Baby Formula Lawsuit

A growing number of baby formula lawsuits have been filed after infants developed severe infections, such as Necrotizing Enterocolitis (NEC), and other severe side effects.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting baby formula induced injury cases in all 50 states. If your baby had an infection from baby formula, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.

UPDATE: Parents Awarded $60 Million in 1st Baby Formula NEC Trial

In March 2024, a jury in Ilinois awarded $60 million to the parents of a premature baby who died after being fed cow’s milk-based Enfamil infant formula in the NICU. Click here to read more.

Nutramigen Baby Formula Recalled for Cronobacter Infection Risk

In December 2023, Reckitt/Mead Johnson Nutrition recalled about 657,000 cans of Nutramigen Hypoallergenic Infant Formula Powder after a batch that was made in Michigan and sent to Israel tested positive for Cronobacter sakazakii. No illnesses were reported.

The recall involves Enfamil Nutramigen Hypoallergenic Infant Formula Powder in 12.6 ounce cans with batch codes ZL3FHG, ZL3FMH, ZL3FPE, ZL3FQD, and ZXL3FXJ. The recall also includes 19.8 ounce cans with batch code ZL3FRW.

Gerber Good Start Infant Formula Recall

In March 2023, Perrigo recalled certain cans of Gerber® Good Start® SoothePro Powdered Infant Formula due to a risk of contamination with Cronobacter sakazakii.

The recalled products were sold nationwide in the U.S. after March 5, 2023 and no illnesses were reported. These products include:

Gerber® Good Start® SoothePro 12.4 oz:

300357651Z – USE BY 04JUL2024
300457651Z – USE BY 05JUL2024
300557651Z – USE BY 06JUL2024
300557652Z – USE BY 06JUL2024
300757651Z – USE BY 08JUL2024
300857651Z – USE BY 09JUL2024
301057651Z – USE BY 11JUL2024
301057652Z – USE BY 11JUL2024
301157651Z – USE BY 12JUL2024

Gerber® Good Start® SoothePro 30.6 oz:
301357652Z – USE BY 14JUL2024
301457652Z – USE BY 15JUL2024
301557651Z – USE BY 16JUL2024

Gerber® Good Start® SoothePro 19.4 oz:
301557652Z – USE BY 16JUL2024I

Enfamil ProSobee Plant-Based Baby Formula Recall

In February 2023, Reckitt recalled 145,000 cans of Enfamil ProSobee Plant-Based Infant Formula due to a risk of bacteria contamination. No infections were reported, but the formula may have been cross-contaminated with Cronobacter sakazakii, a bacteria that can cause severe, life-threatening infections in babies.

ByHeart Baby Formula Recalled for Cronobacter Infection Risk

In December 2022, ByHeart recalled 5 batches of ByHeart Whole Nutrition Infant Formula due to a risk of contamination with Cronbacter sakazakii. No complaints of illnesses were reported, but Cronbacter was found in a 3rd-party facility where the formula is canned. The recalled batches include: 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1 with use-by dates of 01 JAN 24 or 01JUL 24.

Liquid Similac® Baby Formula Recalled for Spoilage Risk

On October 14, 2022, Abbott recalled certain lots of 2-oz. bottles of ready-to-feed liquid formula for babies and children because the lid may not be sealed completely, posing a risk of spoilage.

“If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur,” the recall warns. For a list of lot numbers, visit www.similacrecall.com.

The recall includes the following products:

Similac® Pro-Total ComfortTM
Similac® 360 Total Care®
Similac 360 Total Care Sensitive
Similac® Special Care® 24
Similac Stage 1
Similac® NeoSure®
Similac Water (Sterilized)
Pedialyte Electrolyte Solution

Baby Formula Lawsuits Centralized in Federal Court

In April 2022, federal judges centralizes more than 36 separate baby formula lawsuits into a single federal court, under one judge. From now on, NEC baby formula lawsuits will be centralized in Multi-District Litigation (MDL No. 3026) in the U.S. District Court for the Northern District of Illinois under Judge Rebecca R. Pallmeyer — IN RE: Abbott Laboratories, et al., Preterm Infant Nutrition Products Liability Litigation.

2022 UPDATE: Similac, Alimentum, EleCare Baby Formula Recalled After Deadly Infection Outbreak

In February 2022, a recall was issued for Similac, Alimentum and EleCare powdered baby formula from a facility in Sturgis, Michigan, after the products were linked to a deadly infection outbreak.

There were 4 reports of babies who were hospitalized due to infections with Cronobacter or Salmonella bacteria, including 1 baby who died, according to the FDA.

The recall involves the following types of powdered infant formula:

Similac, Alimentum and EleCare
Product code: First two digits are 22 through 37
The code on the container contains “K8,” “SH,” or “Z2”
Expiration date: 4-1-2022 (APR 2022) or later.

Full List of Recalled Baby Formula Brands

The following products are included in the recall if they have all three items below:

the first two digits of the code are 22 through 37 and
the code on the container contains K8, SH, or Z2, and
the expiration date is 4-1-2022 (APR 2022) or later

Similac Products
Abbott Similac 360 Total Care Infant Formula with Iron
Abbott Similac Advance
Abbott Similac Advance Step-1
Abbott Similac Advance Step-2
Abbott Similac Advance Infant Formula with Iron
Abbott Similac Human Milk Fortifier
Abbott Similac Organic
Abbott Similac Organic with A2 Milk Infant Formula with Iron
Abbott Similac Organic with A2 Milk Toddler Drink
Abbott Similac Organic Toddler with A2 Milk Infant Formula with Iron
Abbott Similac Pro-Advance
Abbott Similac Pro-Advance Infant Formula with Iron
Abbott Similac Pro-Sensitive Infant Formula with Iron
Abbott Similac Pro-Total Comfort Infant Formula with Iron
Abbott Similac Sensitive
Abbott Similac Sensitive Infant Formula with Iron
Abbott Similac Sensitive Lactose Sensitivity
Abbott Similac for Supplementation
Abbott Similac For Spit Up Infant Formula with Iron
Abbott Similac Total Comfort
Abbott Similac Total Comfort Infant Formula with Iron
Abbott Similac EleCare HMO
Abbott Similac EleCare
Abbott EleCare Similac Gold
Abbott EleCare Similac
Abbott Similac PM 60/40 – only lot code 27032K80 (can) / 27032K800 (case)

Alimentum Products
Abbott Infant Formula Powder
Abbott Similac Alimentum
Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula
Abbott Similac Alimentum with 2′-FL HMO
Abbott Similac Alimentum Eye Q Plus
Abbott Similac Alimentum HMO
Abbott Alimentum HMO
Abbott Similac Alimentum infant formula
Abbott Similac Alimentum Infant Formula with Iron
Abbott Similac Alimentum Toddler Drink

EleCare Products
Abbott EleCare
Abbott EleCare Amino Acid-Based Powder Infant Formula with Iron
Abbott EleCare Infant Formula Unflavoured
Abbott EleCare Junior Vanilla
Abbott EleCare Jr Similac Vanilla
Abbott EleCare Jr Amino Acid-Based Nutrition Powder Unflavored
Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana
Abbott EleCare Jr Amino Acid-Based Nutrition Powder Chocolate
Abbott EleCare Similac
Abbott EleCare Similac Gold
Abbott Similac EleCare HMO
Abbott Similac EleCare
EleCare LCP Hypoallergenic

Baby Formula Lawsuits for NEC

For more than 30 years, the manufacturers of baby formula have known that it can significantly increase a premature baby’s risk of Necrotizing Enterocolitis (NEC), a life-threatening intestinal disease. Unfortunately, these companies still fail to warn about NEC on the label for Similac, Enfamil, and other popular baby formulas — including formulas specifically for premature infants.

Baby Formula Lawsuits Accuse Manufacturers of Failing to Warn About NEC

In recent years, a growing number of lawsuits have been filed by angry parents who accuse baby formula companies of downplaying the deadly risks of giving cow’s milk-based formula to an infant.

Not only do the labels on Similac and Enfamil fail to warn about NEC — they also fail to provide instructions on how to reduce the risk of NEC when feeding formula to a premature infant (such as using pasteurized donor breast milk instead of cow’s-milk baby formulas).

What Do the Labels Say?

The label on Similac has no warnings about NEC, and only a vague warning that “very low birth-weight infants are particularly susceptible to gastrointestinal complications.” The label on Enfamil does not include a single warning about NEC or other intestinal complications.

Are Lawsuits Being Filed Against NICU Doctors or Nurses?

No. Doctors and nurses in the Neonatal Intensive Care Unit (NICU) are not being sued. Instead, baby formula lawsuits are specifically targeted at manufacturers who are intentionally not warning about the dangers of feeding their products to preterm babies.

Similac Lawsuits

Similac lawsuits are being filed against Abbott Laboratories, Inc., the company that manufacturers and advertises all Similac infant formula, including products for premature infants.

Abbott Laboratories sells the following types of infant formula:

Similac
Similac Special Care
Similac Human Milk Fortifier
Similac NeoSure
Similac Alimentum
Similac Human Milk Fortifier
Similac Liquid Protein Fortifier
And more

Enfamil Lawsuits

Enfamil lawsuits are being filed against Mead Johnson & Company (also known as Mead Johnson Nutrition Company), the company that manufactures and advertises all types of Enfamil infant formula, including products for premature babies.

Mead Johnson & Co. sells the following types of infant formula:

Enfamil
Enfamil NeuroPro EnfaCare Infant Formula
Enfamil Premature Infant Formula 24 Cal High Protein
Enfamil Premature Infant Formula 30 Cal with Iron
Enfamil Premature Infant Formula 24 Cal with Iron
Enfamil Premature Infant Formula 20 Cal with Iron
Enfamil Human Milk Fortifier
And more

Why Doctors Feed Formula to Premature Infants

Babies are designed to eat breast milk, but premature babies may not be coordinated enough to suck or breastfeed effectively. The baby also needs to grow rapidly, but the mother may not have enough milk supply. This is why it is so common for NICU doctors to use baby formula, milk fortifier, or baby formula mixed with donor breast milk.

The Many Benefits of Breast Milk

Breast milk is beneficial for premature infants, including those with NEC, because it is the easiest food for a baby to digest. Breast milk also supports the growth of healthy bacteria in the intestines, which can help fight the heavy overgrowth of bacteria that erodes the intestinal wall. Breast milk contains antibodies that boost a baby’s immune system, and proteins that provide anti-inflammatory benefits.

Why Are Premature Infants So Susceptible to NEC?

The intestines of a premature infant may not be developed enough to digest cow’s-milk proteins and other ingredients in baby formula. This can result in severe inflammation in the intestines, which can lead to the death of intestinal tissue, or a hole (perforation) in the intestines.

What Happens in NEC?

If the inflammation is not controlled, bacteria can cause a severe infection that causes parts of the intestines to die (called “necrosis”).

The necrotic sections of the intestines will never heal, so they may need to be removed surgically. NEC can also create a hole in the intestines that allows bacteria to spread into the body, resulting in an infection. The infection can spiral out of control within hours or days.

Signs & Symptoms of NEC

Belly is red, swollen and tender
Poor feeding
Failure to thrive
Slow digestion
Constipation or diarrhea with bloody stools
Sleepiness or less activity
Green vomit (containing bile)
Slow heart-rate
Low blood pressure
Pauses in breathing

Studies Linking Baby Formula and NEC

No one knows exactly what causes NEC, but numerous studies have confirmed the baby formula is far more likely to cause NEC in premature infants, compared to babies who are only fed breast milk.

Here are just a few examples of recent studies:

1. In 1990, a study of 926 premature infants found that NEC was 6-10 times more likely to occur in formula-fed babies compared to breast milk-fed infants (Source: “Breast milk and neonatal necrotising enterocolitis”)
2. In 2010, a study found that premature babies were 90% less likely to develop severe NEC requiring surgery if they were only fed human milk, breast milk, donor milk, and human milk fortifier (Source: “An Exclusively Human Milk Diet Reduces Necrotizing Enterocolitis”)
3. In 2021, the journal of the American Academy of Pediatrics published a study that concluded that “feeding preterm infants human milk is associated with a significant reduction (58%) in the incidence of necrotizing enterocolitis (NEC).” (Source: “Breastfeeding and the use of human milk”)

Do I have a Baby Formula Lawsuit?

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