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Zofran Lawsuit

This case is no longer active

The Legal Team

Kimberly Barone Baden

Ann E. Rice Ervin

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Medical Drug Attorneys

Case Overview

Severe morning sickness can be difficult and painful to deal with as an expectant mother, but the last thing you would want to take is a medicine that may be linked to life-threatening birth defects in unborn children.

While the prescription drug Zofran® (generically known as ondansetron) is approved to treat nausea and vomiting in patients following chemotherapy or surgery, it has been prescribed off-label to treat morning sickness in expectant mothers. Some studies, however, have noted an association between Zofran use in the first trimester and birth defects such as congenital cardiac (heart) malformations.

Attorney Kimberly Baden is co-lead counsel for plaintiffs in multidistrict litigation In re Zofran (Ondansetron) Products Liability Litigation No. 2657 in the District of Massachusetts under Judge F. Dennis Saylor. She has experience handling birth defect cases allegedly caused by numerous pharmaceutical drugs, including Paxil, Zoloft^®, Effexor^®, and Topamax^®.. Kimberly was also appointed to the Plaintiffs' Steering Committee in In re Zoloft (sertraline hydrochloride) Products Liability Litigation, MDL 2342.

Zofran Information

The injectable form of Zofran, which is manufactured by GlaxoSmithKline (GSK), was approved by the FDA in 1991 for the treatment of chemotherapy-induced nausea and vomiting. Oral dosage forms were approved in 1995 for the treatment of post-operative nausea and vomiting and an oral disintegrating tablet, Zofran ODT, was approved in February 1999. The first generic versions of Zofran were approved in 2006. Sandoz marketed the authorized generic for Zofran tablets and Zofran ODT.

There have been several studies that reflect an association between Zofran and severe birth defects, including an increased risk “for a cardiovascular defect and notably cardiac septum defect." The Toronto Star newspaper published an article in June 2014 that detailed many of the concerns we have with Zofran. Read the full article.

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News Coverage

Law360 (Feb. 5, 2019): GSK Can't Escape MDL Alleging Zofran Caused Birth Defects
Law360 (Sept. 13, 2018): FDA Never Saw Birth-Defect Tests On GSK Drug, Families Say
CTV News (Dec. 7, 2015): Women say they weren't warned of possible side effects of anti-nausea drug

Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor's advice can result in injury or death.