Lawsuits regarding NEC & Specialized Preterm Hospital Nutrition Products

• Specialized preterm hospital nutrition products are used by neonatologists to feed and treat premature infants in hospitals and NICUs. 
• These products should not be confused with retail-brand formula made for full-term and older babies that is available for purchase in retail stores, pharmacies, and online.
• Specialized preterm hospital nutrition products are administered by a medical team in an acute care setting. According to the American Academy of Pediatrics, “Special formulas designed for preterm infants provide an essential source of nutrition. Using human breast milk to feed preterm infants may reduce the risk of NEC, but it does not eliminate this risk. Donated human milk is also used when the mother’s own milk is not available in sufficient quantities, but there is not enough donated human milk to be used as the only source of nutrition for these infants.  Providing special formula is a routine and necessary part of care of these preterm infants.”¹
• Mead Johnson firmly believes that mother’s own milk is the most important nutritional source, but we also recognize that not every baby has that option. Depending on how early a baby is born, some mothers may not yet be able to produce enough breast milk, in which case donor breast milk might be used if it is available.   
• When mother’s or donor milk is unavailable or insufficient, specialized preterm hospital nutrition products are routinely recommended by neonatologists when clinically appropriate, and can provide essential, lifesaving nutrition.

¹_{AAP Statement In Response to NEC Lawsuit Verdicts (July 27, 2024) https://www.aap.org/en/news-room/news-releases/aap/2024/aap-statement-in-response-to-nec-lawsuit-verdicts/}

• Each year in the US, there are more than 380,000 infants born prematurely, requiring specialist care by neonatologists and hospital staff, and often admitted to neonatal intensive care units (NICUs).
• There’s a misconception that premature infants are “just small babies,” but in fact, every organ in their bodies is typically under-developed. Complications that preterm infants face can include problems breathing, low blood pressure, bleeding in the brain, anemia, jaundice, weakened immune systems, metabolic problems, and digestive problems – such as necrotizing enterocolitis.²

²_{https://www.mayoclinic.org/diseases-conditions/premature-birth/symptoms-causes/syc-20376730}

• NICU staff, including neonatologists and their medical teams, are knowledgeable, highly trained specialists who have the experience necessary to evaluate and make treatment recommendations for the preterm infants under their care. That includes talking to parents about the potential implications of any specific feeding decision.
• Hospital staff are making decisions based on science and their experience treating and feeding preterm infants on a daily basis. NICU staff are concerned with feeding the preterm infants under their care to prioritize their growth and survival. These highly trained professionals are constantly weighing the benefits and risks of all treatment options.
• In general, hospital NICU policies and guidelines prioritize the use of mother’s own milk, and, where that is not available in sufficient amounts, donor breast milk. Both options are routinely fortified with preterm fortifiers to make sure that premature babies receive enough calories and nutrients. The preterm infant’s neonatologist may prescribe a specialty preterm hospital nutrition product when, for whatever reason, mother’s own milk or donor milk are not available or sufficient to ensure appropriate growth. 

• Breast milk is naturally formulated to meet the needs of a full-term, fully developed baby. Even when an infant is fortunate enough to have breast milk through a parent or a donor, that still may not meet the specialized nutritional needs of a preterm baby. In these cases, breast milk is routinely fortified with preterm fortifiers to make sure that babies receive enough calories and nutrients.   

• Our guiding purpose at Mead Johnson Nutrition is the care of infants. And we stand behind the safety and efficacy of our specialized preterm hospital nutrition products when used, as intended, under the care of a licensed physician in accordance with hospital guidelines.
• These products are recommended by neonatologists when clinically appropriate and provide essential, lifesaving nutrition to the most vulnerable infants when mother’s or donor milk is unavailable or when supplementation is necessary. As the American Academy of Pediatrics explained, “Providing special formula is a routine and necessary part of care of these preterm infants.”¹
• NICU staff are incredibly knowledgeable, highly trained specialists that have the experience necessary to evaluate and make treatment recommendations for the babies under their care. That includes talking to parents about the potential implications of any specific feeding decision.
• If you have any specific concerns about the safety of a product or any questions about feeding choices for your child, we recommend you contact your baby’s doctor.

¹_{AAP Statement In Response to NEC Lawsuit Verdicts (July 27, 2024) https://www.aap.org/en/news-room/news-releases/aap/2024/aap-statement-in-response-to-nec-lawsuit-verdicts/}

• Necrotizing enterocolitis (NEC) is a complex gastrointestinal disease that almost exclusively affects preterm infants. Preterm infants are at risk of NEC precisely because of their prematurity.
• Given varying medical conditions, including weight, number of weeks premature, single infant versus twin birth, and other factors, preterm infants each bring a unique set of medical challenges and considerations. 
• That is why highly trained medical professionals are constantly weighing the benefits and risks of all treatment options available to preterm infants. 
• The NEC Society, the leading organization of parents affected by NEC, has helpful resources at https://necsociety.org.

• We stand behind the safety and efficacy of our products, which neonatologists recommend when clinically appropriate as a crucial part of the standard of care in neonatal intensive care units. 
• Claims by plaintiffs’ lawyers that these products cause NEC are not supported by the science or the medical consensus and are irresponsible. 
• As the American Academy of Pediatrics explained, “Part of what is so challenging about NEC is that the causes are multifaceted and not completely understood. Our science does not tell us exactly how to prevent it.”¹
• And as the NEC Society explained, and Mead Johnson agrees, NEC is a complex, multifactorial disease with no single cause, no clear etiology, no cure, and no known way to entirely eliminate the risks for medically fragile preterm infants.
• All preterm infants are at risk for developing NEC due to their under-developed digestive systems. 

¹_{AAP Statement In Response to NEC Lawsuit Verdicts (July 27, 2024) https://www.aap.org/en/news-room/news-releases/aap/2024/aap-statement-in-response-to-nec-lawsuit-verdicts/} 

• Yes. None of the NEC lawsuits involve retail-brand Enfamil products that are available for purchase in grocery stores, pharmacies, and online.  
• Rather, the products subject to the litigation are specialized preterm hospital nutrition products given to preterm infants in hospitals and NICUs. They should not be confused with retail-brand formula for full-term and older babies available for purchase in retail stores, pharmacies, and online. 
• Neonatologists continue to recommend and use specialized preterm hospital nutrition products as a specialty option for premature infants being treated in hospital NICUs. 

• Mead Johnson stands behind the safety and efficacy of our specialized preterm hospital nutrition products. We strongly reject any assertion that any of our specialized preterm hospital nutrition products cause NEC, a serious gastrointestinal problem that all preterm infants are at risk for developing due to their under-developed digestive systems. 
• We agree with the statement from the American Academy of Pediatrics that verdicts like this, “[J]eopardize the availability of these formulas,” and that, “Courtrooms are not the best place to determine clinical recommendations for the care of infants. Feeding decisions should be made by clinicians and families.”¹
• We are of course deeply disappointed with the verdict and will pursue all options to have it overturned. 
• While we continue to offer our deepest condolences to Ms. Watson, we strongly disagree with the jury’s decision to fault Mead Johnson and award damages. We continue to believe that the allegations from the plaintiff’s lawyers in this case were not supported by the science or experts in the medical community.  This was underscored during the trial by a dozen neonatologists, who all testified to the critical necessity of Mead Johnson’s products in the NICU. 
• It is important to note that this is a single verdict in a single case and should not be extrapolated. 
• This case and others like it, exclusively involve products used under the supervision of neonatologists in the NICU and provide lifesaving nutrition options for vulnerable premature infants. 

¹_{AAP Statement In Response to NEC Lawsuit Verdicts (July 27, 2024) https://www.aap.org/en/news-room/news-releases/aap/2024/aap-statement-in-response-to-nec-lawsuit-verdicts/}