Result: Confidential settlements
Simply Thick Lawsuit Summary
Lieff Cabraser represented parents whose infants died or suffered grave injuries linked to Simply Thick, a thickening agent for adults that was promoted to parents, caregivers, and health professionals for use by infants to assist with swallowing.
The individual lawsuits alleged that when fed to infants, Simply Thick caused necrotizing enterocolitis (“NEC”), a life-threatening condition. In 2014, the litigation was resolved on confidential terms.
Image source: FDA
FDA Warnings on Simply Thick Risks Including NEC
The U.S. Food and Drug Administration (FDA) first warned parents and doctors in May 2011 that Simply Thick might cause necrotizing enterocolitis in premature infants. NEC is the death of intestinal tissue. It is a disease that results in feeding intolerance, increased gastric residuals, abdominal distension, bloody stools, and can progress to include intestinal ischemia, leading to intestinal perforation.
Signs and symptoms of NEC include the appearance of a bloated abdominal area, general illness, feeding intolerance, greenish-tinged bile vomiting, and bloody stool. NEC has a mortality rate of 25%, and can cause severe life-long impairment even in children who survive it.
At the time the warning was first issued, the FDA was aware of 15 cases of NEC, including two deaths, involving infants who were fed Simply Thick. The FDA directed “parents, caregivers and health care providers not to feed SimplyThick to infants born before 37 weeks gestation who are currently receiving hospital care or have been discharged from the hospital in the past 30 days.”
In June 2011, the FDA announced that Simply Thick, LLC was voluntarily recalling its Simply Thick thickening gel manufactured at a food processing plant located in Stone Mountain, Georgia, due to concerns over contamination of the product. However, when the product was returned to the market in July 2011, the FDA warned that Simply Thick was not to be fed to infants.
In September 2012, the FDA repeated its warning but made a significant change: The FDA said “infants of any age” may face an increased risk of developing NEC if fed Simply Thick.
In this video from 2011, Lieff Cabraser attorney Fabrice Vincent discussed the Simply Thick litigation: