The parents of a girl who was born prematurely in 2010 say that SimplyThick, a thickening agent used in patients diagnosed with swallowing difficulties, caused her to suffer severe and permanent injuries.
The parents filed a lawsuit against Simply Thick LLC, the maker of SimplyThick, and its president and chief executive officer (CEO). The baby girl was given SimplyThick to aid her swallowing when she was two months old; the infant girl and her twin brother were born prematurely at 27 weeks. The baby boy was not treated with SimplyThick, according to HeraldOnline.com.
After nine days of taking SimplyThick, the girl was diagnosed with Necrotizing Enterocolitis (NEC), a disease known to cause inflammation and death of intestinal tissue and that is associated with a 25 percent mortality rate, according to HeraldOnline.com. The baby girl underwent three surgical procedures, including to remove a large amount of her intestines. She has since been diagnosed with “Short Bowel Syndrome,” which is irreversible.
The U.S. Food & Drug Administration (FDA) previously issued a warning against use of SimplyThick, which is made from xanthan gum, in premature infants born before 37 weeks. The agency first learned of adverse events potentially tied to SimplyThick in 2011. At that time, the FDA indicated that it was aware of 15 NEC cases, including two deaths, involving premature infants fed SimplyThick. Additional adverse event reports were received and the FDA then updated its warning to apply to all infants.
According to a prior The New York Times report, an agency investigation of 84 NEC cases published in The Journal of Pediatrics in 2012 revealed a “distinct illness pattern” in 22 cases, some of which involved infant death or surgery, suggesting a potential association between SimplyThick and NEC.