What Attorneys Should Know about FDA’s MedWatch Data
February 11, 2014
Adverse drug reactions, especially following the introduction of new drugs, often result in lawsuits. Attorneys must be mindful of the limitations of available data that the Food and Drug Administration (FDA) uses to assess post-marketing drug safety, according to "What Attorneys Should Know about FDA's MedWatch Data," coauthored by Managing Principals Mei Sheng Duh, Pierre Cremieux, and Paul Greenberg, and Vice President Brian Ellman (Law360, January 29, 2014).
In the article, the authors explain that the FDA's MedWatch data -- voluntary spontaneous adverse event reports collected via the FDA Adverse Event Reporting System -- provide incomplete sources for proving a causal relationship between a drug and a subsequent adverse event. This is, in part, because the data contain inherent biases and incomplete information, and reflect voluntary filing from diverse sources. Although the FDA's data can be useful for researchers and policymakers to form hypotheses on potential adverse drug reactions, attorneys need to understand the limitations of these spontaneous adverse event report data and validate associated methodologies, especially in a litigation setting.