Was Abbott’s Recalled Baby Formula the Cause of Infant Deaths?

When we have a baby, we do everything in our power to ensure that they are well taken care of; they get the clothes that they need, the toys that they want, and the food that is best for them. There is only so much we can do, only so much we can prepare for. Unfortunately, many things are simply out of our hands.

One of those things is the baby formula shortage – a nightmare come to life for parents throughout the country. While there are many reasons for the shortage, recalls are a major cause. In February of this year, the Food and Drug Administration (FDA) issued a recall of several baby formula products by Similac, Alimentum, and EleCare. The FDA began investigating these products due to consumer complaints of bacterial infections diagnosed in four infants who had been fed the formula. All four infants required hospitalization, and two of the babies died.

Since the initial recall, the total number of infant deaths has risen to nine. The problem, per reporting in the Washington Post, is that the FDA is having difficulties determining whether the children’s deaths were caused by contaminated formula. Per the Post:

In all nine fatalities, the agency was unable to identify the source of the infection. In some cases, there was not enough leftover formula to test. Of the babies who died of infections from cronobacter, genomic sequencing turned up different strains than what was discovered at the Sturgis plant during an inspection this spring.

But the disclosure deepens questions about Abbott’s maintenance of the plant, which makes a large share of the nation’s powdered formula supply. It also raises further doubts about the FDA’s handling of complaints related to the Sturgis factory, which was shuttered for five months over food safety concerns, contributing to a nationwide shortage of baby formula.

The FDA has come forward and said that of the 128 complaints made by parents, “only four complaints could be included in the case series associated with the Abbott Nutrition investigation.”

So – what does all this mean? No one knows, for sure. We know that nine children are dead, and that 105 other parents issued complaints to the FDA about injuries to their children. We know that the Centers for Disease Control & Prevention (CDC) confirmed the bacteria in the original four cases, but has not been involved in any others. We know that children were injured, and some died, yet neither the FDA nor Abbott seem prepared to take any responsibility. And we know that the Sturgis plant is back in operation, though we do not know if any changes have been made to the way the plant is run.

What is cronobacter bacertia?

The infection that has been reported have all been instances of Cronobacter sakazakii. According to the CDC, “Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Cronobacter infections are rare but are especially high risk for newborns.”

Symptoms of Cronobacter infections include: poor feeding, irritability, jaundice, grunting breaths, and odd body movements. If you suspect that your child is suffering from a Cronobacter infection, it is critical that you contact your child’s health care provider, and inform them of your child’s symptoms. Immediate care is important. The CDC details how dangerous and possibly fatal Cronobacter infections can be:

Cronobacter germs can cause a dangerous blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis). Infants 2 months of age and younger are most likely to develop meningitis if they get sick from Cronobacter. Other infants more likely to get sick are those born prematurely and those less able to fight germs and sickness because of illness or medical treatment, such as infants receiving chemotherapy for cancer.

Past dangers with baby formula

Healthcare providers have typically recommended certain cow’s milk-based formulas to premature babies or infants that require extra nutrition. Unfortunately, these formulas have been linked to another bacterial infection called Necrotizing Enterocolitis (NEC), which we have discussed in the past. When an infant suffers from NEC, “the wall of an infant’s intestine becomes infected and inflamed, which can lead to destruction of the bowel wall. This can cause bowel perforation, forcing the contents of the intestine to spill into the infant’s abdomen, resulting in massive infection and possible death.”

Another type of formula that can lead to injuries and health conditions is elemental baby formulas.  These types of formulas are a type of hypoallergenic infant formula containing individual amino acids, which are the building blocks of protein, and are responsible for helping your child to grow and develop. However, researchers found that young children who have allergies to things like dairy or soy, and require a certain diet, suffered from hypophosphatemia when on elemental baby formula.

Hypophosphatemia occurs when your child suffers from low phosphate levels. Phosphate is necessary for producing strong bones, so low phosphate levels can lead to serious health complications. Low phosphate levels in the body over an extended period can cause serious health issues. Hypophosphatemia can cause its own problems such as muscle breakdown, acute respiratory failure, and heart arrhythmia.

What do I if my child was injured from defective baby formula?

Once you have removed any dangerous products from your home, and your child is receiving medical attention, there are a few things you can do. If your doctor prescribed a formula to you that has been known to cause the issues your child suffered, then they may be liable for medical malpractice. You can also file a claim against the companies of the formulas. Mead Johnson and Abbott Laboratories are currently being brought to litigation by several plaintiffs across the country. A products liability claim is when you file a claim against the manufacturers of the defective or harmful product.

Please contact Paulson & Nace, PLLC through this contact form or by calling 202-463-1999.