It seems so obvious as not to require a citation – but this is the Drug and Device Law Blog, so we’ll provide some anyway.
Furnishing an adequate warning satisfies a product manufacturer’s duty to warn.
Thus, in a prescription medical product case, “if the manufacturer provides complete, accurate, and appropriate warnings about the product
This post comes from the non-Reed Smith side of the blog.
The phrase may be biblical in origin, coming from the story of Cain and Abel, but its meaning certainly persists and has relevance today. Being both a sibling and a parent of siblings, this blogger doesn’t want to give the impression that her family
We all know that absent extraordinary circumstances, failure to warn claims against generic drug manufacturers are preempted under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). But as far as we are aware, no other court has been asked to decide whether that same preemption applies to cross-claims for contribution or indemnity. Until now.
This post is from the non-Reed Smith side of the blog.
If you know this blog, you know we leave no stone unturned when it comes to preemption. As far as we know, Greager v. McNeil-PPC, Inc., 2019 WL 5549524 (N.D. Ill. Oct. 28, 2019) is a preemption issue of first impression. Plaintiff alleged she
Indulge us for a moment as we recount another airline adventure. Recently, we traveled thousands of miles to an important argument. Our first flight boarded right on time, left the gate right on time, and taxied down the runway . . . partway. Then stopped. Enter the inevitable announcement: “Ladies and gentlemen, we’re very sorry,
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,