We did that silly little post on Tuesday about the Canadian medical monitoring decision, and we fully expected it to wither on the vine. (The big news Tuesday was the proposed new CBE regulation, about which we’ll have more to say momentarily.)
But a funny thing happened on the way to the CBE reg: Canada
The other day we got a tip that the FDA had just posted something on its website that we’d want to read. Even though we were both swamped (Herrmann was preparing for yet another trial, and Bexis had two appellate briefs to finish, including one about “the largest class certified in history” – the court’s
Late last week, the FDA filed a short post-argument submission with the Third Circuit in Colacicco, which the parties recently received. Here’s a copy. It’s only a couple of pages. The submission has three purposes: (1) It provides the court with a copy of the brief that the agency recently filed with the
The FDA posted on its website today a regulatory initiative that will affect many prescription drug/implied preemption arguments. It’s an agency’s proposal to change amend its “Changes Being Effected” regulations for drugs, devices and biologics rule to restrict the ability of manufacturers to make label changes that add/strengthen warnings prior to FDA approval.
We’re both
We can’t spell Canada.
We have enough trouble with “USA.”
We don’t speak Canadian.
And we sure as heck don’t do Canadian law.
But just when the United States seems to be coming to its senses about claims for medical monitoring, Canada slipped a gasket. In Peter v. Medtronic, Inc., No. 05-CV-295910CP, slip op. (Ontario
We had previously predicted that the Supreme Court would decide whether to grant certiorari in Wyeth v. Levine at the January 11, 2008, Friday conference.
Here’s an update: The case is now set to be considered at the January 18 conference. If the Supreme Court grants cert on January 18, the case will be heard
One of us argued in print this week — in the January 7 National Law Journal — that blogs are, in may ways, more powerful tools than the print media. That article was later posted on-line, and the results of that dual publication have proven the article’s thesis.
Blogs, unlike print media, can induce an
There are lots more cases recognizing broad preemption in product liability cases involving pre-market approved (PMA) medical devices than refusing to, but strange things happen in tort preemption cases, so we don’t view anything – especially in state court – as a sure thing.
Blog reader Alan Lazarus over at Drinker Biddle has just (and
While Bexis was somewhere hiking on glaciers in New Zealand, the court in the Fosamax MDL litigation did an entirely expected thing – it denied class certification. As we’ve posted before, in virtually every prescription drug MDL somebody seeks to certify a class, and with almost as great regularity, that motion is denied. One
When Bexis got back from hiking the Milford Track and doing all sorts of other ridiculously strenuous things in New Zealand, a friend of his from the Tar Heel State had sent along a new decision by a local appellate court rejecting medical monitoring where the plaintiff had no present injury. Our readers know we