NEW YORK--()--Wendy R. Fleishman and the lawyers at the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, reminded parents today that the U.S. Food and Drug Administration has warned parents that “infants of under 12 months or children with a history of bowel problems may face an increased risk of developing a life-threatening intestinal tissue disease called necrotizing enterocolitis, or NEC, if SimplyThick is used to thicken their formula or breast milk.”
“Manufacturers and the FDA must do more to ensure similar disasters never occur again. At a minimum, food products for infants should be tested for safety prior to their marketing and sale.”
“In May 2011, the FDA first warned parents and doctors that SimplyThick has been linked to NEC in premature infants,” Ms. Fleishman stated. “A year later, 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.”
This week, SimplyThick, LLC, the manufacturer of SimplyThick, announced online a major change to its product warnings. The new warning will state that SimplyThick is “NOT intended for use with preterm or infants under 12 months of age. Or children under the age of 12 years with a history of NEC.” Earlier this week, the New York Times reported on the tragedy of infants dying from NEC after being fed SimplyThick.
Prior to the first FDA warning in 2011, SimplyThick, LLC, promoted the product for use in infant formula and breast milk in order to assist infants in swallowing. The company conducted no clinical tests on the safety and effectiveness of SimplyThick when fed to infants in breast milk or infant formula.
In the New York Times article, Wisconsin resident Julie Mueller, whose daughter Addison was born at full term in December 2011 and died a month later after being fed SimplyThick, stated, “It was a nightmare. I was astounded how a hospital and manufacturer was gearing this toward newborns when they never had to prove it would be safe for them. Basically we just did a research trial for the manufacturer.”
Devon Addonizio, a New York resident, is the mother of a premature infant who nearly died, was permanently disfigured, and is now disabled as a result of being diagnosed with NEC after she was started on SimplyThick by hospital staff just before discharge. “I am grateful that greater media attention is being focused on the dangers of feeding SimplyThick to infants, and deeply hope that no more babies are ever exposed to this product. However, no words can explain how much suffering this has caused our little girl and other children and how much despair and grief we and other families have endured," Ms. Addonizio stated. “Manufacturers and the FDA must do more to ensure similar disasters never occur again. At a minimum, food products for infants should be tested for safety prior to their marketing and sale.”
Lieff Cabraser represents the parents of Addison Mueller in a lawsuit against SimplyThick, LLC, for the wrongful death of their daughter. Lieff Cabraser also represents Ms. Addonizio in a personal injury lawsuit to obtain just compensation for the horrendous injuries her daughter suffered and for the cost of care she will require for the rest of her life.
YouTube Video on Simply Thick Side Effects and Lawsuit Allegations
Lieff Cabraser has released a video on YouTube which explains the side effects linked to SimplyThick when fed to infants. The video also summarizes the allegations made in the SimplyThick lawsuits, including that SimplyThick, LLC, failed to adequately test, study, and warn parents and the medical community of the risk to infants from being fed SimplyThick.
Watch the video at http://www.youtube.com/watch?v=tCsF2g_geEk
More information on the SimplyThick recall and the legal rights of parents can be found at http://www.lieffcabraser.com/simplythick
About Lieff Cabraser
Recognized as "one of the nation's premier plaintiffs’ 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.
Since 2003, The National Law Journal has selected Lieff Cabraser as one of the top plaintiffs' law firms in the nation. We are one of only two plaintiffs' law firms in the United States to receive this honor for the last ten consecutive years. Best Lawyers and U.S. News named Lieff Cabraser as their 2012 "Law Firm of the Year" for representing plaintiffs in class actions and mass torts.
SimplyThick is a trademark of SimplyThick, 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 SimplyThick, LLC.