Failure to Warn: The Risk of Cronobacter Infection from Powdered Formula

A lawsuit brought in 2012 against the manufacturers of Enfamil alleges that the powered form of the product was contaminated with Cronobacter, a bacteria which can cause meningitis. The product was consumed by three infants in 2011, each of whom contracted meningitis, and the meningitis resulted in the death of one of the infants.   The case, Shelby Schrack, et al. v. Mead Johnson Nutrition, was filed in St. Clair County, Illinois, and alleges, among other things, the powered formula failed to include adequate safety warnings of the dangers associated with using the product. The case is still ongoing.

According to the Center for Disease Control, there were a total of 13 cases of Cronobacter illness in infants in 2011. (www.cdc.gov/features/cronobacter/). Any of the purported risk with using the product stems from the fact that the product cannot be sterilized by the manufacturer against the bacteria, for any sterilization process would also result in the products' proteins being deactivated. The CDC provides recommendations to protect against the bacterial infection, such as heating the water used to a precise temperature and utilizing other aseptic techniques. Id. Moreover, the manufacturer does provide a liquid version of its product, and the CDC recommends that newborns only be fed the liquid form. Id. 

Even so, increased warnings of the risk associated with use of the product might not result in any decrease in cases, for the procedures recommended by the CDC are inherently difficult and time-consuming for a typical household to perform effectively. Id. Indeed, the liquid form is arguably unworkable as an alternative for a majority of households because the product is significantly more expensive.  

The failure to warn issue was explored in Sec. Nat’l Bank of Sioux City v. Abbott Labs, 947 F. Supp. 2d 979 (N.D. Iowa 2013), another Cronobacter infection case where the infection was allegedly caused by contaminated powdered formula. Abbott Labs sought summary judgment on the plaintiff’s warning defect claim on the basis that the child’s mother who fed her the formula did not read the formula label, and therefore did not consider the warnings in her decision-making process, and therefore could not have been the “factual cause” of the child’s illness.  Id. at 999. The court ruled that Abbott simply missed the point, and that this was not necessary to support a failure to warn claim. Id. Rather, the plaintiff needed only to aver that the mother would not have fed the child the powdered formula if the label stated it was unsuitable for an infant under 28 days, that it may contain harmful bacteria, or that the liquid formula was safer for her child.   Id. at 1000. Thus, according to the court, Abbott misconstrued the nature of “factual causation” in a warning defect case. Id. 

Whether the mother would have actually used the liquid form is anyone’s guess, for the liquid form is unworkable as an alternative for a majority of households because the product is significantly more expensive. Such is evident from the fact that the USDA's Special Supplemental Nutrition Program for Women, Infants, and Children ("WIC") which provides assistance to mothers, primarily provides households with the powdered form. ("Winner Takes (Almost) All: How WIC Affects the Infant Formula Market", www.ers.usda.gov). In any event, because bacterial infection can occur after the product is opened, there is a strong possibility that any meningitis suffered by the infants in these lawsuits could have occurred after the powdered formula was handled. See www.cdc.gov/features/cronobacter; see also Sec. Nat’l Bank of Sioux City, 947 F. Supp. 2d. at 990-991 (denying the defendant’s Daubert motion and allowing plaintiff’s expert testimony to submit his “ruling in” methodology).

As these cases demonstrate, practitioners should be mindful of those jurisdictions where, in a “failure to warn” case, factual cause can be established by showing a warning “would have altered the plaintiff’s conduct so as to avoid injury.”  Id., quoting Mercer v. Pittway Corp., 616 N.W. 2d 602, 624 (Iowa 2000).