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Michael Monheit
Michael Monheit
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Zofran Lawsuit Update: Parties Clash Over “Sequenced Discovery” Proposal


With the Zofran litigation moving along at a fast clip, Plaintiffs in more than 200 birth defect lawsuits have raised concerns over GlaxoSmithKline’s new proposal for Sequenced Discovery.

Families from across the country have filed suit against GlaxoSmithKline, a multinational pharmaceutical conglomerate with US bases of operation in Philadelphia and North Carolina’s Research Triangle Park. In over 270 lawsuits, parents say the company failed to warn patients and health experts of its anti-nausea drug’s Zofran alleged potential to cause birth defects.

Glaxo Wants To Focus On These Two Questions

In a proposed court order filed on June 3, 2016, GlaxoSmithKline suggests a possible order, or “sequence” in the document’s language, for how discovery should proceed. In the discovery phase of a lawsuit, both parties are allowed to demand evidence from one another, each attempting to buttress its own case. For its part, GlaxoSmithKline wants the litigation to turn to two major questions first:

  1. General Causation – Does Zofran (or its active ingredient ondansetron) cause the specific types of birth defects alleged in the Zofran lawsuits? Most of the families’ claims have named congenital heart defects, cleft palate or cleft lip. In 2012, a study out of Harvard University found a more than doubling in the risk of cleft palate after prenatal exposure to Zofran. Over the following years, several large epidemiological studies discovered evidence that Zofran can increase the risk of developing a specific subset of congenital heart defects, atrial septal defects.
  2. Federal Preemption – Did GlaxoSmithKline withhold relevant risk information from the FDA, preventing the agency from making fully-informed decisions about Zofran’s potential side effects? As a federal agency, the FDA’s decisions have a certain authority, especially when it comes to the safety and efficacy of a drug. That means some product liability claims, which are usually premised on state law, could be dismissed out of hand. But if GlaxoSmithKline withheld pertinent info 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.

Obviously, these are questions on which the Zofran litigation may hinge at some point, but are they the right ones to focus on at this early stage?

But Plaintiffs Aren’t Buying The Company’s Plan

Plaintiffs have answered that question with a resounding “no.” In a sharply-worded rebuttal, parents fired back at GlaxoSmithKline’s proposal on June 24, 2016.

The company’s suggestions on discovery, they argue, effectively take 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 overpromotion of a dangerous drug for an unapproved use to doctors and pregnant women can be discovered.” That’s not how similar litigations have worked in the past, the families claim, citing a number of previous MDL proceedings.

In coordinated mass tort actions, Courts have “overwhelmingly” adopted an “ordinary pattern of developing […] evidence necessary for both sides to prove the elements of their case,” Plaintiffs write. This pattern, they say, emphasizes neither liability nor causation, but allows both questions to be probed at once.

“Deceit And Orchestrated Misrepresentations”

By focusing on causality, GlaxoSmithKline is eluding the question of how ondansetron, a drug never approved for use during pregnancy, became America’s top-selling morning sickness treatment in the first place. 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.”

The point of GlaxoSmithKline’s emphasis on causation and preemption, according to Plaintiffs? It appears this may merely be an attempt by the defendant to circumvent an investigation into important questions related to proving claims of GlaxoSmithKline’s negligence.

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