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Is your child experiencing unexplained bone fractures or developmental issues after using the Neocate formula?
A landmark 2017 Yale study found that 94% of infants using Neocate developed serious complications. Learn how families are seeking justice and what steps you can take to protect your child’s rights.
This article will provide a detailed overview of the Neocate lawsuits, potential health risks, and what parents can do if their child has been affected.
Table Of Contents
- What is Neocate?
- Neocate Line of Brands
- Neocate Formula Linked to Bone Fractures, Broken Bones, Skeletal Deformities: Study
- Side Effects of Neocate
- Has the Manufacturer Warned of Neocate Risks?
- What is Hypophosphatemia?
- What is Rickets?
- Rickets Symptoms
- How is Rickets Treated?
- Can I File a Neocate Lawsuit?
- FAQs
- Get a Free Neocate Lawsuit Evaluation With Our Lawyers
What is Neocate?
Neocate is a line of nutritionally complete elemental or amino acid formulas designed for infants and toddlers who cannot tolerate soy and cow’s milk formulas due to issues like soy or milk allergy, malabsorption, short bowel syndrome, and other GI disorders.
According to a 2018 study by the National Library of Medicine, Neocate has been sold in the United States as Neocate Splash, EO28 Splash, Neocate Junior Probiotic, Neocate Junior, Neocate Nutra, Neocate Infant DHA/ARA, and Neocate Syneo Infant [1].
Neocate Line of Brands
- Neocate Syneo Infant
- Neocate Infant DHA/ARA
- Neocate Nutra
- Neocate Junior
- Neocate Junior with Probiotics
- Neocate Splash
Neocate Formula Linked to Bone Fractures, Broken Bones, Skeletal Deformities: Study
A 2017 study from the National Library of Medicine, conducted by researchers at Yale University, revealed a troubling link between the use of Neocate products and severe bone fractures in infants [2].
The condition, known as hypophosphatemia, stems from low phosphate levels in the blood, which can result in rickets and skeletal deformities.
- Key Findings: 94% of 51 infants diagnosed with hypophosphatemia exclusively used Neocate products. These infants suffered from various bone disorders, including fractures.
- Improvement Upon Switching: Many children significantly improved after switching to alternative formulas.
- Critical Warning Signs:
-
- Bone Fractures
- Growth Delays
- Muscle Weakness
Case Study: Robbie Elam and the Risks of Neocate
The case of Robbie Elam, a child with cerebral palsy, underscores the risks some families have faced with Neocate as a primary nutritional source.
Timeline of Events
- Early 2018: Robbie suffers unexplained fractures, leading to a child abuse investigation against his father, Bill Elam.
- Mid-2018: Fractures persist despite careful monitoring. Bill consults a personal injury lawyer who presents the BONE study, linking Neocate to bone fractures.
- Late 2018: Charges have been dropped, and Robbie has been weaned off Neocate.
As Neocate is a relatively popular product, families are being urged to check on their children who have been fed Neocate and, if necessary, contact a Neocate injury lawyer to pursue compensation.
An 18-month-old boy had a history of esophageal atresia/tracheoesophageal fistula repair and necrotizing enterocolitis. He was orally fed, receiving diuretics and glucocorticoids, and was relatively immobile. After 1 year of Neocate feeding, he demonstrated irritability associated with knee and skeletal manipulation. Stated Luisa F. Gonzalez Ballesteros from Yale University School of Medicine, Department of Pediatrics, New Haven, CT, United States
Related Article: Baby Foods Toxic Metals Lawsuit
Side Effects of Neocate
Serious side effects of Neocate include:
- Bone Fractures – Phosphorus is just as important as calcium in maintaining bone strength. Neocate has been linked to causing low phosphate levels in children’s bones, making them so weak that unexplained fractures can occur.
- Hypophosphatemia – This is an abnormally low level of phosphate in the blood. While hypophosphatemia can be an underlying cause of bone fractures and rickets, there are various other cellular diseases linked to chronically low phosphate levels.
- Rickets – A common disease, but one that is very rare in wealthy countries like the United States. Rickets is usually caused by a lack of vitamin D in the diet. Low phosphate levels can cause hypophosphatemic rickets, which causes the bones to become soft and bendy.
- Decreased Bone Mineral Metabolism – Calcium, phosphorus (which combine to form calcium phosphate), and vitamin D are cited among the key nutrients we need for healthy bones. Patients in the BONE study presented with decreased bone mineralization/bone disorders / broken bones.
- Osteomalacia – a softening of the bones linked to vitamin D and calcium deficiency. This can be present in children and young adults. Worryingly, osteomalacia might show up with few symptoms until an x-ray is carried out.
Other, less severe side effects of the Neocate formula may include:
- Headache
- Nausea
- Hair loss
- Skin irritation
- Multiple food allergies
- Other physical problems
- And more
Has the Manufacturer Warned of Neocate Risks?
In March 2016, Neocate’s manufacturer Nutricia issued a warning that stated that babies using Neocate as a primary or sole source of nutrition “should be routinely monitored by clinicians.” Our lawyers feel this warning is inadequate and does not mention the link between Neocate and hypophosphatemia/rickets, or the seriousness of these complications.
As of 2024, many cases may be consolidated into multidistrict litigation (MDL) due to the similar nature of claims regarding health risks.
What is Hypophosphatemia?
This condition leads to dangerously low levels of phosphate, which is necessary for bone growth and cellular function. Children with low phosphate in the blood can develop weight problems, muscle weakness, breathing problems, and loss of appetite. This condition can also lead to fragility, pain, and improper development.
What is Rickets?
Rickets is a condition that causes weakening and softening of the bones in children. This condition can cause pain in the legs, pelvis, and spine; delayed growth; muscle weakness; and skeletal deformities. Children with rickets may develop bowed legs, breastbone projection, or thickened ankles or wrists.
The most common cause of rickets is vitamin D deficiency, but low phosphate levels can also cause the condition. Children may recover from rickets after months of treatment, but surgery may be necessary to correct deformities.
Rickets Symptoms
Rickets is a medical condition characterized by the softening and weakening of bones in children.
Signs and symptoms include:
- Delayed growth
- Pain in the spine, pelvis, and legs
- Muscle weakness
Vitamin D deficiency is the most commonly reported cause of rickets. However, diseases that cause soft bones in infants, including hypophosphatemia, can also lead to rickets.
How is Rickets Treated?
Unfortunately, rickets can take months or even years to recover from. Surgery may be needed in severe cases to repair bone deformities. Other complications, including chest / pelvic deformities and growth retardation, may be impossible to correct.
Can I File a Neocate Lawsuit?
Only a qualified personal injury attorney can determine whether you are eligible to file a lawsuit against Nutricia, the maker of Neocate, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.
Most cases involving pharmaceuticals allege that a drug was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain side effect.
In the case of Neocate, our attorneys suspect that patients may be able to take legal action in light of claims that Nutricia failed to adequately warn doctors and patients about the risk of bone fractures and other serious potential complications.
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FAQs
How can parents determine if their child’s health issues are related to Neocate?
Parents can determine if their child’s health issues are related to Neocate by consulting with healthcare providers, reviewing their child’s medical history, and considering whether symptoms began or worsened after starting the formula.
Are there any recalls associated with Neocate?
While there may not be official recalls, parents should stay informed about any safety advisories or updates from healthcare providers and the FDA regarding Neocate. Checking for any public warnings or legal actions can provide additional information.
What steps should I take if my child is injured by Neocate?
If your child is injured by Neocate, seek immediate medical attention, document the injury and any treatments, retain medical records and product packaging, and consult a lawyer to discuss potential legal action and compensation.
What If We Used Multiple Formulas?
If you used multiple formulas it doesn’t disqualify you. Document each formula used and discuss details with your attorney.
Can I Join If We Switched Formulas?
Yes, you can join if you switch formulas. Provide all product details to help assess your case.
What Documentation Do I Need?
The documentation that you need includes medical records, receipts, product packaging, and any communications with healthcare providers.
How Long Does the Process Take?
The amount of time the process can take varies, often taking several months to years, especially if litigation or mediation is involved. Your attorney can provide a clearer estimate based on your case.
Get a Free Neocate Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Neocate lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Again, if your child or other loved one sustained a bone fracture or other serious injury from Neocate, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.
References:
- https://www.ncbi.nlm.nih.gov/pubmed/28167344
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5884631/