09-993, 09-1039, 09-1501 bsac national conference of state legislators

8/6/2019 09-993, 09-1039, 09-1501 Bsac National Conference of State Legislators

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Nos. 09-993, 09-1039, 09-150131n tbe supreme

PLIVA, INC., ET AL., PETITIONERSv.

GLADYS MENSING, RESPONDENT

ACTAVIS ELIZABETH, LLC, PETITIONERv.

GLADYS MENSING, RESPONDENTACTA VIS INC., PETITIONER

v.JULIE DEMAHY, RESPONDENT

ON WRITS OF CERTIORARI TO THE UNITED STATES COURTSOF APPEALS FOR THE EIGHTH AND FIFTH CIRCUITSBRIEF FOR THE NATIONAL CONFERENCEOF STATE LEGISLATORS AS AMICI CURIAEIN SUPPORT OF RESPONDENTS

SUSAl'J PARNAS FREDERICKFederal Affairs Counsel

National Conferenceof State Legislators

444 N. Capitol Street, N.W.Suite 515

Washington, DC 20001

SEAN H. DONAHUE*Donahue & Goldberg, LLP2000 L Street, N.W.Washington, DC 20036(202) [email protected] T. GOLDBERGDonahue & Goldberg, LLP99 Hudson Street, 8th FloorNew York, NY 10013*Counsel of Record

Counsel for Amici Curiae[Additional Counsel Listed on Signature Page]


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TABLE OF CONTENTS

Sumnlary of Argument ................................................ 3}\.rgllment .....................................................................61. Broad Claims of Implied Preemption Likethose i\,dvanced Here Are Inconsistent with OurConstitutional Framework and Threaten toUndermine State Government and Administration .. 6II. Petitioners' Rule of Broad Immunityfor Generic Drug Manufacturers from State LawWould hnpair Important State Interests andWould Disrupt State Health Case and ConsumerProtection Policy .......................................................... 9

.i\.. State Generic Substitution Laws HavePlayed an Important Role in the Developmentof Generic Drug Markets and Illustrate theStates' \lital Interest in this Area ....................... 10B. Petitioners' Proposed Tort Immunity forGeneric Nlanufacturers Would SeriouslyUnsettle State Policy ........................................... 15

III. Petitioners' Obstacle Preemption ArgumentsFail .............................................................................20

.i\.. Buclunan Does Not Support PreemptionHere ...................................................................... 20


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B. Petitioners' Efforts to Invent Sweeping NewImplied Conflict Preemption Doctrines Basedupon Language from Buckman Should BeRejected ................................................................ 28

COllclusion .................................................................. 35


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TABLE OF AUTHORITIESCasesAlexander v. Sandoval, 532 U.S. 275 (2001) ............. 7Altria Group, Inc. v. Good, 129 S. Ct. 538

(2008) .............................................................. 23, 33Arkansas Louisiana Gas Co. v. Hall, 453 U.S. 571

(1981) ............................................................passimBates v. Dow Agrosciences LLC, 544 U.S. 431

(2005) .................................................................... 33Bruesewitz v. Wyeth LLC, No. 09-152, 2011 WL

588789 (U.S. Feb. 22, 2011) ........................... 18, 19Buckman Co. v. Plaintiffs'Legal Committee, 531

U.S. 341 (2001) .............................................passimBurnet v. Cornado Gas Co., 285 U.S. 393 (1932) ..... 26Chicago & North Western Transportation Co. v.

Kalo Brick & Tile Co., 450 U.S. 311(1981) .......... ......... ......... ......... ......... ......... ... 5, 24, 28Cipollone v. Liggett Group, Inc., 505 U.S. 504

(1992) ..................................................................... 9Clinton v. Jones, 520 U.S. 681 (1997) .......................34Demahy v. Actavis, Inc., 593 F.3d 428 (5th

Cir. 2010) ........................................................ 12, 16Frontiero v. Richardson, 411 U.S. 677 (1973) ..........34Gade v. National Solid Wastes Management.Association, 505 U.S. 88 (1992) ............................. 6


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Garcia v. San Antonio Metropolitan TransitAuthority, 469 U.S. 528 (1985) .............................. 7

Geier v. American Honda Motor Co., 529 U.S. 861(2000) .................................................................... 23

Gonzales v. 0 Centro Espirita Beneficente Uniaodo Vegetal, 546 U.S. 418 (2006) ...........................34Grable & Sons Metal Products, Inc. v. DarueEngineering & Manufacturing, 545 U.S. 308

(2005) .................................................................... 31Gregory v. Ashcroft, 501 U.S. 452 (1991) ................... 7Holmes v. Securities Investor Protection Corp.,

503 U.S. 258 (1992) .............................................. 23Louisiana Public Service ConI-mission v. FCC, 476

U.S. 355 (1986) ...................................................... 6Louisville & Nashville Railroad Co. v. Mottley,

211 U.S. 149 (1908) .............................................. 31Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ...... 21, 22Rice v. Norntan Williams Co., 458 U.S. 654

(1982) .................................................................... 27Rice v. Santa Fe Elevator Corp., 331 U.S. 218

(1947) .................................................................... 21Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) .... 23, 32S i l l ~ w o o d v. Kerr-McGee Corp., 464 U.S. 238(1984) .......... .......... .......... ......... .......... ....... 19, 21, 22


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Thompson v. Western States Medical Center, 535U.S. 357 (2002) .....................................................34Wainwright v. Sykes, 433 U.S. 72 (1977) ................... 9Warner-Lambert Co. v. Kent, 552 U.S. 440(2008) .............................................................. 31, 32Williamson v. Mazda Motor ofAmerica, Inc.,No. 08-1314, 2011 U.S. Lexis 1711 (Feb. 23,2011) ............................................................... 23, 33Wyeth v. Levine, 129 S. Ct. 1187 (2009) ............passim

Federal Statutes and Regulations21 U.S.C. 352(f)(2) .......... ......... .......... ......... ......... .... 2321 U.S.C. 355 .............................................2, 6, 1728 U.S.C. 2403(b) ..................................................... 842 U.S.C. 1396b(z)(2)(E) ......................................... 1521 C.F.R. 201.57(e) .......... ........... ........... ...... 23, 25, 3044 Fed. Reg. 2932 (1979) ........................................... 10

State StatutesALA. CODE 34-23-8 .................................................. 11ALASKA STAT. 08.80.295 .................................... 11, 13ARIZ. REV. STAT. 32-1963.01 ............................. 11, 13


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ARK. CODE ANN. 17-92-503 ..................................... 11Cal. Bus. & Prof. Code 4073 ................................... 11COLO. REV. STAT. 12-22-124 ................................... 11CONN. GEN. STAT. 20-619 .................................. 11, 14DEL. CODE A N ~ . tit. 24, 2549 .................................. 11D.C. CODE 48-803.02 ............................................... 11FLA. STAT. 465.025 ............................................ 11, 14GA. CODE ANN. 26-4-81 ........................................... 11HAW. REV. STAT. 328-92 .................................... 11, 14IDAHO ADMIN. CODE r. 27.01.01.188 ................... . 11, 14225 Ill. Comp. Stat. 85/25 .......................................... 11I ~ D . CODE 16-42-22-8 ........................................ 11, 15IND. CODE 16-42-22-10 ............................................ 15Iowa Code 155A.32 ................................................. 11Kan. Stat. Ann. 65-1637 ................................... 11, 13Ky. Rev. Stat. Ann. 217.822 ................................... 11LA. ADMIN. CODE tit. 46, 2511 .......................... 11, 12ME. REV. STAT ..A.NN. tit. 32, 13781 ............... .......... 11Md. Code Ann., Health Oee. 12-504 ................. 11, 13MAss. GEN. LAWS eh. 112, 12D ............................... 11


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Mich. Compo Laws 333.17755 ................................. 11Minn. Stat. 151.21 ............................................ 11, 12Miss. Code Ann. 73-21-117 ..................................... 11Mo. Rev. Stat. 338.056 ............................................ 11Mont. Code Ann. 37-7-505 ...................................... 11Nev. Rev. Stat. 71-5403 .......................................... 11Nev. Rev. Stat. Ann. 639.2583 ............................... 11N.H. Rev. Stat. Ann. 318:47-d ................................ 11N.J. STAT. ANN. 24:6E-7 .......................................... 11N.M. Stat. 26-3-3 .......... .......... .......... .......... ......... .... 11N.Y. EDUC. LAw 6816-a ..................................... 11, 13N.C. Gen. Stat. 90-85.28 ......................................... 11N.D. Cent. Code 19-02.1-14.1 ..................... ...... 11, 13Ohio Rev. Code Ann. 4729.38 ................................. 11Okla. Stat. tit. 59, 353.13 ....................................... 11Or. Rev. Stat. 689.515 ....................................... 11, 1435 Pa. Cons. Stat. 960.3 .......................................... 11Pa. Cons. Stat. 960.6(6)(B) ............................... 11, 13R.I. Gen. Laws 5-19.1-19 ........................................ 11S.C. Code Ann. 39-24-30 ......................................... 11


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S.D. Codified Laws 36-11-46.1 ............................... 11S.D. Codified Laws 36-11-46.2 ...............................13TENN. CODE ANN. 53-10-204(a)(I) .......................... 12TENN. CODE ANN. 53-10-205 ................................... 1122 TEX. ADMIN. CODE 309.3 .............................. 11, 13UTAH CODE ANN. 58-17h-605 .................................. 11VT. STAT. ANN. tit. 18, 4605 .................................... 11VA. CODE ANN. 54.1-3408.03 ................................... 11WASH. REV. CODE 69.41.120 ............................. 12, 13W. Va. Code 30-5-12b; Wis. Adm. Code DRS

107.10 ...................................................................12WYO. STAT. 33-24-149 .............................................12

Secondary and Miscellaneous SourcesBrief of National Conference of State Legislatures,Wyeth v. Levine, 129 S. Ct. 1187 (2009) ............ 1, 8Brief of United States, Wyeth v. Levine, 129 S. Ct.

1187 (2009) ........................................................... 31Brief of U.S. Solicitor General, Warner-Lambert

Co. v. Kent, 552 U.S. 440 (2008) ...... .............. 31, 32Executive Order 13132 (Aug. 4, 1999) ....................... 8FDA, 1979 Model Drug Product Selection Act ......... 10


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FTC, Bureau of Consumer Protection, DrugProduct Select ion (1979) ...................................... 10

Henry J. Kaiser Family Foundation, StateMedicaid Outpatient Prescription DrugPolicies: Findings from a National Survey(October 2005) ................................................ 14-15Nina A. Mendelson, Chevron and Preemption, 102

MICH. L. REV. 737 (2004) ....................................... 8Nevada State Legislature, Background Paper 79-

11, Generic v. Brand Name Drugs at 6 (1979) .... 11Office of Inspector General, Department of Health

and Human Services, Generic Drug Utilizationin State Medicaid Programs (2006) ........... .......... 15

William H. Shrank, et aL, State GenericSubstitution Laws Can Lower Drug OutlaysUnder Medicaid, 29 HEALTH 1383 (2010) ... 15

Herbert Wechsler, The Political Safeguards ofFederalism: The Role of the States in theComposition and Selection of the NationalGovernment, 54 COLUM. L. REV. 543 (1954) ........ 19

Kenneth W. Shafermeyer et aL, The FDA OrangeBook: Expectations Versus Realities, 1 J.PHARM. & L. 13 (1991) .................................... 10-11

Transcript, No. 98-1768, Buckman Co. v.Plaintiffs'Legal Comntittee, 531 U.S. 341(2001) .................................................................... 22


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Statement of Interest*Amicus the National Conference of State

Legislatures (NCSL) is a bipartisan organizationthat serves the legislators and staffs of the Nation's50 States, its commonwealths and territories. NCSLprovides research, technical assistance, andopportunities for policymakers to exchange ideas onth e most pressing state issues. NCSL advocates forthe interests of state governments before Congressand federal agencies, including the Food and Drug.A.dministration (FDA), and it regularly submitsbriefs amicus curiae to this Court in cases that raiseissues of vital state concern.

In Wyeth v. Levine, 129 S. Ct. 1187 (2009), thisCourt held that the federal regulatory regimegoverning pharmaceuticals does not preempt statelaw failure-to-warn claims against the manufacturerof a brand name drug. Petitioners here claim thatvarious federal regulations relating to generic drugsshould be interpreted to preempt traditional statelaw remedies as to manufacturers of generic drugs.Like Wyeth, in which NCSL submitted a briefopposing preemption, this case implicates severalareas of core concern and special expertise for NCSL,its members, and their respective States.

The state interests implicated here are many andvital. The formulation of public policy on health* Pursuant to Supreme Court Rule 37.6, amicus

affirms that no counsel for a party authored this brief inwhole or in part and that no person other than amicusand its counsel made a monetary contribution to itspreparation or submission. All parties' letters consentingto the submission of amicus briefs have been filed withthe Clerk's office.


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care, insurance, safety, and welfare, includingregulation of medicine and pharmacy, havehistorically been the responsibility of the States.Consumer protection and providing means of redressfor personal injuries have also been the province ofstate legislatures and courts.

State legislatures have decades of experiencewith the issues most directly implicated in this case.Even before the 1984 Hatch-Waxman Amendmentsto the Food, Drug and Cosmetic Act (FDCA), Stateswere at the forefront of efforts to control public andprivate health care costs through policies aimed atincreasing the availability and public acceptance ofgeneric drugs. Moreover, state legislatures acrossthe country have considered and enacted significantcivil justice reform measures, carefully weighingcomplaints about the fairness, predictability andefficiency of liability rules. While different Stateshave taken different approaches, these effortstypically represent serious efforts to reconcileimportant state interests in promoting safety andproviding redress with reducing litigation and healthcare costs.

States have a strong interest in vindicating thepresumption against preemption and thepresumption's corollary: that, consistently with theConstitution, decisions to oust States from areas oftheir traditional authority, even when fully withinCongress's powers, should be made by Congress.Not only is that the branch of government in whichStates enjoy representation, but neither courts noradministrative agencies are as well-equipped toevaluate the complex, competing policyconsiderations that preemption questions typicallypresent.


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Indeed, this case vividly illustrates the reasons foradhering to the constitutional allocation ofpolicymaking authority - and the dangers of freeform judicial or administrative preemption.

SUMMARY OF ARGUMENTThe plea at the heart of this case fails for the

same reason as the one rejected in Wyeth: theabsence of any showing that Congress intended todivest States of their historic power to provide aremedy against those whose defectively marketedproducts caused injury. Federalism not only aprinciple, bu t a system of government: Asmentioned, providing compensation for injuredcitizens and regulating health care professions arenot merely areas where the States claim jurisdictionby tradition, but ones where they haveresponsibilities that federal authorities do not share.

This Court's precedents counsel great hesitationbefore accepting claims of implied preemption, andfor good reason. Implied preemption based uponpenumbras and emanations from federal regulation,and facile claims of federal administrativeinconvenience, deprives States of their best,constitutionally promised means of upholding theirduly enacted policies: their representation inCongress. In this case, the argument againstpreemption is overwhelming beca use Congressdisplayed no intent to disturb States' longstandingand complementary role. Petitioners' claims of"irreconcilable conflict" are painfully thin and aredisavowed by the agency on whose behalf they areostensibly asserted.


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Under the regime petitioners advocate, anindividual prescribed the same drug bearing thesame inadequate warning and injured thereby willbe denied recourse - either because the pharmacistelected to fill the prescription with a generic drug, orbecause the insurer or State's Medicaid law providesfor or insists on generic substitution. Such a rulewould unsettle bedrock assumptions that haveguided state law in this field for decades. All of theStates have adopted carefully drawn policies ongeneric substitution, which encourage and oftenrequire the dispensing of generic drugs except wherethe patient has a specific medical need for the branddrug. These policies have been a major factor inexpanding demand for generic drugs. The bizarre,disparate liability regime for brand and genericdrugs that petitioners posit would put both healthcare providers and patients in a quandary and wouldcause the confusion and reluctance to acceptbioequivalent drugs that petitioners claim arecritical federal concerns.

In the absence of any indication that Congressintended such a regime, petitioners advancearguments based on Buckman Co. v. Plaintiffs'LegalCommittee, 531 U.S. 341 (2001), and ArkansasLouisiana Gas Co. v. Hall, 453 U.S. 571 (1981)(Ar}?'La) , to th e effect that tort duties of care areincompatible with the FDA's exercise of it s statutoryresponsibilities. Buckman has little if any relevanceto this case. As the Wyeth Court explained inrejecting a similar Buc}?'man-based argument, claimsbased upon traditional common law duties do notresemble the novel "fraud on the FDA" third-partyclaim at issue in Buckman.


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ArkLa and Chicago & North WesternTransportation Co. v. Kalo Brick & Tile Co., 450 U.S.311 (1981), are no more helpful. Like Buckman,both cases entailed attempts to have a state courtoverturn a particular federal agency decision on amatter within the core of th e agency's jurisdiction.Here, petitioners do not attack any FDA decision,and th e agency's approval of an abbreviated newdrug application (ANDA) or its corresponding labelis not a determination that warnings are adequatefor al l time. On the contrary, consistent with thecommon law, the agency requires that warnings bemodified as new risk information develops. Indeed,for reasons Wyeth highlighted, the regime here isnearly the opposite of the "filed rate" approach toutility rate regulation at issue in ArkLa. Tortliability gives regulated parties practical incentivesto take actions - updating warnings to reflect newinformation - that serve core federal safetyobjectives. Those same objectives would beundermined by a "filed-rate" type rule requiringadherence to outdated warnings no matter what thecircumstances.

Equally unavailing are petitioners' efforts toderive general preemption principles claim frombroad language in the Buckman and ArkLa opinions.They worry that state law might "skew" a tacitfederal balance; that a federal standard may be aceiling rather than a floor; or that state law mightlead to unwelcome burdens on federal regulators.But such amorphous concerns are less arguments forpreemption here than for unrestricted preemptioneverywhere, including anywhere the federalgovernment has acted or could have, but did not.


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ARGUMENT1. BROAD CLAIMS OF IMPLIED PREEMPTION

LIKE THOSE ADVANCED HERE AREINCONSISTENT WITH OUR CONSTITIONALFRAMEWORK AND THREATEN TOUNDERMINE STATE GOVERNMENT ANDADMINISTRATIONThe preemption plea at the heart of this case is in

every way extraordinary. Petitioners do not identifyany statutory basis for preemption. Nor do theyseriously argue that Congress considered displacingany state law, including traditional state commonlaw remedies, in enacting the FDCA or the HatchWaxman Amendments. Rather, petitioners invitethe Court to invalidate the laws of fifty States andupset decades of state-level policymaking based on aclaimed "conflict" between the common law dutiesand a disputed agency interpretation of certain of it sregulations indeed, one for which the agency itselfdisclaims preemptive intent or effect.

Under the Constitution and this Court'sprecedents, such claims warrant severe skepticism.Precisely because the Constitution limits the powerto displace state law to "laws of the United States,"i.e., acts that have withstood a carefully craftedlegislative process hedged with safeguards for"States qua States," such claims must clear "a highthreshold." Cade v. Nat'l Solid Wastes Mgmt. Ass'n,505 U.S. 88, 110 (1992) (Kennedy, J., concurring). Alesser standard would undercut "the principle that itis Congress rather than the courts that pre-emptsstate law." Id. at I l l . See also Louisiana Pub. ServoComm'n v. FCC, 476 U.S. 355, 374 (1986) ("[A]nagency literally has no power to act, le t alone pre-


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empt the [law] of a sovereign State, unless and untilCongress confers power upon it."); cf. Alexander v.Sandoval, 532 U.S. 275, 291 (2001) (with "implied"rights of action, "[a]gencies may play th e sorcerer'sapprentice but not the sorcerer himself').

Indeed, insistence on a congressional warrant forpreemption takes on greater significance as judicialenforcement of limits on federal power has ebbed,and th e federal government has not only claimed,but pervasively exercised, authority in numerousareas previously left to the States. See Gregory v.Ashcroft, 501 U.S. 452, 464 (1991) (,,[I]nasmuch asthis Court in Garcia [v. San Antonio l\IIetropolitanTransit Authority, 469 U.S. 528, 550-54 (1985)], hasleft primarily to the political process the protectionof the States against intrusive exercises of Congress'Commerce Clause powers, we must be absolutelycertain that Congress intended such an exercise.");Wyeth, 129 S. Ct. at 1205-17 (Thomas, J., concurringin the judgment).

It is telling that petitioners' amici assert that"only the FDA can see the whole picture." GenericPharm. Ass'n Br. 27-28. But such faith in theperipheral vision of federal administrators ismisplaced. Single-subject administrative agenciesare not empowered to consider, le t alone ac t upon,the broad range of interests and perspectives statelegislatures must weigh. For exanlple, in this case,it is undisputed that compensation for personsinjured by prescription drugs is simply not withinth e FDA's mandate. 1

1 Thus, while the FDA regularly adverts to itsreluctance to intrude on the "practice of medicine" as areason broadly to allow off-label uses of drugs, it is States


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Indeed, al l too often, federal agencies have scantinterest in seeing as much of "the whole picture" asthey could. NSCL's amicus brief in Wyeth describeda stark example: Although Executive Order 13,132("Federalism") (Aug. 4, 1999) requires in the plainestterms that every agency provide to "all affected Stateand local officials" advance notice, and appropriateopportunity to be heard, whenever they "proposeD toact through adjudication or rule-making to preemptState law," the FDA had afforded no consultationand prepared no "federalism impact statement" forthe 2006 regulatory preamble considered in Wyeth.This preamble had purported, for the first time, topreempt tort suits against drug manufacturers. SeeNCSL Br. 2 (explaining that NCSL ExecutiveBranch Liaison had requested, but had been denieda copy of the proposal, on which the FDA acceptedcomments from industry groups); see also Nina A.Mendelson, Chevron and P r e e n ~ p t i o n , 102 MICH. L.REV. 737, 783 (2004) (reporting that "only five"federalism impact statements had been filed "for theover 11,000 final rules" reviewed).

Much of the same may be said of courts. Although28 U.S.C. 2403(b) requires notice to a State'sAttorney General whenever "the constitutionality ofany statute of that State" affecting th e publicinterest is drawn in question," providing the Statewith the litigation rights (far stronger protectionthan the administrative regime applicable, though

that are responsible for oversight of the medicalprofessions - and that have a strong and independentinterest in ensuring that physicians are kept fully up-todate about hazards associated with prescription drugs.


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casually disobeyed, in Wyeth), this rarely, if everoccurs in implied preemption cases.Finally, lax and casual standards for

a d m i n i s t l ~ a t i v e agency conflict preemption createpowerful incentives to bypass Congress entirely,particularly since in Congress where States arerepresented preemption proposals can becontested. Under our federal system, congressionaldebates over the appropriate role for state lawshould be the "main event," rather than a mere"tryout" prefatory to an agency preemption decision.Wainwright v. Sykes, 433 U.S. 72, 90 (1977). Toparaphrase Justice Scalia, "only the most sporting of[industry interest groups]," would run the legislativegauntlet and seek preemption from Congress, ifstatutory silence plus an agency preamble (or brief),or a generalized claim of agency diversion, wereenough to extinguish venerable common law rulesnationwide. See Cipollone v. Liggett Group, Inc., 505U.S. 504, 548 (1992) (dissenting in part).ILPETITIONERS' PROPOSED RULE OF BROAD

IMMUNITY FOR GENERIC DRUGMANUFACTURERS FROM STATE LAWWOULD IMPAIR IMPORTANT STATEINTERESTS AND WOULD DISRUPT STATEHEALTH CARE AND CONSUMERPROTECTION POLICYThe immunity for manufacturers of generic drugs

would have significant adverse consequences for theStates as the principal protectors of their citizens'health, safety, and welfare; as guardians of thepublic fisc; and as licensors and regulators of theirhealth care professionals. Petitioners' rule wouldcreate an odd disparity, invisible an d unfathomableto ordinary consumers, between the legal remedies


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respecting brand versus generic drugs. It would, inpractical effect, make States financially responsiblefor injuries caused by the negligence of a class of forprofit corporations. It would give doctors andpatients incentives not to select cost-saving genericsubstitutes. It would undermine basic premises ofstate legislation concerning substitution of genericdrugs. While petitioners profess concerns abouthypothetical burdens on the federal agency (goingfar beyond even those expressed by the agency), theyentirely ignore the drastic implications their rulewould have for the state-federal balance.A. State Generic Substitution Laws Have Played

an Important Role in the Development ofGeneric Drug Markets and Illustrate theStates' Vital Interest in this Area

Partially in response to the enactment of Medicaidin 1965, an d with the active encouragement of theFDA and the Federal Trade Commission (FTC),every State adopted laws permitting substitution ofgeneric drugs between 1970 and 1984.2 State

2 lVlany States drew guidance from th e FDA's 1979Model Drug Product Selection Act, which encouragedStates to permit pharmacists to select cheaper genericdrug equivalents for brand name prescriptions byreqUIrIng doctors to affirmatively indicate whensubstitution was not allowable. See 44 Fed. Reg. 2932(1979); FTC, Bureau of Consumer Protection, DrugProduct Selection (1979). Twenty-three States adopted oramended their generic drug substitution laws after theModel Act's promulgation. See Kenneth W. Shafermeyer,et aI., The FDA Orange Book: Expectations VersusRealities, 1 J. PRARM. & L. 17 (1991). See also, e.g.,Nevada State Legislature, Background Paper 79-11,Generic v. Brand Name Drugs at 6 (1979).


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"generic substitution" policies have also contributedsignificantly to the dramatic growth in the use ofgeneric drugs.

All the States and the District of Columbia nowhave statutes providing for the substitution ofgeneric drugs when a prescription refers to a branddrug. 3 These laws encourage, and often require, thatpharmacists fill a prescription identifying a branddrug with a medically equivalent, lower-cost generic

3 ALA. CODE 34-23-8; ALASKA STAT. 08.80.295;ARIZ. REV. STAT. 32-1963.01; ARK. CODE ANN. 17-92-503; CAL. Bus. & PROF. CODE 4073; COLO. REV. STAT. 12-22-124; CONN. GEN. STAT. 20-619; DEL. CODE ANN.tit. 24, 2549; D.C. CODE 48-803.02; STAT. 465.025; GA. CODE ANN. 26-4-81; HAW. REV. STAT. 328-92; IDAHO ADMIN. CODE r. 27.01.01.188; 225 ILL.COMPo STAT. 85/25; IND. CODE 16-42-22-8; IOWA CODE 155A.32; RAN. STAT. Al"JN. 65-1637; Ky. REV. STAT. ANN. 217.822; LA. ADMIN. CODE tit. 46, 2511; ME. REV.STAT. ANN. tit. 32, 13781; MD. CODE ANN., HEALTHOcc. 12-504; MASS. GEN. LAws ch. 112, 12D; MICH.COMPo LAws 333.17755; MINN. STAT. 151.21; MISS.CODE ANN. 73-21-117; Mo. REV. STAT. 338.056; MONT.CODE ANN. 37-7-505; NEV. REV. STAT. 71-5403; NEV.REV. STAT. ANN. 639.2583; N.H. REV. STAT. A1'JN. 318:47-d; N.J. STAT. ANN. 24:6E-7; N.M. STAT. 26-3-3;N.Y. EDUC. LAW 6816-a; N.C. GEN. STAT. 90-85.28;N.D. CENT. CODE 19-02.1-14.1; OHIO REV. CODE ANN. 4729.38; OKLA. STAT. tit. 59, 353.13; OR. REV. STAT. 689.515; 35 PA. CONS. STAT. 960.3; R.I. GEN. LAws 5-19.1-19; S.C. CODE ANN. 39-24-30; S.D. CODIFIED LA\VS 36-11-46.1 -46.4; TENN. CODE ANN. 53-10-205; 22 TEX.ADMIN. CODE 309.3; UTAH CODE ANN. 58-17b-605; VT.STAT. ANN. tit. 18, 4605; VA. CODE ANN. 54.1-3408.03;WASH. REV. CODE 69.41.120; W. VA. CODE 30-5-12b;WIS. ADM. CODE DHS 107.10; Wyo. STAT. 33-24-149.


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when one is available unless the prescribing healthprofessional has specifically directed that only thebrand drug be used (often called a "Dispense asWritten" instruction), or (in some jurisdictions) if thepatient refuses substitution. 4 While state lawspreserve physicians' discretion to specify that onlybrand drugs be dispensed, some require an expressdetermination by the prescriber that th e brand drugis "medically necessary,"5 or forbid the pre-markingof prescription forms to preclude genericsubstitution, or require that "brand only"specifications be hand-written.6

4 For example, the Minnesota statute in respondentMensing's case, see J.A. 402, provides that, if the doctorprescribes a brand drug and specifies "Dispense asWritten," or ~ ~ D . A . W . , " the pharmacist shall dispense thespecified brand drug, but that if the prescriber does not sospecify, and "there is available in the pharmacist's stock aless expensive generically equivalent drug that, in thepharmacist's professional judgment, is safelyinterchangeable with the prescribed drug, then thepharmacist shall, after disclosing the substitution to thepurchaser, dispense the generic drug, unless thepurchaser objects." MINN. STAT. 151.21(2), (3). See alsoLA. ADMIN. CODE tit. 46, 2511 (statute at issue inDemahy).

E.g., TENN. CODE ANN. 53-10-204(a)(1) (definingmedical necessity as situations where "[a]n adversereaction previously experienced by the patient to ageneric equivalent" or a generic equivalent "haspreviously been demonstrated as ineffective for thepatient"; or "[a]ny other clinically based prescriberdetermined need").

6 See, e.g., S.D. CODIFIED LAws 36-11-46.2; 22.. illMIN. CODE 309.3(c)(2)(A),(C).


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Recognizing that potential tort liability couldaffect physicians' willingness to allow genericsubstitution, or pharmacists' willingness tosubstitute generic for brand drugs even thoughauthorized by the prescription, many States haveenacted laws shielding health professionals fromsuits for substituting generic drugs in accordancewith state law.7

The generic substitution statutes also attest toStates' interest in ensuring that patients are awareof their options concerning generic substitution.Some States require that prescription forms makeclear whether the physician has directed that onlythe brand drug be dispensed;8 others requirepharmacists to inform patients of lower-pricedprescription options;9 while still others requirepharmacies to post prominent signs informing

7 E.g., RAN. STAT. ANN. 65-1637(c)(2) (physicians);N.Y. EDUC. LAw 6816-a(6)(d); N.D. CENT. CODE 19-02.1-14.1; 35 PA. CONS. STAT. 960.6(B)."). See also ARIZ.REV. STAT. 32-1963.01(G) (pharmacists); ALASKA STAT. 08.80.295(b); MD. CODE ANN., HEALTH OCC. 12-504(h).

8 E.g., WASH. REV. CODE 69.41. 120. ("[T]heprescription must be legible and the form shall have twosignature lines at opposite ends on the bottom of theform. Under the line at the right side shall be clearlyprinted the words 'DISPENSE AS WRITTEN'. Under theline at the left side shall be clearly printed the words'SUBSTITUTION PERMITTED"').

9 E.g., HAW. REV. STAT. 328-92(a) (requiring thatpharmacists, when filling a prescription for a brand drug,"offer the consumer an equivalent generic drug product"upon request, "inform the consumer of the savings," and"[i]nform the consumer of the consulner's right to refusesubstitution").


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customers of their option of filling their prescriptionswith generic a l t e l ~ n a t i v e s . l O

State policies favoring generic substitution aregiven special force in the context of publicly-fundedprograms such as Medicare, Medicaid and StateChildren's Health Insurance (SCHIP). Some genericsubstitution statutes distinguish betweengovernmentally financed health care programs andprivate insurance or self-funding patients. See, e.g.,IND. CODE 16-42-22-8, 16-42-22-10. Many Statesrequire that prescriptions for patients whose drugexpenses are covered by those programs be filledwith generic drugs. l I The Federal government has

lO For example, Connecticut requires each pharmacy topost, on a sign bearing large block letters posted at theprescription counter, "THIS PHARMACY MAY BE ABLETO SUBSTITUTE A LESS EXPENSIVE DRUGPRODUCT WHICH IS THERAPEUTICALLYEQUIVALENT TO TH E ONE PRESCRIBED BY YOURDOCTOR UNLESS YOU DO NOT APPROVE." CONN.GEN. STAT. 20-619 (d). See also FLA. STAT. 465.025(7); IDAHO ADMIN. CODE r. 27.01.01.188; OR. REV. STAT. 689.515.

11 HSince 2000, there has been a steady trend towardincreased mandatory generic substitution. In 2005,nearly all states * * * reported that they require genericsto be dispensed when available." Henry J. Kaiser FamilyFoundation, State Medicaid Outpatient Prescription DrugPolicies: Findings from a National Survey (October2005). See also William H. Shrank, et al., State GenericSubstitution Laws Can Lower Drug Outlays UnderMedicaid, 29 HEALTH AFF. 1383, 1384 (2010) (discussingvarieties of mandatory generic substitution and patientconsent laws affecting state Medicaid progralns); id. at1386 Ex. 1 (table).


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actively encouraged these policies. See, e.g., 42U.S.C. 1396b(z)(2)(E); Office of Inspector General,Department of Health and Human Services (HHS),Generic Drug Utilization in State MedicaidPrograms at i (2006) ("The [HHS] Centers forMedicare & Medicaid Services (CMS) hasencouraged generic drug substitution * * * as a safeand effective way for States to increase generic drugutilization and reduce costs.").

B. Petitioners' Proposed Tort Imm unity forGeneric Manufactures Would SeriouslyUnsettle State Policy

The broad tort immunity sought here would havefar-reaching and problematic consequences for thelaws just summarized, and the important stateinterests and policies these serve. States haveencouraged the substitution of generic drugs becauseof the significant benefits these drugs' lower costsoffer for state citizens, and for state-funded publichealth and insurance programs. They haveproceeded on the premise that (save for unusualinstances of individual medical need), generic drugsare not, from citizens' perspective, materiallydifferent from brand ones, except for the lower price.

Granting the federal law tort immunitypetitioners seek would mean that, contrary toappearances, there is, in fact, a significant butlatent difference between every brand and everygeneric drug from the perspective of doctor andpatient. If a consumer is injured as a result of aninadequate warning on a brand drug, he would haverecourse under state law against the manufacturer.But if the injury was caused by "the same" warningon a bioequivalent generic drug, the injured person


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has no remedy against a manufacturer who knew ofthe danger but did nothing to prevent it .

Such a regime is not only "bizarre" from theperspective of the unwitting consumer, see Demahy,593 F.3d at 449, but it would present seriousproblems for States. The state generic substitutionlaws just discussed - which have been enacted withthe active encouragement of the federal government(and without objection from generic drugmanufacturers) have informed citizens that theyshould not hesitate to accept generic alternatives,even when their doctor has prescribed the branddrug. Often, particularly in the case of poorercitizens under programs like Medicaid, these policiesprovide that they must accept the genericalternative. Similarly, the statutes have encouragedor required physicians to allow generic substitutionunless there is a medical reason for specifying thebrand, and, in many circumstances, have mandatedthat pharmacists fill prescriptions for brand drugswith generic substitutes.

Petitioners' preemption rule would underminebasic premises of this regime. Consumers withoutmedical or pharmacy degrees would be unlikely to beaware of this major disparity between the legalincidents flowing from the choice between brand andgeneric drugs. Out of candor to their citizens) Statesmight well alter their rules, to inform the public ofthat potentially significant disparity betweenproducts they have been repeatedly told are "thesame." .A.nd disseminating the message that"MANUFACTURERS OF GENERIC DRUGSCANNOT BE LIABLE FOR FAILURE TO WARNOF HEALTH RISKS ASSOCIATED WITH THEIRPRODUCTS" could lead some patients at least


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those financially able to do so - to spurn generIcdrugs, undermining the policies of the HatchWaxman Act and state generic substitution lawsalike.

Immunity for manufacturers would also havesignificant repercussions for States in their capacityas regulators of the health care professions. Statelaws shielding physicians an d pharmacists fromliability for allowing or undertaking genericsubstitution reflect the commonsense reality thatlegal liability rules can influence the behavior evenof highly trained professionals concerning the choicebetween medically equivalent drugs. If generic drugmanufacturers are immune, however, some doctorsmay be deterred from allowing generic substitution,knowing that they alone could face liability if ageneric drug caused their patient to suffer injury. Ifthey specified the brand name drug, however, thesituation would be markedly different. Even doctorswho did not share that concern or chose not to act onit might feel qualms about relegating their patientat least without express consent - to a drug whosemanufacturer would be immune from suit when itfailed to disclose information that would haveprevented grievous harm. (Whether such actionwould be permissible under current laws limitingbrand specification to "medical necessity" is unclear.)And, of course, physicians' very ability to treat theirpatients effectively depends upon their receiving upto-date and comprehensive information concernInghealth risks associated with drugs.

Indeed, this calls attention to two very basicembarrassments in petitioners' argument. First,while their plea for preemption depends almostentirely on the notion that Congress or the FDA


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require "sameness" for generic and name-branddrugs, these arguments are made in service of a ruleof permanent difference. Second, the more modestpurposes that "sameness" actually serves in theregime structuring the process by whichmanufacturers make required label changes to warnproperly against newly known risks, to avoidunnecessary consumer confusion would beparticularly undermined. Whatever individualregulators or physicians or insurers decided, theclear, coherent, and largely uniform messageconcerning substitution would be compromised.A rule by which generic drug manufacturers canremain silent despite know edge of serious riskswould impair States' vital interest in promoting thehealth and safety of their citizens, see Wyeth, 129 S.Ct. at 1202-03 ("State tort suits uncover unknowndrug hazards and provide incentives for drugmanufacturers to disclose safety risks promptly"); cfBruesewitz v. Wyeth LLC, No. 09-152, 2011 WL588789 (U.S. Feb. 22, 2011) ("Design-defect torts,broadly speaking, have two beneficial effects: (1)prompting the development o f improved designs, and(2) providing compensation for inflicted injuries.").

Immunizing generic drug manufacturers wouldnot only deprive injured citizens of compensation,but would leave others, often state governments,financially responsible for their care. "[S]tates'traditional authority to provide tort remedies totheir citizens," Silkwood v. Kerr-McGee Corp., 464U.S. 238, 248 (1984), exists not only because thepolitical community's moral concern for it s members'welfare and interest in compensation, but alsobecause, when a person becomes injured or severelydisabled, the State will often bear many of the costs


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of providing medical care, rehabilitation, an d familysupport services.

The immunity petitioners claim simply was notpart of the legal background against which Statesadopted their prescription drug laws, including thegeneric substitution statutes that played such acritical role in promoting the generic drug industry.Had Congress - in 1984, or at any point since -actually proposed to preempt state tort remediesagainst manufacturers of generic drugs, Stateswould have had the opportunity to present theirobjections through their political representatives inCongress, "the principal means chosen by theframers to ensure the role of the States in the federalsystem." Garcia, 469 U.S. at 550, 551 n.11 (citing,inter alia, Herbert Wechsler, The PoliticalSafeguards of Federalism: The Role of the States inthe Composition and Selection of the NationalGovernment, 54 COLUM. L. REV. 543 (1954.12III. PETITIONERS' OBSTACLE PREEMPTION

ARGUMENTS FAILAs an alternative to their conflict "impossibility"

arguments, Petitioners Pliva, et al. and their amiciseek to enlist this Court's "impliedD preempt[ion]"decision in Bucknlan, 531 U.S. at 347, insistingthat reversal here follows from the holding orreasoning of that case an d others, such as Ar/f-ansasLouisiana Gas Co. v. Hall, 453 U.S. 571 (1981)

12 As the statutory regime in Bruesewitz illustrates, onthose rare occasions where Congress decides, in the faceof truly compelling policy concerns, to preempt traditionalState tort law, it typically acts with a scalpel, not a chainsaw.


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(ArkLa) , claimed to rest on the same "principle." Butthese arguments reflect an extravagant misreadingof these decisions. Petitioners' reading violates firstprinciples of this Court's preemption jurisprudence,and would allow the casual, unconsidered overridingof settled state policies in a host of areas, withconsequences as disruptive as those we have justsummarized.

A. Buckman Does Not Support Preemption Here.To begin, contrary to the impression fostered by

petitioner's brief, Buckntan is hardly a milestone inthis Court's federalism and preemptionjurisprudence. It has appeared in a majority opiniononly once, when the Court in Wyeth observed thatthe "dissent's reliance [on it was] * * * especiallycurious," as Buckman had "involved state-law fraudon-the-agency claims," and had expresslydistinguished tort suits involving "health andsafety," 129 S. Ct. at 1231 n.3. The Court inBuckman rebuffed a decidedly non-traditional tortcause of action, ostensibly pleaded underPennsylvania common law, whereunder a personinjured by an FDA-approved medical device couldrecover from a contractor involved in securingfederal approval by showing that the consultant haddeceived the agency. In holding that cause of actionpreempted, Buckman emphasized that ordinarypreemption principles were inoperative, because,unlike claims in cases like Medronic, Inc. v. Lohr,518 U.S. 470, 485 (1996), and Silkwood "based ontraditional state tort law principles" and implicating"federalism concerns and the historic primacy ofstate regulation of matters of health and safety," 531U.S. at 342, "[P]olicing fraud against federal agenciesis hardly 'a field which the States have traditionally


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occupied,'" id. at 347 (quoting Rice v. Santa FeElevator Corp., 331 U.S. 218, 230 (1947. Andwhereas the duties sued upon in the earlier caseswere independent of federal statutes, the novel causeof action in Buckman owed "its existence" to theFDCA. 531 U.S. at 353.

Not only would the "very subject matter" of theclaim in Buckman be defendants' "relationship" andcompliance with requirements governing regulatedparties' "dealings with" th e agency - which the Courtobserved were "inherently federal in character" - buta judgment for plaintiffs would have effectivelyimpugned the validity of the FDA approval decision,see 531 U.S. at 347 (describing allegation that"improperly given market clearance" led to injury).

Buckman contrasted "clear evidence * * * thatCongress intended [these statutory duties to] beenforced exclusively by the Federal Government"with Silkwood, in which Congress had disclaimedinterest in displacing "adequate remedies for thoseinjured." 464 U.S. at 257. The B u c J ~ n ~ a n Court notedthat the tort would intrude on the agency's authorityto determine and calibrate its own response tomisconduct directed toward it by a regulated party,and did so unnecessarily, given the manifold waysthe "federal statutory scheme amply empowers FDAto punish and deter fra ud against theAdministration," 531 U.S. at 348.

To summarize the Buckman decision is toappreciate why the case does not support thepreemption claim here Unlike the exotic theory ofrecovery there, th e duties on which the plaintiffs'claims are based are ones traditionally imposedunder state common law. See 531 U.S. at 352(""Silkwood's claim was not based on any sort of


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fraud-on-the-agency theory, but on traditional statetort law principles of the duty of care").13 AccordWyeth, 129 S. Ct. at 1195 n.3. Respondents' claimshere do not "exist solely by virtue" of federalrequirements, Buckman, 531 U.S. at 353(distinguishing Lohr, 518 U.S. at 481), and thegravamen of those claims is not to "police" the"relationship" between federal agencies andregulated entities. Instead, respondents seek onlycompensation for a breach of traditional common lawsafety duties running from the manufacturer of aproduct to an injured consumer. Federal law, andthe federal agency, enter the picture not becausethey are the font (let alone the sole source) of theplaintiffs' claim, bu t because the defendant hasasserted that a verdict could be inconsistent withfederal obligations. And there is no claim here thatthese suits impinge on the FDA's discretion inresponding to misconduct in regulated entities'"dealings with" the agency. See Holmes v. Sec.Investor Prot. Corp., 503 U.S. 258, 269-70 (1992)("[D]irectly injured victims can generally be countedon to vindicate the law * * * without any of the

13 Indeed, at oral argument in B u c l ~ n t a n , the UnitedStates, which took an aggressively pro-preemptionposition) acknowledged that traditional common lawclaims were not preempted: "The fraud claim ispreempted, but if there is negligent design, negligentmanufacturing, failure to warn, common law malpractice,all of those claims are available, but insofar as they wouldbe asserting an essential element of the claim would bethat the FDA was defrauded, that is an area of exclusivefederal concern, an d the State common law cause ofaction would be preempted." No. 98-1768, Tr. at 21(emphasis added).


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problems attendant upon suits by plaintiffs injuredmore remotely."). To the contrary, federal lawprovides that a generic drug misbranded if thelabel lacks adequate warnings of a serious risk forwhich there is reasonable evidence of an associationSee 21 U.S.C. 352(f)(2), 21 C.F.R. 201.57(e). Ifpresented with a recommendation to cure an existingsituation of misbranding, the FDA would surely act.

Perhaps most fundamentally, the claims here,unlike those in Buckman and ArkLa, do not entailany sort of collateral attack on an agency action ordecision. Here, the plaintiffs do not complain thatthe FDA's approval of the l ~ D A for Reglan, or ofANDAs for metoclopramine, were invalid or harmfulor the cause of their injuries. See Buckman, 531U.S. at 347 (claim that "improperly given marketclearance" led to injury); Altria Group, Inc. v. Good,129 S. Ct. 538, 549 (2008) (explaining that claimsheld preempted in Riegel v. Medronic, Inc., 552 U.S.312, 336-37 (2008), had "sought to impose differentrequirements on precisely those aspects of the devicethat the FDA had approved"); Williamson v. MazdaMotor of Am., Inc., No. 08-1314, 2011 U.S. Lexis1711 at *16-*22 (distinguishing Geier v. Am. HondaMotor Co., 529 U.S. 861 (2000.

Respondents here claim that defendants'adherence to a label that failed to warn of risks thatbecame known post-marketing was irresponsible andharmful, in violation of duties state law (as well asthe FDCA) has long imposed. The FDA denies thatit s approval of respondents' drugs (or labels) may betreated as its judgment of adequacy for all times.Indeed, Wyeth settles that responsibility for the label(and for adequate warnings) is the manufacturer's,not the agency's, and that the federal labeling


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obligation (like the state warning duties) depend onthe hazards currently known, not those at the time ofthe agency's NDA or ANDA decisions. See 129 S.Ct at 1197-98.

These fundamental differences also explain whyArkLa and Kalo Brick lend no support forpreemption here. Both those decisions arose fromstate court suits that sought to attack decisions offederal agencies on matters over which Congress hadgiven the agencies "exclusive and plenary" authority.Kalo Brick, 450 U.S. at 321. In Kalo Brick, a shippersought to recover under Iowa law for damagesresulting from an interstate railroad's decision toabandon track action the Interstate CommerceCommission specifically considered and approved. Inholding the suit preempted, the Court emphasizedthat the "exclusive an d plenary nature of theCommission's authority to rule on carriers' decisionsto abandon lines [was] critical" to a congressionalscheme developed after "'[m]ultiple control' ha[d]proved 'detrimental to the public interest,'"describing the suit as "little more than an attemptby a disappointed shipper to gain from the Iowacourts the relief it was denied by the Commission."Id. at 320, 324. Even under these circumstances, theCourt took care to assure itself that preemptionwould "not leave a shipper in respondent's positionwithout a remedy if it is truly harmed." ld. at 331.

ArkLa applied an even more venerable rule ofplenary federal agency jurisdiction: the "filed ratedoctrine," which forbids parties subject toadministrative rate regulation, such as the naturalgas producer in ArkLa (which was regulated by theFederal Power Commission) from collecting rates


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other than the one "filed" and approved by theagency. 453 U.S. at 573.Although th e FDA regime here and the one in

ArkLa may bear a superficial similarity the FPCapproved Hall's rate, and FDA approved petitioners'labels they are actually in relevant respects polaropposites: The premise of the "filed rate doctrine"(and the holding of Arl'lLa) is that a final agencyjudgment of reasonableness may not be revisited(even by the agency itself); in contrast, it is aviolation of the federal statute here (as well as of thecommon law) to continue to give agency-"approved"warnings once the manufacturer possesses drug riskinformation showing they are inadequate, see 21C.F.R. 201.57(e).

The premises of and purposes served by theunusually stringent rate doctrine are also strikinglydifferent: strict enforcement of publicly-filed rates isessential to combating a primary "evil" againstwhich those laws are directed price discrimination,collecting differing rates from similarly-situatedcustomers. And the stringency of the doctrine worksagainst regulated parties, like the gas seller inArkLa, holding them to arrangements they made andrepresented to the agency were "reasonable" (but didnot turn out well) until they file and obtain agencyapproval for more favorable ones. Thosedisadvantaged by inadequate drug labels, incontrast, are blameless members of the generalpublic, whose bodily injuries could have beenprevented through due care.

While a filed-rate regime gives those regulatedstrong incentive to file and seek approval of higherrates as soon as they become aware of changedcircumstances that would make those "reasonable,"


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the incentives here, as Wyeth recognized, are whollydifferent: Labels (accurately) warning consumersand physicians that products are more dangerousthan currently represented - an d may safely be usedonly for weeks instead of months - are not inregulated parties' commercial interest. A regimethat allowed generic manufacturers a completedefense based on the inaction of a brand-namemaker, even when the generic company is wellaware of the deficiency (and even when, as withsome 32% of drugs, the brand-name company hassimply left the field, see Resp. Br. at 20 & n.24) iseven further from the core safety purposes of thestatute. Of course, th e "harshness" of finality rulesof the sort in ArkLa, which hold regulated parties tothe economic consequences of their own decisions, isnot readily compared to that of a regime that wouldlead to unnecessary, irreversible physical harm formembers of th e public the safety regime is meant toprotect. See Burnet v. Cornado Gas Co., 285 U.S.393, 406 (1932) (Brandeis, J., dissenting) (ineconomic regulation, it is more important that amatter be "settled than that it be settled right").

This case would be closer to ArkLa if, instead ofrelying on FDA's initial approval of their ANDA(subject to modification as new risk informationemerged), petitioners were seeking preclusion basedon an actual agency decision - , a ruling against acitizen petition by generic manufacturers seekingapproval of warnings reflecting the later-developedinformation suggesting that the risk of tardivedyskinesia had been significantly understated andthat prolonged use is more dangerous than firstrecognized. But that is not what happened. Herethere is no such agency decision to impugn; and no


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claim that petitioners did other than sit on theirhands.

To be sure, petitioners' efforts to more accuratelywarn the public could ultimately meet with FDAdisapprovaL Like the manufacturer's argument inWyeth, however, that argument confuses thestatute's primary requirements and objectives -adoption of currently adequate safety warnings byal l manufacturers - with the particular proceduresthe agency has adopted for accomplishing them, inan orderly fashion to prevent undue confusion. Andas in Wyeth, there is no reason here to assume (letalone any evidentiary basis for concluding) that theagency would have stood in petitioners way. Cf. Ricev. Norman Williams Co., 458 U.S. 654, 659 (1982)("The existence of a hypothetical or potential conflictis insufficient to warrant * * * pre-emption").Indeed, in this case, the FDA, eventually ordered anew, "black box" label for this drug.

These cases do not ask a state court (or federalcourts applying state law) to overturn or impeachany FDA decision. Moreover, Congress did notprovide that the FDCA is an "exclusive form ofregulation" for drug warnings. As Wyeth affirms,this is an area in which state and federal law havecoexisted for generations, and federal law has neverattempted to install federal remedies for personsinjured as a result of defective warnings.

B. Petitioners' Efforts to Invent Sweeping NewImplied Conflict Preemption Doctrines Basedupon Language from Buckman Should BeRejected

Rather than acknowledge differences that arefundamental, petitioners and anlici seek to extract


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language in Buckn1an, ArkLa and Kalo Brick fromthe context in which it appears. They attempt toderive a set of preemption "principles" strong enoughto be availing here, arguing that any tort claim thatentails consideration of an agency decision to act ornot to ac t is preempted. They extend this argumentto any decision that has the potential to incidentallyresult in "additional burdens" on an agency or it spersonnel, Pliva Br. at 30 (quoting Buckman, 531U.S. at 351) - or "interfere" with what could beconsidered an agency decision not to act ispreempted. But the "rules" they identify arecontrary in multiple central reRpects to controllingprecedent, and ignore basics of the relationshipbetween federal and state law.

First, what petitioners would deride as"speculation," Pliva Br. 48-49 considering whatwould have happened is no incident of an exotictort cause of action; it is a feature inherent incommon law litigation (indeed, virtually alllitigation). Their suggestion that Buckman, Arkla,and Kalo rest on a categorical rule against any statelaw consideration of federal agency activities simplywishes away the critical common feature of thosecases. All involved collaterally attacking an agency'sdecision on a matter within it s exclusive, plenaryjurisdiction. 14 Indeed, the expansive reading of

14 While the attack in Bucl?man was not presented asan attack on the substance of the agency'sdecisionmaking, the claim concerned a subjectresponding to fraud no less within the aggrievedagency's primary jurisdiction, see 531 U.S. at 349 n.3, andthe judgment sought would have necessarily implied theinvalidity of the agency's action approving the device.


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those cases cannot survive Wyeth, where preemptionwas rejected though the plaintiffs ultimate ability torecover in tort (the same tort as here) depended onessentially the same issue raised here: whether theagency would have approved a label with warningsthat accurately reflected currently known risks. Thefact that this question could or would enter a court'sanalysis did not warrant preemption there, an d itdoes not make federal regulation a "critical element"in the sense meant by Buc/'lman. As noted,Buc/'lman involved duties running to the agency andthe entire cause of action owed its existence tofederal law.

Petitioners' only response - the only one possibleis that brand-name manufacturers may

provisionally change labels pending FDA approval,whereas (they say) generic manufacturers mustobtain approval first,- meaning that the questionarises as part of plaintiffs' case in chief an d istherefore an "element." Pliva Br. 50-54. But this isuntenable for several reasons.

At the outset, it would be a strange rule ofobstacle preemption that distinguished between twocauses of action that entail courts' undertaking thesame inquiry - whether the federal agency wouldhave approved a safer label. And the extent to whichthe statute or agency regulations constrain genericmanufacturers' powers to take "unilateral"(temporary) action to give warnings is itself adisputed question. (Though the agency advances asomewhat narrower understanding of powersretained by generic manufacturers than dorespondents, it does so in the context of expresslydisclaiming preemptive effect or intent for itsinterpretation).


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But even if petitioners' account were accepted, itonly highlights internal tensions basic to theirposition. It simultaneously emphasizes the formaldistinction between the "elements" of a cause ofaction (as against defenses) while at the same timedenying any significance to the contours of theactual state laws (of Louisiana and Minnesota)under which respondents sued. Indeed, it wouldpresumably be within the state law's ken to allowplaintiffs to carry any proof burden by relying on apresumption, stated in Wyeth and grounded inexperience as well as statutory text, that the FDAwould not have disapproved more accurate andeffective warnings. See 21 U.S.C. 352(f)(2), 21C.F.R. 201.57(e).

Federal courts - even this Court are notauthoritative expositors of state law, and it would besurprising for categorical preemption rules to dependon federal determination of what qualifies as an"element" for pleading a state tort cause of action.Neither federal action nor "exclusively" federal lawplays a role remotely like in Buckman, whereplaintiffs were third parties seeking to enforceparticular duties owed only to the federal agency inthe context of a prior presumptively-valid agencydecision. The Court recognized that explicitly,explaining that some, but not every, federal lawduties can be sued upon distinguishing betweenregulations that parallel common law duties to thepublic and those running to the agency. 531 U.S. at353.

Worse still for petitioners, their logically (if notlegally) conceivable basis for distinguishing this casefrom Wyeth is fatally inconsistent with their relianceon the position taken by the United States in


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Warner-Lambert Co. v. Kent, 552 U.S. 440 (2008)(per curiam affirmance by equally divided Court). Inthat case, one primary argument against preemptionwas that the issue of fraud on the agency only arosein the course of overcoming a defense, see Louisville& N.R. Co. v. Mottley, 211 U.S. 149, 153 (1908), andthe government as amicus argued that thecompliance defense would be readily made out inevery case so the real issue in cases under theMichigan law would be the same as in Buckman.See U.S. Kent Amicus Br. at 31 (asserting thatdistinction between '''element' and . . . 'affirmativedefense' [is] "immaterial" and that "no reason" why"label would matter" under Buckman); cf. Grable &Sons Metal Prods., Inc. v. Darue EngfJ & Mfg., 545U.S. 308, 320 (2005) (allowing federal jurisdictionover state-law claim with "dispositive and contestedfederal issue at [its] heart").

Of course, the arguments pressed in that brief areof no more legal or precedential significance thanthose the same agency advanced - without successin Wyeth; indeed, there was a substantial overlapbetween th e two. See U.S. Wyeth Amicus Br. 25-26,and the Executive Branch has since taken amaterially different view of these questions, seeMemorandum on Preemption, 2009 Daily CompoPres. Doc. 384, at 1 (May 20, 2009); Riegel, 552 U.S.at 327 ("The agency's earlier position *** is evenmore compromised, indeed deprived of all claim todeference, by the fact that it is no longer the agency'sposition.").

But accepting the Solicitor General's position inKent would not entitle petitioners to prevail here. Inthat case, the government argued that,notwithstanding the source of the duty enforced, the


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express focus on fraud against the FDA interferedwith the '''inherently federal'" relationship betweenthe agency and regulated parties, so that, underBuellman, the presumption against preemption didnot apply. U.S. Kent Amicus Br. at 15. Here, bycontrast, respondents' state-law claims do notrequire them to prove the FDA was defrauded; thefocus is on whether the defendant had informationabout serious health risks associated with it sproduct. The state law theory does not require acourt to revisit and scrutinize a past agency decisionand declare it tainted. And the claim here,unquestionably, is subject to the presumptionagainst preemption.

Petitioners' other arguments depend on takingstatements the Bueknlan opinion offered in supportof it s limited, unexceptionable holding as thebuilding blocks for a preemption regime entirelyunencumbered by principles settled in controllingdecisions of this Court, including recent andunanimous ones. Of course, assertions that leavingstate law claims unpreempted would "impose" costsor exert "extraneous pull" (Pliva Br. 61) (quotingBueknlan, 531 U.S. at 353), entail tightly circularreasoning: the "pull" of state tort liability is"extraneous" only if Congress's had in fact intendeda "scheme" of field preemption. Compare Wyeth, 129S. Ct. at 1202 (describing "state law as acomplementary form of drug regulation"); seegenerally Gade, 505 U.S. at 110 (Kennedy, J.,concurring) (argument that "assumes that Congressintended exclusive federal jurisdiction" is "not anapplication of our pre-emption standards *** but aconclusory statement of pre-emption").


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And the unanimous decision in Williamson,refusing preemptive effect to an agency decision notto impose a requirement, definitively inters thenotion that every instance of agency inaction may betreated as a "delicate balance" that state law maynot "skew." See Williamson v. Mazda Motor of Am.,Inc., No. 08-1314, 2011 U.S. Lexis 1711 at *20 (U.S.Feb. 23, 2011) (to "infer from the mere existence of[agency] cost-effectiveness judgment" a bar to statelaw would impermissibly "treat all such federalstandards as if they were maximum [s]"). See alsoAltria Group, 129 S. Ct. at 551 n.14 (refusing to relyon agency inaction to support preemption claim"when that inaction is in part the result of the[defendant's] failure to disclose study results"),

As for claims of burdens on agencydecisionmaking or personnel, these are surely selfserving an d doubtful on their own terms. It cannotbe the law that any development in state law thatmight have the effect of encouraging prospectivedefendants to provide more information to or seekmore discovery from federal agencies - a factor thatcertainly could arise in many a products liability,environmental, or state consumer protection case,among others serves as a basis for deeming suchstate claims preempted. See, e.g., Bates v. DowAgrosciences LLC, 544 U.S. 431, 443 (2005) ("quitewrong" to treat changes a verdict might "'induce'" asa "requirement"). Even when pressed by federalofficials, such assertions do not merit - or receive -uncritical acceptance: "mere 'administrativeconvenience,'" Frontiero v. Richardson, 411 U.S. 677,688 (1973), is not a transcendent constitutionalvalue, and in Clinton v. Jones, 520 U.S. 681 (1997),the Court resisted claimed distraction as a basis fora discretionary postponement of a trial against the


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President of the United States, declining to credit a"predictive judgment" of "a deluge of * * * litigation,"noting that other "[s]itting Presidents haveresponded to court orders to provide testimony andother information." Id. at 704. See also Gonzales v.o Centro Espirita Beneficente U.D. v., 546 U.S. 418,435-36 (2006) ("The Government's argument echoesthe classic rejoinder of bureaucrats throughouthistory": If I make an exception for you, I'll have tomake one for everybody, so no exceptions").

The arguments from deluge an d distraction hereare stranger still. First, the federal agency thatpetitioners claim to protect does not agree that anykind of broad preemption is required on that basis.Moreover, the "information deluge" they warnagainst is not so much a prediction as a threat. Inpractice, the premise that more information is a goodthing, see Thompson v. Western States Med. Ctr., 535U.S. 337, 375 (2002), applies when the subjectmatter is late-emerging information concerningserious safety hazards of consumer products. Ifpetitioners and others did in fact flood the agencywith useless information, there is every reason toassume the FDA has ample tools at its disposal,short of nationwide preemption of state law remediesfor injured parties, to manage the quantum of whatis submitted.

Indeed, the notion that a potentially increasedinflow of "unwanted" information or incidentaldistraction of federal agency personnel could be aserious argument in favor of displacing a vast swathof traditional state law and policy is an index of howfar petitioners' claims stray from the core principlesof federalism undergirding this Court's preemptiondoctrine - and of how important it is to guard


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against expansive, causal claims of "impliedpreemption."

ConclusionThe judgments of the courts of appeals should beaffirmed.

Respectfully submitted,Susan Parnas FrederickFederal Affairs CounselNATIONAL CONFERENCE OFSTATE LEGISLATURES

444 N. Capitol St., NWSuite 515Washington, DC 20001Edward BlizzardJ. Scott NabersBLIZZARD, MCCARTHY& NABERS, LLP440 Louisiana, Suite 1710Houston, TX 77002

Sean H. DonahueCounsel ofRecord

DONAHUE & GOLDBERG, LLP2000 L St., NW, Suite 808Washington, DC 20036(202) [email protected] T. GoldbergDONAHUE & GOLDBERG, LLP99 Hudson St., 8th FloorNew York, NY 10013Andy BirchfieldBEASLEY, ALLEN,CROW, METHVIN,PORTIS & MILES, PC234 Commerce St.P.O. Box 4160Montgomery, AL 36103

09-993, 09-1039, 09-1501 bsac national conference of state legislators

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