that the infant formula trials showed a “universal lack of transparency” and may have downplayed the risks of NEC associated with their cow-milk formula products.

More NEC Formula Studies

  • Evidence-Based Feeding Strategies Before and After the Development of Necrotizing Enterocolitis (Expert Rev. Clin. Immunol. July 2014). Here is the key quote: “Necrotizing enterocolitis (N.E.C.) is a devastating disease of premature infants with significant morbidity and mortality. It is well established that the risk is increased by the administration of infant formula.”  This will be a key study in any NEC baby formula lawsuit.
  • Another round of clinical study results was published in 2016 (Beyond Necrotizing Enterocolitis Prevention – Breastfeeding Medicine ) and 2017 (Human milk is the feeding strategy to prevent necrotizing enterocolitisSemin Perinatol.). This language here is pretty unambiguous:   “Extremely premature infants who received an exclusive HUM [Human Milk] diet had a significantly lower incidence of NEC and mortality. The HUM group also had a reduction in late-onset sepsis, BPD, and ROP. This multicenter study further emphasizes the many benefits of an exclusive HUM diet, and demonstrates multiple improved outcomes after implementation of such a feeding protocol.”
  • In 2019, Cochrane (an independent health care research group) released the results of the most comprehensive study to date comparing health results for premature babies fed with bovine formula versus human milk. The results of the Cochrane study put to rest any lingering debate about the existence of a causal relationship between cow-milk-based formulas and NEC in premature infants. This study underscores the risk to babies with NEC.

Makers of Similac and Enfamil Failed to Warn About the NEC Risks

Similac is manufactured and sold by Abbott Laboratories Inc., a large medical device and health care product company based in Illinois. You have likely heard of them.  You are less likely to have heard of  Mead Johnson Nutrition Company, the company that makes Enfamil. But it is a 16 billion-dollar company.

Both Abbott and Mead were well aware of the scientific evidence establishing that their cow-milk-based formulas caused a significantly increased risk of NEC in premature infants. Despite being well aware of the link between their formulas and the risk of NEC, Abbott and Mead deliberately chose not to include a warning label about the NEC risk on their product labeling.

Changing the warning for a baby formula under the United States Federal Food, Drug, and Cosmetic Act is not difficult. (It is a lot easier to change a warning under the FDCA than it is to change, for example, a warning on a drug.)

So why not add a warning? Well, let’s start by saying our lawyers do not know yet. These toxic baby formula NEC lawsuits are just beginning.  But, it is easy to make a prediction based on the facts already on the ground: follow the money.  A warning will lead to fewer sales.  Fewer sales lead to fewer profits and few yachts.  We all know the story, right?

Faced with growing scientific proof that their formulas presented an increased risk for premature infants to develop NEC, Mead and Abbott continue to market their products as safe and failed to warn consumers about this risk.

NEC Lawsuits Against Baby Formula Makers

A growing number of parents and preemies who were fed with Similac and Enfamil formula and subsequently developed NEC are filing product liability lawsuits against the formula manufacturers (Abbott and Mead) for negligent failure to warn.

The lawsuits allege that Abbott and Mead had a duty to warn about the risks of NEC and their baby formula products but deliberately failed to include any such warning while continuing to market their products as safe.

What Are Expected NEC Baby Formula Lawsuits Settlement Compensation Amounts?

These NEC baby formula product liability lawsuits are new. But families have been filing medical malpractice lawsuits in necrotizing enterocolitis lawsuits for years. So the settlement compensation in these lawsuits, if successful, has a history that can guide us in determining possible settlement amounts in these lawsuits.

The average verdict in a successful NEC preemie lawsuit is in the millions of dollars. Our baby formula lawyers anticipate similar compensation payouts if plaintiffs win these trials.

But our lawyers do not expect to see Similac lawsuits or Enfamil lawsuits going to trial.  We could be wrong.  But our attorneys think the makers of these baby formulas will seek an out-of-court global settlement of as many NEC lawsuits as they can.

But settlement amounts and trial amounts are not the same things.  So even if the makers of Similac and Enfamil predicted an average jury verdict compensation payout of $2 million per individual case, it would not mean the average settlement amount would be $2 million.  Why?  A settlement is a compromise.

Will the Necrotizing Enterocolitis (NEC) Baby Formula Lawsuit Become a Huge Class Action Lawsuit?

No, the NEC baby formula lawsuits will not become a huge class action lawsuit. Thankfully, there number of victims is relatively small. NEC is rare.

But the infant formula claims may become a class action, albeit one that does not have thousands of plaintiffs. And while the size of the lawsuits could be smaller, the settlement amounts could be huge. Because the injuries are so extreme in many NEC cases, the average individual settlement compensation payout in the baby formula lawsuits could be extraordinary.

Example NEC Baby Formula Lawsuit

Just to give you some context, let’s look at an example NEC lawsuit.

Late last year,  Abigail Grosshuesch filed an NEC infant formula lawsuit in the County Circuit Court for Madison County, Illinois against Mead Johnson & Company LLC and Mead Nutrition Company, alleging negligence and other claims.

The complaint in this NEC lawsuit alleges that the plaintiff’s baby was born prematurely in 2013. Initially, the baby was “doing well” on her mother’s breast milk and was progressing normally. Two weeks after birth, the baby was fed Enfamil cow-milk-based formula for several days. The lawsuit claims that the formula caused the baby to develop NEC which required “aggressive medical intervention.”

Sadly, the baby died a week later from complications related to the NEC. The complaint alleges failure to warn that we have been talking about. The lawsuit alleges Mead Johnson knew about the dangers of its bovine-based formula and failed to provide adequate warnings about the risk of NEC associated with the formula.

Why is this NEC baby formula lawsuit not barred by the statute of limitations given the child was born in 2013?  I talk about this below.

Mini MDL NEC Class Action Lawsuit Sought in Illinois

Since February 2021, 33 NEC baby formula lawsuits have filed been in Illinois state courts. Why is Illinois has become a hot spot for the emerging NEC formula litigation?  The manufacturers of Enfamil and Similac are both headquartered in the Chicago area. So there is no federal court jurisdiction when Mead Johnson or Abbott are sued in Illinois.

In December 2021, NEC lawyers for the plaintiffs filed a motion with the Illinois Supreme Court asking that the separate cases be consolidated before a single judge. This procedure is the state court equivalent of an MDL class action.

On January 3, 2022, Abbott and Mead Johnson were granted extensions of time to respond to this request. Both companies will probably be in favor of consolidation since defending a single action will be more efficient than defending 30 separate cases at once.

Illinois May Be NEC Baby Formula Lawsuit Epicenter

The creation of a state court MDL for NEC baby formula lawsuits in Illinois would indicate the rapidly growing momentum behind these cases. As more NEC infant formula lawsuits get filed in 2022, our attorneys expect a new infant formula MDL class action in federal court.

But maybe not.  Illinois law is more advantageous to victims than most states.  Illinois liberally allows lawyers from other jurisdictions to be admitted to work on lawsuits in that state.  Mead and Abbott are both based in Illinois. So they cannot object to answering an NEC lawsuit in that jurisdiction. It may be that a large number of NEC baby formula lawsuits are filed in Illinois even if they originated in Florida,
Texas or any other state.

If this (mini) NEC baby formula class action lawsuit takes off, it is an important development because it pushes these lawsuits involving these milk fortifiers forward. This may force these companies to offer fair settlement amounts to resolve NEC-related injuries and deaths.

What Is the Statute of Limitations for an NEC Baby Formula Lawsuit?

The statute of limitations to file an NEC lawsuit is a complicated question. The deadline to sue depends on the state where the harm occurred. There are often different statutes of limitations for the child – who might have a 21-year deadline to file – and the parents, who usually have a shorter deadline to file suit.

An NEC Lawsuit May Have Discovery Rule Statute of Limitations Extension

There is also arguably a discovery rule issue in the NEC lawsuits that could extend the statute of limitations even further.  NEC lawsuits have alleged that because of misleading marketing and lack of adequate warnings of the risk of cow milk, parents did not know and could not have known of the link between NEC and baby formula from cow milk until just recently.

But there could be a short window to file a claim. So if you think you might want to bring a baby formula lawsuit, call an NEC formula lawyer today to fully understand your rights even if you do not have a present intention of filing an NEC lawsuit.

Similac vs. Enfamil: Is One Worse Than the Other?

Similac and Enfamil are the two leading brands of infant formula. When it comes to causing necrotizing enterocolitis (NEC) in premature babies, it appears both Enfamil and Similac are equally bad. (The recent Similac recall is not specific to NEC.)

New studies may prove otherwise but, the science is unclear.  What our lawyers do believe is that both products are derived from cow’s milk and that is the underlying cause of NEC in preemies who take infant formula.

How Will Mead’s and Abbott’s Lawyers Defend NEC Lawsuits?

First, the defense attorneys will argue preemption.  The gist of this argument is that premature infant formula claims under state law are not permitted by the Infant Formula Act (“IFA”) 20 U.S.C. § 350a.  This is not a winning argument and it has never been successfully made.

In a medical malpractice case involving NEC in 2021, one defense expert made this argument which I think you can expect to see from Mead and Abbott:

Plaintiffs’ claim that any provider ‘caused’ NEC is not supported by the literature. The cause of NEC is not understood at this time. Because there is no medically accepted single factor that causes NEC, no one can state within a reasonable degree of medical certainty what causes NEC.

In particular, it is impossible to know what caused the infant plaintiff to develop NEC. Even among exclusively human mild feeding preterm infants, NEC can occur. The fact is NEC can neither be predicted nor prevented.

The main defense against developing NEC is avoiding preterm delivery; however, in this case, the pregnancy could not be extended because [the baby’s mother] experienced a premature preterm rupture of membranes before she arrived at [the hospital.]

Further, the claim that the specific cause of NEC can be identified is rank speculation. Although NEC occurs most frequently in preterm infants, it occurs in term infants

This argument flies in the face of mountains of medical literature.  I think the defense attorneys’ arguments are so flawed in these cases I suspect the defendants will offer reasonable settlement amounts before any NEC lawsuit makes it to trial.

How Does NEC Cause Damage to the Intestine?

The ductus arteriosus is a blood vessel connecting the pulmonary artery and the aorta so the fetus can get air through the mother’s blood. When the child is born, the ductus arteriosus should close.

Patent Ductus Arteriosus

A problem, called patent ductus arteriosus (PDA), can arise when the ductus arteriosus does not shut. What happens is oxygenated blood bypasses organs like the intestines and returns to the lungs.

The blood vessels in the lungs become overloaded which is called pulmonary edema.  As a result, the intestine may not receive enough oxygenated blood.

This problem is worse with low birth weight and premature babies because their intestines are immature.   So the decrease in oxygen to the intestines eats at the lining of the intestinal wall.  The medical literature seems clear that cow milk formula rapidly speeds up the deterioration of the bowel wall.  This causes necrotizing enterocolitis

The damage to the inner surface of the intestine accelerates quickly at this point.  Bacteria from the intestine can cause an infection that can rupture or kill the intestine.

This perforation of the intestine can cause spillage of stool into the infant’s abdomen.  This can cause sepsis which can kill the child.  If the child survives, (becomes necrotic) with or without perforation and death.  For newborn preemie babies with NEC that do survive, they can suffer short gut syndrome and neurological and nutritional complications.

Call Our Lawyers About Your NEC Baby Formula Lawsuit

Our law firm is currently investigating potential NEC toxic baby formula lawsuits. We are particularly interested in hearing from parents of preemies who took Similac or Enfamil formula and subsequently developed NEC.

If you believe your child developed NEC as a result of a cow-milk-based formula, call our NEC baby formula lawyers today for a free consultation at 800-553-8082 or reach out to us online for a free case evaluation.

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