First Zofran Bellwether Trial Delayed Due to Coronavirus

For a second time, the U.S. District Judge presiding over all federal Zofran birth defect lawsuits has delayed the start of the first bellwether trial; this time due to the coronavirus pandemic that has shut down most of civil trials throughout the federal court system.

GlaxoSmithKline currently faces more than 400 product liability lawsuits brought by families nationwide, each involving allegations that consumers and the medical community were not adequately warned about the potential Zofran pregnancy risks, including claims that use of the anti-nausea drug caused children to develop severe birth defects, such as cleft palates, cleft lips, atrial septal defects, ventricular septal defects and other congenital malformations.

Zofran has been commonly prescribed “off-label” for symptoms of morning sickness, and plaintiffs claim GlaxoSmithKline failed to provide sufficient pregnancy warnings. However, the drug maker has previously sought to dismiss the cases, arguing that the claims are pre-empted by federal law, since the FDA would not have allowed a pregnancy warning.

Given the similar questions of fact and law presented in the litigation, cases filed throughout the federal court system 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.

As part of the coordinated proceedings before Judge Saylor, a small group of representative cases have been prepared for a series of Zofran “bellwether” trials, which were expected to begin in January 2020, to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. However, the first trial was delayed in November, after GlaxoSmithKline filed Citizen’s Petition sought to change the drug’s warning label, to give the agency time to respond to the petition.

On March 18, the parties held a status conference to receive updates on the litigation and to update the status of the petition. At the conference, the Court informed the parties that the jury trial, which had been rescheduled to begin May 4, has been cancelled due to coronavirus outbreak concerns. No new date for the trial has been set.

The Court scheduled the next status conference, to be held via telephone, for April 15.

Zofran Birth Defect Risks

According to allegations raised in complaints filed by families nationwide, GlaxoSmithKline knew or should have known about the birth defect risks associated with Zofran, yet withheld critical safety information and failed to warn doctors and consumers against use of the drug to treat morning sickness. Although the FDA never approved Zofran for use to combat pregnancy-associated nausea, plaintiffs allege that the drug maker actively promoted this “off label” use.

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.

According to a study published by the medical journal Reproductive Toxicology in October 2014, there there is a statistically significant increased risk for certain heart defects with Zofran use early in pregnancy.

GlaxoSmithKline has attempted to defend against the lawsuits by arguing that the plaintiff’s failure to warn claims should be preempted by federal law. However, Judge Saylor has previously rejected this argument, finding there was no clear evidence the drug maker was prevented from strengthening the Zofran warnings. In addition, the court found there was not clear evidence the FDA would have rejected such efforts.

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, if the drug maker is unable to otherwise bar the claims.