The Third Circuit has affirmed the finding of extensive preemption in the Colacicco/McNellis suicidality litigation. Here’s a copy of the opinion. Judge Sloviter wrote the opinion. There is a dissent, by Judge Ambro. This is the first federal court of appeals decision to address preemption following the FDA’s 2006 Preemption Preamble.
The
As regular watchers of our Drug Preemption Scorecard know, the good guys had been on a bit of a roll with preemption in prescription drug cases in 2008. We’d gone 5 for five, with courts in Dobbs v. Wyeth Pharmaceuticals, 530 F. Supp.2d 1275 (W.D. Okla. 2008); O’Neal v. SmithKline Beecham Corp., 551
Now we’ve read it, and before we go off to celebrate (and maybe to look for new jobs as IP lawyers – that’s a joke, folks), we thought we’d tell our readers why that’s exactly what we’re doing.
The 7-1 Riegel decision definitively demolishes a lot of the arguments we’ve been seeing for years (if
Ever since the Supreme Court granted certiorari in Warner Lambert v. Kent the other day, we’ve been thinking about what’s at stake. We’ve seen the case described by Bloomberg as a “chance to extend a victory [defendants] won in 2001, when the Supreme Court said patients can’t sue companies for defrauding the U.S. Food and
How many times have we heard that, in deciding preemption issues the “purpose” or “intent” of congress is the “ultimate touchstone” that the courts must respect? Lots. We can start with Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the express preemption case involving medical devices and the Medical Device Amendments to the FDCA:
Preemption, of course, can be a valuable defense in pharmaceutical and medical device product liability cases. The presumption against preemption originated in “field” preemption cases. In a sentence, field preemption is the total exclusion of state regulation from a particular “field” by the nature or comprehensiveness of the federal assertion of responsibility. From there, it’s