One of the most common reasons families rule themselves out of the NEC baby formula litigation is a single sentence: “But my baby was breastfed.” It is completely understandable. The lawsuits are usually described in the headlines as being about Similac and Enfamil formula, so a parent who fought to give their premature baby breast milk in the neonatal intensive care unit (NICU) reasonably concludes the whole thing has nothing to do with them.
That conclusion is often wrong — and the reason is a product most parents were never told the name of. Very premature infants who receive breast milk are frequently given a human milk fortifier, a supplement stirred into the milk to add calories and nutrients. In most U.S. NICUs that fortifier is made from cow’s milk. So a baby the chart describes as “breastfed” may still have been fed a cow’s-milk-based product every day — just mixed into the mother’s or donor’s milk rather than given from a formula bottle. This article explains what fortifier is, the difference between the cow’s-milk and human-milk versions, what the evidence does and does not show, and why a breastfeeding history does not, by itself, close the door on a family’s case.
The one-sentence version. “Breastfed” does not mean “no cow’s-milk exposure” — because a cow’s-milk-based human milk fortifier is a separate bovine product routinely added to breast milk in the NICU, and it is documented in the feeding orders whether or not anyone ever pointed it out to the family.
What a human milk fortifier is, and why NICUs use it
Breast milk is the recommended food for premature infants, but for the smallest and earliest babies, breast milk alone often does not deliver enough of certain nutrients to match the growth a fetus would have achieved in the womb. A baby born at 26 weeks has weeks or months of rapid bone and brain development ahead that would ordinarily happen inside the mother. To close that gap, neonatologists commonly “fortify” the milk — adding a concentrated supplement that increases the calories, protein, calcium, and phosphorus per ounce.
This is standard, evidence-based neonatal care, and the decision to fortify is not itself the issue. The issue is what the fortifier is made of. The additive can be derived from cow’s milk (bovine) or from human milk. That single choice is what determines whether a “breast-milk-fed” baby was also exposed to cow’s-milk protein.
The two kinds of fortifier: cow’s-milk-based vs. human-milk-based
There are two broad categories of human milk fortifier used in the United States, and they are not interchangeable in the way that matters here.
| Feature | Cow’s-milk-based (bovine) fortifier | Human-milk-based fortifier |
|---|---|---|
| What it is made from | Cow’s milk protein and components | Pooled, pasteurized donor human milk |
| Example products | Similac Human Milk Fortifier (Abbott); Enfamil Human Milk Fortifier (Mead Johnson) | Prolact+ H2MF and related products (Prolacta Bioscience) |
| How common in NICUs | The large majority of U.S. NICU fortification | Far less common; used in some units and for the smallest infants |
| Relevance to NEC cases | Introduces cow’s-milk protein even when the base is breast milk | Keeps the diet exclusively human-milk-based |
The takeaway from the table is simple: if a preemie’s breast milk was fortified, the odds are that the fortifier was a cow’s-milk-based product, because bovine fortifier is what most NICUs stock and use. That is the exposure hiding behind the word “breastfed.”
What the evidence shows — stated honestly
The scientific literature on fortifier is more nuanced than the marketing on either side, and it is worth being precise, because families deserve the real picture rather than an overstatement.
The landmark study is Sullivan and colleagues (2010), a randomized trial published in The Journal of Pediatrics. It compared extremely premature infants fed an exclusively human-milk-based diet — including a human-milk-based fortifier — against infants whose diet included cow’s-milk-based products (a bovine fortifier, and preterm formula when mother’s milk was unavailable). The groups on the exclusively human-milk diet had significantly lower rates of NEC and of NEC requiring surgery than the group that received bovine milk-based products. That finding is one of the pillars behind the broader push toward human-milk feeding for preterm infants, which we cover in the science linking cow’s-milk formula to NEC.
At the same time, head-to-head trials isolating fortifier type alone are limited. A Cochrane systematic review of human-milk-derived versus bovine-milk-derived fortifier found only one eligible randomized trial (127 infants) and rated the evidence as low-certainty, concluding that on the current data human-milk-derived fortifier “may not change” the risk of NEC or death compared with bovine fortifier. A separate 2024 randomized trial likewise did not show a reduction in a combined outcome of NEC, sepsis, or death. In plain terms: the body of evidence that cow’s-milk products broadly raise NEC risk in preemies is strong, while the evidence comparing one fortifier against another head-to-head is still thin and mixed.
Why we say this out loud. The honest scientific picture actually matters to a family’s case, because these lawsuits are not decided on slogans. They are decided on what a specific child was fed and what that child’s records show — which is exactly why the fortifier question is worth asking rather than assuming away.
Why “my baby was breastfed” doesn’t settle the question
Put the two facts together. Most premature babies who get breast milk in the NICU also get their milk fortified, and most fortifier is cow’s-milk-based. That means the word “breastfed” in a parent’s memory — or even in a discharge summary — does not tell you whether the baby was exposed to a cow’s-milk product. Only the detailed feeding record does.
“The single most common reason a family wrongly rules themselves out is that they remember breast milk and stop there,” says Alex Alvarez, Managing Partner of The Alvarez Law Firm and a Board Certified Civil Trial Lawyer. “Nobody at the bedside says, ‘we’re now adding a cow’s-milk fortifier to your milk.’ They say ‘we’re fortifying to help her grow,’ and the parent hears that as part of breastfeeding. I never want a family to disqualify themselves on a memory. Whether there’s a case is a records question, and the records are the only thing that answers it.”
None of this means a fortified-breast-milk history automatically becomes a claim. It does not. The point is narrower and more important: it means the question is open rather than closed, and it can only be answered by looking, not by assuming.
Where fortifier shows up in the NICU record
Because this is a documentation question, it is worth knowing where the answer lives. Fortifier is recorded in the parts of the chart that track what actually went into the baby, day by day.
“When I review a NICU file, the feeding history is where I spend my time, and fortifier is right there in it,” says Herb Borroto, M.D., J.D., the firm’s Medical-Legal Expert. “I’m looking at the feeding orders and the intake flowsheets for entries like ‘HMF,’ ‘human milk fortifier,’ or a brand name, and for a caloric target — feeds fortified to 24 or 26 calories per ounce, for example. The nursing notes will show the date fortification started and how the feeds were advanced. Lined up against when the first signs of trouble appeared, that timeline is often the whole ballgame, and it is completely invisible to a family that was simply told their baby was being ‘breastfed and fortified.’”
Parents can obtain the complete record themselves. The specific documents to ask the hospital for — and how to read them — are covered in our guide to reading a NICU progress note, and identifying the exact product ties into which cow’s-milk product your baby was given.
What this means for families
A few practical points if you assumed a breastfeeding history took your family out of the picture.
First, don’t rule yourself out on the word “breastfed.” Fortified breast milk and exclusively human-milk feeding are two different things, and the difference is a cow’s-milk product you may never have been told about. The distinction lives in the feeding orders, not in memory.
Second, the record is retrievable. You have the right to request your child’s complete NICU record under HIPAA, including the feeding and nutrition documentation. If a specialized fortifier or a caloric-density order appears, that is the detail that reopens the question.
Third, filing deadlines run regardless of the confusion. The statute of limitations that could apply to a claim depends on your child’s dates and your state’s law, and those deadlines are frequently shorter than parents expect. Time spent assuming you don’t qualify is still time on the clock. A short, no-cost review of whether your family qualifies for an NEC lawsuit is the way to replace an assumption with an answer.
This is general information, not legal or medical advice. The presence of a cow’s-milk-based fortifier in a feeding record does not, by itself, establish that it caused a particular child’s NEC or that a claim exists. Whether a specific child’s injury can be tied to a cow’s-milk product requires review of that child’s complete medical record by qualified professionals. Past results do not guarantee future outcomes; each case is evaluated on its own facts.
How The Alvarez Law Firm approaches the fortifier question
When a family tells us their premature baby was breastfed and asks whether there is any point in going further, we do not answer from the phone call — we answer from the chart. Our team, led by Board Certified Civil Trial Lawyer Alex Alvarez and supported by Medical-Legal Expert Herb Borroto, M.D., J.D., obtains and reviews the full NICU feeding record: the orders, the intake flowsheets, the nutrition notes, and the timing of every change. If the milk was fortified with a cow’s-milk-based product, we can see it; if it was not, we can tell you that too. Either way, the family gets a real answer instead of a guess. We do this for families nationwide, at no cost.
Free, confidential case review. No fees unless we recover compensation for you.
- Understand the underlying science: the science linking cow’s-milk formula to NEC.
- Identify the product used: which cow’s-milk formula was your premature baby given?
- Learn to read the record: reading a NICU progress note.
- See if your family qualifies: Do I qualify for an NEC lawsuit?
Frequently asked questions
My premature baby was breastfed — can our family still have an NEC case?
Possibly. Being breastfed does not by itself rule a family out, because many premature infants who received breast milk were also given a cow’s-milk-based human milk fortifier — a separate bovine-milk product added to breast milk in the NICU to increase calories, protein, and minerals. A baby recorded as receiving mother’s milk or donor milk may still have been exposed to a cow’s-milk-derived product through fortification. Whether that exposure supports a claim is fact-specific and depends on the child’s full feeding record, so the only way to know is to have the record reviewed.
What is a human milk fortifier and why is it added to breast milk?
A human milk fortifier is a supplement mixed into breast milk for very premature or very low birth weight infants because breast milk alone often does not provide enough calories, protein, calcium, and phosphorus for a preemie’s rapid growth needs. Most fortifiers used in U.S. NICUs are cow’s-milk-based (bovine), such as Similac Human Milk Fortifier and Enfamil Human Milk Fortifier. A 100% human-milk-based fortifier alternative also exists. The point families often miss is that fortifying breast milk with a bovine product means the baby received cow’s-milk protein even though the base was breast milk.
Is cow’s-milk-based fortifier part of the NEC baby formula litigation?
The NEC litigation centers on cow’s-milk-based nutrition products fed to premature infants, and the federal MDL is formally captioned as preterm infant nutrition products liability litigation rather than formula alone. Whether a particular child’s exposure — including exposure through a cow’s-milk-based fortifier added to breast milk — fits within a viable claim is a fact-specific question that turns on that child’s records and the applicable law. It is not something a general article can answer for an individual family; a lawyer has to review the specific record.
How do I find out whether my baby received a cow’s-milk-based fortifier?
It is documented in the NICU medical record. Look in the feeding orders, nursing intake and output flowsheets, and dietary or nutrition notes for entries such as HMF, human milk fortifier, fortified feeds, or a specific brand name like Similac HMF or Enfamil HMF, often written with a caloric density such as fortified to 24 or 26 calories per ounce. You can request the complete record from the hospital under HIPAA. If reading it is difficult, an attorney or medical-legal reviewer can obtain and interpret the feeding history for you.
Sources
- Sullivan S, Schanler RJ, Kim JH, et al. “An Exclusively Human Milk-Based Diet Is Associated With a Lower Rate of Necrotizing Enterocolitis Than a Diet of Human Milk and Bovine Milk-Based Products.” The Journal of Pediatrics, 2010;156(4):562-567. pubmed.ncbi.nlm.nih.gov
- Premkumar MH, Pammi M, Suresh G. “Human milk-derived fortifier versus bovine milk-derived fortifier for prevention of mortality and morbidity in preterm neonates.” Cochrane Database of Systematic Reviews. ncbi.nlm.nih.gov
- American Academy of Pediatrics — Policy on the use of human milk for preterm infants and the reduction of NEC risk. aap.org
- Abbott Nutrition — Similac Human Milk Fortifier (product information). abbottnutrition.com
- Prolacta Bioscience — Human milk-based fortifier information for parents. prolacta.com
- U.S. District Court, Northern District of Illinois — In re: Abbott Laboratories, et al., Preterm Infant Nutrition Products Liability Litigation, MDL No. 3026 (Hon. Rebecca R. Pallmeyer). ilnd.uscourts.gov