Researcher Taking Notes On Lab Animal
17 October 2017

Families, GSK Fight Over Raw Data From Zofran Animal Tests

In hundreds of product liability lawsuits, families from across the country maintain that GlaxoSmithKline’s anti-nausea drug Zofran causes severe birth defects in human children. But an even more contentious sticking point, at least at this point in the ongoing litigation, may be the results of 33 animal toxicology studies conducted by GlaxoSmithKline prior to the drug’s US approval. 21 of these studies, plaintiffs say, involved the administration of Zofran to pregnant rats and rabbits.

Japanese Animal Studies At Center Of Dispute

The animal studies, orchestrated by researchers in the United Kingdom and Japan, were designed to gauge the antiemetic drug’s effects during pregnancy and on the offspring that resulted from those pregnancies. While plaintiffs have been allowed to review internal corporate reports summarizing the results of these crucial animal trials, they say Glaxo has been less than forthcoming with the raw data.

Lab Rabbits In Cage

That means the families are being “forced to accept the conclusions of […] GSK scientists at face value,” plaintiffs’ attorneys write in an October 3 status report to the Massachusetts federal court. A more equitable approach, the lawyers argue, is to allow the hundreds of families to draw their own conclusions. In the final analysis, this dispute comes down to “six boxes of documents,” counsel says, six boxes that GlaxoSmithKline “now refuses to produce or allow plaintiffs to inspect.”

Massachusetts Court Orders GSK To Release Data

The Court, plaintiffs claim, has already decided the question in favor of families. During a June hearing, The Honorable Judith Dein made her feelings on the raw data clear, saying “[it] seems to me that this is the kind of material that doesn’t actually need to be reviewed [by GSK], it is what it is. It’s not going to be privileged, it’s going to be raw data of lab analyses, so produce it.” Magistrate Judge Dein’s holding began a lengthy process of discovery. And, despite Judge Dein’s belief that reviewing the lab results isn’t necessary, Glaxo insists on reviewing the documents (which are mostly in Japanese) and doing so at plaintiffs’ expense.

The Court ordered Glaxo to produce a list of toxicology studies involving pregnant animals for the plaintiffs to review. After doing so, the families selected 21 studies to review in detail, requesting the raw data for examination. In the beginning, Glaxo looked ready to play ball, the plaintiffs write. The company began producing raw data, but oddly, only selections of data from studies carried out in the United Kingdom.

Raw data from Japan was never produced, attorneys claim. That was about to change, the families say, when on September 12, defense counsel told plaintiffs’ lawyers, “we recently located additional information that we plan to produce. We believe the information relates to the [Japanese] studies […] it is almost exclusively in Japanese. [We] will let you known when [we] have an estimate of the anticipated production date.”

Raw Data Shows Evidence Of Birth Defects, Plaintiffs Say

A promising turn of events. But only eight days later, attorneys continue, the company changed course, deciding to withhold the raw data from Japan. The plaintiffs’ attorneys aren’t particularly surprised by Glaxo’s change of heart, court documents suggest. “The raw data that GSK is now seeking to withhold,” the lawyers write, “is from GSK’s Japanese animal studies that revealed multiple birth defects in animal offspring – the same birth defects alleged by plaintiffs in this litigation.”

Most of the families who have joined the Zofran MDL say the nausea drug causes congenital heart defects and cleft palate, two birth defects highlighted in a series of large epidemiological studies conducted over recent years. These same congenital abnormalities, plaintiffs allege, made an appearance in the Japanese animal toxicity studies.

And out of the 15 depositions of GSK officials conducted so far, attorneys continue, the Japanese studies became a focus in 9 of them. Yet the raw data from these trials remains unavailable to the families. One problem, as corporate representatives argue, is that some of the study information could reasonably be considered confidential data.

Who Should Review The Documents?

That partially explains the company’s request that plaintiffs pay GlaxoSmithKline for Japanese-fluent reviewers to look over the documents, determine their relevance and possibly redact confidential details.

The translators, GSK argues, would need to be paid around $150 per hour. Based on an estimate that the reviewers would need around 125 hours to look over the 14,900 pages of documents (all six boxes), the company projects a total translation cost of up to $18,750.

The families countered with an offer of their own: let us review the documents with our own Japanese-fluent hires in Philadelphia, where GlaxoSmithKline is headquartered. GSK hasn’t accepted that proposal, instead asking the Court to deny the plaintiffs their request for additional raw data.

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