Lieff Cabraser Heimann & Bernstein, LLP

Recall of Simply Thick Infant Formula/Breast Milk Thickener

SimplyThick is a thickening agent added to infants’ feed regimen (mixed together with either breast milk or formula) to assist infants in their swallowing. SimplyThick is sold in packets of individual servings and in 64-ounce dispenser bottles. Images of the SimplyThick label and packaging can be viewed here.

FDA Warning on Simply Thick

On May 20, 2011, the Food and Drug Administration (FDA) warned  that Simply Thick may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by the inflammation and death of intestinal tissue. The FDA directed that “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.”

Signs and symptoms of NEC include appearance of a bloated abdominal area, appearance of illness, feeding intolerance, greenish-tinged (bile) vomiting, and bloody stool. NEC has a mortality rate of 25%, and it can cause severe life-long impairment in children who survive it. 

Simply Thick Recall

On June 4, 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, owned and operated by Thermo Pac, LLC. Simply Thick gel manufactured at two other food processing plants was not recalled. To identify the specific packages of Simply Thick that have been recalled, click here.

The FDA stated it had received reports of 15 cases, including two deaths, in which premature infants who were fed Simply Thick developed NEC.

Product Returned to Market, But Still Not to be Fed to Premature Infants

On July 6, 2011, SimplyThick, LLC announced that it had resumed shipping limited quantities of its product in 15g and 30g packets following the FDA’s determination that the Stone Valley, Georgia processing plant’s redesigned procedures ensured a commercially sterile product.

However, consistent with the FDA’s May 20 warning, boxes containing the new 15g and 30g packets have been labeled "WARNING: Do Not Feed SimplyThick to Premature Infants.”

Parents File Lawsuit Against Simply Thick

On September 7, 2011, parents represented by Lieff Cabraser filed the first lawsuit against Simply Thick, LLC, for life-threatening and permanent injuries allegedly caused by Simply Thick. 

As alleged in the complaint, the Georgia manufacturing facility for Simply Thick failed to process food in a manner sufficient to destroy microorganisms dangerous to public health. Bacteria was found in samples of finished Simply Thick product that the FDA tested. 

“Infant food manufacturers owe a duty to parents and babies to prepare and sell safe products,” stated 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 family were responsible for their daughter developing NEC.” 

Contact Lieff Cabraser

Lieff Cabraser represents parents across America whose infants have suffered severe injuries allegedly due to Simply Thick. 

Please click here to contact a personal injury attorney at Lieff Cabraser to discuss your legal rights. Or call us toll free at 1-888-321-1510 and ask to speak to attorney Paulina do Amaral in our New York office.

We handle all inquiries with the strictest confidentiality and sensitivity. There is no charge or obligation for our review of your case

Trademark Information

Simply Thick is a trademark of Simply Thick, LLC. The use of this mark and any other marks is solely for informational and product identification purposes. Lieff Cabraser Heimann & Bernstein, LLP, is not affiliated in any way with Simply Thick, LLC.