Unreliable Studies Used to Support Baby Formula Health Claims

Unreliable Studies Used to Support Baby Formula Health Claims

Many families rely on baby formula to feed their infants the nutrients they need to be healthy. To market their products, most baby formula brands claim that their formula supports general growth and development, or has specific benefits like an immunity boost. A close examination of over 800 baby formula brands has revealed that the studies used to support these claims are highly prone to bias and relied on inconsistent or inadequate studies. 

Accusations have surfaced that this lack of oversight may be related to the recent baby formula crises. This includes the discovery that cow-based baby formulas like Similac and Enfamil are likely responsible for a serious gastrointestinal condition known as NEC. Additionally, the makers of Similac were forced to issue a massive recall due to an unrelated strain of infections caused by their product, creating a nationwide shortage. 

Parents are currently pursuing compensation for medical bills, lost wages, pain and suffering, and other damages related to their child’s injuries. Product liability attorneys can be assets to parents looking to hold negligent manufacturers accountable by analyzing evidence, enlisting expert witnesses to support their claims, creating a strategy to establish liability, and negotiating for a fair settlement.

Baby Formula Advertising May Be Misleading Due to Researcher Bias, Limited Regulation

A new study claims that the assertions that baby formula manufacturers make about the health benefits of their products aren’t sufficiently supported by data. Additionally, the study published in the highly reputable British Medical Journal found that many of the researchers involved in these studies were motivated to provide data that supported baby formula makers’ marketing agenda. In some cases, the clinical trials were even funded by the baby formula industry itself.

When marketing their products, baby formula manufacturers like Abbott Laboratories and Mead Johnson based their claims on a mix of clinical trials and other less reliable sources, such as opinion pieces, reviews, and animal experiments. The clinical trials themselves are also questionable, as less than 7% of the evidence used to validate baby formula makers’ marking claims are registered clinical trials conducted by researchers without industry ties.

While the FDA does provide guidelines for baby formula makers in regard to how the product should be marketed, they aren’t mandatory. The lack of regulation and credible scientific evidence supporting baby formula’s health benefits is cause for concern. Families who have trusted brands like Abbott Laboratories, the makers of Similac, may be able to recover compensation if the baby formula has harmed their infant, as in the deadly cases of NEC that resulted from contaminated products. 

Consequences of Unreliable Monitoring of the Baby Formula Industry

When the makers of baby formula are allowed to advertise their products as healthy for infant development using biased information, consumers can easily be misled as to the efficacy and safety of these products. Two recent incidents illustrate how this can cause serious injury or even death. The first issue is that baby formulas like Similac and Enfamil have been connected to incidents of Necrotizing Enterocolitis in vulnerable infants. 

Formula is commonly given to infants in the hospital for a number of reasons, but it is especially beneficial for premature babies or those with low birth weights. Unfortunately, underdeveloped infants may not be able to properly digest cow-based baby formula, leading them to develop holes in their intestines that allow harmful bacteria to cause life-threatening infections. 

Contracting NEC as an infant can have life-long consequences, including neurological issues and digestive issues. Baby formula manufacturers were potentially aware of this risk and failed to provide consumers with a warning label and continue to reassure parents their products are safe, despite evidence to the contrary. The second issue related to the unreliable testing and surveillance of baby formula is that dangerous contaminants can quickly sicken vulnerable infants and deplete the available supply.

In the U.S., the baby formula industry is quite limited in terms of competition. When Abbott Laboratories issued multiple recalls after babies developed Cronobacter sakazakii infections from ingesting Similac, it triggered a massive baby formula shortage which was exacerbated by existing supply chain issues. If the shortage had continued, in the long term, nutrient deficiencies can do irreparable damage to a child’s health.

It was later discovered that the Michigan factory conditions at Abbott Laboratories were the source of the bacteria that hospitalized multiple infants and claimed two infants’ lives. In conjunction with the lack of testing that allows NEC-causing formulas on the market, this constitutes a pattern of negligence. Parents should be able to trust that the formula they are giving their infants is free from harmful bacteria, and instead provides the health benefits it touts. 

Recovering Damages in an NEC Baby Formula Lawsuit

Parents whose children have become ill or died due to the negligent practices and deceitful marketing of baby formula products may be able to recover compensation in a product liability lawsuit. During the course of caring for their sick infant, parents make have to take time off work, become stressed about their child’s health, and incur thousands of dollars in unexpected medical bills.

In a product liability lawsuit, plaintiffs can claim compensation for economic and non-economic damages to secure financial relief for these losses. Economic damages provide plaintiffs with compensation for monetary losses related to their injuries. Non-economic damages offer financial compensation for intangible losses, like the emotional cost of losing a child.

Examples of Damages in a Baby Formula Lawsuit:

  • Medical bills
    • Medication
    • Surgery
    • Hospital stays
    • Lab tests
    • Imaging
  • Job-related losses
    • Lost wages
    • Missed promotions
    • Reduced earning capacity
  • Pain and suffering
  • Loss of quality of life
  • Wrongful death
    • Funeral and burial expenses
    • Loss of companionship

Baby Formula Manufacturers May Be Found Liable for Negligence

Currently, an NEC baby formula multidistrict litigation is being considered in the Northern District of Illinois. Bellwether claims have been selected for trial, which will give future plaintiffs and defendants a better idea of what the average NEC baby formula claim is worth. Additionally, dozens of other NEC baby formula lawsuits have been filed across the country, many of which accuse hospitals of playing a role in their infant’s injuries. 

Baby formula makers like Abbott Laboratories and Mead Johnson may be held accountable for allowing their products to become contaminated in the case of the Cronobacter sakazakii infections, or for failure to warn consumers of the risk their products presented in the case of the NEC claims. Plaintiffs will need to demonstrate that the manufacturer’s negligence breached their duty of care to consumers, and that this resulted in their infant’s injuries and the family’s subsequent damages.

Parents who intend to pursue compensation for their infant’s injuries related to NEC or other infections from baby formula should consider discussing the details of their claim, such as the extent of their damages, with a qualified product liability lawyer. Product liability attorneys can offer helpful legal insight, craft a persuasive claim for compensation, and protect your right to pursue a fair settlement. 


Matthew Dolman

Personal Injury Lawyer

This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has represented over 11,000 injury victims and has served as lead counsel in over 1000 lawsuits. Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess of $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.

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