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Plaintiffs are anxiously awaiting Judge F. Dennis Saylor’s decision on a motion filed by GlaxoSmithKline to dismiss every Zofran lawsuit currently filed in the US District Court for Massachusetts.

More than 200 lawsuits, which allege that GlaxoSmithKline failed to disclose Zofran’s link to birth defects, are consolidated in Boston, where they await the beginning of pre-trial proceedings. But on December 11, 2015, GlaxoSmithKline argued that all of the lawsuits should be thrown out, in an Omnibus Motion to Dismiss filed with the court. An “Omnibus” motion bundles multiple requests together.

Zofran Lawsuits Preempted By Federal Law, GlaxoSmithKline Argues

As GlaxoSmithKline sees it, the problem is that the lawsuits make a number of allegations based on various state laws. One of the most important allegations, that the company failed to warn patients of the drug’s alleged risks, is premised on state laws that require drug manufacturers to adequately present the risks of a drug to the public.

That requirement, however, is “preempted by federal law,” according to Glaxo. In effect, Glaxo is saying that the FDA would have rejected the warning label changes that plaintiffs believe should have been presented to patients.

The question now is whether “clear evidence” exists to support that claim. Following the Supreme Court’s decision in Wyeth v. Levine (2008), drug manufacturers aren’t immediately shielded from liability just because their products were approved as safe and effective by the FDA. FDA clearance doesn’t equal legal protection in all cases, but it can, if a defendant is able to show that there’s “clear evidence” the FDA would have rejected the labeling changes advocated by plaintiffs in their lawsuit.

Plaintiffs Respond, Say “Clear Evidence” Isn’t Clear Enough

That “evidence” doesn’t exist, Plaintiffs fired back, in a Response filed on January 5, 2016. At least it hasn’t been entered into the public record, they say, since GlaxoSmithKline never applied for Zofran’s approval as a morning sickness treatment. Thus any evidence that would deny Zofran’s link to birth defects is still private property of the corporation, if it exists at all. Until discovery begins, and Plaintiffs begin gathering evidence, there’s no way to scrutinize the data on Zofran’s potential risks.

Glaxo did submit a kernel of such “evidence,” along with its Motion to Dismiss, the so-called “Woodcock Letter.” Sent by Janet Woodcock, Director of the FDA’s Center for Drug Evaluation & Research, the Woodcock Letter denied a citizen’s petition to change Zofran’s warning label, down-grading the drug’s pregnancy category from B to C, D or X and notifying patients that its use may be associated with fetal harm. That denial, for Glaxo, is enough to suggest that any warning label change would have been denied, too. Plaintiffs don’t think that’s enough, and believe the court should be able to investigate a wider range of evidence before considering a motion to dismiss.

Glaxo’s Motion to Dismiss is “unripe, unprecedented and violates established federal law,” according to Plaintiffs’ response. Whether or not that argument holds water is still in doubt. The results of a status conference scheduled for January 14, 2016, in which Judge Saylor was expected to consider the issue, still haven’t been made public.

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