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Families Now Preparing Individual Complaints in Zofran Birth Defect Litigation

Jul 11, 2016

As part of pretrial proceedings in the Zofran birth defect lawsuits against GlaxoSmithKline, families are now completing documents with individual details of their cases.

More than 200 birth defects lawsuits have been consolidated in a multidistrict litigation in federal court in Massachusetts overseen by Judge F. Dennis Saylor, IV. The lawsuits allege that GlaxoSmithKline's anti-nausea drug Zofran caused birth defects in the children of mothers who took the drug during pregnancy.

Both sides are filing standardized documents to make the pretrial process more efficient. Three weeks ago, the families filed a Master Long Form Complaint document that outlines the allegations shared in all the lawsuits. Now, each family must submit a Short Form Complaint, in which the family provides the details of their particular case. When these complaints are filed, together they will become legally binding.

The families will name one or both companies as defendants. Every plaintiff will name GlaxoSmithKline, and families whose child's injury occurred on or after March 23, 2015 will be able to name Novartis as well, because Novartis took on the right to sell Zofran in U.S. markets in March 2015.

The families claim that Zofran (ondansetron) causes major birth defects in children whose mothers took the drug to treat nausea and vomiting in pregnancy. The lawsuits cite studies that show Zofran, which is often prescribed off-label to pregnant women to treat morning sickness, increases the risk of heart defects, cleft lip and cleft palate, kidney defects and other congenital abnormalities, the Legal Examiner reports. The parents claim that GlaxoSmithKline has been aware of the birth defect risks for two decades, but failed to warn the public or the medical community.

While Zofran received Food and Drug Administration (FDA) approval for patients suffering nausea or vomiting in after chemotherapy, radiation, or anesthesia, the drug was never approved for use during pregnancy. A doctor may prescribe a drug for any use he or she deems appropriate, but a drug company may not promote a drug for uses other than those approved by the FDA. The plaintiffs say the GSK did in fact promote the use of Zofran as a morning sickness treatment.

In this phase of the proceedings, plaintiffs will provide details about the child's injuries and about the mother's use of Zofran-whether she took Zofran during the first, second, or third trimester of pregnancy and whether she took a tablet, an oral solution, or an injectable or IV form. The plaintiffs will describe the child's birth defects and injuries and any injuries the parents suffered as a result of their child's condition.

Plaintiffs will select the allegations (outlined in detail in the Master Long Form Complaint) they would like to adopt for their individual cases. Claims include negligence, misrepresentation, failure to warn, and breach of warranty (express and implied), and wrongful death.

GlaxoSmithKline will respond to the short form complaints with a master answer, and will also have the option to file a motion to dismiss each specific case. If the company does not file a motion to dismiss, the court will consider GSK's master answer an official answer to the short form complaint.

Additional families may still be eligible to file a lawsuit during this phase of the pretrial proceedings.

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