First Ruling in Zoloft Trial Questions Birth Defect Link

Pfizer Inc.’s flagship antidepressant, Zoloft, has long faced accusations that it may cause birth defects in children whose mothers took the drug while pregnant. The claims are based on SSRI (selective serotonin reuptake inhibitors) research that found an increased risk of certain heart defects in patients taking Zoloft, including a Danish study that found a slightly increased risk of atrial septal defects and ventricular septal defects in the children of Zoloft users. Pfizer, of course, has always denied the alleged side effects, and when lawsuits were filed – now numbering well over five hundred in federal court alone – the company defended its product. Hundreds of lawsuits were joined together in a multidistrict litigation under U.S. District Judge Cynthia M. Rufe in Pennsylvania, while others remained in state courts. Last week, the first case to go to court received its verdict from a state jury in St. Louis – and it’s good news for Pfizer.

The case in question was filed by Kristyn Pesante, a 31-year old mother who argued that taking Zoloft had lead to her son Logyn’s cardiac defects. While not a part of the federal MDL, the suit was part of a multiplaintiff complaint made up of around twenty cases, all filed in 2012. The Pesante’s trial was the first of the group to be held – and, in fact, was the first Zoloft trial since the birth defect accusations came to light. That’s why the outcome is seen as so important – and why Pfizer couldn’t be happier with the outcome. After just a week in court, the jury returned its verdict against the plaintiffs, ruling that Pfizer did not owe compensatory damages for personal injury. The jury did not rule on Pfizer’s failure to warn or the causation of Logyn’s heart problems.

So, what does this mean? Pfizer is certainly seeking to highlight the case’s importance, releasing a statement that noted:

“The decision is particularly significant as the plaintiffs’ lawyers selected this case for their first trial, and after all the evidence was heard, the jury found in favor of Pfizer. Equally significant, some of the same plaintiff’s experts and theories, which the Pesante jury found unpersuasive, have been put forth in other pending Zoloft cases."

On the other hand, this is one case, in one court. Pfizer still faces accusations that its drug can cause birth defects, while plaintiffs still need to convince a jury that the link between Zoloft and heart defects is provable. In Kristyn Pesante’s case, the jury simply couldn’t see a definite link between Zoloft and Logyn’s health problems. During the trial Pfizer argued that the rate of birth defects in the general population – roughly three to five per cent – had not changed since Zoloft was introduced in the 1990s, and that while Zoloft users may give birth to children with heart problems, the correlation does not imply causation. Pfizer also told the jury that many people do not realize how common birth defects actually are.

The second Zoloft trial at state level is expected to take place in May in the Philadelphia Court of Common Pleas. The first federal bellwether trial – an important step in seeing which way an MDL might go – is scheduled for January, 2016 in Pennsylvania.