Judge rejects GSK motion to dismiss Zofran birth defects lawsuit in Massachusetts MDL

by John Chapman

A Massachusetts federal judge has rejected a motion filed by drug maker GlaxoSmithKilne to dismiss all claims in multidistrict litigation regarding the alleged off-label promotion of the company’s anti-nausea drug, Zofran. U.S. District Judge F. Dennis Saylor IV ruled that the lawsuits, filed by the families of children who were born with birth defects allegedly caused by Zofran, could move forward, saying GSK’s motions to dismiss the claims were premature at best.

The Massachusetts Zofran litigation (Zofran Birth Defect MDL No. 2657) involves about 200 lawsuits filed by parents over cases in which the mother was treated with Zofran during pregnancy to treat symptoms of nausea or morning sickness. Multiple studies have found that women who use Zofran while pregnant are more likely to give birth to a child with serious and potentially fatal birth defects, including congenital heart defects.

Lawsuits filed against GSK allege that the company promoted Zofran to treat nausea in pregnant women despite the fact that the drug was never approved for this use by the FDA. Zofran was originally approved in 1991 by the FDA to treat nausea and vomiting in cancer patients undergoing chemotherapy or radiation therapy, as well as for surgical patients.

These Zofran lawsuits also allege that GSK failed to properly warn patients taking the drug about the increased risk of birth defects their child could face from prenatal exposure to the drug. Children whose mothers used Zofran while pregnant have been diagnosed with birth defects such as congenital heart defects, cleft lip, cleft palate, and other malformations.

Other Zofran lawsuits filed against GSK have alleged that the company knew as early as the 1980s about the link between Zofran and birth defects, but continued to promote the drug to treat pregnant women. GSK allegedly continued to promote the use of the drug during pregnancy despite the fact that other FDA-approved nausea treatments were available for use among pregnant women.

The Massachusetts Zofran MDL was established in Fall 2015 to oversee the early trial stages for the roughly 200 lawsuits involved in the litigation. The Massachusetts MDL is still in its early stages, with several thousand additional lawsuits expected to join the litigation by the end of the year.

Lawsuits Filed Over Birth Defects Caused by Zofran During Pregnancy

Women who gave birth to a child with heart defects or other birth defects (including cleft lip or cleft palate) after taking Zofran while pregnant may be eligible to file a lawsuit and receive compensation. The first step in filing a lawsuit is to speak with an experienced attorney with the knowledge and resources to handle pharmaceutical liability claims.

The lawyers at Heygood, Orr & Pearson have years of experience handling cases involving defective drugs, as well as injuries caused by dangerous medical devices and other products. Our attorneys are trial lawyers in the truest sense of the term, and can handle your case from the very beginning all the way to a verdict or settlement in order to ensure that you receive the best results possible.

For more information about filing a lawsuit and to find out whether you may qualify to file a case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us 24 hours a day by following the link to our free case evaluation form and answering a few simple questions to get started.

by John Chapman

John Chapman is a licensed attorney with experience in complex commercial litigation (including securities fraud, RICO, shareholder oppression, and derivative actions) and personal injury litigation.