A 2017 case series in the journal Bone linked Neocate-only feeding with low blood phosphate, rickets and fractures in 51 children. The series shows an association and does not prove cause.
The series covered 17 centres in North America and Ireland. Most of the children had complex illnesses and had been fed only Neocate. The authors urge close monitoring of mineral levels in children on elemental formula.
No MDL names Neocate. Nutricia North America makes Neocate as a medical food for use under medical supervision. A separate 2009 recall of one lot was unrelated to bone harm.
- Case or litigation name: Neocate infant formula and bone disease (no MDL)
- Defendants: No MDL defendants named
- Court and docket number, when available: No MDL docket
- MDL number, judge, and case count, when an MDL exists: No MDL
- Filing date: No MDL transfer order
- Main allegations: The 2017 Bone case series reported low blood phosphate (hypophosphatemia), rickets and fractures in children fed only Neocate, an association and not proof of cause
- Products or people involved: Neocate formulas and the infants and children fed them
Table Of Contents
Latest Neocate Lawsuit Updates
February 4, 2017: Case Series on Neocate and Low Phosphate Is Published
Researchers led by Luisa F. Gonzalez Ballesteros published a case series in the journal Bone [1]. It described 51 children at 17 centres who had low blood phosphate. All were fed Neocate as their sole nutrition.
The authors found fractures, undermineralization or rickets on X-rays in 94% of the children. Most improved after added phosphate or a change to a different formula.
October 9, 2009: Nutricia Recalls One Lot of Neocate Infant
Nutricia North America announced a voluntary recall of Neocate Infant Lot P91877 in a press release [2]. About 3,700 cans were involved.
Protein in that lot fell below the label minimum. The company said it would replace the cans. The notice reported no adverse events, and the recall is unrelated to bone problems.
What Is Neocate?
According to a Nutricia notice on neocate.com, Neocate is a family of hypoallergenic, amino acid-based medical foods. They are for use under medical supervision [3].
Neocate is indicated for cow milk allergy and multiple food allergies. It is also indicated for related gastrointestinal and allergic conditions. The line includes Neocate Infant, Neocate Junior, Neocate Syneo Infant, Neocate Syneo Junior and Neocate Splash.
Who May Be Affected?
Children fed Neocate formula products as their sole source of nutrition may be affected. Often they had complex medical conditions and a diagnosis of low blood phosphate, rickets or unexplained fractures. The series shows how varied these cases were:
- Median age at identification: 3.0 years, with a range of 0.2 to 15.5 years.
- Median Neocate feeding time: 1.3 years, with a range of 1 week to 8 years.
- Medications: 91% of those with medication records took drugs that reduce stomach acid.
Your child’s records decide whether a claim exists, and only an individual legal review of those records can say so.
Reported Injuries or Damages
The Bone case series reported low blood phosphate in children fed Neocate. It also reported rickets, undermineralized bone and fractures. MedlinePlus says a lower than normal phosphate level is called hypophosphatemia [4].
The study was a retrospective chart review. It covered cases from 2014 to 2016. Doctors found low phosphate while checking fractures or rickets. X-rays were used to look for the bone changes.
The authors recommend careful monitoring of mineral metabolism in children fed elemental formula. These are findings from a medical paper, not allegations tested in court.
Recall and Regulatory Background
The 2009 Lot P91877 recall followed a one-time blending error. The cans were distributed between September 1, 2009 and September 11, 2009.
The company said the FDA had been apprised. A later Nutricia notice says Neocate was not part of the Abbott Nutrition recall.
Nutricia also issued a March 2016 monitoring statement to prescribers, as the Bone paper reports. No Neocate MDL has been created by the Judicial Panel on Multidistrict Litigation. See our baby formula recall lawsuit page.
Evidence to Preserve
Keep every record that shows which formula your child used and what followed:
- Product name, can size and lot number, or photographs of the labels on the cans.
- Purchase receipts, insurance or WIC records and prescriptions showing which formula was used and for how long.
- Feeding records and the feeding method used for your child, with dates.
- Medical records, X-rays and lab results for blood minerals such as phosphate and calcium.
- A list of the medications your child took, with start and stop dates.
- Messages, letters and notes from conversations with your child’s doctors and with Nutricia.
- A dated timeline of symptoms, fractures and diagnoses, written down while you still remember them.
Filing Deadlines
Filing deadlines come from state law and depend on where you live. The time limit also depends on when the illness, injury and diagnosis happened, and some states start the clock at diagnosis.
Missing a deadline can end a claim even when the facts are strong, so ask a lawyer promptly about your child’s situation.
Frequently Asked Questions
Is There a Neocate Recall?
Yes, there is a Neocate recall, but only for one lot in 2009, and it was unrelated to bone problems. The press release listed the Nutricia North America Customer Helpline at 1-800-365-7354 for questions.
What Does the Research Say About Neocate and Bone Problems?
The research on Neocate and bone problems is one case series from centres in North America and Ireland. Its authors recommend periodic monitoring of serum phosphorus, calcium and alkaline phosphatase in children fed elemental formula.
What Is Hypophosphatemia in Children Fed Neocate?
Hypophosphatemia in children fed Neocate means a lower than normal blood phosphate level, according to MedlinePlus. In the Bone case series, the low level showed up when doctors evaluated fractures or rickets.
Can I File a Neocate Lawsuit If My Child Used Other Formulas?
A child who used other formulas can still ask about a Neocate lawsuit, because the child’s own records decide whether a claim exists. Records showing each formula used and the dates help show the feeding history.
References
- https://pmc.ncbi.nlm.nih.gov/articles/PMC5884631
- https://www.healthcarepackaging.com/industry-news/regulatory/press-release/13281521/nationwide-voluntary-product-recall-of-neocate-infant-specialized-formula-lot-p91877
- https://neocate.com/blog/information-from-nutricia-regarding-current-availability-of-neocate-products
- https://medlineplus.gov/lab-tests/phosphate-in-blood/