Preemption, Federalism And Legal Realism

This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the authority of the United States, shall be the supreme Law of the land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.

-Article VI, Clause 2 of the US Constitution

Of all the articles, clauses and sections of the Constitution, it can be argued that the Supremacy Clause is the most direct and unambiguous. "Shall be the Supreme Law of the Land" is pretty conclusive. And yet one of the most confusing and disputed areas of the law is the preemption doctrine - particularly the concept of implied preemption. Today, Adam Liptak writes about an important case on preemption to be heard in the Supreme Court:

In November, the Supreme Court will hear arguments about whether Ms. Levine may keep more than $6 million that a Vermont jury ordered Wyeth, a pharmaceutical company, to pay her for failing to warn her adequately about the risks of one of its drugs. The case, the latest in a brisk parade of similar ones, will help define the contours of a signature project of the Roberts court.

In legal jargon, the cases concern “pre-emption,” a doctrine that can bar injured consumers like Ms. Levine from suing in state court when the products that hurt them had met federal standards. The issue is less boring and more consequential than it sounds, and Ms. Levine’s case is shaping up to be the most important business case of the term.

“Federal pre-emption is the fiercest battle in products liability law today,” said Catherine M. Sharkey, a law professor at New York University. “The court clearly recognizes this, as it has agreed to hear so many cases and seems eager to give clarity to what has been, to date, an undisputably muddled area of law.”

In his 2004 book, The Supremacy Clause, Christopher Drahozal argued:

Given the federalism revival under the Rehnquist Court, one would expect the Court to have become less likely to hold state statutes preempted in recent years. As Professor David O'Brien explains, "A Court composed of Justices who genuinely value 'dual federalism' arguably would strongly favor the states in the area of implied federal preemption."

You would think. But, as we have found throughout the history of the Court, principles are pliable. In my view, Legal Realism provides the better framework for predicting Court decisions than reviewing pronounced views on federalism and the like. Liptak writes:

In February, in Riegel v. Medtronic, an eight-justice majority of the Supreme Court ruled that many suits concerning injuries caused by medical devices were pre-empted by a 1976 federal law, in so many words. Ms. Levine’s suit represents the next frontier. “Riegel boiled down to statutory interpretation,” said Professor Sharkey, of N.Y.U. “Levine challenges the court to define the parameters of pre-emption outside the safe confines of the legislators’ text.”

The law at issue in the Levine case does not expressly require pre-emption. Rather, Wyeth and the F.D.A. argue that the company could not comply with both federal law, given its requirement that the agency approve drug labels, and the jury’s verdict, which punished Wyeth for not using a different one. That conflict, they say, amounts to “implied pre-emption.” The Vermont Supreme Court rejected that argument and upheld the jury’s verdict in 2006. Federal law, the majority ruled, “provides a floor, not a ceiling, for state regulation.”

Reigel indeed seemed straightforward. Justice Scalia wrote for the Court:

The MDA includes an express pre-emption provision that states:

“Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

“(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

“(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.” §360k(a).

The Levine case does not contain an express preemption clause. In Levine, the Vermont Supreme Court stated:

Absent clear congressional intent to supersede state law, including state common law duties, there is a presumption against preemption. Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) ("[B]ecause the States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly pre-empt state-law causes of action."); Cipollone, 505 U.S. at 516 ("Consideration of issues arising under the Supremacy Clause 'start[s] with the assumption that the historic police powers of the States [are] not to be superseded by . . . Federal Act unless that [is] the clear and manifest purpose of Congress.' " (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947))). This presumption has "add[ed] force" when there has been a "long history of tort litigation" in the area of state common law at issue. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449 (2005).

. . . In fact, Congress has expressed its purposes clearly, not only in the general sense that the statute was intended to "protect the public," but also more specifically, with respect to the FDCA's preemptive effect. In the 1962 amendments to the FDCA, Congress included a clause expressly limiting the preemptive effect of the statute: "Nothing in the amendments made by this Act to the Federal Food, Drug, and Cosmetic Act shall be construed as invalidating any provision of State law . . . unless there is a direct and positive conflict between such amendments and such provision of State law." Drug Amendments of 1962 (Harris Kefauver Act), Pub. L. No. 87 781, ¶ 202, 76 Stat. 780, 793 (1962).

This seems dispositive. But the Bush Administration FDA rides to the rescue for the drug manufacturer:

The FDA's New Statement on Preemption

Defendant, after oral argument in this case, cited a new FDA regulation that contains a statement relating to the preemptive effect of the FDCA. . . . The rule's "Supplementary Information" section . . . contains a broad statement regarding the preemption of state common-law failure-to-warn claims. Id. at 3933-36. In this statement, the FDA asserts that recent cases rejecting preemption of these claims, including those cited above, pose an obstacle to the agency's enforcement of the labeling requirements.

The Vermont Supreme Court does not buy it:

We are ordinarily required to defer to an agency's interpretation of a statute it administers. Chevron, U.S.A., Inc. v. Natural Res. Def. Council, 467 U.S. 837, 844 (1984) . . . Under Chevron, deference to an agency's interpretation is appropriate only when a statute is "silent or ambiguous with respect to the specific issue" the agency has considered; otherwise, "the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress." 467 U.S. at 842-43. . . . [T]he FDA's statement deserves no deference. We have already concluded . . . that Congress intended the FDCA to preempt only those state laws that would make it impossible for manufacturers to comply with both federal and state requirements. Nothing in the FDA's new statement alters our conclusion that it would be possible for defendant to comply with both its federal obligations and the obligations of state common law. The regulatory framework for prescription drug labeling allows drug manufacturers to add or strengthen a warning "to increase the safe use of the drug product" without prior FDA approval. . . . The FDA does not attempt to establish such a conflict or explain the inconsistency between its position and the language of the preemption amendment. The statement cites the amendment, but then proceeds as if Congress had not spoken on the issue of preemption. The agency relies on Geier to support its disregard of Congress's "direct and positive conflict" language, asserting that "[t]he existence of a legislative provision addressing pre-emption does not bar the operation of ordinary principles of implied preemption." 71 Fed. Reg. at 3935 (citing Geier, 529 U.S. at 869). Geier does state that implied preemption applies even when a statute addresses preemption expressly, 521 U.S. at 869, but it does not allow courts or agencies to preempt state laws that have been expressly preserved by Congress. . .

Here is my bold prediction -- 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.

Speaking for me only

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  • Display: Sort:
    Good golly, what a bold prediction ... (5.00 / 1) (#2)
    by Maryb2004 on Thu Sep 18, 2008 at 11:42:06 PM EST
    But, seriously, it's always nice to see you write about law.

    Full disclosure (none / 0) (#1)
    by Big Tent Democrat on Thu Sep 18, 2008 at 11:05:23 PM EST
    I have argued for conflict preemption myself against attempted state regulation of an "evil" corporation, but I never had the luxury of having a federal agency issue a comment supporting my argument while the litigation was ongoing.

    Further disclosure, while I have represented pharmaceuticals in the past in many matters, I have never represented Wyeth, and I have never represented any client in this type of case.

    Ha. "I have never had the luxury . . ." (none / 0) (#3)
    by oculus on Thu Sep 18, 2008 at 11:48:45 PM EST
    Another luxury (none / 0) (#6)
    by Steve M on Thu Sep 18, 2008 at 11:56:22 PM EST
    is arguing the pro-business side of a case before the Roberts Court.

    Good time to be a prosecutor too. (none / 0) (#7)
    by oculus on Thu Sep 18, 2008 at 11:58:01 PM EST
    Your google books link (none / 0) (#4)
    by andgarden on Thu Sep 18, 2008 at 11:49:30 PM EST
    brings up "image not available."

    I don't know if that's the link, google, or my browser.

    You're probably right. (none / 0) (#5)
    by Pegasus on Thu Sep 18, 2008 at 11:54:51 PM EST
    I trust Kennedy to do the right thing about as far as I can throw him.  I am holding out some hope here though, because as you say in the post, the FDCA preemption provision definitely seems dispositive.  Quite clearly so, IMO.

    And in my even more hopeful moments, I think even a couple of the conservative justices may not want to cede this much power to federal agencies to go against statutory intent, and thus will distinguish Chevron.  If not, it's a bit of a "God help us" moment for me.

    Query (none / 0) (#8)
    by kaleidescope on Fri Sep 19, 2008 at 02:25:16 AM EST
    Was the FDA action a full-blown regulation re preemption or was it just a comment or letter?  Here in California the FDA did this wrt nicotine patches -- simply by writing a letter -- and got the California Supreme Court to buy their preemption argument.