This post does not announce late-breaking news. Given the speed at which information travels on the web, an opinion decided in May is ancient history. But the world seems to have overlooked the implications of Thomson v. Novartis Pharmaceuticals Corp., No. 06-6280 (JBS), 2007 WL 1521138 (D.N.J. May 22, 2007), so we’re here to
Bexis is now involved in the Colacicco/McNellis appeal, so he can no longer post on that subject. He thus was not involved in drafting this short post; it’s Herrmann’s work alone.
And Herrmann doesn’t really have much to say, either. (No surprises there.)
If you’re trying to read the tea leaves for the upcoming Colacicco/McNellis
Implied preemption in prescription drug cases basically comes down to how a judge feels about whether a manufacturer can unilaterally change its label to “strengthen” warnings under 21 C.F.R. §314.70(c) – the so-called “Changes Being Effected” (CBE) regulation. Our side claims that the CBE regulation doesn’t change anything fundamentally, because the FDA still has to
The parties have now received the notice of oral argument for the consolidated appeals of Colacicco and McNellis, the first of the drug preemption cases to arrive in a federal circuit court of appeals.
The argument is scheduled for Monday, December 10, in Philadelphia.
The appellate panel consists of Third Circuit judges Ambro and
We’ve now had a chance to read it.
Not think about it, mind you. Just read it.
Here’s the story:
Pfizer moved to prevent plaintiffs’ experts from providing the following 6 opinions:
(1) 200 mg/d of Celebrex causes heart attacks and strokes;
(2) 400 mg/d of Celebrex causes heart attacks and strokes;
(3) Celebrex causes
The newswires reported this morning that Pfizer picked off a Daubert motion in its Celebrex multidistrict litigation proceeding.
It did, indeed, with Judge Breyer rejecting as junk science plaintiffs’ proffered expert testimony that Celebrex is capable of causing heart attacks or strokes at the 200mg/day level.
We may have more to say after we have
Here’s our conundrum: On the one hand, we try to be completely transparent in our blog posts, linking to cases wherever possible. On the other hand, we try to steer clear of issues that colleagues or clients might not want to have publicized. So we’re cloaking today’s post in anonymity — but we do both
Here’s more proof (as if more were needed) that Herrmann’s a step slow. (And it’s again only Herrmann. This post relates to the Vioxx settlement, and Bexis is playing no role in drafting this.)
We posted last week about the Vioxx settlement. The aspect of the settlement that interested us most was finality: After AmChem
As you know, we’ve chosen to host the Drug and Device Law Blog on “Blogger.”
Blogger permits folks to publish “comments” reacting to what we’ve written, although Blogger automatically (so far as we can tell) postpones publishing a comment until one of the co-hosts of the blog “moderates” it. (We’re given the choice of either
Herrmann posted last weekend about the Vioxx settlement. Everybody and his brother seems to be looking for “experts” to comment on the settlement; by posting on the subject, we knowingly entered the fray. And that’s fine. Herrmann is happy to discuss the settlement, but please remember three things:
1. Bexis has had nothing to do