Zofran Birth Defects Litigation Continues to Grow

Published on April 23, 2015 by Sandy Liebhard

The litigation involving Zofran and birth defects continues to grow, as two more filings were submitted on April 17th in Texas and Massachusetts. According to court documents, both complaints accuse GlaxoSmithKline of concealing data that linked the anti-nausea drug to fetal abnormalities.

One Zofran lawsuit pending the U.S. District Court, District of Massachusetts, details a particularly tragic case, as it was filed on behalf of a woman who terminated her pregnancy after her unborn baby was diagnosed with severe and life-threatening birth defects, including abdominal malformations. The case filed in the U.S. District Court, Eastern District of Texas, claims that Zofran was responsible for numerous congenital defects, including a heart murmur, sustained by a baby who was born in 2014.

Both mothers were treated with Zofran during their first trimester of pregnancy to alleviate morning sickness, a use that has not been approved as safe and effective by the U.S. Food & Drug Administration (FDA).

Zofran Plaintiffs Question Drug’s Labeling

“GSK failed to state prominently in the Indications and Usage section of its drug label that there is a lack of evidence that Zofran is safe for the treatment of morning sickness in pregnant women, despite GSK’s knowledge that the safety of Zofran for use in human pregnancy had and has not been established…,” the complaints say.

The plaintiffs also claim that Glaxo illegally marketed Zofran as a morning sickness remedy, even though it had never been cleared by the FDA for that use. In 2012, the company reached a settlement with U.S. Department of Justice that involved allegations that the company had “promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis and pregnancy-related nausea); made and/or disseminated unsubstantiated and false representations about the safety and efficacy of Zofran concerning the uses described in subsection (a) [hyperemesis and pregnancy-related nausea]; and offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran,” according to the lawsuits.

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