Formula Death Complaints, FDA Reporting, and Closed Files

In September 2016, a grieving mother sent Mead Johnson a furious message about infant formula she believed had killed her son. She demanded that the company remove her from its mailing list and stop contacting her. In the email, she blamed what she called the company’s “animal based pre-term artificial baby food” for her baby’s death from NEC, the abbreviation for necrotizing enterocolitis. NEC is a serious and often fatal condition in which tissue in the intestine dies, allowing infection to spread through an infant’s body, especially in babies born prematurely.

Mead Johnson responded internally with a memo that relied on the company’s “extensive quality and safety checks.” The company concluded there was “not a reasonable possibility” that its formula caused the baby’s death. “No further investigation is needed. This file can be closed,” the memo said. That decision did more than end a single complaint. It also limited the chance that the mother’s report could draw wider attention to any risk the formula might pose to other infants.

The mother’s email and Mead Johnson’s memo later became evidence in Watson v. Mead Johnson and Whitfield v. St. Louis Children’s Hospital, et al. They are part of a broader picture of how infant formula complaints are handled when babies become sick or die after receiving formula in hospitals or elsewhere. Under federal rules, when a complaint about infant formula suggests a possible health hazard, the manufacturer must investigate. But a company does not always have to tell the Food and Drug Administration about the complaint.

The reporting duty is narrower than the investigation duty. A manufacturer must finish its investigation and notify the FDA within 15 days only if it 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, through public records requests, whether it had received any such notifications from infant formula makers since Jan. 1, 2020. Kimberly Jones, a government information specialist at the agency, said the FDA’s Human Foods Program “did not receive any.” KFF Health News then asked the agency to search going back to Jan. 1, 2000. Jones wrote on May 5 that after “a diligent search,” the FDA did not locate any responsive records.

Those search results matched what surfaced in court testimony. John Wallingford, a paid expert witness for Abbott, testified in Missouri court in October 2024 that Abbott had never reported a single death under any regulation for preterm infant formula. Wallingford said he was not talking about adverse events in clinical trials, which are research and development studies and follow different procedures. He testified that Abbott did inform the FDA about adverse events that occurred during a clinical trial.

Another court record pointed in the same direction. Christina Valentine, who served for seven years as Mead Johnson’s medical director for North America, testified in a 2024 deposition that she never sent the FDA a report of death from NEC during her time in that role. In the deposition, which was used in the Whitfield case, she said she never concluded there was a reasonable possibility that an infant’s NEC death might have been related to a Mead Johnson product. Valentine testified in the Watson trial that, as medical director for North America, she was responsible for signing off on those determinations. She also said she was not sure whether anyone else at the company had sent a death report to the FDA.

In late May and mid-June, Mead Johnson spokesperson Jen O’Neill added more detail in writing, though key questions remained unanswered. O’Neill said that when there is a physician report stating that one of the company’s products caused NEC in a preterm infant, Mead Johnson has treated that as a reasonable possibility of a causal relationship and submitted an adverse event report to the FDA. She said these physician reports were generally made by plaintiffs’ paid experts, and she said the company disagreed with them. But she did not say whether the events the company reported to the FDA were first raised in lawsuits, or whether Mead Johnson had reported them before they appeared in litigation. When asked repeatedly when the company filed the reports, O’Neill did not say. It is still unclear why the FDA found no record of any such reports. O’Neill also would not say whether Mead Johnson submitted a report related to the mother’s September 2016 complaint. Her name was not publicly disclosed in the court record containing her complaint.

O’Neill also wrote that before the current litigation, Mead Johnson received very few reports about its products and NEC, and even fewer in which the company’s investigation uncovered evidence supporting a reasonable possibility of a causal relationship. Court records from Watson, Whitfield, and Gill v. Abbott Laboratories show industry personnel sometimes responded to complaints in a circular way: company staff did not believe their products caused harm, and they did not view new cases as evidence of harm.

The legal fights are unfolding against a larger backdrop of NEC deaths and lawsuits. According to a KFF Health News analysis of a government dataset, about 2,300 newborns died of necrotizing enterocolitis in the United States from 2017 through 2023, or nearly one per day. The database does not explain what caused those babies to develop NEC, and it does not count babies who survived the condition. Lawsuits have alleged that infant formula made by Abbott or Mead Johnson harmed or killed preterm babies by causing or contributing to NEC.

As of late January, Abbott spokesperson Scott Stoffel said there were 1,760 NEC lawsuits pending against the company, clarifying a disclosure in a regulatory filing. The story drawn from trial transcripts, deposition videos, and exhibits involves three cases that went to trial in 2024. In Watson v. Mead Johnson, the plaintiff won a $60 million judgment. In Gill v. Abbott, the plaintiff won a $495 million judgment. In Whitfield v. St. Louis Children’s Hospital, et al., a jury originally found in favor of Abbott and Mead Johnson, but the judge later found errors and misconduct by defense counsel, faulted his own performance, and ruled that the plaintiff was entitled to a new trial. That ruling is now on appeal.

Appellate courts have since changed the picture in two of the cases. On May 5, a Missouri appeals court upheld the $495 million judgment against Abbott and said, “we find Abbott’s conduct significantly reprehensible.” The court wrote that the jury heard evidence showing Abbott knew its formula posed significant risks to preterm infants weighing under 1500g, yet made little effort to reduce that risk. Then, 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 court said the trial judge had risked prejudicing the jury by admitting evidence about Mead Johnson’s finances, including revenues, profits, and executive compensation, and had also given erroneous instructions. The appeals court said Mead Johnson’s negligence claim turned on failure to warn, and that the company’s duty was to warn doctors rather than the mother in that case.

In April, after a different trial, a jury in Chicago ordered Abbott to pay four plaintiffs a total of $70 million. Abbott is challenging that verdict and the Missouri appeals court ruling. In at least four other cases, judges have granted summary judgment for Abbott before trial.

Abbott sells Similac products, and Mead Johnson sells Enfamil. The two companies have competed for placement in neonatal intensive care units, which can serve as gateways to hospital contracts and the retail market. A Mead Johnson slide deck for a 2020 national sales meeting, later used in the Whitfield trial, outlined a plan for “Branding NICU Babies.” The slide deck included a product for babies born prematurely who are transitioning to home. The litigation has opened a wider view into the business and regulatory issues surrounding infant formula, but some questions remain unresolved, including how often manufacturers reported infant deaths to the FDA and whether any report connected to the 2016 mother’s complaint was ever filed.