Zofran Birth Defect Lawsuit Claims Drug Caused Cleft Alveolus

ZofranLegal.com reports on a lawsuit filed by parents in Idaho who allege that their son’s multiple birth defects were caused by exposure to anti-nausea drug Zofran while the child developed in utero. The lawsuit has been filed against Zofran manufacturer GlaxoSmithKline as well as Sandoz Incorporated.

Details of the suit state that the infant boy was born in 2007 with craniofacial defects including a cleft alveolus and ear deformities. After his birth, the boy required multiple surgeries including an alveolar bone graft in order to attempt to correct his defects. The complaint specifically states: “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.” Per the suit, the family is seeking compensation from the defendants.

Zofran was approved by the U.S. Food and Drug Administration in 1991, however, surprisingly enough it was not approved for use in pregnant women, or tested for safety on this consumer group. It was approved specifically for individuals dealing with bouts of nausea and vomiting after chemotherapy, radiation, or anesthesia. After Zofran’s approval, however, GlaxoSmithKline allegedly went on to market the drug “off-label” to treat morning sickness in pregnant women. It was marketed to OB/Gyns directly, and to the general public as well. Today, Zofran is prescribed “off-label” to an estimated 1 million pregnant women annually.

Now, there are over 200 lawsuits which have been filed against GSK, alleging that Zofran has caused a range of birth defects including cleft lip and palate, atrial septal defect and ventricular septal defect, transposition of the greater vessels, and clubfoot. The drug is taken by most women during their first trimester of pregnancy. This is the time that morning sickness is most prevalent and also, unfortunately, the time when much of a fetus’ limb, mouth, and heart development occurs.

Lawsuits against Zofran were consolidated by the Judicial Panel on Multidistrict LItigation in mid-October under MDL number 2657. They will be overseen by U.S. District Judge F. Dennis Saylor in Boston, Massachusetts. This consolidation does not prevent new cases from being filed, however, and it is widely expected that others will join the current suits. The attorneys at Monheit Law are working to ensure that anyone who was prescribed Zofran while pregnant and who subsequently gave birth to a child with defects will be able to explore their legal rights. These individuals and their families may be entitled to substantial compensation. Monheit Law is currently offering those involved free legal consultations.

For additional information on Zofran Birth Defect Lawsuits, or to ask questions, please contact Attorney Michael Monheit by calling (877) 620-8411.