Legal Battles Surrounding NEC & Infant Formula: Exploring the Litigation

While NEC lawsuits play out in real time, two of our current board members, Angka Hinshaw, Esq. and Shelley Jackson, Esq., have provided a summary of these critically important lawsuits.

In the United States, most babies receive nutrition from human breast milk or formula. Some infants who received Enfamil or Similac formulas – whether by choice or necessity – developed Necrotizing enterocolitis (NEC) which has led to recent lawsuits.

Necrotizing enterocolitis (NEC) is a poorly understood illness that primarily affects premature infants. Much remains to be learned about NEC, but the research shows that a 100% human milk diet plays an important role in preemie care, as it can lower the occurrence of NEC by 75%[1a].

Current Legal Landscape of NEC Litigation

Enfamil and Similac are two leading brands of baby formulas. Enfamil formulas are manufactured by Mead Johnson (“Mead”), and Similac formulas are manufactured by Abbott Laboratories (“Abbott”). These respective companies have been and continue to operate under scrutiny for allegedly failing to warn families and medical providers of the associated risks of feeding formula that contains cow milk to premature and medically vulnerable babies.

Hundreds of pending lawsuits allege Enfamil and Similac formulas caused premature babies to die or suffer from the intestinal disease NEC. The disease happens when the large intestine becomes inflamed and dies.[1b] The large intestine is part of the digestive system and the last part of the gastrointestinal tract where waste is stored before it’s removed by defecation. According to Cleveland Clinic, 9 of 10 babies diagnosed with NEC are premature, low birth weight, and medically fragile.[2] More than 3,500 babies are diagnosed with NEC each year and at least one baby dies every day from NEC.[3]

The essence of the various lawsuits entails allegations that Mead and Abbott were aware their formulas contained cow milk and did not inform the consumers of the side effects and risks

associated with consumption of the formula. Many of the babies who are the subjects of the lawsuits were fed a combination of human milk and formula, or only formula. Plaintiffs purport that the manufacturers advertised Similac and Enfamil formulas as safe but the manufacturers knew or should have known the dangers of cow milk as a primary ingredient or component of the formula. The correlation of cow milk and NEC has been well established in medical literature.[4] The Plaintiffs allege the manufacturers failed to include the risk of NEC and other medical conditions as possible side effects.

Abbott and Mead defend their products as beneficial and safe. Furthermore, the manufacturers assert that NEC could occur in breast milk fed infants and gastrointestinal diseases can naturally occur in any infant.

As of March 1, 2024, there were more than 400 pending lawsuits in the NEC infant formula federal multidistrict litigation (MDL), Hall v. Abbott Laboratories, Case No. 1:22-cv-00071, MDL 3026, United States District Court for the Northern District of Illinois[5]. A federal MDL is created when different federal district court cases with similar fact scenarios (e.g., product liability, antitrust, mass casualties) are reviewed by the Judicial Panel on Multidistrict Litigation and aggregated into one federal district court for the purpose of conducting discovery and pretrial practice. In contrast to class action lawsuits, in which all members of a certified class who receive notice will be bound by the results of the litigation unless they opt out, only the parties to each MDL lawsuit will be bound. In order to “test” the facts and legal theories at issue, one or more lawsuits within an MDL may be selected as bellwether cases. In the Hall MDL, the Court has not yet officially designated a bellwether case, although at least one trial is expected to begin in 2024. The next status hearing will take place on April 17, 2024.

Dozens of similar lawsuits are also pending in state courts around the country, and one such lawsuit has produced a dramatic result. On March 13, 2024, a jury in St. Clair County, Illinois reached a $60 million dollar verdict against Mead and in favor of plaintiff Jasmine Watson, whose infant died from NEC after being fed Enfamil formula[6]. One day after the verdict, Mead announced its plans to appeal; however, the fallout has already begun[7]. Mead’s parent company, Reckitt Benckiser Group Plc, lost roughly $7 billion in market value immediately following the verdict[8]. And while the Watson case is not an official bellwether for the MDL, its outcome provides valuable insight into the viability of such cases.

Ethically Sourced Human Milk from The Milk Bank

The Milk Bank is a human milk bank that supports premature and medically compromised babies by providing human milk and community education about the benefits and safe use of human milk.[9] Human milk is ideal nutrition, with nutrients and antibodies that protect against infections and improve the health outcomes of fragile infants.

Pursuant to the guidelines developed by the Human Milk Banking Association of North America (HMBANA), The Milk Bank receives milk from lactating mothers who have been carefully screened for medical conditions including communicable diseases, similar to the screening done by blood banks

As a public health organization, The Milk Bank is an uncompromising champion of science that cares deeply about everyone involved in the process of donating and receiving human milk. The Milk Bank adheres to strict safety guidelines that steers donation, pasteurization, and dispensation processes. As leaders in maintaining safe, evidence-based standards, The Milk Bank is committed to transparency, public health education, and the integration of research, science, medicine, and service.

Human Milk is not the answer for every infant, but it is the ONLY answer for many. Connect with The Milk Bank’s mission by sharing this information with a colleague and requesting resources for your patients.

Learn more about Angka Hinshaw, Esq., & Shelley Jackson, JD, board members for The Milk Bank. We’re grateful to them for sharing their time and talents to help us better understand this complex issue.

Disclaimer: This article is not a substitute for professional legal or medical advice. This article does not create an attorney-client relationship, nor is it a solicitation to offer legal or medical advice. The Milk Bank and its board of directors are not liable for any action or inaction as a result of the article and provide the article as information to the community at-large.