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Zoloft Birth Defects Lawsuits Face Setback in MDL

Zoloft birth defects lawsuitsThe judge overseeing coordination of Zoloft birth defects lawsuits in Pennsylvania has excluded the testimony of one of the expert witnesses for the plaintiff.

Judge Cynthia Rufe determined that testimony provided by Dr. Anick Berard will not be allowed because the methods by which she drew her conclusions were “scientifically unsound.”

Testimony excluded from Zoloft litigation

Dr. Berard’s conclusions regarding the link between Zoloft use during pregnancy and birth defects were based on “trends” she noted across a series of studies. However, Judge Rufe ruled those trends did not offer conclusive evidence of a positive association between the antidepressant and birth defect risk, based on determinations made by other researchers in the same field.

“Dr. Berard takes a position in this litigation which is contrary to the opinion she has expressed to her peers in the past, relies upon research that her peers do not recognize as supportive of her litigation opinion, and uses principles and methods which are not recognized by the relevant scientific community and are not subject to scientific verification,” Judge Rufe states in her position.

While this move could weaken the position of plaintiffs in these lawsuits, it is likely to be a necessary setback in order to allow plaintiffs to build a stronger case against Zoloft manufacturer Pfizer. This is commonly achieved during the pre-trial process, when plaintiffs collect the strongest scientific arguments they can to convince a jury of their position.

Expert witness is true expert

Dr. Berard is a perinatal pharmacoepidemiologist who currently teaches at the Universite de Montreal. She holds a Ph.D. in Epidemiology and Biostatistics from McGill University and has conducted research on the influence of Zoloft and other drugs on fetal development. Dr. Berard has concluded from her research that antidepressants in the category of selective serotonin reuptake inhibitors (SSRIs) like Zoloft, when taken at normal therapeutic levels, can cause a range of birth defects.

Dr. Berard includes a variety of birth defects in her expert report, such as cardiac defects, craniosystosis, gastrointestinal defects, neural tube defects and limb abnormalities. She also cites persistent pulmonary hypertension of the newborn (PPHN) as a possible risk from Zoloft; a link that the FDA also voiced in a safety notice in 2011. Dr. Berard concluded in her report that Zoloft use during pregnancy could increase the risk of “spontaneous abortion and congenital malformations in multiple organ systems.”

In recent years, Zoloft has been linked to a number of potential birth defects in the children of mothers who took the drug during pregnancy. Currently, dozens of those Zoloft birth defects lawsuits have been coordinated into U.S. District Court for the Eastern District of Pennsylvania, where they are overseen by Judge Rufe. Plaintiffs in these complaints allege Zoloft use led to a number of defects, including heart defects, limb abnormalities and PPHN.

Multidistrict litigation is established when a growing number of lawsuits have similar complaints against a single defendant. The coordination is used to streamline early trial proceedings for a more efficient and convenient legal process. Part of this process is to determine which evidence and testimony will be positively received by a jury. In this case, plaintiffs may now look to stronger scientific arguments in order to convince a jury of their position.

  1. FDA, FDA Drug Safety Communication: Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressant Use During Pregnancy and Reports of a Rare Heart and Lung Condition in Newborn Babies,
  2. U.S. District Court, Eastern District of Pennsylvania, MDL No. 2342, Zoloft (Sertraline hydrochloride) Products Liability Litigation,
  3. Harris Martin, Zoloft MDL Judge Rejects Testimony of Plaintiffs’ Causation Expert as “Scientifically Unsound,”
  4. National Law Journal, Judge Rejects Plaintiffs’ Expert Testimony in Zoloft Case,