Lawsuit Over Zoloft Pregnancy Risks Goes to Trial in St. Louis

Trial is underway for a birth defect lawsuit in Missouri state court, involving allegations that Pfizer failed to adequately warn about the potential side effects of Zoloft in pregnant women.

Early evidence presented in the case suggests that the drug manufacturer knew about the potential Zoloft pregnancy risks, yet withheld information from consumers and the medical community.

Opening statements began last week in St. Louis for a Zoloft lawsuit brought on behalf of Logyn Pesante, an 11-year-old boy who suffered birth defects after his mother took Zoloft during pregnancy.

Part of the opening salvo by plaintiffs was an internal Pfizer report from May 2014, which suggests that taking Zoloft during pregnancy increased the risks of a child being born with congenital heart defects, digestive system problems and lung defects. The memo was held forth as evidence that Pfizer knows about the risks of Zoloft, but still refuses to provide women with adequate warning. Pfizer’s attorneys say plaintiffs have taken one line in the report out of context.

Pfizer currently faces hundreds of similar Zoloft birth defect lawsuits at both the state and federal level. In addition to large numbers of cases pending in Missouri and Pennsylvania state courts, there are at least 545 product liability lawsuits over Zoloft pending throughout the federal court system.

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 MDL 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.

While the Pesante case is not one of the federal bellwether trials, it will be closely watched by those involved in the litigation, as it may help gauge the strengths and weaknesses of certain arguments.

The first federal Zoloft trial is slated to go before a jury in January 2016. After a series of cases are presented to different juries, if Pfizer fails to reach Zoloft settlements or another resolution for the litigation, it could face hundreds of individual trials in courts throughout the country.

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.