SimplyThick, a popular food thickener that is intended to help premature babies swallow food and keep it down, has been linked to several babies’ deaths. A Central Florida family lost their premature son after giving him SimplyThick, and one month later, the FDA issued a warning advising parents not to feed their premature infants the gel. However, after several deaths, the FDA warns parents that infants of any age may face an increased risk of developing necrotizing enterocolitis (NEC), a severe type of tissue inflammation in the intestines that can result in death.

Erik Santos and his wife have filed a lawsuit against SimplyThick, Florida Hospital, and the operators of the product’s manufacturing plant after their premature son, Jaden Santos, died shortly after ingesting packets of the thickening gel. Hospital staff had sent the family how with packets of the gel to help Jaden swallow his food, but he soon developed severe diarrhea and grew ill. Jaden’s parents rushed him to the emergency room on April 8, 2011. Despite their efforts, Jaden died later that day, and an autopsy later revealed that Jaden died from NEC.

A month after Jaden died, the U.S. Food and Drug Administration issued a warning that advised parents not to feed SimplyThick to premature babies as the product could cause the development of NEC. According to Santos’ lawsuit, the FDA investigated the SimplyThick’s manufacturing facility, which is operated by Thermo Pac. Bacteria were found in packets of SimplyThick, and the company didn’t officially recall the product until two weeks after the FDA issued an alert. Florida Hospital promptly pulled the product from use, but Jaden had already passed away more than a month before.

The Santos family claims that SimplyThick was aware of the defects in the product prior to his son’s death, yet none of the defendants took steps to control the problem. At the time of the FDA’s warning, authorities were aware that 15 infants had developed NEC after being fed SimplyThick, and two had died. Although more cases and deaths have surfaced, further study is needed to determine if there is an actual link between SimplyThick and the development of NEC.

Jaden’s twin sister was not given the thickening gel and is reportedly doing well. The FDA’s latest warning advises parents to be aware of the potential risk before deciding to feed SimplyThick to infants, although their recommendation is not a product recall. Despite the family’s loss, the Santos’ attorney states that Jaden’s parents are “most interested in ensuring that the processing of these food supplements are done in a way that doesn’t harm other children.”