When Deborah Discenza gave birth to her premature baby, she was thrown into a world of medical uncertainty, where every decision carried immense weight. Like many parents of preemies, she trusted the infant formula her infant was being fed was safe. Hospitals commonly use cow’s milk-based fortifiers to supplement breast milk for preterm infants, aiming to provide essential nutrients for growth. However, Discenza’s personal experience with these products would forever change her perspective.

In an article Discenza wrote for the Fairfax County Times, Discenza described how her baby, like many others, suffered severe complications after being fed cow’s milk-based formula in the neonatal intensive care unit (NICU). Discenza would later learn about the connection between cow’s milk-based fortifiers and necrotizing enterocolitis (NEC), a deadly intestinal disease that primarily affects preterm infants. The realization that her child’s struggles could have been avoided ignited a passion in her to advocate for safer alternatives. Her story is just one of many from parents who trusted formula manufacturers, only to face devastating consequences.

Discenza underscores the need for greater awareness about the risks associated with cow’s milk-based products in NICUs. She emphasizes the need for parents to be fully informed about alternatives that can prevent unnecessary suffering. Her story is an important starting point for a bigger talk about baby nutrition. It highlights the risks of cow’s milk-based fortifiers. It also shows the benefits of human milk-based fortifiers (HMBFs).

The Risks of Cow’s Milk-Based Fortifiers

For years, hospitals have used cow’s milk-based fortifiers to provide essential nutrients to premature infants. However, a growing body of research shows that these products come with significant risks. NEC is one of the most severe and deadly conditions linked to cow’s milk-based formulas. This disease causes intestinal inflammation, tissue death, and, in many cases, leads to emergency surgeries or death.

A study published in Neonatology Today found that very low birth weight (VLBW) infants who consumed cow’s milk-based fortifiers had a 3.3-fold higher risk of developing NEC compared to those who received human milk-based fortifiers. Furthermore, the study found that these infants faced a 2.4-fold higher risk of developing retinopathy of prematurity (ROP), a severe eye disorder that can lead to blindness. Alarmingly, cow’s milk-based fortifiers were also linked to a 40% higher risk of combined mortality and morbidity rates.

Despite these alarming statistics, many hospitals continue to use cow’s milk-based fortifiers as a standard practice. Critics argue that this reliance stems from outdated nutritional policies, aggressive marketing by formula manufacturers, and a lack of awareness among healthcare providers about the potential dangers.

Legal Actions Against Formula Manufacturers

The growing awareness of NEC’s link to cow’s milk-based fortifiers has led to a wave of lawsuits against formula manufacturers. Parents of preterm infants who developed NEC after consuming products like Similac and Enfamil have filed lawsuits alleging that companies such as Abbott Laboratories and Mead Johnson failed to warn consumers and healthcare providers about the risks.

These cases have been consolidated into multidistrict litigation (MDL 3026) in the U.S. District Court for the Northern District of Illinois. Chief Judge Rebecca R. Pallmeyer is overseeing the litigation, which has gained national attention. As of July 2024, over 500 cases were pending in this MDL, with the first bellwether trial scheduled for May 2025. Legal experts believe that these trials will set a precedent for future NEC-related lawsuits.

A landmark ruling in July 2024 further solidified the seriousness of these claims. A jury awarded $495 million in a case against Abbott Laboratories, reinforcing the argument that formula manufacturers neglected their duty to inform consumers of the risks. This verdict is expected to influence ongoing litigation and push formula manufacturers to reexamine their safety practices.

For parents like Discenza, these lawsuits are about more than financial compensation—they represent a fight for accountability. Families want to ensure that no other parents have to endure the pain of watching their child suffer due to misleading marketing and lack of transparency from formula manufacturers.

The Promise of Human Milk-Based Fortifiers

In contrast to cow’s milk-based fortifiers, human milk-based fortifiers (HMBFs) offer a safer and more effective alternative for preterm infants. These fortifiers are derived from donor breast milk and provide essential nutrients without the associated risks of NEC.

A meta-analysis published in Nutrients found that preterm infants who received human milk-based fortifiers had a 50% lower mortality rate compared to those who were fed cow’s milk-based fortifiers. Another study reported that an exclusive human milk diet significantly reduced the incidence and severity of ROP, with an 84% relative reduction in severe cases.

Hospitals that have transitioned to an exclusive human milk-based nutrition protocol have seen significant improvements in infant health outcomes. In some cases, these hospitals have reported a near-complete elimination of NEC cases, demonstrating the profound impact of removing cow’s milk-based fortifiers from neonatal care.

Economic and Long-Term Health Considerations

Beyond immediate health benefits, human milk-based fortifiers also offer financial advantages. Hospitals that have adopted an exclusive human milk diet have observed up to a threefold return on investment. This is due to the reduced need for costly medical interventions, shorter hospital stays, and lower rates of NEC-related complications.

For families, the long-term benefits are just as crucial. Infants who develop NEC often require multiple surgeries, long-term medical care, and, in severe cases, suffer lifelong complications. By choosing human milk-based fortifiers, parents can significantly reduce these risks and give their children a better start in life.

A Call to Action for Healthcare Providers and Parents

Deborah Discenza’s story is a testament to the urgent need for change in how formula manufacturers approach neonatal nutrition. While these companies continue to profit from cow’s milk-based products, the science is clear—human milk-based fortifiers are the safest option for preterm infants.

At the same time, parents must be equipped with accurate information to make informed decisions about their child’s nutrition.

As legal battles continue and more research emerges, one message remains clear: preterm infants deserve the best possible start in life, and that begins with safe and effective nutrition.