Assorted Pills_SS_46658200Plaintiff’s expert is excluded for relying on a “novel” methodology to support opinion that antidepressant drug causes birth defects. 

On June 27, 2014, in In Re: ZoloftU.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania issued an opinion excluding an expert in a case that bears a striking resemblance to the facts of Daubert v. Merrell Dow. We think Judge Rufe’s decision in Zoloft will serve as useful precedent to the defense bar and their clients in future pharmaceutical product liability litigation.

In Zoloft, Judge Rufe excluded plaintiff’s epidemiological expert. She found that the expert departed from “well-established epidemiological methods” to support her expert opinion that the antidepressant drug Zoloft caused birth defects. Judge Rufe’s 24-page decision explains the specific criteria followed by the scientific community when analyzing the issue of whether a drug causes birth defects. In the scientific field of teratology (which deals with the cause and prevention of birth defects) epidemiologists who study the possible adverse effects of a drug taken during pregnancy must rely on observational evidence. Since their research involves pregnant women and their unborn fetuses, epidemiologists do not have the benefit of relying on the kind of data obtained from clinical trials that is typically available in other types of epidemiological studies. Due to the outside factors that can impact the results of these studies, the teratology community requires “consistent statistically significant human epidemiological findings” before concluding that there is a “true” association between a medication and an adverse outcome.

In Zoloft, the plaintiff offered the expert opinion of Dr. Anick Berard, a perinatal pharmacoepidemiologist, who opined that Zoloft when used during pregnancy is capable of causing a range of birth defects. After holding a Daubert hearing, Judge Rufe held that Dr. Berard’s opinions failed to meet the minimum standard for a “true” association that is strived for in teratolgy research. Dr. Berard was offering an opinion that was not grounded in the methods and principles of the teratology scientific community. The Judge noted that Dr. Berard was selective in the data she considered and that she failed to address scientific studies that indicated there is no conclusive evidence of an association between Zoloft and birth defects. Dr. Berard had also published contradictory opinions in 2007 and 2012.

In short, the research on which the plaintiff’s expert relied was not supported by other researchers in the relevant scientific field. Judge Rufe also noted that some researchers “go further and advocate the use of Zoloft as a first-line drug for treating depression in pregnancy,” which also contradicted the plaintiff’s expert’s opinion.

For practitioners and litigants engaged in the defense of product liability litigation, this case is a “must read.” It is a detailed opinion that explains the various criteria considered by epidemiologists when examining the issue of whether a medication has an adverse effect on pregnancy.

We look forward to any input our readers may have.