Motion to Centralize Zofran Birth Defect Lawsuits Filed by GlaxoSmithKline

As a growing number of Zofran lawsuits continue to be filed on behalf of children born with heart defects, cleft palate or other congenital malformations following exposure to the anti-nausea drug before birth, a motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) that seeks to consolidate all federal cases for coordinated pretrial proceedings. 

GlaxoSmithKline is seeking to establish a federal multidistrict litigation (MDL) for all product liability lawsuits filed in U.S. District Courts nationwide over alleged Zofran birth defect side effects, indicating that the cases should be consolidated before one judge to reduce duplicative discovery into common issues in the litigation, avoid conflicting pretrial rulings from different courts and to serve the convenience of the parties, witnesses and the courts.

According to a motion for transfer (PDF) filed on July 6, there are currently at least 12 Zofran birth defect lawsuits pending in eight different states, which all raise similar allegations that GlaxoSmithKline failed to adequately warn women or the medical community about the potential risks associated with use of the nausea medication during pregnancy.

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“Here, there is no question that these cases share a common core of operative factual allegations,” the company’s motion states. “Plaintiffs all allege that Zofran can cause harm to developing babies through ingestion of the medication by a pregnant mother. Each plaintiff alleges that GSK knew of this alleged risk yet failed to properly warn doctors or patients of the dangers.”

Although Zofran is only approved for treatment of nausea and vomiting associated with cancer treatments or surgery, the drug maker has been accused of illegally marketing the drug “off-label” for treatment of morning sickness among pregnant women. Plaintiffs allege that GlaxoSmithKline pushed use among pregnant women, even though research has suggested it may pose a potential health risk for unborn children.

Given the similar claims raised by families throughout the U.S., the drug maker seeks to have the Zofran litigation centralized before either U.S. District Judge Cynthia Rufe or U.S. District Judge Paul S. Diamond in the Eastern District of Pennsylvania, where the drug maker’s headquarters are based and where a number of similar birth defect lawsuits are currently pending involving Zoloft and Effexor.

“At its core, this litigation involves allegations that plaintiffs’ ingestion of prescription Zofran during their pregnancies resulted in their children suffering from various congenital birth defects. Judge Rufe occupies an advantageous position for guiding this litigation because she currently oversees two other multidistrict proceedings involving alleged birth defects from ingestion of prescription drugs during pregnancy (Zoloft and Effexor),” wrote the drug maker in the motion. “Judge Diamond is also a jurist familiar with some of these issues by virtue of his experience presiding over litigation involving thalidomide birth defect claims brought from 2011-13.”

Zofran Risk of Heart Defects, Cleft Palate

Concerns about the potential link between Zofran and birth defects have emerged in recent years. Although there is an assumption that the medication is safe for pregnant women based on prior marketing by GlaxoSmithKline, 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 like Jacob’s, 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.

As Zofran birth defect lawyers continue to review and file additional cases for children born with heart defects, cleft palate or other congenital malformations, it is ultimately expected that several hundred complaints will be brought throughout the federal court system.

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. However, if the parties fail to reach settlements or otherwise resolve the litigation, each individual case could ultimately be remanded back to the U.S. District Court where it was originally filed for a separate trial date in the future.


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