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Michael Monheit
Michael Monheit
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Japanese Animal Studies Become Sticking Point In Zofran Lawsuits


The Zofran MDL is shaping up to be one of the most contentious drug liability lawsuits in recent memory. Only 3 months after more than 200 lawsuits were transferred to a federal court in Boston, GlaxoSmithKline has asked for all of the cases to be dismissed.

In a motion filed on December 11, 2015, the company said the cases were pre-empted by federal law, invalidated since the FDA would have already changed Zofran’s labeling if the drug is, in fact, a danger to fetal health. Plaintiffs claim Zofran causes a range of birth defects, from cleft palate to congenital heart defects.

Foreign Animal Studies Showed Link To Heart Defects – After Zofran’s Approval, Plaintiffs Allege

On January 5, 2016, Plaintiffs fired back in a blistering response, arguing that Glaxo’s request is “unripe, unprecedented and violates the established federal law.”

“Ripeness,” believe it or not, is actually a legal term. Cornell University‘s Law Dictionary says a claim “ripens” when “the facts of the case have matured into an existing substantial controversy warranting judicial intervention.” But it’s not appropriate for Judge F. Dennis Saylor IV to intervene yet, either for or against the dismissal, Plaintiffs hold.

For one, discovery hasn’t started yet, so the families haven’t been able to scrutinize the company’s records. Beyond that, little relevant medical evidence on Zofran is publicly available, since Glaxo never attempted to have the drug approved as a morning sickness treatment. In other words, Plaintiffs haven’t been given the chance to know what Glaxo knows about the drug’s link to birth defects. Before gaining that evidence, there’s no way to decide what the FDA would have done, if anything at all, to alter Zofran’s warning label.

There is, however, “reason to believe that GSK has important evidence about the defects alleged […], and the link to Zofran,” Plaintiffs wrote in their response.

They point to several “animal teratogenicity studies,” conducted by GlaxoSmithKline in Japan, that found a link between the drug and congenital heart defects. Plaintiffs say these studies took place after the FDA approved Zofran for sale in the US. In at least one, Plaintiffs claim, pregnant animals gave birth to offspring with ventricular septal defects, a heart defect Plaintiffs say Zofran causes. The response continues: “Plaintiffs do not know whether GSK ever provided the FDA this or any other evidence of severe heart defects. What Plaintiffs do know, however, is that the Zofran warning labels and available marketing materials were silent as to such evidence.”

Does Zofran’s Warning Label Hide A Lie About Animal Studies?

In reference to these studies, the response cites one Zofran lawsuit, filed by a California mother who says her child was born with Tetralogy of Fallot (a rare cluster of 4 heart defects) after being exposed to Zofran in the womb. In her complaint, the mother writes:

“GSK conducted additional animal studies after the launch of Zofran in the U.S. that demonstrated increased risks of harm to fetuses in animals exposed to ondansetron [Zofran’s active ingredient] prenatally.”

If that is true, the drug’s warning label would seem to evade the truth, when it mentions that “reproduction studies have been performed in pregnant rats and rabbits at I.V. doses up to 4 mg/kg per day and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron.”

Until discovery begins, and the public is able to scrutinize the results of these alleged animal studies, there’s no way to know whether Plaintiffs’ allegations hold water. It seems clear, however, that GlaxoSmithKline’s claims to Zofran’s safety remain in dispute. Judge Saylor hasn’t yet responded to Glaxo’s motion to dismiss the cases.

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