As of September 2024, the litigation surrounding baby formula and its alleged connection to Necrotizing Enterocolitis (NEC) in premature infants continues to grow. Families across the country are pursuing legal claims against major formula manufacturers, including Abbott Laboratories (Similac) and Mead Johnson & Company (Enfamil), alleging that their cow's milk-based formulas caused NEC in premature infants, leading to serious injury or death. Here’s a look at the latest developments in this ongoing legal battle.
Since the multi-district litigation (MDL) was established in the Northern District of Illinois in late 2022, there has been significant progress in consolidating the hundreds of cases filed nationwide. The MDL allows for pre-trial proceedings to be streamlined, with a focus on the discovery phase, which has been active throughout 2023 and into 2024.
In the last few months, the court has focused on expert witness testimony, which plays a crucial role in proving the link between cow's milk-based formulas and NEC. Both sides have been presenting their expert opinions to establish or contest the medical connection between the use of these formulas in NICUs and the development of NEC in premature infants.
While the scientific evidence supporting the plaintiffs' claims continues to strengthen, formula manufacturers have mounted a vigorous defense, asserting that factors other than their formulas, such as the prematurity of infants, are responsible for NEC.
In MDL cases, bellwether trials are often used to test the viability of claims before proceeding to larger litigation or settlement discussions. In 2024, the first bellwether cases have started to take shape, with trials expected to begin by late 2024 or early 2025. These early cases will be crucial in determining whether the manufacturers will seek settlement or continue defending their products in court.
The outcome of these trials will help set the tone for the broader litigation, potentially influencing settlement negotiations or providing insight into the compensation amounts that could be awarded to families affected by NEC.
The primary legal arguments in these cases remain focused on:
Failure to Warn: Plaintiffs claim that manufacturers did not adequately warn about the risk of NEC, particularly in premature infants, despite evidence linking cow’s milk-based formulas to the condition.
Product Liability: The plaintiffs argue that the formulas are inherently dangerous for premature infants and should have included stronger labeling, or better yet, not been marketed for use in this vulnerable population.
Negligence: Plaintiffs contend that the manufacturers did not sufficiently study the effects of their products in preterm infants or adjust their marketing in light of the risks associated with NEC.
As of September 2024, the number of lawsuits continues to rise, with new claims being filed as more families become aware of the risks and potential legal recourse. Many parents are learning about the connection between cow’s milk-based formulas and NEC for the first time, particularly in light of ongoing media coverage and increased public awareness driven by the litigation.
Some legal experts predict that the volume of claims could double by the end of the year, with the potential for class action lawsuits to emerge alongside the MDL cases. This increase in claims may put further pressure on the manufacturers to negotiate settlements to resolve cases more efficiently.
Although no major settlements have been reached yet, early settlement discussions are reportedly underway. If the bellwether trials result in favorable rulings for the plaintiffs, it’s likely that Abbott Laboratories and Mead Johnson & Company may consider settlement offers to avoid prolonged litigation and the risk of higher verdicts.
Mass tort litigation of this scale often leads to settlement agreements once the companies can assess their exposure and risk. Depending on the outcomes of these early trials, we may see settlement agreements offered to large groups of plaintiffs as the cases progress.
In addition to the legal proceedings, the U.S. Food and Drug Administration (FDA) has been under increasing pressure to review the safety of cow’s milk-based formulas for use in premature infants. Advocacy groups have called for clearer labeling requirements, urging the FDA to mandate warnings about the risks of NEC, particularly for NICUs using these formulas with preterm babies.
While no new regulations have been introduced yet, continued attention from lawmakers and consumer advocacy groups could result in future FDA action. In the meantime, hospitals and healthcare providers are taking steps to reevaluate the formulas they provide to premature infants, with many turning to human milk-based alternatives, which have been shown to reduce the risk of NEC.
As the NEC litigation progresses into late 2024, several key developments will shape the future of these cases:
Bellwether Trial Outcomes: These trials will be a significant indicator of how juries respond to the claims and scientific evidence, potentially influencing broader settlement negotiations.
Settlement Negotiations: If early trials result in favorable rulings for plaintiffs, settlement discussions may accelerate, potentially leading to large-scale resolutions for affected families.
Increased Awareness and New Filings: With ongoing media coverage and awareness campaigns, more families are expected to come forward, potentially increasing the number of lawsuits.
FDA Action: Continued pressure from advocates may prompt the FDA to consider new labeling requirements or guidelines to reduce the risk of NEC in premature infants.
As of September 2024, the NEC baby formula litigation is at a critical juncture, with pre-trial proceedings well underway and bellwether trials on the horizon. The next few months will be pivotal in determining whether manufacturers are held accountable for the alleged risks associated with their products and whether settlements will be reached to provide compensation for affected families.
The outcome of these lawsuits will not only impact the legal landscape but may also drive changes in the infant formula industry, ensuring greater transparency and safety for vulnerable populations. Families affected by NEC will continue to seek justice, hoping to prevent future harm and bring attention to this devastating condition.
LitPRO offers outsourced litigation support and consulting services to streamline lien resolution, ensure compliance, and maximize recoveries in multi-plaintiff litigations. Contact us to learn how we can support your legal team.
