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GSK Files Motion to Coordinate Zofran Birth Defect Claims

scale of justice and gavelZofran lawsuits alleging the drug caused birth defects continue to be filed throughout the nation. The complaints assert that children who were exposed to Zofran in utero were born with cleft palate, cleft lip, heart malformations and other life-altering congenital defects.

In light of mounting litigation, drug maker GlaxoSmithKline has filed a motion to centralize all federal lawsuits for more efficient pretrial handling. The company is requesting that similar claims involving birth defects are consolidated under multidistrict litigation (MDL), which would benefit both parties greatly while reducing the chance of inconsistent pretrial rulings and/or duplicative discovery.

According to the defendant’s motion to transfer, “Plaintiffs all claim that the drug they allegedly ingested was defectively designed, manufactured, and/or marketed by GSK, resulting in serious physical injuries to their children, and that GSK failed to provide adequate warnings of the risks and dangers posed by Zofran. Plaintiffs also allege that GSK improperly marketed Zofran “off-label” to doctors for treating morning sickness during pregnancy without FDA approval.”

GSK requests coordination of Zofran birth defect lawsuits

GlaxoSmithKline has asked that the MDL be established in the Eastern District of Pennsylvania, which is close to the company’s headquarters and where a number of birth defect lawsuits involving Effexor and Zofran have already been filed. The drug manufacturer asks that either U.S. District Judge Paul S. Diamond or the Honorable Judge Cynthia Rufe preside over the litigation. In their petition, GSK states that Judge Rufe is an experienced transferee judge who has proven her ability to handle multidistrict litigations. Similarly, Judge Diamond has presided over complex litigation including pharmaceutical industry litigation and class actions – both indicators of his ability to guide pretrial proceedings in a Zofran MDL.

As it stands, there are currently 12 Zofran cases alleging that the medication, when taken as an off-label treatment for morning sickness, leads to fetal harm. Plaintiffs contend that they were not adequately warned about Zofran pregnancy risks, and that the drug they took was defectively designed, manufactured, and/or promoted by GSK, resulting in serious physical injuries to their children.

Their factual allegations are almost identical in various respects, and each is demanding compensation to account for their child’s past and future medical costs, loss of income and pain and suffering. The plaintiffs hail from Alabama, Arkansas, Massachusetts, Louisiana, New Jersey, Montana, Ohio and Texas.

If the Judicial Panel on Multidistrict Litigation (JPML) decides to establish multidistrict litigation for Zofran cases, similar birth defect lawsuits filed in district courts would be transferred to one court for shared pretrial proceedings. From there, mediation efforts may be initiated, or bellwether cases selected and tried to gauge how jurors will respond. GSK may opt to settle claims prior to trial, or take its chances with individual hearings.

Research on Zofran and fetal development

Morning sickness has the potential to be debilitating, but women must now weigh the risks and benefits of taking Zofran to quell their nausea during pregnancy. The off-label use of this drug to treat severe morning sickness is at the core of Zofran litigation, as plaintiffs argue they were never told of the potential for adverse side effects in children.

Recent research on the medication has suggested that Zofran may increase the chance of heart defects when taken in the first trimester. Specifically, the “risks for a cardiovascular defect and notably a cardiac septum defect were increased and statistically significant,” according to a study published last year in the journal Reproductive Toxicology.

Earlier research on birth defect risks published in the New England Journal of Medicine found no adverse fetal outcomes in mothers who took Zofran while pregnant, which indicates that further investigation is warranted.

  1. Justia, IN RE: Zofran Products Liability Litigation

  2. Reproductive Toxicology, Use of ondansetron during pregnancy and congenital malformations in the infant

  3. Clin Pharmacokinet, Placental transfer of ondansetron during early human pregnancy