Daubert hearings underway in Zoloft MDL

The Daubert hearings have begun in the Zoloft Multi-District Litigation (MDL) in the United States District Court for the Eastern District of Pennsylvania in Philadelphia, PA. U.S. District Court Judge Hon. Cynthia Rufe will make rulings regarding the the admissibility of expert testimony. Judge Rufe invited Philadelphia Court of Common Pleas Judge Lisa Rau to sit in on the hearings. Judge Rau is handling the Zoloft cases on the Philadelphia, PA docket.

A Daubert hearing is held by the Court to determine the admissibility of expert scientific testimony. The Court will look at the following criteria to determine whether an expert’s testimony is relevant and should be admitted at trial.

  1. Whether the scientific theory or technique can be and has been tested;
  2. Whether it has been the subject of publication and/or peer review;
  3. The known or potential rate of error;
  4. The existence or maintenance of standards controlling the technique’s operation; and
  5. General acceptance in the scientific community.

The most hotly disputed expert in the Zoloft MDL is Dr. Anick Berard. Dr. Berard is a Professor at the University of Montreal who researches the effects of medications on pregnancy. She studies the effects of drug exposure to fetuses. Plaintiffs claim that the popular antidepressant Zoloft crosses the placenta and causes birth defects in children born to women who take Zoloft during pregnancy. Dr. Berard is being called as an expert witness by the Plaintiffs to support that claim. Dr. Berard is a perinatal epidemiologist and has published more than 100 papers on issues surrounding the more than a dozen birth defects she claims are linked to the use of Zoloft by pregnant women.

Defense attorneys argue that each Selective Serotonin Reuptake Inhibitor (SSRI) has its own distinct chemical compound. Popular SSRIs include Zoloft, Paxil, Prozac. The defense insists that the differences between them require each SSRI to be treated individually instead of as a class of drugs.

Plaintiffs contend that this argument by Pfizer, the manufacturer of Zoloft, is made for the courtroom only. Outside of the courtroom, Pfizer has stated publicly that Zoloft performs in a manner similar to other SSRI drugs. Specifically, Plaintiffs used evidence of Pfizer’s own words to European regulatory agencies when it was trying to get Zoloft approved for juveniles. This evidence comes from internal Pfizer documentation. Defense attorneys further argue that the FDA has placed Paxil in a higher risk category (Pregnancy Category D) than other SSRIs (Pregnancy Category C), which they state means the FDA doesn’t see Zoloft as a risk to fetuses.

Plaintiffs point to low budget and short resources to undermine that claim. Plaintiff attorneys stated that “Believe it or not, the FDA gets things wrong sometimes.”

Defense further states that Dr. Berard has changed her opinion since 2009 when she testified that Zoloft, but not Paxil, was a suitable treatment for pregnant women with depression.

Other Plaintiff experts scheduled for a Daubert hearing include: Thomas Sadler, an embryologist and developmental biologist; Robert Cabrera, who studies abnormalities in physiological development; and Michael Levin, director of the Tufts University Center for Regenerative and Developmental Biology.

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