SimplyThick has recalled its thickening gel for premature infants manufactured at its Stone Mountain Georgia plant due to a possible link to necrotizing enterocolitis (NEC) a life-threatening condition. SimplyThick manufactured at other sites has not been recalled. The FDA reported that the company failed to prevent harmful bacteria from being killed during the manufacturing process. No confirmed link has been made but an investigation into two reports of infant death allegedly connected to SimplyThick is being conducted. Those who use SimplyThick should not use the product with children born before 37 weeks of gestation currently in the hospital or that have been released from the hospital in the last month. Further information about the recall can be found on the FDA SimplyThick recall website. Replacements or refunds can be requested at the SimplyThick Recall Request website.
Commentary
Its always unfortunate when a drug or other type of medical product intended to help a person may cause harm to that person. As drug makers and medical product manufacturers know all too well they have a legal duty to ensure that their product is safe for consumers to use before releasing it to the public. However a number of issues can result in a product being rushed to market before full safety testing may have been conducted. When a possibly defective product causes injury or death to a person the manufacturer of that product may bear civil liability for the results of any accident resulting from their use of the product.
Texas Defective Product Attorney Michael Grossman
