*1 PLIVA, INC., MENSING et al. v. Argued 23,
No. 09-993. March 2011 Decided June 2011* Elizabeth, *Together Mensing, LLC 09-1039, Actavis with No. also Actavis, v. Demaky, Inc. court, certiorari the same No. on certiorari to the Appeals United Court of the Fifth Circuit. States *3 Jay P. in all for petitioners the cause argued Lefkowitz 09-993 for No. petitioners eases. With him on briefs Joseph Shwmsky, Philippa Scarlett, P. D. Michael were Oetheimer, Jonathan A. Thomas, Maichl, E. Richard Linda Schultz, B. Sheehan. William Price, L and William F. Keyse-Walker, A. Dean Richard Irene C. filed for briefs 09-1501. in Nos. 09-1039 and petitioners Bograd M. Louis in all for respondents the cause argued McLaren, were Lucia J. W. him on the brief cases. With Claire, Tonry Me,Glynn, A. Preste,l, Richard J. Daniel Glorioso, Kristine K. Sims. Brian L.
Deputy Kneedler Solicitor General the cause for argued curiae the United States as amicus support respond Acting Solicitor General were on the brief ents. With him Benjamin Katyal, Attorney West, J. Har- General Assistant Swingle, Ralph Tyler, Douglas S. wich, Letter, N Sharon Blumberg.† M. and Eric Apo in all eases were filod of amici cwriao urging †Briofo reversal *4 Untcrcincr, Fitzpatrick Inc., Roy Jr., Charles A Englert, T. Alan
tex, by Upadhye; for Generic III, Keppel, B. Pharma Arthur and Shashank Austin, Armstrong, and Melissa Evan A Earl B. by ceutical Association N. Pharmaceuticals, Inc., by et al. Young; and for Morton Grove Steffen Johnson, P. Ferranti. Hurst, James F. and William for in all casco wore filed Briefs of amici mriao affirmance urging Swanson, of Attorney General by Minne- Lori of et State Minnesota al. Gilbert, Garry, General, and John S. At- I. Assistant Alan sota, Solicitor Nathan, Attorney of the Acting General Dis- torney General, by Irvin B. Jr., Acting Attorney General of Ryan, H. Columbia, William trict of and respective States as Attorneys for their Pennsylvania, by General and opinion Court, Thomas delivered the ex of Justice cept as to Part III-B-2.* These consolidated lawsuits involve state tort-law claims alleged pro- on certain based manufacturers’ failure to Strange Alabama, fcllows: Luther Alaska, John J. Burns of Thomas 0. of Horno of Arizona, Dustin D. McDaniol of Kamala Arkansas, Ha/rrio of California, John W. George Jepsen Suthers Colorado, Connecticut, of of Joseph R. III Bidón Delaware, Hawaii, David M. Louie of Lawrence G. of Madigan Wasden Lisa of Idaho, Gregory F. Zoeller of Illinois, Indiana, of Tom Conway “Buddy” Miller Jack of D. Iowa, of Kentucky, James Cald- Maine, Douglas well of F. Louisiana, William J. Schneider of Gansler of Coakley Massachusetts, Maryland, Martha Jim Hood of of Mississippi, Chris Kootor Missouri, Bruning StovoBulloch of Jon Montana, of of Ne- braska, Catherine Cortes Nevada, Delaney Masto Michael A. of of New King Carry K. Hampshire, Erie T.Sehneiderman of New Mexico, of New York, Roy Cooper Wayne Stenehjem Carolina, Dakota, of North of North Ohio, Michael E. Scott DeWine Pruitt of Peter F. Kilmartin Oklahoma, of of Marty Jackley Alan Wilson of J. Island, Carolina, Rhode of South Jr., Dakota, Cooper, Robert E. Tennessee, South Shurtlejf Mark L. of of Utah, William H. Sorroll M. Vermont, Robert McKenna of Washington, McGraw, Jr., Darrell V. J. B. Van Hollen Wisconsin, Virginia, West Salzburg A Bruce and of Wyoming; for Administrative Law and Civil Reinert, Rice, Joseph Alexander A F. by Procedure Scholars and Fred III; Thompson by Mindy for the American Association for Justice Mi Roth; by Douglas chaels for the T. ability Constitutional Account Center Kendall and Wyd/ra; Elizabeth B. for the Conference of National State Donahue, Legislators by Goldberg, Andy Sean H. Birchfield, David T. Bdnnnrd J Blizzard, Habers; and Scott by et at. Adino. for Public Citizen Rosenbaum, H. Ziovo, M. Vignory; Mary Allison and Bruce for J. Davis F. Sturley; by et al. Jaffe, Michael Erik S. Christy by for John Graves Williams, Jr., Boundas; Eddie and John T. for Jerome P. et Kassirer al. by Collyn Peddie, Relkin, Jr., Robinson, Ellen P. A Mark and Karen Menzies; Barth M. for Sobol by Mare T. et Thomas Lauren Law al. Barnes; G. Henry Massey S. Rep. Jonathan by A. Waxman Moody, Willard J. Jr. Briefs of amici curiae were filed in all for the American Medical cases by Jay Henderson, Faust, Association et al. Cooper, R. Brent Diana L. Wilcox; P. Donald Against and for the National Censorship Coalition Arkin, Erwin Chemerinsky, Bijan Esfandiari, J. Sharon and Joan E. Berlin. Kennedy joins *Justxce opinion. all but III-B-2 of this Part *5 metoelopramide. warning adequate labels for vide drug regulations question presented is whether federal The directly generic drug applicable conflict manufacturers pre-empt, claims. state-law hold with, thus these We and they do. that
I Metoelopramide drug speed designed to the movement ais system. Drug digestive through The Food and of food (FDA) metoelopramide approved tab- Administration first years Reglan, 1980. Five lets, under the brand name began producing meto- also later, manufacturers commonly drug digestive clopramide. used treat problems gastroparesis gastro- tract such as diabetic esophageal reflux disorder. metoelopramide long-term
Evidence has accumulated dyskinesia, neurological a severe disor- use can cause tardive up patients to 29% of have shown that who der. Studies years develop metoelopramide this condition. take for several (CA5 2006); 364, 370, F. n. see also McNeil v. 462 3d Mackey, Dyskinesia & Tardive Shaffer, Butterfield, Pamer, Metoelopramide Before and After U. Mar- S. Risks Use Cisapride, 44 J. Am. Pharmacists ket Assn. Withdrawal (2004) (noting metoclopramide-related 87 cases dyskinesia reported FDA’s adverse event re- tardive mid-2003). porting system
Accordingly, warning have been labels strengthened In 1985, times. label clarified several “[tjardive dyskinesia may . .. to warn that was modified metoelopramide,” develop patients and the treated with “[tjherapy longer drug’s package than insert added be and cannot recommended.” been evaluated weeks has not (41st 1987); Physician’s 1635-1636 ed. see Reference Desk (hereinafter et 21-22 al. Brief for Petitioner PLIVA also Brief). Reglan manufac- PLIVA In the brand-name requested, approved, a label turer the FDA “[t]herapy 12 weeks in exceed duration.” add that should *6 (hereinafter Brief for 8 United States as Amicus Curiae Brief). And in U. S. the FDA ordered black 2009, box warning strongest “Treatment with met- states: —its —which oclopramide dyskinesia, can cause tardive a serious move- ment disorder is often irreversible. . .. Treatment with metoclopramide longer for than 12 weeks should be avoided Physician’s in all but rare cases.” See Desk Reference 2902 2011) (65th Box). (Warning ed.
Gladys Mensing Demahy, plaintiffs and Julie in these prescribed Reglan cases, consolidated were 2001and 2002, respectively. generic metoclopramide Both received from pharmacists. drug prescribed taking their After for years, dyskinesia. developed several both women tardive separate Mensing Demahy In suits, and sued the produced metoclopramide they manufacturers that (Manufacturers). alleged, took Each as relevant here, that long-term metoclopramide dyskinesia caused her use tardive and that the Manufacturers were liable under state tort law Louisiana) (specifically, failing that of Minnesota and provide adequate They warning labels. claimed that “de- mounting spite long metoclopramide evidence that term use dyskinesia greater carries risk of tardive far than that indi- changed cated label,” on the none of the had Manufacturers adequately danger. Mensing labels warn of that v. (CA8 2009); Inc., Demahy 588 F. 3d 605 see also (CA5 2010). Actavis, Inc., 3dF. In urged suits, both the Manufacturers that federal law pre-empted According the state tort claims. to the Manu- regulations facturers, federal required statutes and FDA safety efficacy labeling them to use the same and as their counterparts. they argued, brand-name This means, that it impossible simultaneously comply was with both federal any duty required law and state tort-law them to use a different label. Appeals Eighth Courts for the Fifth and Circuits
rejected arguments the Manufacturers’ and held that Men- pre-empted. Demahy’s See 588 sing claims were granted certiorari, We at 449. 614; 3d, F. 3d, F. (2010), cases, now reverse consolidated
U. S. each.
II compare analysis requires Pre-emption us to federal by identifying begin tort state law. We therefore applicable labeling requirements to the duties Manufacturers.
A *7 undisputed law Louisiana tort re- and It is that Minnesota quire drug aware of that is or should be its a manufacturer way product product's danger in a renders that label that to applies reasonably law, which to Under Minnesota it safe. product Mensing’s a manufacturer ... of lawsuit, the “where danger knowledge of to users, has actual or constructive duty warning give of such dan- . . manufacturer has a . Frey gers.” Montgomery Co., 782, & 258 N. W. 2d Ward v. (Minn. 1977). applicable Similarly, law under Louisiana 788 duty Demahy's warn in- lawsuit, “a manufacturer's adequate duty provide instructions for use safe a cludes Corp., product.” Pharmaceuticals a v. Novartis Stahl (CA5 2002); also see La. Rev. 254, 283 F. 3d 269-270 2009). (West duty § States, In both Ann. 9:2800.57 Stat. specifically See v. Marks the manufacturer. warn falls (La. 3/31/04), App. pp. 3 Cir. 8-9 OHMEDA, Inc., 2003-1446, Corp., Gray Badger 676 Min. N. W. 1155; 871 2d v. 1148, So. (Minn. 2004). 274 268, 2d pleaded Demahy that Manufactur-
Mensing and have high of tardive of the risk known ers knew or should have product. long-term dyskinesia in the use of inherent They or pleaded knew the Manufacturers also have adequately warn not did known that their labels should have parties App. do 67-69, 94-96. 437-438, of that risk. 612 dispute allegations true,
not if these are that, required different, the Manufacturers to safer label. use
B drug imposes complex labeling Federal law far more re- quirements. begin dispute. We with is what Under Drug Drug, Food, Amendments to the Federal seq., 76Act, 780, Cosmetic Stat. U. S. C. et a manu- seeking approval drug facturer to market a new prove proposed must that it is safe and effective adequate.1 g., label See, accurate and e. U. S. C. §§355(b)(1),(d); Wyeth (2009). S. Levine, Meeting requirements costly lengthy those involves clin- §§355(b)(1)(A),(d); testing. ical Beers, see also D. Generic Drugs: Approval Require- and Innovator A Guide to FDA (7th 2008). §2.02[A] ments ed.
Originally, applied drugs. the same rules to all In 1984, Congress passed Drug Competition however, Price commonly Patent Term Act, Restoration 98 Stat. called “generic Hatch-Waxman law, Under this Amendments. drugs” gain approval simply showing can equiva- FDA already ap- lence to reference listed that has been proved by §355(j)(2)(A). the FDA.2 21 U. S. C. This allows *8 develop generic drugs manufacturers inexpensively, duplicating already performed without the clinical trials equivalent drug. generic on the drug appli- brand-name A [safety efficacy] cation must also “show that the and label- ing proposed labeling approved ... is the as same the 1All relevant predate events Drug cases the and these Food Adminis tration 2007,121 Amendments Act of We therefore Stat. 823. refer exclu sively to prc-2007 the regulations statutes cjcpress and and no view the impact of the 2007 Act. 2 here, “generic drug” drug As we use it designed refers to be a copy of a drug drug), reference (typically listed name brand and thus efficacy. See, e.g., safety, identical in aetive ingredients, and United CFR, Drug States Generix v. Corp., 460 U. S. 453, (1983); 454-455 21 314.3(b) (2006) § (defining drug”). “reference listed §355(j)(2)(A)(v); drug.” see also [brand-name] for the §§ 3.03[A]. supra, §355(j)(4)(G); 3.01, Beers, drug generic manufacturers result, As a brand-name labeling drug A brand-name duties. federal have different responsible drug approval is for seeking new manufacturer g., 21 S. accuracy adequacy See, e. U. C. label. of its the (d); Wyeth, §§ A 355(b)(1), supra, manufacturer at 570-571. respon- generic approval, hand, other is seeking drug on the warning as ensuring the the label is same for its sible §355(j)(4)(G); 355(j)(2)(A)(v); e.g., See, name’s. brand 314.127(a)(7). 314.94(a)(8), §§ CFR dispute disagree. parties is What is
The do not may generic manufacturers extent, whether, and to what Mensing approval. FDA initial labels after provided Demahy several avenues contend that federal through have altered their could which the Manufacturers injuries prevent metoclopramide here. labels in time interprets regulations its it however, tells us that FDA, drug require warning aof brand-name labels always copy thus, be the must its same — duty ongoing of "same- an manufacturers have (1992) Reg. 57 Fed. see also 16; ness.” S. Brief (“[T]he labeling drug’s] be the [generic must same drug product labeling drug product’s the listed because listed [generic drug] approval”). The FDA’s views is the basis inconsistent, with plainly or “controlling are unless erroneous any regulation^]” reason to doubt that other or there judgment. they Auer fair and considered reflect the FDA’s (1997) (internal quotation 461, Robbins, U. S. v. omitted).3 marks represents views of the FDA. States The brief filed the United Co., ante, Telephone 1. America, Michigan Bell n. Inc.
Cf. Talk interpretation regulations, its do agency’s we Although defer to we about whether otate law concluoion ageney’o *9 not defer to an ultimate (2009). Levine, 555, U. S. Wyeth pre-empted. 555 576 be v. should Mensing Demahy urge First, the FDA’s (CBE) “changes-being-effected” process allowed Manu- change necessary. facturers to their labels when See Brief Respondents 33-35; 3d, see also 593 F. at 439-444; Gaeta (CA9 Perrigo Co., 1225, Pharmaceuticals F. 3d 2011); Corp., Foster v. American 3d 165, Home Prods. F. (CA4 1994). process drug permits The CBE manufac- strengthen warning, [or] turers or to “add a contraindication, 314.70(c)(6)(iii)(A) § (2006), precaution,” 21 CFR or to “add strengthen dosage or an instruction about and administra- tion that drug produet,” is intended to the safe use of increase 314.70(c)(6)(iii)(C).
§ making labeling When changes using process, the CBE manufacturers need preapproval by ordinarily not wait for FDA, which necessary Wyeth, supra, They a label. at 568. only simultaneously supplemental application need file a with 314.70(c)(6). § the FDA. 21 CFR The FDA denies that the Manufacturers could have used process unilaterally strengthen warning CBE agency interprets regulation labels. The the CBE to allow changes generic drug only generic drug labels when a changes updated manufacturer label its to match an brand- name label or to follow the FDA’s instructions. U. S. Brief § (interpreting 314.94(a)(8)(iv)); 15, n. 7 21 CFR U. S. argues changes Brief 8. The n. FDA that CBE unilater- ally strengthen generic drug’s warning made to label regulations ge- would requiring violate the statutes and drug’s counterpart’s. neric label to match its brand-name Id., 355(j)(4)(G); 15-16; see also 21 U. S. C. 21 CFR §§314.94(a)(8)(iii), 314.150(b)(10) may (approval be with- drawn drug’s longer if the label “is no consistent brand-name]”). [the with that for interpretation We ge- defer the FDA’s itsof CBE labeling regulations. Although Mensing neric Demahy
615 regulations, ways interpret see Brief for offer other interpreta agency’s Respondents find the 33-35, we do not regulation,” with the “plainly inconsistent tion erroneous or omitted). (internal quotation supra, marks Auer, any Demahy Mensing suggest there is other rea Nor do agency’s reading. therefore conclude We son doubt open process to the Manufacturers that the CBE was not change required law. the sort of Mensing Demahy that the Manufactur- contend Next, letters to send additional “Dear Doctor” ers could have used pro- warnings physicians prescribing and other healthcare §200.5. Respondents 36; CFR Brief for fessionals. See agency’s Again, disagrees, to the views. the FDA and we defer qualify argues “la- Doctor letters The FDA that Dear 321(m); § beling.” 21 CFR also 21 U. S. C. 18; U. Brief see S. §202.1(0(2). any letters must be “consistent Thus, such contrary approved labeling.” drug’s] [the ... with and not 201.100(d)(1). § letter A Dear that contained Doctor CFR warning consistent information would not be substantial new generic labeling. drug’s approved Moreover, if with the drug manufacturer, the brand-name manufacturers, but not inaccurately imply therapeutic that would letters, sent such drugs and thus the brand difference between “misleading.” U. see impermissibly 19; S. Brief could be 314.150(b)(3)(FDA approval may withdraw of a 21 CFR labeling drug is ... false or mis- “the if any particular”). leading regulation, defer to the FDA. Men- we
As with the CBE argument sing Demahy FDA’s inter- no that the offer supra, at pretation plainly Auer, 461. erroneous. See permit Accordingly, law did we conclude that federal through warnings Dear additional to issue Manufacturers Doctor letters.
Though FDA denies that could Manufacturers process have used the CBE or Dear Doctor letters to strengthen warning agency labels, the asserts changing generic drug different avenue existed for labels. According pro- FDA, to the the Manufacturers could have *11 posed required propose stronger warning indeed, were to — — agency they warnings labels to the if believed such were Reg. needed. U. Brief 20; S. If the Fed. 17961. FDA agreed necessary, had that a label was it would have worked with a the to brand-name manufacturer create new generic drug. label the for both brand-name Ibid. agency 352(f)(2), duty traces this to U. C.S. which provides drug [u]nless labeling that a is . its “misbranded . . adequate warnings against dosage bears . . . . . . unsafe or application, or methods duration of administration or such necessary protection maimer form, as are for the By regulation, users.” See U. S. Brief 12. the FDA has interpreted require “labeling that statute to shall be warning to revised include a as soon as there reasonable drug.” of an evidence association of a hazard a serious with §201.57(e). 21 CFR According requirements apply ge- to the FDA, these “ drugs. explains, premise
neric As it a 'central of federal drug regulation [is] responsibil- that the manufacturer bears ity for the content of its label at all times.’” U. S. Brief 570-571). (quoting 12-13 555 S., The FDA rec- duty adequate labeling onciles this to have and accurate with duty way: following drug sameness Generic safety problems manufacturers that become aware of must agency ask the strengthening to work toward the label that applies equivalent both the drug. and brand-name U. S. Brief 20. disagree
The Manufacturers FDA over and the whether alleged duty this request strengthened actually a label argues explained duty existed. The FDA that it this in the implementing regulations preamble the Hatch- to its 1992 (“If Reg. Fed. a Ibid.; see Amendments. Waxman safety manufacturer] [generic drug new information believes labeling, product’s it should contact to a should be added labeling whether FDA, and FDA will determine revised”). drugs The Manufac be and listed should 19-year-old statement did not claim that FDA’s turers any generic duty, evidence create and that there is no any duty. acting pursuant drug such manufacturer ever Arg. Reply Petitioner Brief for PLIVA 19-24; Tr. of See Oral ultimately find even et al. 18-22. we Because assuming duty we do not resolve the matter. existed, such
C requirements and federal To summarize, the relevant state duty directly places on all are these: State tort safely products. adequately label their manufacturers Demahy’s allegations duty Taking Mensing true, this stronger required label different, use a Manufacturers to *12 drug regulations, they actually Federal than the label used. prevented interpreted the Manufacturers FDA, as generic drugs’ safety changing independently la- their from required also assume, federal law Manu- But, we bels. convincing in the brand- to ask for FDA assistance facturers stronger adopt label, a that all so manufacturer name drug corresponding generic do could so manufacturers as question pre-emption. now to well. We turn
I I I Supremacy that federal law shall establishes Clause any Thing supreme Land ... in Consti Law of the be Contrary any notwithstand to the or Laws of tution State ing.” and federal 2. Where state VI, cl. U. Art. Const., S. give way. Wyeth, “directly law must conflict,” law state concurring judgment); supra, see also J., at 583 (Thomas, Foreign U. Crosby Council, 363, 530 Trade S. v. National 618 (2000)(“[S]tate naturally preempted law to the extent statute”). any conflict with We have held federal “impossible
state and federal law it is conflict where private party comply require- with both state and federal Freightliner Corp. Myrick, ments.”4 S. (internal (1995) omitted).5 quotation marks
A impossibility findWe here. It was not under lawful fed- required eral law for the Manufacturers to do what state law they duty of them. And even if their had fulfilled they ask for FDA assistance, not have would satisfied the requirements of state law. independently changed
If the Manufacturers had la- satisfy duty, they bels to their state-law would have violated Taking Mensing Demahy’s allegations federal law. imposed duty true, state law on the Manufacturers to at- generic metoclopramide. tach a safer label to their Federal that, generic drug law, however, demanded be labels the same corresponding at all times as the brand-name labels. §314.150(b)(10). g., impossible See, Thus, e. 21 CFR it was comply for the Manufacturers to both with their state-law duty duty keep label and their federal-law the label the same. Wo do address “directly whether etate and federal conflict” in boyond “impossibility.” S., circumstances See 555 U. 690- (Thomas, J., concurring judgment) they (suggesting might). 5The provision Hatch-Waxman expressly pre Amendments contain no post, empting state (Sotomayor, J., tort claims. See at 633-634 dissent
ing).
they
do
any saving
expressly
Nor
contain
preserve
clause to
America,
tort
Inc.,
claims.
Cf. Williamson v. Mazda
Motor
U. S.
*13
323,339 (2011) (Thomas, J.,
judgment)
concurring
(discussing
in
the saving
clause in the National
Safety
Traffic and
Act of
Motor Vehicle
30103(e)).
U. S. C.
Although
express
pre-emption
an
statement on
is al
ways preferable,
the lack of
inquiry.
such
statement does not end our
Contrary to the dissent's suggestion,
express
pre-emption
the absence
is not a reason
pro omption.
to find no
post,
See
at 643.
conflict
help
strengthening
duty
in
FDA for
The federal
ask
assuming
duty
corresponding
such a
label,
brand-name
Although requesting
analysis.
exists, does not
this
the Manufacturers’
have satisfied
FDA assistance would
duty,
their state tort-law
have satisfied
it would not
duty
adequate
provide
labeling.
demanded
State
to communi-
it
Manufacturers
did not instruct the
label;
safer
possibility
label.
In-
of safer
FDA
cate with the
about
deny
Mensing
Demahy
state
claims
that their
tort
deed,
and
alleged
failure to ask
on the
are based
Manufacturers’
changing
Brief for Re-
in
the labels.
FDA for assistance
Legal
spondents
cf. Buckman Co.
53-54;
Plaintiffs’
(2001)
(holding that federal
and
Comm.,
This raises the novel whether conflict emption possible should take into account these actions the FDA and Here, the brand-name manufacturer. what permitted federal law the Manufacturers do could have changed, depending even itself, absent a in the law on the actions of the FDA and the brand-name manufacturer. generic drug’s Federal law does dictate the text of each but label, rather ties those labels to their brand-name coun- terparts. permit Thus, federal law would Manufactur- comply labeling requirements ers to with the state if, and only changed if, the FDA and the brand-name manufacturer the brand-name label to do so.
Mensing Demahy private party’s assert that when ability comply depends approval with state law proving requires pre-emption assistance from FDA, that party to demonstrate that the FDA not have would allowed compliance they argue, with state Here, law. the Manufac- proving impossibility turers cannot bear their burden of be- they try process might cause did not even start that ultimately have allowed them to ause safer label. Brief for Respondents reject argument, 47. This is a fair but we it. question “impossibility” private for is whether the party independently could do under federal law what state requires law (finding of it. See at S.,U. no “unilaterally” where could defendant do required). Accepting Mensing Demahy’s what state law argument pre-emption largely would conflict render mean- ingless because it make would most conflicts between state illusory. imagine and federal law can often We third party might something or the Federal do Government private party accomplish makes it lawful under fed- requires eral law what cases, it. it In these is certainly possible that, asked had Manufacturers help, they eventually might FDA for have been able to strengthen warning possible course, it label. is also Of that the could have convinced the FDA Manufacturers regulations that would have reinterpret manner in a its Mensing Following process opened to them. the CBE possi- conclusion, logical it also Demahy’s argument to its *15 persuaded' have by asking, could the Manufacturers that, ble entirely drug regulations FDA to rewrite its amending Congress the Hateh-Waxman into or talked Amendments. prevent state conjectures federal and to suffice
If these purposes, conflicting Supremacy it is un- Clause law from Supremacy express pre-emption, the of when, clear outside Suprem- any not read the We do have force.6 Clause would pre-emption acy permit approach that ren- an Clause Suprem- meaningless. pre-emption The conflict all but ders supreme acy law “the Law face, federal Clause, on its makes by Congress. express statement of the Land” even absent an VI, Art. cl. 2. Const., U. S. federal shall the text of the Clause—that
Moreover, any supreme, “any Thing Laws of or in the Constitution be notwithstanding” plainly Contrary contem- to the State — describing plates pre-emption by federal law effec- conflict tively repealing contrary Ibid.; Nelson, state see Pre- law. (2000); id., emption, at 252-253 225, 234 86 Va. L. Rev. Supremacy (describing Clause state rati- discussion of the concerning re- federal law could debates as whether fication versa). “any [state law] phrase peal or law, vice provision. Contrary notwithstanding” is a non obstante legislatures Eighteenth-century Id., at 238-240, nn. 43-45. degree specify provisions which used non obstante forgetting “purposes-and-objectives” that we are The dissent asserts Post, acknowledges, purposes- pre-emption. at But as dissent 640. Post, pre-emption. and-objeetives of conflict at pre-emption a form is hypothetical take into account pre-emption analysis If must 640. conflict Congress, action, of then there including possible changes Acts federal objec purposes to think based little reason that Congress of tives would survive either. repeal potentially conflicting
new older, statute was meant to (citing in the same statutes field. at dozens Id., 238-240 provisions). statutes from the similar 1770’sand 1780’swith provision acknowledged [a] A non obstante “in new statute prior might that the statute contradict law and instructed apply general against presumption implied courts not to repeals.” Abridgment Id., Bacon, M. A New 241-242; (4th 1778) p. (“Although ¶ the Law ed. two Acts of yet seemingly repugnant, Parliament are if be there no they possible latter, Clause non Obstante in the shall if Repeal may have such Construction, the latter not be a by Implication”). provision of the former The non obstante Supremacy suggests in the therefore Clause impliedly repeal conflicting law should be understood to state law. *16 provision suggests
Further, the that courts should not ways strain to find seemingly to reconcile federal law with conflicting Traditionally, great state law. courts went to lengths attempting conflicting to harmonize statutes, in implied repeals. Arell, order to avoid 2 Warder Va. (1796) J.) (“[W]e (opinion ought 296 of to Roane, seek for a together”); [the statutes] such construction as will reconcile (1828) (“[I]f Johnson, Ludlow’s Heirs v. 3 553, 564 Ohio any reasoning fair [statutes] course of the two can be recon- stand”); Bryan, ciled, both shall Doolittle v. How. 563, (1853) (requiring plain” repugnance quite “the be before finding implied repeal). provision A non obstante thus was way legislatures a they useful specify that did not want distorting courts the new law to accommodate the old. Nel- supra, son, at 240-242; Sutherland, J. see also Statutes and (1891)(“[W]hen Statutory p. Construction 147, 199 there is provision [of obstante] in inserted [i]t statute a non . . . supposed is against be that courts less inclined will be recognizing repugnancy applying statutes”); in such Wes- (K. Dyer Case, Eng. Rep. ton’s 347b, 73 347a, 780, 781 B. (“[W]hen 1575) appearance there are statutes, two the one in crossing other, no and clause non is obstante contained ought exposition be that both in second statute ... the Dictionary force”); Jacob, A New Law in G. stand should 1782) (definition (J. ¶ 6: Morgan “statute,” ed., 10th ed. seeming statutes, “[W]hen between two variance there such construction latter, in the no clause of obstante and non stand”). pro may The non obstante be made that shall both Supremacy a court need that Clause indicates of the vision meanin[g]” ordinary law, of federal no than “the look further conflicting to accommodate not distort federal law should concurring J., law. S., (Thomas, omitted). (internal quotation judgment) marks in analysis contingencies pre-emption To consider in our ability in which Manufacturers’ inherent these cases—in depended comply on uncertain federal with state agency third-party be inconsistent decisions—would Supremacy provision of the Clause. with the non obstante continually prove required would be Manufacturers FDA brand-name man- conduct of the the counterfactual supremacy of federal law. ufacturer order to establish contemplates Supremacy Clause do not think the We provision contingent supremacy. obstante The non sort analysis specu- suggests should involve agency third-party ways about which lation potentially federal duties with con- reconcile actions could meaning” “ordinary flicting of fed- state duties. When independently accomp- party private from eral law blocks party lishing requires, that has established what state law *17 pre-emption. sufficiently party private can act sure,
To be whether a independently what law law to do state federal under requires may to determine. But difficult this sometimes be satisfy could is not such a case. Before the Manufacturers agency to -undertake the FDA—a federal law, —had permitting special decide these them to do so. To effort party satisfy enough a cannot cases, it is to hold that when special per- Federal Government’s its state duties without the dependent mission and assistance, which exercise of by judgment agency, party independ- a federal cannot ently satisfy pre-emption purposes. those state duties for imposed duty
Here, state law on the Manufacturers to take certain action, and federal law barred them from tak- ing only that action. The action the Manufacturers could independently asking help for the FDA’s not a take — —is Mensing Demahy’s matter of state-law concern. tort pre-empted. are claims
C Wyeth contrary. to is not ease, In that as here, the plaintiff drug contended that a manufacturer had breached duty provide warning adequate state tort-law an label. Id., at 559-560. The Court that the held lawsuit was not pre-empted possible Wyeth, because it was a brand-name drug comply manufacturer, to with both state federal Specifically, regulation, at Id., law. 572-573.7 the CBE §314.70(c)(6)(iii),permitted drug CFR a brand-name man- Wyeth unilaterally strengthen ufacturer like “to its warn- ing” prior approval. without FDA S., 555 U. at cf. 573; supra, regulations applicable at Thus, 614-615. the federal Wyeth company, allowed the own its volition, strengthen compliance duty.8 its label in its with state tort 7Wyeth urged also that state unacceptable tort an “creat[ed] ‘obsta accompliohmcnt cle to the objectives purpooco execution of the full ” of Congress.’ S., 555 U. Davidowitz, Hines at 563-564 (quoting 312. (1941)). U. S. rejected The Court argument, and that type of post, argued is not (opinion here. Cf. n. Soto mayor, J.). FDA, however, The authority eventually Wy retained rescind eth’s unilateral CBE changes. Accordingly, Wyeth the Court noted that attempted show, could have evidence,” “dear that the FDA would have any change thereby rescinded in the label and demonstrate that it would in fact have impossible been to do under law what state law required. Wyeth, supra, Wyeth at 571. no evidence. offered such analysis That is consistent Wyeth today. with our holding Court ached what the manufacturer could independently do under fodoral *18 of Mensing that from perspective recognize We Wyeth makes not in here but Demahy, finding pre-emption taken Reglan, Mensing Demahy little sense. Had Wyeth would doctors, prescribed brand-name But not be pre-empted. their lawsuits would control and law, accord with state in full pharmacists, acting because law instead, federal metoclopramide substituted generic g., See, e. Minn. Stat. 151.21 these lawsuits. pre-empts (2010) substitute may generic when (describing pharmacists 2007) §37:1241(A)(17) (West Ann. La. Rev. Stat. drugs); (same). hand that federal We the unfortunate acknowledge others simi Demahy, has dealt Mensing, drug regulation situated.9 larly task to decide whether the statu-
But “it is not this Court’s or even unusual bi- by Congress scheme established tory Clearing C,L. Assn., L. House zarre.” Cuomo v. 557 U. S. Wyeth could not have accom law, evidence that the absence of clear it, pre-emption. Wyeth no The plished required of found what state law duties, that, state-law “tho Court held bccauoe fodcral law accommodated enough.” Post, 635; at possibility impossibility” “not see also mere of was (1982) Co., (rejecting “hypo S. Rice Norman Williams here, “existing” directly impossibility). thetical” But conflicts (“Conflict necessarily Post, analysis turns on exist with State at 639 law. law”). possibility io tho ing question in not whethor these cases possibility but rather whether tho impossibility pre-emption, establishes Post, pre-emption. at 634-635. possibility defeats “many said, it characterizes as the That overstates what the dissent Post, First, holding. at 643. the FDA in consequences” of our absurd matter, genuinely now information practical forms about “[a]s us are) (as appears infrequently.” drugs drugs typically long use ordinarily patent protections prevent U. S. Brief 34 35. That is because years for a number of drugs arriving on the market after tho from Indeed, alleged like drug appears. the one here brand-name situations regulation” no “formal establish apparently so rare that the FDA has are change, duty a label nor ing generic drug to initiate docs manufacturers’ Id., process. any regulation setting it have out that label -21. Second, approach, goncric drug that, under its the dissent admits even in a number scenarios. manufacturers could establish Post, at 637. *19 (2009) concurring part dissenting
519,556 (Thomas, J., in (internal omitted). part) quotation marks and brackets It beyond regulations dispute that the federal statutes and apply meaning- that to brand-name manufacturers are fully generic drug apply different than those that to manu- special, regulation it is the Indeed, different, facturers. and generic drug generic drugs of that allowed the market to bringing expand, drugs quickly cheaply more more to public. regulations But different federal statutes may, pre-emption as here, lead to different results. We will Supremacy not distort the Clause order to create similar statutory across a dissimilar scheme. As al- ways, Congress authority change and the PDA retain the regulations they the law and if so desire.
# [*] [*] judgments Eighth The of the Fifth and Circuits are re- versed, proceedings and the cases are remanded for further opinion. consistent with this
It is so ordered. Justice Sotomayor, with whom Justice Ginsburg, Kagan Justice Breyer, and Justice join, dissenting. today impossibility pre- The Court invokes the doctrine emption generic-drug to hold that federal law immunizes manufacturers from all state-law failure-to-warn claims be- they unilaterally change cause cannot I their labels. cannot agree. traditionally claiming have We held defendants im- possibility demanding today, a Until standard: the mere possibility impossibility enough had not been to establish pre-emption. (FDA) Drug permits
The Food and Administration and,— requires generic-drug the Court assumes, manufacturers to — propose change they a label to the FDA when that believe inadequate. agrees their labels are If it that the labels are inadequate, change the FDA a can initiate to the brand-name generic corresponding triggering la- label, in full manufacturer is occurs, bels. Once duty compliance state-law law with both federal may Although generic be to show able manufacturers warn. petitioners, impossibility manufactur- cases, in some (Manufacturers), only metoclopramide have shown ers comply might they with both federal unable to have been respondents Gladys and their duties warn state-law Demahy. Mensing I would is insuffi- hold, This, and Julie cient to sustain burden. opposite It in- conclusion. strains to reach the Court *20 principles thin law out of air to of
vents new justify impossibility It standard. effec- its the dilution of Wyeth tively Levine, U. S. 555 rewrites our decision pre-empt (2009), law does not holds that federal which drug against manufactur- failure-to-warn claims brand-name repeated plurality aside our And a of Court tosses ers. that Con- to conclude that courts should hesitate admonition governing gress pre-empt health to laws and intended safety. today’s consumer decision, whether a As a result of solely inadequate warnings relief turns can obtain harmed pharmacist happenstance filled her her on the prescription of whether drug. generic The Court with a or brand-name gets thing right: “makes little one This sense.” outcome Ante, at 625.
I A percent prescription Today’s of all decision affects position drugs dispensed country. of The dominant this generic drugs drug prescription is the market result in the legislative federal and measures, both state. series Drug Competition Congress Price
In enacted the commonly Act, Stat. Patent Term Restoration 1585— to Amendments the Federal known as the Hatch-Waxman (FDCA) Drug, “make Act available Food, and Cosmetic —to generic drugs by establishing generic drug low more cost approval procedure,” Rep. pt. p.1, H. R. 98-857, No. (1984). majority explains, accomplish goal As the this application process amendments establish an abbreviated generic drugs. Ante, for 612-613; see also U. S. C. §355(j)(2)(A). approval process imple The abbreviated generic principle ments amendments’ core that drugs respects: nearly brand-name must be the “same” in all approval, generic To obtain FDA manufacturer must ordi narily among things, product show, other its has the ingredients approved same active an drug; brand-name “the dosage route of administration, form, strength of the new are the same” as the brand-name drug; product “bioequivalent” and that its the brand- (iv). drug. §§355(j)(2)(A)(ii), (iii), By eliminating name prove the need drugs’ manufacturers safety efficacy independently, the Hatch-Waxman bring drugs Amendments allow manufacturers to expensively. market much less expand consumption
The States have also acted to of low- generic drugs. years leading cost up passage In the legislation Hatch-Waxman Amendments, enacted States authorizing pharmacists generic drugs to substitute when filling prescriptions drugs. for brand-name Christensen, *21 Kirking, Welage, Drug Ascione, Gaither, & Product Selec Legal tion: Issues, 41 Am. J. Pharmaceutical Assn. 869 (2001). Currently, generic all States have some form of generic require substitution law. See ibid. Some States Dept. substitution in certain circumstances. of Health and Expanding Servs., Human ASPE Issue Brief: the Use of (2010) (hereinafter Drugs Expanding Generic 7 the Use of Drugs);1 g., Generic see, e. N. Y. Educ. Law Ann. 6816-a
(West 2010). permit, require, Others but do substitu-
1 at (all Online http://aspe.hhs.gov/sp/reports/2010/GenerieDrugs/ib.pdf Internet 17, 2011, materials as visited in June and available Clerk of file). Court’s case
629 g., Drugs e. Cal. see, 2011). 7; Expanding of the Use Generic tion. (West Supp. §4073 Some Ann. Prof. Code
Bus. & all patient substitution, States require consent States name must be physician specify that the brand “allow although effort from the of levels prescribed, with different Drugs 7.2 Expanding physician.” of Generic the Use expand production con- legislative efforts to These wildly drugs generic proved It sumption successful. have of Amend- in when the Hatch-Waxman is estimated percent drugs generic 19 of constituted were enacted, ments Budget country. Congressional drugs Office, in sold this Drugs Competition From Generic Has Af- How Increased Industry the Pharmaceutical fected Prices Returns (1998).3 Expand- Today,they the market. See 27 ing dominate drugs Drugs (generic 2 constituted of Use Generic 2009). drugs prescription dispensed percent all generic Ninety percent drugs for which version is many generics. Id., at In 3-4. with available are now filled drug market, enter versions of cases, once selling stops the brand-name manufacturer brand-name altogether. et al. as Amici Cu- Law See Brief for Marc T. anywhere (citing showing from one-third studies riae drugs longer have a marketed no to one-half Reflecting equivalent). of their success brand-name including many generic products, manufacturers, Manu- companies. huge, multinational amici, and their are facturers promote ge many plans structured addition, are In insurance Office, Using Effects of Ge Congressional Budget See neric use. (2010), Prescription Drug online at Drugs Spending neric Medicare’s http://www.cbo.gov/ftpdocs/118xx/docll838/09-15-PrescriptionDrugs.pdf. promote generic use. See similarly Kaiser programs
State Medicaid Uninsured, Outpatient State Medicaid Pre on Medicaid and the Comm’n Survey, Update scription Drug Findings Policies: from National (2005), www.kff.org/medicaid/upload/state-medicaid-outpatient- online prescription-drug-policies-flndings-from-a-national-survey-2005-update- report.pdf. *22 http://www.cbo.gov/ftpdocs/6xx/doc655/pharm.pdf. Online at generic-drug
In an total, manufacturers sold estimated $66 drugs country id,., billion of in this at 15. 2009. See
B approval generic As noted, to obtain FDA manufacturer generally drug approved must show that its an the same as drug. brand-name It not conduct clinical trials need prove safety efficacy drug. of the This does not duty mean, however, that a manufacturer has no safety products. under federal law to ensure the of its postapproval FDA limited has conduct resources to monitor ing drug safety. See S., at 578. U. Manufac recognized, superior turers, have infer we “have access to drugs, especially mation about their postmarketing in the phase emerge.” as risks Id., new at 578-579. Federal law obliges drug thus ge manufacturers - both brand-name and safety products. neric - to monitor the of their Under federal “develop law, must manufacturers procedures receipt, written surveillance, evaluation, reporting postmarketing ug experiences” adverse dr (mak §314.98 314.80(b);5 to the FDA.4 21 CFR see also §314.80 ing applicable generic manufacturers); Brief for (hereinafter United as n. States Amicus Curiae 6, Brief). They reports drug S. must review all of adverse experiences §314.80(b). “any received from source.” If a report manufacturer unexpected receives a of a serious drug experience, report adverse it must the event to the days FDA “promptly investigate.” within 15 and must §§314.80(e)(1)(i)-(ii); Arg. see Tr. of also 8. Oral Most other drug experiences reported adverse quarterly must be aon drug An experience adverse “|a]ny is defined adverse event associ humans, ated with of a use whether or considered drug §314.80(a) (2006). related.” 21 CFR majority, Like the I pre-2007 refer to the regulations. statutes and ante, See n. 1. *23 314.80(e)(2). § yearly manufacturers Generic basis.6 or report summarising annual FDA an also submit to the must year previous “significant that from information new labeling drug safety, or might effectiveness, of affect the [manufac- “description including of actions the product,” as a this new turer] to result of take has taken or intends 314.98(c). § §314.81(b)(2)(i); also see information.” majority assumes, also bear manufacturers, the Generic adequacy monitoring responsibility federal law under majority’s warnings. agree I conclusion with of their unilaterally permitted to manufacturers not that are “changes-being-effected” through their labels through (CBE) warnings process or “Dear to issue additional According to the ante, letters. See at 613-615. Doctor” cannot dissemi- however, that manufacturers FDA, warnings that their own does mean nate additional they permits idle when them remain conclude regulations require inadequate. labeling FDA that their is warning labeling as revised to soon that “be include is an association of a serious there evidence of reasonable 201.57(e) (2006), § currently drug.” 21 hazard with a CFR Amendments, repre Hatch-Waxnaan congressional hearings At on the confirmed both generic-drug obliga their sentatives of the manufacturers investigation ability postapproval and of tion their conduct adverse Hearings on H. R. al. drug experiences. Legislation: 1554 et Drug See of the Environment the House before the Subcommittee on Health and (1983) Commerce, Cong., Sess., 1st 98th Energy Committee on and (statement Larsen, chairman of the Generic Pharmaceutical of Kenneth N. (GPhA)) Industry “are to the manufacturers sensitive (generic Association id., reactions”); (“[W]e importance at 47-48 will do looking at adverse performed to required regulatory meet the provide whatever to be requirement safety well-being of those that are provide for the drug, responsibility. obligation This is an using the this is our role and business”); id., (statement Haddad, Bill at executive to be this 50-51 GPhA) (“Every single generic drug company that president officer only large researches I know research staff. It not has they drugs, new copying, bringing are or market but it researches into the reaction[s]”). researches adverse 201.80(e) (2010);
codified 21 CFR see also regulation S.,U. at 570-571. FDA construes this The oblige generic labeling “to manufacturers seek revise provide supporting FDA with information about risks” they warnings necessary.7 when believe additional are Brief U. S. 20. disagree. They regula- the FDA Manufacturers read *24 require only
tion to them to ensure that their labels match the brand-name See Brief Petitioner labels. for PLIVA regulation et al. I 38-41. need decide whether in obliges generic approach fact manufacturers to to FDA propose change. majority a label The that it assumes does. generic duty pro- if And even manufacturers do not have a to pose changes, points undisputed. label two remain First, they duty safety do have a to under law monitor the of products. may they approach And, their propose second, the FDA to change they required.
a label when is believe a
II brings pre-emption This me to the Manufacturers’ defense. obliged dangers State law of Manufacturers warn Remington p. users. Hines v. Co., See 94-0455, Arms 10 7The FDA’s construction of this regulation guidance mirrors the it pro generic vided nearly years ago announcing manufacturero tho final implementing generic rule application process abbreviated drugs: for e., “If an ANDA application approval drug] for a generic applicant [i of safoty believes new product’s information bo to a labeling, ohould addod it FDA, should contact and FDA labeling will determine whether the for the drugs and lioted approval ohould be ANDA, rovioed. Aftor of an if an ANDA holder oafoty added, believes that now information ohould bo provide it adequate should supporting FDA, information to and FDA will determine whether tho labeling drugs tho listed should be (1992). Reg. revised.” Fed. procedures The FDA’s recognize internal Drugs that the Office of Generic will have to consult with components labeling other FDA on “some re- 5200.6, (May 9, 2001). views.” of p. Manual Policies and Procedures involving “possible safety Consultations serious concerns” receive the Id, at 3. highest priority. Frey Montgomery (La. 12/8/94), 337; 2d So. 1977). (Minn. Manu 782, 788 258 N. W. 2d Co.,&Ward agrees, majority that federal law contend, and the facturers claims respondents' because, pre-empts failure-to-warn pro have could not law, the Manufacturers under federal respondents warnings exer without vided additional by this novel judgment I cannot endorse the FDA. cise pre-emption. impossibility conception of
A analysis. principles guide pre-emption First, all Two Congress purpose the ultimate touchstone ‘“the ” (quoting every pre-emption S., at 565 555 U. case.' (1996)). Second, Lohr, Medtronic, Inc. v. 518 S. particularly ‘“[i]n in those in cases, all legislated Congress in a field which the States ... has which assumption occupied,... traditionally with the we start have police powers the States were not be that the historic superseded the clear and was the Federal Act unless *25 Wyeth, Congress.'” at purpose S., 555 U. 565 manifest of quotation (quoting internal some S., 485; 518 at Lohr, U. original). in omitted; marks alterations principles particular in these resonance cases. find These safety traditionally regulated health and have The States Notwithstanding Congress’ “cer- id., at 485. matters. See litigation” prevalence of state tort tain awareness of the Wyeth, against drug S., 575, at Con- manufacturers, 555 U. expressly pre-empted tort actions gress state-law has not prescription whether brand- against manufacturers, contrary, Congress generic. when amended or To the name powers ‘protect “enlarg[e] FDA’s FDCA in 1962to safety, effectiveness, and public health' and ‘assure preserve reliability drugs,’ [it] state law.” took care to of 780); (quoting §202, 76 793 see Stat. Id., 76 at Stat. to the this Act (“Nothing made amendments any invalidating provision of [FDCA] be construed as shall State which in the of would be valid absence such positive amendments unless there is a and conflict direct be- law”). provision tween such State amendments such Notably, although Congress express pre-emption enacted an provision § for medical devices in 1976, 521, 574, see 90 Stat. 360k(a), provision 21 U. C. it S. no included such years Wyeth, eight Hatch-Waxman Amendments later. Cf. Congress' atS., 567, U. on 574-575. “silence the issue powerful [it] . . is . evidence that did not intend PDA over- sight ensuring drug safety to be the exclusive means of effectiveness.” Id., 575.
B impliedly pre-empts Federal law state law when state and impossible pri- federal law “conflict”—i. “it e., when for a is party comply vate with both state and federal law” or accomplishment when state law “stands as an to the obstacle purposes objectives execution of the full Con- gress.” Crosby Foreign v. Council, National Trade (2000)(internal omitted). U. quotation S. 363, 372-373 marks rely solely ground Manufacturers on the former pre-emption.
Impossibility pre-emption, emphasized, we “is a have de manding Wyeth, defense.” at S., 555 U. 573. Because an seeking affirmative defense, defendant to set prove impossibility. aside state law bears the burden to ibid.; Corp., See Silkwood v. 464 U. Kerr-McGee S. (1984). prevail To defense, this defendant must demon “compliance strate [law] with both federal and state is a physical impossibility.” Lime & Growers, Florida Avocado (1963); Inc. Paul, S. 142-143 see also *26 555 S., U. at 573. In words, other there must be an “inevita ble collision” between federal state law. Florida Lime, 373 hypothetical poten S., at U. 143. “The existence of a or tial conflict is insufficient to warrant” of state law. Rice v. Norman Co., Williams 654, 458 S.U. 659
635 Management (1982); Wastes Solid v. National see also Gade (1992) concurring J., 88, Assn., 505 U. S. 110 (Kennedy, concurring part judgment). In other mere words, enough. possibility impossibility is not impossible it that was for contend- Manufacturers warnings respondents provide Men- them to additional prohibited sing Demahy them from law because federal unilaterally.8 They changing concede, however, their labels they a label FDA to initiate could have asked the change change. agreed a was re- label If the FDA pressured, quired, indeed asked, and it could have triggering change label, its brand-name manufacturer to generic change corresponding the Manufacturers’ labels.9 available mecha- Thus, had the invoked Manufacturers may changes, they initiating well have been nism for label respond- change time to warn in sufficient able to labels Having to do the Manufacturers cannot sus- so, ents. failed (at further devel- without factual tain least not their burden impossible opment) it In that was them to demonstrate they comply most, At law. have with state both 8 suggeoted below, that the Manufae Eighth In Circuit its decision merely permitted federal law impossibility not because turoro could show do so. drugs; require Morning them to Sec them to it did not soil (“The (2009) Inc., 3d defendants were 588 F. they If roaliaod their label wao compelled motoclopramide. to market they propose change, even label could insufficient but did not believe product”); they soiling see also Geier v. simply tho stopped could have (2000) Co., (describing “a U. S. case American Honda Motor penalizes law what federal impossibility” as one “in which added)); argu have not this requires” Respondents advanced (emphasis unnecessary ment, I to consider. and find it arose, the FDA of action did not have respondents’ time cause At tho (It label. its authority require a brand name manufacturer 901, 121 924-926, § S. C. authority in Stat. 2007. See received that (2006 III).) did, however, §355(o)(4) ed., equally sig have the Supp. It permission manufacturer’s authority to withdraw tho brand-name nificant requested label to make if the refused to market its manufacturer (2006 314.150(b)(3). 355(e) § ed.); 21 CFR ing change. S. See U. C. *27 only potential hypothetical demonstrated “a or conflict.” Rice, S., 458 U. at 659. majority,
Like the the on the fact that Manufacturers focus they change unilaterally cannot their labels distin —which guishes them from the brand-name-manufacturer defend Wyeth. They correctly Wyeth ant point out regulation we concluded that the FDA’s CBE authorized strengthen receiving the warnings defendant to its before agency approval supplemental application describing of its change. the label see S., 568-571; U. also CFR §314.70(c)(6). change But the label was contin defendant’s gent acceptance, “authority on FDA as the to FDA retained reject labeling changes pursuant regula made to the CBE Wyeth, tion.” long S., at 571. in the Thus, run, compliance duty brand-name manufacturer’s with a state-law required to warn action two actors: The brand-name manu change upon facturer had to the FDA, label review ing supplemental application, agree to had with change.10 approval change The need for FDA of the label compliance did not impossi make with federal and state law every ble in case. Instead, because the defendant bore the impossibility, required produce burden to show we it to approved “clear evidence that the FDA would not have [the] label.” Ibid. apply approach I would the same in these cases. State respondents allege, required law, pro- the Manufacturers strengthened warning dangers long-term vide a about metoclopramide use.11 Just like the brand-name manufac- 10A brand-name ability comply duty manufacturer's with a otate-law to warn depend would only ito own during period unilateral actiono after it changed should have its label but before the FDA would have approved Wyeth disapproved or change. the label claim in does not appear during to have arisen that period. 11Respondents’ state law claim is not that the Manufacturers were re quired to ask the FDA for changing labels; assistance in the role only tho FDA arises pre emption result the Manufacturers’ defense. available them a had the Manufacturers turer in comply their state-law attempting with mechanism the Manu- duty thus “accommodated” to warn. Federal *28 625, n. 8. It was ante, at duties. See facturers’ state-law comply necessarily impossible to Manufacturers for the not they ap- had because, both federal and state with agreed may proached that well have the FDA FDA, Accordingly, Wyeth, change necessary. as in a label was require to that the FDA show I would the Manufacturers They change. approved proposed a not have label would They argue showing: “not do that a have not made such warning required by [they] attempted give the kind to doing law] prohibited [state [were] so the FDA.” from but Wyeth, atS., 572. say generic could never
This is not that manufacturers to generic-manufacturer impossibility. defendant show If a rejected change proposed the FDA FDA but a label to the proposal, impossible to would for defendant it be duty comply impossibil Likewise, with warn. state-law to yet responded ity not would be if the FDA had established request generic at for a label manufacturer’s plaintiff’s injuries A manufacturer time arose. might itself considered whether also that the FDA had show light request warnings of the evidence on enhanced plaintiff’s had decided to leave the which a claim rests but (The just warnings an ar make such as is. Manufacturers g., gument Brief for Petitioner Ac See, in these cases. e. 11.) questions fact to be estab tavis et al. But are these proving through discovery. the burden of lished Because impossibility I would that federal defendant, hold falls impossible manufacturers not for law does render it categorical duty comply as a with a warn state-law matter. overarching prin- naturally
This conclusion from flows supra, ciples governing at doctrine. See our 'independent sovereigns “respect 633. Our for the States system’ ‘Congress in our federal leads us to does assume cavalierly pre-empt state-law causes of action.’” Wyeth, (quoting U. S., Lohr, at n. 3 565-566, S.,U. 485). asserting It is for this reason that we hold defendants impossibility “demanding” to a standard. 555 U. S., presumption against pre-emption particu- at 573. This has lar force when the Federal Government has afforded defend- complying ants a law, mechanism with state even when (The requires agency pre- that mechanism action. sumption greater requires has even force when federal law majority defendants invoke that mechanism, as as- cases.) sumes in these In circumstances, such I hold, would usually defendants will be unable to sustain their burden of showing impossibility they attempted if have not even to em- ploy Any approach that mechanism. other threatens to in- fringe authority the States’ over traditional matters of state *29 interest —such the as claims failure-to-warn here—when Congress expressed pre-empt no intent to state law.
C majority might The the concedes that Manufacturers have accomplish been able to under federal law what state law requires. Ante, at 619. To reach the conclusion that the Manufacturers have nonetheless satisfied burden to impossibility, majority show the invents a new question ‘impossibility’ rule: “The private for is the whether party independently could do under federal law what state requires added). (emphasis Ante, of it.” at 620 Be- changed cause the Manufacturers could not have their labels judgment by majority without the exercise of FDA, the the compliance impos- holds, with both state and federal law was sible in these cases.12 12These eases do not brand-name involve situation where a manufac produces turer drugs. Okie, itself See Multinational Medicines— Ensuring Drug in Quality an Era of Manufacturing, Global 361 New Eng. 73V,
J. (2009); GPhA, Frequently Med. also see Questions Asked precedents. majority’s in our has no basis new test The support only Wyeth majority of its test. As cites Wyeth prop- for the does not stand above, however, discussed comply impossible both federal and with that it is osition required. approval agency is To law whenever federal changes by contrary, manufacturers brand-name the label acceptance. subject Wyeth review and are FDA such Wyeth supra, be charac- if could And, at 636-637. even See turning brand-name manufac- that the terized as on fact unilaterally, possibility change uni- turer could its label rejecting condition a sufficient was, action most, lateral Wyeth impossibility did not hold in that case. defense necessary every condition in case. that unilateral action is majority support un law, so case With little our derstandably ration None to other rationales. turns any First, it ales sense. offers however, that it makes offers, approval possibility of FDA a reductio ad absurdum: If change conflict in cases, possi avoid these of a label sufficient “logical be the so too would warns, it bility as a conclusion” regulations might or that its the FDA rewrite Congress might Amendments. amend the Hatch-Waxman escapes logic me. Con of this conclusion Ante, at 621. The existing analysis necessarily law. It thus flict turns that federal and state law do would be ridiculous to conclude ground the defendant could have not conflict on the Congress agency the law. or asked compliance with their contrast, Here, the Manufacturers’ duty require them to ask for a warn state-law did *30 recognizes. change majority itself in See law, as the (“[F]ederal permit the ante, at would Manufacturers 620 law only requirements comply labeling if, and with the state Generico, http://www.gphaonlino.org/about-gpha/about gcncrics/faq About (“Brand-name generic drugs”). In companies about half of make case, independently change the brand name label the manufacturer could change its regulation, corresponding own triggering undor tho CBE generic label.
640 changed if, the FDA the and manufacturer the brand-name so”). already brand-name label to do The FDA afforded attempting comply them mechanism for with their majority Indeed, state-law duties. assumes that FDA regulations required request a Manufacturers label they when an had “reasonable evidence of association 201.57(e). drug.” aof serious hazard with a 21 CFR any approach majority suggests Second, the other “illusory” “meaning pre-emption would render conflict expresses Ante, less.” at 620. It that, concern without Supremacy robust view of what conflict, the constitutes “any express except Clause would not have in force” cases of pre-emption. majority’s Ante, at To 621. the extent purported by concern is absurdum, driven its reductio ad illusory, ibid., 6, see n. that concern is itself reasons just majority stated. To the extent the is concerned that traditionally impossibil our narrow of what view constitutes ity pre-emption somehow conflict renders as a mean whole ingless, simply repeat that concern no makes sense: We have edly recognized pre-emption may that conflict be even found, impossibility, absent where an “stands as obstacle accomplishment to the purposes of execution the full objectives (inter Congress.” Crosby, of S., 530 U. at 373 quotation omitted); g., nal marks e. Geier v. see, American (2000); Motor Co., Honda 529 861, U. S. 886 Barnett Bank of Cty., (1996); Marion N. A. v. Nelson, U. 25, 517 S. Hines (1941). majority’s v. Davidowitz, 312 52, U. S. ex pansive impossibility unnecessary prevent view thus losing meaning.13 conflict from all Thomas, Justice today's opinion, previously author of has ex i pressed the view that pre emption obstacle is inconsistent with the Const Inc., America, Williamson v. Mazda tution. Motor Sec S. (2011) (opinion Levine, Wyeth concurring judgment); 555 U. S. (2009) (opinion concurring however, judgment). position, That has accepted not been Court, it justify this thus should not majority’s expansion novol impossibility pro emption.
641 theory adopts plurality novel that the of the Court Third, a operate Supremacy Clause to the intended for the Framers provision. ante, at 621-623 See non obstante so-called (2000)). 225 Ac- Preemption, (citing 86 L. Rev. Va. Nelson, provisions cording plurality, in statutes non to obstante the presumption apply general “instruc[t] courts not the (internal quotation against implied repeals.” at 622 Ante, ibid, omitted); (stating when a statute that marks see also provision, in- will be less ‘“courts contains non obstante against repugnancy applying recognizing in stat- such clined Statutory (quoting Con- Sutherland, utes'” J. Statutes (1891))). understanding p. of 199 From this struction 147, princi- extrapolates Supremacy plurality the Clause, ways ple strain to find reconcile “courts should not conflicting seemingly law.” Ante, federal law with at 622. Congress principle to the been news
This would have prece- in 1984:Our enacted the Amendments Hatch-Waxman century, just opposite. than half For more dents hold congressional presume that action we have directed courts powers supersede police not the States does “the historic purpose of . was manifest Con- . . unless that the clear and Corp., gress.” 218, 331 U. Elevator S. 230 Rice v. Santa Fe (1947); Gade, at 111-112 S., J., see U. also 505 (Kennedy, concurring judgment). apply concurring part We Congress pre-emption presumption against both where this spoken pre-emption question and where has it not. has express In context n. 3. S., 566, 555 See U. possible pre-emption, statutes whenever we read federal Group, pre-empt Good, Inc. v. Altria state law. See (2008)(“[W]hen a clause the text 70, S. reading, plausible susceptible courts ordi- one of more than ” pre-emption’ (quot- narily ‘accept reading that disfavors Agrosciences ing LLC, U. S. v. Dow Bates Liggett Group, (2005))); Cipollone Inc., 505 U. S. see also (1992). law im- the claim is that And, when *32 pre-empts “strong” showing pliedly require a law, state we presumption conflict “to that state and of a overcome the regulation constitutionally local . . can coexist with federal . regulation.” County Hillsborough v. Automated Medical (1985). Laboratories, Inc., 471 U. S. plurality’s theory Supremacy
The new Clause precedents.14 long on direct assault these we have Whereas presumed pre-empt, repeal, federal that law does not or plurality today Supremacy oper- law, to reads Clause provision instructing apply gen- ate as a “not courts to against presumption implied repeals.” Ante, eral at 622 (internal added). quotation emphasis omitted; marks And long required we whereas have of a “clear evidence and man- purpose pre-empt, plural- ifest” Rice, S., 230, at T.T. ity ordinary now instructs courts to “lookno further than the meaning concluding Congress of federal law” that before (in- must have law, ante, intended to cast aside state at 623 omitted). quotation ternal marks and alteration plurality necessary That the it to this finds resort novel theory Supremacy theory of the Clause—a advocated no party telling. Proper application or amici these cases—is longstanding presumption against pre-emption of the com- pels compli- the conclusion that federal law does render impossible merely requires ance with state law it because an agency approval. actor seek When federal law provides attempting comply actors with a mechanism for “respect with their state-law duties, for the States ‘inde- ” pendent sovereigns system' require our federal should attempt comply those actors to with state law before 14The author of the law proposing review article theory this the Su premacy acknowledges Nelson, Clause Preemption, as much. See Va. (2000) (“The L. Rev. non rejects obstante provision an artificial prooumption Congress that any did not to contradict intend state laws and that law”). federal statutes must therefore be harmonised with state plurality, hand, carefully the other discussing avoido the ramifications of its thoory now the longstanding prooumption against pre-emption. compliance complain with both being laws was heard to (quoting n. 3 impossible. 565-566, Lohr, S., 485). atS., 518 U.
III many consequences Today’s absurd to so decision leads Congress intended to would have I fathom that cannot pre-empt in these cases. state law analysis strips generic- majority’s pre-emption
First, they injured by compensation are when consumers of deprive inadequate warnings. Congress had intended to “If compensation, long injured parties [this] form of available *33 clearly.” surely expressed more that intent it would have longstanding existence Bates, S., the at 449. Given U. “[ijt liability including product warn, to for failure actions, Congress without com- would, is difficult to believe that injured judicial recourse for those ment, remove all means by illegal at see S., 251; U. also Silkwood, 464 conduct.” (2011) (not- Wyeth S. LLC, Bruesewitz Congress ing previously expressed “doubt would our providing quietly preempt product-liability claims without a substitute”). Congress silently concluding that In generic all from failure-to-warn immunized manufacturers previous majority disregards to claims, the our hesitance sweeping congressional a such infer to effect intent in traditional state-law remedies. right drug majority consumer’s admits,
As the a itself warnings hap- compensation inadequate turns the for now on prescription penstance pharmacist filled her of whether her generic. drug a If consumer takes with or a brand-name drug, for inade- the manufacturer brand-name she can sue Wyeth. quate warnings opinion however, If, in under our percent generic drug, time, of the she takes a occurs majority right offers no reason she now has no sue. The impossibility apart of the from its new articulation to think — Congress such an arbi- intended have standard —that trary would pharmacists must dis- States, In some distinction. pense generic drugs contrary absent instruction to from physician. request a consumer’s Even when consumers can drugs, price drug brand-name brand-name or plans may impossible it consumers’ insurance make to do so. many ability As a preserve in no result, cases, consumers will have injuries right for state-law to recover caused by inadequate warnings. majority’s gap parallel
Second, decision creates regulatory way federal-state scheme in a that could have troubling consequences drug safety. explained As we drug “[s]0tatetort suits uncover unknown hazards and provide safety incentives for manufacturers to disclose promptly.” recognized, risks Thus, 555 U. S., 579. we layer important, “state an law offers additional, and of con protection complements regulation.” sumer FDA Ibid. Today’s decision eliminates the traditional state-law incen tives for manufacturers monitor disclose safety generic drug equiv risks. When a has a brand-name alent the market, the brand-name manufacturer will re safety main incentivized to uncover But risks. brand-name manufacturers often leave the once market versions supra, meaning are available, see at 629-630, that there will subject liability. be no manufacturer to failure-to-warn As generic drugs, layer those there will be no “additional... *34 protection.” of Wyeth, consumer S., at 579. U. Finally, today’s principle decision undoes the core of the generic Hatch-Waxman drugs that Amendments and brand-name nearly respects.15 are the “same” in all See Brief for Rep. Henry majority A. Waxman as Amicus 9. The Curiae pins expansion generic-drug the spe- of the market on “the regulation generic drugs,” cial, and of different, which allows 15According GPhA, to the both generic-drug industry the FDA and the “spend year millions of seeking dollars each . . . to reassure consumers that generic affordable drugs really compelo are as federal thorn to be—the same as their pricier counterparts.” brand-name Brief for GPhA Cert, as Amicus Curiae on 09-993, 09-1039, pp. Pet. for in Nos. 2-3. drugs cheaply. produce more generic their manufacturers story. expansion only half Ante, 626. This tells at drugs generic flowed from the has also for of the market generic drugs acceptance in, con- and trust of, increased legislators physicians, alike. sumers, distinction Today’s a critical between introduces decision drugs. generic of brand-name Consumers brand-name and warnings; inadequate drugs for con- can sue manufacturers divergent liability generic drugs These of cannot. sumers generics, for demand reduce consumer rules threaten to drugs. among afford who can brand-name least consumers may prescribing physi- They pose dilemma” for “an ethical Association et as Brief American Medical al. cians. for they may well cause States to And Amici Curiae 29. longstanding promote generic efforts to their use rethink generic through for laws. See Brief National substitution (state Legislators Amicus Curiae 15 of Conference State proceeded premise generic on the “have substitution laws perspective, generic drugs from citizens’ not, that . . are . except materially ones, for the lower different from brand directly price”). consequences at odds These are with increasing goal consumption Amendments’ of Hatch-Waxman generic drugs. Nothing opinion that, convinces me in enact- in the Court’s requirement generic ing match labels their corre- that Congress sponding intended labels, these absurd brand-name certainly not has shown that such results. The Court was Congress.” purpose “clear manifest (internal emphasis quotation omitted; marks S., at 565 added). generic contrary, federal law because affords To the attempting comply with mechanism manufacturers would warn, I hold federal law state-law duties categorically pre-empt failure-to-warn does state-law light against Especially manufacturers. claims presumption against pre-emption, fall the burden should compliance im- was to show manufacturers *35 possible particular on the By holding facts of their case. ‘‘possibility possibility" “defea[t]” is insufficient to pre-emption in cases, ante, these at 625, 8,n. the Court con- torts our exempts doctrine and defendants from their burden to impossibility. respect, establish With I dissent.