Lawsuit Against Formula Manufacturers

By Brendan Pierson
(Reuters) – A Missouri mother and her lawyers are preparing to convince a jury that Abbott, Reckitt’s Mead Johnson, and St. Louis Children’s Hospital are liable for a severe intestinal illness her premature son developed after ingesting their formulas post-birth at the hospital.

The trial in St. Louis, Missouri state court, kicks off on Monday with jury selection and is part of extensive litigation that has seen verdicts of $60 million against Reckitt and $495 million against Abbott. Approximately 1,000 similar cases remain pending nationwide.

Plaintiffs claim that administering cow’s milk-based formulas to premature infants—especially those weighing under about 1,500 grams (around three pounds)—substantially raises their risk of developing necrotizing enterocolitis (NEC), a condition with an estimated fatality rate exceeding 20%. They assert that the companies failed to fulfill their legal duty to warn about this risk.

Both companies have countered the allegations, stating that the lawsuit lacks supporting evidence and that their products are critical for the nourishment of premature infants.

St. Louis Children’s Hospital has not commented on the ongoing litigation.

Concerns Among Medical Professionals
The sizable verdicts in two previous trials have alarmed doctors, who worry about losing access to crucial products for neonatal care. Abbott and Reckitt are the two exclusive manufacturers of the formulas in question, utilized in newborn intensive care. During a July investor call, Abbott CEO Robert Ford indicated that their formulas could become unavailable due to ongoing litigation. Reckitt likewise mentioned exploring “strategic options” for its formula division.

Despite being essential, these premature baby formulas are not significant revenue generators, with Abbott earning about $9 million and Reckitt less than $1 million annually from these products according to company representatives.

Panic in Medical Community
Jonathan Davis, Chief of Newborn Medicine at Tufts Medical Center in Boston, remarked on a “genuine panic” among healthcare professionals. He referred to the long-established benefits of breast milk for premature infants, evidenced in hospital feeding practices. However, doctors stress that formula remains crucial to feed babies when breast milk is unavailable or inadequate.

• “I would love if every mother could give me breast milk. They can’t,” stated Jill Maron, chief of pediatrics at Women & Infants Hospital in Rhode Island. “If I don’t have access to these products, babies will die.”

A Call for Labeling
Tor Hoerman, the attorney representing the plaintiff from the $495 million verdict, stated that doctors are responding to a “message of fear” promoted by manufacturers, who are unwarrantedly suggesting withdrawal of their products from the market. However, he believes simple risk warnings could be added to the formulas’ labels instead.

At the trial, Elizabeth Whitfield, the plaintiff, will ask the jury to affirm that the companies and the hospital acted negligently under Missouri law. Her son developed NEC shortly after birth in August 2017 due to formula feeding and required surgery to remove part of his intestine, resulting in long-lasting injuries.

The litigation concerning NEC differs from cases involving allegedly tainted formula from an Abbott factory in Michigan; there are currently no claims that the premature baby formula was contaminated.

Ongoing Research and Opinions
Research regarding NEC, breast milk, and formula usage remains inconclusive. A recent NIH report supported the idea that the absence of human milk increases the risk of NEC, rather than the exposure to formula itself. The manufacturers argue against any label warnings, deeming them unfounded since medical professionals are already aware of the associated research.

Some neonatologists have voiced apprehension that a warning could mislead parents into viewing formula as unsafe, despite it being the best available nourishment in certain circumstances.

The NEC Society, focused on combating the disease and led by patient advocacy, has stated that whilst formula can be imperative, their strategy does not involve lawsuits. NEC Society Director Jennifer Canvasser, who founded the organization following her son’s death from the disease, expressed a desire for increased access to mother’s milk and pasteurized donor milk.