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09 May 2017

GSK Fights To Strike Fraud-Related Zofran Lawsuit Claims

In their Zofran lawsuits, hundreds of families accuse GlaxoSmithKline of guiding a sweeping – and illegal – marketing campaign to convince obstetricians into prescribing the nausea drug as an off-label treatment for morning sickness. The company’s attorneys are now petitioning the US District Court of Massachusetts to have those claims of marketing fraud thrown out.

GSK Moves To Throw Out Zofran Marketing Claims

In some sense, the defense attorneys are simply asking Judge F. Dennis Saylor to follow through on one of his previous decisions. On April 24, 2016, Judge Saylor ruled that plaintiffs’ allegations of an illicit marketing campaign were “too broad” to be heard in court. Now, GlaxoSmithKline is urging the Court to strike those allegations from the record, claims that the company’s lawyers have dubbed “immaterial.” This isn’t an idle request, though.

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After quashing the allegations of fraudulent marketing, Zofran’s manufacturer would like Judge Saylor to limit the scope of discovery, effectively blocking the families from accessing corporate documents on the sales visits that company representatives conducted with individual doctors. Many families have said that GlaxoSmithKline’s sales representatives routinely misrepresented the safety and efficacy of Zofran during their consultations – at the behest of corporate executives. While the company vigorously denies this accusation, it now hopes to block plaintiffs from the very evidence that would either confirm or disconfirm their beliefs.

Fight Continues Over Federal Investigation Communications

This isn’t the only front on which GlaxoSmithKline is fighting plaintiffs’ ability to access potential evidence of wrongdoing. In the late-2000s, the company came under federal investigation. Investigators from the US Department of Justice had been tipped off by a whistleblower lawsuit filed in 2003, which accused GlaxoSmithKline of orchestrating numerous illegal marketing campaigns. As two former high-level corporate employees related, their employer had regularly advertised FDA-approved products for off-label indications, flouting federal law in the process. Zofran had been specifically marketed as a morning sickness treatment, the men said.

The federal government soon took the case on. After years of intense scrutiny, the federal investigation yielded a stunning result. In 2012, GlaxoSmithKline agreed to plead guilty to three criminal charges, the Justice Department reports, notably “two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce.” Moreover, the company agreed to pay $2 billion to resolve the government’s civil allegations, including accusations that Zofran had been marketed illegally.

While some details from this investigation have been made public, most of the specifics remain locked in GlaxoSmithKline’s corporate servers. Families are clamoring to obtain these documents, hoping to understand the finer points of the company’s Zofran marketing strategy. In fact, the US District Court of Massachusetts has already ruled that plaintiffs’ have a right to this information, despite GlaxoSmithKline’s arguments to the contrary.

Fraud Dispute Shouldn’t Block Discovery, Magistrate Judge Rules

On April 6, 2017, Magistrate Judge Judith G. Dein denied the corporation’s request for a protective order that would have paused discovery into the documents. GlaxoSmithKline believes that, if the allegations of fraudulent marketing are thrown out, any discovery into the company’s communications with federal investigators should be ruled out as well. After all, and by the company’s own admission, “the DOJ investigation focused on whether the defendant’s sales force had provided false information to physicians.”

Judge Dein, though, felt that the discovery in question could well impinge on allegations beyond those of fraudulent marketing. For example, the families claim that GlaxoSmithKline was “negligent” in warning the medical community of Zofran’s alleged risks. This isn’t a fraud-related allegation, but halting discovery into the company’s communications could have the unintended consequence of preventing plaintiffs’ from gaining evidence to support their negligence-based claims. To avoid that pitfall, Judge Dein felt it was appropriate to compel GlaxoSmithKline to produce documents related to the Justice Department investigation.

The company has yet to produce these documents. Despite Judge Dein’s court order, issued on April 6, 2017, plaintiffs’ attorneys say GlaxoSmithKline is only “constructing new methods of delay and obstruction.” In a new motion to compel the documents filed on May 8, the families have asked the Court to force their opponent into making the information available.

As of May 9, 2017, a total of 366 Zofran birth defect lawsuits have been consolidated in the US District Court of Massachusetts. Judge F. Dennis Saylor has been guiding the litigation through coordinated pre-trial proceedings. Relying on a series of large epidemiological studies, parents from across the country say the potent anti-nausea drug can cause major birth defects, including cleft palate and various forms of congenital heart disease.