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02 March 2018

GlaxoSmithKline Concealed Zofran Birth Defect Reports From FDA, Families Claim

In a dramatic new allegation, hundreds of families who have filed Zofran birth defect lawsuits against GlaxoSmithKline accuse the pharmaceutical company of concealing vast hordes of important safety data from the US Food & Drug Administration. And now, plaintiffs’ attorneys in a motion filed on February 23, 2018 say the manufacturer is pushing for a premature “Science Day” to “deprive” the families of this “key evidence.”

Families Demand “Key” Zofran Adverse Event Data. GSK Refuses.

The dispute, families claim, centers around an internal drug safety database, owned and maintained by GlaxoSmithKline, known as Argus. In part, plaintiffs write in their court motion, “Argus is used to track Zofran-related adverse events.” The database “enables GSK to report those [adverse events] that it deems reportable to the U.S. Food and Drug Administration.”

Computer Servers

Argus, GSK’s Internal Adverse Event Report Database

Somewhere on GlaxoSmithKline’s computer servers is a large database of adverse event reports.

And this database, Argus, a program developed by computer tech firm Oracle, compiles numerous complaints, submitted both by medical care providers and patients, chronicling the side effects and complications associated with the company’s drugs, including Zofran, the widely-used nausea medication that hundreds of parents believe can cause major birth defects.

Yet GlaxoSmithKline, the parents say, refuses to release this information for the purposes of litigation.

Argus Reports Go To “Heart” Of Zofran Litigation, Plaintiffs Say

The birth defect-related reports held on the Argus database, plaintiffs reason, “goes to the heart” of their legal arguments.

In over 800 product liability lawsuits, families from across the country accuse GlaxoSmithKline of promoting Zofran as an off-label treatment for morning sickness (an alleged violation of federal law), despite knowledge that the drug increased the risk of major birth defects in children.

Thus, the company’s “knowledge of adverse events related to Zofran and what GSK did or did not do with that information” lies at the core of each lawsuit’s claims. And the data contained in Argus, plaintiffs continue, is absolutely essential to answering the all-important questions of what GlaxoSmithKline knew about Zofran’s potential risks and whether or not the company adequately informed the FDA and the public.

Argus “contains information from every known Zofran-related adverse event, worldwide, occuring at any time since clinical trials began, including adverse events GSK chose not to report to regulatory authorities,” the families write.

Families: “Inconsistent” Reporting Minimized Appearance Of Risks

Moreover, plaintiffs say, several recent depositions of company employees who worked with Argus “have raised serious issues about whether GSK was accurately maintaining its adverse event database and accurately reporting adverse events to the FDA and the public, including doctors whom GSK induced to believe that Zofran was safe for use in pregnancy.”

Plaintiffs now believe that GlaxoSmithKline has been gaming its own internal adverse event system to minimize the appearance of serious safety risks. In depositions, the plaintiffs say, several GSK employees indicated that the company used “inconsistent” classifications to label pregnancy-related adverse event reports.

That alleged practice, the families say, raises the “reasonable inference” that GSK was “organizing the same adverse events into different buckets so that no bucket had so many [reports] that the FDA or the public would detect a safety signal.”

GSK Releases Cancer Data, But Few Pregnancy Documents

Depositions have also revealed that the information in Argus is readily-accessible. And the families have only asked for a narrow slice of the total Zofran-related information contained in Argus; “plaintiffs have not asked for a data extraction for all Zofran adverse events of any kind, only those relating to pregnancy outcomes.”

Instead, GlaxoSmithKline has only seen fit to release adverse event reports related to the specific mothers involved in the litigation, along with “roughly 538,000 pages” of documents largely related to “Zofran’s on-label uses as an anti-nausea drug for cancer patients.”

Creating A “Level Playing Field”

There’s also a question of basic fairness, the families say.

GlaxoSmithKline will be using the Argus database to prepare its legal defense, and it’s already done so. “GSK has on several occasions since being sued for Zofran-induced birth defects,” plaintiffs write, “used the Argus databases to search for, evaluate and summarize the adverse event data related to the use of Zofran during pregnancy.” Preventing plaintiffs from accessing the information is the opposite of creating a “level playing field.”

To top things off, the plaintiffs argue, databases like Argus “are routinely disclosed in pharmaceutical litigation,” because federal courts in the past have often considered such adverse event data as “fundamental” to the prosecution of failure to warn claims. Our requests are standard business, the families say, but GlaxSmithKline is still refusing to play along. GSK says that it adequately reported every relevant adverse event to the US Food & Drug Administration. At bottom, the plaintiffs are simply asking for the company to prove it.

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