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.