U.S. Appeals Court Upholds Dismissal of Zoloft Lawsuits Against Pfizer

The Third U.S. Circuit Court of Appeals in Philadelphia upheld a lower court’s dismissal last year of more than 300 product liability suits against drug maker Pfizer over its antidepressant Zoloft.

The lawsuits alleged that Zoloft was responsible for birth defects in children whose mothers took the drug during pregnancy. But the plaintiffs failed to produce convincing scientific evidence of the link between the drug and the defects, according to the courts.

The appeals court on June 2 ruled that the district court acted within its discretion when in December 2015 proceedings it excluded testimony from a key witness for the plaintiffs, Dr. Nicholas Jewell, who claimed his research showed a link between the drug and the birth defects. However, U.S. District Judge Cynthia Rufe found that Dr. Jewell “failed to consistently apply the scientific methods he articulates, has deviated from or downplayed certain well established principles of his field, and has inconsistently applied methods and standards to the data so as to support his a priori opinion.”

Judge Rufe decided to ban Dr. Jewell’s testimony and then in April 2016 she granted summary judgment for Pfizer and dismissed most of the Zoloft claims against the drug maker without a trial.

Plaintiffs appealed the exclusion of the testimony of Dr. Jewell and the summary judgment for Pfizer. The plaintiffs argued on appeal that the district court erroneously established a legal standard by holding that an expert opinion on general causation must be supported by replicated observational studies reporting a statistically significant association between the drug and the adverse effect, and that it was an abuse of discretion to exclude Dr. Jewell’s testimony.

But the appeals court, in an opinion written by Judge Jane R. Roth, found that the district court did not establish such a legal standard and did not abuse its discretion in excluding Dr. Jewell’s testimony, thus affirming the district court’s orders.

“This case involves complicated facts, statistical methodology, and competing claims of appropriate standards for assessing causality from observational epidemiological studies,” Judge Roth wrote. “Ultimately, however, the issue is quite clear. As a gatekeeper, courts are supposed to ensure that the testimony given to the jury is reliable and will be more informative than confusing. Dr. Jewell’s application of his purported methods does not satisfy this standard.”

Pfizer has maintained that Zoloft is safe and backed by accepted science.