Baby formula deaths and warnings: who decides to report?

FDA infant – A mother’s 2016 email blaming Mead Johnson for her premature son’s death triggered an internal review that ended the file. Years later, federal records searches found no FDA notifications tied to such “reasonable possibility” conclusions—raising questions abou

In September 2016, a mother wrote to Mead Johnson with a kind of grief that doesn’t fade into paperwork. Her message was blunt: “REMOVE ME FROM YOUR LIST!!!!. DO NOT EMAIL OR MAIL ME ANY MORE!“ She said the product she linked to her son’s death was being sold into neonatal intensive care units. and she blamed it for the death after her premature child developed necrotizing enterocolitis—an often fatal condition in which intestinal tissue can die and allow infection to spread through the body.

The company’s response was narrower, and it came in an internal memo. Mead Johnson cited what it described as “extensive quality and safety checks” and concluded there was “not a reasonable possibility” that the formula caused the death. “No further investigation is needed. This file can be closed,” the memo said.

In court, that email and the company memo became evidence in lawsuits including Watson v. Mead Johnson and Whitfield v. St. Louis Children’s Hospital, et al. The dispute helped spotlight a central question in the business of infant formula: when babies get sick—or die—while receiving a company’s product. how often do those warnings reach the regulator that is supposed to act before more families are harmed?.

What happens after a complaint can hinge on a single regulatory threshold. Under federal rules. if a complaint about infant formula—such as a report of an adverse event—shows a possible health hazard. the company must investigate. The obligation to notify the Food and Drug Administration within 15 days applies only if the investigation finds “a reasonable possibility of a causal relationship between the consumption of an infant formula and an infant’s death.”.

KFF Health News asked the FDA for notifications sent by infant formula manufacturers since Jan. 1, 2020, under that requirement. The agency’s Human Foods Program “did not receive any. ” Kimberly Jones. a government information specialist at the FDA. responded in March. KFF Health News then asked the FDA to search back to Jan. 1, 2000. “After a diligent search of our files, we did not locate any responsive records,” Jones wrote on May 5.

The FDA’s search results were consistent with court testimony. In a Missouri court in October 2024. John Wallingford—described in the proceedings as a paid expert witness for Abbott—testified that Abbott had never reported a single death under any regulation for preterm infant formula. Wallingford clarified that his testimony was not about adverse events in clinical trials. which are research-and-development studies handled under different procedures. He testified that Abbott had informed the FDA about adverse events that occurred during clinical trials.

Christina Valentine also testified in the Whitfield case in 2024. describing her work as Mead Johnson’s medical director for North America. She said she never sent the FDA a report of death from NEC during her seven years in the role. Valentine testified that she never concluded there was a “reasonable possibility” that a death from NEC might have been related to a Mead Johnson product. and that she was responsible for signing off on those determinations.

Mead Johnson later defended its approach when asked about these issues. In late May and mid-June. spokesperson Jen O’Neill wrote that when there is a physician report that includes an opinion that one of its products caused NEC in a preterm infant. the company treats that as a “reasonable possibility of a causal relationship” and submits an adverse event report to the FDA. “These physician reports were generally made by plaintiffs’ paid experts, with which we disagree,” O’Neill wrote.

But O’Neill left key gaps. She did not say whether events Mead Johnson reported to the FDA were raised in lawsuits or whether the company reported them before they surfaced in litigation. Asked when Mead Johnson filed the reports, O’Neill didn’t answer. It also remained unclear why the FDA said it found no record of such notifications.

O’Neill also would not clarify whether Mead Johnson submitted an adverse event report tied to the distraught mother’s September 2016 complaint. The mother’s name was not publicly disclosed in the court record containing her complaint. In a separate statement. O’Neill said that prior to the current litigation. Mead Johnson received very few reports relating to its products and NEC and even fewer where its investigation uncovered any evidence supporting a reasonable possibility of a causal relationship.

The litigation has been expensive and loud, but the regulatory mechanism at the center is comparatively quiet—letters, memos, thresholds. And in that quiet space, industry personnel appear to have treated repeated field complaints differently from what plaintiffs describe as clear warning signs.

Court records from Watson, Whitfield, and Gill v. Abbott Laboratories show how companies managed those warnings. In general, company personnel didn’t think their products caused harm, and they didn’t view new cases as evidence of harm.

While the legal battles unfold, the human stakes are measurable in the country’s hospitals. About 2. 300 newborns died of necrotizing enterocolitis in the United States from 2017 through 2023—an average of almost one per day—according to a KFF Health News analysis of a government data set for those years. The dataset does not attempt to explain what caused babies to develop NEC. and it does not count babies who survived NEC.

A wave of lawsuits has accused infant formula manufacturers—Abbott and Mead Johnson among them—of harming or killing preterm babies by causing or contributing to NEC. By late January, 1,760 NEC lawsuits were pending against Abbott, a spokesperson, Scott Stoffel, said.

The courtroom record shows both wins and reversals. Watson v. Mead Johnson led to a $60 million judgment against Mead Johnson. Gill v. Abbott led to a $495 million judgment against Abbott. In Whitfield v. St. Louis Children’s Hospital. et al. a jury returned a verdict for Abbott and Mead Johnson. but the judge found errors and misconduct on the part of defense counsel. faulted his own performance. and ruled the plaintiff was entitled to a new trial. The judge’s ruling in Whitfield is on appeal.

On May 5. a Missouri appeals court upheld the $495 million judgment against Abbott. saying “we find Abbott’s conduct significantly reprehensible.” The court wrote that the jury heard evidence Abbott knew its formula posed significant risks to preterm infants weighing under 1500g yet made little effort to mitigate that risk.

On June 12. an Illinois appeals court reversed the $60 million judgment against Mead Johnson and sent the case back for a new trial. The appeals court said the trial court risked prejudicing the jury by improperly admitting evidence about Mead Johnson’s finances. including its revenues. profits. and executive compensation. The appeals court also cited erroneous jury instructions. It ruled that any negligence hinged on a failure to warn—but that the company’s duty was not to warn the mother in that case of danger she claimed; it was to warn doctors.

Outside the courtroom. Abbott and Mead Johnson have competed for presence inside NICUs. which can become entry points to hospital contracts and the retail market. Abbott makes Similac products, and Mead Johnson makes the Enfamil line. A Mead Johnson slide deck for a 2020 national sales meeting—later used in the Whitfield trial—outlined a plan for “Branding NICU Babies.”.

In November. Stoffel said Abbott complies with FDA regulations on adverse event reporting. including keeping detailed records of every complaint or adverse event Abbott receives and investigating NEC complaints. He said FDA routinely conducts audits that include Abbott’s adverse event investigations and reporting.

O’Neill echoed that position. “Our adverse event reporting complies with all applicable regulatory requirements,” she wrote in a November statement. She said the FDA audits Mead Johnson on an annual basis and had never identified an issue about its approach to reporting. O’Neill said Mead Johnson submitted reports to the agency through its regional office in Detroit. and she left open whether the FDA reviewed them.

Her responses also highlighted structural differences in what regulators make public. Emily Hilliard. a spokesperson for the Department of Health and Human Services. which includes the FDA. said manufacturers’ notifications about formulas and fortifiers are not publicly reported. even though the FDA posts adverse event reports for drugs and medical devices in databases available to the public.

The comparison matters because it changes what families and markets can verify. The FDA’s standards for drugs and medical devices require more than fatal outcomes; device makers must report not just deaths but also “serious injuries” that a product “may have caused or contributed to.” Drugmakers must report any “serious and unexpected” adverse event. whether or not it is considered drug related.

There is a separate public database for dietary supplements. foods. and infant formulas that includes voluntary reports from consumers and healthcare practitioners. KFF Health News searched that database and found one death report that mentioned NEC and a formula made for premature or low-birth-weight babies. The search also turned up seven other reports of infant deaths that mentioned NEC and fortifiers designed for premature or low-birth-weight babies. One of those reports. obtained through the Freedom of Information Act. said three preterm babies at the same hospital had NEC and died within a month of one another in 2024.

The FDA cautions that reports are not verified and do not prove causation.

The internal picture described in court documents also shows how companies may decide—often case by case—whether to treat a complaint as an urgent warning or as a dead end. In a January 2024 deposition used in the Gill and Whitfield cases. Fabrizis Suarez. who served as director of medical safety and surveillance at Abbott from 2006 to 2023. testified he knew of no instance where Abbott notified the FDA that a baby had died of NEC that could have been caused by Abbott’s formula for preterm infants. He said there were numerous cases where healthcare providers told Abbott they believed the formula caused NEC. but Abbott disagreed each time.

Court testimony from Abbott’s postmarketing medical safety and surveillance director, Courtney Colombo, likewise said she knew of no instance Abbott reported to any regulatory authority worldwide that a preterm formula was possibly related to a death caused by NEC.

Wallingford testified that Abbott wasn’t hiding complaints from the FDA. and that the complaints were in company files FDA inspectors reviewed during annual inspections. In court, plaintiff’s lawyer Kevin Carnie Jr. asked questions that invoked a fox-and-henhouse analogy. Wallingford declined to comment for this article.

If the internal logic that closes a file is a company judgment, the consequence is broader. A regulatory attorney for Mead Johnson, Martin Hahn, told the inquiry that a finding under the “reasonable possibility” standard could trigger a product recall.

In one of the most vivid internal snapshots. a registered dietitian at a Cincinnati hospital notified Abbott in 2010 that three babies had died of NEC shortly after starting an Abbott formula. An internal Abbott summary shown during Colombo’s deposition said the babies were about 17 days old and had no complications other than prematurity. After reviewing the complaint. Colombo concluded “NO OTHER REPORTS OF DEATH AND NO TRENDS FOR NEC REPORTED BY OTHER FACILITIES ASSOCIATED WITH THIS STOCK CODE” and “PREVIOUS COMPLAINT HISTORY INDICATES NO HEALTH HAZARD.”.

Mead Johnson’s decisions appear to have rested on similar internal thresholds and prioritization. In the Whitfield case. Valentine signed off on closing the 2016 file on the distraught mother’s complaint. according to an exhibit and her deposition testimony played in court. Valentine testified she didn’t know which of Mead Johnson’s products the complaint involved when she signed off. During the Watson trial in February 2024. she testified that. in light of the mother’s request never to contact her again. it wouldn’t have been appropriate to call her back for more information.

O’Neill said Valentine testified that the complaint team appropriately investigated death reports from NEC based on the information provided, and that the FDA encourages infant formula companies to send all adverse event reports. O’Neill also said nothing prevented Mead Johnson from doing so.

In a separate email thread used in the Watson case. Valentine reacted skeptically in 2019 after a colleague told her that a particular hospital wanted to exit its contract with Mead Johnson. The colleague reported the hospital had “3 cases of NEC since they started using our formulas” and “0 cases when they were with Abbott.” Valentine agreed to follow up but added. “Sad but please reassure them we are not seeing this with our formula … so no science basis for sure.”.

All of this has played out as Abbott and Mead Johnson insist the science doesn’t support the kind of direct causal link plaintiffs argue for. Stoffel said numerous studies and NEC authorities have made clear that preterm infant formula does not cause NEC; he said the risk is tied to the absence of human milk rather than harm from formula itself. The FDA. the Centers for Disease Control and Prevention. and the National Institutes of Health weighed in with a joint statement in October 2024 saying there is “no conclusive evidence that preterm infant formula causes NEC” and that there is “strong evidence that human milk is protective against NEC.”.

O’Neill said Mead Johnson’s scientific consensus is that there is no established causal link between specialized preterm hospital nutrition products and NEC. pointing to an American Academy of Pediatrics statement that NEC causes are “multifaceted and not completely understood.” Mead Johnson’s legal brief in the Watson case described “the NEC related risks” of formula for preterm infants as “the subject of medical debate.”.

In the end. the regulatory dispute looks less like a straightforward question of science and more like a question of reporting mechanics—who gets to decide when a complaint crosses into the “reasonable possibility” category that triggers notice within 15 days. The FDA’s public record search showing no notifications since Jan. 1. 2020—combined with court testimony that multiple company witnesses said they had never reported NEC deaths under that standard—puts the burden of clarity on investigations that are largely internal.

For families watching NEC unfold. that difference can feel like distance between what happens at a bedside and what reaches a regulator’s inbox. And for companies that say they follow the rules, the gap becomes a matter of process and interpretation. In the court filings and memos, one September 2016 email closes a file. In federal search results, that closure leaves no record—at least not in the FDA’s files.

infant formula NEC FDA Mead Johnson Abbott adverse event reporting preterm infants NICU lawsuits