NEC Baby Formula and Lawsuit

Necrotizing enterocolitis (NEC) in all 50 states. There is strong evidence that cow milk in these formulas contributes to premature newborn babies developing NEC.

Our highly-trained legal team is currently pursuing legal action on behalf of families across the entire United States whose premature babies suffered from necrotizing enterocolitis (NEC) after being fed with Enfamil and Similac baby formula. Extensive research has shown that cow milk present in these formulas may contribute to the onset of NEC in newborns born prematurely. If your family is affected by this issue, our attorneys are here to provide the assistance you need to navigate the complex legal process and obtain the compensation you deserve. Contact us today to schedule a consultation.

Stay abreast of the latest updates on the NEC formula lawsuit as expert attorneys regularly update this page. Our team of legal professionals ensures that the content is accurate and up-to-date, so you can rely on it for any information you need. The page was last updated on May 1, 2023, making it your go-to source for the latest developments in the case. Keep yourself informed and stay ahead of the game by checking this page regularly for all your NEC formula lawsuit updates.

May 1, 2023 Update: E-discovery is crucial in litigation like this case. Plaintiffs need to see the emails, business communications, and other data relevant to litigation that is almost always stored electronically in 2023. So companies’ custodians of records play a critical role in pretrial discovery. Mead and Abbott are huge companies so there is a great deal of work to do.

Because mass tort litigation often involves intricate scientific and liability issues, courts typically set custodial caps exceeding 100 witnesses. In this case, the plaintiffs’ lawyers wanted 65 witnesses. Since the beginning of this NEC baby formula class action lawsuit, the lawyers have worked to ensure the timely completion of discovery, including obtaining electronic discovery (attorneys call it “ECI”) from Defendants’ employees. After months of negotiations, the PLC believed it had reached a deal with Defendants for an additional 45 custodians. Abbott agreed. Mead did not.

After refusing the global compromise, Mead proposed that its ESI custodial cap be limited to 22 additional custodians, with them selecting seven. So plaintiffs’ attorneys have filed a motion to get the court’s help to deal with this problem

April 28, 2023 Update: The pool of 12 bellwether candidate cases in the NEC formula MDL are now going through case-specific fact discovery. These are the first NEC lawsuits that will go to trial.

This pretrial discovery process involves depositions of fact witnesses and doctors in each of the 12 lawsuits and it is intended to provide both sides with more information about the cases. Once this process is completed, four of the 12 cases will be selected for the actual bellwether trials which are set to being around this time next year.

April 18, 2023 Update: Thirty-five new cases were added to the infant formula NEC class action lawsuit over the last month. This is the highest monthly volume of new cases since the start of the litigation and it marks the third month in a row that we have seen an increase in that number. There are now 157 pending cases in the MDL and we could see our first bellwether test trial sometime next year.

March 16, 2023 Update: 17 new pending cases were transferred into the infant formula NEC class action MDL over the last 30 days, bringing the total number of plaintiffs in the MDL up to 122. This marks the second-highest volume of new cases since the MDL began.

March 8, 2023 Update: A new study found no significant differences in the incidence of necrotizing enterocolitis between preterm infants who received an exclusive human milk diet and those who received bovine milk formula and fortifiers. The American Academy of Pediatrics has long recommended that preterm infants receive human milk, preferably their mother’s milk, and encourages the use of human milk fortifiers to provide additional nutrients to support growth and development.

So this study suggests providing newborns with human milk products not sourced from their mothers is just as efficient as using cow’s milk-based infant formula. This is all the more reason parents and hospitals should know some choices do not involve Similac and Enfamil that do not carry the same risk of NEC.

February 25, 2023 Update: Five new cases alleging that formula caused premature infants to develop NEC were transferred into the NEC formula class action MDL over the last month. The number of pending cases in the NEC formula MDL is now at 97. That is the same number of cases that were pending in July 2022. Why? For starters, many NEC formula cases are being litigated in state courts, which means they never get transferred into the MDL.

January 17, 2023 Update: Nine new infant formula NEC cases were transferred into the class action lawsuit over the last month. This brings the total number of pending cases in the NEC formula MDL to 97. This litigation has no claims registry, so this total reflects all claims other than those brought in state court.

January 10, 2023 Update: The Judge in the NEC infant formula class action MDL in the Northern District of Illinois is attempted to schedule a “science day.”

Science days are a standard tool used in mass tort MDLs. They allow both sides to make presentations designed to educate the court on the pertinent scientific evidence. A date for the NEC infant formula science day is expected to be set at the January monthly status conference.

December 15, 2022 Update: By the end of this month, the group of 12 formula NEC cases that will participate in the bellwether program will be finalized. Eight of the cases have already been named, and the defense will select the last four next week.

On November 10th, the PLC submitted a proposed schedule for the bellwether program, setting a fact discovery deadline of April 2023. The proposed expert discovery deadline would be December 2023. The proposed schedule suggests that the first bellwether trials could begin in the spring of 2024. Four of the twelve bellwether program cases would be selected for trial and those selections would be made in May 2023.

November 11, 2022 Update: Eight infant formula NEC cases in the federal class action lawsuit have already been selected to take part in the bellwether program. Another four NEC lawsuits will be selected by the defendants by the end of the month.

Last week, the MDL judge issued a new Case Management Order formally approving a fact sheet questionnaire form that each of the twelve plaintiffs in these bellwether cases will be required to complete as the first step of the discovery process. That will be followed by depositions of the plaintiffs and then expert witness discovery.

November 7, 2022 Update: The plaintiffs in 29 cases pending in the NEC infant formula MDL successfully moved to have their cases remanded back down to Pennsylvania state court earlier this month. All of these cases involved both product liability claims against the formula manufacturers, and tort claims against the local hospitals that fed the formula to the pre-term infants. These cases were subject to remand primarily because the inclusion of the local hospitals as defendants meant that the requirements for diversity jurisdiction in federal court were not met. The removal of these 29 NEC formula cases brings the total number of cases pending in the MDL down to 106.

October 9, 2022 Update: This week attorneys for victims and the formula companies in the Formula NEC class action MDL provided the judge with a list of 66 pending cases that the court could randomly choose to be the first NEC lawsuit to go to trial. The plaintiffs and defendants have each picked four cases. Four random lawsuits will be picked by the court will for the initial pool of 12 bellwether candidate cases. These 12 cases will go through pretrial discovery and then a group of four will be picked for trials. Each side will select two.

October 1, 2022 Update: The judge in the formula NEC class action lawsuit issued a significant order last month establishing the schedule and protocol for the selection of bellwether test cases.

First, a pool of 12 “bellwether discovery cases” will be selected. The plaintiffs will pick four of the cases. The defendants will also select four cases. The Court will randomly select the remaining four cases for this pool. This selection process will complete by November 23.

These 12 cases will then go through a short fact-discovery phase. Once this discovery is completed, four of the 12 cases will be picked for the initial bellwether test trials. The plaintiffs will pick two and the defendants will pick two. The four bellwether trials will then be held 12 weeks apart, alternating between cases selected by the plaintiffs and the defendants.

September 1, 2022 Update: Lawyers in the NEC infant formula class action lawyers have turned their eyes to the plan to choose which NEC lawsuit goes to trial first. The MDL judge now has a draft plan outlining a process for the selection of a pool of 12 cases for the opening round of bellwether test trials.

The lawyers will submit a list of 12 NEC lawsuits that could potentially be fully prepared for trial. This would involve even numbers of cases involving both Abbott and Mead Johnson together or as sole defendants. Once these 12 cases are selected, they will go through pretrial discovery, interrogatories, depositions, etc. After discovery is completed, each side will pick two NEC lawsuits out of the group of 12 for a total of four initial bellwether trials.

August 11, 2022 Update: The medical community continues to slide toward the plaintiffs’ view of baby formula for preemies. As the number of NEC lawsuits against formula manufacturers continues to rise, the American Academy of Pediatrics (AAP) published an updated opinion statement urging parents to avoid infant formula when human breast milk is an alternative.

The AAP is encouraging hospitals to stop allowing formula makers to promote their products in maternity wards, which is a huge step to solve this problem.

July 15, 2022 Update: Only nine victims filed an NEC lawsuit that was transferred into the Preterm Infant Nutrition MDL over the last month. There are now 97 NEC baby formula class action lawsuits pending in federal court. Many NEC attorneys are still filing NEC formula lawsuits in state court in Illinois.

July 1, 2022 Update: The judge in the federal NEC baby formula class action lawsuit has indicated that she wants to allow plaintiffs to file NEC formula lawsuits against Abbott and Mead Johnson directly in the MDL-3026. Previously, Judge Pallmeyer had been hesitant to permit direct filings which meant new plaintiffs had to file in their home district and have the case transferred into the MDL.

A proposed order allowing direct filings were issued earlier this week. Mead Johnson filed an objection to the proposed order. Which is nonsense. Even Abbott did not object.

June 17, 2022 Update: Thirty-seven new plaintiffs were added in the first month of the newly formed preterm infant formula NEC MDL in the Northern District of Illinois (Abbott Laboratories Preterm Infant Nutrition Prod. Liab. Lit. – MDL No. 3026). This means that the size of the MDL doubled in the first 30 days. Our NEC formula lawyers expect to see an average of 30-60 new cases added to the MDL each month from now through the end of 2022. The pace of new lawsuits added to class action will likely slow down in 2023.

June 6, 2022 Update: The federal baby formula class action lawsuit is moving forward. The judge in the newly formed Baby Formula NEC MDL (Hon. Rebecca R. Pallmeyer) recently issued a 2nd Case Management Order finalizing appointments of the Plaintiffs’ Lead Counsel, Liaison Counsel, and Steering Committee.

These NEC lawyers will act on behalf of all the plaintiffs involved in the NEC formula class action lawsuit moving forward. Meanwhile, the MDL continues to grow exponentially, with new cases being transferred from courts across the country. Since May 16th, an additional 26 new cases have been transferred. This brings the total number of pending NEC baby formula lawsuits in the class action up to 78.

May 23, 2022 Update: The baby formula NEC class action lawsuit in the Northern District of Illinois (In re: Abbott Laboratories, et al., Preterm Infant Nutrition Prod. Liab. Lit.- MDL No. 3026) is officially underway. Judge Rebecca Pallmeyer has been assigned to the MDL class action. The judge held her opening status conference last week on May 19. Within the next two weeks, Judge Pallmeyer is expected to announce her selections for the plaintiffs’ Lead Counsel, Liaison Counsel, and leadership committee. A total of 52 cases are pending in the MDL as of May 16, 2022. That number is expected to triple by next month.

May 4, 2022 Update: There are now three baby formula class action lawsuits. There is a baby formula NEC class action in federal court. Illinois state court also has roped off NEC lawsuits filed in that state from all over the country. We also have a Similac recall class action lawsuit that does not involve NEC. All three pieces of NEC litigation are moving forward.

April 11, 2022 Update: We now have an NEC baby formula class action lawsuit in federal court. The JPML issued a transfer order which consolidates all pending NEC infant formula lawsuits into a new mass tort MDL: In re: Abbott Laboratories, et al., Preterm Infant Nutrition Products Liab. Lit. (MDL No. 3026).

The NEC formula MDL has been assigned to Judge Rebecca R. Pallmeyer, Chief Judge of the Northern District of Illinois. Illinois was the venue preferred by the plaintiffs’ NEC baby formula lawyers. The defendants (Abbott and Mead Johnson) were ironically pushing to leave their home state and put in the MDL NEC class action in Connecticut. Now every NEC infant formula lawsuit in federal court will be transferred into the MDL for consolidated pretrial proceedings.

April 1, 2022 Update: Just over 40 NEC formula lawsuits have been filed against Mead and Abbott in federal courts over the last year. Twelve of these NEC lawsuits in federal court were filed in March 2022. As we discuss below, there is also a mini-class action NEC lawsuit in Illinois.

March 31, 2022 Update: The Supreme Court of Illinois previously granted the request to consolidate a group of about 20 NEC formula cases pending in Illinois state courts before a single judge (Dennis Ruth) in Circuit Court for Madison County. This effectively created a mini-MDL NEC class action lawsuit 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 nonconveniens (inconvenient forum).

Why do you care about the Illinois baby formula lawsuits if you live in California, Texas, New York, or any other state outside of Illinois? Because many NEC baby formula lawsuits will file lawsuits in Illinois even if the claim arose in another jurisdiction.

March 1, 2022 Update: It looks like an NEC baby formula class action lawsuit that will house all federal court NEC lawsuits is coming. The only question is whether the class action will be housed in Connecticut or Illinois.

Last week, Mead Johnson, the maker of Enfamil, advised the Judicial Panel on Multidistrict Litigation (JPML) that it was in favor of consolidating the NEC lawsuits into a new NEC MDL class action. In January 2022, Abbott, the manufacturer of Similac, filed a petition with the JPML requesting the formation of a new MDL for the consolidation of all NEC infant formula lawsuits in the federal courts.

Abbott’s attorneys are requesting the District of Connecticut, while lawyers for NEC plaintiffs’ lawyers favor the Northern District of Illinois where Abbott is headquartered.

February 20, 2022 Update: As if Abbott did not have enough problems with Similac in the NEC lawsuits, the FDA announced a massive Similac recall impacting thousands of children.

February 11, 2022 Update: As pressure from NEC lawsuits continues to grow, baby formula manufacturers face a new challenge. Two consumer protection groups filed a petition last week asking the FDA to ban the use of certain additives in infant formula. The petition seeks to prevent companies like Abbott and Mead Johnson from using additives (known as nanomaterials) in their products because of the potential health impact of these ingredients.

February 1, 2022 Update: In December, NEC baby formula lawyers filed a motion asking the Supreme Court of Illinois to consolidate all pending preemie NEC infant formula lawsuits in the state into a single action in Madison County.

The court granted motions by defendants Abbott and Mead Johnson for an extension of time to respond until this month to respond to the consolidation request. Will Mead and Abbott ultimately oppose the request? Both companies are based in the Chicago area. Combining the Illinois cases into a single consolidated action would be much more efficient than defending potentially hundreds of NEC baby formula lawsuits separately.

Why so much interest in the Illinois NEC cases? Many attorneys plan to file all their NEC Similac and Enfamil baby formula lawsuits in Illinois. So if you are in New York, California, Texas, or anywhere in the U.S., your NEC lawsuit might be filed in Illinois.

December 18, 2021 Update: A large number of infant formula NEC lawsuits are being filed in Illinois state court. Illinois has become a common venue for NEC lawsuits because Abbott Laboratories and Mead Johnson are headquartered in Chicago. This week, lawyers for some of the plaintiffs in these state court NEC lawsuits filed a motion asking the Supreme Court of Illinois to consolidate the NEC cases before a single judge for coordinated pretrial proceedings. This is the Illinois state court equivalent of an MDL request.

The motion identified 33 NEC infant formula lawsuits currently pending in Illinois civil courts (31 in Madison County). All 33 of these NEC cases were filed in the last 10 months, indicating the growing momentum behind the NEC formula litigation. Consolidation of these cases in Illinois could be followed by the creation of a national baby formula MDL for NEC lawsuits in federal court. This could help clear a path toward an eventual global NEC settlement for most or all these claims.

December 10, 2021 Update: A new study published last month further confirms that feeding cow-milk-based formula to premature infants dangerously increases their risk of NEC while also slowing their development. A research team from McMaster University in Ontario published their findings in the journal Pediatrics and Child. The study found that when premature babies are fed infant formula instead of breast milk, newborn preemies are three times more likely develop NEC and be sent to the NICU.

December 5, 2021 Update: As more victims look to file an NEC lawsuit against infant formula manufacturers, the maker of Similac (Abbott Laboratories) is now defending a related consumer class-action lawsuit alleging it made false and misleading comparisons between Similac Pro Advance and breast milk. Plaintiffs filed this new necrotizing enterocolitis lawsuit on November 20, 2021, in the Southern District of Illinois where many of these claims will be filed. The NEC baby milk lawsuit asserts various consumer fraud claims against Abbott based on false and deceptive marketing claims.

This class action suit seeks refunds for the thousands of parents of newborns who bought Similac formula based on the false assumption that it would give their baby the same type of immune system and developmental support as breast milk. This newborn NEC lawsuit highlights some of the questionable marketing strategies pursued by Abbott in support of their Similac formula products. This suit will serve as a nice support piece to the NEC infant formula lawsuits alleging actual injuries and death.

Failure to Warn of Cow Milk in Similac and Enfamil

Many parents out there with prematurely born babies who suffered from NEC would never think of calling an infant formula lawyer because they do not know the connection between these infant formulas and NEC.

In fact, for years malpractice lawyers brought medical malpractice lawsuits indirectly making the same claims attorneys are now making in the infant formula lawsuits. Those malpractice suits alleged that the doctors should not have decreased feedings for premature babies with NEC and that the doctors should have stopped providing cow-based milk products because it is known to cause NEC.

The doctor’s response in many of these malpractice lawsuits is that they did not know of the medical literature connecting Similac and Enfamil and NEC. The plaintiffs’ lawyers finally connected the dots and realized that infant formula lawsuits made sense because parents and doctors were never properly informed of the NEC risks.

Even in 2023, after so many victims have filed an NEC lawsuit, ask a pediatrician whether baby formula can cause NEC. You will get a mixed response.

The bottom line is that research has long shown that premature infants fed with cow’s milk-based formula have a higher risk of developing NEC compared to those fed with human milk or formula made from hydrolyzed protein. Cow’s milk-based formula contains complex proteins that are difficult for the immature digestive system of premature infants to digest and absorb. This can cause inflammation in the gut, leading to tissue damage and even death of intestinal tissue. Why not make this clear to doctors and mothers with a clear warning?

Necrotizing Enterocolitis (NEC)

Necrotizing enterocolitis (NEC) is a severe and potentially fatal disease primarily occurring in premature infants. What happens is bacteria invades the intestinal wall. This leads to inflammation and infection.

Bacteria can damage the intestinal wall, causing infection and inflammation, resulting in a weakened intestinal wall. This may create an opening or fissure, allowing bacteria to seep into the abdominal cavity. Basically, what happens is that the lining of the baby’s intestines becomes inflamed, and then parts of it can start to die off. If not properly addressed, NEC can result a hole or perforation in the intestine, which can be dangerous and even life-threatening. Ultimately, NEC can cause partial or complete destruction of the baby’s bowel. The complications can cause decreased oxygen supply to vital organs which can cause all sorts of permanent injures.

Why is this litigtion focused on premature babies? NEC is more common in premature babies fed formula instead of breast milk, but it can also occur in babies fed breast milk. The exact cause of NEC is not fully understood, but it is thought to be related to an imbalance in the baby’s gut bacteria. So the risk to these children has been clear for a long time.

The long-term outcomes for infants with NEC can vary depending on the severity of the disease and whether surgery was required. Infants who have had NEC may be at an increased risk for long-term complications such as short bowel syndrome, developmental delays, and growth problems. Prevention strategies for NEC include promoting breast milk feeding, careful monitoring of feeding tolerance, and judicious use of antibiotics.

Symptoms and Diagnosis of NEC

Symptoms of necrotizing enterocolitis include metabolic acidosis, abdominal distention, feeding intolerance, feeding residuals, jaundice appearance, green fluid in the abdominal wall, lethargy, decreased bowel sounds, an increase or decrease in stools, trouble breathing, acidosis, and bradycardia (slow heart rate).

NEC is progressive, so identifying symptoms for prompt treatment is critical. With prompt diagnosis and treatment, most babies with NEC do well and have a normal life expectancy without complications.

NEC is initially diagnosed based on clinical observation of symptoms by a pediatrician. In addition to clinical symptoms, diagnostic tools include blood testing and cultures, abdominal imagining, and blood gas levels, all of which can help confirm the diagnosis of NEC.

Treatment of NEC

When NEC is suspected, it is treated by discontinuing all oral feeding and immediately administering strong antibiotics to the baby. Nutrients must be supplied intravenously until the infection is eliminated and the baby’s intestinal tissue has fully healed. Nasogastric drainage is sometimes necessary along with circulatory support. In some cases of NEC, tissue in the intestines may be left decayed and dead. Surgery will be necessary to remove the dead intestinal tissue when this occurs. So the infant may require surgery to remove necrotic tissue or repair a perforation in the intestines. This can often lead to short gut syndrome and other complications.

NEC is a brutal disease. Even with prompt and aggressive treatment, NEC can still result in significant morbidity and mortality, with up to 50% of affected infants requiring surgery and a mortality rate of 20-30%.

Cow Milk

Fasting sounds counterintuitive. But doctors have long known that the rapid advancement of feeds in a premature infant often significantly increases the incidence of NEC.

Most infants develop NEC after being fed, and few feedings decrease the likelihood of NEC. We now know that the cause of premature babies developing NEC after getting Similac or Enfamil is because they contain cow-based milk.

Research for years found an association between cow milk formulas and NEC in premature infants. Yet there was never a warning on these products that baby formula might be a safer choice for premature infants than Enfamil, Similac, or other cow milk-based formulas.

Enfamil Baby Formula Lawsuits

Our baby formula NEC lawyers are evaluating claims against Mead Johnson Nutrition for failing to warn about Enfamil’s risks. If your baby was fed any of the following products, you could have a viable Enfamil baby formula lawsuit if your baby developed NEC:

Enfamil NeoPro EnfaCare Infant Formula (Mead Johnson says it is the “best” for premature babies)

Enfamil Premature Infant Formula 20 Cal with Iron

Enfamil 24 Cal Infant Formula

Enfamil Premature Infant Formula 24 Cal High Protein

Enfamil Premature Infant Formula 24 Cal with Iron

Enfamil Premature Infant Formula 30 Cal with Iron

Enfamil Human Milk Fortifier

Similac Baby Formula Lawsuits

Similarly, our attorneys are also evaluating NEC lawsuits against the maker of Similac, Abbott Laboratories Inc., for premature babies who developed NEC. The cow milk products for Similac include:

Similac NeoSure

Similac Alimentum Expert Care

Similac Liquid Protein Fortifier

Similac Human Milk Fortifier

Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid

Similac Special Care 20

Similac Special Care 24

Similac Special Care 24 High Protein

Similac Special Care 30

Scientific Evidence Linking NEC and Cow Milk Formula

The scientific evidence establishing a causal link between cow milk-based infant formula and NEC has been developing for 30 years. Below is a chronology of the studies establishing that cow-milk formula increases the risk of NEC in premature infants.