If you have followed the NEC baby formula litigation, you may have noticed something that looks contradictory. State-court juries in Missouri and Illinois have heard the evidence and returned verdicts for families. Yet in the federal litigation, several early cases were thrown out by the judge before a jury ever heard a word of testimony. How can the same basic claim — that a cow’s-milk-based premature-infant formula caused a baby’s necrotizing enterocolitis — win in front of one jury and never reach another?
The answer is not that the science changed from one courtroom to the next. It is a rule of evidence called the Daubert standard, and the power it gives a judge to act as a “gatekeeper” over expert testimony. Understanding it explains the single most confusing feature of this litigation — and it explains why Inman v. Mead Johnson, the first federal NEC case to clear that gate and reach a jury, is such a closely watched event. This article walks through what Daubert is, why it decided the fate of the early federal cases, and what families should — and should not — take from it.
The one-sentence version. In NEC cases, causation is proven through expert witnesses; the Daubert standard lets a judge exclude an expert whose opinion is not reliable enough or does not fit the specific child’s facts closely enough, and when a plaintiff’s causation expert is excluded, the case can end on summary judgment before any jury hears it — which is exactly what happened in several early federal cases but not in Inman.
What is the Daubert standard?
The Daubert standard takes its name from the U.S. Supreme Court’s 1993 decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, and it is applied today through Federal Rule of Evidence 702. In plain terms, it makes the trial judge a gatekeeper: before a jury is allowed to hear an expert, the judge must decide whether that expert’s testimony is both reliable and a good fit for the facts of the case.
Reliability asks whether the expert used sound methods — tested theories, peer-reviewed literature, known error rates, and reasoning that other scientists in the field would accept. Fit asks a narrower and often decisive question: does this expert’s general opinion actually apply to this case, with its particular facts? An epidemiologist may be highly qualified and rely on solid studies, but if the judge concludes the opinion does not connect tightly enough to the specific infant in front of the court, the testimony can be limited or excluded.
That gatekeeping role is why expert admissibility, and not just what a jury believes, can decide a product-liability case. In a NEC claim, a family cannot prove causation by testimony from parents alone. It requires medical and scientific experts to establish both that cow’s-milk-based formula can cause NEC and that it did so for their child. Remove the admissible expert, and there is nothing left to put to a jury.
General causation vs. specific causation — and why the difference matters at the gate
NEC cases run on two separate causation questions, and Daubert can be applied to the experts behind each one.
Can it happen at all?
Whether cow’s-milk-based formula is capable of causing NEC in premature infants as a scientific matter. This rests on the body of neonatology and epidemiology research.
Did it happen here?
Whether, for this child, on these records, the product was a cause of the injury — accounting for gestational age, what was fed and when, and the documented course of the illness.
We explain how a jury weighs these two questions in our piece on what a defense verdict and “specific causation” mean for families. But there is an earlier stage most families never hear about: long before a jury weighs anything, the judge decides which experts are even allowed to speak. A case can survive on general causation — the science is sound — and still be dismissed if the specific-causation expert is excluded for not fitting the individual child’s facts. That distinction is the key to the entire federal story.
Why several federal Similac bellwethers were dismissed before trial
The federal NEC cases are consolidated in a multidistrict litigation, MDL No. 3026, before U.S. District Judge Rebecca R. Pallmeyer in the Northern District of Illinois. To test how these claims would fare, the court selected “bellwether” cases — representative cases tried first to guide the rest. The early federal bellwethers all involved Abbott’s Similac products.
Those early cases did not reach juries. In reported rulings, the court granted summary judgment for the manufacturer after limiting or excluding the plaintiffs’ specific-causation experts under Daubert. In the Diggs bellwether in 2025, for example, the court found an insufficient fit between the expert’s causation opinion and the particular infant’s gestational profile — and without an admissible specific-causation expert, there was no way for that plaintiff to prove the product caused that child’s NEC. A separate ruling addressed whether an alternative product was a feasible substitute. In each instance, the case ended at the gate rather than in front of a jury.
What is easy to miss — and what matters enormously — is that the court did not reject the underlying science. In the same litigation, Judge Pallmeyer declined to exclude certain of the plaintiffs’ general-causation experts, at one point describing some of the defense’s challenges to that testimony as “groundless.” In other words, the proposition that cow’s-milk-based formula can cause NEC in preterm infants survived the gate. What sank the individual Similac bellwethers was the fit of the specific-causation opinions to those particular children — not a finding that the science was junk. The research summarized in our overview of the science linking cow’s-milk formula to NEC remained standing.
Why this distinction is not a technicality. “General causation survived; specific causation didn’t fit” is the difference between “this science is unproven” and “this particular expert didn’t tie the science tightly enough to this particular baby.” The first would be a body blow to every case. The second is a case-by-case, records-by-records question — which is why it says almost nothing about the family reading this page.
How Inman v. Mead Johnson became the first federal case to reach a jury
Against that backdrop, Inman v. Mead Johnson stands apart. It is an Enfamil case — against Mead Johnson, not Abbott — and in May 2026, Judge Pallmeyer denied Mead Johnson’s motion for summary judgment, ruling that genuine factual disputes about causation and the adequacy of the product’s warnings had to be resolved by a jury rather than by the court. That ruling cleared the gate the earlier bellwethers could not, and the trial began in July 2026 in the Northern District of Illinois — the first time a federal jury has been positioned to weigh NEC formula causation evidence directly.
Whatever a single trial produces, the procedural milestone is real: a federal NEC case survived the expert-gatekeeping stage that had ended the prior bellwethers. For the broader picture of where the federal docket stands, see our NEC MDL 3026 update.
“Families see a headline that a case was ‘thrown out’ and they assume the courts have decided formula doesn’t cause NEC. That is not what those rulings said,” says Alex Alvarez, Managing Partner of The Alvarez Law Firm and a Board Certified Civil Trial Lawyer. “The science that these products can cause NEC has been allowed to stand. What the early federal rulings turned on was whether a specific expert’s opinion fit one specific child’s facts. That is a question we answer child by child, from the records — and it is exactly why a family should never disqualify themselves based on someone else’s bellwether.”
Why state and federal courts have looked so different
The apparent split between state verdicts for families and federal dismissals is less contradictory once the gate is in view. Different courts apply expert-admissibility rules with different emphasis, the bellwether cases chosen for the federal track had their own particular facts, and a summary-judgment dismissal on one child’s specific-causation fit is a legal ruling about that record — not a jury’s verdict on the merits of the science.
| Question | Decided by | What it turns on |
|---|---|---|
| Is the expert allowed to testify? | The judge (Daubert / Rule 702) | Reliability of the method and fit to the specific child’s facts — resolved before trial. |
| Can formula cause NEC at all? (general causation) | Admitted experts, then the jury | The body of neonatology and epidemiology evidence. |
| Did it cause this baby’s NEC? (specific causation) | The jury | This child’s records: gestational age, feeding history, and clinical course. |
“When a case turns on expert fit, it turns on the record,” says Herb Borroto, M.D., J.D., the firm’s Medical-Legal Expert. “A causation opinion has to be anchored to what actually happened to that infant — the gestational age, whether a cow’s-milk-based product or fortifier was fed and on what dates, and how the NEC unfolded in the notes and imaging. When we build a case, we are building that anchor from the chart so the specific-causation opinion fits the child in front of us. A gatekeeping loss in someone else’s file tells me nothing about whether that anchor is strong in yours. It tells me to read the records.” The documents that anchor matter most are the ones we describe in our guide to reading a NICU progress note.
What this means for families
A few practical takeaways if you have seen news of federal cases being dismissed.
First, “dismissed on summary judgment” is not “the science was rejected.” In the federal NEC litigation the general-causation science was allowed to stand. The early dismissals turned on the specific-causation fit in individual bellwether records — a case-by-case question, not a verdict on the litigation as a whole.
Second, one bellwether does not decide your case. Bellwethers exist to give both sides information about how representative cases perform. They do not bind other families, and they do not resolve the specific facts of a child who was not part of that trial.
Third, the strength of your child’s record is what matters — so preserve it. Because these cases live and die on the fit between the expert opinion and the documented facts, the completeness of the NICU record is central. You have the right to request your child’s complete record under HIPAA.
Fourth, filing deadlines keep running regardless of the headlines. The statute of limitations that could apply depends on your child’s dates and your state’s law, and it is often shorter than parents expect. A short, no-cost review of whether your family qualifies for an NEC lawsuit replaces a headline-driven assumption with an answer grounded in your own records.
This is general information, not legal or medical advice. Court rulings described here are summarized from public reporting on MDL No. 3026 and general principles of evidence law; they do not decide any other family’s case. Whether a specific child’s NEC can be tied to a cow’s-milk-based product — and how expert testimony would fit those facts — 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 causation question
Because these cases turn on the fit between expert testimony and the record, that is where our review starts. Our team, led by Board Certified Civil Trial Lawyer Alex Alvarez and supported by Medical-Legal Expert Herb Borroto, M.D., J.D., obtains the complete NICU record and builds the timeline that a specific-causation opinion has to rest on: the gestational age, the feeding orders and what was actually fed, and the first documented signs of NEC. If the record supports a tight link, we can see it. If it points elsewhere, we tell the family honestly. Either way a family gets a real answer instead of a guess drawn from someone else’s headline. We do this for families nationwide, at no cost.
Free, confidential case review. No fees unless we recover compensation for you.
- Understand the two causation questions: what a defense verdict and “specific causation” mean.
- Read the underlying science: the science linking cow’s-milk formula to NEC.
- See where the federal cases stand: NEC MDL 3026 update.
- See if your family qualifies: Do I qualify for an NEC lawsuit?
Frequently asked questions
What is the Daubert standard, and why does it matter in NEC lawsuits?
The Daubert standard comes from the U.S. Supreme Court’s decision in Daubert v. Merrell Dow Pharmaceuticals (1993) and is applied through Federal Rule of Evidence 702. It makes the trial judge a gatekeeper who decides whether expert testimony is reliable enough and fits the facts closely enough to be heard by a jury. In NEC baby formula cases, causation is proven through expert witnesses — neonatologists and epidemiologists who explain the link between cow’s-milk-based formula and necrotizing enterocolitis. If a judge excludes a plaintiff’s key causation expert under Daubert, the plaintiff may have no admissible way to prove causation, and the case can be dismissed on summary judgment before a jury ever hears it.
Why were some federal NEC bellwether cases dismissed before trial?
In the federal NEC litigation (MDL 3026, before Judge Rebecca Pallmeyer in the Northern District of Illinois), several early Similac bellwether cases were resolved on summary judgment for the manufacturer rather than going to a jury. In reported rulings, the court limited or excluded plaintiffs’ specific-causation experts — for example, finding an insufficient fit between an expert’s opinion and the particular infant’s gestational profile in the Diggs bellwether in 2025. When the specific-causation expert testimony is excluded, the plaintiff cannot prove that the product caused that child’s injury, so the case ends before trial. Notably, the same court declined to exclude certain general-causation experts, meaning the science that cow’s-milk-based formula can cause NEC was allowed to stand.
What is Inman v. Mead Johnson and why is it significant?
Inman v. Mead Johnson is the first federal NEC baby formula case to survive summary judgment and reach a jury. In May 2026, Judge Pallmeyer denied Mead Johnson’s motion for summary judgment, ruling that genuine disputes about causation and the adequacy of the product’s warnings had to be decided by a jury rather than the court. The trial began in July 2026 in the Northern District of Illinois. It is significant because the three prior federal bellwethers — all Similac cases against Abbott — had been dismissed at the gatekeeping stage, so Inman is the first time a federal jury has been positioned to weigh the causation evidence directly.
If cases can be dismissed over experts, should families assume they have no case?
No. A dismissal in one bellwether does not decide any other family’s case, and it does not mean the underlying science was rejected — in the federal NEC litigation, general-causation experts were allowed to testify. Gatekeeping rulings turn on the specific fit between an expert’s opinion and one child’s records: gestational age, what was fed and when, and the documented course of the illness. That is a fact-specific, records-driven question. The practical lesson is the opposite of giving up — it is that the strength of the medical record and the expert analysis tied to your child’s specific facts is what matters, which is exactly what a case review examines.
Sources
- Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) — U.S. Supreme Court decision establishing the trial judge’s gatekeeping role over expert testimony. supreme.justia.com
- Federal Rule of Evidence 702 — Testimony by Expert Witnesses. law.cornell.edu
- 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
- AboutLawsuits.com — “Enfamil NEC Lawsuit Cleared For MDL Trial in July 2026,” reporting the denial of Mead Johnson’s summary judgment motion in Inman. aboutlawsuits.com
- U.S. Judicial Panel on Multidistrict Litigation — docket and case-count information for MDL 3026. jpml.uscourts.gov