Zofran Birth Defect MDL To Be Considered by U.S. JPML During Hearing in October

As a growing number of Zofran birth defect lawsuits continue to be filed against GlaxoSmithKline, the U.S. Judicial Panel on Multidistrict Litigation (JPML) has scheduled oral arguments for October 1, 2015 on whether to centralize the cases before one judge for coordinated pretrial proceedings. 

In early July, the drug manufacturer filed a motion asking that all federal Zofran litigation be consolidated as part of an MDL, or multidistrict litigation. GlaxoSmithKline proposed that the cases be transferred to the Eastern District of Pennsylvania, before either U.S. District Judge Cynthia Rufe or U.S. District Judge Paul S. Diamond.

There are currently at least 33 cases reportedly pending in 20 different federal district courts brought by families of children born with heart defects, cleft palate, cleft lip or other congenital malformations, which were allegedly caused by side effects of Zofran used during pregnancy. However, as lawyers continue to review and file complaints in U.S. District Courts nationwide, it is ultimately expected that several hundred, if not thousands, of cases could be included in the litigation.

Nearly two dozen different plaintiffs have filed responses to GlaxoSmithKline’s request, supporting the establishment of a Zofran birth defect MDL. However, none of the plaintiffs support centralization in the Eastern District of Pennsylvania, which they argue is already overloaded with cases and would provide GlaxoSmithKline with a “home court” advantage. Various other districts have been proposed by the plaintiffs, including the Northern District of Alabama, the Northern District of California, the Southern District of Illinois, the Eastern District of Louisiana, the District of Massachusetts and the Northern District of Ohio.

According to a hearing order (PDF) issued August 14, the U.S. JPML will consider oral arguments on the motion during a hearing scheduled for October 1, at the Daniel Patrick Moynihan U.S. Courthouse in New York City.

Zofran Birth Defect Risk

All of the current litigation over Zofran stems from use of the drug by pregnant women for treatment of morning sickness. Although the medication is not approved for treatment of pregnancy related nausea and vomiting, GlaxoSmithKline has been accused of illegally marketing Zofran for off-label use during the first trimester of pregnancy.

Several studies have highlighted potential Zofran pregnancy risks, which plaintiffs maintain were not adequately disclosed on the warning label.

As early as 2006, a study published by Hong Kong researchers confirmed that Zofran crosses the placenta in significant amounts when taken by pregnant women. Researchers concluded that the “developmental significance of this drug exposure requires further investigation,” yet millions of women have continued to be prescribed the medication without warnings about the potential Zofran birth defect risks.

In November 2011, a study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology concluded that women may be 2.37 times more likely to give birth to a child with a cleft palate following Zofran use. This may leave children with a severe facial deformity, which can occur when development of the fetus is impacted during the first trimester.

Additional studies have also identified potential Zofran heart defect risks. An August 2013 study that reviewed data on more than 900,000 pregnancies in the Danish Medical Birth Registry found that children may be two to four times more likely to suffer a septal defect, involving holes in the heart, following Zofran exposure. Heart murmurs following Zofran use during pregnancy may be a sign or symptom of these heart problems.

More recently, a study published by the medical journal Reproductive Toxicology in October 2014 found that there is a statistically significant increased risk for certain heart defects with Zofran use early in pregnancy.

If an MDL is established, the cases would be centralized before one judge for coordinated discovery and pretrial proceedings similar to a Zofran class action. The centralized management is designed to reduce duplicative discovery into common issues raised in the cases, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

Following centralized pretrial proceedings, if the parties fail to reach Zofran birth defect settlements or otherwise resolve the litigation, each individual case could be ultimately remanded back to the U.S. District Court where it was originally filed for a separate trial date.