Court Rejects Appeal in Similac Special Care Lawsuit Over NEC Warnings

Judges say hospital had no other formula or milk to feed the newborn, so a NEC label warning would not have changed the outcome.

A federal appeals court has refused to reinstate a Similac necrotizing enterocolitis (NEC) wrongful death lawsuit filed by the mother of a newborn who died after being fed the infant formula, indicating that the hospital had no other food to feed her child.

The lawsuit was brought by Ericka Mar on behalf of herself and her deceased infant, RaiLee Mar, who was born 12 weeks premature on New Year’s Day in 2014. After RaiLee’s mother was unable to provide human milk about a week after the child was born, the hospital began feeding her Similac infant formula.

The child contracted NEC and died a day later, which her mother blames on Similac side effects. She filed the lawsuit in January 2022, presenting claims of strict liability, design defect, negligence and failure to warn. However, Abbott was granted a motion for summary judgment by a federal judge after arguing the hospital had no alternatives for feeding the child, making the lack of a label warning moot.

Infant Formula NEC Risks

NEC is a dangerous condition that occurs when bacteria breaches the walls of the intestines, which can cause tissue inflammation and necrosis. Infants, particularly preterm, already face an increased risk of NEC due to their underdeveloped gastrointestinal systems, but health researchers worldwide warn that cow’s milk-based formula, like Similac, carries a much higher risk of the condition than human milk.

Newborns with NEC often require emergency surgery that could involve the removal of parts of the intestinal tract, often leaving the child with life-long health problems. In many cases, the infant does not survive.

Mar’s complaint is one of thousands of infant formula NEC lawsuits filed against Abbott Laboratories and its competitor, Mead Johnson, the makers of Enfamil. Each claim alleges the manufacturers placed profit ahead of infant safety by failing to provide adequate warnings of the products’ true risks.

Infant NEC Injury Appeal

After U.S. District Judge Rebecca Pallmeyer dismissed the case in the Northern District of Illinois, Mar appealed to the U.S. Court of Appeals for the Seventh Circuit. Following oral arguments on May 20, the appeals court issued an opinion (PDF) on July 24 affirming the lower court’s decision and refusing to reinstate Mar’s wrongful death lawsuit.

Chief Judge Michael B. Brennan wrote the opinion, indicating that the hospital’s policy and a lack of human donor milk at the time meant there was no other choice of food to give to RaiLee.

“The hospital turned to the Abbott formula at issue because it had no donor milk. Another patient at the hospital who had recently given birth offered to donate some of her breast milk to RaiLee. But hospital policy forbade sharing milk because diseases can be transmitted without first treating the milk.”

– Chief Judge Michael B. Brennan, U.S. Court of Appeals for the Seventh Circuit

According to the opinion, Mar argued that if Similac carried a stronger label warning, the hospital would have chosen to use the unpasteurized donor milk instead of putting RaiLee at risk of NEC. However, the judges disagreed, saying the hospital’s policy of not sharing untested breast milk would not likely have changed.

Abbott also asked the judges to find there was insufficient evidence that Similac caused the child’s fatal case of NEC, a ruling that could have affected other infant formula lawsuits. However, the panel declined to decide that issue, finding it was sufficient for the appeal to conclude that Mar’s proposed alternative warning would not have prevented RaiLee’s death.

Infant Formula NEC Lawsuits

Judge Pallmeyer, who dismissed Mar’s lawsuit, is also overseeing the federal infant formula NEC litigation, where hundreds of similar claims have been consolidated for coordinated pretrial proceedings and discovery. She is expected to preside over a series of early bellwether trials involving representative cases, which are intended to help both sides evaluate how juries may respond to evidence and arguments that could arise throughout the litigation.

The first federal Enfamil NEC lawsuit trial began on July 6, involving claims filed by Alexis Inman. A second trial is scheduled to start on August 10, focusing on claims brought by Mary Kelton.

Several trials have already been held at the state level, including a 2024 trial in Missouri that led a jury to order Abbott to pay nearly $500 million to a woman whose daughter suffered brain damage due to NEC. Also in 2024, another Missouri case initially ended in a defense verdict. However, the judge ordered a new trial after finding Abbott improperly introduced certain evidence.

In April, a Cook County, Illinois, jury handed down a $70 million verdict in a Similac lawsuit. Another Cook County jury returned a $60 million verdict against Mead Johnson in a lawsuit involving Enfamil formula, yet an appeals court tossed that verdict out on June 12 and ordered a new trial.

While the results of these bellwether trials are not binding on other cases, the outcomes are being carefully watched since they could help attorneys reach a future Similac infant formula NEC settlement agreement. If the litigation is not resolved by the end of the bellwether trials or pretrial proceedings, Judge Pallmeyer is likely to begin remanding cases back to their originating federal districts for individual trial dates.

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