Statute
21 U.S.C. §337(a)
5 published works
Drug & Device Law
Clip, Clip Hooray
By Bexis
A month or so ago, we castigated some extremely poorly reasoned expert exclusion decisions in the Bulox v. Coopersurgical litigation. The end results weren’t horrible (p-side motions were denied), but…
Drug & Device Law
Contract Claim Based on Alleged CGMP Violations Held Impliedly Preempted
As defense attorneys who represent drug and device companies, we generally cheer when a state-law claim is held preempted by the FDCA. We are, however, not sure whether to cheer…
Drug & Device Law
International Trade Commission, Meet Buckman
By Bexis
Bexis vividly remembers how he first learned of 21 U.S.C. §337(a). It was early 1995, and he had just joined the Danek Medical legal team in the early going of…
Drug & Device Law
Does State Law Really Allow Tort Claims For Failure To Report To Governmental Agencies?
By Bexis
Claims predicating prescription medical product liability claims on purported failure to report adverse events to the FDA – á la Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013)…
Drug & Device Law
Sleeper Case, Sleeper Issue
By Bexis
It got hardly any attention in the blawgosphere at the time – aside from us, 360, and the hardcore Supreme Court junkies over at SCOTUSBlog (and even they buried it…