Mutual Pharmaceutical Co. v. Bartlett - 12-142 (2013)



No. 12–142



on writ of certiorari to the united states court of appeals for the first circuit

[June 24, 2013]

     Justice Breyer, with whom Justice Kagan joins, dissenting.

     It is not literally impossible here for a company like petitioner to comply with conflicting state and federal law. A company can comply with both either by not doing busi- ness in the relevant State or by paying the state pen- alty, say damages, for failing to comply with, as here, a state-law tort standard. See post, at 16–18 (Sotomayor, J., dissenting). But conflicting state law that requires a company to withdraw from the State or pay a sizable damages remedy in order to avoid the conflict between state and federal law may nonetheless “ ‘stan[d] as an obstacle to the accomplishment’ of” the federal law’s ob- jective, in which case the relevant state law is pre-empted. Post, at 17 (quoting Crosby v. National Foreign Trade Coun-cil, 530 U. S. 363, 373 (2000) ).

     Normally, for the reasons I set forth in Medtronic, Inc. v. Lohr, 518 U. S. 470, 503 (1996) (opinion concurring in part and concurring in judgment), in deciding whether there is such a conflict I would pay particular attention to the views of the relevant agency, here the Food and Drug Administration (FDA). Where the statute contains no clear pre-emption command, courts may infer that the administrative agency has a degree of leeway to determine the extent to which governing statutes, rules, regulations, or other administrative actions have pre-emptive effect. See id., at 505–506 (citing Smiley v. Citibank (South Dakota), N. A., 517 U. S. 735 –741 (1996); Hillsborough County v. Automated Medical Laboratories, Inc., 471 U. S. 707, 721 (1985) ; Lawrence County v. Lead-Deadwood School Dist. No. 40–1, 469 U. S. 256 –262 (1985); Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837 –845 (1984)). See also Wyeth v. Levine, 555 U. S. 555 –577 (2009). Cf. Skidmore v. Swift & Co., 323 U. S. 134, 140 (1944) . The FDA is responsible for administering the relevant federal statutes. And the question of pre-emption may call for considerable drug-related expertise. Indeed, one might infer that, the more medically valuable the drug, the less likely Congress intended to permit a State to drive it from the marketplace.

     At the same time, the agency can develop an informed position on the pre-emption question by providing interested parties with an opportunity to present their views. It can translate its understandings into particular pre-emptive intentions accompanying its various rules and regulations. And “[i]t can communicate those intentions  . . . through statements in ‘regulations, preambles, interpretive statements, and responses to comments.’ ” Medtronic, supra, at 506 (opinion of Breyer, J.). (quoting Hillsbor-ough, supra, at 718).

     Here, however, I cannot give special weight to the FDA’s views. For one thing, as far as the briefing reveals, the FDA, in developing its views, has held no hearings on the matter or solicited the opinions, arguments, and views of the public in other ways. For another thing, the FDA has set forth its positions only in briefs filed in litigation, not in regulations, interpretations, or similar agency work product. See Bowen v. Georgetown Univ. Hospital, 488 U. S. 204 –213 (1988) (“[A]gency litigating positions that are wholly unsupported by regulations, rulings, or administrative practice” are entitled to less than ordinary weight). Cf. Christensen v. Harris County, 529 U. S. 576, 587 (2000) .

     Finally, the FDA has set forth conflicting views on this general matter in different briefs filed at different times. Compare Wyeth, supra, at 577, 579, 580, n. 13 (noting that the FDA had previously found no pre-emption, that the United States now argued for pre-emption, and that this new position was not entitled to deference), with PLIVA, Inc. v. Mensing, 564 U. S. ___, ___, n. 3, ___ (2011) (slip op., at 6–7, n. 3, 8–11) (declining to defer to the United States’ argument against pre-emption and, instead, finding pre-emption), and with Brief for United States as Amicus Curiae 12–13 (now arguing, again, for pre-emption). See National Cable & Telecommunications Assn. v. Brand X Internet Services, 545 U. S. 967, 981 (2005) (agency views that vary over time are accorded less weight); Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co., 463 U. S. 29 –42 (1983) (same); Verizon Communications Inc. v. FCC, 535 U. S. 467 , n. 20 (2002) (same).

     Without giving the agency’s views special weight, I would conclude that it is not impossible for petitioner to comply with both state and federal regulatory schemes and that the federal regulatory scheme does not pre-empt state common law (read as potentially requiring petitioner to pay damages or leave the market). As two former FDA Commissioners tell us, the FDA has long believed that state tort litigation can “supplemen[t] the agency’s regulatory and enforcement activities.” Brief for Donald Ken- nedy et al. as Amici Curiae 5. See also Wyeth, supra, at 578 (“In keeping with Congress’ decision not to pre-empt common-law tort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation”).

     Moreover, unlike the federal statute at issue in Medtronic, the statute before us contains no general pre-emption clause. See 518 U. S., at 481–482. Cf. Wyeth, supra, at 574 (presence of pre-emption clause could show that “Congress thought state-law suits posed an obstacle to its objectives”). Furthermore, I have found no con- vincing reason to believe that removing this particular drug from New Hampshire’s market, or requiring damage payments for it there, would be so harmful that it would seriously undercut the purposes of the federal statutory scheme. Cf. post, at 21–22.

     Finally, similarly situated defendants in other cases remain free to argue for “obstacle pre-emption” in respect to damage payments or market withdrawal, and demonstrate the impossibility-of-compliance type of conflict that, in their particular cases, might create true incompatibility between state and federal regulatory schemes.

     For these reasons, I respectfully dissent.

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