Zoloft Birth Defect Trial in Philadelphia Ends in Defense Verdict

A Philadelphia jury has determined that label warnings regarding the potential pregnancy side effects of Zoloft provided adequate information for women about the risk of birth defects, handing Pfizer its second defense verdict. 

The verdict came following less than one day of deliberations after a week-and-a-half long trial in the Philadelphia Court of Common Pleas.

The case is one of more than 1,000 Zoloft birth defect lawsuits pending against Pfizer in state and federal courts, and the outcome of this bellwether trial has no binding effect on those remaining cases. However, the trial was closely watched by those involved in the litigation as all of the cases raise similar allegations that Pfizer failed to provide adequate warning about the link between Zoloft and birth defects.

The Philadelphia trial involved a complaint filed by Rachel Robinson in 2011, whose daughter, Mia Robinson, now 8, was born with cardiac defects, including a hole in her heart. The family said the defects were caused by the mother’s use of Zoloft and that the label warnings were insufficient. The jury disagreed and returned a defense verdict in favor of the drug maker.

This is at least the second defense verdict at the state level in just under two months. In April, a jury in Missouri state court ruled in favor of Pfizer’s label warnings in a similar case.

In addition to cases pending at the state court level, more than 550 Zoloft lawsuits filed in U.S. District Courts throughout the country are consolidated in the federal court system as part of an MDL, or multidistrict litigation. The federal cases are centralized before U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania, where the first Zoloft bellwether trials are expected to begin in January 2016.

These early trial dates are designed to help gauge how juries may respond to certain evidence and testimony may be repeated throughout a number of different cases. However, ultimately if Pfizer fails to reach Zoloft settlements or otherwise resolve the case, the drug maker face hundreds of individual trials, where juries will determine in each case whether the drug maker failed to adequately warn about the birth defect risk with Zoloft.

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.