NEW YORK--(BUSINESS WIRE)--Attorneys Wendy Fleishman and Paulina do Amaral of the national plaintiffs' law firm Lieff Cabraser Heimann & Bernstein, LLP, announces that Leslie and Michael Nesheim of Gastonia, North Carolina, today filed a personal injury lawsuit charging that the food thickening agent SimplyThick caused their daughter catastrophic and permanent injuries. The action was filed against the product’s manufacturer, Simply Thick, LLC, and its President and CEO, John L. Holahan.
Identified in the complaint as Baby L.N., the Nesheim’s daughter and her twin brother were born prematurely at 27 weeks and 2 days gestational age in November 2010. Two months later, Baby L.N. was fed SimplyThick. Within 9 days of exposure to SimplyThick, Baby L.N. was diagnosed with the potentially fatal condition Necrotizing Enterocolitis ("NEC"). Her twin brother did not receive SimplyThick and never developed NEC.
NEC causes the inflammation and death of intestinal tissue, and has a typical mortality rate of 25%. As a result of developing NEC, Baby L.N. underwent three surgeries and had a large portion of her intestine removed. The complaint alleges that Baby L.N. has a greatly increased risk of neurologic impairment, intestinal diseases, and a shortened life expectancy.
“Within days of being fed Simply Thick, my daughter developed NEC. To save her life, a large portion of her intestines were removed, which resulted in her now living with an irreversible condition called Short Bowel Syndrome,” stated Leslie Nesheim. “We are blessed that she survived and is with us today. But no words can describe how this product has affected the lives of so many precious children and their families.”
Introduced to the market in 2001, the primary ingredient of SimplyThick is Xanthan gum. The complaint charges that SimplyThick never conducted any analysis on the potential health risks of Xanthan gum specific to prematurely born infants. As early as 2004, an article published in the Archives of Diseases in Childhood suggested a link between NEC and SimplyThick. One year later, the company received reports from neonatal intensive care nurses of NEC associated with SimplyThick use. In 2006, another cluster of NEC was reported in infants fed SimplyThick at Phoenix Children’s Hospital.
Wendy Fleishman, one of the attorneys for the Nesheim family, stated, “Infant food manufacturers owe a duty to parents and babies to prepare and sell safe products. SimplyThick failed to meet this fundamental duty. The complaint charges that for years Simply Thick downplayed any association between its product and NEC. Instead, it continued to promote SimplyThick to health professionals and caregivers as suitable for use in infants.”
“The complaint alleges that children across the U.S. have been killed or maimed for life due to SimplyThick’s staggering refusal to determine the safety of the product in preemies prior to its sale for use in those infants, and then failure to investigate reports of NEC in preemies fed Simply Thick after it was introduced to the market,” added attorney do Amaral.
To date, claims have been filed on behalf of more than 20 injured children, including 10 who died, against Simply Thick and the inventor of the product, John Holahan, alleging exposure to the product caused NEC, other serious injuries, and/or the death of the child.
SimplyThick Recall and FDA Inspection of Manufacturing Facility
In May 2011, the U.S. Food and Drug Administration first warned parents and doctors that SimplyThick could cause NEC in premature infants. At the time, the FDA reported it was aware of 15 cases of NEC, including two deaths, involving infants who were fed SimplyThick.
Soon thereafter, the FDA conducted an inspection of Thermo Pac, LLC's Stone Mountain, Georgia, facility, where SimplyThick was manufactured, and found numerous problems at the plant. As alleged in the complaint, based on the facility inspection, the FDA found that Thermo Pac, LLC failed to properly thermally process acidified food, including SimplyThick, in a manner sufficient to destroy microorganisms dangerous to public health. The FDA also found bacillus cereus, a type of bacteria, present in twelve of thirty samples of finished SimplyThick product that it tested.
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 SimplyThick, not just infants born prematurely.
Legal Resources for Parents
Lieff Cabraser is representing parents across America whose infants have suffered severe injuries allegedly due to SimplyThick. Visit our SimplyThick case page to learn more about the Simply Thick recall lawsuits.
Parents are also invited to call Lieff Cabraser toll-free at 888 321-1510 and ask to speak to Attorney Paulina do Amaral. All inquiries will be handled with the strictest confidentiality and sensitivity. There is no charge or obligation for our review of your case.
About Lieff Cabraser
Recognized as "one of the nation's premier plaintiff's firms" by The American Lawyer magazine, Lieff Cabraser Heimann & Bernstein, LLP is a sixty-plus attorney law firm with offices in San Francisco, New York and Nashville.
Both Best Lawyers/U.S. News and the National Law Journal have recognized Lieff Cabraser as one of the top plaintiffs' law firms in America. Learn more at www.lieffcabraser.com.
SimplyThick is a registered trademark of Simply Thick, LLC. The use of this trademark is for informational and product identification purposes only. Lieff Cabraser is in no way affiliated with Simply Thick, LLC.