Okay, that’s a klutzy title. The football obsession doesn’t leave us until the morning after the Super Bowl. But the Iggles have been ignominiously bounced from the NFL playoffs, so the Supreme Court oral arguments have been our favorite spectator sport over the last week. One involved the continuing saga of the Anna Nicole Smith
One of us had a conversation yesterday with a lawyer (who will remain nameless because we haven’t asked otherwise) about off-label use issues in a malpractice case against a doctor who used something called a Nidek Laser in eye surgery. We haven’t looked at any facts of any case or about the device. We know
We have a weakness for holiday-themed posts, so it’s a pity the recent Vicks Vitamin C case didn’t come out around Mother’s Day. You’ll see why in a few short paragraphs.
The case, Loreto v. Procter & Gamble, No. 1:09-cv-815 (N.D. Ohio Sept. 3, 2010), was a class action claiming that Defendant misled consumers
The Ninth Circuit just issued a major decision reaffirming the principle that FDA exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation claims in the guise of private civil litigation. See Photomedex, Inc. v. Irwin, No. 07-56672, slip op. (9th Cir. April 15, 2010).
First, an aside. Are we reading that number right? This is a 2007 appeal? We’ve heard criticism that the Ninth Circuit has become too big and ponderous, but we never thought about it all that much – being on the opposite coast. Well, if the Ninth Circuit’s got a three-year appeal backlog, that’s just too much, and something really ought to be done to divide that court in half, or some other approach. Justice delayed is justice denied, and so on and so forth…. Is the Ninth Circuit simply to big to succeed?
But back to the main point.
We’ve gone on until we’re blue in the face about how 21 U.S.C. §337(a) represents express congressional policy that nobody but the government (that is, the Department of Justice or the FDA) can seek to enforce the Food, Drug and Cosmetic Act (“FDCA”) in a court of law. We’d list some posts, but there are, frankly, too many of them, so here’s the search results for “337(a).”
The no-private-right-of-action argument is especially important in dealing with negligence per se claims and the so-called “parallel violation” claims that are essentially the only avenue arguably left open to plaintiffs in Class III PMA medical device cases after Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).Continue Reading FDA Exclusive Enforcement, Lanham Act Division
This post is about un-preempted fraud on the FDA claims and how to approach them….
“Heresy!” We hear you shout. “There’s no such thing as an unpreempted fraud on the FDA claim – at least one not brought by DoJ on behalf of the FDA itself. You guys have said so yourselves, in your
Bexis just got back from his Wyoming vacation, hiking in mountains where even his Blackberry couldn’t disturb him, and sure enough, the world didn’t grind to a halt in his absence. That’s fortunate, because if it had there wouldn’t be any material for this post. Bexis found a couple of interesting things in his in
A tip of the old cyberhat – and not for the first time – to Alan Modlinger at Lowenstein Sandler for passing along to us the latest good news on the off-label promotion front – dismissal (with leave to replead under Twombly) in In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, slip op.
Sometimes we just happen to speak too soon. That happened yesterday, with our “rant” about off-label promotion. If we’d just waited until a day later, we’d have been able to incorporate the new opinion on that subject from the Epogen/Aranesp litigation. Here’s the money quote, from our perspective, in that opinion, about truthful off-label promotion:
We’re pleased by the dismissal of Myers-Armstrong v. Actavis Totowa LLC, 2009 WL 1082026 (N.D. Cal. April 22, 2009). In M-A, the defendant was basically shut down by the FDA over Good Manufacturing Practices issues at its plant. The defendant recalled over 100 drugs (it was a generic manufacturer) at the wholesale, but
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.