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SCOTUS Rules FDA Labeling Regs Do Not Preempt State Law Tort Claims

By Big Tent Democrat

I was wrong when I predicted that "the Roberts Court will disagree with the Vermont Supreme Court on the deference due the Bush FDA's pronouncements on conflict preemption and declare that, adhering to Chevron, it will reverse the Vermont Supreme Court in Levine. It's the Legal Realist in me." Today, the Supreme Court, by a 6-3 vote, ruled that FDA's labelling regulations do not preempt (PDF) state law tort claims:

Justice Stevens, writing for himself, and Justices Souter, Ginsburg, Breyer and Kennedy (Justice Breyer also wrote a separate short concurrence and Justice Thomas concurred in a very interesting opinion that merits a separate post which I will undertake later), stated:

If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the FDCA’s 70-year history. But despite its 1976 enactment of an express preemption provision for medical devices, see §521, 90 Stat. 574 (codified at 21 U. S. C. §360k(a)), Congress has not enacted such a provision for prescription drugs. See Riegel, 552 U. S., at ___ (slip op., at 14) (“Congress could have applied the pre-emption clause to the entire FDCA. It did not do so, but instead wrote a preemption clause that applies only to medical devices”).8 Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness. . . . Despite this evidence that Congress did not regard state tort litigation as an obstacle to achieving its purposes,Wyeth nonetheless maintains that, because the FDCA requires the FDA to determine that a drug is safe and effective under the conditions set forth in its labeling, the agency must be presumed to have performed a precise balancing of risks and benefits and to have established a specific labeling standard that leaves no room for different state-law judgments. In advancing this argument, Wyeth relies not on any statement by Congress, but instead on the preamble to a 2006 FDA regulation governing the content and format of prescription drug labels. See Brief for Petitioner 8, 11, 42, 45, and 50 (citing 71 Fed. Reg. 3922 (2006)). In that preamble, the FDA declared that the FDCA establishes “both a ‘floor’ and a ‘ceiling,’” so that“FDA approval of labeling . . . preempts conflicting or contrary State law.” Id., at 3934–3935. It further stated that certain state-law actions, such as those involving failure-to-warn claims, “threaten FDA’s statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs.” Id., at 3935.

This Court has recognized that an agency regulation with the force of law can preempt conflicting state requirements. See, e.g., Geier v. American Honda Motor Co., 529 U. S. 861 (2000); Hillsborough County v. Automated Medical Laboratories, Inc., 471 U. S. 707, 713 (1985). In such cases, the Court has performed its own conflict determination, relying on the substance of state and federal law and not on agency proclamations of preemption. We are faced with no such regulation in this case, but rather with an agency’s mere assertion that state law is an obstacle to achieving its statutory objectives. Because Congress has not authorized the FDA to preempt state law directly, cf. 21 U. S. C. §360k (authorizing the FDA to determine the scope of the Medical Devices Amendments’ preemption clause),9 the question is what weight we should accord the FDA’s opinion.

In prior cases, we have given “some weight” to an agency’s views about the impact of tort law on federal objectives when “the subject matter is technica[l] and the relevant history and background are complex and extensive.” Geier, 529 U. S., at 883. Even in such cases, however, we have not deferred to an agency’s conclusion that state law is preempted. Rather, we have attended to an agency’s explanation of how state law affects the regulatory scheme. While agencies have no special authority to pronounce on preemption absent delegation by Congress, they do have a unique understanding of the statutes they administer and an attendant ability to make informed determinations about how state requirements may pose an“obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Hines, 312 U.S, at 67; see Geier, 529 U. S., at 883; Lohr, 518 U. S., at 495–496. The weight we accord the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness. Cf. United States v. Mead Corp., 533 U. S. 218, 234–235 (2001); Skidmore v. Swift & Co., 323 U. S. 134, 140 (1944).

Under this standard, the FDA’s 2006 preamble does not merit deference. When the FDA issued its notice of pro posed rulemaking in December 2000, it explained that the rule would “not contain policies that have federalism implications or that preempt State law.” 65 Fed. Reg. 81103; see also 71 id., at 3969 (noting that the “proposed rule did not propose to preempt state law”). In 2006, the agency finalized the rule and, without offering States or other interested parties notice or opportunity for comment, articulated a sweeping position on the FDCA’s preemptive effect in the regulatory preamble. The agency’s views on state law are inherently suspect in light of this procedural failure.

Further, the preamble is at odds with what evidence we have of Congress’ purposes, and it reverses the FDA’s own longstanding position without providing a reasoned explanation, including any discussion of how state law has interfered with the FDA’s regulation of drug labeling during decades of coexistence. The FDA’s 2006 positionp lainly does not reflect the agency’s own view at all times relevant to this litigation. Not once prior to Levine’s injury did the FDA suggest that state tort law stood as an obstacle to its statutory mission. To the contrary, it cast federal labeling standards as a floor upon which States could build and repeatedly disclaimed any attempt to preempt failure-to-warn claims . . .

Ouch. Justice Stevens called out the Bush FDA there. Justice Alito, writing for himself and Chief Justice Roberts and Justice Scalia, argued for the Bush FDA:

[T]he Court today distinguishes Geier because the FDA articulated its preemptive intent “without offering States or other interested parties notice or opportunity for comment.” Ante, at 21; see also ante, at 24. But the Geier Court specifically rejected the argument (again made bythe dissenters in that case) that conflict preemption is appropriate only where the agency expresses its preemptive intent through notice-and-comment rulemaking.Compare 529 U. S., at 885 (“To insist on a specific expression of agency intent to pre-empt, made after notice-and comment rulemaking, would be in certain cases to tolerate conflicts that an agency, and therefore Congress, is most unlikely to have intended. The dissent, as we have said, apparently welcomes that result . . . . We do not”), with id., at 908–910 (STEVENS, J., dissenting) (emphasizing that “we generally expect an administrative regulation to declare any intention to preempt state law with some specificity,” and that “[t]his expectation . . . serves to ensure that States will be able to have a dialog with agencies regarding preemption decisions ex ante through the normal notice-and-comment procedures of the Administrative Procedure Act” (internal quotation marks omitted)). Indeed, preemption is arguably more appropriate here than in Geier because the FDA (unlike the DOT) declared its preemptive intent in the Federal Register. See 71 Fed. Reg. 3933–3936. Yet the majority dismisses the FDA’s published preamble as “inherently suspect,” ante, at 21, and an afterthought that is entitled to “no weight,” ante, at 25. Compare Lohr, supra, at 506 (opinion of BREYER, J.) (emphasizing that the FDA has a “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 withfederal objectives,” and that “[t]he FDA can translate these understandings into particularized preemptive intentions . . . through statements in ‘regulations, pre-ambles, interpretive statements, and responses to comments’”).

Justice Alito's gamesmanship on the FDA preamble is simply funny to me. He knew what the Bush FDA's game was.

The real news to me is Justice Kennedy is looking more and more like a firm vote in the Breyer/Stevens group. In a business case like this, I figured he would slip in with Roberts & Co. and that Thomas would be dragged along to make a 5 vote majority.

Obviously, I was wrong.

Speaking for me only

Full post as published by TalkLeft on March 04, 2009 (boomark / email).