Plaintiffs in more than 200 birth defect lawsuits have raised concerns over the pharmaceutical company GlaxoSmithKline’s (GSK) new proposal for Sequenced Discovery. Parents say the company neglected to warn patients and health experts of its anti-nausea drug Zofran’s alleged potential to cause serious birth defects, according to The Legal Examiner.
On June 3, 2016, GSK suggests possible order, or “sequence” in the document’s language, for how discovery should proceed. In the discovery phase, both parties are allowed to demand evidence from one another. For its part, GSK wants this litigation to turn to two major questions:
General Causation: Does Zofran (ondansetron) cause the specific types of birth defects alleged in the Zofran lawsuits? A 2012 Harvard University study found a more than doubling in the risk of cleft palate after prenatal exposure to Zofran as well as incidences of congenital heart defects, and atrial septal defects.
Federal Preemption: Did GSK withhold relevant risk information from the U.S. Food and Drug Administration (FDA) preventing the agency from making fully informed decisions about Zofran’s potential side effects? The FDA’s decisions have a certain authority, especially concerning the safety and efficacy of a drug. If GSK withheld pertinent information from the FDA, there would have been no way for the agency to adequately evaluate Zofran’s safety, creating an opening for Plaintiffs’ lawsuits to proceed.
On June 24, 2016, parents fired back at GSK’s proposal. They argue that the company’s suggestions on discovery, effectively takes the question of liability off the table. “GSK proposes a […] discovery plan where scientific causation must be established.” Plaintiffs write, “before any of the sordid evidence of GSK’s liability for its over-promotion of a dangerous drug for an unapproved use to doctors and pregnant women can be discovered.” The families claim that’s not how similar litigations have worked in the past, citing a number of previous multidistrict litigation (MDL) proceedings, The Legal Examiner reports.
By focusing on causality, GSK is eluding the question of how ondansetron, a drug never approved for use during pregnancy, became America’s top-selling morning sickness treatment at all. It’s highly “convenient” the families suggest, that the company’s attorneys are pushing to focus on the science “before Plaintiffs can demonstrate to the Court evidence of GSK’s deceit and orchestrated misrepresentations that resulted in Zofran’s ubiquitous presence in obstetricians’ and gynecologists’ offices.”