This opinion involves cigarette warnings, so we have to be careful, since Dechert represents tobacco companies. We recommend that our readers interested in First Amendment issues take a look at R.J. Reynolds Tobacco Co. v. FDA, No. 11-1482 (RJL), slip op. (D.D.C. Nov. 7, 2011), with an eye towards the court’s analysis of “compelled
Last week saw the birth of the seven billionth current human on the planet. This week sees us comment on the parallel claim exception to Riegel preemption for what feels like the seven billionth time. It puts us in mind of Nietzsche’s theory of the eternal return, where everything we’ve done we’ll do again an infinite number of times. Really? We’ve got to go through that junior prom again, with all the plaid bell-bottoms and the awful Peter Frampton “tribute” band playing “Show Me the Way” as we fought off the effects of smuggled-in Southern Comfort?
We wish courts would do a better job of showing us the way on the parallel claim exception. Is it possible that the parallel claim exception is poorly conceived and poorly described, thereby prompting plaintiffs to parade various attempts to plead around it, leading to courts issuing rulings on the issue that are inconsistent and opaque? Yes, it is. Some parallel claims decisions have been reasonably coherent; others have blessed complaints resembling mackerels in the moonlight — they shine, they stink. Bausch is an example of the latter, and yet the Seventh Circuit waved it by. We’ll not regale you again with our Why We Hate Bausch litany, though the U.S. Supreme Court’s recent refusal to review it led to a marathon teeth-grinding session here on the West Bank of the Schuylkill.
Can our BFF TwIqbal save us from the craziness? Sometimes yes and sometimes no. Here is how we think the analysis ought to play out:
(1) What exactly is the alleged violation of federal law? Cite the specific regulation and the specific problem with the product.
(2) How exactly does state law make such violation actionable? (And here we will confess our esurient desire to appropriate Judge Posner’s identicalness test from the Turek case we blogged about a couple of weeks ago. Yeah, yeah, it’s a different statute. That being said…. Oh, heck, maybe it’s asking too much for drug-and-device law to make sense.)
(3) How exactly did the alleged infraction cause the plaintiff’s alleged injury?Continue Reading Why Does the Parallel Violation Exception Remind us of Nietzsche and Frampton?
Bexis gave blood last weekend at the Red Cross – not just any old donation, either, but pheresis, a procedure that takes a couple of hours to complete. Because pheresis takes that long, the Red Cross supplies donors with movies to watch. This time it was the 2006 James Bond remake, “Casino Royale,” the type of movie that Bexis waits for the Red Cross rather than actually spends money to see. In “Casino Royale” a delectable baddie poisons 007’s martini with digitalis, nearly causing him to die from a v-fib.
Bexis being Bexis, James Bond’s digitalis overdose got him wondering about whatever happened to the Digitek MDL, which involved an FDA-approved form of digitalis, called Digoxin. We hadn’t posted anything about it in well over a year, since the court blew out some meritless economic loss class actions. Before that, we were impressed by the MDL court’s Rule 11-based order requiring the plaintiffs’ counsel to demonstrate that they’d done a bare minimum of investigation of their clients’ supposed “cases” before filing suit.
Turns out, we didn’t have long to wait. Yesterday, Madeleine McDonough over at Shook Hardy was good enough to tip us off to the ignominious end of that MDL. Yesterday, the MDL court filed three orders (documents 70, 149, and 608) that, frankly, all look pretty much the same to us. They all go under the general description of PTO (that’s “pre-trial order” for you laypeople) 87, so we’re only attaching the one that’s actually called that.
Our first reaction: My God! Has there ever been a more meritless MDL? We thought Bone Screw was bad, since the plaintiffs never in ten years of litigation were able to find a practicing orthopedic surgeon who would opine on defect. But at least in (some of) those cases there were broken screws. In Digitek, the plaintiffs couldn’t even prove exposure to the allegedly defective product! The alleged “defect” was that some Digitek tablets were manufactured bigger than they were supposed to be and thus contain too much of the active ingredient (see James Bond). But it turns out that, after years of litigation, no plaintiff ever proved that a single one of the supposedly defectively too large Digitek tablets was ever sold to any consumer.Continue Reading The Ignominious End Of The Digitek Mass Tort
Yesterday’s Wall Street Journal has an interesting article about the FDA’s off-label promotion ban being “in some jeopardy” after the Supreme Court’s Sorrell decision, and pointing to the Caronia case, to be decided “within weeks,” as the leading example of possible First Amendment scrutiny. Well, you heard it here first. We pointed out this implication
Back in April, we put up a post complaining about Weeks v. Wyeth, 2011 WL 1216501 (M.D. Ala. March 31, 2011), one of the few courts anywhere not to dismiss a Conte-type non-manufacturer liability claim for failure to state a claim. Instead, contrary to five prior Alabama decisions (and literally scores of cases
As our regular readers know, here at DDlaw we concentrate pretty single-mindedly on content. We don’t do pictures; we don’t do videos, we don’t do gossip. We just try to keep everyone on the defense side of prescription drug and device product liability litigation informed of whatever we think is interesting or important at any
A reader contacted us the other day, a little miffed because we hadn’t updated one of our “scorecards.” That surprised us, because we do try to keep our scorecards, and our cheat sheets, up to date as new cases are decided. So we replied, interested to find out what we had apparently been missing.
It turns out that what we hadn’t updated wasn’t anything we considered a scorecard at all. Rather, it was a comparison we had run between two mass torts, Aredia/Zometa and Zyprexa. He was right, we hadn’t updated that, but also wrong in that it wasn’t something we intended to keep updated.
But we can’t expect our readers to know that if we don’t tell them. So first, the explanation. Our “scorecards” involve issues where the defense clearly has the upper hand. In the scorecards, we keep track of every decision we know on a subject, good or bad. However, most of the decisions will be good. After all, we’ve said on numerous occasions, that because we’re an unabashedly defense blog, we don’t do the other side’s research for them.
Our “cheat sheets” are a little different. Cheat sheets cover important issues where the law isn’t overwhelmingly favorable to our side. It can be said (and we’ve said it) that, because those issues are more evenly divided, that it’s even more critical to get the word out about the caselaw that’s favorable to our position. Our cheat sheets try to do precisely that. But, since we don’t care to do the other side’s research, we only include the favorable cases.
Everything else is just a post.
Our Aredia (and Zometa) versus Zyprexa post was simply that. We were interested in those two litigations because they had gotten to the stage where the defense wasn’t killing off the entire mass tort at one fell swoop (something that only preemption is really capable of doing – see Sprint Fidelis), nor was it killing off entire categories of injury at a stroke (which is what successful Daubert motions do (see Seroquel)). Rather Aredia and Zyprexa are both like our old Bone Screw litigation – a mass tort being litigated, case by case, on (usually) learned intermediary rule issues.
But maybe it is time to check in again. After all, our comparative post is now over two years old – my, how time flies when we’re having fun.
But we were pushed over the edge the other day when we received from Robert Johnston, at Hollingsworth a copy of Eberhart v. Novartis Pharmaceuticals Corp., No. 1:08-cv-2542-WSD, slip op. (N.D. Ga. Oct. 31, 2011), making it a Happy Halloween indeed. Eberhart is as good a place to start as any. It demonstrates what good defense counsel have to do in difficult learned intermediary situations – keep pushing and keep asking questions.Continue Reading A To Z Revisited
Yesterday, the Court GVRed (grant/vacate/remand) Perringo v. Gaeta back to the Ninth Circuit for reconsideration in light of Mensing. That’s hardly unexpected, since the same thing happened with straggler cases after Levine and other preemption decisions. Watch the Ninth Circuit. If the court thinks that the plaintiff in Gaeta has a plausible argument against