Lawsuits Threaten the Future of Neonatal Care and Neonatal Nutrition

Few patients in modern medicine are as fragile and more difficult to care for than a prematurely born infant. Premature infants are defined as those babies having a birth gestation less than 37 weeks, with normal gestation lasting between 38 and 42 weeks. With advances in neonatal care, babies as mature as 32-36 weeks’ gestation are relatively easy to care for successfully, with very high survival rates. At the lower end of the spectrum, however, are infants between 23 and 27 weeks’ gestation, whose care is far more complicated and challenging, though the majority of these infants survive as well.

In neonatal intensive care units (NICUs) across the country, one of the common problems healthcare professionals confront in very premature infants is a serious disease called necrotizing enterocolitis (NEC). NEC is a life-threatening inflammation of the intestine that primarily affects infants born at less than 28 weeks’ gestation. It can occur, however, in more mature babies, and rarely in full-term infants as well. Though a 2023 study found that fewer infants now die from NEC, it is still a very serious illness worthy of a cure and complicates the care of the premature infant in many ways.

Few issues in the management of the premature infant are as problematic as providing nutrition to these babies, and this challenge has perplexed neonatologists and neonatal nurses since the introduction of NICUs in the United States in the 1960’s. Yet increasing numbers of lawsuits that allege a link between NEC and infant formula products may ultimately cause substantial harm in NICUs, leading to even more death and disability among premature babies, since they will hamper the ability of neonatologists to provide adequate care and nutrition for these infants.

Premature babies and their families are already fighting against the odds as soon as they are born. There are many reasons why babies require approximately 40 weeks of gestation, since many organ systems take that long to mature. Thanks to the miracles of modern science, however, premature babies’ survival rates have improved dramatically during my nearly 40 years of neonatal practice, but serious issues like NEC still arise in the NICU.

Despite decades of research and studies, there is no clearly defined cause for NEC. It can occur in premature infants fed their own mother’s milk, donor milk, banked breast milk, and specialized preterm formula products. As a doctor, it is frustrating to not have a solution for every problem that arises in the NICU, and as a parent it can be devastating. As the grandparent of four children who required time in the NICU after birth, I am well aware of the stresses of having a child or grandchild in the NICU from both the physician and the parent/ grandparent perspective. And as a human being, I always want to know why something happens, as do most families. In the absence of a clear explanation, it is not uncommon to try to blame someone or something, even when the facts don’t merit it. 

Unfortunately, at the present time, we do not know what causes NEC. We don’t know why or how it occurs, when it will occur, or which neonatal infants will develop it. And while science and medical professionals continue to seek the answers to those questions, under doctors’ direction, babies must continue to have access to infant formula in NICUs, since breast milk is not always available for feeding the premature infant. 

It is true and well substantiated that breastmilk is the best possible nutrition for premature infants. The American Academy of Pediatrics has recommended that premature infants should be fed breast milk whenever possible. This statement reflects the unique, protective characteristics of human milk, especially mother’s own milk, many of which are not entirely understood. Yet premature babies, given that their bodies were not finished developing before entering the world, can rarely grow adequately on their mother’s milk or donor milk alone. For very small or sick preemies, neonatologists need to be able to rely on preterm infant formula and human milk fortifiers to supplement required nutrients in the amounts that their very tiny patients require and can tolerate. Arguing that the protective qualities of human milk somehow means that formula and fortifiers cause NEC runs counter to decades of rigorously tested scientific research. Furthermore, the most common associated factor in the development of NEC is prematurity itself, not what a premature baby has been fed.

It is worth noting also, that premature formulas are hospital products. They are not the typical formulas that parents commonly purchase in supermarkets. Like other hospital products, they are used and are labeled to be given under the supervision of doctors. It is up to the trained doctors and nurses to make decisions based on what is best for their patients, in consultation with the babies’ families. This process would obviously apply to most neonatal decisions, including nutrition. As the NEC Society, the leading nonprofit working to accelerate the science and prevent NEC, recently stated, “Neonatal feeding decisions should be made at patients’ bedsides, not in courtrooms.” 

As doctors, we need all the tools available to us in the critical early days of a premature infant’s life. Decisions on feeding occur in real time in the NICU, every minute of every day. That is why preterm infant formula and human milk fortifiers are included as a standard of care for premature infants in virtually all leading hospitals and medical centers across the country. 

The parents and families that go through the NICU and preterm baby experience are true warriors. The infant fights for his or her life and the family makes sure that the medical team is delivering the best possible care. It is an unbelievably overwhelming and scary time for everyone involved. Families need to trust their doctors to make the best decisions for their baby’s health and wellbeing, with all the tools they need at their disposal. Doctors carefully weigh nutritional decisions with the utmost clarity and cognizance of what a premature infant requires. The doctors must have access to preemie formulas and fortifier options. Removal of these products because of ongoing litigation will only serve to jeopardize preemie care and survival. Lawsuits against formula manufacturers are counterproductive on all fronts, but worst of all, removal of infant nutritional products could be unbelievably harmful to the future of all neonatal care. 

Alan R. Spitzer, MD was a practicing neonatologist for 40 years. Formerly the Director of the Center for Research, Education, Quality, and Safety at Pediatrix Medical Group,  he also served as Chief of the Division of Neonatology at the State University of New York at Stony Brook, and as Professor of Pediatrics at Stony Brook. Earlier, he was the Chief of Neonatology and Chairman of the Department of Pediatrics at Thomas Jefferson University in Philadelphia. He is serving in the capacity of a scientific advisor to Abbott.