As we emerge from our fourth month-long trial in a little over two years, we are sure that we have missed some recent legal developments. As good as this Blog is as a source for what is going on in drug and device product liability litigation, you do actually need to read it to absorb
Way back in September 2012, we—in its Blog-specific veiled singular usage—did our first post. We introduced ourselves with some rare first personal singular statements before proceeding to trash a Louisiana intermediate appellate court’s affirmance of a large verdict under Louisiana’s Medical Assistance Programs Integrity Law. Among our criticisms was the lack of detail on
That seems like it should be an obvious statement. FDA regulations draw important distinctions between brand drugs and generic drugs. A manufacturer seeking FDA approval of a new drug must prove safety and efficacy involving expensive and lengthy clinical trials. Once approved, that drug becomes the reference list drug. If a manufacture wants to market
“Don’t major in minor things.” A wise professor once shared those words and they’ve always stuck. As a general approach to life, it makes a lot of sense. Learning to let go of the small stuff is easer said than done, but it is usually well worth the effort. But the same does not
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,
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