Published in: For The Defense

Products regulated in the United States by the U.S. Food and Drug Administration (FDA) and in Canada by Health Canada are subject to a complex set of regulatory requirements. These regulatory requirements will often include a review and the approval of the safety and the efficacy of a product and the consideration of the adequacy and the content of the product’s label. When consumers allege that these same products are either not safe, effective, or include inadequate warnings, after the products went through the review and approval process, the legal effect of the previous regulatory approval process needs to be considered by the courts.

In the United States, the intersection of regulation and subsequent liability has been the subject of fairly extensive analysis through the concept of preemption. In Canada, a dedicated preemption doctrine has not emerged either through regulatory guidance, legislation, or in the courts. An analysis of the regulatory regime governing drugs and medical products has, however, led to a few court decisions in which Canadian courts have considered the regulatory regime as part of the legal framework of product liability class actions. This article discusses the approaches taken on both sides of the border.

Download the full article: Comparing the United States and Canadian Experience

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