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The Search for Jackpot Justice- Trial Lawyers Set Sight on New Industry

Introduction

In America’s courtrooms a disturbing trend is unfolding that is threatening the health and lives of the most vulnerable among us: premature infants relying on life-sustaining baby formula.

Trial lawyers, armed with dubious science and driven by the prospect of massive paydays, have zeroed in on baby formula manufacturers, risking yet another public health crisis that could leave parents scrambling. We need only recall the panic and shortages of 2022 to understand the potential impact on newborns and their desperate caretakers as this needless litigation threatens to upend infant food supplies.

Plaintiffs’ lawyers in these cases claim that prescribed, fortified infant formula increases the risk of a life-threatening intestinal disease in preemies called necrotizing enterocolitis, pinning the blame for tragic loss on manufacturers of life-sustaining formulas. 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 that have dedicated their careers to protecting some of the most vulnerable. 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 “they have adequately warned the prescribing physician as opposed to the patient about the risks inherent in a drug.”

Additionally, the products’ labels are regulated by the Food and Drug Administration (FDA). The FDA does not require warnings about NEC risk because the science simply doesn’t support such claims.

What Do the Real Experts Say?

These rulings, along with the evidence on which they are based, fly in the face of established medical science and regulatory guidance.

The American Academy of Pediatrics (AAP) 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, prescribed 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.”

In October, the FDA, Center for Disease Control (CDC), and the National Institutes of Health (NIH) together issued a consensus statement concluding that there is no conclusive evidence that preterm infant formula causes NEC. The agencies also noted that preterm infant formulas are part of the standard of care for premature infants where the supply of human milk is insufficient. The statement stressed the importance of feeding preterm babies “as soon as is medically feasible through whatever appropriate nutritious food source is available.”

This statement follows a report published in September by the NIH’s Working Group on NEC. Like the AAP and NEC Society, the Working Group declared that NEC is a multifactorial disease with many associated risk factors. It stated that the best way to prevent the disease is focusing on preventing pre-term birth.

Even plaintiffs’ experts agree that removing these products from the market “would be a significant concern for our premature population” and would cause significant public health problems. They also have admitted that they continue to prescribe the formula and that they have not learned anything through the litigation that has impacted their use of products.

“Courtrooms are not the best place to determine clinical recommendations for the care of infants.”

–The American Academy of Pediatrics (AAP)

Plaintiffs’ Lawyers Success In Judicial Hellholes

Unsurprisingly, lawyers peddling junk science related to baby formula safety already are seeing some success finding big payouts with juries in Judicial Hellholes® awarding nuclear verdicts®. In July, a St. Louis, Missouri, jury handed down a nearly $500 million verdict against Abbott Laboratories while in March, Mead Johnson was ordered to pay $60 million by a St. Clair County jury.

This may be just the tip of the iceberg. Many claims still are pending, with an overwhelming majority in St. Clair and Madison Counties in Illinois — both of which are mainstays in the Judicial Hellholes® report. These jurisdictions, known for plaintiff-friendly rulings, are magnets for speculative litigation based on junk science that puts profit before public health.

Conclusion

The consequences of this legal onslaught could be dire. Formula manufacturers, facing the prospect of crippling liability, may be forced to remove these vital products from the market. There also is the risk of parents of infants in need, stoked by fear, refusing doctor-recommended formula for premature infants.

When faced with litigation based on dubious science, judges must embrace their roles as gatekeepers and prevent junk science from flooding their courts. They should defer to true experts and place public health interests above the profit-seeking interests of the plaintiffs’ bar.