Since this past September, pharmaceutical giant GlaxoSmithKline has argued five Zofran birth defect lawsuits should be dismissed from the litigation because they do not meet discovery deadlines. However, Judge F. Dennis Saylor IV, who is presiding over the litigation, held the cases may proceed.
The five families who missed discovery deadlines argued they needed more time to obtain the necessary medical records and have since filed all required documents. Seeing that all the submissions are now complete, Judge Saylor stated, “dismissal is not appropriate under the circumstances.”
Over 350 Zofran birth defect lawsuits are consolidated in a multidistrict litigation (MDL) in the U.S. District Court for the District of Massachusetts. Plaintiffs allege the anti-nausea medication Zofran caused birth defects to children in utero and GSK never warned patients of the risks.
A key issue in the litigation is whether or not GSK committed fraud by marketing Zofran to pregnant women. Currently, Zofran is not approved by the FDA for the treatment of morning sickness in pregnant populations; however, the drug became one of the most popular treatments for morning sickness.
Plaintiffs believe the drug’s popularity for an unapproved use arose out of illegal marketing practices by GSK. Plaintiffs point to the 2012 settlement between GSK and the U.S. Department of Justice. GSK pled guilty and agreed to pay $3 billion to resolve criminal and civil fraud allegations that the company illegally marketed several of its best selling drugs, including Zofran.
GSK has tried to circumvent fraud allegations in the birth defect litigation by proposing a sequenced discovery that would not address its marketing activity, but plaintiffs would not agree to the proposed discovery plan.
The highly contested Zofran litigation has moved forward slowly, but the litigation is making process. Although a trial date has yet to be scheduled, plaintiffs are hopeful the New Year will see several significant steps forward in the litigation.