Zofran Heart Defect Lawsuit Alleges Morning Sickness Drug Caused Atrial Septal Defect

A California couple has filed a lawsuit after their child was born with congenital heart defects from Zofran used during the first trimester of pregnancy, alleging that GlaxoSmithKline failed to adequately warn about the risks associated with prescribing their anti-nausea drug for treatment of morning sickness. 

The complaint (PDF) was filed by Katherine and Matthew Murray in the U.S. District for the Northern District of California on September 29, on behalf of themselves and their daughter, identified in the lawsuit only as J.M.

Zofran (ondansetron) is a prescription medication approved for treatment of nausea and vomiting associated with chemotherapy and surgery. However, in recent years, it has been widely used “off-label” to treat morning sickness and hyperemesis gravidarum among pregnant women.

Kathleen Murray indicates that she was prescribed Zofran during the first trimester of her pregnancy, before the birth of J.M. in 2007. According to the lawsuit, exposure to the medication caused the child to suffer severe cardiac problems, including an atrial septal defect that has required cardiac catheterization and placement of a septal occluder when she was just four years old.

The case joins a growing number of similar Zofran birth defect lawsuits filed against GlaxoSmithKline over the past year, alleging that the anti-nausea drug was illegally marketed for use among pregnant women, even though the drug makers failed to establish to government regulators that it was safe or effective for mothers and unborn children.

The Murrays are pursing claims against GlaxoSmithKline for negligence, strict product liability, intentional misrepresentation, concealment, negligent misrepresentation, breach of warranty and violation of California business and consumer protection laws.

Zofran Birth Defect Risks

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 at that time 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 side effects on the development of the heart. 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.

Zofran Lawsuit Consolidation Under Consideration

The Murray lawsuit was filed just days before the U.S. Judicial Panel on Multidistrict Litigation (JPML) heard oral arguments from both the manufacturer and plaintiffs calling for all Zofran lawsuits filed throughout the federal court system to be consolidated before one judge for 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 cases pending in at least 20 different federal district courts, involving nearly identical allegations brought by families of children born with heart defects, cleft palate, cleft lip or other congenital malformations. 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.

Plaintiffs have opposed centralizing the litigation in the Eastern District of Pennsylvania, arguing that the venue 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.

A decision is expected later this week. If a Zofran MDL is created, the Murray lawsuit will be transferred to whatever court the JPML chooses as the most appropriate venue for the centralization of the cases.