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Parents fight to revive Zofran birth defect lawsuits

The world’s sixth-largest drug company is accused of covering up information that could have prevented serious injuries to fetuses.

BOSTON (CN) — Hundreds of families whose children suffered birth defects after their mothers were prescribed Zofran for morning sickness urged the First Circuit on Tuesday to let them sue British drugmaker GlaxoSmithKline.

After their babies were born with cleft palates, skull deformities and heart defects, among other problems, some 425 people went to court, saying that GSK is liable for failure to warn because it was aware of three animal studies conducted in Japan 20 years ago that linked Zofran to a higher risk of fetal injuries.

A federal judge tossed the suits in June 2021 on preemption grounds, however, noting that the Food and Drug Administration did not deem the studies significant enough to warrant a new warning label when the agency found out about them in 2019.

But that’s “obviously incorrect,” Louis Bograd, an attorney for the families with the Washington firm Motley Rice, argued Tuesday before the First Circuit in Boston. “For preemption, the FDA has to tell the manufacturer that a warning would not be permitted. That never happened here. GSK could have changed its label at any time.”

Bograd said GSK should have changed its label based on a review by an “internationally renowned” expert who found that, even though the Japanese studies didn’t directly find evidence of birth defects, they would have if they were reanalyzed under more modern standards.

GSK’s lawyer, Lisa Blatt of Williams & Connolly in Washington, disputed this. “You can’t just put on a label, ‘By the way, some expert thinks maybe there’s a risk of harm.’ That’s illegal,” she said. “As a matter of law, you can’t say the FDA is wrong. You can’t do that … you can’t second-guess the agency.

“It’s insulting to the FDA, when they’re so focused on women having morning sickness, to say they’re not doing their job,” she added.

Zofran (ondansetron) is approved by the FDA for nausea and vomiting caused by chemotherapy, radiation treatment and surgical recovery. The FDA has never approved it for morning sickness, but it’s prescribed off-label for that purpose to as many as 25% of pregnant women, according to WebMD.

That’s in large part because there are few other prescription medications approved for morning sickness. The most common other treatment is a combination of antihistamine and vitamin B6.

Drug companies aren’t allowed to promote their drugs for off-label uses, but GSK agreed to pay $3 billion in 2012 to resolve claims brought by the U.S. Department of Justice that it promoted several of its drugs, including Zofran, for uses that were unapproved.

GSK had mentioned the Japanese studies in an early FDA filing, but it downplayed them by claiming that they were conducted “specifically to satisfy Japanese regulatory requirements” and “provide no new significant safety information.”

GSK sold Zofran to Novartis in 2015. After parents started filing lawsuits against GSK, Novartis asked the FDA for a label change based on other birth-defect research, and GSK came forward with more details about the Japanese studies. The FDA announced in early 2021 that it wouldn’t require a new warning label, although there’s no clear evidence that it considered the Japanese studies when it did so.

When he threw out the plaintiffs’ suit, Chief U.S. District Judge F. Dennis Saylor said he had to assume that the FDA must have looked at the Japanese studies simply because the agency is supposed to consider all the evidence.

U.S. Circuit Court Judge William Kayatta pressed Blatt on whether the FDA’s failure to require a warning that Zofran shouldn’t be used in pregnancy meant that GSK couldn’t have issued a lesser warning that said doctors should think twice before prescribing it.

Blatt said yes, because the FDA found that “the available data and evidence just don’t show a risk of harm.” She also said that the FDA must be considered to have looked at the Japanese research because, by 2019, the plaintiffs and others “beat the FDA over the head with these animal studies.”

“So you’re saying that it’s one thing if someone just sorts of floats something before the FDA, but if someone jams it in their face and screams about it, that’s different?” Kayatta asked.

“Absolutely,” Blatt replied.

Kayatta, an Obama appointee, worried that “it’s easier for an agency to do nothing, whether by error, incompetence, or whatever, than to do something. So if we start giving the force of law to agencies not doing something, we’re going down a tricky path.”

But Blatt replied, “You don’t have a duty to falsely indict yourself on a label.”

Kayatta was joined on the panel by U.S. Circuit Court Judge Jeffrey Howard, a George W. Bush appointee, and U.S. District Judge Lance Walker, a Trump appointee sitting by designation from the District of Maine. Neither said a word during the argument.

Kayatta asked a number of questions indicating that he had read the Japanese studies but also suggesting that he didn’t relish further immersing himself in the details of teratology, the study of congenital abnormalities. At one point he asked if the panel could simply remand the preemption issue for a jury to decide, but Bograd said that U.S. Supreme Court precedent didn’t allow that.

“So we have to grapple with the science here?” Kayatta asked.

“Yeah, I think you’re stuck with that,” Bograd replied.

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