Written by Faith Anderson on November 20, 2012
Bacterial Contamination at SimplyThick Plant
SimplyThick is a thickening agent that is sometimes added to a baby’s formula in an effort to prevent spit-ups after eating. The product, which can be used in both children and adults, has been on the market in the United States since 2001. In May 2011, the FDA issued a warning to consumers indicating that SimplyThick should not be used with premature infants before 37 weeks of gestation. The following month, the FDA issued a SimplyThick recall after discovering that the products manufactured at a Thermo Pac facility in Georgia did not have a proper protocol in place to prevent contamination with harmful bacteria. In the wrongful death lawsuit, the Santos family alleges that issues at the manufacturing plant allowed bacteria to contaminate packets of SimplyThick, like those sent home with their family after Jaden and his twin sister were born. The Florida hospital, however, maintains that it stopped distributing SimplyThick as soon as it received the FDA warning regarding the contamination problems.
FDA Issues SimplyThick Recall
In September 2012, the FDA expanded its SimplyThick warnings, indicating that the thickening agent should not be used for infants of any age, due to potentially life-threatening side effects linked to the product. The warnings came after the FDA began receiving reports of premature infants suffering necrotizing entercolitis (NEC) after being fed SimplyThick. According to the FDA, nearly 40 infants, both premature and full-term, have become ill after being fed the thickening agent, with at least nine infant deaths attributed to the product and 14 infants requiring surgery. Necrotizing entercolitis is a condition in which the intestinal tissues become inflamed and begin to die, often requiring surgery to remove the necrotized tissue. Symptoms of NEC typically present as bloody stools, green-colored vomit and a bloated stomach.
Wrongful Death Lawsuits for SimplyThick Side Effects
The Santos complaint is at least the second wrongful death lawsuit filed against the manufacturers of SimplyThick. The first was filed in September 2011, after a 17-week-old infant allegedly fell into a coma and died after being fed the thickening agent. No consumer product, especially a product intended for use in children, should put a patient at risk of life-threatening injuries or death. If you or your child has suffered a serious injury, or if your child died after using a product like SimplyThick, our consumer advocates can put you in contact with a product liability lawyer in your area. With an experienced product liability attorney on your side, you can protect your legal rights and pursue the compensation you deserve for your losses.