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It is never a slow news day as long as Aredia-Zometa litigation is going on somewhere and as long as Joe Hollingsworth is kind enough to update us. Last week, Novartis prevailed on a Daubert motion and consequently got out on summary judgment in Luttrell v. Novartis Pharmaceuticals Corp., 2012 U.S. Dist. LEXIS 142816…

We’re not keen on taking potshots at law review articles. 
As we have mentioned more than once, we usually find the first part of law
review articles, the analysis of the case law, to be useful.  But the part
of the article proposing some new approach usually contains more twaddle 
than logic.  Sometimes that twaddle

…

We all know how easy it is to complain about bad decisions. Right now, sports pundits and fans are holding a gripeathon about the National Football League ‘s replacement referees. There has been more talk about the officiating mistakes than about the athletic performances. A sense of perspective is in order.　 The comparison baseline is

…

Here’s a shocker: your average drug and device law lawyer seldom hoists more weight at any one time than 22 ounces of F.3d or three ounces of The Glenlivet. There is usually a long, nerdy history behind this state of indolence. For example, when we were in high school, we got a varsity letter for…

This makes two Wednesdays in a row where we have the pleasure of discussing courts that applied Mensing in a clear-headed manner.  To review the bidding:  the Supreme Court decided in Mensing that claims against generic drug manufacturers for failing to disclose risks are preempted because generic manufacturers are powerless to deviate from the FDA-approved…

The scope of Mensing is one of the hotter issues in drug and device law these days. (The Bartlett appeal is one example.) To our defense-hack eyes, Mensing seems perfectly straightforward: a claim is preempted to the extent it alleges that the risks of a generic drug were not adequately disclosed. But the doctrinal landscape…

We have always tried hard not to inflict our vacation replays on friends.  When we were kids, September often saw neighbors invite folks over for a dinner followed by a droning slide show of Summer hijinks at the Jersey shore or, for our more posh acquaintances, Myrtle Beach. We thought it was a bore then.…

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn more about this book