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Will Hundreds of Zoloft Lawsuits Be Dismissed?

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Since April 2012, federally filed Zoloft lawsuits have been proceeding in centralized litigation in the Eastern District of Pennsylvania under the direction of U.S. District Judge Cynthia Rufe. Currently, there are just shy of 300 cases pending against Zoloft manufacturer Pfizer, with plaintiffs claiming that the antidepressant caused birth defects, and that Pfizer failed to warn about this dangerous risk.

As the parties work toward early bellwether trials, which are expected to begin in March, Pfizer would like to have hundreds of Zoloft lawsuits dismissed. It bases its request on an earlier decision by Judge Rufe, when she refused to admit the testimony of plaintiffs’ expert Nicholas Jewell, Ph.D. Dr. Jewell was expected to testify as to the link between the ingestion of Zoloft during pregnancy and the increased risk of birth defects in children.

Court Considers Whether to Admit Dr. Jewell’s Testimony

Dr. Jewell believes that the maternal use of Zoloft was capable of causing or contributing to heart defects in newborns. Plaintiffs wanted to include Jewell’s opinion as expert testimony, but Pfizer challenged its admissibility, claiming that the doctor’s opinion was based on unreliable methods.

In a December 2, 2015 opinion, Judge Rufe stated that because Zoloft is used in pregnant women—on whom epidemiological studies, considered the gold standard, cannot be ethically conducted—researchers have to more carefully examine other studies to determine if there are associations between a drug and possible side effects. She added that it’s necessary to include large samples of women in both exposed and unexposed groups to get accurate results.

In considering whether or not to include Dr. Jewell’s testimony, the court considered the methods he used to reach his conclusion. “Expert evidence must be relevant and reliable to be admissible,” Rufe stated. The court considered whether the expert’s theory could be tested, whether studies had been subjected to peer review and publication, the potential for error in a technique used, and the degree to which a technique or theory is generally accepted in the scientific community.

Based on these criteria, the court held that Dr. Jewell’s testimony was inadmissible.

Judge Pokes Holes in Jewell’s Methodology

According to the opinion, Dr. Jewell submitted a report to the court detailing a review of 11 published, peer-reviewed epidemiological studies examining the potential relationship between selective-serotonin reuptake inhibitor anti-depressants like Zoloft and birth defects. He noted that several of the studies found a statistically significant association between Zoloft and heart defects, but subsequent studies found conflicting results. He also performed his own re-analysis of some of the data from some of the studies, but his analysis has not been subjected to peer review or been published.

Pfizer argued that Dr. Jewell employed a flawed methodology to form his opinion, and relied on data from overlapping study populations in asserting statistically significant results. It also stated that he employed inconsistent standards when reviewing and relying on various studies, choosing some over others depending on whether such studies supported his opinion.

The court acknowledged Dr. Jewell’s expertise, and that a number of studies have reported statistically significant increases in heart defects in infants born to mothers taking SSRI anti-depressants. The court added, however, that many of the studies relied on the same data on the same population, which meant they weren’t really repeated results. Other issues with the studies were examined as well, including the difficulty in duplicating some of the results.

In the end, Judge Rufe ruled that Dr. Jewell’s opinion was not based on sound scientific methods. She also found that the testimony was likely to confuse or mislead a jury.

Litigation Continues as Plaintiffs Expected to Appeal

Without Dr. Jewell’s testimony, plaintiffs may be hard-pressed to prove that Zoloft caused or was a factor in causing birth defects in infants born to women who took the drug in early pregnancy. Recognizing that difficulty, Pfizer has now requested that all remaining Zoloft lawsuits be dismissed.

In response, Judge Rufe signed a pretrial order on December 9, 2015, ordering the parties to report to the court their respective positions on scheduling, motions practice, and mediation, and that plaintiffs had to respond to the defendant’s motion for summary judgment by January 29, 2016. It is expected that the plaintiffs will appeal the decision regarding Dr. Jewell as well.