We are deeply concerned about the SimplyThick formula additive for premature infants, and the FDA’s warning about it.
St. Louis, MO (PRWEB) February 16, 2013
Nationally recognized defective medical products lawyer John J. Driscoll announced today that his law firm is now reviewing cases involving a potentially deadly illness that may be connected to SimplyThick, an additive used to thicken formula that is fed to premature infants.
The U.S. Food and Drug Administration (FDA) said in a September 2012 warning that “infants of any age may face an increased risk of developing a life-threatening condition if fed a thickening product called SimplyThick.”
According to the FDA, the agency needed “further study” to determine whether there was an “actual link” between consumption of SimplyThick and necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies.
In May 2011, the FDA had advised against feeding SimplyThick to infants born before 37 weeks gestation due to concerns that it could cause NEC, according to the September 2012 warning.
Since May 2011, the FDA said, it had identified 22 infants who had developed NEC after being fed SimplyThick. Seven of those infants died.
In June 2011, SimplyThick, LLC announced a voluntary recall of its thickening gel products manufactured at a food processing plant in Stone Mountain, Georgia, since June 1, 2009. A month later, the company said it had resumed shipping limited quantities of the product in 15g and 30g packets after the FDA had determined that the plant’s redesigned procedures “ensure a commercially sterile product.”
“We are deeply concerned about the SimplyThick formula additive for premature infants, and the FDA’s warning about it,” Driscoll said. “Our firm wants to help the families that believe their children have been harmed by this product.”
The Driscoll Firm, P.C., is a nationally recognized personal injury firm that focuses on complex civil litigation in areas that include dangerous pharmaceuticals and defective medical products.
Driscoll pointed to a New York Times report that was published February 4, 2013, headlined “Warning Too Late for Some Babies.” The report cited the FDA’s investigation, which was published in the August 2012 issue of the Journal of Pediatrics.
SimplyThick is made from xanthan gum, a widely used food additive on the FDA’s list of substances “generally recognized as safe,” the Times reported. SimplyThick is classified as a food, and the FDA did not assess it for safety, according to the article.
Driscoll said his firm is investigating whether design or manufacturing flaws involving the SimplyThick additive have caused illnesses.
About The Driscoll Firm, P.C.
The Driscoll Firm, P.C., is dedicated to fighting for the rights of people and families injured by the wrongful acts of individuals and companies. The firm is currently investigating national injury claims involving product liability, defective drugs, dangerous medical devices, medical malpractice, car accidents, premises liability, spinal cord injuries, birth injuries, Cerebral Palsy, brain injuries, Erb's palsy and other circumstances that have caused serious injury or death. The Driscoll Firm, P.C., is based at 211 N. Broadway, 40th Floor, St. Louis, MO, 63102, and serves clients nationwide. To learn more, call (800) 305-9800 or use the firm’s online contact form. All initial consultations are free and confidential.