Ask and ye shall receive edition. Within fifteen minutes of mentioning that we hadn’t seen the preemption brief that GSK had filed yesterday in Colacicco, we had a copy of it. As indicated previously, it addresses the SSRI facts of repeated FDA rejection of the warning at issue as scientifically unsubstantiated. Leafing
April 2009
Preemption 2.0
Defense counsel considering whether they still have good preemption arguments in drug product liability matters after Levine would do well to review preemption briefs recently filed by defendants in major product liability litigation. The litigation involves two fact patterns that we have previously mentioned as candidates for preemption even after Levine. FDA regulatory activity…
Medical Monitoring – Another 50-State Survey
We’ve been doing some research in anticipation of the upcoming ALI meeting at which the Principles of the Law of Aggregate Litigation will be voted on (we hope ALI members interested in class actions and the like will come out, debate the issues, and vote), and in the spirit of cross-fertilization, we thought we’d share…
On The “Custom Device” Exemption
We posted nearly a year ago about the trial court decision in United States v. Endotec.
The Eleventh Circuit has deemed it time for an update. United States v. Endotec, __ F.3d __, 2009 WL 804399 (11th Cir. Mar. 30, 2009).
We confess that we’d forgotten all about this puppy, so you probably need…
Don’t Mess With Bexis!
This post was written by Herrmann alone. I’m coming to the defense of my co-conspirator, Bexis.
As soon as the Supreme Court decided Wyeth v. Levine, we published a post analyzing the implications of the case. We represent drug companies in product liability cases, so we naturally weren’t delighted by the result. We did, however,…
NYU Preemption Symposium Available Online
We’ve previously shared with you snippets from NYU’s 2009 Annual Survey of American Law Symposium on “Tort Law in the Shadow of Agency Preemption.”
We can do even better now. NYU videotaped the day’s events and has posted the videos online. To see Judge Guido Calabresi’s keynote address, or Peter Schuck and Richard Nagareda (and…
Non-Prescribed Plaintiffs, In Pari Delicto, And Duty
As far as pharmaceutical mass torts go, the fen-phen litigation has been around for as long as any. But just because it’s mature litigation doesn’t mean that the old dog can’t do new tricks. Last month a fen-phen case produced the first post-Levine decision recognizing implied preemption, as we discussed here. This month…
The Web On Wyeth v. Levine
In his regular FindLaw.com column, Professor Anthony Sebok writes that Wyeth v. Levine can be read either of two ways: Preemption might exist if a drug company (1) “had submitted to the FDA exactly the warning required by the Vermont jury,” or (2) “had proven that the FDA rejected the reasoning behind the warning required…
FAS 5 Update: Report On FASB Roundtable
We’ve posted before about the Financial Accounting Standard Board’s proposal to revise how the accounting rules deal with loss contingencies, such as pending litigation.
The FASB held its roundtable regarding the proposal to revise FAS 5 on Friday, March 6. Although neither of your humble scribes attended that meeting, we’ve seen a report about that…
Another Levine Client Alert
Shortly after Wyeth v. Levine came down, we linked to the client alert on the case that Bexis’ firm prepared. To avoid sounding like shills, we offered to link to other firms’ client alerts, too, on the theory that great minds don’t necessarily think completely alike.
Well, we finally got one – nearly a month…