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Neocate Lawsuit in 2024 (Latest Updates)

A recent study has linked Neocate formula to an increased risk for serious side effects including rickets, low blood phosphate levels (hypophosphatemia), and bone fractures in infants and children. Neocate is made by Nutricia, and serves as an amino acid based formula that is intended for children with food and milk allergies. There are a number of products marketed under the brand name Neocate.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt
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If your child or other loved one suffered broken bones, stunted growth or skeletal deformities after drinking Neocate infant formula, and you are in need of legal assistance, don’t hesitate to contact a Neocate Lawyer for a free case evaluation.

Consumers may be entitled to compensation for medical expenses by filing baby formula lawsuits, and our lawyers can help. Please click the button below for a Free Case Evaluation or call our law firm today by dialing (866) 588-0600.

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Neocate Line of Brands

  • Neocate Syneo Infant
  • Neocate Infant DHA/ARA
  • Neocate Nutra
  • Neocate Junior
  • Neocate Junior with Probiotics
  • Neocate Splash

Baby milk bottle

Neocate Formula Linked to Bone Fractures, Broken Bones, Skeletal Deformities: Study

According to a 2017 study from the National Library of Medicine conducted by researchers at Yale University, a link was specified between infants and young children using Neocate products and severe bone fractures, thought to be the result of phosphate supplements, a condition known as hypophosphatemia or rickets [1].

While in some cases these complications can be reversed by discontinuing Neocate in favor of an alternative soy-based elemental formula, in some babies the multiple fractures resulted in permanent disfigurement.

Specifically, the lawsuit found that 94% of 51 infants diagnosed with a disease called hypophosphatemia had been feeding on Neocate products only. The infants had also been diagnosed with bone disorders like fractures and rickets.

Moreover, those infants who switched to a different brand of infant formula showed demonstrable improvement in their conditions. 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.

The study from Yale and the Mayo Clinic, which was published by BONE journal, is not the only one that links Neocate to infant health issues. Another appeared in the UK-based Bone Abstracts journal, finding “seven cases of exclusively Neocate-fed babies who developed hypophosphataemic rickets.”

The most worrying disorders linked to Neocate relate to the child’s bones, which are caused by an imbalance of the phosphate levels in the body.

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

The most high-profile case linked to Neocate involved the then-10-year-old Robbie Elam. Robbie has cerebral palsy and uses a feeding tube and wheelchair.

In December 2017, Robbie was found to have unexplained fractures by doctors. His father, Bill Elam, who cares for Robbie full-time, was investigated for suspected child abuse by Mississippi Child Protection Services.

Fractures continued to appear on Robbie’s bones throughout early 2018 while his father was being investigated. Eventually, Bill Elam contacted a personal injury lawyer, who was able to provide Elam and authorities with information on the BONE study linking Neocate – Robbie Elam’s only source of nutrition at the time – to fractures. The charges on Bill Elam were dropped, and Robbie was weaned off Neocate.

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

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 [2].

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.

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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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.



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