Injuries and deaths of more than 20 children are the focus of lawsuits brought against SimplyThick, LLC, the maker of SimplyThick, a food-thickening agent. SimplyThick was used in baby formula to manage swallowing disorders.
A recent lawsuit involves a baby girl who suffered what is being described as catastrophic and permanent injuries. The lawsuit also names SimplyThick’s president and chief operating officer (CEO), John L. Holahan, according to HeraldOnline.com.
In this recent case, the daughter and her twin brother were born prematurely at about 27 weeks. Two months later, the infant girl was fed SimplyThick and, within nine days, was diagnosed with the potentially fatal Necrotizing Enterocolitis (NEC). Her twin brother did not receive SimplyThick and was not diagnosed with NEC, according to HeraldOnline.com. NEC is a life-threatening condition characterized by inflammation and death of intestinal tissue.
NEC is also associated with a 25 percent mortality rate, according to HeraldOnline.com. The baby girl underwent three surgeries, which included removing a large portion of her intestine. She is now diagnosed with “Short Bowel Syndrome.”
The U.S. Food & Drug Administration (FDA) previously issued a warning against the use of SimplyThick in feedings to premature infants who are born before 37 weeks. The FDA first learned of adverse events potentially tied to SimplyThick on May 13, 2011. At that time, the agency indicated that it was aware of 15 cases of NEC, including two deaths, that involved premature infants fed SimplyThick for various time frames. The product was mixed with mothers’ breast milk or infant formula products.
When more adverse event reports were received, the FDA updated its prior warning on SimplyThick, recommending against its use in all infants. According to a prior The New York Times report, an FDA probe into 84 NEC cases published in The Journal of Pediatrics in 2012, revealed a “distinct illness pattern” in 22 cases, which suggested a potential association between SimplyThick and NEC.
At the time of the FDA’s prior warning, SimplyThick was used in all neonatal intensive care units. Following a number of injuries and lawsuit allegations, concern was raised about the way in which infant food additives are monitored, according to The New York Times report. Made from xanthan gum, SimplyThick is a broadly used additive that is classified as a food, is on the FDA’s list of “generally recognized as safe” substances list, and was not assessed by the agency for safety, The New York Times indicated.
Adding to the controversy, some batches of SimplyThick were contaminated with dangerous bacteria and Simply Thick issued a recall for some products manufactured at a Stone Mountain, Georgia food processing plant, which was then owned and operated by Thermo Pac, LLC. The agency indicated that products manufactured at that plant were being recalled after the FDA advised the company that Thermo Pac failed to conduct a scheduled process meant to ensure that vegetative cells (harmful bacteria) of possible public health significance are destroyed during the manufacturing process. This failure was discovered during a 2011 FDA inspection. According to the Times, some babies may have ingested the potentially contaminated, recalled batches. FDA report authors theorized that the intestinal membranes of babies might have suffered damage when bacteria broke the xanthan gum down into a number of toxic byproducts, said The New York Times.
Used in adults since 2001 for swallowing issues, SimplyThick produces a liquid similar in consistency to honey and enables the drinker additional time to close his/her airway and prevent aspiration, the New York Times explained.