In September 2016, a distraught mom despatched toddler components 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 mom was referring to neonatal intensive care models and necrotizing enterocolitis, an usually deadly situation during which intestinal tissue can die and permit an infection to unfold via the physique of an toddler born prematurely.
In an inner memo, Mead Johnson cited its “extensive quality and safety checks” and concluded there was “not a reasonable possibility” that the components precipitated the infant’s dying. “No further investigation is needed. This file can be closed,” the memo stated.
And with that call, the corporate narrowed the possibility that the mom’s anguish may draw consideration to any hazard the components may pose to different infants.
The mom’s electronic mail and the corporate’s memo assessing it had been used as proof within the courtroom circumstances Watson v. Mead Johnson and Whitfield v. St. Louis Children’s Hospital, et al.
When docs, hospitals, dad and mom, or others alert producers that infants acquired sick or died whereas receiving toddler components, what occurs subsequent is left largely to producers resembling Abbott Laboratories and Mead Johnson Nutrition, giants of the business.
Mead Johnson’s dealing with of the mom’s electronic mail confirmed how that may play out.
Under federal rules, if a grievance about an toddler components — resembling a report of an opposed occasion — exhibits a doable well being hazard, the corporate should examine.
But it doesn’t all the time have to tell the federal government company that oversees the security of toddler components.
An organization should full an investigation and notify the Food and Drug Administration inside 15 days provided that it finds “a reasonable possibility of a causal relationship between the consumption of an infant formula and an infant’s death.”
If that occurred even as soon as over greater than 1 / 4 century, the FDA may discover no document of it, in line with info obtained via public data requests.
‘Never Reported’
Under the Freedom of Information Act, KFF Health News requested the FDA for all notifications that producers of toddler components despatched the company per the regulatory requirement since Jan. 1, 2020. The company’s Human Foods Program “did not receive any,” Kimberly Jones, a authorities info specialist on the FDA, responded in March.
KFF Health News then requested the FDA to return many years additional — 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 outcomes had been in line with courtroom testimony.
John Wallingford, a paid skilled witness for Abbott, testified in a Missouri courtroom in October 2024 that Abbott had never reported a single death below any regulation for preterm toddler components.
Wallingford clarified that he was not referring to opposed occasions in scientific trials, that are research used for analysis and growth and are topic to totally different procedures. Abbott knowledgeable the FDA about opposed occasions that occurred throughout a scientific trial, Wallingford testified.
John Wallingford, an skilled witness for Abbott Laboratories, testified in 2024 that, exterior of scientific trials, the corporate had by no means reported to the FDA that there was an affordable risk a dying was brought on by an Abbott preterm components, in line with a transcript posted by the Missouri Court of Appeals Eastern District in an enchantment of the Whitfield v. St. Louis Children’s Hospital case. (CVN courtroom video from the Whitfield trial.)
Christina Valentine testified in a 2024 deposition that she by no means despatched the FDA a report of dying from NEC throughout her seven years as Mead Johnson’s medical director for North America. In the deposition, used within the Whitfield case, she stated she by no means concluded there was an affordable risk that an toddler’s dying from NEC might need been associated to a Mead Johnson product.
As medical director for North America, she was liable for signing off on these determinations, she testified within the Watson trial.
In the deposition, Valentine stated she wasn’t certain whether or not anybody else on the firm despatched a dying report back to the FDA.
In late May and mid-June, Mead Johnson spokesperson Jen O’Neill added to the image.
“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 or not occasions Mead Johnson reported to the FDA had been raised in lawsuits and, if that’s the case, whether or not the corporate reported them to the FDA earlier than they surfaced in litigation.
Asked repeatedly when Mead Johnson filed the studies, O’Neill didn’t say.
It’s unclear why the FDA discovered no document of them.
Nor would O’Neill say whether or not the corporate submitted one associated to the distraught mom’s September 2016 grievance.
That mom’s identify wasn’t publicly disclosed within the courtroom document containing her grievance.
“[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 round reasoning, as proven by courtroom data from the Watson, Whitfield, and Gill v. Abbott Laboratories circumstances. Company personnel didn’t assume their merchandise precipitated hurt, and so they didn’t view new circumstances as proof of hurt, data present.
‘Reprehensible’ Conduct
About 2,300 newborns died of necrotizing enterocolitis within the United States from 2017 via 2023, the equal of virtually one per day, in line with a KFF Health News evaluation of a government data set for these years. The database doesn’t try to clarify what precipitated these infants to develop NEC, and it doesn’t rely infants who survived NEC.
A wave of lawsuits has alleged that toddler components made by Abbott or Mead Johnson harmed or killed preterm infants by inflicting or contributing to circumstances of NEC. As of late January, 1,760 NEC lawsuits had been pending towards Abbott, firm spokesperson Scott Stoffel stated, clarifying a disclosure in a regulatory filing.
This article is predicated largely on transcripts, deposition movies, and displays from three courtroom circumstances that went to trial in 2024. The lawsuits had been filed by dad and mom of infants who suffered or died from NEC.
Abbott and Mead Johnson have denied fault. They, together with numerous medical authorities together with federal regulatory agencies and the American Academy of Pediatrics, have stated that, when dietary wants can’t be met with human milk, components is important.
One of the circumstances, Watson v. Mead Johnson, led to a $60 million judgment towards Mead Johnson. Another, Gill v. Abbott, led to a $495 million judgment towards Abbott. The third, Whitfield v. St. Louis Children’s Hospital, et al., led to a jury verdict in favor of Abbott and Mead Johnson, however the choose discovered errors and misconduct on the a part of protection counsel, faulted his personal efficiency, and ruled the plaintiff was entitled to a new trial.
The choose’s ruling within the Whitfield case is on enchantment.
On May 5, a Missouri appeals courtroom upheld the $495 million judgment towards 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 courtroom wrote.
On June 12, an Illinois appeals courtroom reversed the $60 million judgment towards Mead Johnson and despatched the case again for a brand new trial. The trial courtroom risked prejudicing the jury by improperly admitting proof about Mead Johnson’s funds, together with its revenues, earnings, and government compensation, the appeals courtroom stated.
In addition, the trial choose gave the jury faulty directions, the appeals courtroom dominated. Any negligence on Mead Johnson’s half hinged on a failure to warn, and the corporate’s obligation was to not warn the mom in that case of any hazard, as she had claimed, however somewhat to warn docs, the appeals courtroom dominated.
In April, after one other trial, a jury in Chicago ordered Abbott to pay 4 plaintiffs a complete of $70 million. Abbott is contesting that verdict and the Missouri appeals courtroom’s resolution.
In at the least 4 circumstances, judges have granted summary judgment in favor of Abbott — ruling for the corporate earlier than the lawsuits reached trial.
‘Branding NICU Babies’
Abbott makes Similac merchandise, and Mead Johnson makes the Enfamil line.
The two firms have vied to put their merchandise in neonatal intensive care models, which function entry factors to hospital contracts and the retail market, KFF Health News reported in a March article based mostly largely on data from courtroom circumstances.
For occasion, a Mead Johnson slide deck for a 2020 nationwide gross sales assembly — later used within the Whitfield trial — outlined a plan for “Branding NICU Babies.”
A Mead Johnson slide for a 2020 nationwide gross sales assembly outlined a plan for “Branding NICU Babies.” The slide featured a product for infants born prematurely transitioning to house. The slide deck was used within the Whitfield v. St. Louis Children’s Hospital lawsuit.
The litigation opened a wider window into the enterprise and regulation of toddler components, together with opposed occasion studies.
“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 stated 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 stated in a November assertion 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 studies the corporate filed with the FDA had been submitted via the company’s regional workplace in Detroit, she stated.
It’s unclear whether or not the FDA seemed in Detroit.
FDA guidelines require producers to ship written confirmations to a central office within the Washington space that oversees toddler components and different meals.
Asked if the corporate despatched them to that workplace, O’Neill didn’t reply.
KFF Health News requested an interview with Mead Johnson to make clear its statements about the way it dealt with opposed occasion studies. The firm didn’t grant one.
Plaintiffs have used inner paperwork from the businesses to allege that, in home, folks have lengthy acknowledged a correlation between NEC and using preterm formulation comprised of cow’s milk.
For instance, in a 2010 analysis proposal proven in a deposition used within 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 doc from 2010 stated 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 doc was displayed in deposition video clips KFF Health News obtained from the Missouri Court of Appeals Eastern District. The video was filed with the courtroom in an enchantment of the Gill v. Abbott lawsuit.
A Mead Johnson doc used within the Whitfield lawsuit cited “80% necrotizing enterocolitis (NEC) risk reduction when human milk is used in place of formula.”
Abbott has argued that correlation doesn’t 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 stated.
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 stated the scientific consensus is that there is no such thing as a established causal hyperlink between using specialised preterm hospital vitamin merchandise and NEC.
O’Neill cited an announcement by the American Academy of Pediatrics saying the causes of NEC “are multifaceted and not completely understood.”
In a authorized transient filed with an Illinois appeals courtroom within the Watson case, the corporate stated “the NEC related risks” of a components for preterm infants “are the subject of medical debate.”
Managing Potential Warnings
Court data from lawsuits make clear how the producers have managed potential warnings from the sector.
Fabrizis Suarez, who was director of medical security and surveillance at Abbott from 2006 to 2023, stated in a January 2024 deposition used within the Gill and Whitfield circumstances that he knew of no occasion during which Abbott notified the FDA {that a} child had died of NEC that would have been brought on by Abbott’s components for preterm infants.
There had been quite a few circumstances during which healthcare suppliers informed Abbott they believed the components precipitated the NEC, however Abbott disagreed each time, Suarez testified.
Abbott tracks and evaluations each NEC report it receives and appears for patterns, Suarez testified.
Fabrizis Suarez, figuring out himself as director of medical security and surveillance at Abbott from 2006 to 2023, testified in a January 2024 deposition about Abbott’s dealing with of opposed occasion studies. KFF Health News obtained deposition video clips from the Missouri Court of Appeals Eastern District. The video was filed with the courtroom in an enchantment of the Gill v. Abbott lawsuit.
Courtney Colombo, who recognized herself in a March 2024 deposition used within the Gill and Whitfield circumstances as director of postmarketing medical security and surveillance at Abbott, likewise testified that she knew of no occasion during which Abbott reported to any regulatory authority anyplace on the planet that considered one of its preterm toddler formulation was probably associated to a dying brought on by NEC.
Abbott wasn’t hiding complaints from the FDA, in line with testimony from Wallingford, a paid skilled witness on regulatory issues who spent 10 years on the FDA. The complaints had been in firm recordsdata FDA inspectors reviewed throughout annual inspections, he stated within the Whitfield case.
Wallingford additionally testified that inspections are not a replacement for reporting toddler deaths.
Questioning Wallingford in courtroom, plaintiff’s lawyer Kevin Carnie Jr. invoked the cliché in regards to the fox guarding the henhouse.
Wallingford declined to remark for this text. Valentine and Colombo didn’t reply to messages despatched through LinkedIn. Valentine and Suarez didn’t reply to letters mailed to addresses that gave the impression to be related to them. A letter to Colombo with signature required, despatched to an handle apparently related together with her, was returned unopened.
Not Publicly Reported
Adverse occasion studies can immediate the FDA to take motion to guard the general public.
For instance, in 2011, the FDA warned dad and mom, caregivers, and healthcare suppliers to not feed SimplyThick, a thickening gel, to untimely infants becoming a selected profile. The product, used to handle swallowing difficulties, may trigger NEC, the FDA stated.
The FDA first realized about doable issues with SimplyThick from physicians, in line with an FDA doc that an legal professional for Abbott, Sierra Elizabeth, learn from throughout the Whitfield trial.
The stakes for firms and customers are excessive.
A discovering below the “reasonable possibility” customary may set off a product recall, stated Martin Hahn, a regulatory legal professional for Mead Johnson.
The FDA’s dealing with of opposed occasion studies for toddler formulation — and fortifiers, that are used to nutritionally complement a mom’s milk when infants are born prematurely — contrasts with its dealing with of studies about medicine and medical gadgets.
The FDA posts producers’ opposed occasion studies on drugs and medical devices on-line in databases accessible to the general public.
But the notifications producers are required to submit about formulation and fortifiers usually are not publicly reported, stated Emily Hilliard, a spokesperson for the Department of Health and Human Services, which incorporates the FDA.
In addition, the FDA’s reporting necessities for medicine and medical gadgets are, in key methods, extra demanding than these for toddler components.
Device makers must report not simply deaths but additionally “serious injuries” that the product “may have caused or contributed to.”
Drugmakers are required to report any “serious and unexpected” opposed occasion, “whether or not considered drug related.” That goes beyond deadly or life-threatening occasions.
The FDA additionally maintains a public database about dietary dietary supplements, meals, and toddler formulation, amongst different merchandise, that features voluntary reports from customers and healthcare practitioners.
KFF Health News searched that database and located one dying report that talked about NEC and a components made for untimely or low-birth-weight infants.
The search turned up seven different studies of toddler deaths that talked about NEC and fortifiers designed for untimely or low-birth-weight infants. One of these studies, obtained by KFF Health News via the Freedom of Information Act, stated three preterm infants on the similar hospital had NEC and died inside a month of each other in 2024.
The FDA cautions that studies usually are not verified and don’t show causation.
A former legal professional for Abbott now leads the FDA.
Before changing into the FDA’s deputy commissioner for food final yr and being named performing head of the company in May, Kyle Diamantas represented Abbott within the Gill and Whitfield lawsuits, courtroom data present.
Diamantas “complies with all applicable ethics laws and regulations,” stated 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 stated.
‘No Health Hazard’
KFF Health News requested the FDA a sequence of questions for this text. The company left many unanswered.
“Infant formula safety is a top priority of the FDA given the vulnerability of the intended population,” Hilliard stated.
KFF Health News requested Abbott and Mead Johnson for information on all toddler dying studies the businesses obtained and people they forwarded to the FDA. Neither firm offered that info.
Court data present fragmentary information.
Abbott lawyer Elizabeth stated in courtroom that, earlier than Wallingford took the stand as an skilled witness, the corporate gave him 789 complaint files from 2005 via 2022 that contained the search time period “NEC.”
When Wallingford went via the recordsdata, he discovered about 130 that talked about dying and NEC, he testified.
If Similac Special Care merchandise for preterm infants had been an issue, and if just one% of opposed occasions 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 infants had died of NEC shortly after beginning on an Abbott components. The dietitian thought there could be a correlation, in line with an inner Abbott abstract of the grievance proven throughout Colombo’s deposition. The infants, who had been about 17 days previous, had no problems aside from prematurity, the abstract stated.
After reviewing the grievance, Abbott’s Colombo wrote, as proven in a deposition video, that she discovered “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 recognized herself in a March 2024 deposition as director of postmarketing medical security and surveillance at Abbott, testified about Abbott’s response to a report that three infants had died of NEC shortly after beginning on an Abbott components. KFF Health News obtained deposition video clips from the Missouri Court of Appeals Eastern District. The video was filed with the courtroom in an enchantment 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 corporate spokesperson, informed KFF Health News.
Valentine — who was Mead Johnson Nutrition’s medical director for North America from 2014 to 2021 and dad or mum firm Reckitt’s chief medical officer from 2022 to 2023, in line with a LinkedIn profile — signed off on the choice to shut the 2016 file on the distraught mom’s grievance, in line with an exhibit and her deposition testimony performed within the Whitfield trial.
When she signed off, Mead Johnson didn’t know which of its merchandise the grievance concerned, Valentine stated within the deposition.
Asked about it throughout the Watson trial in February 2024, Valentine testified that, in mild of the mom’s request by no means to contact her once more, it wouldn’t have been acceptable to name her again for extra info.
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 stated.
Valentine additionally testified that the FDA encourages toddler components firms to ship in all opposed occasion studies and that nothing prevented Mead Johnson from doing so.
As mirrored in an electronic mail thread used within the Watson case, Valentine reacted skeptically in 2019 when a colleague informed her a selected hospital needed 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 observe up however 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 accredited the choice to shut the corporate’s file on a 2016 grievance a couple of child’s dying. (CVN courtroom video from the Whitfield v. St. Louis Children’s Hospital, et al., trial.)
Share your story with us: Do you may have expertise with necrotizing enterocolitis (NEC) or toddler components that you simply’d wish to share? We’d like to listen to from you. Click here to contact the KFF Health News reporting workforce.