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The U.S. Judicial Panel on Multidistrict Litigation (JPML) established the Zoloft MDL on April 17, 2012, centralizing all federal Zoloft lawsuits into the Eastern District of Pennsylvania. Plaintiffs have filed lawsuits against manufacturer Pfizer, claiming the medication increases the risk of birth defects, and that the company failed to provide adequate warnings to expectant mothers.

A number of studies have linked selective serotonin reuptake inhibitors (SSRIs)—a certain class of depressants—to an increased risk of some birth defects. Pfizer, however, argues that Zoloft is different, and actually does not increase risk.

Plaintiffs have brought expert Dr. Anick Berard forward to provide testimony alleging Zoloft does cause birth defects when taken by pregnant women. In the Daubert hearing—in which the court determines whether certain testimony will or will not be allowed at trial—both sides debated the issue.

Are All SSRIs Alike?

According to a recent article in the Legal Intelligencer, the parties have narrowed this argument down to one thing—can you lump all SSRI antidepressants together?

If studies find that Paxil, for example—another type of SSRI—increases risk of birth defects, can we infer that Zoloft does, too? Pfizer’s argument is that we cannot. Plaintiffs counter that Pfizer itself did this very thing when trying to get Zoloft approved for treatment of juvenile depression in Europe. Regulatory agencies ordered the company to provide tests to prove the drug’s efficacy, and Pfizer “responded that pharmaceutical company Eli Lilly had already done these studies and that Zoloft would perform similarly.” (Eli Lilly manufacturers Cymbalta, a so-called “SNRI” antidepressant, or serotonin-norepinephrine reuptake inhibitor.)

The FDA classifies Zoloft as a Category C, which means that animal studies have shown an adverse effect on the fetus, and that there are no well-controlled studies in humans. Pfizer, nonetheless, claims that there is no real proof that Zoloft causes all the birth defects for which it’s been accused, and seeks to have Dr. Berard’s testimony deemed inadmissible.

Studies Provide Increasing Evidence of SSRI-Birth Defect Link

Several studies have linked antidepressants with birth defects, but each one has varied slightly. Here are a few:

• 2005: FDA warns that Paxil, another SSRI, is associated with a risk for heart defects.
• 2006:  A study published in the New England Journal of Medicine (NEJM) finds that women taking the SSRI “fluoxetine” (Prozac) late in the third trimester had a higher risk of persistent pulmonary hypertension of a newborn (PPHN). A number of studies after that provided conflicting evidence, leading the FDA in 2011 to issue a notification stating it was “premature” to reach any conclusion.
• 2007: Two studies on antidepressants and birth defects are published in the NEJM. One concludes that use of SSRIs during early pregnancy may be associated with three types of birth defects, including anencephaly, craniosynostosis, and omphalocele. The other does not find this association with SSRIs overall, but does suggest that some individual SSRIs may increase risks for some specific effects. Zoloft, for instance, was found to be associated with omphalocele and septal heart defects.
• 2009: A study by Danish researchers showed that women who take antidepressants during pregnancy have an increased risk for a specific heart defect. Those drugs most associated with the defect included Zoloft (sertraline) and Celexa (citalopram).
• 2010: A Danish study finds an association between the use of SSRIs in pregnant women and cardiac malformations.
• 2014:  A meta-analysis published in the BMJ indicates that exposure to SSRIs in late pregnancy increased risk of PPHN.

Plaintiffs Maintain Testimony is Scientifically Valid

Dr. Berard, a professor at the University of Montreal, is a perinatal epidemiologist. She studies prenatal drug exposure and the effects on newborns, and argues for the plaintiffs that evidence shows SSRIs increase risk of birth defects.

Pfizer’s legal team argues that SSRIs should not be lumped together, and that studies that did not include Zoloft should not be considered when determining the risks, if any, of the medication. They point to the fact that Dr. Berard stated drugs like Zoloft were preferable to Paxil as first-line treatments for pregnant women with depression.

Berard holds that position that Zoloft and other similar SSRIs increase risk of birth defects affecting the heart, neural tube, stomach, cranium, and more. The plaintiffs note that all her conclusions have been reached through scientifically valid methodology.

It remains to be seen how the court will decide this issue. The first bellwether trial in the MDL is scheduled to begin November 3, 2014.

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