Zofran Litigation Over Pregnancy Risks Centralized In Massachusetts Federal Court

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has decided to centralize all Zofran lawsuits pending throughout the federal court system before one U.S. District Judge in Massachusetts for coordinated discovery and pretrial proceedings. 

There are currently more than 50 product liability lawsuits pending against GlaxoSmithKline in about a two dozen different U.S. District Courts nationwide, each involving similar allegations that the drug maker failed to adequately warn about the potential pregnancy risks of Zofran.

Following oral arguments heard earlier this month, the Panel decided to establish a federal multidistrict litigation (MDL) for the Zofran cases, given the similar questions of fact and law raised in the complaints brought by families of children born with various heart defects, cleft palate, cleft lip and other congenital malformations, which were allegedly caused by use of Zofran for morning sickness during pregnancy.

As lawyers continue to review and file complaints in courts nationwide over the coming months and years, it is ultimately expected that the Zofran litigation will include hundreds, if not thousands, of complaints. Centralizing the cases before one judge is designed to reduce duplicative discovery, avoid conflicting pretrial rulings from different courts and to serve the convenience of the parties, witnesses and the judicial system.

Zofran MDL

In a transfer order (PDF) issued on October 13, the U.S. JPML indicated that the litigation will be assigned to U.S. District Judge Dennis Saylor, IV, in the District of Massachusetts, who was already presiding over at least four cases, including the very first Zofran complaint brought in the federal court system.

GlaxoSmithKline filed the original request to consolidate the Zofran birth defect litigation in early July, proposing that the cases be transferred to the Eastern District of Pennsylvania, where the drug maker’s headquarters are located.

While most plaintiffs with pending cases agreed that it was appropriate to establish a Zofran MDL, they urged the U.S. JPML not to transfer the litigation to the Eastern District of Pennsylvania, which they argued was already overloaded with cases and would provide the drug maker with a home court advantage.

Following oral arguments heard on October 1, the U.S. JPML determined that Judge Saylor’s court was the most appropriate venue for the MDL, given the number of cases he was already handling and his experience with this type litigation.

Zofran Pregnancy Risks

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.

Establishment of an MDL means that the cases will be handled somwhat similar to a Zofran class action. However, following centralized pretrial proceedings, if the parties fail to reach Zofran settlements or otherwise resolve the birth defect 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.