In September 2016, a distraught mom despatched toddler formulation 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 items and necrotizing enterocolitis, an typically deadly situation by which intestinal tissue can die and permit an infection to unfold by means of 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 formulation induced the child’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 might draw consideration to any hazard the formulation would possibly pose to different infants.
The mom’s e-mail and the corporate’s memo assessing it had been used as proof within the court docket instances Watson v. Mead Johnson and Whitfield v. St. Louis Kids’s Hospital, et al.
When medical doctors, hospitals, mother and father, or others alert producers that infants received sick or died whereas receiving toddler formulation, what occurs subsequent is left largely to producers resembling Abbott Laboratories and Mead Johnson Diet, giants of the business.
Mead Johnson’s dealing with of the mom’s e-mail confirmed how that may play out.
Underneath federal guidelines, if a grievance about an toddler formulation — resembling a report of an antagonistic occasion — exhibits a doable well being hazard, the corporate should examine.
But it surely doesn’t at all times have to tell the federal government company that oversees the protection of toddler formulation.
An organization should full an investigation and notify the Meals 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 might discover no file of it, in accordance with info obtained by means of public data requests.
‘Never Reported’
Underneath the Freedom of Info Act, KFF Well being Information requested the FDA for all notifications that producers of toddler formulation despatched the company per the regulatory requirement since Jan. 1, 2020. The company’s Human Meals Program “did not receive any,” Kimberly Jones, a authorities info specialist on the FDA, responded in March.
KFF Well being Information then requested the FDA to return a long time additional — to Jan. 1, 2000. “After a diligent search of our files, we did not locate any responsive records,” Jones wrote on Might 5.
The FDA’s search outcomes had been in keeping with court docket testimony.
John Wallingford, a paid skilled witness for Abbott, testified in a Missouri court docket in October 2024 that Abbott had by no means reported a single dying beneath any regulation for preterm toddler formulation.
Wallingford clarified that he was not referring to antagonistic occasions in scientific trials, that are research used for analysis and growth and are topic to completely different procedures. Abbott knowledgeable the FDA about antagonistic occasions that occurred throughout a scientific trial, Wallingford testified.
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. Within the deposition, used within the Whitfield case, she stated she by no means concluded there was an affordable chance that an toddler’s dying from NEC might need been associated to a Mead Johnson product.
As medical director for North America, she was accountable for signing off on these determinations, she testified within the Watson trial.
Within the deposition, Valentine stated she wasn’t positive whether or not anybody else on the firm despatched a dying report back to the FDA.
In late Might 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, in that case, whether or not the corporate reported them to the FDA earlier than they surfaced in litigation.
Requested repeatedly when Mead Johnson filed the stories, O’Neill didn’t say.
It’s unclear why the FDA discovered no file 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 title wasn’t publicly disclosed within the court docket file 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.
Business personnel have reacted to some complaints with round reasoning, as proven by court docket data from the Watson, Whitfield, and Gill v. Abbott Laboratories instances. Firm personnel didn’t suppose their merchandise induced hurt, they usually didn’t view new instances as proof of hurt, data present.
‘Reprehensible’ Conduct
About 2,300 newborns died of necrotizing enterocolitis in the US from 2017 by means of 2023, the equal of just about one per day, in accordance with a KFF Well being Information evaluation of a authorities information set for these years. The database doesn’t try to clarify what induced these infants to develop NEC, and it doesn’t rely infants who survived NEC.
A wave of lawsuits has alleged that toddler formulation made by Abbott or Mead Johnson harmed or killed preterm infants by inflicting or contributing to instances 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 submitting.
This text relies largely on transcripts, deposition movies, and displays from three court docket instances that went to trial in 2024. The lawsuits had been filed by mother and father of infants who suffered or died from NEC.
Abbott and Mead Johnson have denied fault. They, together with varied medical authorities together with federal regulatory companies and the American Academy of Pediatrics, have stated that, when dietary wants can’t be met with human milk, formulation is significant.
One of many instances, Watson v. Mead Johnson, led to a $60 million judgment towards Mead Johnson. One other, Gill v. Abbott, led to a $495 million judgment towards Abbott. The third, Whitfield v. St. Louis Kids’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 dominated the plaintiff was entitled to a brand new trial.
The choose’s ruling within the Whitfield case is on attraction.
On Might 5, a Missouri appeals court docket 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 court docket wrote.
On June 12, an Illinois appeals court docket reversed the $60 million judgment towards Mead Johnson and despatched the case again for a brand new trial. The trial court docket risked prejudicing the jury by improperly admitting proof about Mead Johnson’s funds, together with its revenues, income, and government compensation, the appeals court docket stated.
As well as, the trial choose gave the jury faulty directions, the appeals court docket dominated. Any negligence on Mead Johnson’s half hinged on a failure to warn, and the corporate’s responsibility was to not warn the mom in that case of any hazard, as she had claimed, however relatively to warn medical doctors, the appeals court docket 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 court docket’s resolution.
In not less than 4 instances, judges have granted abstract 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 2 corporations have vied to position their merchandise in neonatal intensive care items, which function entry factors to hospital contracts and the retail market, KFF Well being Information reported in a March article based mostly largely on data from court docket instances.
As an illustration, 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.”
The litigation opened a wider window into the enterprise and regulation of toddler formulation, together with antagonistic occasion stories.
“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 Well being Information. “The FDA audits Mead Johnson on an annual basis and has never identified any issue about our approach to reporting.”
The stories the corporate filed with the FDA had been submitted by means of the company’s regional workplace in Detroit, she stated.
It’s unclear whether or not the FDA regarded in Detroit.
FDA guidelines require producers to ship written confirmations to a central workplace within the Washington space that oversees toddler formulation and different meals.
Requested if the corporate despatched them to that workplace, O’Neill didn’t reply.
KFF Well being Information requested an interview with Mead Johnson to make clear its statements about the way it dealt with antagonistic occasion stories. The corporate 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 constructed from 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.”
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 Facilities for Illness Management and Prevention, and the Nationwide Institutes of Well being weighed in with a joint assertion 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 court docket within the Watson case, the corporate stated “the NEC related risks” of a formulation for preterm infants “are the subject of medical debate.”
Managing Potential Warnings
Courtroom 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 instances that he knew of no occasion by which Abbott notified the FDA {that a} child had died of NEC that might have been brought on by Abbott’s formulation for preterm infants.
There have been quite a few instances by which healthcare suppliers advised Abbott they believed the formulation induced the NEC, however Abbott disagreed each time, Suarez testified.
Abbott tracks and opinions each NEC report it receives and appears for patterns, Suarez testified.
Courtney Colombo, who recognized herself in a March 2024 deposition used within the Gill and Whitfield instances as director of postmarketing medical security and surveillance at Abbott, likewise testified that she knew of no occasion by which Abbott reported to any regulatory authority anyplace on this planet that one in all its preterm toddler formulation was probably associated to a dying brought on by NEC.
Abbott wasn’t hiding complaints from the FDA, in accordance 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 substitute for reporting toddler deaths.
Questioning Wallingford in court docket, plaintiff’s lawyer Kevin Carnie Jr. invoked the cliché concerning the fox guarding the henhouse.
Wallingford declined to remark for this text. Valentine and Colombo didn’t reply to messages despatched by way of 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 along with her, was returned unopened.
Not Publicly Reported
Adversarial occasion stories can immediate the FDA to take motion to guard the general public.
For instance, in 2011, the FDA warned mother and father, 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, would possibly trigger NEC, the FDA stated.
The FDA first discovered about doable issues with SimplyThick from physicians, in accordance with an FDA doc that an lawyer for Abbott, Sierra Elizabeth, learn from in the course of the Whitfield trial.
The stakes for corporations and customers are excessive.
A discovering beneath the “reasonable possibility” commonplace might set off a product recall, stated Martin Hahn, a regulatory lawyer for Mead Johnson.
The FDA’s dealing with of antagonistic occasion stories 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 stories about medication and medical units.
The FDA posts producers’ antagonistic occasion stories on medication and medical units on-line in databases obtainable to the general public.
However the notifications producers are required to submit about formulation and fortifiers will not be publicly reported, stated Emily Hilliard, a spokesperson for the Division of Well being and Human Companies, which incorporates the FDA.
As well as, the FDA’s reporting necessities for medication and medical units are, in key methods, extra demanding than these for toddler formulation.
Gadget makers should report not simply deaths but in addition “serious injuries” that the product “may have caused or contributed to.”
Drugmakers are required to report any “serious and unexpected” antagonistic occasion, “whether or not considered drug related.” That goes past 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 stories from customers and healthcare practitioners.
KFF Well being Information searched that database and located one dying report that talked about NEC and a formulation made for untimely or low-birth-weight infants.
The search turned up seven different stories of toddler deaths that talked about NEC and fortifiers designed for untimely or low-birth-weight infants. A type of stories, obtained by KFF Well being Information by means of the Freedom of Info Act, stated three preterm infants on the identical hospital had NEC and died inside a month of each other in 2024.
The FDA cautions that stories will not be verified and don’t show causation.
A former lawyer for Abbott now leads the FDA.
Earlier than changing into the FDA’s deputy commissioner for meals final yr and being named appearing head of the company in Might, Kyle Diamantas represented Abbott within the Gill and Whitfield lawsuits, court docket 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 Well being Information requested the FDA a collection 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 Well being Information requested Abbott and Mead Johnson for information on all toddler dying stories the businesses acquired and people they forwarded to the FDA. Neither firm supplied that info.
Courtroom data present fragmentary information.
Abbott lawyer Elizabeth stated in court docket that, earlier than Wallingford took the stand as an skilled witness, the corporate gave him 789 grievance recordsdata from 2005 by means of 2022 that contained the search time period “NEC.”
When Wallingford went by means of the recordsdata, he discovered about 130 that talked about dying and NEC, he testified.
If Similac Particular Care merchandise for preterm infants had been an issue, and if only one% of antagonistic 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 formulation. The dietitian thought there is likely to be a correlation, in accordance with an inner Abbott abstract of the grievance proven throughout Colombo’s deposition. The infants, who had been about 17 days outdated, 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.
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, advised KFF Well being Information.
Valentine — who was Mead Johnson Diet’s medical director for North America from 2014 to 2021 and father or mother firm Reckitt’s chief medical officer from 2022 to 2023, in accordance with a LinkedIn profile — signed off on the choice to shut the 2016 file on the distraught mom’s grievance, in accordance 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.
Requested about it in the course of the Watson trial in February 2024, Valentine testified that, in gentle 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 formulation corporations to ship in all antagonistic occasion stories and that nothing prevented Mead Johnson from doing so.
As mirrored in an e-mail thread used within the Watson case, Valentine reacted skeptically in 2019 when a colleague advised 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 comply with up however added: “Sad but please reassure them we are not seeing this with our formula … so no science basis for sure.”
Share your story with us: Do you might have expertise with necrotizing enterocolitis (NEC) or toddler formulation that you simply’d prefer to share? We’d like to listen to from you. Click on right here to contact the KFF Well being Information reporting group.
