By Nate Raymond

A federal appeals court on Monday declined to revive hundreds of lawsuits by women who claim that GlaxoSmithKline Plc failed to warn them that taking the anti-nausea drug Zofran during pregnancy could cause birth defects.

The Boston-based 1st U.S. Circuit Court of Appeals ruled that federal law preempts the plaintiffs’ state-law claims that GSK failed to warn doctors and pregnant women that animal studies found a link between birth defects and taking Zofran.

The ruling upheld a 2021 ruling by U.S. District Judge F. Dennis Saylor that marked the end of 425 lawsuits consolidated before him in long-running multidistrict litigation.

GSK in a statement welcomed the ruling, saying the U.S. Food and Drug Administration has “repeatedly rejected the product labeling that the plaintiffs’ lawyers have advocated for in this litigation.”

Louis Bograd, a lawyer for the plaintiffs at Motley Rice, did not respond to a request for comment.

The FDA approved Zofran in 1991 for preventing nausea and vomiting caused by surgery, chemotherapy or radiation therapy, but the plaintiffs said GSK promoted the drug as an off-label treatment for morning sickness without adequately warning of the risks.

The plaintiffs’ lawyers contended that Japanese animal studies they claimed GSK had withheld from the FDA would have justified a change on the drug’s warning label indicating the studies revealed adverse effects on the fetus.

But U.S. Circuit Judge William Kayatta, writing for the three-judge panel, said those studies did not constitute newly acquired information and that the risks were already known to the FDA as a result of other research when it approved Zofran.

Without any newly acquired information, GSK could not legally change the label without the FDA’s blessing, Kayatta wrote.

Even if the Japanese studies did reveal new information the FDA had not originally considered, Kayatta said the agency’s later decision in 2021 to approve an updated warning label undercut the plaintiffs’ claims.

The 2021 update was in response to a request by Novartis AG, which was not a party to the litigation but had acquired Zofran from GSK in 2015 and proposed warning of the risks of harm to fetuses.

But Kayatta said the FDA, by then aware of the Japanese studies, instead approved a label that said “animal data revealed “no significant effects of (Zofran) on the maternal animals or the development of the offspring.”

“When the FDA formally approves a label stating one thing with full and obvious notice of the directly contrary position, one can read the approval as rejecting the contrary position,” Kayatta wrote.

The case is In re Zofran (ondansetron) Products Liability Litigation, 1st U.S. Circuit Court of Appeals, No. 21-1517.

For the plaintiffs: Louis Bograd of Motley Rice

For GSK: Lisa Blatt of Williams & Connolly

Read more:

Zofran birth defect cases should be revived, say hundreds of plaintiffs

GSK defeats 425 lawsuits alleging Zofran causes birth defects

(NOTE: This story has been updated with a comment from GSK.)




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