A Mom Said Infant Formula Killed Her Baby. The Manufacturer Closed the File. - KFF Health News
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A Mom Said Infant Formula Killed Her Baby. The Manufacturer Closed the File.
When makers of infant formula hear that babies got sick or died while using their products, what happens next is left largely to the manufacturers.
(Moment/Getty Images)
A Mom Said Infant Formula Killed Her Baby. The Manufacturer Closed the File.
When makers of infant formula hear that babies got sick or died while using their products, what happens next is left largely to the manufacturers.
By David Hilzenrath and Holly K. Hacker
July 2, 2026
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This story also ran on USA Today. It can be republished for free.
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Inside the High-Stakes Corporate Fight Over Feeding Preterm Babies
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.
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...