The first really, really major post-Riegel preemption battle in the PMA device product litigation has been the Sprint Fidelis implantable cardiac defibrillator lead MDL, in which Medtronic moved to dismiss (that means on the pleadings – without discovery) against all claims on the strength of the express preemption clause as interpreted by Riegel.
As far back as the Bone Screw litigation, we’ve argued that many attempts to gin up litigation about alleged off-label promotion are really prohibited back-door attempts at private enforcement of FDCA violations. See Beck & Valentine, “Challenging The Viability Of FDCA-Based Causes Of Action In The Tort Context: The Orthopedic Bone Screw Experience,” 55 Food
We’ve been following the long migration of Farm Raised Salmon for some time now. Our prior posts on the California Supreme Court’s decision and on the Supreme Court’s request for the government’s views on the defendants’ certiorari petition are here, here, here, and here, respectively.
While Farm Raised Salmon is a
It got hardly any attention in the blawgosphere at the time – aside from us, 360, and the hardcore Supreme Court junkies over at SCOTUSBlog (and even they buried it in the middle of a routine post) – but earlier this month the Supreme Court indicated interest in the certiorari petition from the
“Parallel” requirements.
That’s where they’re going to come after us. We know it. They know it.
Plaintiffs have no choice. Under Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), supposedly “parallel requirements” – alleged tort duties congruent with FDA requirements – are essentially the only thing the Supreme Court did not find preempted
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
Fish.
Well, not exactly.
In reading and actually thinking about yesterday’s Farm Raised Salmon decision (now published at 42 Cal. 4th 1077; 175 P.3d 1170) from the California Supreme Court, the operative four-letter word is “food.”
“Food” is what puts the “F” in the FDCA – not federal – and that seems to be the
Ok, we’ve worried about what might happen if our side (the defense, for any new readers) were to lose the preemption wars currently in progress before the Supreme Court. Today we’re going to speculate a bit about what might happen if we win. Suppose that the Court in Kent for a second time drives a
OK class, for today’s lesson, assume you are a major, sophisticated drug company. That means you have to have at least one (actually, a bunch) FDA-approved drug that’s safe and effective for its indicated use. So assume that, too – let’s say your drug alleviates muscular inflammation from over-exercise.
There being at least some reality
Courts have said over and over again that there’s no private right of action under the Food, Drug and Cosmetic Act. There’s a footnote four pages long to that effect in Bexis’ book (§4.01[1], note 14). Still people don’t seem to get it. Instead, they try to take over the FDA’s function of enforcing the