Friday, December 28, 2012
Our Favorites - The Best Prescription Drug/Medical Device Decisions Of 2012
We hope all our readers had an excellent holiday-of-your-choice. We did, and we’re back just in time for our favorite (and nearly last) post of the year, our choices for the best prescription medical product liability decisions of 2012. This time, we have to admit, there’s no obvious winner, since the year passed without a United States Supreme Court decision from our area of interest to top our tree. But that’s happened before and we certainly haven’t let that stop us. All that means is that, who knows, maybe an intermediate state appellate decision might make this list. Keep reading and you’ll find out.
Without further ado, let’s start the celebrations. Here are our ten favorite judicial decisions (and some honorable mentions) involving drugs, medical devices, and vaccines in 2012.
1. Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012). We had to think a bit on this one – as we do any time we list a case in which any of us were involved. But only a little. Texas was by far the largest remaining state where its supreme court had not adopted the learned intermediary rule. Not anymore. In Hamilton, the court did that in unanimous fashion. And there’s lots more. The court all but did away with any semblance of a direct-to-consumer exception to the rule (the recognition of which landed the intermediate decision that Hamilton reversed in #-4 of our worst of 2010). If a DTC exception lurks out there after Hamilton, it would only be in a case of intentional and deliberate falsehood (which just isn’t in all those bland TV ads), that must go beyond mere “fraud” – which the court held doesn’t vitiate the rule. Hamilton also held that the learned intermediary rule wasn’t an affirmative defense. Thus the plaintiff retains all relevant burdens of proof. The learned intermediary rule requires warnings only to prescribing physicians – not to any other health care provider with which the plaintiff may happen to come into contact. Nor does information designed for patient consumption in any way trump the learned intermediary rule. Finally, Hamilton applied the rule and held as a matter of law that prior prescriber knowledge broke any possible causal link. So the result went from a multi-million plaintiff’s verdict to judgment n.o.v. It’s hard to win a more total victory than that. We exulted in Hamilton here .
2. Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012). Walker is our favorite preemption case of 2012. In Walker the court interpreted the “parallel claim” exception to preemption in a PMA medical device case in a quite limited fashion. The plaintiff claimed that a statistic in the FDA-approved package insert wasn’t met by this particular device and thus could be a violation supporting a parallel claim. The Fourth Circuit said “not so fast.” Unless the FDA had promulgated a formal “performance standard” by notice and comment rulemaking, no standard existed to be violated. Instead, the plaintiff was asserting a tort requirement “different from or in addition to” the FDA’s oversight of the device. Short of a formal performance standard, mere deviations from expected performance could not support parallel claims. Thus, an arguable device malfunction, by itself, did not defeat preemption under Riegel. If only every circuit took the skeptical view of parallel claims adopted in Walker, we’d be pretty happy. We praised Walker here .
3. Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012). This is another really good appellate preemption case. It slips in under Walker mostly because Lofton is not as unique. Preemption is a bit of a hash in the Fifth Circuit right now, but Lofton is on the good side of that morass. In Lofton, the court held that the fraud on the FDA exception to the Texas FDA compliance immunity statute was preempted by Buckman. In so doing, the court explicitly rejected the Desiano approach (which we revile), for all the right reasons – chiefly because Buckman is more than a mere pleading case and to follow Desiano would ignore the practical consequences that drove the result in Buckman. Sooner or later the Supreme Court is going to have to clear this up, but until now, we’ll hail decisions such as Lofton, as we did here .
4. Rodriguez v. Stryker Co., 680 F.3d 568 (6th Cir. 2012). Pain pump litigation is hot all over the country right now, and the state of the art defense is at the heart of almost all of these cases. In the first published appellate ruling on the issue, Rodriguez affirmed summary judgment, holding that the hodgepodge of old, largely tangential articles the plaintiff had collected did not establish inquiry notice of the causal connection in question (that certain anesthetics could damage joint cartilage) as a matter of law. These articles were “isolated instances” relating to other substances. An inference that anesthetics would have the same consequences was unreasonable. The snippets that the plaintiffs offered were “too conjectural and too many steps removed from the problem that developed.” Nor did the FDA’s rejection of a §510k (substantial equivalence) application establish anything about safety. All that meant is that there was no predicate device to compare the pain pump to. Lohr established that §510k did not evaluate safety – and plaintiffs have to live with that decision just like defendants do. Nor is there a duty to test a product in the absence of any knowable risk. A defendant is not an insurer. Nor does off-label promotion create any kind of claim, in the absence of any knowable risk. Finally, the prescriber’s testimony failed to show that any warning would have made changed the outcome, so Rodriguez is a win on warning causation as well. We haven’t conducted complete research, but we think that Rodriguez is probably the best Pain pump decision to date. We urged other courts to emulate Rodriguez here .
5. In re Pelvic Mesh/Gynecare Litigation, 43 A.3d 1211 (N.J. Super. App. Div. 2012). We’ve been kvetching for years about the ongoing erosion of defense rights to contact treating physicians (supposedly guaranteed by the Stempler decision) in New Jersey mass tort litigation. In Pelvic Mesh, an appellate court finally did something about this. The Pelvic Mesh mass tort procedures were very restrictive of defense access to treating physicians, so that defendants had a hard time simply finding experts. A high percentage (over 1,000 in number) of the relevant medical specialists had treated one or another of the plaintiffs and thus were forbidden to serve as defense expert witnesses. On mandamus (a tough standard) the court reaffirmed a simple principle – that plaintiffs waive any physician/patient privilege as to relevant injuries when they bring lawsuits. Physicians have no duty of loyalty requiring them to support their patients in litigation. We looked forward to the ultimate demise of New Jersey limitations on the equal availability of critical physician evidence to both sides here.
6. In re Schering Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235 (3d Cir. 2012). We don’t like third-party payer class actions, whether formal class actions or brought under some other purported method of aggregation. Unless somebody was actually harmed by a drug or device, these suits are artificial contrivances by which TPPs attempt to get out of what they have contracted to do – that is, to pay for prescribed treatments that help patients. Intron hits all the right notes – particularly that TPP plaintiffs can’t use RICO as cover for improper attempts to enforce the FDCA with respect to off-label promotion. In the absence of proof that real people were exposed to products that were unsafe or ineffective (instead of just improperly promoted), there is simply no injury, and thus no standing, for any sort of claim by a TPP or other beneficiary for purely economic loss. We praised the demise (on the pleadings) of this bogus class action, and hopefully others like it, here.
7. United States v. Caronia, ___ F.3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012). It would rank higher, maybe even #1, if the same ruling had occurred in a product liability action. Still, Caronia’s holding, even in the purely criminal context, that the First Amendment protects truthful promotion of off-label uses, is significant enough to make our top ten. Courts and the common law are part of the government, and thus equally subject to First Amendment limits, as we discussed here . Thus, neither tort plaintiffs, nor TPPs, nor FCA relators, nor state AGs, nor the federal government in its own FCA actions, can base liability (assuming Caronia remains good law) on truthful statements about the benefits and risks of off-label uses. We’ve been waiting for a ruling like Caronia for a long time, ever since we began piecing together a First Amendment defense in Bone Screw cases in the mid-1990s. Maybe the millennium has finally arrived. We discussed Caronia here and here (the latter making us first on the web with the decision).
8. Pom Wonderful LLC, v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012). This is another case that suffers a bit from being somewhat out of our target area. Pom Wonderful is a Lanham Act case brought by a very litigious (search the name sometime) purveyor of pomegranate juice against the defendant’s FDA-approved food labeling. For our purposes, Pom Wonderful is important because it applies one of our favorite principles, that the is no private right of action (direct or indirect) to enforce the FDCA, in order to establish the principle of FDA primary jurisdiction as an alternative to preemption. California notoriously leads the country in bogus “consumer protection” litigation over the labeling of many FDA-approved products, so to get an appellate decision telling plaintiffs to lay off labeling that's within the FDA’s regulatory sphere is a major win for the good guys. We savored Pom Wonderful here .
9. Holmes v. Merck & Co., 697 F.3d 1080 (9th Cir. 2012). Yes, the Supreme Court really meant what it said in Bruesewitz (we’ve finally memorized how to spell it). That’s essentially the holding in Holmes, and with Holmes probably falls the last serious post-Vaccine Act product liability litigation involving these statutorily-protected products – which is precisely what Congress intended. Even if the vaccine litigation does not involve a covered claim (the plaintiff was a parent, rather than the actually injured child, a common ruse to try avoiding the Act), the plaintiff couldn’t escape the Act’s limits on liability. Preemption under the Vaccine Act applies to all suits against vaccine manufacturers. Thus, summary judgment affirmed. It’s a home run for vaccine manufacturers, but since there’s much less litigation nowadays over vaccines than over drugs and devices, we had to move Holmes down a few notches. We lauded Holmes here .
10. Casey v. Merck & Co., 722 S.E.2d 842 (Va. 2012). We hate cross-jurisdictional class action tolling. In Casey the Virginia Supreme Court unanimously decided that it did too. The court held that a meritless and never certified federal class action involving Fosamax did not have any effect on that state’s statute of limitations. All in all it was a good year on the cross-jurisdictional class action tolling front, with other big wins in Louisiana (non-drug/device) and Massachusetts (A-Z). We cheered Casey on here .
So that’s our top ten, but as we have in the past, we just couldn’t limit ourselves to ten. 2012 was good to defendants, and Santa Judge left us a lot more presents under the tree. So here are our Honorable Mentions: (11) Sandoz, Inc. v. State, 100 So.3d 514 (Ala. 2012) – Would rank higher, except it’s largely a reprise of an excellent 2009 (2009 #1) decision. Reverses a $70+ million verdict in an AG suit over purported fraud on state health care reimbursement programs. We reviewed it here. (12) In re Abbott Laboratories, Inc., 698 F.3d 568 (7th Cir. 2012) – Nice CAFA decision that plaintiffs can’t consolidate separate cases for trial without triggering the statute’s mass action provisions. We discussed it here . (13) Zimmerman v. Novartis Pharmaceuticals Corp., ___ F. Supp.2d ___, 2012 WL 3848545 (D. Md. Sept. 5, 2012) – We saw a lot of Aredia/Zometa decisions in 2012; but liked this one the best. It’s good on fraud on the FDA/Buckman, and even better on FDA prosecutorial discretion, so it’s our highest-ranked district court case. See our posts here and here . (14) Weston v. Kim’s Dollar Store, 731 S.E.2d 864 (S.C. 2012) − Nice PMA preemption result, and from a state high court, but the reasoning was thin and hard to follow; we’ll take it, but not on the big list. We discussed it here. (15) Metz v. Wyeth, Inc., 872 F. Supp.2d 1335 (M.D. Fla. 2012) – It was close, but we think it’s the best of a raft of generic preemption trial-level cases. That it was early, and thus more of a trailblazer, helped us choose. See our post here. (16) In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3610237 (E.D. Ky. Sept. 5, 2012) – MDLs do ensure that issues get thoroughly briefed. In Darvocet it produced an excellent decision on generic preemption, rejecting Conte, and affirming Erie conservatism. We discussed it here . (17) In re Chantix (Varenicline) Products Liability Litigation, ___ F. Supp.2d ___, 2012 WL 3030097 (N.D. Ala. July 23, 2012) – Yes, MDLs are indeed thoroughly briefed, and here the defendant’s black box warning was held adequate as a matter of law. Because it’s to be published, Chantix beats out a similar Accutane ruling from about the same time. We discussed it here . (18) Ali v. Allergan USA, Inc., 2012 WL 3692396 (E.D. Va. Aug. 23, 2012) – Maybe the best pure TwIqbal decision of the year, occurring in the context of PMA preemption. Demolishes Hofts. We covered it here. (19) Marsh v. Genentech, Inc., 693 F.3d 546 (6th Cir. 2012) – Given a chance to back down, the Sixth Circuit didn’t, and reaffirms that its broad application of Buckman in Garcia. We cheered here . (20) United States ex rel. Ge v. Takeda Pharmaceutical Co. Ltd., 2012 WL 5398564 (D. Mass. Nov. 1, 2012) – We don’t like fraud on the FDA claims. Ge killed such a claim in the False Claims Act context where preemption doesn’t apply. Not even in D. Mass. We discussed it here .
Looking back, all of our top ten from 2011 remain intact. We did lose one of our honorable mentions, however, when the Degelman case (2011 #14) was settled while on en banc review, and thus vacated. The Dobbs SSRI preemption decision (2011 #8) is currently before the Tenth Circuit. On the other side of the ledger, as we pointed out in our discussion of Hamilton, the Murthy case (2011 #-8) is no longer a proper prediction of Texas law. Appeals are pending in both Daniel (2011 #-7), and in the E.D. Pa. “nerve center” (2011 #-10) cases, so maybe we’ll have good news to report on those fronts in 2013. The Lance case (2010 #-6) remains pending in the Pennsylvania Supreme Court, some two years after oral argument. Another holdover, the Kiobel Alien Torts Statute case we mentioned last year, was pushed back to the pending term by the Supreme Court, which broadened the questions to be considered.
Looking ahead, we have Bartlett (our worst case of 2012) now pending in the Supreme Court. We are cautiously optimistic that the Court, having decided Mensing, will not reverse course in Bartlett, and we hope the result will rank highly on our top ten of 2013. The awful Caldwell case (2012 #-2) from Louisiana is also being appealed, but as so far the writ hasn’t been acted upon by the Louisiana Supreme Court. That’s another excellent candidate for reversal. In Weeks, the Alabama Supreme Court will become the first state high court to rule on Conte branded liability where only generic drugs were consumed. In Stengel, the Ninth Circuit en banc will address what can and can’t constitute a “parallel claim” under Riegel and Buckman. Finally, we’re aware of an interesting Vioxx class action/All Writs Act case, Plubell, currently on appeal in the Fifth Circuit. Of course, numerous other preemption-related decisions involving generic drugs and medical devices under Mensing and Riegel are in the appellate process in federal and state appellate courts.
So now it’s on to 2013. Happy New Year to all our readers.