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Toxic NEC Baby Formula Lawsuit: 2024 Critical Updates

Our lawyers are now actively investigating potential lawsuits for parents and/or guardians of children who developed necrotizing enterocolitis (NEC) or other severe food poisoning injuries after eating recalled baby formulas such as Similac and Enfamil.
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Free Confidential Baby Formula NEC Lawsuit Evaluation: If your child or other loved one developed symptoms of necrotizing enterocolitis nec after eating toxic baby formula, you should contact our law firm immediately. You may be entitled to compensation by filing a baby formula lawsuit against the manufacturer and our NEC baby formula lawyers can help.

Update: Latest Updates in Baby Formula Lawsuits

As of Nov. 2023, there were at least 275 active toxic baby formula NEC lawsuits pending against Mead Johnson in MDL 3026 in Illinois before U.S. District Judge Rebecca R. Pallmeyer. To date, there have been no jury verdicts or settlements in the litigation.

Following the completion of discovery, the first bellwether test trials are likely to start in early 2024. Discussions regarding jury selection and procedures for the bellwether trials against Mead Johnson are currently underway.

Baby Formula NEC Recall List

1. Walmart Recalls 23,000 Containers of Toxic Baby Formula Over Metal Contamination

According to an FDA recall letter issued on Saturday, Perrigo Company is recalling over 23,000 containers of toxic baby formula over concerns the products may contain tiny pieces of metal [1].

Affected products were sold exclusively at Walmart stores, and include 23,388 35 oz. containers of Parent’s Choice Advantage NEC Infant Formula Milk-Based Powder with Iron, FDA said.

The recalled toxic baby formula NEC has a Lot Code of C26EVFV and a “use by” date of February 26, 2021, on the bottom of the package.

To date, the FDA is not aware of any injuries or other adverse events associated with the recalled toxic baby formula NEC, and the problem was discovered following a consumer complaint to the FDA’s MAUDE reporting system.

Related Article: Baby Food Toxic Metals Lawsuit & Attorneys

2. Solgar Recall

As claimed by the U.S. Centers for Disease Control and Prevention (CDC), 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 [2].

According to a 2021 research by Britannica, 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 NEC infant formula produced at Abbott Nutrition’s facility in Sturgis, Michigan. The agency is advising consumers not to use Similac and Enfamil 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 (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, the FDA announced a nationwide recall 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 have found that probiotics may prevent necrotizing enterocolitis (NEC), 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.

3. SimplyThick Recall

As claimed by NPR Organization, the FDA warns parents and nursing staff not to feed babies SimplyThick [5], a product used to help babies with swallowing difficulties because it had been linked to a life-threatening skin disorder known as necrotizing enterocolitis (NEC), which is characterized by severe blistering and peeling of the skin.

The agency was aware of at least 15 cases of baby formula 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.

According to the FDA, reports of negative side effects associated with SimplyThick mixed with breast milk first surfaced on May 13, 2011, with 2 reports to the FDA’s MedWatch Adverse Event Reporting system [6]. Nationwide, at least 4 different medical centers reported toxic epidermal necrolysis in infants during the first half of 2011.

4. Similac Baby Formula NEC Recall

Abbott Laboratories recalled its Similac formula 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 plastic containers or in specific-size cans including 8-ounce, 12.4-ounce, and 12.9-ounce cans.

Similac and Enfamil have also recently been linked to an increased risk for necrotizing enterocolitis.

5. Enfamil Baby Formula NEC

Enfamil, another cow’s milk-based baby formula like Similac, has recently been linked to necrotizing enterocolitis. 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.

Baby Formula NEC Lawsuit Updates

  • November 2023: Justice Pallmeyer has signed an order stating that Mead Johnson’s motions to dismiss are entered and continued for briefing. The plaintiffs’ responses should be filed before the end of the first week of 2024.
  • October 2023: Pallmeyer signed an order outlining the definition of terms and procedures the plaintiffs and Mead Johnson agreed to for how necrotizing enterocolitis pathology reports and expert analysis will be handled.
  • July 2023: Status conference held.
  • April 2023: Lawyers were negotiating how discovery should proceed.
  • March 2023: Science Day was scheduled for May 3, 2023. Both sides present the science of necrotizing enterocolitis and its link to cow’s milk-based baby formula before the court.
  • August 2022: The JPML consolidated approximately 100 lawsuits over NEC claims against Mead Johnson in Illinois MDL 3026.

Similac and Enfamil Studies

According to the National Institute of Health, the 1st study identifying a potential link between cow’s milk-based baby formulas and necrotizing enterocolitis was first published in the Lancet [7] in 1990, which found that formula-fed babies were 20x more likely to develop NEC compared to children who were nourished with breast milk.

Journal of Pediatrics Study
A decade after the Lancet study came out, a study published in the Journal of Pediatrics found that babies fed with breast milk or human milk fortifiers were 90% less likely to develop NEC compared to those fed with formula products. In 2013, a pair of additional studies were published which reached even more definitive results about the association between NEC and cow formulas.

New NEC British Medicine Study
A study published in October 2021 by the British Medical Journal (BMJ) [8] suggested that the makers of Similac and Enfamil infant formulas have funded biased and unreliable clinical product trials. The study’s authors determined that the infant formula trials showed a “universal lack of transparency” and may have downplayed the risks of NEC linked to their cow-milk formula products.

More NEC Formula Studies
A study titled Evidence-Based Feeding Strategies Before and After the Development of Necrotizing Enterocolitis, which was published in Expert Review of Clinical Immunology in July 2014), stated that “Necrotizing enterocolitis (N.E.C.) is a devastating disease of premature infants with significant morbidity and mortality. It is well established that the risk is increased by the administration of infant formula.” This should be a key study in any successful NEC baby formula lawsuit.

In 2016, another round of clinical study results were published in Seminars in Perinatology titled Beyond Necrotizing Enterocolitis Prevention – Breastfeeding Medicine and Human Milk is the Feeding Strategy to Prevent Necrotizing Enterocolitis. The authors concluded that “Extremely premature infants who received an exclusive HUM [Human Milk] diet had a significantly lower incidence of NEC and mortality. The HUM group also had a reduction in late-onset sepsis, BPD, and ROP. This multicenter study further emphasizes the many benefits of an exclusive HUM diet, and demonstrates multiple improved outcomes after implementation of such a feeding protocol.”

In 2019, the independent healthcare research group Cochrane published the results of the most comprehensive study to date comparing health results for premature babies fed with cow’s milk-based formula versus human milk. The findings put to rest any lingering confusion about the existence of a causal relationship between cow-milk-based formulas and NEC in premature infants.

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).

According to the U.S. Federal Food, Drug, and Cosmetic Act (FFDCA) [9], infant formula is “a food which purports to be or is represented for special dietary use solely as a food for infants because it simulates human milk or its suitability as a complete or partial substitute for human milk.” It applies to cow’s milk-based formula and other derivatives.

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.

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

According to research by Courtesy Johns Hopkins Medical [10].

Abbott Faces New NEC Lawsuits Over Baby Formula’s Risk of Deadly Illness

Abbott Nutrition faces an increasing number of NEC infant formula lawsuit cases 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 cow’s milk-based Abbott’s Similac, Alimentum, and EleCare brands of infant formula. Abbott recalled certain products 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 infant formula NEC 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 cow’s milk-based Similac infant formula due to the ensuing NEC baby formula lawsuits.

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 cow’s milk-based NEC baby formula lawsuits.

Our NEC baby formula lawyers feel that if there is a successful resolution to these cases, individual NEC baby formula lawsuits, not class actions will be the best way to get maximum payouts to our clients from baby formula manufacturers.

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 from baby formula manufacturers for the damages caused by your injuries. Contact us today to learn more about your legal rights during an NEC baby formula lawsuit case.

Settlement Amounts in the NEC Baby Formula Lawsuit

The cases with the highest potential payout in the NEC Baby Formula Lawsuit are those where the child needs ongoing medical care. The cost of lifelong care for many of these children runs into millions of dollars.

Other Baby Formula Lawsuit incidents with high settlement amounts are wrongful death cases. Settlements in these NEC lawsuits could be in the range of $250,000 to $750,000.

In baby formula lawsuit cases where the child endured a great deal of pain and suffering but ultimately managed to recover, the compensation is still likely to be high. These NEC formula lawsuits could range from $50,000 to $400,000, depending upon the extent of the child’s injuries.

It is important to understand that this litigation is new and these are just estimates. So take these estimates with a grain of salt and contact our lawyers today to learn more about your legal rights during NEC infant formula lawsuits.

Hiring a NEC Baby Formula Lawyer

When pursuing an NEC lawsuit, you should seek a lawyer who has extensive experience handling mass torts, which are large litigations for hundreds or even thousands of different claimants. In most cases, these torts are filed against large corporations that employ big legal teams to defend them.

A baby formula NEC lawsuit is complex and involves a significant amount of complicated science and law. Lawyers with experience in large injury litigations are equipped to acquire the needed evidence and prove their client’s case in front of a jury.

It also helps to find an NEC baby formula lawyer who works with a law firm that has a proven track record of settling cases and obtaining jury verdicts.

Related Articles:

See all related food poisoning lawsuits our attorneys covered so far.

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Have you or a loved one suffered food poisoning from consuming contaminated food or beverages?

Get a Free NEC Baby Formula NEC Lawsuit Evaluation With Our Lawyers

The Food Poisoning Litigation Group at Schmidt & Clark, LLP 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 NEC infant formula lawsuits in all 50 states.

Free Baby Formula NEC Lawsuit 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 baby formula NEC Lawsuit and we can help.

References:

  1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/perrigo-issues-voluntary-recall-parents-choice-advantage-infant-formula-milk-based-powder-iron
  2. https://www.cdc.gov/fungal/outbreaks/rhizopus-investigation.html
  3. https://www.britannica.com/science/Rhizopus
  4. https://www.cdc.gov/fungal/diseases/mucormycosis/index.html
  5. https://www.npr.org/sections/health-shots/2011/05/23/136574547/fda-warns-against-food-thickener-for-premature-infants
  6. https://open.fda.gov/data/faers/
  7. https://pubmed.ncbi.nlm.nih.gov/1979363/
  8. https://www.bmj.com/content/375/bmj.n2202
  9. https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
  10. https://www.hopkinsmedicine.org/health/conditions-and-diseases/toxic-epidermal-necrolysis

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