Courts v. FDA: A Lesson from Pelvic Mesh Litigation on Relative Competence to Decide a Legal Question

Luther T. Munford

fense of Johnson & Johnson in pelvic mesh cases. He is grateful to his fellow Butler Snow lawyer, Beth Roper, for her help with this Article, and to Jeffrey K. Shapiro for his comments.ABSTRACT

The extent to which courts should defer to an administrative agency’s interpretation of the law governing the agency is the subject of considerable debate. In that debate, judges have asserted that the judicial branch is the most competent branch to decide what the law is and that it need not defer to agency opinion.

In assessing relative competence, it is helpful to consider an instance in which, in multibillion dollar product liability litigation, the courts have made a fundamental, and in retrospect obvious, legal error which has led them to say, contrary to FDA’s well-founded assurances of reasonable safety and effectiveness, that the FDA clearance process does not “go to” safety at all.

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