Zofran Birth Defect Cases Expected to Grow, GlaxoSmithKline Acknowledges

GlaxoSmithKline continues to push for all Zofran birth defect cases filed throughout the federal court system to be centralized in Philadelphia, indicating that the number of lawsuits is expected to continue to grow and that plaintiffs have not proposed a better venue for the litigation.

In early July, the drug maker filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML), asking that all federal Zofran lawsuits be centralized in the Eastern District of Pennsylvania, where GlaxoSmithKline asks that either U.S. District Judge Cynthia Rufe or U.S. District Judge Paul S. Diamond be assigned to preside over the cases.

There are currently at least 33 Zofran cases pending in 20 different federal district courts brought by families of children born with heart defects, cleft palate, cleft lip or other congenital malformations. Each of the complaints raise similar allegations that GlaxoSmithKline failed to adequately warn women and the medical community about the pregnancy side effects of Zofran.

More than 19 different plaintiffs have filed responses to GlaxoSmithKline’s motion to establish a Zofran MDL, or multidistrict litigation. While all of the responses agree that the birth defect cases should be centralized before one judge for coordinated discovery and pretrial proceedings, each of the plaintiffs oppose consolidation in the Eastern District of Pennsylvania.

In a reply brief (PDF) filed on August 5, GlaxoSmithKline continues to push for the cases to be centralized before either Judge Rufe or Judge Diamond, indicating that plaintiffs have not put forth a compelling argument for any other venue and that there is no consensus among alternate proposals from the different plaintiffs.

GlaxoSmithKline maintains that the Eastern District of Pennsylvania is the most appropriate venue because that is where the drug maker’s headquarters are based, where a number of witnesses and documents are located and it is a central location.

“A significant portion of the witnesses and documents relating to the clinical development, regulatory history, and sales and marketing of Zofran are located in the District,” the company’s attorneys argue. “This factor strongly favors transfer to the Eastern District [of Pennsylvania].”

Plaintiffs have argued that the federal court in Philadelphia is already overloaded with cases, arguing that other districts are more appropriate, 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.

The U.S. JPML is expected to schedule oral arguments during for an upcoming hearing session set for October 1, in New York City.

Zofran Birth Defect Risk

Although Zofran is not approved for treatment of morning sickness, there has been an assumption that the the drug is safe for pregnant women. However, a number of studies have identified potential Zofran pregnancy risks when the drug is used during the first trimester.

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.