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Drug manufacturer loses attempt to throw out birth defect lawsuit

The off-label use of medications can result in serious injury. A recent case involving a medication approved by the United States Food and Drug Administration (FDA) for use by chemotherapy or radiation therapy patients provides an example.

More on the medication: What was it and where did it come from?

The United Kingdom based pharmaceutical giant, GlaxoSmithKline (GSK), manufacturers the medication at issue. The company developed the medication, Zofran, as an anti-nausea option for use by cancer patients. Recently filed lawsuits state the company also recommended the off-label use of the medication to treat nausea in pregnant women.

More on the case: What are the accusations and what is the most recent development in the lawsuit?

Pregnant women state they used the medication based on the company’s recommendation to help with nausea. Over 400 have filed lawsuits against the company, stating use of the medication directly contributed to serious birth defects including damage to the heart, mouth and face of the infant.

The company moved for summary judgement, attempting to get almost 100 of the lawsuits thrown out. GSK argued these women lacked the evidence needed to establish the medication caused birth injuries “other than cardiac defects and isolated cleft palate.” 48 patients who had taken the medication and given birth to infants with mouth and face abnormalities disagreed.

Ultimately, the federal judge agreed with the women. In a win for patients’ suffering similar injuries throughout the country, their cases will move forward. The first trial in this case is currently scheduled to move forward in November. We will provide updates as they become available.

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