The wave of lawsuits against baby formula manufacturers could soon spell trouble for the supply of specialized formulas for premature infants.
At a Glance
- Lawsuits claim that cow’s milk-based formulas increase the risk of a fatal disease in preterm infants.
- Major manufacturers like Abbott and Mead Johnson are at the center of these lawsuits.
- The litigation could lead to the withdrawal of specialized formulas from the market.
- The outcome may set a precedent for future medical product liability cases.
The Heart of the Legal Battle
In the past few years, a series of lawsuits have targeted leading baby formula manufacturers Abbott Laboratories and Mead Johnson. The cases center on the claim that cow’s milk-based formulas, such as Similac and Enfamil, increase the risk of necrotizing enterocolitis (NEC), a severe and often fatal condition affecting premature infants. Families of affected infants argue that manufacturers failed to adequately warn about these risks. This has led to a flood of lawsuits, now consolidated into a multidistrict litigation (MDL), with hundreds of cases still pending. The stakes are high, with manufacturers defending their products while plaintiffs seek justice for their children.
The lawsuits have put a spotlight on the practices of neonatal intensive care units (NICUs) where these formulas are commonly administered to preterm infants. Plaintiffs assert that had they been properly informed about the risks, they might have opted for alternatives, like donor human milk, which is gaining traction as a safer option.
The Players and Their Positions
The litigation involves a web of stakeholders, each with vested interests. Abbott and Mead Johnson are the primary defendants, fiercely defending their products against claims they consider unfounded. Meanwhile, plaintiff families, driven by the desire for accountability and compensation for medical costs and suffering, are gaining collective strength through class actions. The legal landscape is further complicated by medical experts providing conflicting testimony on the causation of NEC. On one side, experts argue the formulas increase NEC risk; on the other, some suggest the disease results from a lack of human milk, not the formula itself.
In this complex legal battle, U.S. District Judge Rebecca Pallmeyer plays a pivotal role, overseeing the MDL cases. Her recent decision to allow key plaintiff expert testimony has been a significant win for the plaintiffs, keeping their hopes alive for a favorable outcome.
Recent Developments and Future Implications
As of July 2025, the MDL has 744 pending lawsuits, with several bellwether trials scheduled to influence the litigation’s trajectory. In a recent development, Abbott secured a summary judgment in the first federal bellwether trial, though the decision’s impact on other cases remains limited. The legal proceedings have been anything but straightforward, with some state court victories for the defense overturned for retrial due to alleged misconduct.
These legal battles could have far-reaching consequences. If manufacturers face unsustainable litigation risks, they might withdraw specialized formulas from the market, impacting hospitals and NICUs that rely on them. The industry could see changes in product labeling and warnings, influenced by the litigation’s outcome. For parents of preterm infants, the ongoing cases heighten anxiety and could drive a shift towards alternative feeding options.
