The Dangers of Infant Milk Formulas

The Food and Drug Administration (FDA) started receiving complaints in late 2021 that infants who ingested baby formulas made by Abbott Nutrition were being infected with dangerous bacteria that can cause gastronomical distress, sepsis, and death. The bacteria, Cronobacter, found in the Abbott Nutrition baby formulas, has a mortality rate of up to 40 percent.

According to Trial magazine, a legal publication, the babies who developed the infections were not premature infants (the more usual category of infants who suffer from bacterial infections from baby formulas). The infants who suffered illness from the Abbott Nutrition baby formula were healthy infants whose parents bought the baby formulas after their children had left the hospital. Ninety percent of Cronobacter infections have been traced, according to research, to powdered formulas.

Abbott did recall its powdered baby formulas, but claimed they tested their products for pathogens and found no evidence of Cronobacter in the products. An FDA representative testified before Congress that the agency did find positive findings of Cronobacter when it examined the Abbott site in Michigan – in 2019 and 2020 batches that Abbott destroyed. Abbott agreed to quality control, testing requirements, and other safety measures, to be conducted by the FDA, for four years.

According to Trial, the manufacturers of infant formulas have a virtual monopoly. Abbott, Nestlé USA, Mead Johnson Nutrition, and Perrigo Co. control about 90% of the infant formula market. According to the World Health Organization (WHO), the baby formula industry is worth $55 billion worldwide. Trial states the manufacturers engage in “systematic and unethical marketing strategies.”

Another dangerous infection from baby formula is called necrotizing enterocolitis (NEC). Trial states that one in 1,000 infants develop NEC. The infection occurs most often in premature infants, especially those with very low birth weights. The disease normally develops several weeks after birth. Symptoms include vomiting, bloody stools, and a distended stomach. NEC can also cause bowel perforation and necrosis. NEC kills about one in seven of the infants who develop the infection. Survivors often live with severe complications.

What is the current ligation status of defective baby formula claims?

In one early NEC case, the plaintiffs claimed that Abbott and Mead Johnson violated Connecticut’s product liability law. The claim against the baby formula manufacturers focused on the defective packaging and faulty warning labels that did not warn of the increased risk of developing NEC or death, and instructions about how to avoid these risks.

NEC claims are now part of a multi-district litigation (MDL) in the Northern District of Illinois. Discovery is being scheduled in some of these cases. It is expected that about 1,000 plaintiffs will be involved in the MDL.

Other lawsuits have also been filed in the states where the manufacturers do business. Additional lawsuits have been initiated against Abbott in response to the FDA finding that the plant in Michigan was contaminated. The lawsuits claim that Abbott should be found liable for the injuries and deaths their baby formula caused based on several legal theories, including:

• Breach of warranty
• Failure to warn
• Negligent recall
• Strict product liability
• Unjust enrichment

These new lawsuits were mostly filed in federal court and are now being consolidated with the MDL litigation in Illinois.

Trial states that the claims against Abbott for contamination also include, based on information from a whistleblower, allegations that Abbott falsified records, released formula that was not properly tested, had “lax cleaning policies,” and failed to comply with current “good manufacturing practices.”  The whistleblower also alleges that Abbott’s Michigan plant’s automatic labeler failed frequently, “creating product tracing issues.”

What damages can I claim for my newborn?

Damages in product liability cases generally include compensation for your infant’s:

• Medical expenses, current and future
• Loss of function
• Physical pain and emotional suffering

The parents of an infant who dies due to an infection caused by baby formula have a right to file a wrongful death claim based on the laws of the state where the parents live, or the state where the defendants are subject to lawsuits.

In addition to seeking damages for the infants and the families of infants who died, additional goals of the litigation are to remove cow’s-based milk formula products from natal intensive care units (NICUs) and to ensure that parents and healthcare providers are warned and educated about the dangers of cow’s-based milk formula products for premature infants.

Trial states that when the industry won’t regulate itself and outside regulators cannot provide enough protection, the legal process is the only effective way to hold the manufacturers accountable.

The experienced product liability and personal injury lawyers at Martin & Helms, P.C. have the experience and resources to hold the makers of defective products liable for the injuries and the deaths their products cause. We are skilled at handling the different types of injury claims, including negligence, product liability, and breach of warranty. We demand the maximum compensation that state or federal law permits for the devastating infections these products cause.

To schedule a consultation to discuss your case, please call us or fill out our contact form to schedule an appointment. We have offices in Huntsville and Decatur, and serve clients in Madison, Athens, and North Alabama.