Discovery is underway in the Zofran multidistrict litigation (MDL). U.S. District Judge Dennis Saylor has ordered discovery in four phases. Phase 1 includes Fact Sheets (Plaintiff and Defense) and related authorizations. Phases 2 and 3 include deposition and document production regarding electronically stored information (ESI), corporate organization, general causation, and federal preemption. Phases 1, 2, and 3 are currently ongoing. Phase 4 includes discovery on other general liability issues, and is expected to begin this month.
So far, GlaxoSmithKline (GSK) has produced its U.S. Food and Drug Administration (FDA) submissions, and the Plaintiffs’ Steering Committee (PSC) has finished reviewing those 600,000 pages. The PSC has also deposed corporate witnesses regarding GSK’s Corporate Organization and ESI. Through those depositions, they were able to identify dozens of present and former GSK employees who were significantly involved with Zofran, and identify the electronic systems that contain important regulatory, science, safety, and marketing information. So far, GSK has committed to producing custodial files of 25 witnesses involved in the science and regulatory submissions for Zofran. In a recent status conference, Judge Saylor expressed his hopes to have general discovery completed in 2017.
GSK has also filed two additional Motions to Dismiss. As you may remember, Judge Saylor denied GSK’s first Motion to Dismiss all of the pending Zofran cases on preemption grounds last year. GSK has now filed a Motion to Dismiss all claims that relate to Fraud or Negligent Misrepresentation, saying that the Master Complaints do not plead the underlying facts supporting those allegations with sufficient particularity. The PSC has responded, and Judge Saylor heard arguments at the January 26 status conference.
GSK has also filed a Motion to Dismiss lawsuits filed by women in Georgia, Indiana, Kentucky, Massachusetts, and Oklahoma who alleged that they used a generic form of Zofran. GSK argues that it cannot be held liable for injuries alleged to be related to a pill that it did not manufacture or market. However, under FDA regulations, generic manufacturers have to match their labeling to the label for brand-name Zofran. So, even though GSK did not manufacture the specific pills, it wrote the language in the label. The PSC responded to this Motion, arguing that the plaintiffs’ negligent misrepresentation claims should not be dismissed, and asking Judge Saylor to certify the question to the high courts of each of these states. The court will hear oral arguments on Feb. 16.
Lawyers in our firm’s Mass Torts Section continue to investigate cases involving children born with a heart defect or cleft palate after in utero exposure to Zofran. If you would like more information about this litigation, or if you or someone you know has had a family member who suffered from a congenital heart defect or cleft palate as a result of prenatal Zofran exposure, contact Roger Smith or Liz Eiland, lawyers in our firm’s Mass Torts Section, at 800-898-2034 or by email at Roger.Smith@beasleyallen.com or Liz.Eiland@beasleyallen.com.