By Steve Levine
Published: November 24, 2025 · Updated: June 14, 2026
▼
Allegations Only · No Settlement Yet
This article describes ongoing product-liability litigation. The statements below are unproven
allegations. Abbott Laboratories (Similac) and Mead Johnson/Reckitt (Enfamil) have not been found
liable in the federal MDL, there is no certified class, and there is no settlement or claim form at
this time. This page is general information, not legal or medical advice.
Status
Active Litigation (MDL 3026)
next bellwether trial July 6, 2026 · ~800 cases pending (spring 2026)
Condition
Necrotizing enterocolitis (NEC)
premature / low-birth-weight infants fed cow's-milk-based formula or fortifier
Is There a Claim Form?
No — individual lawsuits only
no global settlement and no class-wide claim form
The federal Enfamil and Similac NEC cases are consolidated in a multidistrict litigation,
In re: Abbott Laboratories, et al., Preterm Infant Nutrition Products Liability Litigation,
MDL No. 3026, in the U.S. District Court for the Northern District of Illinois before Chief Judge
Rebecca Pallmeyer. As of spring 2026, roughly 800 NEC baby formula cases were pending in the MDL
against Abbott (Similac) and Mead Johnson, now part of Reckitt (Enfamil).
• Next federal trial: The next MDL bellwether trial is scheduled for July 6, 2026.
Bellwether trials are test cases that help both sides gauge how juries respond; they do not resolve
every case, but their outcomes often shape later settlement discussions.
• Earlier federal bellwethers: In 2025, the court entered judgment for the defense in the
first federal test cases, largely on causation grounds. Plaintiffs' attorneys have continued to
litigate expert and causation issues heading into the 2026 trial.
• State-court verdicts: Separate state-court juries have returned large verdicts, including
a reported $495 million verdict against Abbott and a $60 million verdict against Mead Johnson, with
another multimillion-dollar Abbott verdict reported in Illinois in April 2026. These verdicts are
specific to individual cases, may be reduced or appealed, and do not guarantee any result in other
cases.
There is no global settlement and no class-wide claim form. Each NEC case proceeds individually. The
statements in these cases remain unproven allegations, and Abbott and Mead Johnson deny wrongdoing.
If your child was born premature, given Enfamil, Similac, or other cow's-milk-based formula or fortifier,
and later diagnosed with necrotizing enterocolitis, families in this situation have filed product-liability
lawsuits seeking compensation for NICU care, surgeries, long-term complications, and other losses. Many
cases involve fragile newborns who received these products in the hospital before parents ever knew there
could be a higher risk of NEC.
This page explains what NEC is, the symptoms and risk factors, and which formulas the lawsuits focus on. For
the current status of the litigation, the MDL 3026 bellwether schedule, and step-by-step help finding a
lawyer on your own, see our
Enfamil and Similac NEC baby formula lawsuit guide.
Similac and Enfamil are two of the most widely used infant formula brands in the United States.
Similac is produced by Abbott Laboratories and Enfamil is produced by Mead Johnson, now part of Reckitt.
Both offer cow's milk based formulas and fortifiers that are often used in hospitals, NICUs, and at home
when breast milk is not available or needs to be supplemented.
These brands have also faced separate class action settlements in the past over serving size and false
advertising issues, including the Similac baby
formula false advertising settlement and the Enfamil serving size class action
settlement.
Eligibility for a NEC baby formula lawsuit usually focuses on a few key facts:
• A confirmed diagnosis of necrotizing enterocolitis (NEC)
• Premature birth or low birth weight
• Use of cow's milk based formula or human milk fortifier, often in the NICU
• Records showing these products were given before NEC developed
Parents pursuing these claims often report:
• A baby born before 37 weeks or weighing less than 5.5 pounds
• Enfamil or Similac formulas or fortifiers added to breast milk in the hospital
• Sudden symptoms such as abdominal swelling, bloody stool, vomiting, or feeding intolerance
• An NEC diagnosis confirmed by imaging, x rays, or surgical findings
• Emergency surgery to remove damaged or dead intestine in severe cases
If this sounds familiar, a product-liability attorney licensed in your state can review the medical records
and explain whether your family may have a claim.
Necrotizing enterocolitis is a serious intestinal disease that mostly affects premature babies. It causes
inflammation in the lining of the intestines. In severe cases parts of the intestine can become damaged or
begin to die, which can lead to perforation, infection, and life threatening complications.
NEC is far more common in premature infants and those who receive formula derived from cow's milk instead
of exclusive human milk. The condition can progress quickly, which is why early recognition and emergency
treatment are so important.
Enfamil and Similac are two of the most widely used formula brands in the United States. Many premature
babies receive these products in the hospital or NICU when breast milk is unavailable or when extra calories
are needed.
Lawsuits claim that cow's milk based formulas and fortifiers from companies such as Abbott Laboratories
(Similac) and Mead Johnson (Enfamil) can significantly increase the risk of NEC in premature infants, yet
parents and even some caregivers were not adequately warned about these risks.
Some hospital focused products have received special attention in research, including formulas intended for
very small premature babies and fortifiers added to human milk. Studies suggest that certain cow's milk
based products may be more likely to trigger intestinal problems than human milk or human milk based
fortifiers.
Several baby formulas have been recalled in recent years for safety reasons. In February 2022, Abbott
recalled specific lots of Similac, Alimentum, and EleCare after reports of Cronobacter sakazakii infections
and infant deaths linked to products produced at its Sturgis, Michigan plant. The plant temporarily shut
down while the company and regulators investigated.
In October 2022, Abbott announced another recall for certain ready to feed liquid formulas because some
bottles may not have been sealed correctly, raising concerns about spoilage and stomach problems.
While these recalls dealt with contamination and packaging issues and not NEC directly, they highlighted
broader questions about how infant formulas are manufactured, tested, and monitored for safety.
Recognizing NEC early can make a major difference in outcomes. Parents and caregivers are often told to
watch for changes such as:
• Abdominal pain or unusual fussiness that is hard to soothe
• A swollen, puffy, or tender belly
• Feeding difficulties or sudden refusal to eat
• Green or yellow vomiting
• Bloody stool
• Lethargy or a sudden drop in energy
• Trouble gaining weight or unexplained weight loss
• Unstable body temperature
• Changes in breathing, heart rate, or blood pressure
In more advanced or severe NEC cases, babies may also have:
• Generalized swelling or fluid retention
• Low sodium or other electrolyte problems
• Kidney issues and high potassium levels
Any of these signs require immediate medical attention. Only a doctor can diagnose NEC and decide whether
antibiotics, bowel rest, surgery, or other interventions are needed.
Several factors are known to raise the risk of necrotizing enterocolitis, especially in premature infants.
These can include:
• Premature birth before 37 weeks
• Low birth weight under 5.5 pounds
• Cow's milk based formula or fortifier instead of exclusive human milk
• Serious illness or infections in the NICU
• Hospital outbreaks of harmful bacteria
• Blood transfusions in fragile newborns
• Low oxygen levels around the time of birth
NEC is most common in premature babies in the hospital. It is relatively rare in full term infants. Feeding
premature babies with mother's milk or donor human milk can significantly reduce NEC risk, which is part of
why cow's milk based formulas and fortifiers are under legal and medical scrutiny.
Strong documentation can make it easier for attorneys to review and process a potential NEC claim. Helpful
records can include:
• NICU and hospital records describing feeding protocol and formulas used
• Chart notes showing when Enfamil, Similac, or other formulas or fortifiers were started
• Medical records confirming the NEC diagnosis
• Imaging, x ray, and surgical reports documenting intestinal damage
• Discharge summaries and follow up notes about ongoing digestive problems or short bowel syndrome
• Bills and statements showing the cost of NICU stays, surgeries, and ongoing care
NEC baby formula lawsuits seek compensation for a wide range of losses. Depending on the case, potential
damages can include:
• Medical expenses: NICU care, surgeries, hospital stays, medications, and specialist visits
• Future medical care: Treatment for long term digestive issues, short bowel syndrome, or other
complications
• Pain and suffering: Physical pain, emotional distress, and trauma for both the child and
family
• Loss of earnings and support: When a parent must miss work or leave a job to care for a child
with serious health needs
• Wrongful death damages: For families who lost a child to NEC complications
There is no single nationwide deadline for NEC baby formula lawsuits. Each state has its own statutes of
limitations and sometimes statutes of repose. These laws can limit how long parents have to file a claim
after an NEC diagnosis, surgery or other major NEC treatment, or learning that formula or fortifier could be
linked to their child's condition. Because these deadlines can be strict and complex, it is important to
speak with an attorney as soon as possible if you believe baby formula may have harmed your child. Our
NEC baby formula lawsuit guide
explains how to find a lawyer on your own.
This page provides general legal information, not medical advice. For questions about NEC, baby formula, or
feeding options, always speak with your pediatrician or neonatologist. Never change your baby's feeding plan
without guidance from a qualified healthcare provider.
What is the Enfamil and Similac NEC lawsuit about?
These lawsuits claim that cow's-milk-based formulas and fortifiers such as Enfamil and Similac increase the risk of necrotizing enterocolitis in premature babies and that manufacturers did not adequately warn parents and providers. Families seek accountability and financial support for the intensive medical care and long-term challenges NEC can cause. These are unproven allegations, and the manufacturers deny wrongdoing.
Who may qualify for a NEC baby formula claim?
You may have a potential claim if your child was born premature, received Enfamil, Similac, or other cow's-milk-based products, and later developed NEC that required medical treatment or surgery. Attorneys look at gestational age, feeding records, the severity of NEC, and long-term outcomes.
What are common signs and symptoms of NEC in babies?
Warning signs of necrotizing enterocolitis can include abdominal swelling, feeding intolerance, vomiting, bloody stool, lethargy, unstable body temperature, breathing changes, and difficulty gaining weight. In severe cases babies may have low blood pressure, electrolyte problems, or require surgery to remove damaged intestine. Any of these signs require immediate medical attention.
Have Enfamil or Similac formulas been recalled for safety issues?
Several Similac products were recalled in 2022 after reports of Cronobacter infections and concerns about improperly sealed bottles. Those recalls focused on contamination and spoilage rather than NEC, but they increased scrutiny of infant formula safety and how these products are manufactured and marketed.
Is there a deadline to file an NEC baby formula lawsuit?
Yes. Statutes of limitations can limit how long you have to file a claim. In many states the clock starts around the time of diagnosis, treatment, or discovery that formula may have contributed to your child's condition. Talking with a lawyer quickly can help you avoid missing important deadlines.
NEC Baby Formula Lawsuit Information
This page is for general information only. OpenClassActions.com is not a law firm and is not a claims
administrator. For legal advice, speak with an attorney licensed in your state.
For more class actions keep scrolling below.
Status
Active litigation — no settlement
Condition
Necrotizing enterocolitis (NEC)
Case Title
In re: Abbott Laboratories, et al., Preterm Infant Nutrition Products Liability Litigation
Case Number
MDL No. 3026
Court
U.S. District Court, Northern District of Illinois
Defendants
Abbott Laboratories (Similac); Mead Johnson / Reckitt (Enfamil)
Next Trial
July 6, 2026
federal bellwether trial
Category
Mass tort / product liability