WPCf6 2hBcR ZY3|["m^36Gff%==\o3=33ffffffffff33oooQzKfzztzp=o=o\%ffQi\=bp:6m:p\ifQUGpbbbX=o=o=3============i:fffffQ\\\\K:K:K:K:p\\\\ppppbfi\\b\zifffQQQQi\\\\bbbbbbppK:K:K:K:fmz:z:z:z:z:pppp\\QQQtUtUtUtUzGzGzGppppppbpXpXpXiz:pQtUzGbbi\pNo3o\6QNNfff=7f=f=%GGf//\\pp%G=ooee3o<gwZZskkkkB{sssZZcJRRRkkkl_dRZ>\J\B\JlZoN21mRgR\lNaJlRsRSRYZB\BhVrNlRwgsg_BZ11RVVg_]Zk___________________BBBBBBBZZZZZZZZZZZZZZZZZZZZ111111111111RRRRRRRVVVVVVVVVVVVggggggggggggggggggggl\l2lhs2hR"m^!$/CCdb((gn|g|n|SR}{nnnRRnnnnnnnRRRRRRRRRRRRSS2]#c4cc"X^?S}}SSS}?S?F}}}}}}}}}}SS}a}SFS}S}ooS}FSF}oaS}}}oc7cS?SS*SSSSSSSSSSF}}}}}oooooaFaFaFaF}}}}}}}}}}}}}oooooooo}}}}}}aFaFaFaF}FFFFF}}oooaaaaSSS}oooFoaS}}}NX?}S}}}}}}KS}K}KF}}}SS}}S}KF*RRdE|>gn|g|n|SR{nnnRRnnnnnnnRRRRRRRRRRRRSS"m^*,:SS}z22K[*2**SSSSSSSSSS**[[[Collluldu}=Sudzudul_dzljj\2[2[KWWW]WP]d1C]Pqb]P]WLPbWvTTI2[2[2*222222222222V/lSlSlSlSlSwlClKlKlKlK=/=/=/=/z\uKuKuKuKz\z\z\z\jQlSuVuKuKjQuKdVlSlSlSlClClClCuVlKlKlKlKuQuQuQuQuQuQ}\}\=/=/=/=/SuYd/d/d/d/d/z\z\z\z\uKuK}lClClC_E_E_E_Ed:d:d:z\z\z\z\z\z\ujQ\H\H\HuVd/z\lC_Ed:jQjQuVuKz\N[*[K,C@@SSS2-}}S2ooS}2::S''KK\\:2[[RRk*[11RRRkskk[ZZ<[){kJ%>gwZZskkkkB{sssZZcJRRRkkklWdPZH\I\I\IlWoY2(mWgRklWaMlWs\SCYG\IhSr\lWw_s\_BZ11RVVg_]Zk___________________BBBBBBBZZZZZZZZZZZZZZZZZZZZ111111111111RRRRRRRVVVVVVVVVVVVggggggggggggggggggggl\l2lhs2hR"m^*2gwZZskkkkB{sssZZcJRRRkkkl_dRZ>\J\B\JlZoN21mRgR\lNaJlRsRSRYZB\BhVrNlRwgsg_BZ11RVVg_]Zk___________________BBBBBBBZZZZZZZZZZZZZZZZZZZZ111111111111RRRRRRRVVVVVVVVVVVVggggggggggggggggggggl\l2lhs2hR"m^3=Iff%==\o3=3offffffffff33oooQzKpzzz~~z=o=o\%ifQpQ=bp=:f=p\ifQQAp_\\U=o=o=3============f=iiiiiQQQQQK=K=K=K=p\\\\pppp~\ip\\~\\ziiiiQQQQpQQQQbbbbbbppK=K=K=K=pfz=z=z=z=z=pppp\\QQQzQzQzQzQ~A~A~Apppppp~\zUzUzUpz=pQzQ~A~\~\p\pNo3w\=QNNfffMDf=f=3GG\==\\pp%G=ooee3o<>RRR1,zzR1llRz199R&&IIZZ91YYQQi)Y00QQQiqiiYXX;Y(yiH$<euXXqiiii@yqqqXXaHQQQiiij]bQX>RRR1,zzR1llRz1BQck QuoteSingle spaced indented quote - Circv C   (  Cd  ( ( ( 226Hw/T1 4r4Footnotes*rsFormats for ASTERISK footnotes'#[ P['CdP# ddf < X01Í Í1*'(Í Í #o P['Cn&P#X` hp x (#%'0*,.8135@8: LORA LOHR, et vir, PETITIONERS  J@ *, 95!8867v.ă 1hMEDTRONIC, INC.  ?  hhx  on writs of certiorari to the united states court ' of appeals for the eleventh circuit 1 hxf #[ P['CdP# d [June 26, 1996] *,   #o P['Cn&P#  J 'Footnotes*#[ P['CdP# ff X01Í Í1*'(Í Í , , #o P['Cn&P#X` hp x (#%'0*,.8135@8: agree with Justice O'Connor's discussion of this point  J and with her conclusion. See post, at 2!4. The statute's language, read literally, supports that conclusion. It says: BQ C  , , (  [N]o State ... may establish ... with respect to a  J device ... any [state] requirement ... which is different from, or in addition to, any [federal] requirement .... 21 U.S.C. 360k(a) (emphasis """## added).BQ d   ( , ,   One can reasonably read the word requirement as including the legal requirements that grow out of the application, in particular circumstances, of a State's tort law.  J  Moreover, in Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), the Court made clear that similar language easily encompassed tort actions because [state] regulation can be as effectively exerted through an award of damages as through some form of preven J tive relief. Id., at 521 (plurality opinion) (internal  J quotation marks omitted); see id., at 548!549 (Scalia,  J J., concurring in judgment in part and dissenting in  J\ part). Accord CSX Transp. Inc. v. Easterwood, 507 U.S. 658, 664 (1993). This rationale would seem applicable to the quite similar circumstances at issue here.  Finally, a contrary holding would have anomalous consequences. Imagine that, in respect to a particular hearing aid component, a federal MDA regulation requires a 2inch wire, but a state agency regulation requires a 1inch wire. If the federal law, embodied in the 2inch MDA regulation, preempts the state 1inch agency regulation, why would it not similarly preempt a state law tort action that premises liability upon the defendant manufacturer's failure to use a 1inch wire (say, an award by a jury persuaded by expert testimony that use of a more than 1inch wire is negligent)? The effects of the state agency regulation and the state tort suit are identical. To distinguish between them for preemption purposes would grant greater power (to set state standards different from, or in addition to federal standards) to a single state jury than to state officials acting through state administrative or legislative lawmaking processes. Where Congress likely did not focus specifically upon the matter, see  J ante, at 14!19, I would not take it to have intended this anomalous result.""# Ԍ Consequently, I believe that ordinarily, insofar as the MDA preempts a state requirement embodied in a state statute, rule, regulation, or other administrative action, it would also preempt a similar requirement that takes the form of a standard of care or behavior imposed by a statelaw tort action. It is possible that the plurality also agrees on this point, although it does not say so explicitly.  9H1 d d7II؃  2  The answer to the second question turns on Congress'  J intent. See, e.g., Barnett Bank of Marion Cty., N.A. v.  J Nelson, 517 U.S. ___, ___ (1996) (slip op., at 4); Allis J Chalmers Corp. v. Lueck, 471 U.S. 202, 208 (1985);  J ante, at 13. Although Congress has not stated whether the MDA does, or does not, preempt the tort claims here at issue, several considerations lead me to conclude that it does not.  First, the MDA's preemption provision is highly ambiguous. That provision makes clear that federal requirements may preempt state requirements, but it says next to nothing about just when, where, or how,  JN they may do so. The words any [state] requirement and any [federal] requirement, for example, do not tell  J us which requirements are at issue, for every state  J requirement that is not identical to even one federal requirement is different from, or in addition to that single federal requirement; yet, Congress could not have intended that the existence of one single federal rule, say, about a 2inch hearing aid wire, would preempt  J every state law hearing aid rule, even a set of rules related only to the packaging or shipping of hearing  J aids. Thus, Congress must have intended that courts look elsewhere for help as to just which federal requirements preempt just which state requirements, as well as just how they might do so.  Second, this Court has previously suggested that, in"   the absence of a clear congressional command as to preemption, courts may infer that the relevant administrative agency possesses a degree of leeway to determine which rules, regulations, or other administrative actions  J` will have preemptive effect. See Hillsborough County  J8 v. Automated Medical Laboratories, Inc., 471 U.S. 707,  J 721 (1985); cf. Smiley v. Citibank (South Dakota), N.A.,  J 517 U.S. ___, ___ (1996) (slip op., at 3!5); Lawrence  J County v. Lead-Deadwood School Dist. No. 40!1, 469  J U.S. 256, 261!262 (1985); Chevron U. S. A. Inc. v.  Jp Natural Resources Defense Council, Inc., 467 U.S. 837, 842!845 (1984). To draw a similar inference here makes sense, and not simply because of the statutory ambiguity. The Food and Drug Administration (FDA) is fully responsible for administering the MDA. See 21 U.S.C. 393. That responsibility means informed agency involvement and, therefore, special understanding of the likely impact of both state and federal requirements, as well as an understanding of whether (or the extent to which) state requirements may interfere with federal  J objectives. See Hillsborough, 471 U.S., at 721. The FDA can translate these understandings into particularized preemptive intentions accompanying its various  Jh rules and regulations. See id., at 718. It can communicate those intentions, for example, through statements in regulations, preambles, interpretive statements, and  J responses to comments, ibid., as well as through the exercise of its explicitly designated power to exempt state requirements from preemption, see 21 U.S.C.  Jx 360k(b); see also ante, at 24 (noting that FDA's authority to exempt state requirements from preemption necessarily requires FDA to assess federal laws' preemptive effect).  Third, the FDA has promulgated a specific regulation designed to help. That regulation says: BQ C  , , ( N N " State ... requirements are preempted only when  J ... there are ... specific [federal] requirements"   applicable to a particular device ... thereby making  J any existing divergent State ... requirements applicable to the device different from, or in addition  J to, the specific [federal] requirements. 21 CFR 808.1(d) (1995) (emphasis added). 1*vBQ 8d  ( , , The regulation does not fill all the statutory gaps, for its word divergent does not explain, any more than did the statute, just when different devicerelated federal and state requirements are closely enough related to trigger preemption analysis. But the regulation's word specific does narrow the universe of federal requirements that the agency intends to displace at least some state law.  Insofar as there are any applicable FDA requirements here, those requirements, even if numerous, are not  J  specific in any relevant sense. See ante, at 25!26, 29!30. Hence, as the FDA's abovequoted preemption rule tells us, the FDA does not intend these requirements to preempt the state requirements at issue here. At least in present circumstances, no law forces the FDA to make its requirements preemptive if it does not think it appropriate.  J  I cannot infer a contrary intent from Justice  J ԚO'Connor's characterization of the federal standards  J applicable here as comprehensive and extensive, post,  J| at 6!7, both because that characterization is question JT able, see ante, at 25!26, 29!30, and because this Court has previously said that it would seldom infer, solely from the comprehensiveness of federal regulations, an intent to preempt in its entirety a field related to  J health and safety. Hillsborough, supra, at 718. It therefore seems to me that the better indicator of the FDA's intent is its preemptionrelated regulation. And that regulation's word specific would seem a reasonable exercise of the leeway that statutory language and practical administrative circumstance suggest Congress intended to grant to the agency."  Ԍ Fourth, ordinary principles of conflict and field preemption point in the same direction. Those principles make clear that a federal requirement preempts a state requirement if (1) the state requirement actually conflicts with the federal requirement"either because  J8 compliance with both is impossible, Florida Lime &  J Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142!143 (1963), or because the state requirement stands as an obstacle to the accomplishment and execution of the full  J purposes and objectives of Congress, Hines v. David Jp owitz, 312 U.S. 52, 67 (1941)"or (2) the scheme of federal regulation is so pervasive as to make reasonable the inference that Congress left no room for the States  J to supplement it, Rice v. Santa Fe Elevator Corp., 331  J U.S. 218, 230 (1947). See, e.g., Barnett Bank, 517  J U.S., at ___ (slip op., at 4!5); Gade v. National Solid  J Wastes Management Assn., 505 U.S. 88, 98 (1992)  JX (opinion of O'Connor, J.); Wisconsin Public Intervenor v.  J0 Mortier, 501 U.S. 597, 604!605 (1991); English v.  J General Elec. Co., 496 U.S. 72, 79 (1990).  It makes sense, in the absence of any indication of a contrary congressional (or agency) intent, to read the preemption statute (and the preemption regulation) in light of these basic preemption principles. The statutory terms different from and in addition to readily lend themselves to such a reading, for their language parallels preemption law's basic concerns. Without any contrary indication from the agency, one might also interpret the regulation's word divergent in light of these same basic preemption principles.  Insofar as these basic principles inform a court's interpretation of the statute and regulation, they support the conclusion that there is no preemption here. I can find no actual conflict between any federal requirement and any of the liabilitycreatingpremises of the plaintiffs' state law tort suit; nor, for the reasons discussed above, can I find any indication that either Congress or the`"   FDA intended the relevant FDA regulations to occupy entirely any relevant field.  For these reasons, I concur in the Court's judgment. I also join the Court's opinion, but for Parts IV and VI. I do not join Part IV, which emphasizes the differences between the MDA and the preemption statute at issue  J in Cipollone, because those differences are not, in my view, relevant in this case. I do not join Part VI, because I am not convinced that future incidents of MDA preemption of commonlaw claims will be few or  Jp  rare, ante, at 31.