Zoloft Birth Defect Lawsuits Dismissed Over Lack of Causation Experts

The U.S. District Judge presiding over all federal Zoloft birth defect lawsuits has granted Pfizer’s motion for summary judgment to dismiss the cases, after finding that plaintiffs have been unable to produce experts who will be allowed to testify that the antidepressant was capable of causing the injuries claimed by families nationwide.

There were nearly 300 product liability lawsuits pending throughout the federal court system, which each involve allegations that infants were born with severe congenital defects and malformations due to side effects of Zoloft used during pregnancy. However, Pfizer successfully challenged the admissibility and reliability of several expert witnesses designated by plaintiffs to present evidence on the causal connection between Zoloft and birth defects.

Since April 2012, the federal litigation has been centralized before U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania, as part of an MDL, or multidistrict litigation. The cases have been consolidated for discovery and pretrial proceedings, and it was expected that a series of “bellwether” trials would be presented to help gauge how juries would respond to certain evidence and testimony that was likely to be repeated throughout the litigation.

In an opinion (PDF) issued April 15, Judge Rufe explained why the cases would not be allowed to proceed, indicating that “Plaintiffs have failed to raise a jury question on the necessary predicate to success in any case: that Zoloft was capable of causing their injuries.”

During the course of the MDL proceedings, Judge Rufe has excluded the testimony of several expert witnesses plaintiffs proposed to use at trial, which would have explained how Zoloft could cause birth defects when taken by pregnant women. Without these causation experts, the plaintiffs have been left with no way to link the antidepressant to the birth defects.

Judge Rufe said that the witnesses and other efforts to establish causation failed to meet the court’s standards for reliability. Following her ruling, Pfizer filed a summary judgment in December, seeking to have all cases pending in the MDL dismissed.

In the opinion issued last week explaining the decision to grant that motion, Judge Rufe acknowledged that Pfizer’s own internal documents suggest that the company knew about the potential for Zoloft birth defects. However, she indicated that does not prove that Zoloft were the cause and were not enough to keep the cases afloat.

“The internal documents demonstrate that Pfizer employees raised questions about associations between Zoloft and birth defects and discussed possible changes to the product label, generally without reaching conclusive findings,” Judge Rufe wrote. “The documents may be relevant to questions of Pfizer’s knowledge and actions if Zoloft were found to cause birth defects, but do not raise a genuine issue of material fact as to causation.”

Judge Rufe noted that the question on whether Zoloft does in fact cause birth defects is still an open one, but said that at this point the plaintiffs were unable to prove the connection.

“The Court recognizes that the final scientific verdict as to whether Zoloft can cause birth defects may not be delivered for many years,” she wrote. “Nevertheless, Plaintiffs chose when to file their cases, and the Court concludes that for the Plaintiffs who have continued to pursue their claims, the litigation gates must be closed.”

It is expected that Plaintiffs will appeal the ruling.