Zofran Lawsuits Over Birth Defects to be Selected for Early Bellwether Trials

The U.S. District Judge presiding over all federal Zofran birth defect lawsuits filed against GlaxoSmithKline has ordered both sides to select eight cases each, which will be prepared for potential bellwether trials, to help gauge how juries may respond to certain evidence and testimony that may be repeated throughout hundreds of claims brought by families nationwide. 

GlaxoSmithKline currently faces nearly 450 product liability lawsuits over Zofran, each raising similar allegations that the drug maker failed to adequately warn women and doctors about the potential side effects of Zofran during pregnancy. The litigation involves claims brought on behalf of children born with cleft palate, cleft lip, atrial septal defects, ventricular septal defects and other congenital malformations.

Given the similar questions of fact and law presented in the litigation, cases filed in U.S. District Courts nationwide have been centralized for coordinated pretrial proceedings 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.

In an order (PDF) issued on May 17, Judge Saylor called for the plaintiffs and defendants to select a total of 16 cases by June 15, with each side designating half.

The cases must include a completed fact sheet, and all relevant medical and other authorizations, which were executed and submitted to GlaxoSmithKline at least 60 days in advance of the case selections. In addition, the claims are to involve either structural heart damage birth defects, like atrial or ventricular septal defects, or crainofacial birth defects, such as cleft palate and cleft lip.

After the Zofran lawsuits are selected for the bellwether program, the parties will meet no later than October 31 to discuss procedures for selecting individual cases from that group for future trial dates.

Zofran Pregnancy Risks

In the litigation, families allege that GlaxoSmithKline knew or should have known about the Zofran pregnancy risks for years, yet failed to warn doctors or consumers against use of the drug to treat morning sickness.

As early as 2006, plaintiffs note that studies have found that Zofran crosses the placenta in significant amounts when taken by pregnant women, with Hong Kong researchers 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.

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.

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.