Judge Cynthia Rufe has ruled to exclude the testimony of one of Plaintiffs’ experts, Dr. Anick Berard, after the July Daubert hearings in the national Zoloft MDL.
“Dr. Berard opines that SSRIs, in general, and Zoloft, in particular, cause a wide range of birth defects when used during pregnancy.”
Pfizer did not challenge Dr. Berard’s academic qualifications as an epidemiologist focusing on teratology, the scientific study of the cause and prevention of birth defects. Rather, Judge Rufe opined that “other researchers in her field have concluded that the epidemiological research on which Dr. Bernard relies provides no conclusive evidence of an association between Zoloft and birth defects.”
The problem: To be conclusive, the gold standard of medical studies, a double blind, randomized controlled trial would have to be performed. The catch: It would be unethical to perform such a trial on a pregnant woman. Epidemiologists are limited to correlating data and observational evidence to determine relative risk: They divide risk of a defect in exposed women to the risk of developing the same defect in children without exposure.
It should be noted that animal reproductive studies are allowed and they have shown an adverse effect of Zoloft, a FDA pregnancy Category C drug on the fetus.
Judge Rufe pointed out in her opinion that the Louik study in 2007 linked septal defects to the use of Zoloft by pregnant women. She also pointed out that this study’s results were replicated in 2009 and 2010. She specifically mentioned these studies as they followed the current scientifically accepted methodology for epidemiologist.
The rulings regarding the admissibility of Plaintiffs’ other experts have not been issued yet.