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Michael Monheit
Michael Monheit
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Judge Denies GlaxoSmithKline’s Request To Throw Out Every Zofran Lawsuit


Earlier in the week, we reported on GlaxoSmithKline’s bid to have every Zofran lawsuit dismissed. The company argued that a failed citizen’s petition, which urged the FDA to strengthen Zofran’s warning label, provided clear evidence that the government agency doesn’t agree with families who say GlaxoSmithKline must warn the public about its nausea drug’s link to birth defects.

Plaintiffs called Glaxo’s motion “unripe,” and said their claims should be allowed to proceed. But at the time, we had little idea of how Judge F. Dennis Saylor IV would view the contentious debate. Saylor, who has been appointed to preside over the consolidation of more than 200 Zofran lawsuits, was slated to hear oral arguments on the subject, but no decision had been released.

Zofran Lawsuits Can Proceed, Judge Saylor Rules

On January 22, 2016, families got their answer: Saylor won’t be dismissing the lawsuits – at least for now. In MDL Order No. 9, Saylor denied GlaxoSmithKline’s motion to dismiss without prejudice, which means that the company has the right to renew its argument in the future.

For now, however, trial attorneys will be allowed to proceed with discovery, the stage before any trial in which parties are allowed to gather evidence from one another.

Glaxo’s “Citizen’s Petition” Not Enough

The issue at hand was whether or not federal law “preempted” Plaintiffs’ failure-to-warn claims, which are based on state law. In their lawsuits, families say that GlaxoSmithKline failed to warn the public about Zofran’s potential association with birth defects. That would be illegal, under various state laws. Drug companies, though, might not be bound by those laws if following a federal law makes it extremely difficult for them to comply.

This is complicated. According to the Supreme Court, a person’s failure-to-warn allegations may be preempted by federal law, if a drug company can show “clear evidence” that a federal agency wouldn’t have been interested in the warnings proposed. Essentially, the opinion of a federal agency trumps any claim plaintiffs may have under state law. But that “clear evidence” is absolutely essential, and GlaxoSmithKline offered the failure of a citizen’s petition, rejected by an FDA reviewer in October 2015, as just the clear evidence its argument requires.

Families Get “Opportunity To Develop The Facts”

Saylor disagreed, for a number of reasons.

For one, the Supreme Court’s Opinion, developed in the 2008 case Wyeth v. Levine, implies that a citizen’s petition alone can’t stand as “clear evidence.” Filed by individual citizens, these petitions can’t hope to include the kind of information, often privately-held by drug companies, that would go to accurately reflect a drug’s true risks. Usually, petitions are written on the basis of publicly-available studies, but lots of the research pertaining to a drug’s risks is actually private property of its manufacturer, and shielded from scrutiny by intellectual property laws. The point here is that, while the citizen’s petition was rejected, it may not have presented an accurate picture of Zofran’s link to birth defects.

That accurate picture will only develop after discovery is completed for the Zofran lawsuits. Once all of the relevant studies, currently controlled by GlaxoSmithKline, are presented, the court can begin scrutinizing the evidence. Before that happens, the question of whether or not the FDA would have rejected a warning about birth defects is anything but “clear.” That was Saylor’s line of reasoning; he wants to give “the plaintiffs some opportunity to develop the facts, whatever those facts may be.”

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