Abstract

http://ssrn.com/abstract=2082318
 
 

Footnotes (277)



 


 



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


Ralph Hall, JD


University of Minnesota, Twin Cities - School of Law

Michelle K. Mercer


affiliation not provided to SSRN

June 11, 2012

Minnesota Legal Studies Research Paper No. 12-24

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





Download This Paper

Date posted: June 12, 2012  

Suggested Citation

Hall, JD, Ralph and Mercer, Michelle K., Rethinking Lohr: Does 'SE' Mean Safe and Effective, Substantially Equivalent, or Both? (June 11, 2012). Minnesota Legal Studies Research Paper No. 12-24. Available at SSRN: http://ssrn.com/abstract=2082318 or http://dx.doi.org/10.2139/ssrn.2082318

Contact Information

Ralph Hall, JD (Contact Author)
University of Minnesota, Twin Cities - School of Law ( email )
229 19th Avenue South
Minneapolis, MN 55455
United States
Michelle K. Mercer
affiliation not provided to SSRN ( email )
Feedback to SSRN


Paper statistics
Abstract Views: 235
Downloads: 19
Footnotes:  277

© 2014 Social Science Electronic Publishing, Inc. All Rights Reserved.  FAQ   Terms of Use   Privacy Policy   Copyright   Contact Us
This page was processed by apollo6 in 0.359 seconds