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Publications

Out of Your Jurisdiction: Why FDA Recalls and Courts Do Not Mix

August 2011 - IADC Drug, Device and Biotechnology Newsletter

Publications

Out of Your Jurisdiction: Why FDA Recalls and Courts Do Not Mix

August 2011 - IADC Drug, Device and Biotechnology Newsletter

A lesser known but equally helpful cousin of federal preemption, the doctrine of primary jurisdiction allows courts to avoid consideration of complex legal issues involving a regulatory agency’s particular expertise.1 Courts can defer the case until the agency with “primary jurisdiction” over an issue has had an opportunity to consider the dispute.2 In recent years, courts have put this established doctrine to a new use in cases involving the recall of medical devices and pharmaceutical medications by manufacturers regulated by the U.S. Food and Drug Administration.  Read more

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