Neocate Infant Formula Lawsuit Alleges Nutritional Defect Caused Rickets, Bone Fractures

Studies and case reports have raised concerns that infants and young children who rely on Neocate formula for nutrition may face increased risks to their bones and skeletal systems.

An Illinois mother has filed a Neocate infant formula lawsuit on behalf of her three children, alleging nutritional deficiencies in the specialized formula caused them to develop rickets, weakened bones and repeated fractures.

The complaint (PDF) was brought by Susan Millner on behalf of her minor children, who were identified with the initials A.M., E.M. and S.M. The case was originally filed in Illinois state court on June 25, naming Nutricia North America Inc. and Danone North America LLC as defendants, but it was later removed to the U.S. District Court for the Northern District of Illinois on July 28.

Millner claims Neocate was marketed as a nutritionally complete formula for medically fragile infants, despite problems with the bioavailability of phosphorus that allegedly left some children unable to adequately absorb the mineral.

Neocate Nutritional Concerns 

Neocate is an amino acid-based, hypoallergenic elemental formula manufactured by Nutricia, which is owned by Danone. The products are designed for infants and children with cow’s milk protein allergies, gastrointestinal disorders and other feeding problems.

Because children who require elemental formulas may be unable to tolerate other sources of nutrition, Neocate is sometimes used as their primary or sole source of nourishment. However, prior studies and case reports have raised concerns that Neocate infant formula may contribute to rickets and bone fractures among infants and young children who rely on the product for nutrition.

These risks are separate from those presented by other products such as Abbott Laboratories’ Similac and Mead Johnson’s Enfamil cow’s milk-based infant formulas. Concerns about premature infants developing necrotizing enterocolitis (NEC) from those products have resulted in hundreds of infant formula NEC lawsuits filed in federal courts nationwide.

Neocate Rickets and Bone Fracture Allegations

Millner’s three children were born prematurely in March 2012 and spent about three months in neonatal intensive care. All three experienced feeding problems and milk allergies, resulting in the hospital giving them Neocate with calcium and phosphorus supplements shortly after birth.

By October 2012, each child showed signs of serious bone problems. A.M. was diagnosed with extensive rickets and widespread bone demineralization after suffering an unexplained clavicle injury, while E.M. and S.M. were diagnosed with osteopenia and hypophosphatemic rickets.

The complaint indicates all three children subsequently suffered multiple fractures involving their ribs, arms or legs despite receiving nutritional supplementation.

Millner claims the children continue to experience complications from their bone injuries. A.M. allegedly suffers chronic pain and gross motor impairments that require ongoing medical care, physical therapy and use of a wheelchair. E.M. continues to experience chronic pain and an increased risk of future fractures, while S.M. requires ongoing medical treatment, physical therapy, pain management and parental assistance.

“Defendants, as the manufacturers and/or sellers of the products at issue in this litigation, owed a duty to the consuming public in general, and Plaintiffs in particular, to manufacture, sell, and distribute their products in a manner that was not unreasonably dangerous.”

— Susan Millner et al. v. Nutricia North America Inc. et al.

The filing further alleges Nutricia marketed Neocate as a “nutritionally complete” formula for infants and children who may depend on it as their primary or sole source of nutrition, despite problems with phosphorus absorption.

Millner claims Nutricia and Danone knew or should have known about the risk of phosphate malabsorption but failed to adequately warn about hypophosphatemia, rickets, skeletal demineralization and fractures.

According to the complaint, published research eventually prompted Nutricia to recommend monitoring phosphate and other micronutrients among medically complex children who rely on Neocate as their sole source of nutrition. Millner maintains those warnings should have been provided earlier or the formula should have been changed to reduce the risk.

The lawsuit points to a 2017 multicenter study involving 51 infants and children who developed unexpected hypophosphatemia and bone disease while relying on Neocate products as their sole source of nutrition. Although the formulas appeared to provide adequate phosphorus, researchers found evidence that the mineral was not being properly absorbed.

Some children reportedly improved after discontinuing Neocate or switching formulas, while low phosphorus levels returned in certain cases after Neocate was reintroduced.

The lawsuit raises allegations of strict liability for design defect, failure to warn, negligence, intentional misrepresentation, negligent misrepresentation and breach of express and implied warranties. It seeks compensation on behalf of Millner’s children for their injuries, medical care and other losses, as well as reimbursement for past and future medical and caretaking expenses.

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