A Seminole County family is suing Florida Hospital and the maker of product used to thicken breast milk and formula after their 3-month old son died.
Orlando attorney Joe Taraska said the parents of 3-month old Jaden Santos are "absolutely distraught."
Taraska said Jaden and his twin sister, Genesis, were born premature at Florida Hospital.
Three months later, Jaden was able to go home.
The family attorney said Florida Hospital gave Jaden's parents packets of SimplyThick, which is added to breast milk or formula to help preemies swallow their food and keep it down.
But on his first day home, Taraska said Jaden became extremely ill. The parents said a pediatrician advised them to keep feeding him SimplyThick. A few days later, they rushed him back to the ER, where he died, according to Taraska.
An autopsy revealed Jaden had necrotizing enterocolitis (NEC), a disease that attacks intestines and can be fatal, Taraska said.
"His twin sister did not get SimplyThick and she's alive and well today and thriving," said Taraska.
A month after Jaden died, the Food and Drug Administration noticed a pattern and issued a warning not to give the product to premature babies. That warning now includes all infants. So far, the FDA has identified 22 infants who'd been fed SimplyThick and developed NEC with symptoms like bloated stomachs and green vomit. Seven have died. Despite those illnesses, the FDA has not made a direct link between SimplyThick and NEC.
A month after Jaden died, SimplyThick issued a voluntary recall citing a paperwork problem at a manufacturing plant in Georgia that raised concerns about possible contamination with harmful bacteria.
Unfortunately, those warnings were a month too late for Jaden.
"Even to talk about it at this point takes (Jaden's parents) to a place that is so emotionally difficult for them they just can't bare it," said Taraska.
In response to the lawsuit, Florida Hospital issued the following statement to WKMG-TV:
"Florida Hospital considers the safety of our patients to be our number one priority. We work diligently with the FDA to comply with all alerts and recalls placed on products used in the hospital. In regards to SimplyThick, we received an alert from the FDA on May 20, 2011 to stop administering the product to premature infants and promptly pulled it from use. This was prior to the company’s official product recall on June 5, 2011. Unfortunately, Florida Hospital was only notified six weeks after the incident had occurred that there were any concerns with the product."
John Holahan, President of Simply Thick LLC, issued the following statement:
"We offer our sincere condolences to the Santos family. Nothing is more important to us than the health and safety of our customers."