We hope all our readers had an excellentholiday-of-your-choice. We did, andwe’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 of2012. This time, we have to admit,there’s no obvious winner, since the year passed without a United StatesSupreme Court decision from our area of interest to top our tree. But that’s happened before and we certainlyhaven’t let that stop us. All that meansis that, who knows, maybe an intermediate state appellate decision might make thislist. 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 in2012.
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 statewhere 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 semblanceof a direct-to-consumer exception to the rule (the recognition of which landedthe intermediate decision that Hamilton reversed in #-4 of our worst of2010). If a DTC exception lurks out thereafter Hamilton, it would only be in a case of intentional and deliberatefalsehood (which just isn’t in all those bland TV ads), that must gobeyond mere “fraud” – which the court held doesn’t vitiate the rule. Hamilton also held that the learnedintermediary rule wasn’t an affirmative defense. Thus the plaintiff retains all relevantburdens of proof. The learnedintermediary rule requires warnings only to prescribing physicians – not to anyother health care provider with which the plaintiff may happen to come intocontact. Nor does information designedfor patient consumption in any way trump the learned intermediary rule. Finally, Hamilton applied the rule andheld as a matter of law that prior prescriber knowledge broke any possiblecausal link. So the result went from amulti-million plaintiff’s verdict to judgment n.o.v. It’s hard to win a more total victory thanthat. We exulted in Hamilton here.
2. Walker v. Medtronic, Inc., 670 F.3d 569 (4thCir. 2012). Walker is ourfavorite preemption case of 2012. In Walkerthe court interpreted the “parallel claim” exception to preemption in a PMAmedical device case in a quite limited fashion. The plaintiff claimed that a statistic in the FDA-approved packageinsert wasn’t met by this particular device and thus could be a violation supporting a parallelclaim. The Fourth Circuit said “not sofast.” Unless the FDA had promulgated aformal “performance standard” by notice and comment rulemaking, no standardexisted to be violated. Instead, theplaintiff was asserting a tort requirement “different from or in addition to”the FDA’s oversight of the device. Shortof a formal performance standard, mere deviations from expected performancecould not support parallel claims. Thus,an arguable device malfunction, by itself, did not defeat preemption under Riegel. If only every circuit took the skeptical viewof parallel claims adopted in Walker, we’d be pretty happy. We praised Walker here.
3. Lofton v. McNeil Consumer & SpecialtyPharmaceuticals, 672 F.3d 372 (5th Cir. 2012). This is another really good appellatepreemption case. It slips in under Walkermostly because Lofton is not as unique. Preemption is a bit of a hash in the Fifth Circuit right now, but Loftonis on the good side of that morass. In Lofton,the court held that the fraud on the FDA exception to the Texas FDA complianceimmunity statute was preempted by Buckman. In so doing, the court explicitly rejectedthe Desiano approach (which we revile), for all the right reasons – chiefly because Buckman is more than amere pleading case and to follow Desiano would ignore the practicalconsequences that drove the result in Buckman. Sooner or later the Supreme Court is going tohave 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 hotall over the country right now, and the state of the art defense is at theheart of almost all of these cases. Inthe first published appellate ruling on the issue, Rodriguez affirmedsummary judgment, holding that the hodgepodge of old, largely tangentialarticles 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 oflaw. These articles were “isolated instances”relating to other substances. Aninference that anesthetics would have the same consequences wasunreasonable. The snippets that theplaintiffs offered were “too conjectural and too many steps removed from theproblem that developed.” Nor did theFDA’s rejection of a §510k (substantial equivalence) application establishanything about safety. All that meant isthat there was no predicate device to compare the pain pump to. Lohr established that §510k did notevaluate safety – and plaintiffs have to live with that decision just likedefendants do. Nor is there a duty totest a product in the absence of any knowable risk. A defendant is not an insurer. Nor does off-label promotion create any kindof claim, in the absence of any knowable risk. Finally, the prescriber’s testimony failed to show that any warningwould have made changed the outcome, so Rodriguez is a win on warningcausation as well. We haven’t conductedcomplete research, but we think that Rodriguez is probably the best Painpump decision to date. We urged othercourts to emulate Rodriguez here.
5. In re Pelvic Mesh/Gynecare Litigation, 43 A.3d1211 (N.J. Super. App. Div. 2012). We’vebeen kvetching for years about the ongoing erosion of defense rights to contact treating physicians(supposedly guaranteed by the Stempler decision) in New Jersey mass tortlitigation. In Pelvic Mesh, anappellate court finally did something about this. The Pelvic Mesh mass tort procedureswere very restrictive of defense access to treating physicians, so that defendants had ahard time simply finding experts. A high percentage (over 1,000 innumber) of the relevant medical specialists had treated one or another of theplaintiffs and thus were forbidden to serve as defense expert witnesses. On mandamus (a toughstandard) the court reaffirmed a simple principle – that plaintiffs waive anyphysician/patient privilege as to relevant injuries when they bring lawsuits. Physicians have no duty of loyalty requiringthem to support their patients in litigation. We looked forward to the ultimatedemise of New Jersey limitations on the equal availability of criticalphysician evidence to both sides here.
6. In re Schering Plough Corp. Intron/Temodar ConsumerClass Action, 678 F.3d 235 (3d Cir. 2012). We don’t like third-party payer class actions, whether formal class actions or broughtunder some other purported method of aggregation. Unless somebody was actually harmed by a drugor device, these suits are artificial contrivances by which TPPs attempt to getout of what they have contracted to do – that is, to pay for prescribedtreatments that help patients. Intronhits all the right notes – particularly that TPP plaintiffs can’t use RICO ascover for improper attempts to enforce the FDCA with respect to off-labelpromotion. In the absence of proof thatreal people were exposed to products that were unsafe or ineffective (insteadof 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) ofthis bogus class action, and hopefully others like it, here.
7. United States v. Caronia, ___ F.3d ___, 2012 WL5992141 (2d Cir. Dec. 3, 2012). It wouldrank higher, maybe even #1, if the same ruling had occurred in a productliability action. Still, Caronia’sholding, even in the purely criminal context, that the First Amendment protectstruthful promotion of off-label uses, is significant enough to make our topten. Courts and the common law are partof the government, and thus equally subject to First Amendment limits, as wediscussed here. Thus, neither tort plaintiffs, norTPPs, nor FCA relators, nor state AGs, nor the federal government in its own FCAactions, can base liability (assuming Caronia remains good law) ontruthful statements about the benefits and risks of off-label uses. We’ve been waiting for a ruling like Caroniafor a long time, ever since we began piecing together a First Amendment defensein 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.3d1170 (9th Cir. 2012). This is another casethat suffers a bit from being somewhat out of our target area. Pom Wonderful is a Lanham Act casebrought by a very litigious (search the name sometime) purveyor of pomegranatejuice against the defendant’s FDA-approved food labeling. For our purposes, Pom Wonderful isimportant because it applies one of our favorite principles, that the is noprivate right of action (direct or indirect) to enforce the FDCA, in order toestablish the principle of FDA primary jurisdiction as an alternative topreemption. California notoriouslyleads the country in bogus “consumer protection” litigation over the labelingof many FDA-approved products, so to get an appellate decision tellingplaintiffs to lay off labeling that's within the FDA’s regulatory sphere is a majorwin for the good guys. We savored PomWonderful here.
9. Holmes v. Merck & Co., 697 F.3d 1080 (9thCir. 2012). Yes, the Supreme Courtreally meant what it said in Bruesewitz (we’ve finally memorized how tospell it). That’s essentially theholding in Holmes, and with Holmes probably falls the lastserious post-Vaccine Act product liability litigation involving thesestatutorily-protected products – which is precisely what Congressintended. Even if the vaccine litigationdoes not involve a covered claim (the plaintiff was a parent, rather than theactually injured child, a common ruse to try avoiding the Act), the plaintiffcouldn’t escape the Act’s limits on liability. Preemption under the Vaccine Act applies to all suits against vaccinemanufacturers. Thus, summary judgmentaffirmed. It’s a home run for vaccinemanufacturers, but since there’s much less litigation nowadays over vaccines thanover 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-jurisdictionalclass action tolling. In Caseythe Virginia Supreme Court unanimously decided that it did too. The court held that a meritless and nevercertified federal class action involving Fosamax did not have any effect onthat state’s statute of limitations. Allin 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 presentsunder the tree. So here are our Honorable Mentions: (11) Sandoz, Inc. v. State, 100 So.3d514 (Ala. 2012) – Would rank higher, except it’s largely a reprise of anexcellent 2009 (2009 #1) decision. Reversesa $70+ million verdict in an AG suit over purported fraud on state health carereimbursement programs. We reviewed ithere. (12) In re Abbott Laboratories,Inc., 698 F.3d 568 (7th Cir. 2012) – Nice CAFA decision that plaintiffscan’t consolidate separate cases for trial without triggering the statute’s massaction provisions. We discussed it here. (13) Zimmerman v. NovartisPharmaceuticals Corp., ___ F. Supp.2d ___, 2012 WL 3848545 (D. Md. Sept. 5,2012) – We saw a lot of Aredia/Zometa decisions in 2012; butliked this one the best. It’s good onfraud on the FDA/Buckman, and even better on FDA prosecutorialdiscretion, 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 highcourt, but the reasoning was thin and hard to follow; we’ll take it, but not onthe big list. We discussed it here. (15) Metz v. Wyeth, Inc., 872 F. Supp.2d1335 (M.D. Fla. 2012) – It was close, but we think it’s the best of a raft of genericpreemption trial-level cases. That itwas 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 excellentdecision on generic preemption, rejecting Conte, and affirming Erieconservatism. 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 thedefendant’s black box warning was held adequate as a matter of law. Because it’s to be published, Chantix beats out asimilar 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 theyear, occurring in the context of PMA preemption. Demolishes Hofts. We covered it here. (19) Marsh v. Genentech, Inc., 693F.3d 546 (6th Cir. 2012) – Given a chance to back down, the Sixth Circuitdidn’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. Gekilled such a claim in the False Claims Act context where preemption doesn’tapply. Not even in D. Mass. We discussed it here.
Looking back, all of our top ten from 2011 remainintact. We did lose one of our honorablementions, however, when the Degelman case (2011 #14) was settled whileon en banc review, and thusvacated. The Dobbs SSRIpreemption decision (2011 #8) is currently before the Tenth Circuit. On the other side of the ledger, as wepointed 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 maybewe’ll have good news to report on those fronts in 2013. The Lance case (2010 #-6) remainspending 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 rankhighly on our top ten of 2013. The awfulCaldwell case (2012 #-2) from Louisiana is also being appealed, but asso 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 Courtwill become the first state high court to rule on Conte brandedliability where only generic drugs were consumed. In Stengel, the Ninth Circuit en bancwill address what can and can’t constitute a “parallel claim” under Riegeland Buckman. Finally, we’re awareof 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 genericdrugs and medical devices under Mensing and Riegel are in theappellate process in federal and state appellate courts.
So now it’s on to 2013. Happy New Year to all our readers.
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