NEC Infant Formula Update

Santa Clara, CASadly, another infant formula lawsuit has been lodged against Abbott Nutrition by parents of a baby who died last year allegedly from its bacteria-tainted infant formula. Cow milk-based infant formulas such as Similac and Enfamil have been linked to a dangerous and potentially deadly neonatal medical condition known as necrotizing enterocolitis (NEC), in which bowel tissue dies.

The NEC formula lawsuits claim that the makers of these formulas knew of the risk of NEC and did nothing to warn families and give them a choice. Further, the companies failed to warn health professionals that infants receiving formula have a greater risk of NEC compared to infants who are breast-fed or given donor milk or human milk-derived formula.

This latest lawsuit was filed by parents of Willow Jade Dellaquila, of Kentucky. The Associated Press (AP) reported in December 2023 that the bacteria in the recalled Similac Total Comfort powdered formula killed Willow. And 6-week-old Mira White was diagnosed with a brain infection caused by the bacteria, which was detected in an open container of Similac NeoSure formula in her home. The FDA, however, said there was no evidence that the infections were linked to manufacturing and no reason to issue new recalls. The agency explained that bacteria are found naturally in the environment and also can make their way into infant formula after the packaging is opened.

The FDA was criticized for a slow response to previous bacterial illnesses. The AP obtained documents in April 2023 of an FDA inspection at Abbott’s Arizona site which found lapses in contamination-prevention protocols, multiple detections of cronobacter and nearly two dozen complaints of confirmed cronobacter, salmonella or other infections in infants who had been fed formula made at the plant. Abbott officials said no link was found between the illnesses and the company’s formula. Mira consumed formula made at the company’s Arizona plant. Evidence of cronobacter was found in open cans of Abbott formula in the homes of Willow and Mira and confirmed to be the cause of their infections, according to AP.

Abbott is still reeling from a Missouri state court case in July 2024 that ended in a $496 million plaintiff’s verdict, a few months after a $60 million plaintiff’s verdict in Illinois. The Illinois trial involved Mead Johnson’s Enfamil formula, while Missouri trial involved Abbott’s Similac brand formula. 

Both cases were aimed at resolving baby formula manufacturers' liability for their products causing preterm babies to develop NEC. The first $60 million verdict was awarded by an Illinois jury to a mother who alleged that Mead Johnson’s Enfamil formula caused her son to die from NEC. In July, Reuters reported that the $496 million verdict in St. Louis, Missouri state court (the jury awarded $95 million in compensatory damages and $400 million in punitive damages) was the first trial against Abbott Laboratories out of hundreds of similar claims over the formula pending in courts around the country.

Plaintiff and mother Margo Gill accused Abbott of failing to warn that its formula could cause NEC in premature babies. Her child developed NEC after being given Abbott premature infant formula while in a neonatal intensive care unit in 2021. She survived but suffered irreversible neurological damage because of her illness, which will require long-term care. Abbot’s lawyers attributed Gil’s daughters’ medical issues to a “major hypoxic event” suffered during birth and explained that she had numerous pulmonary hemorrhages and surgeries before receiving any Similac and stressed that Similac is given to babies already in precarious health. The jury found otherwise. Gill v. Abbott Laboratories was the first NEC case brought against Abbott and was the second trial alleging that cow's milk-based baby formula given to premature infants can cause NEC.

Baby Formula Litigation Rising

Baby Formula Litigation against Abbott and other manufacturers is gaining momentum. Approximately 1,000 lawsuits have been filed against Abbott, Enfamil formula maker Reckitt Benckiser or both in federal or state courts.

In August thirty-three new cases were added to the infant formula NEC class action multidistrict litigation. There are currently 571 NEC baby formula lawsuits pending in the MDL 3026 before U.S. District Judge Rebecca Pallmeyer in the Northern District of Illinois, which contains mostly Similac and Enfamil lawsuits. Other lawsuits are pending in Illinois, Missouri and Pennsylvania. And there are separate lawsuits and ongoing litigation against Abbott over the shutdown of its Sturgis, Michigan, plant and subsequent recall of batches of baby formula for possible contamination. The recall contributed to a nationwide formula shortage in 2022.

Bellwether Trials

This September, four lawsuits were chosen for bellwether trials. According to one law firm, after the court hears pre-trial motions, and with both sides reserving the right to request summary judgment on these matters, these four lawsuits are scheduled for bellwether trials in 2025:

1. Mar v. Abbott Laboratories (Case No. 1:22-cv-00232)
2. Diggs v. Abbott Laboratories (Case No. 1:22-cv-05356)
3. Etienne & Brown v. Abbott Laboratories (Case No. 1:22-cv-02001)
4. Inman v. Mead Johnson & Co. (Case No. 1:22-cv-03737)

Tragically, the first claim, Mar, is a wrongful death lawsuit. A premature baby girl was originally fed only her mother's milk but when transferred to the NICU, she received Similac Special Care 24 (a formula derived from cow's milk) and quickly developed severe NEC symptoms. The baby underwent surgery to fix severe damage to her intestines, remove dead tissue and repair a perforation. Her mother claims she had no idea that Similac baby food could cause these devastating problems.

About Abbott

Meanwhile, Abbott announced in a press release last month a new baby formula recipe, “backed by 100 Years of Research and Commitment to Quality”. Its Similac “pure bliss formulas provide even more choices for families backed by a brand that invests in clinical research and product development to advance nutrition science for all babies…Abbott offers infant formulas that support the most vulnerable infants, formulas for food allergies, formulas for sensitive tummies, formulas for dietary preferences, and our closest to breastmilk formula that has five HMOs for parents and caregivers who need or prefer formula.”

Abbott also reported its total worldwide sales in the first quarter of 2024 were $9.964 billion, an increase of 2.2 percent. Forbes reported that less than two years after shutting down its baby formula plant in Michigan that fueled the shortage crisis, Abbott Laboratories has “reclaimed its previous market-leading position.”