Studies have found that premature infants who are fed cow’s milk–based formulas like Similac face an increased risk of developing necrotizing enterocolitis (NEC), a severe, potentially fatal gastrointestinal disease that inflames intestinal tissue, causing it to die.
Update: Lawsuit Filed After Newborn Died From NEC
The parents of a child who died of NEC have filed a wrongful death lawsuit against the makers of Similac, alleging the infant formula caused the serious intestinal disease.
The complaint was filed in the U.S. District Court for the Eastern District of California on May 14, 2021, by Alicia Restad and Daniel Renteria-Hernandez, alleging Abbott Labs and Mead Johnson & Company, LLC are responsible for the death of their child, Daniel Renteria-Hernandez.
According to the lawsuit, baby Daniel was born on April 29, 2019 at Dignity Hospital in Merced, California. He was born premature, with a birth weight of only two pounds and two ounces after only 31 weeks of pregnancy and was put in the Neonatal Intensive Care Unit (NICU) at Valley Children’s Hospital.
At only 16 days, Daniel died from NEC, which the parents blame Similac fed to him during his short life, according to lawsuit notes.
What's the Problem?
Premature babies do best on breast milk for a balanced diet. However, breastfeeding is not always possible in NICUs. Many premature infants also need additional calories, so many NICU medical professionals use natural milk with a Similac human milk-based fortifier.
Unfortunately, most baby formulas are cow's milk-based, which is difficult for premature babies to digest properly, leading to a severe and often deadly gastrointestinal disease known as necrotizing enterocolitis.
Numerous studies have found that cow milk-based formulas can increase the risk of premature babies developing NEC. The risk of sepsis increased in preemies by nearly 18% for every 10% increase in formula.
Unfortunately, Similac is used in NICUs across the U.S. Similac Special Care is specially designed for newborn preemies. In addition, NeoSure and Human Milk Fortifier are both made by Similac. When babies feed on them, these products may increase the risk of NEC.
What is Similac?
Similac (for "similar to lactation") is a brand of infant formula that was developed by Alfred Bosworth of Tufts University and marketed by Abbott Labs. The product is a manufactured food designed and marketed for feeding to babies and infants under 12 months of age, usually prepared for bottle-feeding or cup-feeding from powder (mixed with water) or liquid (with or without additional water).
Is Similac FDA Approved?
No. The U.S. FDA does not approve premature infant formulas before they can be marketed. However, all formula marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula.
Related Article: Baby Formula Recall Lawsuit
Which Formulas Use Cow's Milk as Base?
About 80% of baby formulas are cow’s milk-based, and almost every major brand (and store brand equivalent) offers a bovine-based formula, including:
- Similac Special Care
- Human Milk-Based Fortifier
- Earth’s Best
- Happy Baby
- Go & Grow
- Parent’s Choice
- Baby’s Only
What is Necrotizing Enterocolitis?
NEC is a serious gastrointestinal problem that mostly affects premature babies. The condition inflames intestinal tissue, causing it to die.
A hole (perforation) may form in the intestines of babies with NEC. Bacteria can leak into the abdomen or bloodstream through the hole. NEC usually develops within 2 to 6 weeks after birth.
In some infants, NEC is mild. Others experience severe, life-threatening symptoms.
- A swollen, red, or tender belly
- Abdominal Distension
- Feeding Intolerance
- Hypotension (low blood pressure)
- Bradycardia (slow heart rate)
- Temperature Instability
Necrotizing enterocolitis may require medication, but severe cases will require surgery – and even the surgery may pose serious risks of permanent injury to premature babies.
In some cases, scarring and narrowing of the bowel may develop and can lead to future intestinal obstruction or blockage.
Another residual problem may be malabsorption (the inability of the bowel to absorb nutrients normally). This is more common in young children who require multiple surgeries for NEC and lose a large segment of intestine.
Still, there are some infants who lose so much intestine from the infection that they do not have enough intestine left to survive. These infants may end up requiring a bowel transplant to survive.
Similac Infant Formula Side Effects
In addition to an increased risk for necrotizing enterocolitis, baby formula products have been linked to more moderate side effects including constipation, diarrhea, and upset stomach. These effects are usually temporary and may disappear as the baby's body adjusts to the medication.
Human Breast Milk vs. Formula: How Similar Are They?
There are ways in which formula is similar to breast milk: they both provide energy, healthy foods, hydration and nutrients, so your baby will grow whichever milk he is given.
However, despite advances in how baby milk powder is formulated and manufactured, it doesn’t come close to matching the health benefits of human breast milk.
Human milk has evolved over millions of years to be the perfect health food for human babies. It’s much more complex than other mammals’ milk, as it builds our more complex brains and unique digestive and immune systems.
In contrast, cow’s milk, from which most formula is made, meets the specific needs to be fed to calves. It’s not safe for human babies to drink, so has to be processed intensively when made into formula to be fed to infants.
Lawsuit Claims Abbott Laboratories Deceptively Marketed Similac
Abbott Inc. is facing a proposed class action lawsuit alleging that Similac Go & Grow toddler drink are defectively manufactured in a way that offers minimal nutritional needs to children while maximizing sales for the company.
New York caretaker Giovanna Smith claims Abbott fraudulently advertises its so-called “transition formulas” by claiming they’re suitable for toddlers and an appropriate next step in their development. However, Smith says Similac Go & Grow toddler drink are essentially identical to infant formula.
The lawsuit states that Abbott is adapting to a shift in how mothers are feeding their babies, citing findings from the American Academy of Pediatrics showing an increase in breastfeeding since 2003.
The resulting drop in infant formula sales led Abbott to re-brand their products, creating a “transition formula” category, including the Similac Go & Grow toddler drink, according to the class action.
Other products in this category are labeled as “follow-on formulas,” “weaning formulas,” “toddler milks” and “growing-up milks.”
As evidence of the branding effort, Smith points to U.S. Nielsen data between 2003 and 2015 that shows advertising on these transition formulas quadrupled.
The complaint further elaborates on Smith’s claims of how infant formula and the Similac Go & Grow toddler drink are the same by comparing the labels.
The label on the toddler drink doesn’t indicate how it’s different, according to Smith. Similac Go & Grow and the infant formulas are labeled similarly, with parallel design choices.
Additionally, Smith claims advertising on these products has created a false impression that Similac Go & Grow are needed by growing children.
Smith cited research conducted by University of Connecticut’s Rudd Center for Food Policy and Obesity that looked at public opinion on toddler formula products.
What are Similac Lawsuits Alleging?
If your baby received Similac in a hospital or NICU, or if they developed necrotizing enterocolitis after taking Similac, you can file a lawsuit against the manufacturers of Similac with the help of our attorney.
These lawsuits allege that Abbott knew about the risk of developing NEC, but failed to warn of this risk.
If your child suffered harm from NEC, he or she may require a lifetime of care and medical treatment to deal with complications of the disease. Tragically, you may even have experienced a death from this condition. When this occurs, you need someone on your side who can fight for justice.
Do I Have a Similac Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Similac Lawsuits. We are handling individual litigation nationwide and currently accepting new necrotizing enterocolitis cases in all 50 states.
If your baby or other loved one received Similac in a hospital / NICU, or if your premature baby was diagnosed with NEC after receiving Similac, you should contact our attorneys immediately. You may be entitled to a settlement by filing a suit and we can help.