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08 January 2018

What We Learned From The Latest Zofran Litigation Update

As of mid-December 2017, over 400 Zofran lawsuits remain pending in the US District Court of Massachusetts, according to a new joint status report written up by GlaxoSmithKline’s defense attorneys and the lawyers representing families who say the anti-nausea drug causes major birth defects in unborn children.

400+ Zofran Lawsuits Consolidated In Massachusetts

Filed in the Boston federal court on December 14, 2017, the joint litigation update provides an unprecedented overview of the Zofran litigation’s progress to date. The vast majority of Zofran birth defect lawsuits have been consolidated in Boston under the guidance of Judge F. Dennis Saylor IV. As the parties report in their litigation update, around 406 cases are centralized in the Massachusetts federal court, where the discovery phase of litigation is in full-swing.

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Depositions Of Key Zofran Marketing Players Continue

In December, plaintiffs’ attorneys conducted depositions involving Denise Shirrell and Christine “Chris” Aytug, both of whom played key roles in the controversial anti-nausea drug’s launch.

In their lawsuits, plaintiffs accuse GlaxoSmithKline of promoting Zofran, a drug designed and approved to treat nausea and vomiting primarily in cancer patients, as an “off-label” treatment for morning sickness. Similar allegations were made in a case filed by the US Department of Justice. The government’s lawsuit, which included claims of illegal conduct involving multiple drugs, was settled for $3 billion in 2012.

Plaintiffs Object To “Lack” Of Documentation

Denise Shirrell served as the Senior Product Manager for Zofran marketing at GlaxoSmithKline. She is listed as the custodian on over 4,300 relevant documents, plaintiffs’ attorneys report. Another 4,268 documents reference her name. And because of her apparent importance in GlaxoSmithKline’s initial marketing of Zofran, plaintiffs have asked the company to produce Mrs. Shirrell for two days of deposition, a request GSK has thus far refused.

Chris Aytug specialized in market research and sales for GlaxoSmithKline’s oncology division before moving on to a smaller firm, Florida Biologix. At the time of these depositions, plaintiffs’ attorneys say they were ham-strung by a limited amount of information.

In producing relevant documents, the lawyers continue, GlaxoSmithKline chose to provide only documentation from “the timeframe in which the [Department of Justice] was investigating GSK for Zofran-related conduct.” Aytug and Shirrell’s importance in the launch of Zofran, however, went far beyond that period, the attorneys argue. To date, the company has refused to produce files that would detail either Aytug or Shirrell’s activities outside the DOJ investigation, plaintiffs’ lawyers say.

Six Depositions In January, February 2018

In the coming month, six more depositions have been scheduled:

  • Phillip Whitman (served as Associate Director, then Director, for Global Regulatory Affairs in GlaxoSmithKline’s oncology division between 2005 and 2015) – January 11, 2018
  • Jeff Persinger (worked in Brand and Sales Management for GlaxoSmithKline between 1993 and 2003) – January 23, 2018
  • Peter Chattin (Strategic Insights Manager for GlaxoSmithKline from 2001 to the present) – January 24, 2018
  • Beth Howard (served as Product Director for Zofran between 2002 and 2004, then moved on to become the company’s Executive Director for Oncology Products) – January 25, 2018
  • Sara Ephross (worked as Director for GlaxoSmithKline’s Pregnancy Epidemiology and Academic Collaborations from 1995 to 2015, now a private consultant in Chapel Hill, North Carolina) – January 31, 2018
  • Keri Chen – February 1, 2018

Most of these depositions are scheduled to take place in Philadelphia, where GlaxoSmithKline maintains one of its two US headquarters. Ephross and Chen will be deposed in North Carolina and Irvine, California respectively.

State Court Zofran Cases

In addition to these 406 federally-consolidated Zofran cases, 14 similar lawsuits are pending in state courts: 1 in Oregon, 1 in Kentucky and 12 in California. In California, at least 12 Zofran lawsuits are still pending in the Superior Court of Orange County. While the cases were initially assigned to the Honorable Thierry Colaw, Judge Colaw announced his retirement from the bench during a status conference on November 29, 2017. Before leaving his seat, Judge Colaw lifted the stay on discovery in the 12 cases, allowing the crucial phase of evidence gathering to begin in the California Court. Another status conference has been scheduled for January 19, 2018.


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