July 11, 2019 / 12:56 AM / 4 months ago

Judge to seek FDA's views on Zofran birth defect cases against GSK

A federal judge on Wednesday said he would seek the views of the U.S. Food and Drug Administration as he considers whether federal law preempts state law claims by women who used the anti-nausea drug Zofran during pregnancy and say GlaxoSmithKline failed to warn them of the risks of their babies developing birth defects.

U.S. District Judge F. Dennis Saylor in Boston said at a hearing that at GSK’s request he would invite the FDA to file an amicus brief addressing whether it believes studies the plaintiffs say the drugmaker never gave the agency could have warranted a change in the warnings on the drug’s label.

To read the full story on Westlaw Practitioner Insights, click here: bit.ly/32l24Ir

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