First Zoloft Birth Defect Trial Set for November 2014


The first trial in the multidistrict litigation (MDL) established for all Zoloft birth defect lawsuits filed in federal courts is set to go before a jury in November 2014.

At this time more than 420 personal injury lawsuits against Pfizer have been consolidated in the Eastern District of Pennsylvania before U.S. District Judge Cynthia M. Rufe. All of the lawsuits were filed on behalf of families with children born with serious congenital birth defects allegedly caused by the popular antidepressant. The suits are based on claims that Pfizer failed to provide adequate warnings about the risks linked to Zoloft.

Twenty-five of the cases were selected by Pfizer and the plaintiffs’ lawyers appointed as leadership counsel in the MDL as part of an “Initial Discovery Pool” and are in the process of pretrial discovery.

On Nov. 18, Judge Rufe issued a Pretrial Order which amended the schedule for selecting the first cases to appear before juries and delayed the start of the first trial by roughly three weeks, setting the first Zoloft birth defect trial to begin on Nov. 3, 2014.

The order gives each side the ability to use two “strikes” to remove cases from the Initial Discovery Group by May 5, 2014. Later in May, selections of cases to be ready for the November 2014 trial will be exchanged and the details of any bellwether trials will be determined at a future date. There is an Aug. 15, 2014 deadline for all generic and case-specific discovery for cases included in this Trial Pool.

According to the Pretrial Order, testimony will continue for roughly three weeks after opening on Nov. 3. Each side is allotted 25 hours total for the presentation of cases, which includes opening statements, testimony and closing arguments. It is expected that jury instructions will be issued and deliberation will begin on Monday, Nov. 24, 2014.

Zoloft (sertraline) is among the most widely prescribed antidepressants in the United States and has been prescribed to tens of millions of patients. Use of Zoloft during pregnancy has been linked to an increased risk of multiple serious and potentially fatal birth defects.

Zoloft warning labels were amended to include warnings of the risk of persistent pulmonary hypertension in newborns (PPHN) by the FDA in November 2006. Multiple studies have also linked Zoloft to a heightened risk of skull development abnormalities, gastrointestinal malformations, brain defects and multiple heart defects.

In the Zoloft lawsuits, plaintiffs argue that Pfizer knew or should have known of these risks but failed to furnish adequate warnings. Such warnings, according to the suits, may have prevented pregnant women from using the drug for the protection of their unborn children.