Zoloft Bellwether Trial Scheduled to Begin in January 2016

The U.S. District Judge presiding over hundreds of Zoloft birth defects lawsuits has scheduled the first “bellwether” trial to begin early next year. 

There are currently at least 545 product liability lawsuits pending throughout the federal court system, which all involve similar allegations that Pfizer failed to adequately warn about the potential side effects of Zoloft for pregnant women.

Complaints have been filed by families of children born with severe birth defects and malformations that were allegedly caused by exposure to the antidepressant during pregnancy, including heart defects, spina bifida, persistent pulmonary hypertension in newborns (PPHN), lung defects, abdominal defects, cranial defects and other health problems.

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Since April 2012, all federal Zoloft lawsuits have been centralized for coordinated pretrial proceedings as part of an MDL, or Multidistrict Litigation, which is assigned to U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania.

As part of the coordinated pretrial proceedings in the litigation, a group of cases are being prepared for early “bellwether” trials, which are are designed to evaluate how juries may respond to certain evidence and testimony that is likely to be repeated throughout a number of cases.

In a pretrial order (PDF) issued on April 1, Judge Rufe indicates that she will determine the order in which this pool of cases will be tried by May 1. The parties will then complete expert discovery and any challenges to the admissibility of expert testimony over the remainder of this year.

According to Judge Rufe, jury selections will begin in the first Zoloft bellwether trial on January 19, 2016.

While the outcome of these early trial dates will not be binding in other cases, they will be closely watched by lawyers involved in the litigation as they may influence negotiations with Pfizer to reach Zoloft birth defect settlements. Following the bellwether trials, if the parties fail to resolve cases, hundreds of individual lawsuits may be remanded back to the U.S. District Courts where they were originally filed for separate trial dates.

Zoloft Birth Defect Risk

Zoloft (sertraline) is one of the most widely prescribed medications in the United States, and has been used by tens of millions of individuals. However, several studies have suggested that use of Zoloft by pregnant women has been linked to a potential increased risk of serious and potentially life-threatening birth defects and malformation for children.

In November 2006, the FDA added warnings about a potential risk of persistent pulmonary hypertension in newborns (PPHN) from Zoloft and other newer antidepressants when taken after the 20th week of pregnancy. The side effects of Zoloft and other similar medications were linked to a six times greater risk of PPHN.

In June 2007, studies found an association between the use of antidepressants like Zoloft early in the pregnancy and a risk of abnormal skull development, gastrointestinal abnormality and brain defects.

In September 2009, a study published in the British Medical Journal (BMJ) found that SSRI antidepressants like Zoloft increase the risk of heart defects when taken during the first trimester, a time when many women do not even know they are pregnant.


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