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Zoloft Lawsuit Over Birth Defect Risk in MDL Scheduled For Trial in March 2016

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The first federal trial for a Zoloft lawsuit is scheduled to begin in March 2016, serving as a test case in the litigation over birth defects associated with using the antidepressant during pregnancy. 

Pfizer currently faces hundreds of product liability complaints brought by families of children throughout the U.S. who were born with congenital defects and malformations that were allegedly caused by side effects of Zoloft use during pregnancy.

Since April 2012, Zoloft cases filed throughout the federal court system have been centralized before U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania, for coordinated discovery and pretrial proceedings as part of an MDL, or multidistrict litigation.

The parties are preparing a small group of cases for early trial dates, known as “bellwether” cases, which are designed to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout Zoloft litigation.

In a pretrial order (PDF) issued this week, Judge Rufe detailed the schedule that will lead to the first Zoloft bellwether trial early next year. The parties have been directed to complete expert depositions by November 18, all pre-trial motions will be filed by mid-February 2016, and jury selection to begin on March 3, 2016.

Zoloft Birth Defect Warning Change Possible

The approaching trial comes as Pfizer is considering an update to the Zoloft warning label, following an FDA request that the drug maker add data to the pregnancy warnings about the findings of studies linking the antidepressant to congenital heart problems.

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.

While the drug maker has maintained that there is no reliable scientific evidence linking Zoloft and birth defects, Bloomberg News reported last month Pfizer is currently weighing the request made by the federal drug regulatory agency.

The first Zoloft trials will be closely watched by those involved in the litigation, as it may influence any eventual settlement negotiations in the litigation.

According to internal memos uncovered during discovery in the Zoloft birth defect cases, the company’s own scientists have warned for years that the drug may cause birth defects.

In April 2014, a review by Francesca Kolitsopoulous, associate director of Pfizer’s Worldwide Safety Strategy department’s epidemiology group, warned executives at the pharmaceutical company that studies showed a link between Zoloft side effects and heart defects, suggesting that the drug’s label should be modified to add information from the studies.

Prior to that report, Pfizer reviewers warned the company of congenital birth defects that were potentially related to Zoloft in an October 1998 report.

If Pfizer fails to settle the Zoloft lawsuits or otherwise resolve the litigation, it may face hundreds of individual trials involving children left with severe and debilitating birth defects after exposure to the medication during pregnancy.

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