Ongoing Litigation Regarding the Use of Cow's Milk Formulas and Necrotizing Enterocolitis: Issues of Product Liability and Proposed Requirement for Informed Consent.

Recent litigation against the two major U.S. formula manufacturers regarding their products liability, in Gill v Abbott Laboratories and Watson v Mead Johnson, juries in two U.S. states have determined that these manufacturers' created products liability by their failure to warn parents and medical professionals that their formulas posed an increased risk for necrotizing enterocolitis (NEC). They asserted that their products are safe and effective. Juries in state courts in both cases awarded substantial monetary awards for punitive damage, economic and emotional harms to parents whose infant died after being fed "premature special care formulas." The company's defense attorneys unsuccessfully asserted the doctrine of learned intermediaries, namely that it was neonatologists who ordered and/or administered these products to premature infants, thus causing NEC. The Food and Drug Administration (FDA) has regulatory authority over the formula manufacturing processes but does not grant "approval" status, as the FDA classifies these "special care formulas" as exempt because they are nutritional agents. While both cases are being appealed, the impact of these legal actions may discourage further "special care formula" development and may pose the future risk of physician malpractice allegations when an infant develops NEC after receiving a "special care formula." In accordance with American Academy of Pediatrics recommendations, obtaining informed consent for formula use may mitigate some legal risks for neonatologists and other medical providers.