In the past two years, there has been an increasing number of lawsuits against manufacturers of baby formula. These lawsuits are alleging that baby formula products from manufacturers Abbott Laboratories and Mead Johnson led to significant health complications in infants. Namely, these lawsuits allege that their infants developed necrotizing enterocolitis (NEC), which is a rare intestinal disorder.

These lawsuits have come about partly because numerous studies suggest that giving a premature baby formula increases their risk of developing NEC. The lawsuits are alleging that the manufacturers of these products failed to adequately warn customers of the risks and instead marketed the products as safe.

If your child suffered from NEC after taking toxic baby formula, you may be eligible for a lawsuit. There are currently over 100 lawsuits going through the legal system, with the outcome of these trials expected to arrive in the near future. This is why it’s a good idea to explore your options regarding a toxic baby formula lawsuit by speaking to a lawyer sooner rather than later.

Toxic Baby Formula Lawsuit Updates

Is there a toxic baby formula lawsuit?

Yes, there are multiple lawsuits against manufacturers of baby formula, claiming that these companies should have warned that their products were unsafe. The plaintiffs are suing for extensive financial losses and emotional distress, due to their baby suffering injuries or dying. These lawsuits started to appear in 2021 when several plaintiffs alleged that the manufacturers of baby formula did not properly disclose the dangers of using their products. After more cases began to appear, Abbott Laboratories, the makers of Similac baby formula, filed to consolidate all of the cases into one court in January 2022.

Shortly after that, in February of 2022, Mead Johnson, the makers of Enfamil, filed a statement with the courts saying that they agreed with consolidation. Then, on April 8, 2022, the Multidistrict Litigation Panel created a new multidistrict litigation (MDL) under Judge Rebecca Pallmeyer in the U.S. District Court of Illinois. By the beginning of June 2022, there were more than 75 lawsuits consolidated into this MDL.

In August 2022, attorneys for both sides in the MDL submitted a plan for selecting bellwether cases. Bellwether cases are a few choice cases within the MDL. These cases go to trial, where both the plaintiffs and the defendants can learn more about how juries will react to the evidence. Parties on both sides can then use this information to determine how to best proceed with the remaining cases. The bellwether cases have yet to begin trial, but the MDL continues to get more cases. There are now roughly 180 cases inside the MDL, a significant increase over one year prior.

The current lawsuits name a wide range of baby formula products from the brand names Similac and Enfamil. These products include:

  • Similac Special Care
  • Similac Human Milk Fortifier
  • Similac NeoSure
  • Similac Alimentum
  • Similac Alimentum Expert Care
  • Similac Human Milk Fortifier Concentrated Liquid
  • Similac Human Milk Fortifier Powder
  • Similac Liquid Protein Fortifier
  • Similac Special Care 20
  • Similac Special Care 24
  • Similac Special Care 24 High Protein
  • Enfamil Human Milk Fortifier Acidified Liquid
  • Enfamil Human Milk Fortifier Powder
  • Similac Special Care 30
  • Similac Human Milk Fortifier Hydrolyzed Protein- Concentrated Liquid
  • Enfacare Powder
  • Enfamil Human Milk Fortifier Liquid High Protein
  • Enfamil Milk Fortifier Liquid Standard Protein
  • Enfamil NeuroPro Enfacare
  • Enfamil Premature 20 Cal
  • Enfamil Premature 24 Cal
  • Enfamil Premature 24 Cal/fl oz HP
  • Enfamil Premature 30 Cal
  • Enfamil 24 and DHA & ARA Supplement

According to the lawsuits filed against Abbott and Mead Johnson, these products have no warnings about the potential dangerous side effects. In addition, the companies marketed their products as safe for premature infants despite the potential risks.

At the current pace, it’s expected that the first bellwether trials will happen in 2024. Once these trials conclude, the remaining cases will likely finish much faster. It’s probable that once the bellwether cases finish, both sides will use the information learned to negotiate a settlement.

Toxic baby formula linked to necrotizing enterocolitis

There are numerous studies that link toxic baby formula to negative health conditions for infants, including most commonly necrotizing enterocolitis. Necrotizing enterocolitis (NEC) is a gastrointestinal problem that primarily impacts premature babies. With this condition, the infant’s intestinal tissue becomes inflamed, leading to the death of the tissue. In addition, holes may form within the intestine, where bacteria can leak into the abdomen or bloodstream. In some cases, NEC may be mild, but others can experience life-threatening conditions.

Different types of enteral nutrition products are linked to necrotizing enterocolitis

One study from 2017 aimed to explore the effects of different formulas and human milk on the development of NEC in preterm infants. According to the study, preterm infants are extremely vulnerable to several morbidities and mortality and an increased risk of developing NEC. Roughly 5-12% of very-low birth-weight infants develop NEC, while 25-50% of those cases are fatal.

The study found that human milk is the best source of nutrition for preterm infants and for infants at risk of NEC. The researchers also state that “A Cochrane systematic review that evaluated the effect of DHM or bovine milk–based formula on health outcomes for preterm infants also determined that formula significantly increases the risk of NEC.” The study concludes that there may be some biases in the research and that more research is needed to answer remaining questions, such as why a small percentage of infants still develop NEC despite being fed exclusively human milk.

The connection between donor milk and NEC in the NICU

Another study aimed to learn whether the introduction of donor milk to infants in a neonatal intensive care unit (NICU) made a difference in the suspected rates of NEC, growth, length of hospital stay and feeding intolerance. To do this, the researchers explored the medical records of neonates (an infant less than 4 weeks old) in the NICU that met certain criteria, such as the type of milk or formula they received and when they received it.

The researchers concluded that infants who receive formula are at an increased risk of developing NEC. At the same time, there appeared to be no difference in feeding intolerance and some neonates who received fortified PDHM (pasteurized donor human milk) appeared to have better growth rates. In addition, there were no differences in length of hospital stay. This suggests that PDHM is the preferred method for avoiding NEC while also not harming growth rates or the length of hospital stays.

An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis

Finally, a third study from 2019 aimed to evaluate the health benefits of a purely human milk-based diet in extremely premature infants against that of a diet consisting of both human milk and bovine milk-based products. They did this by randomly separating premature infants into three groups, then assigned one group to receive bovine milk-based formula, while the other two groups received different amounts of pasteurized donor human milk.

In the end, the researchers concluded that for extremely premature infants, a human milk-based diet resulted in significantly lower rates of NEC compared to that of a diet based on a mother’s milk that was supplemented with bovine milk-based products.

Projected toxic baby formula lawsuit settlement amounts

As of this writing, there have yet to be any settlements in toxic baby formula-related lawsuits. This makes it hard to determine what a projected settlement may look like. However, it’s possible to make estimates based on previous lawsuits involving necrotizing enterocolitis. For example, some previous cases had compensation worth millions of dollars. Examples of this include:

  • In 2019, parents of a two-day-old newborn in New York filed a lawsuit after the infant suffered from bowel loops distension, which is a common necrotizing enterocolitis symptom. In the lawsuit, the parents allege that the hospital failed to exclusively feed the infant breast milk and instead used a combination of breast milk and formula. In the end, the parents received a $1.34 million settlement.
  • In 2018, a premature infant showed signs of necrotizing enterocolitis, with symptoms like anemia and respiratory distress. The child died shortly after, prompting the parents to file a malpractice lawsuit. The result was a settlement for $2.9 million.

Other related settlements include a $10 million dollar settlement in California, a $900,000 settlement in Florida and a $347,000 settlement in Louisiana. There have also been cases that went to trial, with one trial reaching a $5 million verdict in New York, and another $7 million verdict in Massachusetts.

There are many factors that can influence compensation amounts, including the severity of the complications that may be caused by toxic baby formula and whether the case goes to trial or the two parties reach a settlement. In addition, many prior cases were cases that featured doctors and nurses as defendants, rather than the formula manufacturers, which may impact verdict amounts. A baby formula lawyer can provide you with more information about what to expect in terms of potential settlement amounts.

Do you qualify for a toxic baby formula lawsuit?

According to recent lawsuits, Similac and Enfamil failed to warn consumers about the risks of necrotizing enterocolitis. If you had a premature infant who developed NEC after receiving toxic baby formula, you may be eligible for a lawsuit to receive compensation. To learn more, you should consult with a baby formula lawyer. They can help you determine whether your baby received toxic baby formula while they stayed at the hospital. In addition to helping you gather evidence for your case, a baby formula lawyer can walk you through the litigation process, including filing the correct paperwork, and can potentially help you reach a settlement.

Toxic Baby Formula Timeline: 

October 2021: FDA receives a whistleblower complaint about numerous safety violations at the Michigan plant, including claims that employees falsified records and failed to properly test the formula before releasing it. 

December 2021: An interview with the whistleblower employee takes place. 

January 31, 2022: FDA sends inspectors to the Sturgis facility, beginning their investigation. 

February 2022: Abbott initiates a recall of certain Similac, Alimentum, and EleCare powdered infant formulas manufactured at the Sturgis plant and ceases operations at the facility. The FDA issues a warning about Abbott’s recalled formula following four bacterial infections among infants, two of whom died. 

March 2022: FDA inspection reveals that Abbott didn’t maintain clean surfaces used in producing and handling the powdered formula and finds a history of contamination with cronobacter bacteria. 

April 8, 2022: Abbott submits a response and corrective action plan to the FDA. 

April 28, 2022: Abbott announces that none of the distributed formula tested positive for Cronobacter sakazakii or salmonella. 

May 2022: Abbott warns of a delay in getting new products on store shelves. Retailers, including Target, CVS, and Walgreens, impose purchasing limitations on baby formula due to the worsening nationwide shortage. 

June 4, 2022: Abbott restarts production at the Sturgis plant but then pauses production due to severe weather. 

July 1, 2022: Abbott resumes production, starting with EleCare and some metabolic formulas. 

August 2022: Abbott restarts Similac infant formula production at the Sturgis facility and estimates a six-week period before the product begins shipping to retail locations. 

January 2023: The Justice Department’s consumer protection branch begins investigating the conduct at the Sturgis plant that led to its shutdown.