Abbott Ends Sales of Probiotic Infant Formula After FDA Warning, Child’s Death
Decision came after FDA determined Similac Probiotic Tri-Blend is an unadulterated drug product, which could put preterm infants' lives at risk.
Decision came after FDA determined Similac Probiotic Tri-Blend is an unadulterated drug product, which could put preterm infants' lives at risk.
Bellwether NEC lawsuit trials will include one complaint against Abbott, one complaint against Mead Johnson, and two complaints that name both infant formula manufacturers as defendants.
Abbott is using unproven ingredients in Similac Probiotic Tri-Blend that may not be safe for infants, and is marketing the infant formula in a way that makes it an unapproved drug product, according to FDA
Court also plans to hold a series of early bellwether trials for lawsuits brought by families of children injured by contaminated formula, to help the parties negotiate a Similac recall settlement that resolves all claims.
The FDA has issued a number of letters to the infant formula manufacturing industry in recent months, warning about safety violations and urging companies to inform the agency of any potential baby food contamination.
Abbott's marketing tactics discourage breast feeding and do not warn parents or doctors about the risk of Similac causing necrotizing enterocolitis, the lawsuit states.
Officials are requiring several infant formula manufacturers to sanitize their production plants after identifying cronobacter contamination that could pose serious health risks to infants.
Family claims Similac cow's milk-based formula caused a deadly case of necrotizing enterocolitis (NEC), which rendered the newborn's bowels nonviable.
Proposal calls for lawsuits over recalled Similac, Alimentum and Elecare products to be selected as early test cases, involving allegations children were sickened or killed by contaminated baby formula
Lawsuit over the risk of NEC from Similac infant formula presents serious enough claims to meet even stringent punitive damages standards, judge finds