Neocate baby formula is designed for children with difficulty digesting common proteins for a host of reasons, including serious illness. Where traditional baby formula contains long, complex proteins, “elemental formulas” are comprised of amino acids—the building blocks of larger proteins—which are more readily digestible. Despite being an effective product to deliver protein, it does not provide the amount of phosphorus necessary for healthy bone development, ultimately leading to bone fractures and the skeletal disorder rickets. Since Neocate is a “product” for the purposes of an action in tort, strict liability attaches and those injured need only demonstrate that the product was defectively designed.
Nutricia, a subsidiary of Groupe Danone, manufactures Neocate, which is one of the most popular elemental formulas on the market. As with traditional baby formula, Neocate is designed to be “whole nutrition,” i.e., the manufacturer’s intent is for the Neocate to be the only nutrition consumed by the child. Consequently, Nutricia had the duty to ensure that the product was properly formulated to provide all necessary nutrients.
Neocate was popular and widely prescribed, as it proved effective in providing nutrition to sick infants and children. However, in 2015, physicians began to notice high instances of broken bones and rickets associated with Neocate. Rickets is a condition where children develop soft or brittle bones, sometimes caused by a severe phosphorus deficiency. Nutricia was made aware of the problem no later than October of 2015 but did not begin researching phosphorus deficiency—hypophosphatemia—in relationship to Neocate until 2016. When it undertook this research, the company instructed physicians prescribing Neocate to monitor each patient’s blood phosphorus level.
Yale and Mayo Clinic conducted a study on phosphorus deficiency that would conclusively demonstrate the dangers of Neocate. Researchers reviewed a number of cases of infant idiopathic hypophosphatemia—abnormally low phosphorus levels in the absence of an apparent underlying cause. Researchers noticed that an “unexpected” number of such cases occurred where the child had been fed solely Neocate formula products. The researchers identified 51 children with hypophosphatemia specifically associated with Neocate. Of those 51 children, 94% had either existing bone fractures, undermineralization of their skeletal structure, or the disease rickets. The results of the study were published on February 4, 2017.
The study’s findings are troubling. Infants and children who were fed exclusively Neocate had an unexpectedly high rate of phosphorus deficiency. Of those who had a phosphorus deficiency, nearly all had some form of skeletal condition. The specific composition of Nutricia’s caused damage, deterioration, and in some cases, deformity in vulnerable infants and children.
Nurticia did not reformulate its product until April of 2018. Over a year had passed since the findings of the study were published. From the first signs of broken bones and rickets in October of 2015, it took nearly three years before Nutricia modified its product. In the intervening years, children were needlessly put at risk for serious skeletal conditions.
Nutricia markets a nutritional product for use with infants, particularly infants suffering from disorders that restrict their diet. Consequently, it owes a duty of care to not expose those infants to unreasonable and foreseeable dangers. From the moment Neocate was introduced, and especially after the company became aware of the grave flaw in its product, Nutricia, and its parent, Groupe Danone, breached their duty to the public by selling a dangerous nutritional product to parents with infants and small children. Such an egregious transgression of the law entitles those who suffered injury to compensation.