Zofran Birth Defect Lawsuits Cleared to Proceed Toward Trial in MDL

The U.S. District Judge presiding over all federal Zofran lawsuits has rejected a request by the manufacturer to dismiss claims that allege the anti-nausea drug caused children to develop birth defects, clearing the way for a group of “bellwether” cases to continue preparations for early trial dates.  

GlaxoSmithKline currently faces more than 400 product liability lawsuits over Zofran, each raising similar allegations that the drug maker failed to adequately women and doctors about the potential side effects of Zofran during pregnancy, which may cause children to experience life-long health problems

Zofran has been commonly prescribed “off-label” for symptoms of morning sickness, and complaints filed throughout the federal court system allege that exposure to the drug during pregnancy caused children to be born with cleft palates, cleft lips, 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.

On February 5, Judge Saylor issued a memorandum and order (PDF), denying a motion to for summary judgment filed by GlaxoSmithKline, which sought to dismiss all Zofran birth defects cases.

The drug maker had argued that the plaintiffs’ failure to warn claims were preempted by federal law, but Saylor disagreed, indicating that there was no clear evidence that GlaxoSmithKline was prevented from strengthening Zofran label warnings. In addition, the Court found that there was not clear evidence that the FDA would have rejected such efforts; one of which would be necessary for the manufacturer to win the preemption argument.

On the same day, Judge Saylor also issued an order scheduling the phases of case-specific discovery and Daubert and dispositive motions, indicating that the litigation is moving forward with preparations for a series of “bellwether” trials, which are designed to gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

The pretrial schedule calls for depositions involving all case-specific experts to be concluded by May 24, 2019, and motions to exclude or limit case-specific expert testimony or opinions and case-specific dispositive motions to be filed by June 21.

Families allege that GlaxoSmithKline knew or should have known about Zofran pregnancy risks for much longer than the last several years, yet withheld critical safety information, failed to warn doctors or consumers against use of the drug to treat morning sickness, and actively promoted the use during pregnancy, which was never approved by the FDA.

As early as 2006, plaintiffs note studies have found 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.

While the outcomes of any early “bellwether” trials will not be binding on other claims, they may greatly influence any Zofran settlement negotiations that would be necessary to avoid the need for hundreds of individual cases to go to trial in courts nationwide.