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Publications

Excluding Adverse Event Reports in Drug and Medical Device Cases

November 20, 2015 - Bloomberg BNA Pharmaceutical Law & Industry Report

Publications

Excluding Adverse Event Reports in Drug and Medical Device Cases

November 20, 2015 - Bloomberg BNA Pharmaceutical Law & Industry Report

Plaintiffs in prescription drug and medical device personal injury cases often seek to introduce evidence of other incidents where the same product allegedly caused a similar injury. The plaintiffs’ bar points to this ‘‘other incident evidence’’ because it relieves them of the burden of actually proving their case and invites the jury to speculate that if a product caused injuries to other people, it likely caused injury in the case at bar. This evidence is often presented through adverse event reports (AERs) to the United States Food and Drug Administration (FDA). While causation arguments based on AERs have surface appeal to those not versed in FDA’s Adverse Event Reporting System (FAERS), those knowledgeable about adverse event reporting understand that AERs are inherently anecdotal and prone to inaccuracy and untrustworthiness. Because of juror susceptibility to arguments based on AERs, it is important to strategize early in the litigation about how you will frame your motion in limine to exclude such evidence. In order to successfully challenge other incident evidence, you must familiarize the court with the issues surrounding adverse event reporting, the inherent weaknesses of information garnered from AERs, and why courts across the country have excluded this evidence. Read the article here.

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