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New Zofran Lawsuit Claims Medication Caused Craniofacial Defects

An Idaho couple filed a Zofran lawsuit this month against GlaxoSmithKline (GSK), the makers of the medication, claiming that the company is responsible for causing birth defects in their son.

According to court documents, the plaintiffs’ son was born in 2007 with severe craniofacial defects, which included ear deformities and cleft alveolus. Shortly after his birth, the baby endured numerous invasive surgeries to help correct the defects, including an alveolar bone graft. Per the lawsuit,

“His birth defects impair his ability to develop fully and enjoy life both at home and at school because he lives with a craniofacial birth defect that subjects him to teasing and bullying.”

What is Cleft Alveolus?

According to Mount Sinai Hospital, cleft alveolus is a birth defect that occurs in the bones of the gum tissue, in front of the palate. Cleft alveolus varies in severity as it can as minor as a small notch or as severe as a full gap from the nose to the upper teeth. Babies with cleft alveolus most often have difficulties sucking a bottle and may experience loose fluids that come from the nose. The fluid can also develop in the ears, causing ear problems.
Gavel close up

Severe cases of cleft alveolus generally require bone graft surgery. Infants may undergo the surgery when teeth start developing and during growth periods, anywhere from 6 to 12 years of age.

What is Bone Graft Surgery?

Alveolar bone graft surgery is a procedure in which bones are added to the gum ridge in order to repair the hole and stabilize the bone arch between the nose and the upper gums. A piece of the child’s bone is usually taken and added to the gum ridge. The bone is typically taken from an upper portion of the child’s hip bone, the iliac, after a surgeon cuts a 1 to 3 inch incision in the area. The bone from the hip area (a soft bone that can be shaped) is then placed into the alveolar bone, shaped, and closed up. The child will likely get stitches to hold the area in place.

This type of surgery is extremely invasive and may need to be repeated as the child gets older. In addition, it’s not only stressful for a child to undergo this type of procedure, but it’s emotionally taxing on parents who experience their child being put to sleep and undergoing such an intrusive surgery.

GSK and Zofran Lawsuits

The Idaho parents are the latest plaintiffs in a series of lawsuits that have already been filed by other parents against GSK. Zofran is an anti-nausea medication that’s only been approved for use by cancer patients and those undergoing surgery. Yet, GSK began marketing the drug as off-label use for morning sickness without disclosing that infants of mothers who take Zofran may develop birth defects, some of which are life-threatening and even fatal.

Currently, there are more than 200 lawsuits pending against GSK, all of which parents assert that their babies were born with birth defects after their mother was prescribed Zofran for morning sickness. The plaintiffs allege that they were never told that taking Zofran while pregnant increases the risk of babies developing birth defects.

Keep in mind that if you took Zofran while pregnant and your baby developed birth defects as a result, you have the legal right to file for damages against the responsible party.