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Depakote Facial Dysmorphism

What is Facial Dysmorphism?

Facial dysmorphism refers to a single or set of congenital birth defects involving abnormalities in the growth and development of a baby's face in the womb. The importance of the face as the bearer of identity, character, intelligence, and beauty is universal. Facial dysmorphism and deformity birth defects, which can include such manifestations as facial clefts, eyes too closely or widely spaced, deformed ears, eyes mismatched in color, and facial asymmetries, can be devastating to the parents and the child affected. Surgery, dental care, psychological counseling, and rehabilitation may help to ameliorate the problems but often at great cost and over many years.

Causes of Facial Dysmorphism

No single cause has been identified for the facial dysmorphism type of deformities and defects. The development of the face and skull is coordinated by complex morphogenetic events and rapid proliferative expansion, and is thus highly susceptible to teratogenic drugs (anti-epileptics such as Depakote, Depakene, Depakote ER, Depakote Sprinkle, Divalproex Sodium and Valproate Sodium), environmental and genetic factors.

Although each developmental facial defect or syndrome may be somewhat rare, the number of children affected worldwide is in the millions. In addition, facial deformity birth defects form a substantial component of many other developmental birth defects, largely because they occur very early in gestation, when many of the same genes that orchestrate the development of the brain, head, face, and mouth are also directing the development of the limbs and many vital internal organs, such as the heart, lungs, and liver.

By about the third week after fertilization, the three germ layers of the embryo—the ectoderm, endoderm, and mesoderm—have formed, as well as the first of four sets of paired swellings—the branchial arches—that appear at the sides of the head end of the embryo. Some facial deformity birth defects result from failure of the arches to complete their morphogenetic development. Other facial deformity birth defects are the result of the abnormal differentiation of cells derived from the ectoderm and endoderm or from ectomesenchyme cells, which originate in a part of the ectoderm (the neural crest), in interaction with future connective tissue (the mesenchyme).

The most common of all facial dysmorphism anomalies—and among the most common of all birth defects—are clefts of the lip and palate and cleft palate alone. These anomalies result from the failure of the first branchial arches to complete fusion processes. Clefting can occur independently or as part of a larger syndrome that may include mental retardation and defects of the heart and other organs. Not all cases of clefting are inherited; a number of environmental agents that can cause birth defects have been implicated, as well as the potential lack of essential nutrients such as folic acid. The effect of teratogenic drugs such as Depakote, Depakene, Depakote ER, Depakote Sprinkle, Divalproex Sodium and Valproate Sodium has also been linked by the FDA to these types of facial deformities and defects. Smoking by the mother during pregnancy also increases the risk. It is becoming increasingly evident that most diseases and disorders, not just facial dysmorphism anomalies, result from interactions involving multiple factors. Several syndromic examples of facial dysmorphism are listed below:

The Treacher Collins Syndrome—Mandibulofacial Dysostosis

Children with the Treacher Collins syndrome have downward-sloping eyelids; depressed cheekbones; a large fishlike mouth; deformed ears with conductive deafness; a small, receding chin and lower jaw; a highly arched or cleft palate; and severe dental malocclusion. These defects result from defective cranial neural crest cell differentiation, migration, and proliferation. Consequently, the first branchial arch structures are deficient, and all derivative craniofacial components are affected. The underdeveloped facial structures can contribute to airway blockage and repeated upper respiratory infections, either of which can be fatal. The faulty development of the ears leads to a conductive deafness. The severe facial deformities exacerbate the psychological difficulties these youngsters face.

The Pierre Robin Syndrome

Deficient development of the first-branchial-arch-derived mandibular portion results in the lower jaw’s being set far back in relation to the forehead. As a result, the tongue is set back and may obstruct the posterior airway, compromising respiration and, in severe cases, leading to inadequate aeration and failure to thrive. The infant is also at risk for the development of cor pulmonale, an enlargement of the right ventricle of the heart that occurs secondarily to a chronic lung condition. Cleft palate may be another consequence.

The DiGeorge/Velocardiofacial Syndrome

The primary defect in the DiGeorge syndrome results from altered development of the fourth branchial arch and the third and fourth pharyngeal pouches. Deficiencies affecting the thymus, parathyroid glands, and the great vessels that derive from these structures result. The facial features are subtle and include a squared-off nasal tip, small mouth, and widely spaced eyes. Similar facial features, along with heart defects, are seen in the velocardiofacial syndrome. Further characterization of this chromosomal deletion region will provide information on the specific gene(s) affected and its function in craniofacial development. The thymus defects severely compromise cellular immunity, depriving the body of thymus-derived T cells and paving the way for severe infectious disease. Inadequate or missing parathyroid glands cause severe hypocalcemia (low blood calcium levels) and seizures. The great vessel abnormalities alter cardiac output and lead to compromised circulation to heart tissues.

Speak to a Depakote Lawyer

The Willis Law firm has represented clients in Pharmaceutical Product Liability and Personal Injury litigation for over 25 years. We thoroughly understand the pharmaceutical industry and pharmaceutical product-liability drug litigation. You are not alone. If your child was born with Spina Bifida or other major congenital neural tube and skeletal malformations that may have resulted from your being prescribed and taking Depakote during pregnancy, please contact our law firm immediately to discuss your legal options. Please keep in mind that certain states have a statute of limitations regarding the amount of time you have to seek legal action.

The Willis Law Firm has been responsible for recovering significant settlements and verdicts for our clients. Financial recoveries can never bring back a loved one, but can help families deal with the financial stress associated with a life-changing injury or illness. They may also help prevent similar injuries to others in the future by holding pharmaceutical companies responsible today. Consulting a skilled and experienced pharmaceutical products-liability attorney is your first step in receiving the justice you and your family deserve. Contact us today for a free and confidential Depakote Side Effects lawsuit evaluation.

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Child's Injuries (check those that apply)

Spina Bifida
Neural Tube Defects
Facial Dysmorphism
Hand and Arm Deformities
Congenital Heart Defects
Craniofacial Deformities
Cleft Palate
Other Injuries (explain in detail below)
None of the Above


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