The complaint charges that their daughter suffered life-threatening and permanent injuries caused by SimplyThick.
The complaint is believed to be the first lawsuit filed following a warning issued by the US Food and Drug Administration (FDA) that SimplyThick may cause the life-threatening condition of necrotizing enterocolitis (NEC) and that the product should not be fed to prematurely born infants.
The FDA conducted an inspection of Thermo Pac’s Stone Mountain, Georgia, manufacturing facility and found numerous deficiencies. On 4 June, the FDA announced that SimplyThick was recalling SimplyThick manufactured at the Stone Mountain processing plant.
“Infant food manufacturers owe a duty to parents and babies to prepare and sell safe products,” said attorney Wendy Fleishman. “The complaint charges that SimplyThick failed to properly thermally process and test the safety of its product. As a result, the SimplyThick samples given to the Umphress family were responsible for their daughter developing NEC.”
The infant was diagnosed with NEC, evidenced by multiple dark lesions in her intestinal tract. A rare disease in infants post-hospital discharge, NEC is a life-threatening condition characterised by the inflammation and death of intestinal tissue.
NEC has a death rate of 25% and can cause severe impairment in children who survive. The infant was admitted to the Children’s Hospital for nearly 20 days, where she received two blood transfusions.
Mrs Umphress said: “What happened to our daughter was a nightmare that no child or family should ever experience. Her stomach has been left permanently distended. She continues to suffer from NEC symptoms, including having a bloated abdomen area and experiencing frequent pain and constipation.”
Source: Lieff Cabraser Heimann & Bernstein
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