Aggressive Marketing by Pharmaceutical Company Leads to Birth Defects

This case involves multiple mothers who were prescribed a popular antidepressant by their respective physicians while pregnant. Neither the patients’ perinatology physicians nor the drug labels on the medication adequately warned the patients of the teratogenic nature of the drug, despite well-documented cases of the antidepressant in question causing birth defects. As a result of the mothers taking this drug, they gave birth to infants with a myriad of congenital defects, including hypospadia. It is believed that the company intentionally marketed the drugs to young woman, spending upwards of $100 million per year advertising this drug to women of childbearing potential.

Question(s) For Expert Witness

1. What is your experience with marketing plans for the pharmaceutical industry, specifically to the female population?

Expert Witness Response E-007861

The promotion of SSRIs such as this drug specifically to women of child-bearing age has been familiar to me for several years, and I would be interested in reviewing this case. I have been studying the marketing, prescription, and adherence to psychiatric drugs, with a particular focus on SSRIs and atypical antipsychotics, for about 15 years. I have researched inside major drug companies, psychiatric hospitals, and community clinics. Together with the director of pharmacovigilance at the World Health Organization and others, I have founded an organization to collect and evaluate side effect data of common drugs. My role is as an industry expert, which includes analysis of marketing strategies and how these impact claims made about specific drugs, in the scientific literature, in materials used to sell to physicians, and in direct to consumer advertising. Among my research publications into pharmaceutical marketing, several have entailed analysis of court documents (and/or attending trials and depositions). I have studied and taught marketing at the world’s leading business schools, and I have trained alongside medical residents in the field of acute psychiatry.