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# Court Finds Zofran Suit Preempted by Federal Law
- URL: https://www.fdaweb.com/court-finds-zofran-suit-preempted-by-federal-law/
- Published: 2021-06-02T12:00:00.000Z
- Updated: 2026-09-14T17:01:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149450

The Massachusetts federal court has granted a renewed motion for summary judgment submitted by GlaxoSmithKline to dismiss multi-district litigation alleging that the company failed to provide sufficient warning that the use of Zofran (ondansetron) by pregnant women caused birth defects in their children. The court [held](http://www.fdaweb.com/download.php?file=document%2815%29.pdf) that state failure-to-warn claims were preempted by federal law.

The order details the many times that Glaxo (and later Novartis, which bought the drug from Glaxo) submitted information to FDA on Zofran safety when used during pregnancy and the times the companies requested agency approval for a labeling change. Each labeling request was rejected by FDA, the court said.

“The question of whether Zofran poses a sufficiently significant risk to fetal safety to justify an enhanced warning has been considered, and rejected, by FDA on multiple occasions since the drug’s initial approval,” the order says. “As of today, it is not contraindicated for use during pregnancy, and its labeling contains no enhanced form of warning for such use.”

The court says it found no basis to conclude that any relevant information had been withheld from FDA by the time of its 2021 labeling decision and that there is no doubt that the agency would not approve labeling changes sought by the plaintiffs. “It has effectively rejected those changes,” it said, “and indeed approved contrary language…. FDA, acting pursuant to the duty imposed on it by federal law, has rejected the pregnancy warning label that plaintiffs insist was required by state law at the time of the alleged injuries.”