Today’s post contains our annual list of those court decisions concerning prescription drugs and medical devices that are so bad and ugly that they leave us talking to ourselves – or even to the furniture.  With the thirteenth year of the millennium drawing to a close, these opinions demonstrate that – yes, indeed – thirteen can be an unlucky number.  You’ll have to wait until next week for the good, because our custom is to start with the judicial Razzies and end the year with our list of judicial Oscars.  Here are the jurisprudential dross of 2013.

1. Kaiser Foundation Health Plan, Inc. v. Pfizer, Inc., 712 F.3d 21 (1st Cir. 2013), Aetna, Inc. v. Pfizer, Inc., 712 F.3d 51 (1st Cir. 2013), and Harden Manufacturing Corp. v. Pfizer, Inc., 712 F.3d 60 (1st Cir. 2013).  It was close, but due to the amount of money involved and the Supreme Court’s recent decision denying certiorari, this Neurontin Trilogy stands as the buzzard on this year’s pile of. . . .  As last year’s Bartlett decision demonstrated, the First Circuit has recently been an extreme outlier on a variety of matters having to do with pharmaceutical liability.  Nowhere has that status been more pronounced than with aggregation of economic loss claims.  Unlike just about any other jurisdiction, the Neurontin Trilogy allowed causation in these third-party payer actions to be determined on an aggregated and probabilistic fashion – according to the opinion of a statistical “expert” whose work otherwise has been almost universally excluded, both in our pharmaceutical sandbox and elsewhere.  Over $140 million in purported damages was affirmed despite every prescriber who actually testified swearing that the defendant’s conduct had no influence on his/her prescriptions.  This trilogy effectively declared an irrebuttable heeding presumption, at least in RICO cases.  That’s not all.  Another of the Trilogy (Harden) vacated and remanded a decision denying certification of a nationwide class of various TPP claims, 712 F.3d at 70, thus raising the specter of even more massive litigation of a sort not permitted by any other federal Court of Appeals.  With certiorari now denied, the most we can hope for is that the Trilogy’s fraud on the market rationale might fall with a favorable decision on that theory in the Halliburton securities case.  We explained the outlier nature of the Neurontin Trilogy here.

2. Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc).  2013 was not a happy new year very long.  The year was but ten days old when the Ninth Circuit issued this awful decision that, if allowed to stand, robs two Supreme Court opinions of much of their substantive effect.  (Full disclosure, RS was one of the defense counsel in Stengel).  The first of those is Riegel.  If a state’s general tort law on adequacy of warnings, or post-sale duty to warn, is sufficiently close as to constitute a “parallel” violation claim, then “parallel” has lost its meaning, and the Riegel dictum about parallel claims has swallowed Riegel’s holding whole. The second is Buckman.  If a claimed state-law warning or fraud claim alleging failure to notify a third person (such as the FDA) is sufficient to get around the unanimous holding in Buckman that fraud on the FDA claims are preempted, then none of the policy reasons that supported the result in Buckman matter anymore. Because the Ninth Circuit’s decision is incompatible with two Supreme Court decisions and two different forms of preemption, it comes in at #2 on our list.  There’s still hope, though, as the Supreme Court has asked the Solicitor General for his views of the certiorari petition in Stengel.  However, as the Old Perfessor once said, it’s a bad idea to make predictions, especially about the future.  We expressed our dislike for Stengel here.

3. Howard v. Zimmer, Inc., 299 P.3d 463 (Okla. 2013).  Howard is the ugliest FDCA-based negligence per se decision that we’ve seen out of any state supreme court in many a year.  The court has effectively allowed litigants to federalize Oklahoma tort law through the guise of negligence per se based on violations of essentially any federal statute or regulation.  With respect to the FDCA, Howard flies in the face of congressional intent by allowing what is really private enforcement of the statute despite 21 U.S.C. §337(a).  Most states, including Oklahoma until Howard, as a matter of inter-branch comity, decline to apply negligence per se to statutes (state or federal) where the legislature has not evinced an intent to allow private enforcement, and §337(a) is an emphatic expression of precisely that intent with respect to the FDCA.  Howard is an example of the common-law being modified by improper, extraneous factors, since the express purpose of this expansion of negligence per se is to get around the preemptive effect of Riegel. 299 P.3d at 470.  We lambasted Howard here.

4. In re Reglan/Metoclopramide Litigation, ___ A.3d ___, 2013 WL 3874905 (Pa. Super. July 29, 2013) (reconsideration pending), Hassett v. Dafoe, 74 A.3d 202 (Pa. Super. 2013), and In re Reglan/Metoclopramide Litigation, 74 A.3d 221 (Pa. Super. 2013). Another trilogy, and this year’s equivalent of the First Circuit’s Bartlett decision in terms of downright refusal to follow binding Supreme Court precedent.  Pennsylvania is saddled with a very pro-plaintiff Superior (intermediate appellate) Court, and in the Reglan Trilogy, that court  ignored what even it called a “tsunami” of contrary precedent to hold practically all (except for pre-2007 warning claims) the generic drug-related claims before it were not preempted.  Uniquely, the Trilogy allowed post-FDAAA claims to escape preemption, without bothering to identify what in those amendments could possibly make a difference.  Uniquely the Trilogy (or at least one of the cases) held that claims against a generic “reference listed drug” holder could escape preemption.  Uniquely, the Trilogy took allegations of absolute liability seriously.  Uniquely, the Trilogy let design defect claims slide after Bartlett – including a gratuitous footnote about innovator drugs.  Unlike the Supreme Court, the Trilogy applied a “presumption against preemption” in generic drug cases.  The Trilogy also makes a general hash of preemption law, thoroughly jumbling express and implied preemption cases and concepts together.  A dissenting judge aptly pointed out that the Trilogy is almost entirely lacking in legal reasoning and violates the mandate that lower courts “must adhere to extant Supreme Court jurisprudence.”  We vented our spleen at the Reglan Trilogy here.

5. Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013), reconsideration granted, No. 1101397 (Ala. June. 13, 2013), even though the Alabama Supreme Court thankfully agreed to reconsider the case, Weeks was such a terrible ruling – the only state high court to recognize innovator drug liability (which we also call “Conte”) where the innovator didn’t even sell the product that the plaintiff used − that we give it our #5 spot even after the reconsideration.  But for the reconsideration, Weeks almost certainly achieved opprobrium as our #1 worst case of the year.  Product liability is just that, liability for products, and imposing liability on other people’s products turns upside down all the reasons why product liability was created in the first place.  Prior to reconsideration, we let Weeks have it here.

6. Medtronic, Inc. v. Malander, 996 N.E.2d 412 (Ind. App. 2013).  This is another example of courts distorting tort law to get around preemption.  “Good Samaritan” liability under Restatement Second §324A is one of those “last refuge of a scoundrel” theories of liability, and here it was applied to impose liability for the alleged statements of a “clinical specialist” and telephone “hot line” that the defendant voluntarily supplied to answer surgeon questions about an implantable PMA device.  No good deed went unpunished in a case where everything else was preempted.  Section 324A is supposed to be reserved for actions (like poorly performed first aid) that actually make risks worse, but that didn’t stop the court in Malander from misapplying it to a situation where risks allegedly were not revealed, rather than aggravated, and where the surgeon is necessarily the “captain” of the surgical “ship.”  We maligned Malander here.

7. Arters v. Sandoz Inc., 921 F. Supp.2d 813 (S.D. Ohio 2013).  An ugly decision from beginning to end, ignoring TwIqbal (literally, the opinion cites to Conley v. Gibson, 355 U.S. 41 (1957), which Twombly expressly “retired”), applying a presumption against preemption where it doesn’t belong, endorsing the “stop selling” argument later rejected in Bartlett, ignoring a state-law alternative design requirement, and improperly expanding state law in a diversity case by finding a heretofore elusive tort “duty” not to engage in off-label promotion.  We went through the spherical error in Arters here.

8. Neeley v. Wolters Kluwer Health, Inc., 2013 WL 3929059 (E.D. Mo. July 29, 2013).  We really don’t like it when federal courts make up new state-law causes of action.  It’s bad enough when they do it to their own states, so it’s even less justified when they do it to other states.  Then again, the other state might just ignore the loopy out-of-state prediction.  In Neeley a federal court in Missouri predicted that Kentucky would adopt publisher liability – a set of theories every state confronted with it has in fact rejected, as we pointed out hereNeeley then proceeded to mess up generic preemption as well, leaving design defect claims standing because they were based on “consumer expectations.” So what?  You can’t change the design without FDA approval, and the only way a defendant can be responsible for a physician’s “expectations” about the designs of a PMA medical devices is through the information supplied about it. For getting these two “big picture” issues wrong, Neeley lands on our bottom ten.

9. Ramirez v. Medtronic Inc., ___ F. Supp.2d ___, 2013 WL 4446913 (D. Ariz. Aug. 21, 2013). This is the ugliest off-label use case of the year.  Burdened by Stengel, the court viewed off-label promotion allegations as pretty much throwing Riegel preemption out the window – ruling that such promotion created a new “intended use” that the FDA didn’t regulate at all.  That’s totally at odds with how the FDA’s regulations actually treat warnings about risks of off-label use, but there you have it.  On top of that, Ramirez disagreed with the Second Circuit’s treatment of off-label use and off-label promotion in Caronia (2012 top ten #7).  We (or should we say the non-RS side, since RS represented the defendant) tried to avoid gagging when discussing Ramirez here.

10. McLane v. Ethicon Endo-Surgery, Inc., 2013 WL 5556147 (Mag. M.D. Fla. Oct. 8, 2013), terrible discovery result concerning “substantially equivalent” predicate devices.  McLane is our latest poster-child for why the Fed. R. Civ. P. 26 needs to be amended to eliminate its much abused “reasonably calculated to lead to admissible evidence” phrasing.  In McLane the court ordered discovery under that standard of not only other adverse events involving the actual device in question (cleared for marketing and labeling under §510k) but also about adverse events involving the device’s “substantially equivalent” predicate device – a device that in many cases could either no longer be on the market or else could be a product marketed by a totally uninvolved third party.  We carped about the fishing expedition allowed in McLane here.

So there they are. Hopefully none of these not-just-wrong-but-loud-wrong losses were yours – if so, we sympathize, since we know how it feels.  We considered several other candidates – coming closest to making the cut was Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013), but failure to update claims just aren’t likely to be all that widespread in the future.

Now we can stop holding our noses and do something that’s more fun.  Next week we’ll be listing our top ten best drug/device decisions of 2013.