Status of Baby Formula Lawsuits

Status of Baby Formula Lawsuits

In April 2022, baby formula lawsuits filed against Abbott Laboratories and Mead Johnson were consolidated into multidistrict litigation (MDL) in the Northern District of Illinois. These lawsuits target the infant formula manufacturers for failing to warn healthcare providers and consumers about the increased risk of the development of necrotizing enterocolitis (NEC) in premature babies fed cow’s milk-based formulas, like Similac and Enfamil. This serious gastrointestinal illness can have long-term or life-threatening consequences, prompting parents to take legal action.

A clinical trial by Lancet dating back to 1990 linked baby formula to the increased risk of NEC in premature infants, noting that the disease was six to 10 times more common in formula-fed babies born pre-term than in preterm babies receiving breast milk exclusively. NEC was still three times more likely to develop in formula-fed babies born prematurely than in preterm babies receiving both breast milk and formula, according to the study. 

Since that time, many more studies have confirmed that cow’s milk-based formulas present an increased risk of NEC development in premature babies. Additionally, the American Academy of Pediatrics and many other prominent public health organizations strongly caution against feeding Similac or other cow’s milk-based formulas to premature infants. The 30+ years of scientific research and data confirming these findings has led to many parents’ assertion that Abbott and Mead Johnson knew or should have known of the well-established dangers of its infant nutrition products, according to pending lawsuits. 

While baby formula litigation is still in the early stages, it’s expected that the MDL will continue to grow as more parents across the United States file lawsuits on behalf of their injured infants. Compensation could be significant if plaintiffs’ allegations prove successful, potentially resulting in punitive damages and sizeable jury awards or large settlements.

What is necrotizing enterocolitis (NEC)?

There’s a plethora of accessible information and existing research regarding necrotizing enterocolitis (NEC). The severe condition is characterized by the deterioration or death of the intestinal tissue. Once the tissue dies, a hole can form in the intestine, allowing bacteria to leak into the abdomen and cause serious infections, such as sepsis. 

Blood tests for infants with NEC show low white blood counts—meaning the baby’s ability to fight infection is weakened, making the condition more difficult to treat. Treatment is dependent on how premature the baby is, their overall health and medical history, and how far the infection has spread.

Even though the condition is rare, and scientists are still learning more about the debilitating illness and its connection to certain types of baby formulas, many studies and publications offer statistics to help medical professionals, researchers, and parents better understand what NEC is and how it can impact a small child. 

Some available NEC stats generated using data collected by various researchers and published in separate publications by the U.S. National Library of Medicine operating as a part of the National Institutes of Health (NIH) include:

NEC Costs

NEC Recovery Time

  • Recovery is extensive and lengthy, with NICU stays after surgery usually extending beyond 90 days and most likely more than six months.
  • Without surgical intervention, most hospital stays for babies with NEC exceed an average of 22 days more than other premature babies without the condition.

NEC Risk Factors (Including Formula- vs. Breast Milk-Fed Infants)

  • Premature babies are more likely to develop NEC, with nearly 90% of newborns affected by the illness born more than three weeks before their estimated due date or before the 37th week of pregnancy.
  • Term or late pre-term infants born after 36 weeks' gestation who develop NEC are more likely to have been only formula-fed and less likely to have received breast milk.
  • Overall, infants fed breast milk are three to 10 times less likely to develop NEC than formula-fed babies. In addition to the alleged dangers associated with certain types of infant formulas, putting cow's milk-based formula-fed newborns at a greater risk of developing NEC, nutrients present in breast milk help protect newborns against illness.
  • Babies born after 35 weeks' gestation who develop NEC are more likely to suffer from other complications, including both birth defects (primarily related to the cardiac and gastrointestinal systems) and injuries, such as birth asphyxia and sepsis, or have experienced low Apgar scores.
  • Infants needing mechanical ventilation in the first four weeks of life are 13 times more likely to develop NEC.
  • Those requiring respiratory support who did not receive breast milk were 28.6 times more likely to develop NEC. Babies not receiving respiratory support or breast milk feedings were 6.4 times more likely to develop NEC.
  • Babies most at risk of developing NEC are born weighing one pound one ounce to three pounds three ounces at less than 28 weeks' gestation, requiring resuscitation after delivery.

NEC Outlook

  • NEC has a mortality rate as high as 50%. It can range from 10% to 50% based on its effects and how quickly and aggressively it's treated. With advancing NEC, including full-thickness destruction of the intestinal wall and complications like perforation or peritonitis (inflammation of the abdominal wall lining), mortality is imminent, thus the need for fast diagnosis and treatment.
  • Babies requiring surgical intervention for NEC are at a greater risk for long-term complications or death.
  • About 20-40% of infants affected by NEC, or approximately one-third, will need surgery to treat the illness.
  • Some infants, including those who have surgery for NEC, will likely need intravenous feedings for at least two weeks.
  • Long-term post-NEC complications can occur in 10-30% of affected infants and include prolonged intravenous nutritional feedings, ventilation, liver failure, postoperative scarring, obstructions and strictures, short bowel syndrome, intestinal failure, deficiencies like electrolyte abnormalities, anemia, and growth and development delays. Short bowel syndrome (SBS) results due to significant removal of damaged intestines. It happens in about one-fourth of children afflicted by NEC.
  • Average NEC mortality rates have decreased from 80% to 20% over the last 30 years due to medical advances resulting in more timely diagnosis and enhanced intensive care.
  • Babies most at risk of developing NEC are born weighing one pound one ounce to three pounds three ounces at less than 28 weeks' gestation, requiring resuscitation after delivery.

Ultimately, your child’s pediatrician is your greatest resource when determining the severity of your baby’s illness and their short- and long-term prognosis. Be sure to work closely with your child’s health care team for optimal results for your baby.

Abbott Infant Formula Recall and U.S. Shortage

In February 2022, Abbott Laboratories issued a widespread recall for its infant nutrition products manufactured at its Sturgis, Michigan facility, including Similac, EleCare, and Alimentum. This recall was not due to the link between baby formula and NEC, but instead because of certain bacterial infections occurring in infants who used the baby formulas made at the Michigan plant. 

Two babies died as a result of Cronobacter sakazakii infections. In total, five babies were affected, with four having Cronobacter infections and one suffering from a Salmonella Newport infection. 

A report issued by the U.S. Food and Drug Administration (FDA) after an investigation concluded that the Abbott facility “did not establish a system of process controls covering all stages of processing… designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment.” The FDA’s inspection further confirmed the presence of Cronobacter sakazakii on surfaces where baby formula production occurred at the plant. 

The recall remains in effect after the close of the FDA’s inspection, further contributing to a baby formula shortage that’s impacting families across the United States. Abbott CEO Robert Ford issued an apology via an op-ed published by The Washington Post online. Ford stated: “We’re sorry to every family we’ve let down since our voluntary recall exacerbated our nation’s baby formula shortage.” He went on to say that he believes the voluntary recall was “the right thing to do,” but falls short of accepting any link between the products and the infants’ illnesses. 

However, Ford does acknowledge the children hospitalized due to the lack of needed formula, and, getting ahead of another wave of impending lawsuits, nods to the establishment of a $5 million fund “that will be independently administered to help these families with medical and living expenses as they weather this storm.”

Ford concludes his apology by stating: “These steps we’re taking won’t end the struggles of families today…I want everyone to trust us to do what is right, and I know that must be earned back.”

Should I speak with an attorney?

If your child is suffering from necrotizing enterocolitis (NEC) after using cow’s milk-based baby formula, you might have a legal claim. As a consumer, you put your trust in baby formula companies like Abbott Laboratories and Mead Johnson, the makers of Similac and Enfamil infant formulas, to protect your newborn’s health. When these manufacturers break that trust by failing to warn hospitals and caregivers about known dangers associated with their products, such as the increased risk of the development of potentially deadly NEC in premature and low birth weight babies using their formulas, they need to be held accountable for the resulting harm. 

Additionally, if your child suffered from a bacterial infection, including Cronobacter sakazakii or Salmonella Newport, after using one of Abbott’s recently recalled infant formula products, you should speak with an attorney to determine your rights and any legal options available to you. 

It’s important to speak with an attorney specializing in or having extensive experience with product liability and personal injury claims to determine your options for financial compensation to ease the economic repercussions of your infant’s illness and aid in the cost of ongoing treatment for your child. The knowledgeable and caring attorneys at Taylor Martino Rowan have the experience and insight needed to take on the most challenging product liability cases. We are advocates exclusively for the injured. We strive for excellence and commit to contributing value to our work and your family’s future. Contact us today for a free consultation.

Contact us at 251-433-3131 or here on our website to get started.

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