Gavel and hand

In Boston, Plaintiffs Win First Tussle Over Zofran Lawsuits

More than 200 Zofran lawsuits have been consolidated in Boston, Massachusetts since October 2015. As part of a “Multi-District Litigation,” the diverse legal claims, all of which say GlaxoSmithKline’s popular nausea drug causes birth defects, will proceed together through the most important steps necessary before any trial.

One interested party, however, thought Plaintiffs shouldn’t get their hopes too high.

Glaxo Wants Every Zofran Lawsuit Thrown Out

Gavel in front of judge

On December 11, 2015, GlaxoSmithKline, the Defendant in these lawsuits, asked Judge F. Dennis Saylor IV to throw them out entirely. Filing an Omnibus Motion To Dismiss with the US District Court for Massachusetts, Glaxo’s defense attorneys argued that the allegations raised by families are invalidated by federal law. Here’s what that means.

In every Zofran lawsuit, parents have claimed that GlaxoSmithKline failed to warn them about the drug’s potential link to birth defects, abnormalities like cleft palate and congenital heart defects they say their children were born with. That allegation is based on state laws which require drug manufacturers to adequately warn consumers and health professionals about the possible risks of their products.

Glaxo’s argument is that the US Food & Drug Administration, a federal agency, already approved Zofran’s warning labels. Beyond that, one FDA reviewer, Janet Woodcock, already denied a citizen’s petition seeking to have Zofran’s labeling strengthened with information on the drug’s link to birth defects.

That raises a conflict, according to GlaxoSmithKline, between a federal order endorsing the company’s representation of Zofran’s risks and the allegations of families, based as they are on state laws. Since federal law, in this context, trumps state law, the parents’ claims are “preempted” and have no legal ground to stand on.

Families Fire Back

Plaintiffs shot back a lengthy response on January 5, 2016, saying Glaxo’s request to dismiss the cases “is unripe, unprecedented and violates established federal law.”

The issue comes down to a 2008 US Supreme Court Decision called Wyeth v. Levine. In the case, which involved a different nausea drug and a woman who lost her arm after being injected with the medication, the Court held that FDA approval of a drug’s warning label could preempt state failure-to-warn allegations, but only if a Defendant can show “clear evidence” that the FDA would have rejected whatever labeling changes the plaintiffs are demanding.

In this case, GlaxoSmithKline has to show that the FDA would have denied a request to add a warning about birth defects to Zofran’s label.

In its request to dismiss, GlaxoSmithKline argues that a failed citizen’s petition to have Zofran’s labeling strengthened, rejected in October 2015, is clear evidence that the FDA wouldn’t have entertained plaintiffs’ proposed label changes. Families disagree. Considering the petition’s denial alone, “without analysis of any other contextual evidence that will be developed in this case would contravene established law.”

It’s just too early, in other words, to think about dismissing the lawsuits. Discovery hasn’t even begun, and neither families nor the court have been able to scrutinize relevant evidence, much of which remains private property of GlaxoSmithKline. Without a developed body of evidence before the court, there’s no way for Saylor to judge whether or not the FDA would have rejected Plaintiffs’ demands.

Glaxo Doubles Down On Citizen’s Petition Argument

The next development in this saga came on January 12, 2016, when GlaxoSmithKline filed a new reply, arguing that Plaintiffs’ “miss the mark” in their own contentions.

Glaxo concedes the early timing of its motion to dismiss, but frames this as a “unique ability” held by the Court to rule on the company’s argument for preemption.

Saylor doesn’t need to speculate as to whether or not the FDA would have rejected a birth defect warning, since as the company writes, it knows that the FDA already did. Plaintiffs call for a more developed body of evidence, which would allow the court to address substantive questions about Zofran’s link to birth defects, isn’t necessary here. All that matters, for Glaxo’s defense attorneys, is that the FDA rejected the citizen’s petition.

Saylor Rejects Glaxo’s Arguments, Zofran Lawsuits Will Proceed

After a round of oral argument, Judge Saylor made his decision, rejecting GlaxoSmithKline’s claim that the lawsuits are federally preempted under Levine and allowing them to proceed.

In Order 9, issued January 22, 2016, Saylor writes that Glaxo’s argument “is problematic for at least three reasons”:

  1. Levine uses the phrase “clear evidence.” Clear evidence is a nebulous concept, one the Supreme Court only gestured at defining. But whatever it’s intended meaning, Saylor held that “clear evidence” must entail “some form of fact-based evaluation.” He is “reluctant to issue a ruling […] without giving the plaintiffs some opportunity to develop the facts, whatever those facts may be.”
  2. GSK mischaracterized Levine‘s requirements. The decision in Levine was based on a drug manufacturer’s ability (and duty) to unilaterally alter a drug’s warning label to the benefit of public safety. Usually, drug companies aren’t allowed to change their labeling until after the FDA has approved a change, but there’s a loophole, called “Changes Being Effected” (CBE), that allows them to do so. For preemption to work, drug companies have to show clear evidence that their CBE warnings would have been rejected by the FDA. Since a citizen’s petition isn’t the same as a CBE, Saylor critiqued Glaxo for side-stepping the issue. If Glaxo had applied for a CBE update, the application would have contained information on Zofran’s risks unavailable to the public. Obviously, a citizen’s petition wouldn’t include the same information.
  3. The labeling changes requested in the citizen’s petition might be significantly different from those demanded by Plaintiffs. That question hasn’t been answered yet, but it needs to be before Saylor will entertain any motion to dismiss.

It’s a major victory for the families who have already filed Zofran birth defect lawsuits, one that also leaves the door open for other parents who believe they may be entitled to compensation.