Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits

Removing Similac Special Care and other premature infant formula products from the market could staunch the flow of future NEC lawsuits, experts say.

Abbott Laboratories CEO Robert Ford reportedly told investors recently that the company is weighing removing infant formula products designed for premature babies from the market, amid increasing concerns about the risk of necrotizing enterocolitis (NEC), and legal liability the company faces for failing to warn about the increased risks preemies face of developing the devastating gastrointestinal condition from cow’s milk-based formula.

The comments were reported by Bloomberg News in a July 18 report, which indicated Ford said the company has to at least consider the implications of removing Similac Special Care and similar products targeted toward premature infants. However, he maintained that claims raised in hundreds of lawsuits alleging that Similac preterm infant formula caused NEC are without merit and lacks sufficient scientific support.

Although versions of Similac, and its Mead Johnson competitor, Enfamil, have been specifically promoted in recent years for use among premature infants, the lawsuits point to a growing body of evidence that has established cow’s milk formula dramatically raises the risk of necrotizing enterocolitis (NEC), which occurs when harmful bacteria breaches the walls of the intestines, causing portions of the tissue to become inflamed or die. The condition often results in the need for emergency surgery while the baby is still in the NICU, and many infants do not survive.

Ford’s statements come as a St. Louis jury is currently hearing evidence in Missouri state court in a case brought by Margo Gill, on behalf of herself and her minor child, who is identified in the lawsuit only with the initials R.D., presenting claims that Abbott Laboratories has failed to adequately warn parents and the medical community about the devastating risks associated with it’s infant formula.

The case is just one of more than 1,000 Similac lawsuits and Enfamil lawsuits currently pending in both federal and state courts nationwide, each raising similar allegations that the manufacturers knew or should have known about the risks associated with their products, but provided false and misleading information for years about the risks compared to the use of human breast milk.

According to the Bloomberg report, legal observers say removing Similac Special Care and other premature infant formulations from the market could make Abbott more vulnerable in the lawsuits it already faces, but could limit liability in the long term by avoiding future Similac NEC lawsuits.

In addition, they noted that the products only bring in $9 million in sales per year for the massive company, meaning losing them will do very little to hurt the Abbott’s bottom line.

Removing the products from the market could make Similac NEC settlements more likely, since it would allow the company to avoid future liability for more cases of NEC that would develop from the Similac premature infant formula products.

Infant Formula NEC Lawsuits

Gill’s lawsuit is the second such claim to go to trial. In March, another Illinois jury ordered Mead Johnson and its parent company, Reckitt Benckiser, to pay $60 million in damages to Jasmine Watson, who’s child, Chance Dean, died due to NEC caused by Enfamil, which is a competing infant formula product that has also been specifically marketed to preemies without warnings about the potentially devastating health risks.

That trial lasted four weeks, and the jury awarded $25 million more in damages that Watson’s attorneys had requested at trial, sending a strong signal about the strength of the evidence presented.

While these first two trials have been held at the state court level, most of the claims being purused by U.S. families are currently pending in the federal court system, where a baby formula MDL (multidistrict litigation) was established in 2022, centralizing all lawsuits that NEC was caused by Similac or Enfamil before U.S. District Judge Rebecca R. Pallmeyer in the Northern District of Illinois for coordinated discovery and pretrial proceedings.

As part of the management of the litigation, Judge Pallmeyer has established a “bellwether” program, where a group of 12 NEC lawsuits brought against the two infant formula manufacturers are going through case-specific discovery, and the first federal NEC baby formula lawsuit bellwether trial is expected to begin on May 5, 2025.

Although the outcomes of these early trials will not have any binding impact on other claims that continue to be filed, they are being closely watched to determine how juries may respond to similar evidence and testimony that will likely be repeated throughout lawsuits being pursued by families nationwide, and may have a large influence on the amounts of any NEC settlements the manufacturers may be forced to pay to avoid hundreds of individual cases going before juries over the next few years.