Products Liability Expert Witness for Defense Opines on Claim That an SSRI Antidepressant Taken by Mothers Caused Birth Defects

A products liability/consumer product safety expert witness for the defense provides feedback on a case involving multiple plaintiffs who claim that an SSRI antidepressant taken by mothers caused birth defects in their children. The drug at issue is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. Plaintiffs, who are part of multi-district litigation located in Rhode Island, claim the defendant manufacturers of the antidepressant are liable because their defective product causes birth defects like hypospadia in children when it is taken by their mothers while pregnant.

Question(s) For Expert Witness

1. Do SSRIs cause birth defects?

2. What studies support the defense argument?

Expert Witness Response

SSRIs have been well-studied. Recent reviews from various medical professional organizations have concluded that there is no reliable scientific evidence demonstrating that SSRIs can induce congenital malformations. These conclusions stand in marked contrast to those expressed by the plaintiffs' experts, who appear to believe that first-trimester use of SSRIs can cause any and all human malformations, based on a hypothetical disturbance of a serotonin signaling mechanism that is not supported by animal models, preclinical animal testing, or human epidemiological studies.

A 2013 meta-analysis of 29 high quality epidemiological studies of SSRI use during pregnancy concluded that this use was not associated with any increased risk for congenital malformations in general or cardiac defects in particular. Even more recent studies confirm this. Results of earlier studies finding a weak association with malformations are attributable to chance, confounding, or bias, not causation.

Large, recent epidemiological studies and biostatistics demonstrate no increased risk for major congenital malformations associated with SSRIs, when compared with use of other antidepressants, or with pregnancies in untreated pregnant depressed women. Other risk factors such as maternal obesity, diabetes, smoking, alcohol use, lack of folic acid supplementation in early pregnancy, and individual genetic susceptibilities to malformations likely explain inconsistent findings of increased risk in a few of the earlier studies. These opinions are consistent with the general scientific consensus.

The expert is a board-certified pediatrician and medical geneticist. Over the course of 35 years, the expert has worked in clinical genetics, dysmorphology, teratology, developmental disabilities, communicative disorders, and public health aspects of birth defects. The expert has written extensively on birth defects in peer-reviewed publication, and, among other credentials is founder of a birth defects conference.