Neocate® Baby Formula Linked to Hypophosphatemic Rickets and Bone Disease in Infants and Children
Does Your Child Have a Case?
Parker Waichman LLP offers a free consultation to review Neocate-connected rickets and bone disease cases in infants and children to determine if the parent(s) has a case from both a legal and financial perspective. Our Neocate Lawsuit Attorneys will review the facts of the potential case and determine if there is enough evidence to proceed.
Neocate® (an Elemental Formula) is an amino acid-based liquid diet for small children, infants, and babies who have feed intolerance or significant allergies or sensitivities to regular formula, soy milk, cow’s milk or other types of milk. In many cases, Neocate® products are given to infants or children as their primary source of nutrition. New research studies, however, have linked Neocate® baby formula products with rickets, bone fractures, hypophosphatemia, and other severe skeletal deformities.*
The Neocate® Baby Formulas (G556 Elemental Formula) linked to Hypophosphatemic Rickets, and bone disease includes:
- Neocate® Syneo Infant (0-12 months)
- Neocate® Infant DHA/ARA (0-12 months)
- Neocate® Nutra (6+ months)
- Neocate® Junior (1+ Years)
- Neocate® Junior with Probiotics (1+ Years)
- Neocate® Splash (1+ Years)
- Neocate® EO28 Splash (1+ Years)
Nutricia’s advertising claimed its Neocate® line of elemental formulas is “nutritionally complete.” However, some reports have surfaced claiming Nutricia was aware of potential Neocate® health risks back in 2015. It is also alleged that Nutricia failed to issue a proper warning to consumers about these risks . After Nutricia conducted its own internal studies of its Neocate® products, it then changed its formulas to correct the nutritional deficiencies back in 2018.
If your child has suffered from bone damage complications and was using Neocate® baby formulas, Parker Waichman LLP can assist you in ascertaining if your family has grounds to file a product injury lawsuit against the makers of Neocate®.
FREE CASE REVIEW – DO YOU HAVE A CLAIM?
If your baby or young child consumed Neocate® baby formula, and he or she developed rickets, hypophosphatemia, or bone disease, contact Parker Waichman LLP today for information about filing a lawsuit to demand monetary compensation from the manufacturer. For more information about your legal rights and to receive your free consultation, call Parker Waichman LLP at 1-800-YOURLAWYER (1-800-968-7529) or use our Live Chat.
What Are Elemental Formulas?
Elemental Formulas are baby food that is either consumed orally or through tube feeding applications. Elemental Formula baby food products are marketed and sold as nutritional alternatives for babies and small children who have severe food allergies or gastrointestinal medical conditions. Elemental Formula is supposed to provide similar nutritional benefits found in dairy products. An example of one such allergy is a milk protein allergy which is usually diagnosed with infants who show signs of crying in pain, have poor weight gain, and have blood in their stool. These baby food products do not contain any intact proteins, only the building blocks of proteins and individual amino acids. Intact proteins found in milk are the cause for allergic reactions or intolerance reactions in infants with milk sensitivities or allergies. Elemental Formulas are not usually available for purchase at grocery stores.
What Are Amino Acid-Based Baby Formulas?
Baby formulas that are “amino acid-based” are supposed to offer complete nutrition for babies, infants, toddlers, and small children who are in need of additional nutritional support. Amino acid-based formulas are also appropriate for infants and small children who cannot tolerate extensively hydrolyzed baby formulas. Since amino acids are only protein building blocks, these amino acid-based formulas do not contain intact proteins. That is why amino acid-based are tolerated by most infants and children. Amino acid-based baby food formulas are also called “elemental” formulas.
Does Neocate® Cause Rickets or other Bone Disease?
According to Clinical Pediatrics, 2020, Vol. 59(12) 1080–1085, it is estimated that at least “11% and up to 23% of all tube-fed children receiving Neocate develop metabolic bone disease.” Clinical Pediatrics also recommends that pediatricians exercise caution when using amino acid-based formulas (especially Neocate® Infant and Neocate® Junior) and to monitor patients for signs of hypophosphatemia.
Hypophosphatemia (low phosphate) is an electrolyte dysfunction caused by low levels of phosphate in the blood. The symptoms of hypophosphatemia may include trouble breathing, weakness, and loss of appetite. Hypophosphatemia can lead to coma, seizures, rhabdomyolysis, or softening of the bones. Diagnosing hypophosphatemia is performed through a blood test. If the blood phosphate level falls below 0.81 mmol/L (2.5 mg/dL), the patient is diagnosed with low phosphate or hypophosphatemia. Treatment of hypophosphatemia is based on the underlying cause of the patient’s low phosphate. Treatment may include supplementation of phosphate and/or dietary changes.
Clinical Pediatrics concluded in its study that a number of infants and small children who consumed the amino acid-based formulas, Neocate® Infant or Neocate® Junior, as their primary source of nutrition developed “biochemical identification of hypophosphatemia and radiographic evidence of bone disease.” Moreover, children consuming these amino acid–based formulas experienced an increase in serum phosphorus and decreased serum alkaline phosphatase following phosphate supplementation, a formula change, or both. The phosphorus supplementation and/or formula change was shown to be effective in improving and maintaining serum phosphorus and serum alkaline phosphatase levels over an extended period of time.
A research study published in Bone, 2017 April; 97: pages 287–292, found that 51 children treated at 17 different institutions developed EF-associated Hypophosphatemia. In this research study, the children who participated in the study suffered from “complex illnesses,” and were only served Neocate® formula products over different intervals. Hypophosphatemia was discovered when the children were examined for rickets and bone fractures.
According to the research study, skeletal radiographs of the children confirmed under-mineralization of bones, fractures, or rickets which were discovered in 94% of the children who were analyzed in the study. However, the skeletal disease was often initially attributed to an underlying disease; most cases improved with the supplemental phosphate or switching the patient to a different baby formula product. The study concluded that the extensive results of the study’s findings caused the researchers to “strongly recommend” thorough monitoring of mineral metabolism in children fed Elemental Formula (EF) and to either shift to a different formula or begin phosphate supplementation as severe hypocalcemia could develop.
What is the Danger With Neocate Baby Formula?
Research studies have associated Neocate® baby formula products with phosphorus deficiencies in infants and young children. Phosphate deficiencies can cause bone health problems health concerns. The maker, Nutricia, advertised its Neocate® baby food product line as “nutritionally complete.” After knowing about the health risks, Nutricia eventually conducted its own research studies and then changed its formulas to correct the nutritional deficiencies in 2018.
The Dangers of Low Phosphorus Levels
According to the aforementioned research studies, a deficiency in phosphorus levels can lead to several severe side effects. Studies show that some bone problems can be reversed, while other severe side effects can be permanent.
The side effects of low phosphorus may include:
- Metabolic Bone Disease
- Hypophosphatemic Rickets
- Broken bones
- “Soft” bones
- Skeletal deformities/damage
- Poor growth
- Pain and discomfort
- Muscle weakness
What Causes Rickets (Osteomalacia) in Infants or Young Children?
Rickets is a medical condition that affects bone development in small children and typically develops in children who are deficient in certain “bone-building” vitamins and minerals such as calcium, vitamin D, and phosphorus. Rickets is characterized by symptoms including soft, weak bones, which may lead to bone and skeletal deformities. Other symptoms of rickets (Osteomalacia) include bone pain, poor growth, a projected breastbone, thick ankles, and wrists.
Did Your Child Suffer Harmful Side Effects After Taking Neocate®?
Your Family May Be Entitled to Justice and Monetary Compensation
If your child has sustained debilitating and permanent side effects due to a Neocate®, you might be entitled to file a lawsuit to obtain legal justice and monetary compensation from the manufacturer.
Your family may have a claim if:
- Your child consumed Neocate® product for an extended period of time including prior to March 2018; and
- Your child suffered any of these specific side effects & injuries after consuming a Neocate® product:
- Rickets (Osteomalacia)
- Bone Fractures / Bone Breaks
- “Soft” bones
- Metabolic Bone Disease
- Hypophosphatemic Rickets
- Stunted Growth
- Long-term skeletal damage
- Skeletal Deformities/Damage
- Poor Growth
- Bone and joint pain and discomfort
If your child was harmed after consuming Neocate® products, our Neocate® lawyers are here to you help ascertain if you have legal grounds to file a lawsuit against the makers of Neocate® .
FREQUENTLY ASKED QUESTIONS (FAQS) ABOUT NEOCATE® LAWSUITS AND SETTLEMENTS
How Much Time Do I Have to File Our Neocate Lawsuit?
Every state has laws, called “statutes of limitation,” that limit the amount of time someone may bring a product liability lawsuit. In the case of Neocate® Hypophosphatemic Rickets and Bone Disease Lawsuits, the potential plaintiff must be over the age of 18. So, a parent or legal guardian would file a lawsuit on behalf of their child while the minor child is under the age of eighteen.
Because all states have varying state laws, it is crucial that you discuss the statute of limitations that pertains to your potential Neocate® Lawsuit. Furthermore, if the injured child has passed away, the deadline to file a lawsuit could be even shorter.
What Are My Chances of Obtaining Compensation Through a Settlement or Jury Award?
Your probabilities of obtaining full monetary compensation for your child depends on several important elements that include but are not limited to:
- Evidence that your child was using a Neocate® baby formula product;
- Documentation that your child was diagnosed with Rickets, Metabolic Bone Disease, Hypophosphatemia, Hypophosphatemic Rickets, or Skeletal Deformities/Damage;
- Evidence of the financial loss associated with Neocate®, such as medical expenses, or any other expenditures that are linked to the management and treatment of Neocate-related injuries;
- Evidence and expert testimony that establishes a causal link between Neocate® and the aforementioned Neocate-related injuries.
Parker Waichman LLP is currently investigating potential Neocate® Rickets and Bone Disease Lawsuits, and we will review all aspects of your potential claim and what is necessary to move forward.
CALL PARKER WAICHMAN LLP FOR YOUR FREE CASE REVIEW
Time is essential when considering legal action. To learn if you have a potential Neocate® Injury Claim, it is crucial that you act quickly and speak with our firm about your case before missing any important deadlines.
At Parker Waichman LLP, we will thoroughly assess your potential Neocate® Claim and equip you with the critical information and the necessary guidance you need to move forward. To receive your free case review, contact our law office today by calling 1-800-YOURLAWYER (that’s 1-800-968-7529).
*Studies have inferred that by taking children off of a Neocate® diet, symptoms improved. However, some deformities produced by “low phosphorus levels” may be permanent.
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