First Bellwether Trial Over Zofran Birth Defects Set To Begin October 2021

The U.S. District Judge presiding over all Zofran birth defect lawsuits pending throughout the federal court system has scheduled the first bellwether trial to go before a jury in October 2021, which will help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout hundreds of lawsuits filed by families nationwide.

GlaxoSmithKline currently faces more than 400 product liability complaints filed in U.S. District Courts throughout the country, each involving allegations that women and the medical community were not adequately warned about the potential pregnancy risks with Zofran, an anti-nausea medication that has commonly been marketed for use to treat morning sickness. However, families allege use of the medication during pregnancy caused children to be born with severe birth defects and congenital malformations, such as cleft palates, cleft lips, atrial septal defects, ventricular septal defects and other life-long health problems.

Given the similar questions of fact and law presented throughout the Zofran 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. However, the first trial was delayed after GlaxoSmithKline filed a Citizen’s Petition sought to change the drug’s warning label, to give the agency time to respond to the petition.

Following a status conference last week, Judge Saylor reset the first jury trial, which is now tentatively set to begin on October 18, 2021, and is expected to last four weeks. Judge Saylor also set another conference for March 24, 2021, at which time the court will consider arguments over whether some cases should be dismissed, based on a claim by GlaxoSmithKline that plaintiffs have failed to provide causation evidence linking Zofran to septal defects and other heart defects.

In addition, the Court indicated discovery proceedings have temporarily stalled because Novartis is waiting on communications from the FDA regarding proposed labeling changes for the anti-nausea drug. Novartis acquired Zofran from GlaxoSmithKline in 2015. The FDA rejected a proposal for new birth defect warnings proposed by Novartis in November.

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.