This post is from the non-Reed Smith side of the blog.
This blogger is just returned from Ireland where we toured castles and abbeys, drove through amazing landscapes on tiny roads with hairpin turns (can’t say enough about Connemara except that everyone should go), sang about Molly Malone and the Fields of Athenry, visited a
No. It can’t be. PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) took care of that. Just look at our generic preemption scorecard – the proof is there. The warnings on generic drugs must be the “same” as those on branded drugs. Generic drug manufacturers cannot unilaterally alter, amend, or change any warning and
You’ll find plenty of decisions from the amiodarone litigation discussed on the blog. Not surprisingly, because it is a generic drug, they almost exclusively focus on Mensing preemption – or we should say on plaintiffs’ attempts to bypass Mensing. But there are cases involving exposure to the branded product as well. And earlier this
Regular readers of this blog may recall that, each year at this time, we report on our cherished annual trip to the Westminster Kennel Club dog show. This year, the trip was modified at the outset by a work conflict (an argument in Kentucky that we knew we would keep us from attending any part
We opposed the FDA’s ill-advised 2013 proposal to revamp the process for changing generic drug labeling from the outset. We had legal objections – that an FDA regulation could not alter the statutory “sameness” requirement imposed on generic labeling. We had practical objections – that the change was a sop to the plaintiffs’ bar,
Not terribly long ago, we had a series of posts—too many to link—that recounted court decisions rejecting efforts to impose liability on a generic manufacturer for the standard design and labeling claims and/or on an NDA holder for injuries allegedly caused by the use of the generic version of its drug. When the conjunctive
Today’s guest post is by Reed Smith associate Devin Griffin. It’s about preemption in a generic drug case, something that has become so routine that, other than add cases to our generic preemption scorecard, we rarely feel the need to discuss them. But Devin’s case is better than most, and thus worthy of
Aren’t we all guilty of having that drawer, that shelf, that cabinet, maybe even a whole closet where things just get dumped. And as new stuff gets dumped, the old stuff gets pushed to the back. Then one day the space simply can’t hold anymore and you reach to the back to see just what’s
We can be inundated with news. Old news. New news. Fake news. Breaking news. News that makes you want to break something. News that makes you want to go back to bed. In trying to be discerning consumers of the news, it is useful to do not just a reality check but a date check.
With PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), preemption arguments in cases involving generic prescription drugs has become a little like shooting fish in a barrel, as our generic preemption scorecard documents. Still, that’s no reason not to praise good results.