Every now and then we run into a decision that wethink is wrong in so many different ways that we call it an example of“spherical error” – that is, error no matter how one looks at it. We only do that rarely. Back in May, 2010 we first applied that descriptionto In re Gadolinium-Based Contrast Agents Products Liability Litigation,2010 WL 1796334 (N.D. Ohio May 4, 2010). Then in September of that year we likewise identifiedspherical error in Sheet Metal Workers Local 441 Health & Welfare Planv. GlaxoSmithKline, PLC, 737 F. Supp.2d 380 (E.D. Pa. 2010) – or at leastthe Pennsylvania part of it, which dealt with the law we knew best.
That’s it – two cases earned that sobriquet in theblog’s six-plus years of existence.
Make that three.
The recent decision in Arters v. Sandoz Inc.,2013 WL 308768 (S.D. Ohio Jan. 25 2013), likewise bollixed up the law in somany different ways that we think it rises (falls?) to the level of sphericalerror.
Arters involved a question that a lot of courtshave considered lately with almost (but not quite) uniformly good results –preemption in the context of generic drugs following PLIVA v. Mensing, 131 S. Ct. 2567 (2011). As in many generic preemption cases, thedefendant sought to have the case dismissed under Rule 12.
That – Rule 12 – is the first error in Arters. The decision states:
A motion for judgment on the pleadings pursuant to Rule12(c) should not be granted “unless it appears beyond doubt that the plaintiffcan prove no set of facts in support of his claim which would entitle him torelief.” Conley v. Gibson, 355U.S. 41, 45–46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957).
Arters, 2013 WL 308768, at *1.
Umm…. No.
Someone must have been the second coming of Rip VanWinkle and slept through the last five years. In a rather well-publicized decision, back in 2007, the Supreme Courtexpressly overruled Conley on specifically this “no set of facts”point. See Bell Atlantic Corp.v. Twombly, 550 U.S. 544, 561-63 (2007). Twombly? Maybe you’veheard of it. If so, you’re already oneup on Arters. Anyway, the SupremeCourt in Twombly explicitly “retired” the Conley standard reliedupon in Arters:
On such a focused and literal reading of Conley’s“no set of facts,” a wholly conclusory statement of claim would survive amotion to dismiss whenever the pleadings left open the possibility that aplaintiff might later establish some set of undisclosed facts to supportrecovery. . . . It seemsfair to say that this approach to pleading would dispense with any showing of areasonably founded hope that a plaintiff would be able to make a case; Mr.Micawber’s optimism would be enough.
Seeing this, a good many judges and commentators havebalked at taking the literal terms of the Conley passage as a pleadingstandard. [many citations omitted] We could go on, but there is no need to pileup further citations to show that Conley’s“no set of facts” language has been questioned, criticized, and explained awaylong enough. . . . [A]fter puzzling the profession for 50 years, this famous observationhas earned its retirement. The phrase isbest forgotten as an incomplete, negative gloss on an accepted pleadingstandard.
Twombly, 550 U.S. at 561-63 (emphasisadded). Then, a couple of years later,the Court made clear that Twombly’s interrment of the Conleylanguage cited in Arters applies across the board to all types of cases. See Ashcroft v. Iqbal, 556 U.S.662, 684 (2009).
So that’s where the spherical error in Artersgets rolling. The opinion starts offwith the wrong basic standard for review.
And it’s downhill from there. Spherical error keeps rolling.
As we mentioned, Arters is a preemptioncase. So where does the decision gonext? Why, straight to that old saw, thepurported “presumption against preemption”:
In considering whether these claims are preempted by theFDCA, some deference to state law is appropriate: “[I]n all preemption cases, and particularlyin those in which Congress has legislated in a field which the States havetraditionally occupied, we start with the assumption that the historic policepowers of the States were not to be superseded by the Federal Act unless thatwas the clear and manifest purpose of Congress.” Levine, 555 U.S. at 565 (internalquotations omitted).
Arters, 2013 WL 308768, at *4.
Wrong again. Arters is a generic drug case – it’s governed by Mensing,not Levine. And it’s safe to saythat the presumption against preemption was a major bone of contention in Mensing– and a 5-4 majority of the Court chose not to apply any such presumption. Four justices in Mensing went fullbore the other direction: rejecting anysuch presumption and expressing the opposite view, that the Supremacy clause issomething called a “non obstante” provision, and consequently, if anything,there should be a presumption in favor of preemption:
[T]he provision suggests that courts should not strain to find ways to reconcilefederal law with seemingly conflicting state law. . . . A non obstante provision thus was a usefulway for legislatures to specify that they didnot want courts distorting the new law to accommodate the old.
Mensing, 131 S. Ct. at 2580 (emphasisadded) (plurality opinion). Now, this piece of Mensingwasn’t a majority opinion (Justice Kennedy did not join this section), but onlyfour justices wanted to apply a positive presumption against preemption of thesort invoked in Arters – and that’s a minority.
So, before we even get to the merits, Artershas directly contradicted three controlling Supreme Court opinions – taking anerroneous pro-plaintiff position as to each.
Why are we not surprised that the merits aren’t anybetter?
The plaintiff in Arters asserted a “designdefect”/“remove from the market” claim à la Bartlett v. MutualPharmaceutical Co., 678 F.3d 30 (3d Cir.), cert. granted, 133 S.Ct.694 (U.S. 2012). 2013 WL 308768, at*4. Of course, the vast majority ofprecedent is to the contrary. AnotherOhio case, Fulgenzi v. PLIVA, Inc., 867 F. Supp.2d 966 (N.D. Ohio 2012),held, first, that design defect claims were improperly pleaded under the OhioProduct Liability Act (“OPLA”), id. at 972-73, and further that plaintiffcouldn’t replead because there was no way to construct an unpreempted “designdefect” claim:
Even if the pleading deficiencies could be remedied,dismissal of these claims would still be appropriate because, regardless of howPlaintiff attempts to cast these claims, they are, at the core, failure-to-warnclaims that are clearly preempted. . . . [A] generic pharmaceutical product must bethe same as the referenced listed drug in active ingredients, safety and efficacyand hence, as was the case with labeling, federal law pre-empts state laws imposingthe duty to change a drug’s design upon generic manufacturers.
867 F. Supp.2d at 973-74 (citations and quotationmarks omitted). Fulgenziexemplifies decisions reached by many other courts. See Demahy v. Schwarz Pharma, Inc.,702 F.3d 177, 186 (5th Cir. 2012) (design defect claims are “failure-to-warnclaims under different names” and preempted) (applying Louisiana law); Frazierv. Mylan Inc., ___ F. Supp.2d ___, 2012 WL 6641626, at *5-6 (N.D. Ga. Dec.18, 2012) (“a generic drug is designed to be a copy of a reference listed drugand it must be identical in active ingredients and efficacy” rejecting Bartlettbecause generic “was not free to unilaterally pursue a safer alternative design. . . to comply with state law while also being in compliance withfederal law”); Strayhorn v. Wyeth Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 3261377, at *10,12 9-10 (W.D. Tenn. Aug. 8, 2012) (“design claim is “at [its] core” a warningclaim; Bartlett “offered little explanation for accepting the failure towithdraw theory”); Lashley v. Pfizer, Inc., 877 F. Supp.2d 466, 478, 480(S.D. Miss. 2012) (design defect claim without alternative design is really apreempted warning claim; Bartlett “unpersuasive and not a proper basisfor relief”); Metz v. Wyeth, 872 F. Supp.2d 1335, 1341 (M.D. Fla. 2012)(generic drug “was required to be the bioequivalent to the reference listeddrug”); Eckhardt v. Qualitest Pharmaceuticals, Inc., 858 F. Supp.2d 792,801 (S.D. Tex. 2012) (“Generics were required to produce a drug that wasequivalent to the brand-name drug and were not free to unilaterally pursue asafer alternative design in order to comply with state law”); In rePamidronate Products Liability Litigation, 842 F. Supp. 2d 479, 484(E.D.N.Y. 2012) (“the federal duty of ‘sameness’’’ also applies in the contextof generic drug design, and federal law preempts state laws imposing a duty tochange a drug’s design on generic drug manufacturers”); Jacobsen v. Wyeth,LLC, 2012 WL 3575293, at *9 (E.D. La. Aug. 20, 2012) (“federal law requiresa generic drug to be of the same design as its brand name counterpart”); Inre: Accutane Products Liability Litigation, 2012 WL 3194952, at *2 (M.D.Fla. Aug. 7, 2012) (“defective design claims are similarly preempted underMensing because the generic drug was required to be the bioequivalent to thereference listed drug”); Aucoin v. Amneal Pharmaceuticals, LLC, 2012 WL2990697, at *8-9 (E.D. La. July 20, 2012) (“federal law requires a generic drugto be of the same design as its brand name counterpart”); Fullington v.PLIVA, Inc., 2012 WL 1893749, at *5 (E.D. Ark. May 23, 2012) (design defectclaim based on inherent risk really a preempted warning claim); Johnson v.Teva Pharmaceuticals USA, Inc., 2012 WL 1866839, at *4 (W.D. La. May 21,2012) (design defect claims preempted because plaintiff “cannot show that analternative drug design was available to the Generic Defendants”); Cooper v.Wyeth, Inc., 2012 WL 733846, at *6 (M.D. La. March 6, 2012) (“if state lawcould require a generic drug manufacturer to wholly withdraw from the marketbased on the unreasonable danger of the product . . . it necessarilymust repudiate the label approved by the FDA”); In re Darvocet, Darvon &Propoxyphene Products Liability Litigation, 2012 WL 718618, at *3 (E.D. Ky.March 5, 2012) (failure to withdraw claim was “based on the allegedly defectivedesign of the drug, which the Generic Defendants, bound by their ‘ongoingfederal duty of sameness,’ were powerless to change”); Lyman v. Pfizer, Inc.,2012 WL 368675, at *4 (D. Vt. Feb. 3, 2012) (design defect claims “arepreempted as well by Mensing’s logic,” since the “ ‘federal duty ofsameness’ . . . applies to the design or composition of the drug aswell as to its labeling”); In re Fosamax (Alendronate Sodium) ProductsLiability Litigation, 2011 WL 5903623, at *6 (D.N.J. Nov. 21, 2011) (“FDArequires generic Fosamax to have the same active ingredient as Fosamax”); Stevensv. PLIVA, Inc., 2011 WL 6224569, at *2 (Mag. W.D. La. Nov. 15, 2011) (“genericpharmaceutical product must be the same as the referenced listed drug . . .in active ingredients”), adopted, 2011 WL 6224556 (W.D. La. Dec. 2,2011).
Arters’ response to this massive opposing precedent? First, they’re not binding, so theycan be ignored. 2013 WL 308768, at *5(“[n]one of the cases . . . bind this Court on the issue of whetherdesign defect claims are preempted by the FDCA”). Second, if it’s not a failure to warnclaim, it’s distinguishable. Id.(“other district courts within the Sixth Circuit have reached the oppositeconclusion. . . . TheseCourts have considered different state laws and different factual situations.Here, plaintiffs' design-defect claim rests on the alleged violation of anentirely different duty than their failure to warn claim”).
Well, although the first is true, one would expect Artersat least to address the other courts’ reasoning – that bioequivalence means the“same” design as well as warnings – but no, not one word about how there isn’t“sameness” in design claims. As for thesecond, that’s just false. While someother Sixth Circuit district courts (Strayhorn (Tennessee) and Darvocet(Kentucky)), were under other states’ laws, Fulgenzi – which Artersnotably fails to cite – simply isn’t. Fulgenzianalyzed the identical question under identical state law. Arters sweeps the mostdirectly-on-point precedent silently under the rug.
But the scope of the error in Arters is evenworse than ignoring uncomfortable precedent. Rather, Arters should never have been out on that limb, and thusruling contrary to both Mensing and the great weight of precedent, in the firstplace. The decision puts the cart beforethe horse. There has to be a state lawclaim first – before it can be preempted. See Purvis v. Teva Pharmaceuticals, USA, Inc., ___ F.Supp.2d ___, 2012 WL 5364392, at *4 (M.D. La. Oct. 30, 2012) (design defectclaim without alternative design not viable; Bartlett not persuasive); Grinagev. Mylan Pharmaceuticals, Inc., 840 F. Supp.2d 862, 870 (D. Md. 2011)(plaintiff failed to allege a proper design defect claim under state law; noneed to reach preemption); Fisher v. Pelstring, 817 F. Supp.2d 791, 817-18(D.S.C. 2011) (design defect failed when plaintiff failed to demonstrate analternative feasible design). This iswhat “failure to state a claim” is all about.
Unlike Bartlett, where (non-drug) NewHampshire law could at least be plausibly read as allowing a “design defect”based on pure risk/utility balancing without an alternative design, Artersarose under Ohio law. 2013 WL 308768, at *5. Ohio simply does not recognize a designdefect without a feasible alternative design:
A product is notdefective in design or formulation if,at the time the product left the control of its manufacturer, a practical and technically feasiblealternative design or formulation was not available that would haveprevented the harm for which the claimant seeks to recover compensatory damageswithout substantially impairing the usefulness or intended purpose of theproduct.
Ohio Rev. Code §2307.75(F) (emphasis added). That goes double for prescription medicalproducts:
An ethical drug or ethical medical device is not defective in design orformulation because some aspect of it is unavoidablyunsafe, if the manufacturer of the ethical drug or ethical medicaldevice provides adequate warning and instruction . . . concerningthat unavoidably unsafe aspect.
Ohio Rev. Code §2307.75(D) (emphasis added). While Arters cites §2307.75 generally,2013 WL 308768, at *5, it inexplicably ignores the two most directly on-pointsubsections that establish the unavailability of an OPLA design defect cause ofaction in the absence of any alternative design. Nor is there any conceivable otheravenue open in Arters. OPLA is “intendedto abrogate all common law product liability claims or causes of action.” Ohio Rev.Code §2307.71(B).
In short, the “design defect” claim purportedly atissue in Arters does not exist under relevant state law. A “design defect” claim absolutely, bystatute, requires an alternative design in Ohio. Plaintiff cannot assert an Ohio claim that aproduct – particularly a prescription medical product – can simply be removedfrom the market. Because there is no Bartlettrationale under Ohio law, it was error for Arters even to consider preemptionof that claim. “[W]e do not ordinarilydecide constitutional issues if a case can be resolved on non-constitutionalgrounds.” Sistrunk v. City ofStrongsville, 99 F.3d 194, 197 (6th Cir. 1996).
In reaching and resolving this constitutional issue, theDistrict Court ignored the basic and longstanding rule of construction thatwhen two questions are raised, and resolution of the non-constitutionalquestion makes unnecessary a decision on the constitutional question, only thenon-constitutional question should be decided.
Nagy v. Farmers Insurance Exchange, 758 F.2d189, 192 (6th Cir. 1985).
And that’s not the end of it. Arters goes on to hold that somethingit calls “off-label promotion” also survives preemption. 2013 WL 308768, at *6. Arters states that there’s some sortof “duty not to promote a dangerous use of [the drug] that is inconsistent withthe FDA-approved label.” Id. Where does this novel duty come from? Arter cites no law at all, statingonly that the defendant allegedly “promoted a use of [the drug] that was inviolation of Ohio law.” Id.
Wrong again.
Off-label use isn’t illegal in Ohio. The only off-label use ever banned in Ohiohas to do with (you guessed it) abortion. See Planned Parenthood Southwest Ohio Region v. DeWine,696 F.3d 490, 496 (6th Cir. 2012) (discussing Ohio Rev. Code §2919.123(A)). Otherwise, off-label use is perfectly legalunder Ohio common law.
[A]lthough the FDA regulates, among other things, drugsand medical devices, the FDA does not regulate the practice of medicine. . . . [C]ourts addressing issues of FDA-regulateddrugs have determined that physicians are permitted to use federally approveddrugs as they, in their medical judgment, see fit. . . . FDA approved indications were not intended tolimit or interfere with the practice of medicine nor to preclude physiciansfrom using their best judgment in the interest of the patient The Food, Drug and Cosmetic Act does notlimit the manner in which a physician may use an approved drug. Once a product has been approved formarketing, a physician may prescribe it for uses or in treatment regimens orpatient populations that are not included in approved labeling. Thus, the decision whether to use a drug foran off-label purpose is a matter of medical judgment, not of regulatoryapproval.
Klein v. Biscup, 673 N.E.2d 225, 231 (OhioApp.) (citations and quotation marks omitted), review denied, 667 N.E.2d987 (Ohio 1996).
It is well established that the U.S. Food and Drug Administrationneither regulates the practice of medication nor restricts uses of those of the“official” approval, but merely approves or disapproves the use and marketingof medical devices and drugs. The OhioState Medical Association has taken the position that “off-label use” isneither “experimental” nor “investigational.” The off-label use of a medical device is merely a matter of medicaljudgment . . . is not barred by the U.S. Food and Drug Administration.
State ex rel. Bax Global, Inc. v. Industrial Com’n,2007 WL 512529, at *5 (Ohio App. Feb. 20,2007).
So if not off-label use itself, what could be a“violation” of the law? Off-labelpromotion? For one thing, no federalstatute or regulation prohibits that, as the Second Circuit pointed out recently in United States v. Caronia, ___ F.3d ___, 2012 WL 5992141,at *3 (2d Cir. Dec. 3, 2012) (“[t]he FDCA and its accompanying regulations donot expressly prohibit the 'promotion' or 'marketing' of drugs for off-labeluse”). For another, assuming a plaintiffcould nonetheless tease a “plausible” violation out of various FDA regulations: (1) off-label promotion is not inherentlyfalse or fraudulent, as we discussed at length here; and (2) there’s not a scrap of Ohio precedent holding that off-labelpromotion also somehow violates state tort law. It’s not the role of federal courts sitting in diversity to dream up newstate-law tort claims.
[F]ederal courts must proceed with caution when makingpronouncements about state law. Sittingin diversity, we are not commissioned to take a position regarding theadvisability or fairness of the state rule to be applied, but must determinethe issue as would the highest court of the state. This Court’s proper reluctance to speculateon any trends of state law applies with special force to a plaintiff in adiversity case. . . . Whengiven a choice between an interpretation of state law which reasonablyrestricts liability, and one which greatly expands liability, we should choosethe narrower and more reasonable path.
Combs v. International Insurance Co., 354 F.3d568, 577 (6th Cir. 2004) (citations and quotation marks omitted); see Ventas, Inc. v. HCP, Inc., 647 F.3d291, 328 n.15 (6th Cir. 2011 (quoting and following Combs); Kurczi v. Eli Lilly & Co., 113F.3d 1426, 1429 (6th Cir. 1997) (“A federal court in a diversity case is notfree to engraft onto ... state rules exceptions or modifications which maycommend themselves to the federal court, but which have not commendedthemselves to the State in which the federal court sits”) (quoting Day &Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)).
Moreover, there’s another United States SupremeCourt case holding, in the specific context of off-label use, that supposed state-law claims asserting FDA regulatoryviolations are in fact nothing more than improperattempts to sue over alleged violations of a statutory scheme that doesn’tpermit private enforcement. See21 U.S.C. §337(a) (reserving FDCA enforcement exclusively to the federalgovernment). However far Buckman Co.v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), might or might nototherwise extend, it forbids state-law claims such as those in Artersthat allege improprieties involving off-label use:
[Plaintiff’s claims would ] delay health careprofessionals’ ability to prescribe appropriate off-label uses. . . . [I]t is clear that the [Lohr]claims arose from the manufacturer’s alleged failure to use reasonable care inthe production of the product, not solely from the violation of FDCArequirements. In the present case,however, the [plaintiffs’] fraud claims exist solely by virtue of the FDCAdisclosure requirements. . . . [W]ere plaintiffs to maintain their fraud-on-the-agency claims here,they would not be relying on traditional state tort law which had predated thefederal enactments in questions. On thecontrary, the existence of these federal enactments is a critical element intheir case.
531 U.S. at 351-53 (numerous citations omitted). Without the FDA-approved label, there’s nosuch thing as “off-label” use – let alone “promotion” – which is anotherregulatory term. Thus, a tort claim for“off-label promotion” as discused in Arters necessarily runs afoul of Buckman’s“critical element” test.
If that weren’t enough, the Ohio Supreme Court hasalso banned this sort of disguised statutory enforcement claim where, as withthe FDCA, the statute in question bars private enforcement. In Hernandez v. Martin Chevrolet, Inc.,649 N.E.2d 1215 (Ohio 1995), the court considered the effect of a claimedviolation of OSHA, a federal statute that, like the FDCA, explicitly barred itsuse (the so-called “disclaimer”) in private civil litigation. The court, in a rare unanimous decision, said“no” to the claim:
This statutory disclaimer clearly indicates thatCongress did not intend OSHA to affect the duties of employers owed to thoseinjured during the course of their employment. . . . Negligence per se decreases the elements thata plaintiff must prove in a negligence action. Thus, a plaintiff's case is significantlyaided if negligence per se is established. If we held that a violation of OSHAconstitutes negligence per se, we would allow OSHA to affect the duties owed byindividuals to those injured in the course of their employment. Such a holdingwould be contrary to the intent of the legislation. Accordingly, we hold that aviolation of OSHA does not constitute negligence per se.
Id. at 1216-17 (citations omitted). As for "intent" in the FDCA context, as Buckman held, §337(a) is “clearevidence that Congress intended that the MDA be enforced exclusively by theFederal Government.” 531 U.S. at352. And finally, while it only makesthe rubble of Arters bounce, as Caronia, supra, pointed out, there is nothing in the FDCA itself aboutoff-label promotion (or, indeed, off-label use). Ohio law also prohibits violations of meregovernmental regulations from being the basis of an negligence per se claim. See Chambers v. St. Mary’s School,697 N.E.2d 198, 203 (Ohio 1998) (“we hold that the violation of anadministrative rule does not constitute negligence per se”).
Spherical error. In one relatively short opinion (seven Westlaw pages), the Artersdecision manages to:
(1) employa “retired” standard for deciding a rule 12 motion, directly contrary to two ofthe most-widely cited Supreme Court decisions in recent years;
(2) applya presumption against preemption directly contrary to the holding in a third controllingSupreme Court decision;
(3) holdthat a design defect/failure to withdraw claim was not preempted when thatclaim cannot possibly exist under the controlling state (OPLA) statute;
(4) holdthat a design defect/failure to withdraw claim was not preempted ignoring (andin some cases not even acknowledging) the reasoning of the vast weight ofcontrary precedent;
(5) holdthat an off-label promotion claim is not preempted, directly contrary to theholding of a fourth controlling Supreme Court decision;
(6) entertainan off-label promotion claim that no Ohio court has permitted, contrary to thecourt’s limited role when sitting in diversity; and
(7) entertainan off-label promotion claim that’s barred by two Ohio Supreme Court decisionsthat limit the scope of negligence per se claim under controlling state law.
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