Rethinking Lohr: Does 'SE' Mean Safe and Effective, Substantially Equivalent, or Both?

Abstract:     
For fifteen years Courts and Litigants have cited to the Supreme Court case, Medtronic, Inc v. Lohr to find product liability preemption for 510(k) cleared devices. When the Supreme Court decided Lohr in 1996, the Supreme Court correctly assessed the 510(k) system as it existed in 1982 — the year the product in question in Lohr was cleared by FDA. However, the statutory analysis in Lohr is valid today only if there have not been any substantial or material changes in the statute. And, as this Article discusses, it is beyond a question that the 510(k) system in 2012 is very different from the 510(k) system that existed thirty years ago. Therefore, the conclusions in Lohr must be reassessed in light of the current 510(k) system.

Number of Pages in PDF File: 63

working papers series