Is GlaxoSmithKline Looking to “Deconstruct” Zofran Birth Defects Litigation?

Published on November 15, 2016 by Laurie Villanueva

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A federal judge in Massachusetts has agreed to consider two defense motions seeking the dismissal of certain claims and lawsuits pending in the federal Zofran birth defects litigation. Plaintiffs had objected to both, arguing that they were an attempt by GlaxoSmithKline to “deconstruct” the centralized proceeding currently underway in the U.S. District Court, District of Massachusetts.

According to, one of Glaxo’s motions would dismiss lawsuits based on so-called innovator liability theories, which would permit plaintiffs to sue the company for injuries allegedly caused by generic versions of Zofran. The second motion seeks to dismiss all of the Zofran lawsuits’ fraud-based claims, calling them conclusory and vague.

Plaintiffs had asked the court to either strike the two motions, or stay them until expedited discovery could be conducted. However, U.S. District Judge F. Dennis Saylor IV ruled last Thursday that briefing and arguments on Glaxo’s two motions would be allowed to commence.

Zofran and Birth Defects

According to, all of the Zofran lawsuits pending in Massachusetts were filed on behalf of children who were born with birth defects allegedly related to their mother’s use of the Zofran during the first trimester of pregnancy. While the anti-nausea medication has never been approved to treat pregnancy-related nausea and vomiting, it is frequently prescribed off-label for this purpose. Plaintiffs claim that this is due to aggressive and improper marketing on the part of GlaxoSmithKline.

Glaxo is also accused of concealing data linking Zofran to birth defects, and failing to provide patients and doctors with adequate warnings regarding this alleged risk. Plaintiffs also cite a number of recent studies which suggest children exposed to Zofran in-utero during the early months of pregnancy may be more likely to develop serious congenital abnormalities.

In 2012, GlaxoSmithKline agreed to pay $3 billion to resolve charges with the U.S. Department of Justice   regarding the tactics used to market a number of medications. Among other things, the company had been accused of improperly marketing Zofran as an off-label treatment for nausea and vomiting in pregnancy.

Zofran Birth Defects Case Reviews

Bernstein Liebhard LLP is now offering free legal reviews to families interested in filing a Zofran lawsuit on behalf of their child. To discuss your claim with a member of our legal team, please call ((888) 881-3077.

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