Although the U.S. Food & Drug Administration (FDA) says that it needs to study the link between SimplyThick (a xanthan gum-based thickening formula fed to premature infants) and Necrotizing Enterocolitis, parents of children who have been injured, or died, are angry that the manufacturer didn’t do more to warn anyone about known risks.
What Is NEC?
Necrotizing Enterocolitis (NEC) is the death of intestinal tissue, which results in feeding intolerance, increased gastric residuals, abdominal distension and bloody stool. NEC can progress into intestinal ischemia and intestinal perforation and generally affects preemies in the first weeks after birth.
Although the exact cause of NEC is unknown, NEC symptoms include the appearance of a bloated abdominal area, appearance of illness, feeding intolerance, vomiting and bloody stool. NEC may require infants to undergo surgery, subject them to intensive medical support and cause permanent impairment to those who survive. Unfortunately, many don’t. Due to the fragile nature of a newborn’s system and the severity of the disease, NEC has a mortality rate of 25%.
What Is The Link Between SimplyThick And NEC?
That’s a question angry parents, healthcare professionals, the FDA and many others would like to have answered. Xanthan gum is on the FDA’s list of substances that are “generally recognized as safe” and used in many products. However, even though SimplyThick is classified as a food, the FDA admitted that it did not assess it for safety – something that is happening now.
That’s too late for those infants who have already died. Grieving parents blame the manufacturer, SimplyThick LLC. Lawsuits filed against the company allege that it knew, or should have known, that the product could cause serious injury to infants. However, it failed to adequately test, study or warn parents and healthcare professionals of the very serious risk to infants.
SimplyThick Injury Lawsuits
Nothing is worse than an innocent child being injured. If your child has been injured or died from SimplyThick, contact The Driscoll Firm, LLC, to discuss your situation. Our experienced product liability attorneys can help you determine whether taking legal action against the manufacturer makes sense for you. If so, we will fight to get you the compensation you deserve.