In September 2016, a distraught mother sent infant formula maker Mead Johnson a message:
“REMOVE ME FROM YOUR LIST!!!! DO NOT EMAIL OR MAIL ME ANY MORE!
“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.”
The mother was referring to neonatal intensive care units and necrotizing enterocolitis, an often fatal condition in which intestinal tissue can die and allow infection to spread through the body of an infant born prematurely.
In an internal memo, Mead Johnson cited its “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 said.
And with that decision, the company narrowed the chance that the mother’s anguish could draw attention to any danger the formula might pose to other infants.
The mother’s email and the company’s memo assessing it were used as evidence in the court cases Watson v. Mead Johnson and Whitfield v. St. Louis Children’s Hospital, et al.
When doctors, hospitals, parents, or others alert manufacturers that babies got sick or died while receiving infant formula, what happens next is left largely to manufacturers such as Abbott Laboratories and Mead Johnson Nutrition, giants of the industry.
Mead Johnson’s handling of the mother’s email showed how that can play out.
Under federal rules, if a complaint about an infant formula — such as a report of an adverse event — shows a possible health hazard, the company must investigate.
But it doesn’t always have to inform the government agency that oversees the safety of infant formula.
A company must complete an investigation and notify the Food and Drug Administration 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.”
If that happened even once over more than a quarter century, the FDA could find no record of it, according to information obtained through public records requests.
‘Never Reported’
Under the Freedom of Information Act, KFF Health News asked the FDA for all notifications that manufacturers of infant formula sent the agency per the regulatory requirement since Jan. 1, 2020. 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 go back decades further — 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.
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.
Wallingford clarified that he was not referring to adverse events in clinical trials, which are studies used for research and development and are subject to different procedures. Abbott informed the FDA about adverse events that occurred during a clinical trial, Wallingford testified.
John Wallingford, an expert witness for Abbott Laboratories, testified in 2024 that, outside of clinical trials, the company had never reported to the FDA that there was a reasonable possibility a death was caused by an Abbott preterm formula, according to a transcript posted by the Missouri Court of Appeals Eastern District in an appeal of the Whitfield v. St. Louis Children’s Hospital case.
Christina Valentine testified in a 2024 deposition that she never sent the FDA a report of death from NEC during her seven years as Mead Johnson’s medical director for North America. In the deposition, used in the Whitfield case, she said she never concluded there was a reasonable possibility that an infant’s death from NEC might have been related to a Mead Johnson product.
As medical director for North America, she was responsible for signing off on those determinations, she testified in the Watson trial.
In the deposition, Valentine said she wasn’t sure whether anyone else at the company sent a death report to the FDA.
In late May and mid-June, Mead Johnson spokesperson Jen O’Neill added to the picture.
“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,” she wrote.
“These physician reports were generally made by plaintiffs’ paid experts, with which we disagree,” she wrote.
O’Neill left unclear whether events Mead Johnson reported to the FDA were raised in lawsuits and, if so, whether the company reported them to the FDA before they surfaced in litigation.
Asked repeatedly when Mead Johnson filed the reports, O’Neill didn’t say.
It’s unclear why the FDA found no record of them.
Nor would O’Neill say whether the company submitted one related to the distraught mother’s September 2016 complaint.
That mother’s name wasn’t publicly disclosed in the court record containing her complaint.
“[P]rior to the current litigation, we received very few reports relating to our products and NEC and even fewer for which our investigation uncovered any evidence supporting a reasonable possibility of a causal relationship,” O’Neill wrote.
Industry personnel have reacted to some complaints with circular reasoning, as shown by court records from the Watson, Whitfield, and Gill v. Abbott Laboratories cases. Company personnel didn’t think their products caused harm, and they didn’t view new cases as evidence of harm, records show.
‘Reprehensible’ Conduct
About 2,300 newborns died of necrotizing enterocolitis in the United States from 2017 through 2023, the equivalent of almost one per day, according to a KFF Health News analysis of a government data set for those years. The database doesn’t attempt to explain what caused those babies to develop NEC, and it doesn’t count babies who survived NEC.
A wave of lawsuits has alleged that infant formula made by Abbott or Mead Johnson harmed or killed preterm babies by causing or contributing to cases of NEC. As of late January, 1,760 NEC lawsuits were pending against Abbott, company spokesperson Scott Stoffel said, clarifying a disclosure in a regulatory filing.
This article is based largely on transcripts, deposition videos, and exhibits from three court cases that went to trial in 2024. The lawsuits were filed by parents of babies who suffered or died from NEC.
Abbott and Mead Johnson have denied fault. They, along with various medical authorities including federal regulatory agencies and the American Academy of Pediatrics, have said that, when nutritional needs can’t be met with human milk, formula is vital.
One of the cases, Watson v. Mead Johnson, led to a $60 million judgment against Mead Johnson. Another, Gill v. Abbott, led to a $495 million judgment against Abbott. The third, Whitfield v. St. Louis Children’s Hospital, et al., led to a jury verdict in favor of 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 the Whitfield case 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.”
“Throughout the trial, 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,” the court wrote.
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 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 said.
In addition, the trial judge gave the jury erroneous instructions, the appeals court ruled. Any negligence on Mead Johnson’s part hinged on a failure to warn, and the company’s duty was not to warn the mother in that case of any danger, as she had claimed, but rather to warn doctors, the appeals court ruled.
In April, after another trial, a jury in Chicago ordered Abbott to pay four plaintiffs a total of $70 million. Abbott is contesting that verdict and the Missouri appeals court’s decision.
In at least four cases, judges have granted summary judgment in favor of Abbott — ruling for the company before the lawsuits reached trial.
‘Branding NICU Babies’
Abbott makes Similac products, and Mead Johnson makes the Enfamil line.
The two companies have vied to place their products in neonatal intensive care units, which serve as entry points to hospital contracts and the retail market, KFF Health News reported in a March article based largely on records from court cases.
For instance, a Mead Johnson slide deck for a 2020 national sales meeting — later used in the Whitfield trial — outlined a plan for “Branding NICU Babies.”
A Mead Johnson slide for a 2020 national sales meeting outlined a plan for “Branding NICU Babies.” The slide featured a product for babies born prematurely transitioning to home. The slide deck was used in the Whitfield v. St. Louis Children’s Hospital lawsuit.
The litigation opened a wider window into the business and regulation of infant formula, including adverse event reports.
“Abbott complies with all applicable FDA regulations on adverse event reporting, including by keeping detailed records of every single complaint/adverse event report Abbott receives and investigating NEC complaints,” Stoffel said in November. “FDA routinely conducts audits that include Abbott’s adverse event investigations and reporting as part of its active regulation of infant nutrition.”
Mead Johnson’s O’Neill echoed that.
“Our adverse event reporting complies with all applicable regulatory requirements,” O’Neill said in a November statement to KFF Health News. “The FDA audits Mead Johnson on an annual basis and has never identified any issue about our approach to reporting.”
The reports the company filed with the FDA were submitted through the agency’s regional office in Detroit, she said.
It’s unclear whether the FDA looked in Detroit.
FDA rules require manufacturers to send written confirmations to a central office in the Washington area that oversees infant formula and other foods.
Asked if the company sent them to that office, O’Neill did not answer.
KFF Health News requested an interview with Mead Johnson to clarify its statements about how it handled adverse event reports. The company did not grant one.
Plaintiffs have used internal documents from the companies to allege that, in house, people have long recognized a correlation between NEC and the use of preterm formulas made from cow’s milk.
For example, in a 2010 research proposal shown in a deposition used in the Gill 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.”
An Abbott document from 2010 said necrotizing enterocolitis “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.” The document was displayed in deposition video clips KFF Health News obtained from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.
A Mead Johnson document used in the Whitfield lawsuit cited “80% necrotizing enterocolitis (NEC) risk reduction when human milk is used in place of formula.”
Abbott has argued 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,” Abbott spokesperson Stoffel said.
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 “there is strong evidence that human milk is protective against NEC.”
Mead Johnson’s O’Neill said the scientific consensus is that there is no established causal link between the use of specialized preterm hospital nutrition products and NEC.
O’Neill cited a statement by the American Academy of Pediatrics saying the causes of NEC “are multifaceted and not completely understood.”
In a legal brief filed with an Illinois appeals court in the Watson case, the company said “the NEC related risks” of a formula for preterm infants “are the subject of medical debate.”
Managing Potential Warnings
Court records from lawsuits shed light on how the manufacturers have managed potential warnings from the field.
Fabrizis Suarez, who was director of medical safety and surveillance at Abbott from 2006 to 2023, said in a January 2024 deposition used in the Gill and Whitfield cases 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 for preterm infants.
There were numerous cases in which healthcare providers told Abbott they believed the formula caused the NEC, but Abbott disagreed every time, Suarez testified.
Abbott tracks and reviews every NEC report it receives and looks for patterns, Suarez testified.
Fabrizis Suarez, identifying himself as director of medical safety and surveillance at Abbott from 2006 to 2023, testified in a January 2024 deposition about Abbott’s handling of adverse event reports. KFF Health News obtained deposition video clips from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.
Courtney Colombo, who identified herself in a March 2024 deposition used in the Gill and Whitfield cases as director of postmarketing medical safety and surveillance at Abbott, likewise testified that she knew of no instance in which Abbott reported to any regulatory authority anywhere in the world that one of its preterm infant formulas was possibly related to a death caused by NEC.
Abbott wasn’t hiding complaints from the FDA, according to testimony from Wallingford, a paid expert witness on regulatory matters who spent 10 years at the FDA. The complaints were in company files FDA inspectors reviewed during annual inspections, he said in the Whitfield case.
Wallingford also testified that inspections are not a replacement for reporting infant deaths.
Questioning Wallingford in court, plaintiff’s lawyer Kevin Carnie Jr. invoked the cliché about the fox guarding the henhouse.
Wallingford declined to comment for this article. Valentine and Colombo did not respond to messages sent via LinkedIn. Valentine and Suarez did not respond to letters mailed to addresses that appeared to be associated with them. A letter to Colombo with signature required, sent to an address apparently associated with her, was returned unopened.
Not Publicly Reported
Adverse event reports can prompt the FDA to take action to protect the public.
For example, in 2011, the FDA warned parents, caregivers, and healthcare providers not to feed SimplyThick, a thickening gel, to premature infants fitting a particular profile. The product, used to manage swallowing difficulties, might cause NEC, the FDA said.
The FDA first learned about possible problems with SimplyThick from physicians, according to an FDA document that an attorney for Abbott, Sierra Elizabeth, read from during the Whitfield trial.
The stakes for companies and consumers are high.
A finding under the “reasonable possibility” standard could trigger a product recall, said Martin Hahn, a regulatory attorney for Mead Johnson.
The FDA’s handling of adverse event reports for infant formulas — and fortifiers, which are used to nutritionally supplement a mother’s milk when babies are born prematurely — contrasts with its handling of reports about drugs and medical devices.
The FDA posts manufacturers’ adverse event reports on drugs and medical devices online in databases available to the public.
But the notifications manufacturers are required to submit about formulas and fortifiers are not publicly reported, said Emily Hilliard, a spokesperson for the Department of Health and Human Services, which includes the FDA.
In addition, the FDA’s reporting requirements for drugs and medical devices are, in key ways, more demanding than those for infant formula.
Device makers must report not just deaths but also “serious injuries” that the product “may have caused or contributed to.”
Drugmakers are required to report any “serious and unexpected” adverse event, “whether or not considered drug related.” That goes beyond fatal or life-threatening events.
The FDA also maintains a public database about dietary supplements, foods, and infant formulas, among other products, 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 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 by KFF Health News 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.
A former attorney for Abbott now leads the FDA.
Before becoming the FDA’s deputy commissioner for food last year and being named acting head of the agency in May, Kyle Diamantas represented Abbott in the Gill and Whitfield lawsuits, court records show.
Diamantas “complies with all applicable ethics laws and regulations,” said Hilliard, the HHS spokesperson. “That included a specific recusal related to Abbott Laboratories, which concluded in January 2026.”
“During that period, Mr. Diamantas voluntarily recused himself from all matters involving infant formula to avoid any appearance of partiality,” Hilliard said.
‘No Health Hazard’
KFF Health News asked the FDA a series of questions for this article. The agency left many unanswered.
“Infant formula safety is a top priority of the FDA given the vulnerability of the intended population,” Hilliard said.
KFF Health News asked Abbott and Mead Johnson for data on all infant death reports the companies received and those they forwarded to the FDA. Neither company provided that information.
Court records provide fragmentary data.
Abbott lawyer Elizabeth said in court that, before Wallingford took the stand as an expert witness, the company gave him 789 complaint files from 2005 through 2022 that contained the search term “NEC.”
When Wallingford went through the files, he found about 130 that mentioned death and NEC, he testified.
If Similac Special Care products for preterm infants were a problem, and if only 1% of adverse events led to a report, “you would expect to see tens of thousands of complaints,” Wallingford testified.
In 2010, a registered dietitian at a Cincinnati hospital notified Abbott that three babies had died of NEC shortly after starting on an Abbott formula. The dietitian thought there might be a correlation, according to an internal Abbott summary of the complaint shown during Colombo’s deposition. The babies, who were about 17 days old, had no complications other than prematurity, the summary said.
After reviewing the complaint, Abbott’s Colombo wrote, as shown in a deposition video, that she found “NO OTHER REPORTS OF DEATH AND NO TRENDS FOR NEC REPORTED BY OTHER FACILITIES ASSOCIATED WITH THIS STOCK CODE.”
“PREVIOUS COMPLAINT HISTORY INDICATES NO HEALTH HAZARD,” she concluded.
Courtney Colombo, who identified herself in a March 2024 deposition as director of postmarketing medical safety and surveillance at Abbott, testified about Abbott’s response to a report that three babies had died of NEC shortly after starting on an Abbott formula. KFF Health News obtained deposition video clips from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.
As for Mead Johnson, Valentine “testified that NEC was not one of the top adverse event complaints for Enfamil premature formulas of the 68 received between 2015-2019,” O’Neill, the company spokesperson, told KFF Health News.
Valentine — who was Mead Johnson Nutrition’s medical director for North America from 2014 to 2021 and parent company Reckitt’s chief medical officer from 2022 to 2023, according to a LinkedIn profile — signed off on the decision to close the 2016 file on the distraught mother’s complaint, according to an exhibit and her deposition testimony played in the Whitfield trial.
When she signed off, Mead Johnson didn’t know which of its products the complaint involved, Valentine said in the deposition.
Asked about it during the Watson trial in February 2024, Valentine 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.
Valentine “testified that she believes that the Mead Johnson complaint team appropriately investigated reports of death from NEC based on the information provided,” Mead Johnson’s O’Neill said.
Valentine also testified that the FDA encourages infant formula companies to send in all adverse event reports and that nothing prevented Mead Johnson from doing so.
As reflected in an email thread used in the Watson case, Valentine reacted skeptically in 2019 when a colleague told her a particular hospital wanted to exit its contract with Mead Johnson.
“They had 3 cases of NEC since they started using our formulas. They had 0 cases when they were with Abbott,” the colleague reported.
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.”
Christina Valentine, who was Mead Johnson Nutrition’s director of medical affairs for North America, testified that she approved the decision to close the company’s file on a 2016 complaint about a baby’s death. (CVN courtroom video from the Whitfield v. St. Louis Children’s Hospital, et al., trial.)
Share your story with us: Do you have experience with necrotizing enterocolitis (NEC) or infant formula that you’d like to share? We’d like to hear from you. Click here to contact the KFF Health News reporting team.
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