Zofran Birth Defect Lawsuit Discovery Continues in MDL

With several hundred Zofran lawsuits pending in the federal court system, each involving similar allegations that children suffered severe birth defects and malformations following exposure to the anti-nausea drug during pregnancy, coordinated discovery continues to move forward into issues common to all of the claims.

For the past year, all product liability lawsuits filed in U.S. District Courts nationwide against GlaxoSmithKline over the failure to warn about the birth defect side effects of Zofran have been centralized in the federal court system as part of an MDL, or Multidistrict Litigation (MDL). The cases are consolidated before U.S. District Judge Dennis Saylor in the District of Massachusetts to reduce duplicative discovery, avoid conflicting pretrial rulings from different courts and to serve the convenience of the parties, witnesses and the judicial system.

There are currently about 350 claims pending in the Zofran MDL, involving children born with cleft palate, cleft lip, atrial septal defects, ventricular septal defects and other congenital malformations after the mother was prescribed the anti-nausea drug when pregnant to treat symptoms of morning sickness. However, as Zofran birth defect lawyers continue to review and file additional cases in the coming months and years, it is expected that there will ultimately be more than 1,000 claims eventually be filed by families nationwide.

As part of the coordinated pretrial proceedings, Judge Saylor has established five phases of discovery (PDF), including: (1) the exchange of written fact sheets and medical records; (2) discovery of electrically stored information from GlaxoSmithKline and concerning the organization of the drug maker; (3) discovery concerning general causation issues on the link between Zofran and specific birth defects, as well as issues related to federal pre-emption; (4) discovery concerning other potential issues generally relevant to liability, but not specific to individual cases; and (5) discovery concerning remaning issues relevant to individual cases, such as causation, product identification and damages.

A general order concerning discovery (PDF) was issued by Judge Saylor on November 10, and many of the phases outlined in a separate order are already underway. The fourth phase is set to begin in February 2017, and the fifth phase, concerning individual issues, will begin at a time to be determined by the Court in a subsequent order.

Zofran Pregnancy Risks

Zofran (ondansetron) is a prescription medication approved for treatment of nausea and vomiting among chemotherapy and surgical patients. However, following aggressive marketing by GlaxoSmithKline, it has been widely used off-label among pregnant women for treatment of morning sickness.

Most of the pending complaints allege that the drug maker engaged in illegal marketing of the drug for use during pregnancy, while withholding information about the potential birth defect risks it may pose for unborn children.

As early as 2006, studies have highlighted potential Zofran pregnancy risks, according to the lawsuits. Hong Kong researchers found that Zofran crosses the placenta in significant amounts when taken by pregnant women, concluding that the “developmental significance of this drug exposure requires further investigation.”

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.

In August 2013, another study highlighted a potential risk of heart defects with Zofran, following a review of data involving more than 900,000 pregnancies in the Danish Medical Birth Registry. Researchers found that children may be two to four times more likely to suffer a septal defect, involving holes in the heart, following Zofran exposure.

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 part of the coordinated pretrial proceedings before Judge Saylor, it is expected that a small group of Zofran claims will be selected for a “bellwether” program, which will be prepared for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

Following pretrial proceedings and any bellwether trials, if the parties fail to reach Zofran settlements for children left with birth defects following exposure to the drug, GlaxoSmithKline may face hundreds of individual trials in U.S. District Courts throughout the country over the failure warn women and the medical community about the potential risk of birth defects linked to the anti-nausea drug.