Abbott and Reckitt on trial over premature baby formula amid alarm from doctors Reuters

By Brendan Pierson

(Reuters) – A Missouri mother and her lawyers will try to convince a jury this week that Abbott, Reckitt’s Mead Johnson and St. Louis Children’s Hospital are responsible for a severe intestinal illness she says her premature son got from the companies’ formulas after he was born at the hospital.

The closely watched trial in state court in St. Louis, Missouri, which begins jury selection on Monday, is part of a sprawling lawsuit that has already resulted in verdicts of $60 million against Reckitt and $495 million against Abbott. Nearly 1,000 similar cases are still pending nationwide.

The plaintiffs allege that giving cow’s milk formula to premature infants—especially the smallest, born weighing less than about 1,500 grams, or about three kilograms—greatly increases their risk of developing necrotizing enterocolitis (NEC). This condition has an estimated mortality rate of over 20%. They also say the companies had a legal responsibility to warn of this risk but failed to do so.

Both companies said in statements that the lawsuit’s claims are not supported by evidence and that their products are essential for premature babies.

St. Louis Children’s did not respond to a request for comment on the litigation.

The large verdicts in the two cases that have gone to trial so far have raised alarm among doctors who fear losing access to the products they depend on to feed babies.

Abbott and Reckitt are the only companies selling the formulas in question, which are specialist products used in neonatal intensive care units. In a call to investors in July, Abbott CEO Robert Ford (NYSE: ) suggested they could become unavailable because of the litigation. Reckitt also said it was considering “strategic options” for its formulas division.

Premature baby products are not big sellers, bringing in only about $9 million for Abbott and less than $1 million for Reckitt annually, according to company spokespeople.

“I would say it’s a real panic,” said Jonathan Davis, who is chief of neonatal medicine at Tufts Children’s Hospital in Boston.

Doctors say the benefits of breast milk for premature babies on a wide range of measures — including lower rates of NEC — have been known for years and are reflected in hospital feeding practices. But, they say, formula remains vital for feeding babies when breast or donor milk is unavailable or in short supply.

“I wish every mother could give me breast milk. They can’t,” said Jill Maron, chief of pediatrics at Women and Infants Hospital in Providence, Rhode Island. “If I don’t have access to these products, children will die.”

“FEAR MESSAGE”

Tor Hoerman, a lawyer representing the plaintiff who won the $495 million verdict and others, said doctors were responding to a “message of fear” sent by manufacturers, who were unnecessarily suggesting the products could be recalled.

“No one is calling for the product to be taken off the market,” Hoerman said. Instead, he said, companies “could put a simple risk warning” on formula labels.

At the next trial, plaintiff Elizabeth Whitfield will urge a jury to find that the companies and the hospital were negligent under Missouri law. She says her son, who was born at less than 28 weeks in August 2017, developed NEC the following month as a result of formula feeding and required surgery to remove part of his intestine.

Whitfield’s son, like many NEC survivors who underwent surgery, “continues to suffer permanent and serious injuries,” according to the lawsuit.

The lawsuit and others like it are separate from cases involving allegedly contaminated formula from an Abbott plant in Michigan. There are no allegations that the premature baby formula was contaminated.

The science behind NEC, breast milk, and formula feeding remains inconclusive.

A recent report by a US National Institutes of Health task force said current evidence “supports the hypothesis that the absence of human milk – rather than exposure to formula – is associated with an increased risk of NEC”.

Manufacturers say a label warning that the formula can cause NEC would be unacceptable. And because doctors are already aware of the research, they say, a label wouldn’t change anything.

Several neonatologists interviewed by Reuters said they were concerned that a warning label could lead parents to believe formula is unsafe, even when it is the best option available.

The NEC Society, a patient-led organization dedicated to fighting the disease, said the formula was sometimes necessary and that lawsuits were not part of its strategy.

“What I would like everyone to focus on is how we increase equitable access to breast milk and pasteurized donor milk,” said NEC Society director Jennifer Canvasser, who founded the organization after losing her own son because of illness.