Statute
FDCA
242 published works
Drug & Device Law
Just How “Illegal” Is Off-Label Promotion?
By Bexis
Until recently it’s simply been accepted that the FDA administratively banned off-label promotion – no ifs, ands, or buts. Bexis’ book used to read: “It is illegal, however, for a manufacturer of…
Drug & Device Law
Getting Pumped Up
By Bexis
We’ve been following all this Pain Pump litigation for some time – our “Pain Pump” topic has 31 posts in it − and with some trepidation. The trepidation has primarily derived…
Drug & Device Law
An Off-Label Conundrum
The legal community is still buzzing about the Second Circuit’s decision in United States v. Caronia, ___ F.3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012) and what…
Drug & Device Law
Negligence Per Se Trivia
By Bexis
Bexis is updating chapter 4 of his book, which includes a thorough discussion of negligence per se. Negligence per se in the context of the Food, Drug & Cosmetic Act…
Drug & Device Law
Everybody Keep Quiet: We Found a Good Decision
In the last few days it seems that we can’t stick our head out the blog's front door in the morning without a court hitting us in the head with…
Drug & Device Law
Caronia Web Roundup
By Bexis
We aren’t the only folks on the web with opinions and commentary concerning the recent decision in United States v. Caronia, ___ F.3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012),…
Drug & Device Law
Who Needs TwIqbal?: Round II
By Bexis
The following is a guest post by Mollie Benedict and Amanda Villalobos, both of Tucker Ellis, about a recent dismissal they won of one of those all-too-common California "consumer protection"…
Drug & Device Law
The FDA On Warning Letters – They’re Sure Not Final
By Bexis
Remember that case about ear candles? Given the product, we had some fun with it in our earlier posts. Well, it turns out that the ear candling folks are nothing…
The Appellate Strategist
Sacred Exclusivity: The Ninth Circuit Steers (Well) Clear of the FDA
The Supreme Court’s opinion in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349-50 (2001), recognizes that any attempt by a plaintiff to enforce the FDCA is preempted by…
Drug & Device Law
Call It Standing
By Bexis
While it remains true that our role in bringing about the Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), preemption decision is probably the highlight of our (read…