FDA Infant Formula Adverse Event Reporting Gap Exposed as NEC Lawsuits Mount Against Abbott and Mead Johnson
核心洞察
A KFF Health News investigation reveals that the FDA has no record of any infant formula manufacturer ever reporting a death under the "reasonable possibility" standard since at least 2000.
Nearly 1,760 NEC lawsuits are pending against Abbott, with a Missouri appeals court upholding a $495 million judgment and calling Abbott's conduct "significantly reprehensible."
Internal company documents show Abbott scientists acknowledged in 2010 that bovine milk-based formulas are "believed to be the primary risk factor" for NEC in preterm infants.
A sweeping investigation by KFF Health News has uncovered a critical gap in the Food and Drug Administration's oversight of infant formula safety: the agency has no record of any manufacturer ever reporting an infant death under the regulatory standard requiring notification when there is "a reasonable possibility of a causal relationship between the consumption of an infant formula and an infant's death."
Under the Freedom of Information Act, KFF Health News requested all such notifications from manufacturers dating back to January 1, 2000. "After a diligent search of our files, we did not locate any responsive records," FDA government information specialist Kimberly Jones responded.
The finding aligns with court testimony. John Wallingford, a paid expert witness for Abbott, testified in a Missouri court in October 2024 that Abbott had never reported a single death under any regulation for preterm infant formula. Christina Valentine, Mead Johnson (搜索)'s medical director for North America from 2014 to 2021, testified in a 2024 deposition that she never sent the FDA a report of death from NEC during her seven-year tenure, stating she never concluded there was a reasonable possibility that an infant's death from NEC might have been related to a Mead Johnson product.
The Scope of NEC and Ongoing Litigation
Approximately 2,300 newborns died of necrotizing enterocolitis (搜索) in the United States from 2017 through 2023, according to a KFF Health News analysis of government data — the equivalent of nearly one death per day. NEC is an often fatal condition in which intestinal tissue dies, potentially allowing infection to spread throughout the body of a prematurely born infant.
As of late January, 1,760 NEC lawsuits were pending against Abbott alone, according to company spokesperson Scott Stoffel. The litigation has produced mixed outcomes. On May 5, a Missouri appeals court upheld a $495 million judgment against Abbott, writing that "we find Abbott's conduct significantly reprehensible" and noting that "the jury heard evidence that Abbott knew its formula posed significant risks to preterm infants weighing under 1500g yet made little effort to mitigate that risk."
Conversely, on June 12, an Illinois appeals court reversed a $60 million judgment against Mead Johnson (搜索), ordering a new trial after finding the trial court improperly admitted evidence about the company's finances and gave erroneous jury instructions regarding the company's duty to warn.
In April, a jury in Chicago ordered Abbott to pay four plaintiffs a total of $70 million. Abbott is contesting that verdict.
Internal Documents Reveal Industry Awareness
Plaintiffs have used internal company documents to argue that manufacturers have long recognized a correlation between NEC and cow's milk-based preterm formulas. In a 2010 research proposal shown in a deposition used in the Gill v. Abbott case, Abbott scientists wrote that NEC "is the most severe GI complication of prematurity and the use of bovine milk-based fortifiers and formulas are believed to be the primary risk factor."
A Mead Johnson (搜索) document used in the Whitfield lawsuit cited "80% necrotizing enterocolitis (搜索) (NEC) risk reduction when human milk is used in place of formula."
Abbott has maintained that correlation does not equal causation. "Numerous studies and NEC authorities have made clear that preterm infant formula does not cause NEC; it's the absence of human milk that increases NEC risk rather than anything harmful in formula," Stoffel said.
In October 2024, the FDA, Centers for Disease Control and Prevention, and National Institutes of Health issued a joint statement saying, "There is no conclusive evidence that preterm infant formula causes NEC" while affirming "there is strong evidence that human milk is protective against NEC."
Regulatory Disparities in Adverse Event Reporting
The investigation revealed significant disparities between how the FDA handles adverse event reports for infant formula versus drugs and medical devices. While the FDA posts manufacturers' adverse event reports on drugs and medical devices in publicly accessible databases, notifications about formulas and fortifiers are not publicly reported, according to Emily Hilliard, a spokesperson for the Department of Health and Human Services.
Furthermore, drugmakers must report any "serious and unexpected" adverse event "whether or not considered drug related," while device makers must report not just deaths but also "serious injuries" that the product "may have caused or contributed to." The infant formula standard is narrower, requiring notification only when the company itself finds a "reasonable possibility" of causation.
Fabrizis Suarez, director of medical safety and surveillance at Abbott from 2006 to 2023, testified in a January 2024 deposition that he knew of no instance in which Abbott notified the FDA that a baby had died of NEC that could have been caused by Abbott's formula. He acknowledged there were numerous cases in which healthcare providers told Abbott they believed the formula caused NEC, but Abbott disagreed every time.
A Mother's Unheeded Warning
In September 2016, a mother whose son died from NEC sent Mead Johnson (搜索) an anguished message: "It is because of your animal based pre-term artificial baby food crap that you peddle to hospital NICU's that my son is dead from NEC."
An internal Mead Johnson (搜索) memo cited the company's "extensive quality and safety checks" and concluded there was "not a reasonable possibility" that the formula caused the baby's death. "No further investigation is needed. This file can be closed," the memo stated.
Mead Johnson (搜索) spokesperson Jen O'Neill told KFF Health News that "where there is a physician report that includes an opinion that one of our products caused NEC in a preterm infant, we have treated that as a 'reasonable possibility of a causal relationship,' and we submitted an adverse event report to the FDA." However, O'Neill declined to specify when those reports were filed or whether the 2016 mother's complaint was among them.
The FDA's search found no record of any such reports. O'Neill said the reports were submitted through the agency's regional office in Detroit, though FDA rules require manufacturers to send written confirmations to a central office in the Washington area that oversees infant formula.
KFF Health News also searched the FDA's public database for dietary supplements, foods, and infant formulas, finding one death report mentioning NEC and a formula for premature or low-birth-weight babies, along with seven other infant death reports mentioning NEC and fortifiers. The FDA cautions that such reports are not verified and do not prove causation.