First Zoloft Trial in Federal MDL for Birth Defect Lawsuits to Begin Nov. 2014

As the parties involved in the federal Zoloft birth defect lawsuits continue to prepare a small group of cases for early trial dates, the judge presiding over the litigation has issued an order indicating that the first case will go before a jury in November 2014.

There are currently more than 420 product liability lawsuits pending against Pfizer in a multidistrict litigation (MDL) that has been centralized before U.S. District Judge Cynthia M. Rufe in the Eastern District of Pennsylvania.

All of the cases involve similar allegations that children where born with serious birth defects or malformations from side effects of Zoloft, claiming that Pfizer failed to adequately warn women or the medical community about the risks associated with using the popular antidepressant during pregnancy.

As part of the coordinated proceedings, a group of 25 cases were previously selected as part of an “Initial Discovery Pool,” including 13 cases selected by Pfizer and 12 cases selected by a group of plaintiffs’ lawyers appointed to leadership roles in the Zoloft litigation. These cases are currently going through pretrial discovery, including depositions and the exchange of documents and medical records relevant to each complaint.

In a Pretrial Order (PDF) issued on November 18, Judge Rufe amended the time-table for selecting the specific cases that will be presented to the first juries, and pushed back the start of the first trial about three weeks. While a tentative trial date was previously set for mid-October, the first Zoloft birth defect case is now scheduled for trial to begin on November 3, 2014.

According to the order, each side will be able to use two “strikes” to remove cases selected by the opposing party from the Initial Discovery Group by May 5, 2014. Later that same month, the parties will exchange selections of cases that will be prepared to be ready for trial by November 2014, with the exact number of cases and orders of any bellwether trials determined in the future. All generic and case-specific discovery for cases in this Trial Pool will be completed by August 15, 2014.

Opening statements and the start of testimony in the first Zoloft trial will begin the first week of November 2014. The Pretrial Order suggests that testimony will continue for about three weeks, with each side allotted 25 total hours to present its case, including opening statements, testimony and closing arguments. Jury instructions and the start of deliberations are expected to begin on Monday, November 24, 2013.

The preparation and outcomes of the early trial dates are designed to help the parties gauge how juries may respond to testimony and evidence that may be repeated throughout the litigation. Following the bellwether process, if a Zoloft settlement agreement is not reached to resolve a substantial portion of the existing cases, Judge Rufe may begin remanding cases back to the U.S. District Courts where they were originally filed for individual trial dates across the country.

Zoloft Birth Defect Risks

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, 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 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.

The complaints allege that Pfizer knew or should have known about the risks associated with using Zoloft while pregnant, but failed to provide adequate warnings for women of child-bearing potential, preventing them from taking steps to avoid using the medication while pregnant.

While the first cases are being prepared for early trial dates next year, the number of lawsuits filed nationwide continues to mount. Zoloft lawyers are continuing to review cases for families as they learn that their child’s birth defects or malformations may have been caused by use of the antidepressant during pregnancy, and it is expected that there may ultimately be several thousand cases brought against Zoloft.