SimplyThick Formula Lawsuits & Settlements
FDA Cites Deaths, Life-Threatening Illnesses from Simply Thick Product
If you or a loved one has an infant who suffered serious health problems or died as a result of the use of SimplyThick formula thickener you may be eligible to file a SimplyThick lawsuit and seek compensation.
Our experienced, aggressive lawyers are now investigating claims from families who have children who have been affected by this product. Please contact us as soon as possible to ensure that all of your legal rights are protected.
There may be time limits involved in certain cases and the earlier you contact us the more effectively we can begin pursuing compensation in cases in which eligibility is determined.
Free consultations are being offered to advise families about the legal options that may be available to them in seeking compensation for the loss of a child, medical costs, pain and suffering or other expenses that may have been incurred as a result of this product.
SimplyThick and health complications in children warning by the FDA.
The shocking news about links between the use of SimplyThick and health complications in children has been raised in a consumer alert issued by the U.S. Food and Drug Administration.
The FDA said that it was informing parents, caregivers and health care professionals to be aware that infants of any age may face an increased risk of developing a life-threatening condition if fed SimplyThick.
"Since May 2011, the agency has identified 22 infants who developed necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died," said the FDA.
Agency officials said that they are awaiting additional studies to determine if there is an actual link between the consumption of SimplyThick and the development of NEC but wants everyone involved in the care of a baby to be aware of the potential risk before deciding whether to feed SimplyThick to infants of any age.
SimplyThick is a brand of thickening agent—available to consumers and medical centers—used to help manage swallowing difficulties. It is sold in individual serving packets as well as in 64-ounce dispenser bottles, which can be purchased from distributors and local pharmacies throughout the United States.
The FDA's director of Infant Formula and Medical Foods staff, Dr. Benson M. Silverman, said that the thickening agent is added to breast milk and infants' formula to help the premature babies swallow their food and keep it down, without spitting up. The product is also used in older children and adults with swallowing problems caused by trauma to the throat, he notes.
What are the NEC Symptoms?
What are the symptoms of NEC? Parents or caregivers are urged to contact their health care professional if a baby has any of the symptoms listed below or if you have other concerns related to using SimplyThick:
- Distended abdomen
- Greenish-tinged vomit
- Bloated stomach
- Blood in stools
- Feeding intolerance
The FDA said that it first learned of bad side effects possibly linked to SimplyThick on May 13, 2011. Silverman says he was alerted by two reports in FDA's MedWatch Safety Information and Adverse Event Reporting Program. He followed up with the physicians who filed those reports and later with a network of other neonatologists, doctors who treat newborns in need of special care.
Karl Klontz, M.D., a medical officer in FDA's Center for Food Safety and Applied Nutrition, says the scope of the problem soon became apparent. At the time, the agency was aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick, reportedly as directed, mixed with mothers' breast milk or infant formula products. The mixture was fed to infants for varying amounts of time.
In May 2011, FDA advised against feeding SimplyThick to infants born before 37 weeks gestation because it could cause NEC. (Gestational, or post-menstrual, age is calculated from the first day of the last menstrual period, which is about two weeks before ovulation.)
After issuing that warning, the FDA said it conducted an extensive review of reports of health problems potentially tied to SimplyThick. Its findings, published recently in The Journal of Pediatrics, included the discovery that among almost two dozen infants ultimately found to develop NEC after ingesting SimplyThick was a baby born at full term—not a premature baby. The other 21 infants, however, were born prematurely.
The infants ranged from about 24 to 48 weeks post-menstrual age when they became sick. (An infant who is 24 weeks post-menstrual age is about four months premature.)
Half of the infants developed NEC in the hospital, while half developed the condition at home following discharge from the hospital. Fourteen required surgery.
If you are a family whose infant has been affected by the use of SimplyThick we urge you to contact us as soon as possible for experienced, aggressive legal representation seeking the compensation you may be due, dependent upon the facts of your case.