As regular readers of this blog know, we’re interested in off-label promotion issues, and we unapologetically take the position that, as long as the information involved is truthful, the right of a company to tell the public about all medical conditions, on and off label, that its product helps prevent or treat is protected by
Dukakis and Riegel
Sometimes, two contrasting images make for a good title.
We figured we’d use two completely unrelated images: Dukakis and Riegel.
First, Dukakis:
Governor Michael Dukakis opposed the death penalty. In the 1988 Presidential debates, a reporter asked Dukakis whether he’d still oppose the death penalty if someone raped and murdered his wife. Dukakis thought for
Scruggs Pleads Guilty
More On Legal Questions And FDA Experts
Sometimes it’s funny how an issue that we all know is out there sits for a long time and then, all of a sudden, it comes back at us from several different directions at once. The recent flurry of interest in the question of whether “FDA experts” – usually former FDA employees – can offer
That Didn’t Take Long
Just after Riegel was decided, we mentioned that there would undoubtedly be attempts made in Congress to strangle the new legal regime that the Court wrought in its cradle. It didn’t take long, either. A couple of days ago, we saw a bill introduced in Congress that would eliminate express preemption under the Medical Device
Riegel and “Parallel” State Law Duties
We started writing over the weekend about “Loopholes in Riegel,” and then went for a walk in the park. We said we might get back to you with the back half of that post.
This is not that post.
(This is also not a post for lay readers or dabblers in drug and
A Simple Twist of Fate (Despain v. Bradburn)
Just two weeks before the U.S. Supreme Court decided Riegel v. Medtronic, the Supreme Court of Arkansas had decided Despain v. Bradburn, No. 07-714, 2008 WL 324356 (S. Ct. Ark. Feb. 7, 2008). We dutifully reported that case in our Device Preemption Scorecard, but otherwise didn’t say much about it, because we’re
Loopholes in Riegel
We got your attention with that title on this blog, didn’t we?
So let’s cut to the chase: There are no loopholes in Riegel.
(Neutral observers sometimes ask why we aren’t more even-handed in our blog posts. We can’t be even-handed because we and our law firms defend pharmaceutical and medical device companies in
We Grow Too Soon Old And Too Late Schmart
This post is the work of Bexis alone; Herrmann had to stay on the sidelines today:
“We grow too soon old and too late schmart.”
That’s what the Pennsylvania Dutch say, and now that seems to be the story of the fen-phen litigation. After a fifteen-year run that produced billions of dollars in settlements, a
California Scheming
Or maybe just legislatively-assisted suicide for the pharmaceutical industry….
Out on the left coast, a bill has been introduced that would put the Golden State in the august company of … West Virginia … by abolishing the learned intermediary rule. We’ve got a copy of it here, but it’s not very long at all