Lawsuits Allege Link Between Similac Baby Formula and Serious Gastrointestinal Infections

Several lawsuits have been filed recently, alleging that Similac baby formula is linked to the development of necrotizing enterocolitis (NEC), a serious gastrointestinal infection, in premature infants fed with Similac.

Dani Alexis Ryskamp, J.D.

Written by
— Updated on April 12, 2022

Lawsuits Allege Link Between Similac Baby Formula and Serious Gastrointestinal Infections

The lawsuits allege that the Similac exposure caused the NEC cases in premature infants who received the formula during their stays in neonatal intensive care units (NICUs). Some plaintiffs also claim that Abbott Laboratories, Similac’s maker, intentionally misled parents and doctors about the risk of NEC linked to the use of Similac to feed premature infants.

Similac is an infant formula that uses cow’s milk as a base, supplemented with the additional nutrients human infants need.

The lawsuits allege that Abbott Laboratories was aware that the formulas increase the risk of premature infants developing necrotizing enterocolitis. Yet, Abbott kept this information to itself, according to the lawsuits. For instance, the lawsuits allege that Abbott failed to place warning labels on Similac. Rather, the lawsuits claim, the existing warning labels are too broad. As such, the labels don’t adequately inform consumers of the risks of NEC or its consequences.

One lawsuit alleges that an infant who received both Similac and Enfamil after a premature birth developed NEC. The infant required surgery for the damage caused by the infection; the infant did not survive the surgery. The lawsuit, like many similar suits, makes several allegations, including strict liability for design defects and failure to warn. The allegations also include negligence and other consumer fraud-related claims.

In addition, several lawsuits allege that Abbott Laboratories and other formula makers have not only failed to disclose the risks of NEC linked to their formula, but have instead carried out large marketing and advertising campaigns designed to encourage parents to use infant formula. Many of these campaigns allegedly encourage formula use as a replacement for breastfeeding. However, studies have indicated that breastfeeding does not pose the same elevated risk of NEC that cow’s milk-based formula does.

The Effects of Necrotizing Enterocolitis

Necrotizing enterocolitis (NEC) occurs when harmful bacteria damage or rupture the walls of the intestines. The damage can cause inflammation and, in serious cases, result in the death of intestinal tissue. As the intestinal tissue becomes inflamed or dies, the risk increases that the bacteria will enter the infant’s bloodstream. This can lead to sepsis or other potentially fatal medical conditions.

Early symptoms of NEC can mimic those of common, non-fatal infant conditions, like gas or colic. Yet NEC can move quickly, developing into a life-threatening condition with little notice.

Premature infants who develop NEC may require antibiotics to treat infections. They may also need IV feedings to supply the body with nutrients while also allowing the intestinal tissue time to heal. In some cases, infants may need surgery to remove damaged or dead intestinal tissue.

Approximately 1 in 10 infants in the US are born prematurely each year, according to the CDC. Many require feeding support in their first days of life. They may also struggle with underdeveloped immune systems that make them more susceptible to infection. 

Similac Recalls

As of March 30, 2022, neither Abbott Laboratories nor the U.S. Food and Drug Administration (FDA) had announced a recall of cow’s milk-based Similac linked to a risk of NEC or any other condition.

Abbott has, however, issued a separate recall affecting certain lots of its powdered Similac infant formula. This was due to concerns about the risk of Cronobacter sakazakii and Salmonella Newport infections. The formula involved in the recall was made in a plant in Sturgis, Michigan where evidence of Cronobacter was discovered on the premises.

Currently, cases are pending in various courts nationwide. Efforts are being made to consolidate these claims in federal district court. Abbott Laboratories is not the only manufacturer of cow’s milk-based infant formula facing lawsuits, either. Several suits name Mead Johnson, makers of Enfamil, and make similar allegations.

One of the first hurdles that plaintiffs will face in these lawsuits is to establish a causal link between infants receiving the formula products and developing necrotizing enterocolitis. Questions concerning what formula makers like Abbott and Mead Johnson knew about any connection between cow’s milk-based formula and NEC and when they knew it will also arise. In addition, the parties are likely to explore what duty the makers had to provide warnings to the public and what warnings were needed.

Expert witnesses on the care of premature infants are likely to be in demand during the trials. Attorneys may ask specialists on the development of necrotizing enterocolitis and its treatment to opine. Additionally, cases may require the input of experts on the manufacture of infant formula and the obligations that its manufacturers have to provide various warnings.

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