This is a guest post by Luther Munford, Butler Snow LLP, who comes to us fresh from the pelvic mesh wars. He is grateful to Jin Yoshikawa of that firm for his help with this post. As always, our guest posters do their own work and thus deserve 100% of the credit (and any blame) for what they write.
As previously stated, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), has nothing useful to say about the FDA’s current system for clearing medical devices. The 1982 world it describes disappeared decades ago. This author’s article in the Food and Drug Law Journal, L. Munford, “Courts v. FDA: A Lesson from Pelvic Mesh Litigation on Relative Competence to Decide a Legal Question,” 76 Food & Drug L.J. 6 (2021), provides the details, and it is hardly alone in its conclusions.