Defense Verdict Returned in First Zoloft Birth Defect Jury Trial

A St. Louis jury has returned a defense verdict in the first product liability lawsuit to go to trial involving claims that side effects of Zoloft used during pregnancy caused an unborn child to develop severe birth defects.

Following a week-long trial in Missouri state court, a verdict in favor of the drug manufacturer, Pfizer, was handed down on Friday in a complaint filed by Logyn Pesante and his mother, Kristyn Pesante.

The case is one of several hundred Zoloft birth defect lawsuits filed against Pfizer by families throughout the U.S., each raising similar allegations that the drug maker failed to adequately warn women and the medical community about the risks associated with using the antidepressant while pregnant.

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According to allegations raised at trial, Logyn Pesante was born with congenital heart defects that the family claimed were caused by exposure to Zoloft before he was born.

Jurors determined that Pfizer provided adequate warning on the Zoloft label, which identifies the drug as a category “C” drug for pregnant women, meaning there is a potential risk of birth defects when taken during pregnancy. Some of the jurors, which voted 11 to 1 in favor of Pfizer, also said the plaintiffs failed to prove Zoloft caused the birth defects.

In addition to large numbers of cases pending at the state court level in Missouri and Pennsylvania, there are more than 545 similar complaints pending in the federal court system, where the lawsuits have been centralized as part of an MDL, or Multidistrict Litigation, before U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania.

As part of the coordinated pretrial proceedings in the federal MDL, a group cases are being prepared for “bellwether” Zoloft birth defect 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. Ultimately, each case will be based on whether the jury finds that Pfizer failed to adequately warn that plaintiff and their doctor, as well as whether it is determined that there is a link between Zoloft and birth defects suffered by the child involved in the case.

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.

While individual verdicts returned in early Zoloft trials are not binding on other cases, they may influence any eventual settlement negotiations. Following a series of bellwether trials in the MDL, if Pfizer fails to settle Zoloft lawsuits or otherwise resolve the litigation, the drug maker may face hundreds of individual lawsuits in U.S. District Courts nationwide for individual trials.


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