Proskauer on FDA preemption

A recent Proskauer alert analyzes two recent Lanham Act false advertising cases reaching different results on FDA preemption. Axcan Scandipharm Inc. v. Ethex Corp., 2007 U.S. Dist. LEXIS 77876 (D. Minn. Oct. 19, 2007), found no preemption of Lanham Act claims alleging false statements about generic equivalence, bioequivalence, etc. Photomedex, Inc. v. RA Med. Sys., Inc., 2007 U.S. Dist. LEXIS 79846 (S.D. Cal. Oct. 29, 2007), by contrast, found that there could be no Lanham Act claim based on an “FDA Approved” ad where the argument was that the FDA had only approved an earlier version of a medical device, not the current marketed version.

Courts try very hard with this problem, but the extent of FDA regulation varies so much that it is difficult to use one case to predict another.