What Attorneys Should Know About FDA's MedWatch Data

Law360, New York (January 29, 2014, 5:11 PM EST) -- Following the introduction of new pharmaceuticals, reports of adverse events often surface in the news media. Some drugs, particularly blockbusters, eventually become the subject of lawsuits. Attorneys involved in these cases need to be fully informed about the quality and limitations of the spontaneous adverse event data used by the U.S. Food & Drug Administration, pharmacovigilance researchers and activist groups in monitoring post-marketing drug safety. Ignoring the limitations of this data may result in erroneous inference about the causal relationship between drug use and reported adverse events.

A recent example illuminates the pitfalls of such an assumption and centers on the...

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