Court rejects foreign information in Zofran Lawsuit
Court Rejects Plaintiffs’ Attempt to Submit Foreign Zofran Info
August 28, 2017
A federal judge in Massachusetts has mostly denied plaintiffs’ attempts to procure and use in a trial foreign regulatory files pertaining to GlaxoSmithKline’s anti-nausea drug Zofran, over which they are suing the drugmaker on claims that it causes birth defects.
Plaintiffs in the case had argued that foreign regulations concerning Zofran could shed light on whether the “Big Pharma” company had misled the U.S. Food and Drug Administration (FDA) about Zofran’s safety.
The judge in the case denied the request to obtain regulatory information on Zofran from the U.K. and Canada, but ruled that GlaxoSmithKline must answer questions about Japanese regulatory measures about the drug.
At issue in the case is whether GSK was aware that Zofran could cause birth defects, as the plaintiffs allege that it does.
GKS maintains that its drug has been properly labeled at all times.
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