Inflated jury verdicts in the first two preterm infant formula cases tried in the country have raised significant concerns for manufacturers and the broader medical community. These cases not only spotlight the legal challenges faced by manufacturers of highly specialized products, such as the formulas involved in these cases, but also underscore the potentially devastating effects on the availability and use of essential formula to provide preterm infants with adequate nutrition. In response to these bloated jury verdicts, the president of the American Academy of Pediatrics, Benjamin Hoffman, M.D., issued a statement declaring that preterm infant formula “is a routine and necessary part of care of these preterm infants” and warning that “[c]ourtrooms are not the best place to determine clinical recommendations for the care of infants . . . we must take steps to protect the supply of infant formula for those who need it.”

In Gill v. Abbott Laboratories, No. 2322-CC01251, Margo Gill (“Plaintiff”) brought numerous tort claims on behalf of her preterm infant daughter, R.D., against Abbott Laboratories (“Abbott”) in St. Louis City court. Plaintiff alleged Abbott’s cow’s milk-based preterm infant formula directly caused R.D. to develop necrotizing enterocolitis (“NEC”), an intestinal disease that often affects preterm infants.

While studies suggest preterm infants fed exclusively preterm infant formula have a higher risk of developing NEC than preterm infants fed exclusively human milk, even Plaintiff’s experts admit no studies have ever concluded that preterm infant formula causes NEC. Defendant’s Renewed Motion for a Directed Verdict and Supporting Memorandum of Law, p. 8-11, Gill v. Abbott Laboratories, No. 2322-CC01251 (22nd Jud. Circ. City of St. Louis, Mo.). In fact, several of Plaintiff’s experts concede that preterm infant formula is “necessary” to have in the NICU, despite the risks of NEC. Id. at p. 6-7.

In pre-trial motions and pleadings, Abbott asserted the learned intermediary doctrine as an affirmative defense. Under Missouri law, the learned intermediary doctrine acts to discharge manufacturers of prescription drugs and medical devices of a duty to directly warn consumers of the risks associated with products so long as the manufacturer provides the prescribing doctor with information about risks. Doe v. Alpha Therapeutic Corp., 3 S.W.3d 404, 419 (Mo. Ct. App. 1999). Plaintiff filed a motion for partial summary judgment, asking the court to order that Abbott was not entitled to numerous affirmative defenses, including the learned intermediary doctrine.

Abbott argued that their preterm infant formula is only given at the direction of a doctor during the course of medical treatment in a hospital’s NICU and is therefore included in the scope and purpose of Missouri’s learned intermediary doctrine. Accordingly, Abbott argued, doctors are responsible for explaining the risks of medical treatment rather than the manufacturer being required to warn the consumer directly. The court held, however, that the learned intermediary doctrine did not apply because preterm infant formula is not a recognized prescription medicine or medical device, despite the significant role doctors and care teams have in providing a care plan which might include cow’s milk-based preterm infant formula administered at the direction of a doctor during the course of medical treatment in a hospital’s NICU.

At trial, nine of the twelve empaneled jurors returned a verdict for Plaintiff against Abbott on the claims of negligent failure to warn, strict liability for failure to warn and negligent design. The non-unanimous jury assessed $95 million in compensatory damages and a shocking $400 million in punitive damages.

Gill is just the second preterm infant formula case to go to trial. The first verdict came in March of 2024 when Mead Johnson, the manufacturer of another preterm infant formula, was saddled with a $60 million jury verdict in a similar case in St. Clair County, Illinois. The same formulas at issue in Gill and Watson are currently the subject of multidistrict litigation coordinated out of the United States District Court for the Northern District of Illinois.

While the pending cases are relatively limited in the direct impact to manufacturers outside the preterm infant formula market, the ripple effects of these cases may be far reaching.

First, the judicial interpretations of the learned intermediary doctrine could present previously unanticipated risks for pharmaceutical and medical device manufacturers whose products may be seen as occupying a grey area surrounding recognized prescription medications or medical devices. Indeed, the breadth of products to which the doctrine applies will likely be litigated in state and federal courts across the country, which may lead to inconsistent interpretations and implications for manufacturers with products distributed nationally.

Second, because only two companies in the United States produce formula for preterm infants, the risk posed by numerous pending lawsuits against these companies may significantly impact the supply or even the availability of preterm infant formula, which Dr. Hoffman describes as “an essential source of nutrition” for preterm infants. Supply impacts may impede medical professionals’ ability to adequately care for preterm infants. The recent jury verdicts against manufacturers of preterm infant formulas signal a critical juncture for the industry. As these cases are litigated, they highlight the complex interplay between legal liability, medical professionals, and the essential need for specialized nutrition for preterm infants. For manufacturers, doctors and families alike, the stakes are high. Potential disruptions in product availability and medical treatment related to litigation concerns may significantly impact the quality of care that can be provided to preterm infants. Court precedent may reshape defense strategies within these specialized formula cases, as well as across the medical products’ industry. It is crucial for manufacturers, medical professionals, and consumers to stay informed and proactive in navigating these challenges so that manufacturers can provide products to meet the healthcare needs of patients across the country.