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Update: Abbott Faces New Lawsuits Over Baby Formula's Risk of Deadly Illness
Abbott Nutrition faces an increasing number of lawsuits after recalling its powdered infant formula, which was linked to the hospitalization of three babies and at least one death.
All four babies had become sick from Cronobacter sakazakii or salmonella infections after ingesting Abbott’s Similac, Alimentum, and EleCare brands of infant formula. Abbott recalled certain product lots of these brands on February 17, 2022.
Less than a month after the recall, the parents of a hospitalized baby in Texas filed a pre-suit petition against Abbott in Kaufman County District Court. According to the lawsuit, the baby developed diarrhea so severe that the parents took him to the hospital, where he stayed for several weeks. Tests confirmed the child had a Cronobacter sakazakii infection.
Another baby died on February 28, with a Cronobacter infection noted by doctors as a “contributing cause of death.” Abbott then expanded its recall to include another lot of its Similac infant formula.
Baby Formula Recall List
Walmart Recalls 23,000 Containers Baby Formula Over Metal Contamination
Perrigo Company is recalling over 23,000 containers of baby formula over concerns the products may contain tiny pieces of metal, according to an FDA recall letter [1] issued on Saturday.
Affected products were sold exclusively at Walmart stores, and include 23,388 35 oz. containers of Parent’s Choice Advantage Infant Formula Milk-Based Powder with Iron, FDA said.
The recalled baby formula has a Lot Code of C26EVFV and a “use by” date of February 26, 2021, on the bottom of the package.
To date, FDA is not aware of any injuries or other adverse events associated with the recalled baby formula, and the problem was discovered following a consumer complaint to FDA's MAUDE reporting system.
Related Article: Baby Food Toxic Metals Lawsuit & Attorneys
Solgar Recall
Three lots of the probiotic ABC Dophilus were recalled in Nov. 2014 when a premature baby died after being given the supplement in a hospital, according to the U.S. Centers for Disease Control and Prevention (CDC) [2].
The agency determined that the affected product contained Rhizopus oryzae [3], a fungus that can cause a severe infection of the sinus, lungs, intestines and skin called mucormycosis [4].
FDA Warns Consumers Not to Use Baby Formulas Produced by Abbott Nutrition
The FDA is investigating consumer complaints of Cronobacter sakazakii and Salmonella Newport infections linked to powdered infant formula produced at Abbott Nutrition’s facility in Sturgis, Michigan [5]. The agency is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if:
- the first two digits of the code are 22 through 37; and
- the code on the container contains K8, SH or Z2; and
- the expiration date is 4-1-2022 (APR 2022) or later.
"The FDA is investigating complaints of four infant illnesses from three states," the agency said. "All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case."
The illnesses occurred in Minnesota, Ohio and Texas.
Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine).
Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.
Baby Dies from Infection Linked to ABC Dophilus
On Nov. 17, 2014, FDA announced a nationwide recall [6] for 3 lots of ABC Dophilus Powder after it was found to contain Rhizopus oryzae.
ABC Dophilus was used as part of the in-hospital treatment course for a preterm infant who died after being given the product. The baby suffered from multiple complications, including intestinal mucormycosis, and died on Oct. 11, 2014.
CDC investigators later found Rhizopus oryzae fungus in containers of ABC Dophilus with the same lot number as the product given to the deceased infant.
Which Products Were Recalled?
- Product Recalled: Solgar ABC Dophilus® Powder NET Wt. 1.75 oz (50 g)
- UPC Code: 0 33984 00010 0
- Label: Solgar
- Lot Numbers: Lot# 074024-01R1, 074024-01, 074024-02
- Expiration Date: 7/31/15
ABC Dophilus products affected by this recall were distributed to Alabama, Arkansas, Arizona, California, Connecticut, Colorado, Florida, Iowa, Illinois, Indiana, Michigan, Maine, Montana, Massachusetts, North Carolina, Nebraska, New York, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Utah, Tennessee, Texas, Vermont, Kentucky, Wisconsin and Washington.
What is ABC Dophilus Powder?
ABC Dophilus Powder is a probiotic blend of bacteria specially formulated to maintain digestive health in children and infants. The supplement can be purchased over the counter for use at home, and is also used in some hospitals.
Medical studies [7] have found that probiotics may prevent necrotizing enterocolitis (NEC), an inflammation and necrosis (death of tissue) of the bowel. ABC Dophilus Powder is manufactured by Solgar Inc. of Leonia, New Jersey.
Rhizopus Oryzae
Rhizopus oryzae is a common fungus found in decaying organic matter like leaves and rotting wood. An outbreak of mucormycosis of the skin caused by rhizopus oryzae occurred during the cleanup of the Joplin, Missouri tornado in 2011.
According to a Solgar spokesperson, because the fungus is so ubiquitous, “the exact source of where this mold came from is extremely difficult to determine.” ABC Dophilus is made for Solgar by a contract manufacturer, but the company declined to name its supplier.
SimplyThick Recall
FDA warns parents and nursing staff not to feed babies SimplyThick [8], a product used to help babies with swallowing difficulties, because it had been linked to a life-threatening skin disorder known as necrotizing entercolitis (NEC), which is characterized by a severe blistering and peeling of the skin.
The agency was aware of at least 15 cases of NEC -- including 2 infant deaths -- linked to SimplyThick.
SimplyThick is added to breast milk and formula to help keep food down without spitting up, and may also be used in older children and adults with swallowing problems caused by throat trauma.
Reports of negative side effects associated with SimplyThick first surfaced on May 13, 2011, with 2 reports to FDA’s MedWatch Adverse Event Reporting system [9]. Nationwide, at least 4 different medical centers reported toxic epidermal necrolysis in infants during the first half of 2011, FDA said.
Related Article: Onfi Toxic Epidermal Necrolysis Lawsuit
What is Necrotizing Enterocolitis (NEC)?
Necrotizing enterocolitis is a rare but extremely serious medical condition seen almost exclusively in premature infants that is characterized by necrosis (tissue death) in the bowels. The inner lining of the intestines contains millions of normally harmless bacteria called the ‘normal flora’ that are part of the digestive process. In NEC, however, the bacteria begin to attack the intestinal wall.
Eventually, a hole can form through the bowel wall (a perforation), spilling its contents into the abdominal cavity. Bowel perforation is a medical emergency that requires immediate surgery and has a high mortality rate.
Although it affects only 1 in 2,000 to 4,000 births, or between 1% and 5% of neonatal intensive care unit (NICU) admissions, NEC is the most common and serious gastrointestinal disorder among hospitalized preterm infants.
Symptoms of Necrotizing Enterocolitis
- feeding intolerance
- increased gastric residuals
- abdominal distention
- bloody stools
- bloated stomach
- greenish-tinged vomiting
(Courtesy Johns Hopkins Medical) [10]
Similac Baby Formula Recall
Abbott Laboratories recalled its Similac formula recall after the FDA said the product could cause internal discomfort and could lead infants to refuse to eat. Affected products included powdered formula (not liquid Similac), and were sold in either in plastic containers or in specific size cans including 8-ounce, 12.4-ounce, and 12.9-ounce cans.
Similac has also recently been linked to an increased risk for necrotizing entercolitis.
Related Article: Similac NEC Lawsuit
Enfamil Baby Formula Linked to NEC
Enfamil, another cow's milk-based baby formula like Similac, has recently been linked to necrotizing entercolitis. Premature infants who are fed Enfamil may develop a perforation (hole) in their intestines.
Dangerous bacteria can leak into the abdomen or bloodstream through the hole. Children develop NEC within 2 to 6 weeks after birth.
Related Article: Enfamil NEC Lawsuit
Should You Feed Your Child Baby Formula?
FDA classifies baby formula as a food, not a drug. The products are designed and marketed for feeding to babies and infants under 12 months of age, usually prepared for bottle-feeding or cup-feeding from powder (mixed with water) or liquid (with or without additional water).
The U.S. Federal Food, Drug, and Cosmetic Act (FFDCA) [11] defines infant formula as "a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk"
Despite conflicting clinical trials and lack of FDA approval, probiotic supplements like ABC Dophilus have been increasingly used in neonatal intensive care units (NICUs) to prevent necrotizing enterocolitis (NEC), a disease of premature infants where the intestinal wall becomes inflamed and bacteria invade the bowel wall.
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Can I File a Class Action?
Although Schmidt & Clark, LLP, is a nationally recognized class action firm, we have decided against this type of litigation when it comes to baby formula recall lawsuits.
Our lawyers feel that if there is a successful resolution to these cases, individual suits, not class actions will be the best way to get maximum payouts to our clients.
If your child or other loved one has been harmed by the side effects of a baby formula product, we know you’ve suffered emotionally and economically, and want to work with you personally to obtain the maximum compensation for the damages caused by your injuries. Contact us today to learn more about your legal rights.
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Get a Free Toxic Baby Formula NEC Lawsuit Evaluation With Our Lawyers
The Food Poisoning Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in baby food recall lawsuits. We are handling individual litigation nationwide and currently investigating new injury and death cases in all 50 states.
Free Case Evaluation: Again, if your child got sick after eating recalled baby formula products, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.
