The shortage of donor milk at NICUs is difficult to explain. The risk of necrotizing enterocolitis (NEC) and the benefits of breast milk are well-established. Human milk banks have offered pasteurized donor milk to parents and hospitals for decades. Recent NEC baby formula lawsuits have focused on Abbott Laboratories and Mead Johnson & Company, the manufacturers of Enfamil and Similac baby formula. Neither manufacturer warns consumers about the dangers of NEC. Both also continue to aggressively market cow’s milk-based formula to the parents and hospitals that care for very small infants.The link between cow’s milk-based formula and NEC
As early as 1990, a study on 926 preterm infants found that NEC was six to ten times more common in exclusively formula-fed babies than in those fed breast milk alone and three times more common than in those who received formula plus breast milk. NEC was rare in babies born at more than 30 weeks gestation whose diet included breast milk, but it was 20 times more common in those fed formula only. A 2010 study similarly showed that preterm babies fed an exclusively human milk-based diet were 90 percent less likely to develop surgical NEC as compared to a diet that included some bovine milk-based products.
Human donor milk is widely available
In 2012, the American Academy of Pediatrics advised that all preterm infants should be fed either their mother’s milk or, if their mother’s milk is unavailable, pasteurized human donor milk. Safety standards for donor milk have been established by the Human Milk Banking Association of North America (HMBANA). The HMBANA, founded in 1985, accredits nonprofit milk banks in the U.S. and Canada and sets international guidelines for pasteurized donor human milk. Each milk bank tests donated breastmilk to ensure it is free from harmful bacteria and then pasteurizes it to eliminate any infecting organisms that may be present in the milk. Some milk banks offer information and services directly to hospitals and medical professionals, as well as to parents.
So why is there a shortage? Recent lawsuits have focused on Abbott Laboratories’ and Mead Johnson’s failures to disclose risks and both companies’ aggressive marketing campaigns. This may be a situation where bad information has drowned out better information.
No information
At a minimum, there was no information. According to the Complaint filed in Meier v. Abbott Laboratories in July 2022, the manufacturers of Similac:
“Despite knowledge of a causal connection between Cow’s Milk Products and NEC … the Defendants did nothing to change their product, packaging, guidelines, instructions, and/or warnings.”
Similarly, according to the Complaint filed in August 2022 in Peebles v. Mead Johnson & Company, the manufacturers of Enfamil formulas:
“Despite the knowledge of the significant health risks posed to preterm infants ingesting the Cow’s Milk-Based Products, including the significant risk of NEC and death, Defendants did not warn parents or medical providers of the risk of NEC in preterm infants, nor did Defendants provide any instructions or guidance on how to properly use its Cow’s Milk-Based Products so as to lower the risk or avoid NEC or death.”
False equivalence
Then there is disinformation. As set forth in Meier, a particular advertisement for Similac called out breast feeding mothers as “judgmental” and attempted to put formula and breast milk on an even playing field. Another ad characterized Similac formulas as “modeled after breast milk.”
That advertisement continued, “No significant difference has been shown between milk derived from rBST-treated and non-rBST-treated cows. Ingredients not genetically engineered.” Abbott claims mothers should trust its ‘thoughtfully crafted ‘product which comes after ‘90 years of crafting’ infant formula.’”
Moving in for the money play
New parents are very vulnerable – especially those with at-risk infants. And they are immediately deluged with gift baskets full of all the things they have never needed before –formula, diapers and wipes, at least. Much the same seems to be true of those who have to wait to bring tiny infants home.
Is this predatory? Parents of premature and very low birth weight babies need to decide. It is important to seek unbiased information from a competent medical professional before harm happens. Are the bad actions of formula manufacturers a basis for a lawsuit? This is something with which a lawyer may be able to help.