Andrew E. Costa


The notion of addressing the vagaries of negligence per se theories in the context of pharmaceutical and medical device litigation seems to promise little more than a monograph anesthetized by a body of obscure pharmaceutical and medical device provisions viewed through the lenses of various states' negligence law. Maybe little more than that can be assured. However, the issue of how courts should address negligence per se theories in this context implicates a variety of “larger” (or, possibly, more interesting) legal issues in general and pharmaceutical and medical device litigation in particular. Perhaps foremost among these issues is the interaction of legislative intent and judicial deference to that intent. Possibly no less important (and, likely, more common) an issue is the application of a regulatory body's judgment and how that judgment should be treated--whether it should be given the status of law on par with that of the legislature's judgment and, if so, whether a judge or jury should second-guess those judgments. This Article concludes that, if negligence per se is intended to represent judicial deference to legislative judgments and intent, then such theories are wholly inappropriate in pharmaceutical and medical device litigation. On the regulatory front, use of this theory to give lay judges and juries license to review and second-guess an FDA ruling or refusal to make a ruling risks superimposing potentially (or, perhaps, necessarily) inconsistent state tort regimes on the efforts to regulate the pharmaceutical and medical device industry. Short of a prohibition of these theories in this context, however, use of negligence per se theories should be severely restricted to situations in which (1) the court has determined that the specific provision is appropriate to support the imposition of civil liability, (2) the FDA has determined that a defendant violated a specific provision, and (3) the plaintiff proves that the violation caused his or her injury.

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