You all know this is a defense blog. You all know we focus on defense victories. So, it shouldn’t be surprising that when a defense win comes at the hands of some questionable calculations (or miscalculations) by plaintiffs’ counsel, we find it blog worthy. (Stay tuned, we have another one for you tomorrow too.)
The
While waiting for next month’s Bartlett oral argument and then the Supreme Court’s decision, and as plaintiffs continue to prod and poke to find ways around Mensing, the Fifth Circuit gave us a nice (though unpublished) Valentine’s Day present in Morris v. Pliva USA, Inc., No. 12-30319, 2013 U.S. App. LEXIS 3167 (5th
With both sides lobbing us cases (yes the PR war over Aredia/Zometa has heated up to the point that even plaintiffs send us stuff) in the ongoing Aredia/Zometa (hereafter “A/Z” – for obvious reasons) product liability struggle, we know of four new decisions. Here’s what’s happening (in chronological order).
On February 8, the Fourth Circuit, in a (thankfully) unpublished and thus non-precedential opinion, affirmed the plaintiff’s verdict in Fussman. See Fussman v. Novartis Pharmaceuticals Corp., ___ Fed. Appx. ___, 2013 WL 474330 (4th Cir. Feb. 8, 2013). This is the case where an obviously runaway jury awarded over $12 million in punitive damages. Well, after that punitive damages award was reduced by over 93% (to $861,000), the Fourth Circuit affirmed it, stating that there was “sufficient foundation” to find “willful” conduct. Id. at *8. It’s hard to comment, because the opinion doesn’t state what this conduct evidence was, but any time a punitive award is affirmed (a fortunately rare occurrence), we’re not happy.
What struck us about this aspect of Fussman is the lack of any discussion about the magnitude of the alleged increased risk posed by A/Z. Our biggest problem with punitive damages in prescription medical product cases is that the absolute risks of harm are generally small – on the order of 1% or less (often much less). In such cases, even if the product doubled or trebled a pre-existing risk, we’re still talking about a small percentage likelihood that any particular person gets hurt. The Restatement, on the other hand, uses a “substantial certainty” of harm standard for an inference of intent in the punitive damages context. See Restatement (Second) of Torts §§8A, 500 (1965). Lots of cases address this point – here’s a representative example:
This approach is consistent with the view expressed by American Law Institute in distinguishing recklessness − where a defendant knows there is a high risk of physical harm to another, but “deliberately proceeds to act, or fails to act, in conscious disregard of … that risk” − from simple negligence, characterized as “mere inadvertence, incompetence, unskillfulness, or a failure to take precautions.” Restatement (Second) of Torts § 500 cmts. a & g (1965). The latter, lacking malice, cannot support punitive damages, while the conscious disregard of a known and sufficiently serious risk of harm is the equal of malice. [Courts] regularly emphasize[e] the awareness of risk necessary to justify an award of punitive damages: only in those instances where an “actor has intentionally done an act of an unreasonable character in disregard of a known or obvious risk that was so great as to make it highly probable that harm would follow, and which thus is usually accompanied by a conscious indifference to the consequences”. . . .
Accordingly, we hold that the culpability necessary for an award of punitive damages based on reckless or wanton misconduct requires evidence that the defendant acted, or failed to act, in conscious and deliberate disregard of a known, substantial and intolerable risk of harm to the plaintiff, with the knowledge that the acts or omissions were substantially certain to result in the threatened harm.
Fly Fish Vermont, Inc. v. Chapin Hill Estates, Inc., 996 A.2d 1167, 1176 (Vt. 2010) (numerous citations omitted) (emphasis added). Accord, e.g., Strenke v. Hogner, 694 N.W.2d 296, 304-05 (Wis. 2005). There are lots more examples – perhaps enough for a separate post.Continue Reading The Latest On Aredia/Zometa
Until recently it’s simply been accepted that the FDA administratively banned off-label promotion – no ifs, ands, or buts. Bexis’ book used to read: “It is illegal, however, for a manufacturer of a prescription medical product to promote an off-label use.” §4.01[4] at p. 4.01-45. We sort of took that much, at least, for granted – even though we vociferously dissented, on First Amendment grounds, from this “ban” applying to truthful promotion, as we’ve done in most of our posts under our “First Amendment” blog topic.
Not so fast.
As Einstein demonstrated, sometimes even the most seemingly established propositions are questionable.
In fact, as we learned in Caronia, the FDA’s path to prosecution of off-label promotion is anything but direct and certain. United States v. Caronia, 703 F.3d 149, 160 (2d Cir. 2012). In actuality, “[t]he FDCA and its accompanying regulations do not expressly prohibit the ‘promotion’ or ‘marketing’ of drugs for off-label use.” Id. (emphasis added). Indeed, for all the frequency with which “promotion” gets bandied about, there isn’t even a definition of the term “promote” or “promotion” in either the FDCA or in FDA regulations. Rather, the Agency seems to be hiding the ball with regulatory statements – notably in the investigational drug context – that “[t]his provision [barring but not defining “promotion”] is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media.” 21 C.F.R. §312.7(a).
That’s a load of malarkey. Barring “full exchange of scientific information” is precisely what the FDA’s been doing with its off-label promotion stance for decades.Continue Reading Just How “Illegal” Is Off-Label Promotion?
We’ve been following all this Pain Pump litigation for some time – our “Pain Pump” topic has 31 posts in it − and with some trepidation. The trepidation has primarily derived from the Pain Pump defendants’ rather powerful state of the art defense in many of the current cases (mostly involving older surgeries). As always, when the defendants have a solid defense, we see plaintiffs resorting to a variety of more-or-less novel and expansive causes of action in attempt to circumvent it. In Pain Pump we’ve seen duty to test, post-sale duty to warn, off-label promotion, and “no good deed goes unpunished” FDA-related allegations that amount to private FDCA enforcement. As to the latter, a word to the wise: If you’ve already received a general use indication from the FDA for your device, anything you do to seek a more precise indication, especially if you aren’t successful, might be used against you by plaintiffs improperly trying to impose their peculiar view of the FDCA
Well, with the plaintiffs unsuccessful (twice) in getting a federal MDL, they haven’t all been able to pile on in one forum. Instead, it’s been the legal equivalent of guerilla warfare in various courts – state and federal – around the country. Some of those cases have been approaching the trial stage. As veterans of the Baycol and Vioxx wars (among others), we know how important early trial wins can be.
Well, on February 6, 2013, the defense won a big one – in a difficult jurisdiction (California), but not in the worst parts of it (Orange County), which is where hundreds of California state Pain Pump (against all defendants) cases have been “coordinated.” This bellwether case, the first to be tried in California, was called McKenna and the target defendant was Breg. Previously, other Pain Pump defendants also won a trial in federal court in Oregon, and we believe another in Wyoming.Continue Reading Getting Pumped Up
Well, not really. But what else were we going to call a post about class action litigation over whether honey can properly be called honey? That’s right, since last September there have been five decisions rendered in five separate class actions over whether labeling honey as honey is fraudulent, misleading, and misbranded. Brod v. Sioux Honey Ass’n Cooperative, 2012 U.S. Dist LEXIS 129391 (N.D. Cal. Sept. 11, 2012); Ross v. Sioux Honey Ass’n Cooperative, 2013 U.S. Dist. LEXIS 6181 (N.D. Cal. Jan. 14, 2013); Overton v. CVS Caremark Corp., 2012 U.S. Dist. LEXIS 185697 (C.D. Cal. Dec. 11, 2012); Regan v. Sioux Honey Ass’n Cooperative, 2013 U.S. Dist. LEXIS 13166 (E.D. Wis. Jan. 31, 2013); and Guerrero v. Target Corp., 2012 U.S. Dist. LEXIS 125055 (S.D. Fla. Sept. 4, 2012). And, we believe there are other class actions with the same allegations pending (we know others have been filed and that MDL status was denied).
But before these class actions, back in 2007, there was the ultimate honey lawsuit — Bees v. Humans. From the mind of Jerry Seinfeld we got The Bee Movie. In it, two bees voiced by Seinfeld and Matthew Broderick sue the humans for stealing their honey and profiting from it illegally. Frankly, we think that lawsuit has more merit than these real ones. At least the bees suffered a real injury – they did all the work, people got all the benefit. There are some pretty funny courtroom scenes in the movie. John Goodman plays the over-the-top dramatic lawyer defending the humans. The bees berate singer Sting for stealing his moniker from the bee community and cross-examine Ray Liotta about his Ray Liotta Private Select Honey. If Ray Liotta really did market honey, you can bet today’s honey plaintiffs would be checking his product for pollen (Ray Liotta scene is also pretty funny, but couldn’t find any clips).
That’s what these class actions are all about – whether honey can still be called honey if the pollen has been removed. Some plaintiffs seem to contend that pollen has certain health benefits and that had they been aware that the honey they purchased didn’t contain pollen, they wouldn’t have bought it. Putting aside the seeming absurdity of the lawsuits, these plaintiffs are bringing mislabeling claims involving the FDA and FDCA, and since we are talking about food, the Nutrition Labeling and Education Act (“NLEA”). So, at the heart, these are preemption cases and preemption cases get our attention every time. The fact that five decisions came down so relatively close together also piqued our curiosity and so we decided to take a closer look. We are happy to report, that just like dentists who recommend Trident gum, 4 out of 5 courts got it right.Continue Reading A Honey of A Litigation
This post is from the Dechert half of the blog as the Reed Smith team is involved in this litigation.
We’ve seen courts struggle applying preemption in device cases when the plaintiff’s claim is based on off-label promotion. Plaintiffs have argued that the PMA process addresses only the approved use of the product and that the FDA’s regulation therefore doesn’t extend to off-label use or promotion. And, so the argument goes, state-law claims based on off-label promotion are not preempted.
This is hogwash. The FDA regulates the device, not just a particular use. In fact, as we all know, the FDA has regulations that specifically address off-label promotion, something that would strike us as highly unusual for a body that supposedly doesn’t regulate off-label promotion of products.
In any event, while some courts get caught up in this argument, others – like the court in Caplinger v. Medtronic, Inc., No. CIV-12-630-M (W.D. Ok. Feb. 6, 2013) – don’t. The plaintiff in Caplinger had posterior lumbar interbody fusion surgery on his back, a surgery that involved the defendants’ Infuse Bone Graft device (“Infuse Device”). Id. at 1. This was an off-label use of the Infuse Device, as the FDA had approved it for anterior (through the stomach), not posterior (through the back), surgery. Id. at 1-2. It had nevertheless been approved under the FDA’s PMA process, which brought into play FDCA §360k, which preempts any state-law claim that is “different from or in addition to” the FDA’s regulation. Id. at 2.
The plaintiff had significant problems after the surgery and filed claims against the manufacturers of the Infuse Device for fraud, failure to warn, design defect, breach of implied and express warranties, negligence and negligent misrepresentation. Id. at 1-2. Defendants moved to dismiss. The court easily found the majority of plaintiff’s claims to be preempted. We highlight here, however, two important areas of the court’s decision that focus on plaintiff’s off-label allegations. Because this is a court that got it right.Continue Reading How to Apply Preemption to Off-Label Claims: Caplinger v. Medtronics, Inc.
We’ve been on the verge of triskaidekaphobia. So far 2013 hasn’t been a very good year for us, with Weeks, Stengel, Arters, and Wells. At this rate, we could fill up our Worst Decisions of 2013 by mid-March. And yes, we’re not Dr. Pangloss here on DDLaw – we do cover our side’s losses, if rather grudgingly.
But finally this week turned out better, judging by the cases we’ve learned about so far. First and foremost is a case we on the Reed Smith side just can’t talk about very much, since it’s our case. That’s Caplinger v. Medtronic, Inc., No. CIV-12-630-M, slip op. (W.D. Okla. Feb. 6, 2013). All we can say is that it involves PMA device preemption (Riegel), and off-label use issues, and it’s favorable. We’re hoping that our Dechert contingent can give readers an update on just how it’s favorable. Until then, we’ve given you a link – and put it on the medical device preemption scorecard.
We also learned about a good class action decision, In re Celexa & Lexapro Marketing & Sales Practices Litigation, MDL No. 09-02067-NMG, slip op. (D. Mass. Feb. 5, 2013). As readers can tell from our federal and state class action cheat sheets, successful class actions in drug/device product liability litigation don’t happen much anymore, if at all. Indeed, we’ve been following this topic more generally, and we believe that, since the groundbreaking Supreme Court decisions of the late-1990s (Amchem Prods. Inc. v. Windsor, 521 U.S. 591 (1997), and Ortiz v. Fibreboard Corp., 527 U.S. 815 (1999)), not a single contested personal injury merits class action (as opposed to settlement, where the fix is in) has survived appeal in the federal court system – that’s not just drug/device but any form of personal injury.
Is it any wonder that the purveyors of class actions have turned away from personal injury to economic loss? We don’t think so. But as our cheat sheets indicate, they haven’t done very well there either, at least where drugs/medical devices are concerned. We’re pleased to report that Celexa/Lexapro
continues that trend – even though the forum-shopping plaintiffs ensconced themselves in a relatively defense-unfriendly forum (District of Massachusetts)
and eventually retreated to invoking extremely defense-unfriendly law (the infamous California UCL, and the less infamous, but we’d say now about equally bad, Missouri consumer fraud statute).Continue Reading Finally, A Decent Week