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First Personal Injury Lawsuit Following May 2011 FDA Warning Concerning Breast Milk and Infant Formula Thickening Agent

A New Mexico couple has filed suit against Georgia companies, Simply Thick, LLC, the owners of SimplyThick, a product used to thicken breast milk and infant formula, and Thermo Pac, LLC, who manufactures and supplies the product in Georgia State Court. The complaint is believed to be the first filed following a warning issued in May of this year by the U.S. Food and Drug Administration that SimplyThick may cause the life-threatening necrotizing entercolotis (NEC). After the May warning, the FDA inspected Simply Thick’s Stone Mountain, Georgia manufacturing plant and found numerous deficiencies. At that point a complete recall was issued for every product manufactured at the Stone Mountain plant. The suit alleges that Simply Thick failed to properly thermally process and test the safety of its product, and as a result the SimplyThick ingested by the couple’s daughter was responsible her developing NEC.

The infant was born prematurely, and after being discharged from the hospital the couple was given samples of SimplyThick with instructions to use it when feeding. The couple says after using the product the baby’s health deteriorated so rapidly from the NEC that she had to be airlifted from a local hospital to a specialty Children’s Hospital in Albuquerque. NEC is a rare disease in infants post-hospital discharge that is normally life-threatening causing inflammation and death of intestinal tissue. NEC has a death rate of 25% and can cause severe impairment in children who survive.


Though infant did survive the bout with NEC, she was forced to receive two blood transfusions, and her stomach has been left permanently distended. She also continues to suffer from other complications related to NEC.

As Georgia Product Liability Lawyer, I can only hope that this product was not widely consumed, as I have the seen the incredible anguish that both the child as well as the parents experience in an infant injury. The FDA is still investigating the product and is instructing consumers to call the company at 1-800-205-7115 for a full refund. At this point, only the pouches produced at the Stone Mountain plant are subject to the recall, but if it were my child I would bypass all Simply Thick products at this point.