What’s Happening With the NEC-Baby Formula Litigation?

The NEC lawsuits have been going on for a while now. The litigation represents a bitter battle between the manufacturers of two major baby formula brands and families of infants who developed necrotizing enterocolitis.

Studies have found that babies, particularly those born prematurely, can develop NEC when fed cow’s milk formula. Premature infants have an immature gastrointestinal system that may not be ready to handle certain proteins.

Typically, breast milk contains numerous protective factors, including antibodies, anti-inflammatory agents, and growth factors that support gut maturation and immune function. Cow’s milk-based formulas lack these protective factors, which could potentially increase the risk of NEC in susceptible infants.

In today’s article, let us explore some of the latest developments, the key components of the litigation, and what lies ahead.

The Multi-District Litigation Progression

We are closing in on two years since the first NEC baby formula lawsuit case was filed against Abbott Laboratories. This refers to the original Shannon Hall et al. vs. Abbott Laboratories in January 2022.

We know that things are in the capable hands of District Judge Rebecca R. Pallmeyer. In a notable move, she appointed 26 lawyers to oversee more than 60 lawsuits against Abbott Laboratories.

Things moved slowly for a bit, but by July 2023, the case count in the Multidistrict Litigation (MDL) had jumped from 90 at the start of the year to a whopping 191.

A pivotal moment in the litigation came in November 2022, when a set of 12 cases was earmarked for an NEC lawsuit bellwether pool. This would set the stage for a series of early trial dates expected to kick off in 2024.

As of October 17, 2023, there are now 275 cases in the MDL.

Which Brands Are Under Scrutiny?

At the heart of the lawsuits are several brands of Enfamil and Similac cow’s milk baby formulas. The litigation is fueled by parents’ allegations that these products were wrongly marketed as safe and beneficial for premature infants. Despite the lurking risks, there was no advisory on NEC or proper guidelines for usage provided by the manufacturers.

Who are these manufacturers?

There are two main defendants. Abbott Laboratories, which makes Similac, and Mead Johnson Nutrition, which makes Enfamil. Both manufacturers are facing lawsuits from parents of premature babies who were fed their formula products in hospitals. On a broader scale, the FDA has also been investigating certain companies, including Perrigo, Byheart, and Reckitt/Mead Johnson, following concerns related to baby formula.

Similarly, the FTC has been investigating Abbott and other companies regarding a possible collusion among baby formula manufacturers. This deals with the state contract bidding for supplying baby formula to the U.S. Department of Agriculture’s Women, Infants, and Children program​.

So, What’s Next?

To start off, the discovery process will continue, with both sides gathering evidence to build their cases. This includes the contentious e-discovery process, where plaintiff lawyers are seeking more access to electronic communications and data from the defendants. This could reveal crucial information pertinent to the lawsuit​.

Depending on the progress and outcomes of the bellwether trials and other legal developments, there may be settlement negotiations. According to TorHoerman Law, settlement payouts could be anywhere between $5,000 and $500,000.

Why Are the Bellwether Trials Important?

Bellwether trials are important for several reasons, especially in the context of mass tort litigation, where many individuals have been harmed by the same product or entity. When a large number of cases are filed against the same entity, a small, selected group of cases is taken to trial. The outcomes of these trials will then influence how the other cases are handled.

They are often conducted because they save a lot of time and money for all parties involved. Moreover, they also favor settlements. If the bellwether trials result in favorable outcomes for plaintiffs, they may encourage defendants to settle other similar cases.

Conversely, if the outcomes favor defendants, plaintiffs might be more inclined to settle their claims for lesser amounts or even drop their claims altogether.

Lastly, although not binding, the verdicts and legal rulings in bellwether trials can set important precedents for similar cases in the future.


The consequences of the NEC lawsuits will likely extend far beyond the courtroom. Hopefully, they will usher in a new era of enhanced regulatory oversight and improved safety standards in the infant formula market.

However, those who have seen similar cases might believe this is unrealistic. While the lawsuits have been damaging to Abbot and Mead, settlement sums and fines rarely deter pharmaceutical companies. As a society, we need to urgently find more effective ways to penalize pharmaceutical companies besides monetary fines.