Abbott Seeks Federal Protection From Similac NEC Lawsuits

Lawmakers say improving access to human milk-based products is a better solution than granting legal protections to formula manufacturers for failing to warn about the risk of necrotizing enterocolitis and other injuries.

As a growing number of families continue to push forward with infant formula lawsuits over the development of necrotizing enterocolitis (NEC) among premature babies, Abbott Laboratories has increased lobbying efforts to obtain legal protections from Congress.

According to a Bloomberg News report published on December 11, Abbott has warned lawmakers that it may stop selling certain formula products for premature babies unless it receives federal protections from lawsuits brought over the alleged failure to warn families and medical providers about the risks associated with it’s cow’s milk-based products.

The company argues that the growing litigation puts its preemie formula business at risk, but some lawmakers have pushed back, suggesting that the U.S. government should focus on making sure there is greater availability of donor breast milk and human milk-based fortifiers, rather than stepping in to absolve manufacturers of liability for injuries caused by their products.

Abbott and its competitor Mead Johnson, the maker of Enfamil, currently face more than 750 Similac lawsuits and Enfamil lawsuits filed by families nationwide, each raising similar allegations that the companies placed a desire for profits before the health and safety of infants, by concealing information from families and the medical community about the link between cow’s milk-based formulas and NEC among premature babies.

NEC occurs when harmful bacteria damage the lining of a newborn’s intestines, causing inflammation, tissue death, and in many cases intestinal perforation. Infants who develop NEC often require emergency surgery while still in the neonatal intensive care unit, and many do not survive.

Parents bringing these lawsuits say the manufacturers failed to adequately warn that feeding premature babies cow’s milk-based formula carries higher risks than feeding human breast milk. Bloomberg reported that Abbott’s request for legal protections comes despite more than two dozen studies linking cow’s milk-based formula to increased NEC risk in preterm infants.

Families and survivors argue that safer alternatives, including human milk-based products, have been known for years and that companies continued marketing their formulas for vulnerable premature infants without fully disclosing the risks.

Bloomberg reports that Abbott has spent millions of dollars lobbying lawmakers for legal protections from the ongoing Similac NEC lawsuits being pursued by parents, according to federal records. The company has warned that without such protections, it may pull its preterm infant formula from the market and has suggested that the federal government take over sales and distribution of those products.

Company officials reportedly argue that their cow’s milk-based products do not actually cause NEC, instead claiming it just fails to prevent NEC as effectively as human milk.

However, one U.S. lawmaker says that what the government should do is look toward increasing the availability of donor breast milk and human milk fortifiers to address the issue, instead of intervening to defend a large corporation worth billions from parents with permanently injured or deceased children seeking compensation.

On December 5, U.S. Representative Rosa DeLauro, a Connecticut Democrat, issued a press release announcing that she and a group of other House representatives and senators sent a letter (PDF) to Health and Human Services Secretary Robert F. Kennedy, Jr., pointing out that Abbott’s litigation woes came from its failure to warn parents and caregivers of the potential risks of NEC linked to its products.

“I will never support blanket liability protections for major companies because protecting our youngest and most vulnerable infants should be our highest priority. We must take action to stabilize the preterm infant formula market based on the overwhelming scientific consensus that human milk is the best source of infant nutrition.”

– U.S. Rep. Rosa DeLauro (D-Conn)

The letter to Kennedy notes that out of 22 studies comparing human milk-based fortifiers to those that do not use human milk, “all 22 studies have shown lower rates of NEC in the babies fortified with human-milk-based fortifiers.” The letter also points out that preterm infants given human milk products instead of cow’s milk-based infant formula like Similac spend less time in the NICU ward, saving $307,916 to $2,520,000 per institution annually.

The lawmakers are calling on the FDA to take a number of steps to protect infants instead of Abbott, including:

• Ensuring the FDA receives all adverse event reports from infant formula manufacturers linked to the use of non-human milk derived fortifiers in very low birth weight (VLBW) infants, defined as those weighing under 1,250 grams
• Exploring ways to make pasteurized donor human milk safe and more accessible
• Adding warning labels to non-human derived infant formula that it should only be fed to preemies weighing more than 1,250 grams
• Improving access to human milk-based fortifiers

In addition to Delano, the letter was signed by Reps. Madeleine Dean and Riley M. Moore, as well as Senators Dr. Roger Marshall, Martin Heinrich and Jeffrey Merckley.

Infant Formula NEC Lawsuits

Given facts and laws common throughout the litigation, all federal NEC infant formula lawsuits have been consolidated in the Northern District of Illinois for coordinated discovery and pretrial proceedings under U.S. District Judge Rebecca R. Pallmeyer, as part of a federal MDL, or multidistrict litigation.

Over the past few years, Judge Pallmeyer has worked with the plaintiffs, Abbott and Mead Johnson to prepare a series of bellwether trials designed to see how juries respond to evidence and testimony likely to be repeated throughout the litigation. The first federal NEC infant formula bellwether trials were initially expected to begin in April 2025. However, those trials were canceled after the judge determined that the plaintiffs lacked sufficient evidence to support their claims.

As a result, the court is readying a second wave of bellwether selections, each of which involve infants given Similac products. Judge Pallmeyer anticipates those trials will begin in August 2026.

These will be closely watched, as any jury awards are likely to influence how much Abbott and Mead Johnson may need to pay in NEC infant formula lawsuits settlements to resolve the litigation. If no settlement is reached after the bellwether trials, Judge Pallmeyer could start remanding each individual claim back to the U.S. District Courts where it originated for separate trial dates.

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