Has your baby suffered an otherwise unexplained illness and was drinking powdered baby formula?
In 2022, a recall was issued for powdered baby formula from manufacturer Abbott Laboratories due to the potential of the formula containing a germ called Cronobacter sakazakii. This is a substance that, when ingested by very young babies or those with a weakened immune system, can lead to the onset of a range of health conditions, including the onset of necrotizing enterocolitis (NEC). This disease can cause significant health risks for children, often requiring hospitalization, and in some situations, it can be fatal.
Some of those impacted may not know their child had this exposure.
The most recent outbreak of this germ was found in powdered baby formula. These children were found to have NEC from September 20, 2021, to February 24, 2022, which resulted in hospitalization and death in two of the four cases. Investigations by the CDC are still pending to determine if the illness was directly related to the products produced by Abbott Laboratories in its Sturgis, MI, manufacturing plant.
Has your child suffered due to the baby formula risk? Join The Many wants to help you.
History of Baby Formula
Baby formula is a form of food given to babies quite commonly. Several types of baby formula are regulated by the Food and Drug Administration (FDA). Those include:
- Cow-milk protein-based formulas. These are the most common form made with cow’s milk that’s been modified to be more like breast milk. The formulation aims to improve the nutrient balance in cow’s milk to ensure the digestion process is easier. Some children develop an allergen to this milk and need specialized formulas.
- Protein hydrolysate formulas. This form has a protein that’s hydrolyzed or broken down, either partially or more significantly, into smaller sizes than those found in other types of formula. This could help some children who do not do well on other forms of formula.
- Soy-based formulas. Often a secondary choice to cow’s milk and preferred by those who do not want their child to consume animal products, soy-based baby formula comes from soy products.
These formulas come in three formats, powdered formulas, concentrated liquid formulas, and ready-to-use formulas, according to the Mayo Clinic.
- Baby formula, infant formula
- There are both generic and name brand products
Overview of Research Findings
How could your child’s formula have made them ill? To understand what occurred in relation to the NEC recall for baby formula, it is important to have some details about how baby formula could put a child at risk.
Cronobacter sakazakii is a type of germ found throughout the environment. It’s naturally occurring, and when most people are exposed to it, there’s no negative or serious outcome. It can leave on many dry foods especially powdered infant formula, powdered milk, starches, and herbal teas.
A Cronobacter infection is considered rare, but when it does occur in newborns and other medically compromised infants, it can cause hospitalization and death. These infections may be at the highest risk in general within their first days or weeks of life.
Each year, the U.S. Centers for Disease Control and Prevention receive 2 to 4 reports of Cronobacter infections from hospitals. However, that number is not considered accurate to the number of children exposed because there is no reporting requirement for this condition to health departments.
When a Cronobacter infection occurs, it can cause blood infections, called sepsis, and also cause meningitis, a condition that impacts the lining of the brain and spinal cord. Those who are under 2 months of age are most at risk of developing this condition, as well as those born prematurely and others who have a weakened immune system that cannot fight off the germs.
NEC occurs from exposure to Cronobacter infections. It is a type of intestinal disease that often affects these children causing inflammation in the intestinal tissue. Some children may suffer lifelong neurological and nutritional complications because of their exposure to NEC. Some also die from it.
The treatment options for NEC are limited and sometimes not fully recognized. NEC is a leading cause of infant mortality in the U.S.
Recalls of Baby Formula
Recalls are one way the government can try to stop the spread of disease. In this case, the recalls related to baby formulas were far reaching.
The FDA Coordinated Outbreak Response and Evaluation Network (CORE) received reports of the potential Cronobacter infections from cases found in Ohio, Minnesota, and Texas. There were four illnesses detected, with two of them leading to death. The infections occurred between September 20, 2021, through February 24, 2022.
It was determined the children in these cases were given powdered baby formula – like so many other parents do. All of the infant formula products given were produced through Abbott Laboratories at its Sturgis, Michigan, manufacturing plant.
The FDA has conducted preliminary investigations into the matter and found Cronobacter was present at the manufacturing plant. Its investigation thus far has not found any evidence of the bacteria being present in the actual baby formula at the plant, though.
The presence of the bacteria and the claims made of illness being linked to the baby formula led to the voluntary recall of the baby formula by the manufacturer, Abbott Laboratories. The recalled products recalled include Alimentum, Similac, and Elecare infant formulas.
The recalled products are identified by the 7-to-9-digit code and expiration date on the packaging. The recall impacted all products that met the following criteria:
- The first two digits are 22 through 37 AND
- The code has the combinations K8, SH, or Z2, AND
- The expiration date was April 2022 or later (expressed 4-1-2022)
Additionally, Abbot Nutrition recalled Similac PC 60/40, with Lot # 27032J80 in cans and Lot # 27032K800 in cases.
The plant was closed for a period of time, which led to a significant slowdown in the production of baby formula, creating a nationwide shortage of formula. The recalled products do not include liquid baby formula.
What You Should Know
If your child has experienced a diagnosis of NEC or Cronobacter infection, it is important to reach out to learn more about whether your child could have been impacted due to their use of the recalled baby formulas, even if the child consumed those formulas at a time outside of the illness range.
Many cases of Cronobacter infections in hospitals are not reported to the health department, which means your child’s case may fall in line with these others. Also, note that your child may be eligible for financial compensation. There are numerous lawsuits pending in the U.S. federal courts specifically related to the NEC baby formula infections.
There is no doubt that for some children, the use of formula is necessary, especially if the mother is unable to produce breastmilk for any reason. However, numerous organizations are encouraging mothers to try to use breast milk or breastfeed instead of using formula. The U.S. Department of Health & Human Services states that human milk is safer for children. There are a number of local milk banks that are helping to supply breastmilk to babies whose mothers cannot provide it. This includes the Human Milk Banking Association of North America.
The American Academy of Pediatrics also has stepped forward to state that children should consume breastmilk for the first six months of their life. Though they did not outright say not to use formula products, they stressed the value and nutritional benefits of human breastmilk over other products.
History of Lawsuit
The NEC baby formula recall has led to numerous people coming forward to claim their child has suffered due to exposure to Cronobacteria and NEC. There are many such pending lawsuits throughout the U.S. You will not see settlements from these lawsuits right now (as of September of 2022) due to most cases just being brought to court. This is due to just how new the information is.
Keep in mind that if your child has suffered an NEC infection due to Cronobacter infection, you can be a part of these legal actions. Your first step is to have a legal case review to determine if you qualify. There is no cost or risk to you in that process.
As a fast-moving situation, there are weekly changes to the lawsuits and legal proceedings related to the NEC baby formula recall and deaths.
The latest information available (September of 2022) indicates that multidistrict litigation panels are working to align cases with the proper judges. Since there are cases throughout the U.S., both Abbott Laboratories and Mead Johnson have asked for the creation of federal multidistrict litigation so that all cases and current class action lawsuits can be moved under one judge. As of this writing, there are two separate litigation districts in place, one under U.S. District Judge Matthew Kennelly based in Chicago, Illinois, and one that contains 97 lawsuits and claims under U.S. District Judge Rebecca Pallmeyer.
What are they claiming?
There are several specific types of legal actions being made against these baby formula manufacturers. The first is that the companies had the responsibility to create a safe product for their children to use, and they did not do so. These parents and attorneys believe that the negligence in doing this led to their children suffering medical losses due to their exposure to the germs as well as to NEC in general. Many of these children spent time in the hospital, and there are some reporting their child died from NEC that could be linked to powdered formula.
Other lawsuits focus on the risks associated with cow’s milk formulas. They claim that the manufacturers knew that there was a high risk that products made from cow’s milk are at a high level of risk for the presence of Cronobacter and that the manufacturers failed to provide warnings of that risk or to give families an alternative solution to it. They believe that their children suffered as a result of this.
What could happen now?
There is a lot of work for attorneys to do to collect data on each of the cases involving baby formula exposure to Cronobacter. Many attorneys are seeing dozens of cases being reported over the last few months and expect to continue to see them develop in the coming months through the middle of 2023.
What you need to know about those lawsuits
If your child suffered from any type of loss related to Cronobacter infections and they were using powdered baby formula, especially from these two manufacturers, it is critical to seek out immediate help from an attorney to protect your child’s rights to compensation. Many of these children suffered long-term results neurologically and nutritionally as a result of these infections. Many parents don’t even know what caused their child’s NEC.
You have a right to demand justice for your child.
When you join the many, you do not have to pay anything. We will provide you with a way to gather information about your case and then provide a review to determine if you should move forward seeing legal support. Many parents are finding this to be a critical step.
We can help you to connect to an attorney that specializes in these cases. This can help you to get fast help so that your child’s losses can be a component of the class action lawsuits occurring. You can make sure that manufacturers do not allow this same loss to happen to other children. Key is your ability and willingness to take action now.
Trusted Sources for More Information
If you are looking for more information on the baby formula recall as well as on NEC and Cronobacter infections, reach out to the following resources:
- Mayo– Baby Formula
- DA Questions and Answers on Infant Formula
- FDA Investigation of Cronobacter Infections in Powdered Infant Formula
- CDC Cronobacter and Powdered Infant Formula Investigation
- NEC Society – What Is NEC?
- CDC Cronobacter Infection and Infants
- CDC Cronobacter
- U.S. Department of Health & Human Services – Information for Families During the Formula Shortage
- American Academy of Pediatrics – Support for Breastfeeding