Three sets of parents claim their babies died from the food product; two sets of parents claim their babies got sick.
Devon K. Addonizio et al. sued Simply Thick LLC and its CEO John Holahan.
They claim the illnesses were caused by the defendants’ using an unapproved “cold fill” process developed by H.J. Heinz Co., which is not a party to the case.
“Prior to July 30, 2008, during precise dates yet unknown, H.J. Heinz Company owned the Stone Mountain, Georgia manufacturing facility where SimplyThick was manufactured, formulated, processed, formulated, packaged, assembled, tested, and distributed from,” the complaint states. “Upon information and belief, H.J. Heinz Company, developed a ‘cold fill’ manufacturing process to manufacture SimplyThick, which Thermo Pac LLC and AmeriQual Group LLC continued to use long after July 30, 2008 – a process that was not approved by the Food and Drug Administration (‘FDA’).
“In or about late 2010, FDA received a number of reports that premature infants who were fed SimplyThick had developed NEC. Over a period of only six months, FDA received a total of fifteen reports of NEC, including two deaths, from only four hospitals (out of the thousands of hospitals across the United States) associated with the ingestion of SimplyThick.
“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, which may require surgery and intensive medical support. NEC has a mortality rate of25 percent, and it can cause severe lifelong impairment in children who survive. For those who do survive, the consequences flowing from NEC may not be known for years. These complications include malnutrition from limited intestinal absorptive surface, anaemia, biliary dysfunction, rickets, cholelithiasis, and endocarditis.”
Similar complaints have been filed around the country. Courthouse News first reported on the complaints in October 2012; at least 13 related lawsuits have been filed so far.
SimplyThick is a food addictive that thickens liquids and makes them easier for a baby to swallow. The FDA recalled SimplyThick in 2011 after inspecting a manufacturing plant.
The latest complaint is similar to the previous ones.
“The first production run of SimplyThick was conducted at Thermo Pac LLC’s Stone Mountain plant sometime in 2001,” the complaint states. “In the fall of 2001, defendant Simply Thick LLC, contracted with Thermo Pac LLC, as owned and operated by Heinz to serve as the manufacturer of SimplyThick.
“In 2007, Heinz approached Holahan and suggested modifying the processing and developed the cold fill manufacturing process for manufacturing Simply Thick.
“In 2007, Heinz developed a ‘cold fill’ process to manufacture SimplyThick.
“The ‘cold fill’ process was never approved by the FDA.
“The ‘cold fill’ process was not intended to or capable of sterilizing the Simply Thick (also referred to as the ‘Product’).
“The process was not tested as a method to manufacture food to be used by infants.
“Defendants did not disclose that the process was not tested for use in infant food as a food thickener.
“‘Cold fill’ was attractive to manufacturers because cold fill processes are 30 percent or more inexpensive than hot fill so the process maximizes profits.”
The plaintiffs claim reports of SimplyThick’s harming babies surfaced as early as 2004, with more reports in 2005 and 2006.
“Similarly, when questions arose again in 2008 and 2009 about potential association with NEC, defendants’ response was to downplay the potential association and thereby ignore the staggering potential health and safety implications, all to increase product sales,” the complaint states.
The plaintiffs say the FDA became aware of the complaints in 2010.
“Specifically, FDA became aware of fifteen cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time,” the complaint states. “In all the cases, SimplyThick was mixed with mothers’ breast milk or infant formula products. The fifteen reported cases came from only four hospitals.
“Post-hospital-discharge development of NEC in infants is exceedingly rare. Yet, many of the fifteen infants reported to the FDA were stricken with NEC after having been discharged from the hospital. It was only after beginning a feeding regimen that included SimplyThick that many of the infants later fell ill.”
The plaintiffs claim a 2011 FDA inspection of the Thermo Pac plant in Stone Mountain, Ga., revealed a litany of violations that caused the contamination of SimplyThick.
“Specifically, the FDA found that ‘unopened product yielded diarrheal toxin-producing Bacillus cereus’ in twelve of the thirty samples taken of SimplyThick,” the complaint states. “Bacillus cereus was also present in one of the raw materials used to manufacture SimplyThick.”
That led to the recall of SimplyThick.
The plaintiffs seek punitive damages for product liability, negligence, breach of implied warranty, wrongful death and loss of consortium. They are represented by Michael J. Hart with Sher Corwin Winters in St. Louis.
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