Zofran: MDL 2657: On the Reverse Trail

Defective Drugs
Zofran Birth Defects Lawsuit

Zofran (Ondansetron) Products Liability Litigation, is being presided over by Honorable F. Dennis Saylor IV, at the US District Court for Massachusetts. The number of Zofran lawsuits filed has substantially increased from 200 in 2015 to 350 lawsuits in 2016. That number has further catapulted to more than 400 lawsuits to date. Surely there are more are to follow.

In accordance with the April 6, 2017, court order, the court granted plaintiffs’ motion to compel production of documents and communications related to the Department of Justice’s Investigation of GlaxoSmithKline LLC’s Off-Label Promotion of Zofran” (Docket No. 576). This additional evidence should make the case even stronger for the plaintiffs.

The first Zofran lawsuit was filed in 2015 by a mother who delivered two girls with congenital heart issues. Zofran complaints soon grew to the size of a mass tort and were consolidated into MDL 2657. As the news spread with regards to the MDL formation, more and more women came forward and became a part of it. It is anticipated that the number of lawsuits will soon go up to 500 by the end of the year.

GSK already experienced its first jolt, in 2012, when it had to cough up a whopping $3 Billion penalty for generating millions ‘off label’ prescriptions such as Paxil, Wellbutrin and Avandia. Nondisclosure of crucial clinical trial data and failure to update the warning label are other strong factors that make the ground shakier for GSK.

Zofran, manufactured by GlaxoSmithKline (GSK), was launched in the early 1990’s in the US market as an antiemetic drug, used for nausea and vomiting caused by cancer chemotherapy, radiation therapy, surgery, and gastroenteritis. It garnered popularity when it became one of the leading ‘off-label’ drugs, prescribed for morning sickness and hyperemesis gravidarum, a serious type of morning sickness that causes severe nausea and weight loss. Eventually, more pregnant women were also offered this medication for morning sickness and nausea without any specific caution or warning. Very soon, abnormalities were observed and reported in newborns across the country such as jaundice, severe congenital birth defects: cleft lip, cleft palate, webbed toes and many more. All these could be linked to one common factor: Zofran.

For a Zofran lawyer, MDL 2657 is a crystal clear case of serious lapse on part of the Manufacturer. What you need at this time is a good medical review by an expert who can help you with Proof of usage (POU) and Proof of Injury (POI); this would conclusively and surely favor the plaintiff’s cause.

This article was submitted by Neural IT. Neural IT provides cost effective and timely medical reviews for screening potential mass tort cases. For more information, please visit www.neuralit.com. You may email us at [email protected] or call +1-844-NIT-TEAM (648-8326).

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