Junk Science Fuels Litigation
Baby Formula Litigation
Plaintiffs’ lawyers have launched a dangerous assault on life-sustaining baby formula as they search for the next litigation jackpot. The litigation claims that prescribed, fortified infant formula increases the risk of a life-threatening intestinal disease in preemies called necrotizing enterocolitis (NEC), pinning the blame for a tragic medical condition on the formula manufacturers. This misguided litigation potentially jeopardizes a critical nutritional lifeline for at-risk infants.
By allowing the plaintiffs’ lawyers to pursue these “failure to warn” consumer protection claims, judges are second-guessing the expertise of doctors, nurses and other health care professionals who have dedicated their careers to protecting some of the most vulnerable people. It must be emphasized that these formulas are not available for over-the-counter purchase by parents and caretakers. They are highly specialized products that are prescribed and administered by health care professionals. Unfortunately, courts have rejected the defendants’ use of the learned intermediary doctrine for these products, even though they are prescribed and administered by healthcare professionals in an intensive care hospital setting. This defense doctrine protects manufacturers from liability provided that they have adequately warned the prescribing physician, who can make a recommendation to the patient about use of the product based on the patient’s particular health condition and circumstances.
Additionally, the products’ labels are regulated by the Food and Drug Administration. The FDA does not require warnings about NEC risk because the science simply doesn’t support such claims.
The American Academy of Pediatrics stated unequivocally in a response to these lawsuits: “Courtrooms are not the best place to determine clinical recommendations for the care of infants.” The organization emphasized that special formulas for preterm infants are an essential source of nutrition, pre-scribed by doctors in neonatal intensive care units.
The NEC Society echoed these sentiments and cautioned that recent nuclear verdicts® “may prompt ICUs to reconsider their approaches to feeding neonatal patients, but not necessarily in a way that better protects infants from NEC.” The NEC Society’s statement continued, “Moreover, such litigation may result in unintended harmful consequences for babies and the elimination of potentially beneficial therapy choices.”
Litigation Updates
In March 2025, a St. Louis court ordered a new trial in a case that previously resulted in a verdict in favor of the formula manufacturers. The jury rejected the plaintiffs’ lawyers’ invitation in that case to award an astounding $6 billion verdict. The judge vacated the defense verdict because, according to the opinion, the defense “intentionally violated the Courts orders and rulings by improperly introducing the inadmissible evidence to the jury, time after time.” The case is now before the Missouri Court of Appeals.
This is a disturbing overreach by the St. Louis judge. The conduct at issue was properly handled at trial and had no bearing on the outcome of the case. Perhaps most troubling is that the St. Louis court inappropriately applied a pro-plaintiff standard to overturn the jury’s verdict. The trial court also reversed its own rulings “in hindsight” after the outcome. In response, the companies noted the jury’s discretion and its unanimous decision to find the manufacturers not liable.
Roundup Litigation
St. Louis has been home to tens of thousands of lawsuits against Monsanto involving its Roundup® weed-killer. These lawsuits allege that the active ingredient in the product, glyphosate, causes non-Hodgkin lymphoma. Despite the Missouri legislature requiring closer scrutiny of proposed expert testimony in 2017 by adopting a standard consistent with federal courts and most other state courts, St. Louis judges have allowed junk science in their courtrooms. Law firms across the country flock to St. Louis to file their lawsuits.
In February 2025, a Missouri appellate court upheld a St. Louis jury’s $1.25 million verdict against Monsanto in a Roundup failure-to-warn case. The court agreed with plaintiffs that Roundup bottles should carry cancer warnings, even though federal regulators have not required such labeling. The court held that Missouri’s failure-to-warn standards are not preempted by federal law — meaning Monsanto’s use of the label that the EPA requires for the product does not shield it from liability under state law.
The case is now pending before the U.S. Supreme Court, which has not yet decided whether to grant review. Given the vast scope of Roundup litigation and the central importance of federal preemption, this case warrants the high court’s attention. Federal preemption is critical to ensuring uniform labeling standards and preserving the integrity of the regulatory system. Without it, companies face a fractured marketplace where compliance becomes impossible.