NEC Lawsuit (Enfamil & Similac Baby Formula Lawsuits)

Around 1 in 10 babies are born premature or preterm (before 37 weeks of pregnancy have been completed) in the United States each year. This figure also overlaps with the 1 in 12 babies born with a low birth weight (less than 2500 grams/5.5 lbs, according to the CDC), as those born prematurely are more likely to be underweight. While the majority of preterm babies go on to live healthy lives as adults, it is often the case that they need some feeding support in their early days. Refusing to eat (breastfeed) and lethargy are common among preterm/low birthweight babies, and this compounds the lack of weight gain. As such, it is often the case that preterm and underweight babies will be given supplemental formula.

Unfortunately, studies have demonstrated that certain cow’s milk-based baby formulas might be doing these babies more harm than good. In particular, there are links to a crippling disease called Necrotizing Enterocolitis (NEC). It is now established scientific fact that “Premature infants fed formula are more likely to develop necrotizing enterocolitis (NEC) than those who are breastfed.” Despite this knowledge, companies behind popular baby formula products have done nothing to warn new parents – and medical professionals – about these dangers.

• June 1, 2023 - Recent advances in the treatment of Necrotizing Enterocolitis with potential for translation.
• May 1, 2023 - Black babies are more likely to die of NEC than white babies.
• April 1, 2023 - What to know about NEC in newborns?
  A serious condition that affects the intestines, necrotizing enterocolitis can be fatal for a newborn. A severe inflammation damages and kills the tissues of the colon in a baby, leading to complications including death.
• April 1, 2023 - Study: More black babies die from NEC compared to white babies.
• March 1, 2023 - Six counts are being brought against Enfamil's manufacturer. The plaintiff claims that Enfamil Premature formula contributed to her baby's premature death.
• February 1, 2023 - Mead Johnson and Abbott are being sued by the parents of a premature baby boy. They claim that they failed to warn their infant formula products could cause serious gastrointestinal disorders and other health problems in premature babies. Dana Jupiter and Destin Jupiter filed a complaint against Mead Johnson & Company LLC and Mead Johnson Nutrition Company May 7, claiming strict liability for design defects and failure to warn, negligence, intentional and negligent misrepresentation. In their complaint, the Jupiters claim that their son was prematurely born at Woman's Hospital, Baton Rouge, La on May 9, 2002. He has necrotizing enterocolitis and other long-term health issues, they claim. This is because Simlac and/or Enfamil cow milk-based products were given to him after his birth and during his hospital stay.
• January 15, 2023 - By inhibiting intestinal inflammation and improving the gut barrier, β-glucan protects mice from Necrotizing Enterocolitis.
• January 1, 2023 - A case report on Ductus Arteriosus banding in order to regulate excess pulmonary blood flow in a neonate suffering from Necrotizing Enterocolitis, complex congenital heart disease, and pulmonary atresia.
• December 1, 2022 - National Library of Medicine - The National Center for Biotechnology: Long-term Outcomes of Necrotizing Enterocolitis & Spontaneous Intestinal Peforation
• November 16, 2022 - Families use grief journey to raise awareness about a Necrotizing Enterocolitis (NEC). NEC is a leading cause of infant death.
• October 1, 2022 - Prenatal steroid treatment may improve NEC survival and reduce complications for preterm infants.
• September 1, 2022 - Doctors are hoping a new breakthrough in the lab may have found what causes NEC, allowing them to save more lives of babies with NEC.
• August 1, 2022 - Human milk oligosaccharide composition predicts risk of Necrotising Enterocolitis in preterm infants.
• July 24, 2022 - Stanford Children's Health has published: Necrotizing Enterocolitis in the Newborn - information about NEC.
• July 12, 2022 - The administering of amnion-derived multipotent cell secretome ST266 helps protect against necrotizing enterocolitis in piglets & mice.
• July 9, 2022 - Abbott resumes baby formula production at Michigan plant after shutdown due to a flood.
• July 1, 2022 - NEC New Study: Variability in antibiotic duration for necrotizing enterocolitis and outcomes in a large multicenter cohort.
• June 19, 2022 - National Library of Medicine (The National Center for Biotechnology Information) - New NEC Study: Neurologic consequences of neonatal NEC Children who survive Necrotizing Enterocolitis have been shown to demonstrate neurodevelopmental delay, with significantly worse outcomes than from prematurity alone.
• June 12, 2022 - Donor-dependent fecal microbiota transplantation effectiveness against necrotizing enterocolitis in preterm pigs. The development of NEC, a life-threatening inflammatory bowel disease affecting preterm infants, is associated with gut microbiota dysbiosis. NEC is a terrible intestinal inflammation disease primarily affecting infants born preterm with an incidence of up to 7%.
• June 9, 2022 - National Library of Medicine (The National Center for Biotechnology Information) has published a new NEC study: Evaluation of Risk and Preventive Factors for Necrotizing Enterocolitis in Premature Newborns. A Systematic Review of the Literature.
• June 6, 2022 - A new NEC study: researchers sought to find out how Bifidobacterium shortum subsp. was administered. infantis EVC001 (B Infantis EVC001), was used to determine the impact of Necrotizing Enterolitis (NEC), in preterm infants admitted to a single-level IV neonatal intensive medical unit (NICU).
• June 1, 2022 - In May 2022 we have received over 116 inquiries on our site from parents of babies with NEC who fed their babies problematic Similac (about 48%) or Enfamil (about 39%) formulas listed on this page.
• May 19, 2022 - The National Library of Medicine (National Center for Biotechnology Information) has published a new study: Necrotizing Enterocolitis in Very Low Birth Weight Neonates: A Natural History Study
• May 17, 2022 - Few studies have been done and published on the relationship between neutrophil to lymphocyte ratios (NLR) and NEC (Necrotizing Enterocolitis).
• May 16, 2022 - The FDA has issued Powdered Infant Formula Recall - What You Need to Know - Don't use the recalled Similac and Alimentum powdered infant formulas made in Sturgis, MI.
• May 1, 2022 - In April 2022 we have received over 150 inquiries on our site from parents of babies with NEC who fed their babies problematic Similac or Enfamil formulas listed on this page.
• April 1, 2022 - In March 2022 we have received over 230 inquiries on our site from parents of babies with NEC who fed their babies problematic Similac or Enfamil formulas listed on this page.
• March 15, 2022 - So far this month we have received 170 inquiries on our site from parents of babies with NEC who fed their babies problematic Similac or Enfamil formulas listed on this page over  on February 2022 we have received 240 inquiries.
• February 18, 2022 - FDA warns against powdered infant formula. Abbott recalls products. Three types of baby formula are being recalled after reports of bacterial infections.
• February 17, 2022 - To date, in February 2022 we have received over 150 inquiries on our site from parents of babies with NEC who fed their babies problematic Similac or Enfamil formulas listed on this page.
• February 1, 2022 - National Cancer Institute: Probiotics were used for the prevention of NEC in premature infants.
• January 20, 2022 - In a cohort study, Probiotic Bifidobacterium infantis EVC001, a type of strain of bacteria, was associated with a 73% reduction in NEC.
• January 6, 2022 - New study release: Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants. Exclusion Criteria: NEC requiring treatment.
• January 1, 2022 - U.S. Department of Health and Human Services updated Necrotizing Enterocolitis causes (NEC).
• December 16, 2021 - Jo Shandria White of Edwardville, IL claims the makers of Similac and Enfamil formula failed to warn about the risks of premature infants developing Necrotizing Enterocolitis (NEC) after consuming the cow's milk-based products.
• December 1, 2021 - Carle Foundation Hospital nurse Christine Wetzel received national honor for her achievement in developing a tool to evaluate preterm infants' risk for the potentially deadly gastric disease NEC (Necrotizing Enterocolitis).
• November 2, 2021 - Tylea Hundley was born prematurely and 2 days after her birth from an intestinal disease (NEC). The administrator of Hundley’s estate sued the producers of 3 infant formulas that the doctors at Yale New Haven Hospital fed Tylea Yale New Haven Hospital before she died: Mead Johnson & Company, Mead Johnson Nutrition Company & Abbott Laboratories, Inc. for violating the Connecticut Product Liability.

NEC cases are most found in premature infants born under 32 weeks or in babies with low birthweight.
Other risk factors include:

• Antibiotic treatment given for more than 10 days, or multiple rounds of antibiotics
• Abnormal Doppler test (measure of blood flow from placenta to baby).
• Use of cow’s milk-based formulas (such as Enfamil and Similac)
• Enteral feeding
• Congenital heart disease

1. If your child received Enfamil, Similac, or another cow’s milk-based formula before developing NEC.
2. If your child was diagnosed with NEC.

We asked a group of 173 NEC (Necrotizing Enterocolitis) parents: How many weeks gestation was your baby born?

Two of the most prominent baby formula producers in the United States – Abbott Laboratories and Mead Johnson & Company – have had NEC lawsuits filed against them. The lawsuits claim that Abbot Laboratories’ product Similac and Mead Johnson’s Enfamil should have carried warning labels to make parents aware of the dangers to their newborns. Those behind the lawsuits argue that both manufacturers knew about the risks and failed to act accordingly, and that may have caused serious injury and even death to preterm babies across the United States. The legal proceedings have only just begun, so expert birth injury lawyers are calling for anyone who believes they may have been affected by these products to come forward.

NEC is a gastrointestinal disease that causes inflammation and perforations (holes) in the intestines. This can lead to further problems when bacteria leaks through the hole and stomach and into the bloodstream. While NEC is always described as a “serious” illness, symptoms can range from mild to life-threatening.

NEC is mostly associated with preterm babies (around 9 out of 10 NEC cases are found in preterm babies), particularly those born before 28 weeks, but it can also occur after a child has received a blood transfusion or when the child is fed through the stomach (enteral nutrition). While medical experts know who falls into the at-risk category for NEC, there is no consensus as to what exactly causes NEC.

Stage: IB
Classification: Suspected NEC
Systemic signs: Temperature instability, apnea, bradycardia, lethargy
Intestinal signs: Bright red blood from rectum
Radiologic signs: Normal or intestinal dilation, mild ileus

Stage:IIA
Classification: Proven NEC – mildly ill
Systemic signs: Temperature instability, apnea, bradycardia, lethargy
Intestinal signs: Increased pregavage residuals, mild abdominal distention, emesis, guaiac-positive stool, bright red blood from rectum absent bowel sounds, with or without abdominal tenderness
Radiologic signs: Intestinal dilation, ileus, pneumatosis intestinalis

Stage: IIB
Classification: Proven NEC – moderately ill
Systemic signs: Temperature instability, apnea, bradycardia, lethargy, mild metabolic acidosis, mild thrombocytopenia
Intestinal signs: Increased pregavage residuals, mild abdominal distention, emesis, guaiac-positive stool, bright red blood from rectum absent bowel sounds, with or without abdominal tenderness, absent bowel sounds, definite abdominal tenderness, with or without abdominal cellulitis or right lower quadrant mass
Radiologic signs: Intestinal dilation, ileus, pneumatosis intestinalis, portal venous gas, with or without ascites

Stage: IIIA
Classification: Advanced NEC – severely ill, bowel intact
Systemic signs: Temperature instability, apnea, bradycardia, lethargy, mild metabolic acidosis, mild thrombocytopenia, hypotension, bradycardia, severe apnea, combined respiratory and metabolic acidosis, disseminated intravascular coagulation, and neutropenia
Intestinal signs: Increased pregavage residuals, mild abdominal distention, emesis, guaiac-positive stool, bright red blood from rectum absent bowel sounds, with or without abdominal tenderness, absent bowel sounds, definite abdominal tenderness, with or without abdominal cellulitis or right lower quadrant mass, signs of generalized peritonitis, marked tenderness, and distention of abdomen
Radiologic signs: Intestinal dilation, ileus, pneumatosis intestinalis, portal venous gas, with or without ascites, definite ascites

Stage: IIIB
Classification: Advanced NEC – severely ill, bowel perforated
Systemic signs: Temperature instability, apnea, bradycardia, lethargy, mild metabolic acidosis, mild thrombocytopenia, hypotension, bradycardia, severe apnea, combined respiratory and metabolic acidosis, disseminated intravascular coagulation, and neutropenia
Intestinal signs: Increased pregavage residuals, mild abdominal distention, emesis, guaiac-positive stool, bright red blood from rectum absent bowel sounds, with or without abdominal tenderness, absent bowel sounds, definite abdominal tenderness, with or without abdominal cellulitis or right lower quadrant mass, signs of generalized peritonitis, marked tenderness, and distention of abdomen
Radiologic signs: Intestinal dilation, ileus, pneumatosis intestinalis, portal venous gas, with or without ascites, pneumoperitoneum

As mentioned earlier, the preterm baby formula lawsuits are at an early stage, and we are at a crucial point where child injury attorneys are calling for affected families to come forward. However, several cases have been filed already. This includes a lawsuit filed against both Mead Johnson and Abbott Laboratories by the parents of Daniel Renteria-Hernandez in the Eastern District of California in May 2021. The suit alleges that the companies failed to adequately warn parents and medics of the dangers of feeding their formulas to preterm and underweight babies. Daniel, who died from NEC just days after his birth in 2019, was born weighing only 2 pounds and was subsequently fed Similac during his short life. The wrongful death lawsuit lists a series of failures on behalf of the formula producers, ranging from negligence, negligent misrepresentation and breach of warranty. In a further development occurring in August 2021, a federal judge rejected attempts by Abbott Laboratories to dismiss a case of wrongful death brought by a Connecticut family. The original case for the death of baby Aries Peterson was filed in October 2020. The claim will now move forward after supplementary deliberations by the Connecticut Supreme Court.

Symptoms of NEC usually show up in the first two weeks of a baby’s life. As NEC is linked to preterm babies, particularly those with low birthweight, it’s expected that doctors will be monitoring the babies in that category for NEC symptoms, which includes blood in the stool, lethargy, vomiting, and stomach swelling. However, not all symptoms are so apparent, and that usually means NEC is not diagnosed until the doctor has performed an X-ray on the infant. The doctor will use the X-ray to look for signs such as damage to the intestine (NEC might cause it to look bubbly in appearance) or air in the veins of the liver. They might also use a needle to look for signs of fluid in the abdomen, which is a sign of perforation of the intestines, or uses stool samples and blood tests. NEC can range in severity; and treatment, therefore, will depend on a myriad of factors, including the baby’s age, relative health and strength. Treatment can vary greatly, ranging from IV feeding, stopping feeding and giving antibiotics to the removal of the intestine or bowels in more severe cases.

NEC is a disease that is almost exclusively found in very young children, although some rare cases have presented in adults. While non-preterm babies (those born after 37 weeks of pregnancy) can get NEC, it is much more common in preterm infants with low birthweight. Around nine of every ten cases of NEC is found in preterm babies. Typically, around 3% of babies born at a weight between 1251 – 1500 grams (2lbs 12.13 ounces – 3lbs 4.9 ounces) get NEC, but this rises to around 11% of those babies born with a very low birthweight, weighing less than 750 grams (1lb 10.46 ounces). Unfortunately, around 15 in every 100 cases of NEC result in death, and a significant number of babies who survive will have long-term health complications.

We do not yet know the outcome of the NEC lawsuits. And it’s almost guaranteed that many more parents will join the legal proceedings as awareness of the issue spreads. As such, we can’t put an exact figure on how much you can get from an NEC lawsuit compensation payout. However, the companies behind these products have been forced to pay out millions of dollars in fines and compensation (unrelated to the NEC formula lawsuits) for various infringements in the past. Moreover, some of the current necrotizing enterocolitis lawsuits filed in court allege wrongful death and serious injury linked to Enfamil and Similac products. If it is proven that Abbot Laboratories and Mead Johnson & Company are at fault, then the level of compensation paid out to families could be substantial, perhaps exceeding millions of dollars.

Across the United States, several major law firms are working on baby formula injury compensation claims for different families who believe the manufacturers of Similac and Enfamil are at least partly responsible for the death of, or serious injury caused to, their child. The link between cow’s milk-based baby formula and NEC has been proven, and claimants believe Abbott Laboratories and Mead Johnson & Company had a duty to do more to protect children. For example, one of the baby formula lawsuit cases filed raises the question as to why these two companies continued to market their products specifically for preterm low birthweight babies when the linkage to NEC was apparent. Thousands of babies are born preterm and underweight in the United States each year, and many of them will have had their feeding supplemented by these products. As such, it is possible that a huge number of NEC lawsuits will be filed in the coming years. If you have been affected by defective baby formula, you can take a free evaluation with Select Justice now to see if you might qualify to join one of the lawsuits against Abbott Laboratories and Mead Johnson.

Necrotizing enterocolitis is a very serious disease. To show the dangers of NEC, we can break it down through its etymology: Necrotizing (destroying of the tissue), entero- (relating to the intestines) and colitis (inflammation of the colon). While nobody is sure what causes NEC, understanding its name gives us an insight into its effects on an infant. Some of the possible dangers of NEC include narrowing of the intestines (intestinal stricture), getting a hole (perforation) in the intestine, developing scars of the intestines, being unable to absorb food after damage/removal of the intestine (called short bowel syndrome), and developing a severe infection in the abdomen (peritonitis) or throughout the entire body – known as sepsis. Unfortunately, in some cases, complications from NEC can lead to the death of the infant.

The common symptoms of necrotizing enterocolitis are listed below. Please note that this is not exhaustive:

• Stomach pain
• Stomach swelling
• Blood in the infant’s stool
• Lethargy (tiredness)
• Vomiting, especially when colored green or yellow
• Change in heart rate, blood pressure, breathing or body temperature
• Lack of weight gain, refusal of food

There is not any broad consensus on the cause of NEC, but medical experts have pinpointed certain conditions where the appearance of the disease is more likely. As you might expect, much of that is linked to characteristics often shared by preterm low birthweight infants. For instance, it is known that premature babies generally have weaker immune systems, which might affect their ability to fight the disease. In addition, preterm babies usually have a weaker digestive system and gastrointestinal conditions, which will impact their ability to fight off infection of the intestines. Another issue is that oxygen-carrying blood finds it more difficult to reach the intestines in preterm babies.

While the issues mentioned above are not the direct causes of NEC (or at least, they are not yet proven to be so), they are part of the conditions that commonly lead to the disease. Moreover, while there are a lot of unknowns about NEC, we can say definitively that low birth weight and preterm delivery are risk factors for NEC. Coupled with that, it has been proven (and known for several years now) that preterm babies being fed cow’s milk-based formula, such as Similac or Enfamil, are more likely to get NEC. It’s for that reason that claimants in the Similac and Enfamil lawsuits are wondering why – at the very least – there are no warning labels (or other similar precautionary advice measures) on these products.

It is, unfortunately, all too common to see companies behind baby formulas in the news for the wrong reasons. Baby milk products are carefully marketed as being scientifically proven to help our children’s development, and the companies behind them portray themselves as competent and caring. Sometimes companies are accused of exaggerating the benefits of their products. For instance, the DHA (a type of fatty acid) added to baby formula is claimed to help a baby’s brain development, but the evidence is sketchy at best.

But worse still, manufacturers are often accused of promoting products that are harmful. Abbot Laboratories and Mead Johnson are not alone in this. There is, for example, a Neocate baby formula lawsuit linked to bone injuries in children currently ongoing. And, back in 2011, there was also a DHA baby formula lawsuit, filed as a class-action suit, against Enfamil’s producers for making false and misleading claims about its products. And, this is not the first time one of these companies has found itself in deep legal trouble over baby formula. Back in 1996, for instance, Abbott Laboratories was forced to pay a $32.5 million settlement after 17 states accused it of price-fixing in the baby formula sector. Does this mean baby formula companies are unscrupulous? Not at all. But the current baby formula legal cases aim to ensure that the products they provide are safe for our children, and that they pay suitable compensation to families who have suffered the loss of a child or serious injury due to defective baby formula.

Similac is a range of baby formulas produced by Abbot Laboratories. The company has been in business for over 90 years, and it has a motto – The Promise of Similac – stating that “we promise to help keep your baby fed, happy, and healthy.” Not all Similac products are cited in the NEC baby injury lawsuits. It specifically refers to cow’s milk-based products, and particularly those aimed at premature babies who require supplemental feeding. Products cited in current Similac baby formula lawsuits include Similac Neosure, Similac Human Milk Fortifier and Similac Special Care.

Other cow’s milk-based Similac products include:

• Similac Alimentum
• Similac Alimentum Expert Care
• Similac Human Milk Fortifer Hydrolyzed Protein Concentrated Liquid
• Similac Human Milk Fortifier
• Similac Human Milk Fortifier Concentrated Liquid
• Similac Human Milk Fortifier Powder
• Similac Liquid Protein Fortifier
• Similac Special Care 20
• Similac Special Care 24
• Similac Special Care 24 High Protein
• Similac Special Care 30

Like Abbot Laboratories, Mead Johnson has a huge amount of experience in producing baby foods. Its founder, Edward Mead Johnson, was co-founder of the famous Johnson & Johnson company but split with the family business to create his own company in the late 19^th century. Today, Mead Johnson & Company specializes in children’s nutrition. The Mead Johnson NEC lawsuits allege that cow’s milk-based formula from the company’s Enfamil range may have led to the death or serious injury of premature babies.

Please note that several of the lawsuits filed against Mead Johnson also cite Abbott Laboratories as co-defendant, and vice versa. This is due to the fact that a lot of the preterm babies who died or were injured were fed both Similac and Enfamil products. Mead Johnson’s Enfamil products include:

• Enfacare Powder
• Enfamil 24 and DHA & ARA Supplement
• Enfamil Human Milk Fortifier Acidified Liquid
• Enfamil Human Milk Fortifier Liquid High Protein
• Enfamil Human Milk Fortifier Powder
• Enfamil Milk Fortifier Liquid Standard Protein
• Enfamil NeuroPro Enfacare
• Enfamil Premature 20 Cal
• Enfamil Premature 24 Cal
• Enfamil Premature 24 Cal/fl oz HP
• Enfamil Premature 30 Cal

What are the details of the NEC Lawsuit?

Claimants, some of whom have seen their newborns die from NEC, believe that manufacturers of Enfamil and Similac baby formula should have been more proactive in warning of the potential dangers of their products. Moreover, the claimants believe that Abbott Laboratories and Mead Johnson & Company should be held accountable for wilfully marketing their products towards parents and medical professionals treating preterm babies when they knew the formula could cause NEC.

Can a baby get NEC more than once?

Yes, and this might require more surgery. NEC can also lead to a lifetime of debilitating health issues and, in the worst cases, death of the infant.

Is NEC caused by Enfamil or Similac baby formula?

It has not been proven that Enfamil or Similac causes NEC. However, several studies have shown that preterm babies fed these products are more likely to get NEC. The crux of the argument in the NEC lawsuits is that the defendants – Abbot Laboratories and Mead Johnson & Company – knew of the dangers, but they continued to market the products for preterm babies regardless.

Can non-preterm babies and adults get NEC?

Yes, although it is much rarer in babies born after 37 weeks. Around 90% of the cases of NEC are found in preterm (born before 37 weeks of pregnancy) infants, and there have been very rare cases of NEC found in adults.

How can I protect my baby against NEC?

Nobody knows for sure what causes NEC, so it’s not altogether clear how to prevent it. While it is unlikely that a healthy baby will get NEC, if your baby is underweight and born premature, the risks of developing NEC are somewhat higher (although still relatively rare). If you have any concerns, you should contact your healthcare provider right away.

Is there a current NEC lawsuit for preterm babies?

Several notable law firms specializing in infant injury have filed lawsuits against Abbot Laboratories and Mead Johnson & Company. The NEC legal cases are at an early stage, and more claimants are expected to join the lawsuits in due course. If you believe your child has been affected by defective formula leading to NEC, then use the free evaluation form from Select justice to connect with an experienced personal injury lawyer with expertise in the Enfamil and Similac cases.

Are you Eligible for a NEC Lawsuit?

If your baby was diagnosed with NEC, was born prematurely used Enfamil or Similac baby formula we can help you fight for your rights and compensation.