In September 2016, a distraught mother sent infant formula maker Mead Johnson a message:<\/p>\n
\u201cREMOVE ME FROM YOUR LIST!!!! DO NOT EMAIL OR MAIL ME ANY MORE!<\/p>\n
\u201cIt is because of your animal based pre-term artificial baby food crap that you peddle to hospital NICU\u2019s that my son is dead from NEC.\u201d<\/p>\n
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.<\/p>\n
In an internal memo, Mead Johnson cited its \u201cextensive quality and safety checks\u201d and concluded there was \u201cnot a reasonable possibility\u201d that the formula caused the baby\u2019s death. \u201cNo further investigation is needed. This file can be closed,\u201d the memo said.<\/p>\n
And with that decision, the company narrowed the chance that the mother\u2019s anguish could draw attention to any danger the formula might pose to other infants.<\/p>\n
The mother\u2019s email and the company\u2019s memo assessing it were used as evidence in the court cases Watson v. Mead Johnson<\/em><\/a> and Whitfield v. St. Louis Children\u2019s Hospital, et al<\/em><\/a>.<\/p>\n 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.<\/p>\n Mead Johnson\u2019s handling of the mother\u2019s email showed how that can play out.<\/p>\n Under federal rules<\/a>, if a complaint about an infant formula \u2014 such as a report of an adverse event \u2014 shows a possible health hazard, the company must investigate.<\/p>\n But it doesn\u2019t always have to inform the government agency that oversees the safety of infant formula.<\/p>\n A company must complete an investigation and notify the Food and Drug Administration within 15 days<\/a> only if it finds \u201ca reasonable possibility of a causal relationship between the consumption of an infant formula and an infant\u2019s death.\u201d<\/p>\n 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.<\/p>\n \u2018Never Reported\u2019<\/strong><\/p>\n 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\u2019s Human Foods Program \u201cdid not receive any,\u201d Kimberly Jones, a government information specialist at the FDA, responded in March.<\/p>\n KFF Health News then asked the FDA to go back decades further \u2014 to Jan. 1, 2000. \u201cAfter a diligent search of our files, we did not locate any responsive records,\u201d Jones wrote on May 5.<\/p>\n The FDA\u2019s search results were consistent with court testimony.<\/p>\n John Wallingford, a paid expert witness for Abbott, testified in a Missouri court in October 2024 that Abbott had never reported a single death<\/a> under any regulation for preterm infant formula.<\/p>\n Wallingford clarified<\/a> 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<\/a>.<\/p>\n 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\u2019s Hospital<\/em> case.<\/p>\n 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\u2019s medical director for North America. In the deposition, used in the Whitfield<\/em> case, she said she never concluded there was a reasonable possibility that an infant\u2019s death from NEC might have been related to a Mead Johnson product.<\/p>\n As medical director for North America, she was responsible for signing off on those determinations, she testified in the Watson<\/em> trial.<\/p>\n In the deposition, Valentine said she wasn\u2019t sure whether anyone else at the company sent a death report to the FDA.<\/p>\n In late May and mid-June, Mead Johnson spokesperson Jen O\u2019Neill added to the picture.<\/p>\n \u201cWhere 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 \u2018reasonable possibility of a causal relationship,\u2019 and we submitted an adverse event report to the FDA,\u201d she wrote.<\/p>\n \u201cThese physician reports were generally made by plaintiffs\u2019 paid experts, with which we disagree,\u201d she wrote.<\/p>\n O\u2019Neill 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.<\/p>\n Asked repeatedly when Mead Johnson filed the reports, O\u2019Neill didn\u2019t say.<\/p>\n It\u2019s unclear why the FDA found no record of them.<\/p>\n Nor would O\u2019Neill say whether the company submitted one related to the distraught mother\u2019s September 2016 complaint.<\/p>\n That mother\u2019s name wasn\u2019t publicly disclosed in the court record containing her complaint.<\/p>\n \u201c[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,\u201d O\u2019Neill wrote.<\/p>\n Industry personnel have reacted to some complaints with circular reasoning, as shown by court records from the Watson<\/em>, Whitfield<\/em>, and Gill v. Abbott Laboratories<\/em><\/a> cases. Company personnel didn\u2019t think their products caused harm, and they didn\u2019t view new cases as evidence of harm, records show.<\/p>\n \u2018Reprehensible\u2019 Conduct<\/strong><\/p>\n About 2,300 newborns died of necrotizing enterocolitis in the United States from 2017 through 2023, the equivalent of almost one per day<\/a>, according to a KFF Health News analysis of a government data set<\/a> for those years. The database doesn\u2019t attempt to explain what caused those babies to develop NEC, and it doesn\u2019t count babies who survived NEC.<\/p>\n 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<\/a>.<\/p>\n 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.<\/p>\n Abbott and Mead Johnson have denied fault. They, along with various medical authorities including federal regulatory agencies<\/a> and the American Academy of Pediatrics<\/a>, have said that, when nutritional needs can\u2019t be met with human milk, formula is vital.<\/p>\n One of the cases, Watson v. Mead Johnson<\/em><\/a>, led to a $60 million judgment<\/a> against Mead Johnson. Another<\/a>, Gill v. Abbott<\/em>, led to a $495 million judgment<\/a> against Abbott. The third<\/a>, Whitfield v. St. Louis Children\u2019s Hospital, et al.<\/em>, 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<\/a>.<\/p>\n The judge\u2019s ruling in the Whitfield<\/em> case is on appeal.<\/p>\n On May 5, a Missouri appeals court upheld the $495 million judgment<\/a> against Abbott, saying \u201cwe find Abbott\u2019s conduct significantly reprehensible.\u201d<\/p>\n \u201cThroughout 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,\u201d the court wrote.<\/p>\n On June 12, an Illinois appeals court reversed the $60 million judgment<\/a> 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\u2019s finances, including its revenues, profits, and executive compensation, the appeals court said.<\/p>\n In addition, the trial judge gave the jury erroneous instructions, the appeals court ruled. Any negligence on Mead Johnson\u2019s part hinged on a failure to warn, and the company\u2019s 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.<\/p>\n 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\u2019s decision.<\/p>\n In at least four cases, judges have granted<\/a> summary<\/a> judgment<\/a> in favor of Abbott \u2014 ruling for the company before the lawsuits reached trial.<\/p>\n \u2018Branding NICU Babies\u2019<\/strong><\/p>\n Abbott makes Similac products, and Mead Johnson makes the Enfamil line.<\/p>\n 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<\/a> based largely on records from court cases.<\/p>\n For instance, a Mead Johnson slide deck for a 2020 national sales meeting \u2014 later used in the Whitfield<\/em> trial \u2014 outlined a plan for \u201cBranding NICU Babies.\u201d<\/p>\n A Mead Johnson slide for a 2020 national sales meeting outlined a plan for \u201cBranding NICU Babies.\u201d The slide featured a product for babies born prematurely transitioning to home. The slide deck was used in the Whitfield v. St. Louis Children\u2019s Hospital<\/em> lawsuit.<\/p>\n The litigation opened a wider window into the business and regulation of infant formula, including adverse event reports.<\/p>\n \u201cAbbott 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,\u201d Stoffel said in November. \u201cFDA routinely conducts audits that include Abbott\u2019s adverse event investigations and reporting as part of its active regulation of infant nutrition.\u201d<\/p>\n Mead Johnson\u2019s O\u2019Neill echoed that.<\/p>\n \u201cOur adverse event reporting complies with all applicable regulatory requirements,\u201d O\u2019Neill said in a November statement to KFF Health News. \u201cThe FDA audits Mead Johnson on an annual basis and has never identified any issue about our approach to reporting.\u201d<\/p>\n The reports the company filed with the FDA were submitted through the agency\u2019s regional office in Detroit, she said.<\/p>\n It\u2019s unclear whether the FDA looked in Detroit.<\/p>\n FDA rules require manufacturers to send written confirmations to a central office<\/a> in the Washington area that oversees infant formula and other foods.<\/p>\n Asked if the company sent them to that office, O\u2019Neill did not answer.<\/p>\n 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.<\/p>\n 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\u2019s milk.<\/p>\n For example, in a 2010 research proposal shown in a deposition used in the Gill<\/em> case, Abbott scientists wrote that NEC \u201cis 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.\u201d<\/p>\n An Abbott document from 2010 said necrotizing enterocolitis \u201cis 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.\u201d 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<\/em> lawsuit.<\/p>\n A Mead Johnson document used in the Whitfield<\/em> lawsuit cited \u201c80% necrotizing enterocolitis (NEC) risk reduction when human milk is used in place of formula.\u201d<\/p>\n Abbott has argued<\/a> that correlation does not equal causation.<\/p>\n \u201cNumerous studies and NEC authorities have made clear that preterm infant formula does not cause NEC; it\u2019s the absence of human milk that increases NEC risk rather than anything harmful in formula,\u201d Abbott spokesperson Stoffel said.<\/p>\n The FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health weighed in with a joint statement<\/a> in October 2024, saying, \u201cThere is no conclusive evidence that preterm infant formula causes NEC\u201d and \u201cthere is strong evidence that human milk is protective against NEC.\u201d<\/p>\n Mead Johnson\u2019s O\u2019Neill said the scientific consensus is that there is no established causal link between the use of specialized preterm hospital nutrition products and NEC.<\/p>\n O\u2019Neill cited a statement by the American Academy of Pediatrics<\/a> saying the causes of NEC \u201care multifaceted and not completely understood.\u201d<\/p>\n In a legal brief filed with an Illinois appeals court in the Watson<\/em> case, the company said \u201cthe NEC related risks\u201d of a formula for preterm infants \u201care the subject of medical debate.\u201d<\/p>\n Managing Potential Warnings<\/strong><\/p>\n Court records from lawsuits shed light on how the manufacturers have managed potential warnings from the field.<\/p>\n 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<\/em> and Whitfield<\/em> 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\u2019s formula for preterm infants.<\/p>\n There were numerous cases in which healthcare providers told Abbott they believed the formula caused the NEC, but Abbott disagreed every time, Suarez testified.<\/p>\n Abbott tracks and reviews every NEC report it receives and looks for patterns, Suarez testified.<\/p>\n 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\u2019s 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<\/em> lawsuit.<\/p>\n Courtney Colombo, who identified herself in a March 2024 deposition used in the Gill<\/em> and Whitfield<\/em> 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.<\/p>\n Abbott wasn\u2019t hiding complaints<\/a> 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<\/em> case.<\/p>\n Wallingford also testified that inspections are not a replacement<\/a> for reporting infant deaths.<\/p>\n Questioning Wallingford in court, plaintiff\u2019s lawyer Kevin Carnie Jr. invoked the clich\u00e9 about the fox guarding the henhouse<\/a>.<\/p>\n 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.<\/p>\n Not Publicly Reported<\/strong><\/p>\n Adverse event reports can prompt the FDA to take action to protect the public.<\/p>\n For example, in 2011, the FDA warned<\/a> 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.<\/p>\n 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<\/em> trial.<\/p>\n The stakes for companies and consumers are high.<\/p>\n A finding under the \u201creasonable possibility\u201d standard could trigger a product recall, said Martin Hahn, a regulatory attorney for Mead Johnson.<\/p>\n The FDA\u2019s handling of adverse event reports for infant formulas \u2014 and fortifiers, which are used to nutritionally supplement a mother\u2019s milk when babies are born prematurely \u2014 contrasts with its handling of reports about drugs and medical devices.<\/p>\n The FDA posts manufacturers\u2019 adverse event reports on drugs<\/a> and medical devices<\/a> online in databases available to the public.<\/p>\n 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.<\/p>\n In addition, the FDA\u2019s reporting requirements for drugs and medical devices are, in key ways, more demanding than those for infant formula.<\/p>\n Device makers must report<\/a> not just deaths but also \u201cserious injuries\u201d that the product \u201cmay have caused or contributed to.\u201d<\/p>\n Drugmakers are required to report any \u201cserious and unexpected<\/a>\u201d adverse event, \u201cwhether or not considered drug related<\/a>.\u201d That goes beyond<\/a> fatal or life-threatening events.<\/p>\n The FDA also maintains a public database<\/a> about dietary supplements, foods, and infant formulas, among other products, that includes voluntary reports<\/a> from consumers and healthcare practitioners.<\/p>\n 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.<\/p>\n 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.<\/p>\n The FDA cautions that reports are not verified and do not prove causation.<\/p>\n A former attorney for Abbott now leads the FDA.<\/p>\n Before becoming the FDA\u2019s deputy commissioner for food<\/a> last year and being named acting head of the agency in May, Kyle Diamantas represented<\/a> Abbott<\/a> in the Gill<\/em><\/a> and Whitfield<\/em><\/a> lawsuits, court records show.<\/p>\n Diamantas \u201ccomplies with all applicable ethics laws and regulations,\u201d said Hilliard, the HHS spokesperson. \u201cThat included a specific recusal related to Abbott Laboratories, which concluded in January 2026.\u201d<\/p>\n \u201cDuring that period, Mr. Diamantas voluntarily recused himself from all matters involving infant formula to avoid any appearance of partiality,\u201d Hilliard said.<\/p>\n \u2018No Health Hazard\u2019<\/strong><\/p>\n KFF Health News asked the FDA a series of questions for this article. The agency left many unanswered.<\/p>\n \u201cInfant formula safety is a top priority of the FDA given the vulnerability of the intended population,\u201d Hilliard said.<\/p>\n 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.<\/p>\n Court records provide fragmentary data.<\/p>\n Abbott lawyer Elizabeth said in court that, before Wallingford took the stand as an expert witness, the company gave him 789 complaint files<\/a> from 2005 through 2022 that contained the search term \u201cNEC.\u201d<\/p>\n When Wallingford went through the files, he found about 130<\/a> that mentioned death and NEC, he testified.<\/p>\n If Similac Special Care products for preterm infants were a problem, and if only 1% of adverse events led to a report, \u201cyou would expect to see tens of thousands<\/a> of complaints,\u201d Wallingford testified.<\/p>\n 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\u2019s deposition. The babies, who were about 17 days old, had no complications other than prematurity, the summary said.<\/p>\n After reviewing the complaint, Abbott\u2019s Colombo wrote, as shown in a deposition video, that she found \u201cNO OTHER REPORTS OF DEATH AND NO TRENDS FOR NEC REPORTED BY OTHER FACILITIES ASSOCIATED WITH THIS STOCK CODE.\u201d<\/p>\n \u201cPREVIOUS COMPLAINT HISTORY INDICATES NO HEALTH HAZARD,\u201d she concluded.<\/p>\n Courtney Colombo, who identified herself in a March 2024 deposition as director of postmarketing medical safety and surveillance at Abbott, testified about Abbott\u2019s 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<\/em> lawsuit. <\/p>\n As for Mead Johnson, Valentine \u201ctestified that NEC was not one of the top adverse event complaints for Enfamil premature formulas of the 68 received between 2015-2019,\u201d O\u2019Neill, the company spokesperson, told KFF Health News.<\/p>\n Valentine \u2014 who was Mead Johnson Nutrition\u2019s medical director for North America from 2014 to 2021 and parent company Reckitt\u2019s chief medical officer from 2022 to 2023, according to a LinkedIn profile \u2014 signed off on the decision to close the 2016 file on the distraught mother\u2019s complaint, according to an exhibit and her deposition testimony played in the Whitfield<\/em> trial.<\/p>\n When she signed off, Mead Johnson didn\u2019t know which of its products the complaint involved, Valentine said in the deposition.<\/p>\n Asked about it during the Watson<\/em> trial in February 2024, Valentine testified that, in light of the mother\u2019s request never to contact her again, it wouldn\u2019t have been appropriate to call her back for more information.<\/p>\n Valentine \u201ctestified that she believes that the Mead Johnson complaint team appropriately investigated reports of death from NEC based on the information provided,\u201d Mead Johnson\u2019s O\u2019Neill said.<\/p>\n 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.<\/p>\n As reflected in an email thread used in the Watson<\/em> case, Valentine reacted skeptically in 2019 when a colleague told her a particular hospital wanted to exit its contract with Mead Johnson.<\/p>\n \u201cThey had 3 cases of NEC since they started using our formulas. They had 0 cases when they were with Abbott,\u201d the colleague reported.<\/p>\n Valentine agreed to follow up but added: \u201cSad but please reassure them we are not seeing this with our formula \u2026 so no science basis for sure.\u201d<\/p>\n Christina Valentine, who was Mead Johnson Nutrition\u2019s director of medical affairs for North America, testified that she approved the decision to close the company\u2019s file on a 2016 complaint about a baby\u2019s death. (CVN courtroom video from the Whitfield v. St. Louis Children’s Hospital, et al., trial.)<\/p>\n Share your story with us:<\/strong> Do you have experience with necrotizing enterocolitis (NEC) or infant formula that you\u2019d like to share? We\u2019d like to hear from you. <\/em>Click here<\/em><\/a>\u00a0to contact the KFF Health News reporting team.<\/em><\/p>\n KFF Health News<\/a> is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF\u2014an independent source of health policy research, polling, and journalism. Learn more about KFF<\/a>.<\/em><\/p>\n This <a target=”_blank” href=”https:\/\/kffhealthnews.org\/health-industry\/infant-formula-adverse-events-nec-baby-deaths-fda-reporting\/”>article<\/a><\/a>; first appeared on <a target=”_blank” href=”https:\/\/kffhealthnews.org”>KFF<\/a> Health News<\/a> and is republished here under a <a target=”_blank” href=”https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/”>Creative<\/a> Commons Attribution-NonCommercial-NoDerivatives 4.0 International License<\/a>.<img src=”https:\/\/kffhealthnews.org\/wp-content\/uploads\/sites\/8\/2023\/04\/kffhealthnews-icon.png?w=150"<\/a>; style=”width:1em;height:1em;margin-left:10px;”><\/p>\n
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