Preemption in products liability cases: an analysis of federal product preemption under FIFRA and Bates v. Dow Agrosciences.

AuthorDavis, William M.

THE LANDSCAPE of federal preemption with respect to product liability claims recently underwent a significant shift when the United States Supreme Court decided Bates v. Dow Agrosciences (1) on April 27, 2005. While Bates specifically involved the Federal Insecticide, Fungicide and Rodenticide Act (2) ("FIFRA"), it has much larger ramifications for federal preemption in all cases involving state-law products liability claims where the products at issue are subject to comprehensive federal regulation.

To some consumer advocates, the decision was a "victory for fairness to individuals who are poisoned by toxic pesticides," (3) while some defense counsel have decried it as "a major disappointment for industry." (4) But those on both sides of the issue tend to agree that Bates was a somewhat surprising departure from what had previously appeared to be a rather settled point of law generally favoring preemption.

This article briefly examines the historical development of Supreme Court preemption jurisprudence--particularly in the area of products liability and toxic torts--with a specific focus on Bates and the impact it has had over the last two years.

A Brief History of Preemption

In the products liability arena, federal preemption effectively shifts the responsibility of ensuring that products are developed and manufactured safely. Instead of state courts being the primary arbiters of safety, the responsibility falls to federal administrative agencies. (5)

Generally, the "historic police powers of the States [are] not to be superseded by ...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." (6) In keeping with that sentiment, "'[t]he purpose of Congress is the ultimate touchstone'" (7) of preemption analysis.

Preemption may be either explicit or implicit. In Gade v. National Solid Wastes Group, Inc., (8) the Supreme Court recognized three instances in which federal law preempted state law: "explicit preemption;" and two sub-categories of implied preemption: "field preemption" and "conflict preemption."

Explicit preemption occurs where Congress's intent is to explicitly preempt state law, as when there is clear preemptive language contained within a statute. However, Congress need not explicitly state a purpose to preempt. (9) Thus it is possible for there to be implied preemption, which occurs in two scenarios (10) in the absence of a specific Congressional command: (1) when state law actually conflicts with federal law ("conflict preemption"); (11) or (2) when federal law so thoroughly occupies an area of the law "'as to make reasonable the inference that Congress left no room for the States to supplement it'" ("field preemption"). (12) Conflict preemption-which is most prevalent in the products liability arena--has generally been described by the Supreme Court as arising when "it is impossible for a private party to comply with both state and federal requirements or where state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." (13)

  1. Cipollone v. Liggett Group--The Dawn of Product Preemption

    The first significant Supreme Court case which influenced the decisions of lower courts regarding preemption in products liability cases was Cipollone v. Liggett Group. (14) This case was of particular interest to many practitioners involved in both products liability and toxic tort cases because the facts of Cipollone were similar to that of any generic product case: private litigants attempting to advance state law tort claims (specifically, "failure to warn" and "breach of express warranty") in the face of an apparently preemptive federal regulatory scheme.

    Cipollone specifically involved the preemptive effect of the Federal Cigarette Labeling and Advertising Act (15) ("CLAA") upon state law damage claims. It was also the first Supreme Court decision to significantly discuss the term "requirement" as used in a federal regulatory statute as a basis for preemption of state law. From Cipollone forward, the Court has generally focused upon language in federal regulatory schemes that prohibits states from imposing additional "requirements" upon the regulated entities.

    As explained by the Court, CLAA specifically sought to preempt state law in order to advance two key interests: (1) adequately informing the public that cigarette smoking may be hazardous to individual health; and (2) protecting the national economy from the burden imposed by diverse, nonuniform, and confusing cigarette labeling and advertising regulations. (16) To accomplish that end, the statutory text of the CLAA specified that cigarette packages were to bear a uniform label which was not to be altered pursuant to any state law. (17)


    (a) Additional statements: No statement relating to smoking and health, other than the statement required by section 1333 of this title, shall be required on any cigarette package.

    (b) State regulations:

    No requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of this chapter. (18)

    Based on the text of the statute, it would appear that this is an example of express preemption. However, the issue in Cipollone was whether or not the plaintiff's state law tort claims--to the extent that they alleged that cigarette manufacturers had failed to warn smokers of the inherent dangers of cigarette smoking--could be properly characterized as an attempt by the state to impose case law "requirements" upon cigarette manufacturers which would essentially call for an alteration to the labeling of cigarette packages. In other words: Could it be said that a judgment handed down by the state court in favor of the plaintiffs was, effectively, a state regulation of cigarette labeling? The express preemption statute of CLAA would need to be analyzed.

    The Court recognized that "the term 'regulation' most naturally refers to positive enactments by [lawmaking/rulemaking] bodies, not to common-law damage actions." (19) Indeed, this seems to be a rather common-sense import of "regulation." However, the Court would have to focus upon the textual subtleties of CLAA that were relevant to determining if "regulation" as defined in jurisprudence was similar to "requirement" as used in CLAA.

    The Court found that the phrase "requirement or prohibition" used in CLAA's preemption clause was swept more broadly than the term "regulation" alone. (20) Thus, the Court held that CLAA "suggests no distinction between positive enactments and common law; to the contrary, those words easily encompass obligations that take the form of common-law rules." (21)

    While the semantics of "requirement or prohibition" versus "regulation" may seem to be a bit of a fine line, (22) this interpretation spawned a new series of jurisprudence that hinges upon the subtleties of the term "requirement" as used in various federal preemption statutes. In short, the Supreme Court has given very limited meaning to the word, addressing it solely against the narrow backdrop of the individual legislative scheme in which it is used.

    With the term "requirement" now effectively defined as embracing common-law decisional rules, the Cipollone Court continued to explain that "[state] regulation can be as effectively exerted through an award of damages as through some form of preventative relief. The obligation to pay compensation can be, indeed is designed to be, a potent method of governing conduct and controlling policy." (23) However, even though "the preemptive scope of [CLAA's preemption clause] cannot be limited to positive enactments," (24) it does not necessarily follow "that that section preempts all common-law claims." (25) Therefore, the Court recognized that it "must fairly--but in light of the strong presumption against preemption--narrowly construe the precise language of [CLAA's preemption clause] and ... must look to each of petitioner's common-law claims to determine whether it is in fact preempted." (26)

    Proceeding on a claim-by-claim basis, the Court found that the petitioner's "failure to warn" claim would impose additional "requirements" and was therefore clearly preempted. (27) However, with regard to the petitioner's "breach of express warranty" claim, the Court explained that preemption was inappropriate since a warranty is a contractual undertaking by the warrantor rather than a requirement imposed under state law. (28)

    Cipollone was quickly interpreted by several commentators as establishing a clear distinction between express and implied preemption cases. (29) Where Congress included a preemption provision in a particular legal regime, it was believed that courts must conduct only an express preemption analysis. (30)

  2. Medtronic v. Lohr--Keeping in Pace with Express Preemption

    After Cipollone, the Supreme Court found occasion to revisit its express preemption analysis in Medtronic v. Lohr. (31) This case involved a suit by private litigants against a manufacturer of medical devices who sold them a defective pacemaker.

    Defendant Medtronic argued that the plaintiff's negligence and strict liability claims were preempted by the applicable Medical Device Amendments (MDA) of 1976. (32) Once again, the term "requirement" was at issue; and once again a defendant manufacturer was arguing that "requirements" included state common law damage claims. (33) Yet this time the Supreme Court was unwilling to give the term such a broad meaning.

    The relevant preemption section of the MDA--[section] 360k states:

    State and local requirements respecting devices.

    (a) General rule 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...

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