The makers of SimplyThick face more than 20 lawsuits brought by the parents of children who suffered serious adverse events because of the food thickening agent, including at least 10 wrongful death lawsuits.
SimplyThick is a thickening agent that is used for both children and adults, and has been on the market since 2001. It was previously given to babies by placing it in their formula to prevent them from spitting up.
The SimplyThick lawsuits claim that the infants suffered severe injuries or death after experiencing necrotizing enterocolitis (NEC), which has a mortality rate of 25%. The rare condition causes the tissues of the intestines become inflamed and die, often requiring the necrotized tissue to be surgically removed. Symptoms of NEC often present as a bloated stomach, green colored vomit and bloody stools.
In May 2011, the FDA warned that SimplyThick should not be used with premature infants before 37 weeks of gestation, following reports of at least 15 cases of necrotizing enterocolitis (NEC) among premature infants who were fed it, including at least two deaths.
A SimplyThick recall was issued shortly after the warning, after inspectors discovered that the manufacturer did not have a proper process in place to prevent harmful bacteria contamination.
In September 2012, the FDA expanded their prior SimplyThick warnings, indicating that thickening agent should not be used for infants of any age, due to the potentially life-threatening side effects. The additional warnings were issued after the agency identified at least 22 new cases of NEC with SimplyThick that were reported after the May 2011 warning, including at least one baby that was not premature. At least nine infant deaths had been linked to SimplyThick use, and another fourteen infants had to undergo surgery.
According to allegations raised in the complaints, the primary ingredient in the thickening agent, Xantham gum, is likely to blame for the infections. Plaintiffs claim that Simply Thick, LLC failed to adequately test Xantham gum for potential health risks.
SimplyThick was placed on the market in 2001, but by 2004 researchers were already warning that there could be a link between Simply Thick and NEC. However, the product was not investigated or removed from shelves until 2011.