A Florida family has filed a wrongful death lawsuit against the makers of SimplyThick and a Florida hospital, alleging that an infant suffered fatal injuries after being fed the controversial thickening agent.
Jaden Santos died in April 2011, after the premature infant’s parents gave him SimplyThick, a thickening agent designed to help patients keep down food.
According to allegations raised in the complaint filed by his father, Erik Santos, side effects of SimplyThick caused the infant to die only a month before the FDA issued an advisory warning about the risk of bowel problems from giving SimplyThick to premature infants. Jaden, a twin, was 27 weeks premature.
The lawsuit targets SimplyThick, Thermo Pac, the company that operated the SimplyThick manufacturing plant, and a Florida Hospital.
The family alleges that FDA investigators found a number of problems at the plant, which allowed bacteria to contaminate packets of SimplyThick like those sent home with the Santos family after Jaden and his twin sister were born. The hospital has maintained that it pulled SimplyThick from use as soon as it received the FDA warning.
SimplyThick is a thickening agent that is added to a baby’s formula to prevent spit ups after eating. The product, which is often used for both children and adults, has been on the market since 2001.
In May 2011, the FDA warned that SimplyThick should not be used with premature infants before 37 weeks of gestation.
A SimplyThick recall was issued shortly after the warning, due to a risk of bacterial contamination.
In September 2012, the FDA expanded their prior warnings, indicating that SimplyThick should not be used for infants of any age, due to the potentially life-threatening side effects
The warnings came after the FDA began receiving adverse event reports of premature infants fed SimplyThick suffering necrotizing entercolitis (NEC). Nearly 40 infants, both premature and full-term, have reportedly fallen ill after being fed the thickening agent. At least nine infant deaths have been linked to its use. Fourteen infants had to undergo surgery.
Necrotizing entercolitis is a condition where the tissues of the intestines become inflamed and die, often requiring the necrotized tissue to be surgically removed. Symptoms of NEC often present as a bloated stomach, green colored vomit and bloody stools.
This is at least the second SimplyThick wrongful death lawsuit filed against the manufacturers of the product. The first was filed in September 2011, by the parents of Brayden Flowers, an infant who allegedly fell into a coma and dying at the age of 17 weeks after being fed the thickening agent.