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Generally, the "historic police powers of the States [are] not to be superseded by ...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)
A. 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)
B. 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 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. (34)
Medtronic argued that this section would preempt state law damage claims just as the preemption clause in CLAA did under Cipollone. Recall that the relevant statutory clause in Cipollone preempted any "requirement or prohibition based on smoking and health ... imposed under State law ... with respect to ... cigarettes ... labeled in conformity with the provisions of [CLAA]." (35) Compare this to the relevant provision in Medtronic, which prohibited any "State ... requirement (1) which is different from, or in addition to, any requirement applicable under [the MDA] ... and (2) which related to the safety or effectiveness of the device ..." (36) Seem similar? The Medtronic Court disagreed.
Medtronic's argument is not only unpersuasive, it is implausible. Under Medtronic's view of the statute, Congress effectively precluded state courts from affording state consumers any protection from injuries resulting from a defective medical device. Moreover, because there is no explicit private cause of action against manufacturers contained in the MDA, and no suggestion that the Act created an implied private right of action, Congress would have barred most, if not all, relief for persons injured by defective medical devices. Medtronic's construction of [section] 360k would therefore have the perverse effect of granting complete immunity from design defect liability to an entire industry that, in the judgment of Congress, needed more stringent regulation in order "to provide for the safety and effectiveness of medical devices intended for human use." (37)
The Court squared this reasoning with Cipollone by explaining further:
[I]f Congress intended to preclude all common-law causes of action, it chose a singularly odd word with which to do it. The statute would have achieved an identical result, for instance, if it had precluded any 'remedy' under state law relating to medical devices. "Requirement" appears to presume that the State is imposing a specific duty upon the manufacturer, and although we have on prior occasions concluded that a statute preempting certain state "requirements" could also preempt common-law damages claims ... that statute did not sweep nearly as broadly as Medtronic would have us believe that this statute does. (38)
The Medtronic Court distinguished the case at bar from Cipollone analysis in four distinct ways: First, Court explained that the MDA was a significantly "narrower" regulatory scheme than the one involved in Cipollone and provided no private cause of action against manufacturers. Under this reasoning, the Court explained that the plaintiffs' state-law defective design claims were not "different from, or in addition to" any requirements contemplated by the MDA because the Act itself did not establish any requirements with respect to the safety or effectiveness of the pacemakers. (39)
Second, the MDA itself used the term "requirement" throughout its text in a fashion that suggested it did not include common-law remedies but instead focused upon state laws and/or administrative regulations targeted directly toward a particular medical device. (40) For this reason, the plaintiffs' claims which were based upon the manufacturing and labeling of the pacemaker were not preempted, since the MDA provisions related to manufacturing and labeling were general controls rather than device-specific requirements. (41)
Third, the legislative history of the MDA indicated no Congressional intent to supplant state common law. (42) Moreover, the plain text of the MDA indicated that it preempted state law only to the extent that such law conflicted with requirements promulgated by the FDA, and therefore the MDA was not a self-acting preemptive provision. (43)
Finally--and most importantly--the Court noted that common law causes of action in this case would merely exist as "parallel requirements" to the statutory scheme; thus, the existence of state-law remedies would only provide an additional incentive to medical device manufacturers to do what they were supposed to be doing anyway: complying with FDA safety requirements. Thus, the plaintiffs claims which alleged noncompliance with several of the standards set forth in the MDA were not preempted.
C. Post-Medtronic--A Confusing Landscape
In the legal climate which prevailed after Medtronic, many lower courts continued to produce contradictory opinions regarding whether or not various federal regulatory schema preempted state law. This situation was not improved by a series of confusing Supreme Court decisions discussing implied preemption doctrine. Two Supreme Court cases created a good deal of confusion regarding whether a distinction existed between implied preemption doctrine and express preemption, leading Justice Kennedy to speculate that the Court might be confusing the various preemption doctrines as a veiled effort to limit the effectiveness of product liability remedies. (45)
In Geier v. American Honda Motor Company, (46) the Court applied implied preemption analysis to hold that state tort claims brought against a vehicle manufacturer for failing to equip the vehicle with airbags were impliedly preempted under a federal statute which--similar to those in Cipollone and Medtronic contained a preemption provision. (47) Five years after Medtronic, the Court revisited preemption under the MDA in the case of Buckman Co. v. Plaintiffs' Legal Committee. (48) In that case, the Court employed an implied preemption analysis when discussing the plaintiffs' fraud claims related to bone screws, holding that the unique federal interests at stake required "a somewhat delicate balance of statutory objectives," (49) thus, conflict preemption existed.
The effect of these decisions was to muddle the landscape in product preemption cases, as the proper methodology for express preemption analysis was obscured by improper discussions of implied preemption. The once-clear standard that the intent of Congress, if clearly expressed, determined preemption had diminished value, as many courts began to apply implied preemption analysis in inappropriate situations. This resulted in a number of conflicting opinions.
Consider FIFRA as an example: In the context of the Federal Fungicide, Insecticide and Rodenticide Act--where federal law regulates the labeling of a variety of chemical products--some courts held that all state law causes of action which related in any way to labeling of products governed by FIFRA (such as "failure to warn" or "breach of warranty") were preempted. (50) Other courts produced somewhat similar decisions which explained that FIFRA did not preempt state tort claims which are were unrelated to labeling. (51) Still other courts upheld state tort claims in spite of FIFRA. (52) Such was the post-Medtronic landscape. And then came Bates.
Product Preemption Under the Federal Insecticide, Fungicide and Rodenticide Act ("FIFRA")
Presently, FIFRA requires manufacturers who wish to register their pesticides to submit a proposed label and supporting data to the EPA. (53) The Agency will then decide whether or not to register the pesticide based upon three criteria: (1) efficacy; (54) (2) potential of unreasonable adverse effects on humans and the environment; (55) and (3) compliance with the statutory prohibitions on misbranding. (56)
In response to concerns of the EPA regarding its ability to adequately evaluate pesticide efficacy without diverting too many resources from its primary responsibility of assessing any environmental and health-related impact the proposed pesticides might have, Congress authorized the agency to waive data requirements pertaining to efficacy. (57) The EPA invoked this grant of power in 1979 and has not since revisited the business of efficacy testing. (58)
With respect to state law, FIFRA provides in pertinent part:
(a) In general. A state may regulate the sale or use of any federally registered pesticide or device in the State, but only if and to the extent the regulation does not permit any sale or use prohibited by this Act. (b) Uniformity. Such State shall not impose or continue in effect any requirement for labeling or packaging in addition to or different from those required under this Act. (59)
Thus, FIFRA envisions a joint regulatory scheme in which state and federal officials work together to ensure that so-called "economic poisons" such as pesticides are designed and used in a safe manner; however, in some cases the federal government (acting through the EPA) is given preference with respect to the promulgation of rules.
Dow argued that an adjudication of the farmers' claims by a Texas state court would run afoul of FIFRA's proscriptions. (60) To wit, since the farmers' claims were dependent upon the accuracy of the label, a decision against Dow would effectively be a decision by the state of Texas proclaiming Dow's label insufficient and thereby instituting a state label "requirement" in excess of that required by the EPA.
Now You See It, Now You Don't: The Shifting Opinion of the EPA
While the opinion of the EPA is certainly not legally binding, an analysis of the various actions taken by the EPA helps to shed some light on the key issues surrounding FIFRA litigation, and also provides some interesting insight into the political motivations inherent in policy decisions.
Noting that many of the courts were interpreting FIFRA as preempting state causes of action (61) despite the apparently narrow preemptory context of [section] 136v, the EPA promulgated Pesticide Regulation Notice 96-4 on June 3, 1996. (62) The Notice set out some broad guidelines to assist courts and legal practitioners in understanding the role of the EPA in pesticide regulation under the FIFRA regime. "The EPA is issuing this notice at this time to correct a misunderstanding regarding the FIFRA label approval process and efficacy claims that is reflected in a series of court decisions concerning the preemptive effect of FIFRA." (63)
The EPA began by clarifying its purpose: to mitigate environmental and health-related risks. In carrying out its mandate through the prudent use of limited resources, the EPA is unable to perform tests to determine whether or not chemicals registered pursuant to FIFRA will have a deleterious effect on property. "Having directly given EPA the authority to disregard efficacy issues, Congress could not have intended that, once EPA exercised this authority, the same efficacy issues would come in through the back door of the label approval process. .. In light of EPA's waiver of the efficacy data requirement for initial registration, these [property damage / efficacy] issues would generally only arise following the registration of the pesticide, including approval of the pesticide label." (64) (emphasis added)
The Notice also suggests that the positions of Congress and the EPA are clear regarding the propriety of state law actions as a means of regulating pesticide efficacy. "The legislative history explains that Congress believed that product performance issues for agricultural pesticides were adequately addressed by information from government and university sources and market forces." (65) In requesting from Congress the authority to waive efficacy testing, "EPA concluded that agriculture pesticides are 'effectively regulated by the marketplace.'" (66)
Although the Notice was published shortly before the Medtronic decision, it was remarkably prescient. In very plain language, the EPA succinctly stated that its main concern under FIFRA was the protection of the populace from health risks presented by pesticides--a fact which is readily comparable to the position of the FDA regarding the MDA in Medtronic. (67) Furthermore, the EPA noted that the logical result of its decision to forgo efficacy testing was that most efficacy-related issues would only arise after a label had been approved; thus any redress of such claims would naturally fall under the purview of state courts, as FIFRA does not provide a private fight of action. (68)
After the publication of the Pesticide Regulation Notice, the EPA took extra steps to more clearly articulate its message to the courts by submitting amicus briefs in two critical appeals in Hart v. Bayer and Etcheverry v. Tri-Ag Service, Inc. (69) "In June 1996, recognizing that the decisions holding that FIFRA preempts state tort law reflect a widespread misunderstanding of EPA's role in regulating pesticides, EPA issued Pesticide Regulation Notice 96-4. Having published PR 96-4, the United States submits this brief to more fully inform the Court of its views on the preemptive force of FIFRA." (70)
The attorneys for the EPA explained that "[b]ecause FIFRA does not broadly regulate product efficacy claims, FIFRA should not be held to preempt state damages actions regarding pesticide efficacy." (71) Furthermore, since the EPA had waived efficacy testing, "[e]ven if FIFRA could be read to preempt some state damages actions, it cannot be read to preempt tort actions addressing the efficacy of pesticides." (72)
The briefs filed by the EPA attempted to systematically distinguish the FIFRA regulatory scheme from Cipollone. Using reasoning which paralleled that of the Medtronic Court, the EPA attorneys began by distinguishing the term "requirements" in FIFRA by focusing on its use throughout the statute. (73) "Cipollone and Medtronic may appear to be in some tension but in fact teach the same lesson: that the term 'requirements' must be interpreted in its statutory context." (74)
The United States does not dispute the contention that in some contexts the word "requirements" may encompass obligations imposed through common law damages actions. The text, legislative history and purposes of FIFRA demonstrate, however, that, as it is used in section 136v(b), the term "requirements" means direct commands imposed by law regarding the contents of labels. In this context, the term "requirements" does not include state damages actions because such actions do not mandate any changes in labeling. (75)
Just as the Court did in Medtronic, (76) the EPA spoke to the particular usage of the term "requirement" as used throughout the entirety of FIFRA. (77) The EPA noted that in each of the seventy-five times that the word "requirements" appears in FIFRA, it referred only to positive law enactments rather than common law claims. (78)
The EPA also presented a thorough discussion of the legislative history of FIFRA which suggested that there was little discussion of preemption during the lawmaking process. (79)
[During the floor debates], pesticide industry representatives mentioned, offhandedly, that product liability lawsuits had been brought against their companies, but none of the 250 witnesses, including the 36 pesticide industry witnesses, or any Member of Congress, suggested that Congress should protect the pesticide industry from such actions. In 2,389 pages of committee hearing transcripts, the subject of common law tort actions was raised exactly five times, and not once in the context of preemption. The discussion of preemption, in contrast, exclusively addressed the ongoing regulatory authority (80) of state administrative agencies.
Moreover, the EPA explained that "indirect pressure to change a pesticide label does not frustrate Congress' purpose of establishing nationally uniform pesticide labels ... [The labeling] process is the same whether the labeling change is prompted by state damages liability or state regulation authorized by FIFRA." (81) Additionally, the legislative mechanism for approving labels suggests that Congress expected state courts to continue to serve as the front-line for pesticide efficacy litigation. "Because pesticide manufacturers remain free to seek alterations of their labels, however, EPA approval of a pesticide label should not completely shield a pesticide manufacturer from state law liability." (82)
Finally, the EPA briefs squarely endorsed the Medtronic "parallel requirements" doctrine: "Because the state duty to warn parallels the federal misbranding prohibition, it is not preempted by section 136v(b)." (83)
What is particularly interesting about the EPA's position is that it suggests that the only state law claims related to labeling which should be viable are those related to property damage and / or efficacy. Since the EPA continues to vigorously assess the environmental and health-related impacts of pesticides prior to approval, health-related personal injury claims might stand on less substantial ground.
Changes in Attitude
Changes in administrations often bring changes in direction for executive agencies. The EPA's stance on FIFRA preemption is a stark example of this political phenomenon. Three years after the publication of PR 96-4, the Etcheverry Brief, and the Hart Brief, the United States filed an amicus brief on behalf of the EPA in the Texas case of American Cyanamid v. Geye. (84) The change in tone from the prior briefs is remarkable.
The United States has reexamined the position that it urged in those cases and has concluded that its arguments that FIFRA categorically does not preempt common law actions are incorrect. That position no longer represents the view of the United States. Rather, the United States submits that state-law damages claims are within the scope of Section 136v(b) where the state-created legal duty on which the suit is predicated would "impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under [FIFRA]." (85)
The EPA's new position demands that the inquiry be centered on an analysis of whether or not the particular state law claims would effectively impose a requirement in contravention of FIFRA (86)--a harkening back to the "case-by-case" analysis advocated in Cipollone. Since the Texas Supreme Court had not conducted such an evaluation and because the record did not fully disclose the nature of the plaintiff's claims, the "United States t[ook] no position at [that] time with respect to whether, or to what extent, [plaintiff's] claims are preempted." (87)
The EPA crystallized its drastic change in position just eighteen months later when it filed an amicus brief in the Bates v. Dow Agrosciences case. While the Geye Brief appeared to leave some room open for possible state-law claims which might not be preempted, the Bates Brief signified that the EPA was interested in slamming the door. It presented arguments which specifically attacked the four fundamental precepts which had been coexistent throughout Medtronic, the Hart Brief, and the Etcheverry Brief.
First, the "new" EPA sought to break the distinction between regulations relating to efficacy versus those relating to safety. The waiver of efficacy testing by the EPA established a strong factual similarity between FIFRA preemption issues and the MDA preemption issues which had been litigated in Medtronic; if efficacy was not regulated by the federal government, then an allowance must be made for the states to provide a forum for the redress of grievances. In an effort to sever the ties between the Agency's previous position and the Medtronic reasoning, the Bates Brief insisted that there was "no basis for distinguishing, for purposes of applying Section 136v(b)'s express preemption provision, label requirements respecting product efficacy from other label requirements addressing, for example, safety, health, or environmental concerns." (88)
Second, the government sought to attack the essence of the word "requirement" by suggesting that it clearly included not only enactments of positive law, but also common law claims. (89) Third, the government cited the legislative history (although much less exhaustively than had been done in the Hart and Etcheverry Briefs) for the proposition that Congress actively intended FIFRA to supplant all state legislation and any claims brought under state law. (90)
Finally, the Bates Brief sought to refute the application of the Medtronic "parallel requirements" doctrine to FIFRA claims: "Section 136v(b) also does not exempt from preemption common law duties, such as those prohibiting 'false or misleading' statement, that are facially 'consistent with' FIFRA's misbranding prohibitions." (91)
This was indeed a clear break with tradition for the EPA. (92) The writers of the Hart and Etcheverry Briefs, who crafted their arguments to parallel the Medtronic case, had now been supplanted by the new writers of the Bates Brief who now aligned the EPA with the reasoning in Cipollone.
Bates v. Dow Agrosciences: Setting the Record Straight
The plaintiff farmers in Bates had initially brought an action in Texas state court alleging false advertising, breach of warranty and fraudulent trade practices under the Texas Deceptive Trade Practices Act (93) ("DTPA"). Specifically, the farmers alleged that Strongarm (a herbicide manufactured by Dow) had stunted the growth of their peanut plants, thereby reducing yield and increasing the expense of harvesting future crops.
Strongarm had originally been marketed under a label which extolled the safe use of the product "in all areas where peanuts are grown." (94) However, it was later discovered that the use of Strongarm in soils with a pH (95) of 7.2 or higher (as was the case with the soil of the plaintiff farmers) causes damage to crops. Dow subsequently recognized this effect and changed the Strongarm label after securing an approval from the Environmental Protection Agency (EPA). (96)
Before the Texas proceeding picked up steam, Dow filed an action in federal court seeking a declaratory judgment to establish, inter alia, that FIFRA preempted the farmers' state law claims.
1. The Lower Courts
The United States District Court for the Northern District of Texas granted Dow's motion for summary judgment, and the farmers appealed. The Fifth Circuit affirmed the decision of the lower court, applying reasoning similar to that used at that time by many courts throughout the United States with respect to the issue of FIFRA preemption.
Citing earlier Fifth Circuit decisions, the court annunciated its three-part position regarding FIFRA: (1) "FIFRA does not completely preempt all state or local regulation of pesticides;" (97) (2) "FIFRA does not preempt common law that is unconcerned with herbicide labeling, nor does it preempt those state laws concerned with herbicide labeling that do not impose any requirement in addition to or different from the FIFRA requirements;" (98) and (3) "FIFRA preempts state laws that either directly or indirectly impose different labeling requirements." (99) Under those guidelines, the court framed the issue as: "[W]hether the scope of FIFRA's express preemption clause includes product effectiveness claims which relate to product labeling." (100) Therefore, the "farmer's claims, including those which challenge Strongarm's effectiveness, are within the scope of FIFRA's express preemption clause if they are related to the content of the Strongarm label." (101)
Since the determination of whether or not the farmer's claims should withstand summary judgment rested upon their relatedness to the FIFRA labeling statute, the Fifth Circuit discussed the methodology that should be used to determine the extent of the relatedness. Specifically, the court indicated that a detailed inquiry into the facts and circumstances of the claims is unnecessary; rather, the relatedness of the claims to a particular product label "may be determined simply by reference to the party s pleadings." (102)
At the time, a jurisprudential doctrine which had become known as the "inducement test" had gained some purchase as a means of determining how closely related a plaintiff's claims were to labeling requirements under FIFRA. The Fifth Circuit adopted this test and explained that claims are related to FIFRA (and thus preempted) if they could possibly result in a judgment against the manufacturer that "would induce [the manufacturer] to alter its product label." (103) Thus, since a judgment in favor of the farmers would induce Dow to alter its label (to avoid future liability), the judgment in favor of preemption was upheld.
The legal reasoning of the Fifth Circuit seemed to comport with the general principles which had developed in preemption jurisprudence at that time. Like Cipollone and Medtronic this appeared to be a clear case of express preemption. But making an argument which falls somewhere between Cipollone and Medtronic is an exercise in hair-splitting. In that regard, the Fifth Circuit's "inducement test" seemed like a reasonable standard. If nothing else, it might have been a welcome measuring stick in an area of the law which had never lent itself to precise estimation. But, as the Bates Court would indicate, the contours of preemption are subtle, and the "inducement test" was simply too much of a blunt instrument. Did Congress really intend FIFRA to be a blanket immunity for pesticide manufacturers? (104) The stage was set to address the tension between Cipollone and Medtronic.
2. The United States Supreme Court
Prior to Bates, most court decisions and many of the arguments advanced in briefs drew battle lines between the logic of Cipollone and Medtronic. But the Bates decision indicated that a melding of the two philosophies was more appropriate.
The controversy in Bates centered on [section] 135v of FIFRA, which reads:
(a) In general. A state may regulate the sale or use of any federally registered pesticide or device in the State, but only if and to the extent the regulation does not permit any sale or use prohibited by this Act. (b) Uniformity. Such State shall not impose or continue in effect any requirement for labeling or packaging in addition to or different from those required under this Act. (105)
It should come as no surprise that the term "requirements" as used in [section] 136v was once again at issue. But this time, the Court addressed the question which it had skipped in Medtronic and used the Cipollone reasoning to explain that "the term 'requirements' in [section] 136v(b) reaches beyond positive enactments, such as statutes and regulations, to embrace common-law duties." (106)
Rather than merely deciding whether or not the statute contained a textual basis for preemption, the Court went further to discuss the scope of the preemption. (107) In fact, the scope of preemption was the critical issue, as the Court agreed with the Fifth Circuit that the term "requirements" was broad enough to encompass state common law duties in addition to positive law enactments. (108) Writing for the majority, Justice Stevens noted that the plain language of the statute set out two conditions before state law would be preempted: The proposed "requirement" to be preempted must (1) affect labeling or packaging; and (2) be in addition to or different from federal requirements under the statutory scheme. (109)
Applying this "test" for FIFRA preemption, the majority felt that it "is perfectly clear that many of the common-law rules upon which petitioners rely do not satisfy the first condition." (10)
An example of the Court's reasoning can be found in its analysis of the farmers' breach of express warranty claim--a claim which was similarly analyzed in Cipollone. (111) The Court explained that the claim (as was true of most of the farmers' claims) could not be reasonably understood as a "requirement" in contravention of [section] 136v:
To be sure, Dow's express warranty was located on Strongarm's label. But a cause of action on an express warranty asks only that a manufacturer make good on the contractual commitment that it voluntarily undertook by placing that warranty on its product. Because this common-law rule does not require the manufacturer to make an express warranty, or in the even that the manufacturer elects to do so, to say anything in particular in that warranty, the rule does not impose a requirement "for labeling or packaging." (112)
Thus, the analysis should be brought to bear on the relationship of the state claim to the statutory scheme as was indicated in Cipollone. However, the inquiry should be confined solely to a comparison of the purpose and intent of allowing the claim, rather than the potential effects of allowing the claim. "The proper inquiry calls for an examination of the elements of the common-law duty at issue ... it does not call for speculation as to whether a jury verdict will prompt the manufacturer to take any particular action (a question, in any event, that will depend on a variety of cost/benefit calculations best left to the manufacturer's accountants)." (113)
Hence, the "inducement test" adopted by the Fifth Circuit was abrogated. "The inducement test is unquestionably overbroad because it would impeach many 'genuine' design defect claims that Dow concedes are not pre-empted." (114)
The Court also examined the legislative history of FIFRA, employing reasoning similar to that used in Medtronic. "It is highly unlikely that Congress endeavored to draw a line between the type of indirect pressure caused by a State's power to impose sales and use restrictions and the even more attenuated pressure exerted by common-law suits. The inducement test is not supported by either the text or the structure of the statute." (115) Additionally, the prevailing legal and political background at the time of the enactment of FIFRA was examined in order to illuminate Congress' intent. "The long history of tort litigation against manufacturers of poisonous substances adds force to the basic presumption against pre-emption. If Congress had intended to deprive injured parties of a long available form of compensation, it surely would have expressed that intent more clearly." (16)
The rationale of Medtronic also found its way into the Bates opinion by way of the Court's reiteration of the "parallel requirements" doctrine. "Unlike the preemption clause at issue in Cipollone, [section] 136v(b) prohibits only state-law labeling and packaging requirements that are 'in addition to or different from' the labeling and packaging requirements under FIFRA. Thus, a state-law labeling requirement is not pre-empted by [section] 136v(b) if it is equivalent to, and fully consistent with, FIFRA's misbranding provisions." (117) "The 'parallel requirements' reading of [section] 136v(b) that we adopt today finds strong support in Medtronic, Inc. v. Lohr." (118)
Finally, the Court briefly discussed the policies underlying FIFRA, noting that the regulatory scheme was more similar to that in Medtronic than in Cipollone. "Private remedies that enforce federal misbranding requirements would seem to aid, rather than hinder, the functioning of FIFRA. Unlike the cigarette labeling law at issue in Cipollone, which prescribed certain immutable warning statements, FIFRA contemplates that pesticide labels will evolve over time, as manufacturers gain more information about their products' performance in diverse settings." (118)
This melding of logic from Cipollone and Medtronic resulted in the Supreme Court reversing the decisions of the lower courts and holding FIFRA to not preempt claims for defective design, defective manufacture, negligent testing, breach of express warranty and violation of the DTPA. (120) As the determination of preemption must be made on a "claim-by-claim" basis, the Court indicated that caution should be exercised when dismissing FIFRA cases under summary judgment. "Unlike their other claims, petitioner's fraud and negligent-failure-to-warn claims are premised on common-law rules that qualify as 'requirements for labeling or packaging.'" However, "some of those courts too quickly concluded that failure-to-warn claims were pre-empted under FIFRA, as they were in Cipollone, without paying attention to the rather obvious textual differences between the two pre-emption clauses." (121)
In undertaking a pre-emption analysis at the pleadings stage of a case, a court should bear in mind the concept of equivalence. To survive pre-emption, the state-law requirement need not be phrased in the identical language as its corresponding FIFRA requirement; indeed, it would be surprising if a common-law requirement used the same phraseology as FIFRA. If a case proceeds to trial, the court's jury instructions must ensure that nominally equivalent labeling requirements are genuinely (122) equlvalent.
The decision concluded with a clarifying instruction from the Court, indicating that preemption under FIFRA is still alive and well, albeit tempered by the "parallel requirements" doctrine. "[U]nder our interpretation, [section] 136v(b) retains a narrow, but still important, role. In the main, it preempts competing state labeling standards ... The provision also pre-empts any statutory or common-law rule that would impose a labeling requirement that diverges from those set out in FIFRA and its implementing regulations. It does not, however, pre-empt any state rules that are fully consistent with federal requirements." (123)
Was Bates a radical departure from prior preemption cases? Perhaps not. But it certainly ran contrary to much of the case law that had accumulated in the various federal circuits. The Bates Court cleared up the confusion by adopting what appears to be a relatively simple, back-to-basics approach of statutory construction. In his dissenting opinion, Justice Scalia agreed with this idea:
Today's decision thus comports with this Court's increasing reluctance to expand federal statutes beyond their terms through doctrines of implied preemption. This reluctance reflects that pre-emption analysis is not "[a] freewheeling judicial inquiry into whether a state statute is in tension with federal objectives," but an inquiry into whether the ordinary meanings of state and federal law conflict. (124)
Post-Bates: What lmpact Has It Had?
It is clear that Bates' re-focused preemption analysis on the critical issue of whether state statutory and common law rules impose different requirements upon a federally-regulated industry as opposed to merely parallel requirements. In this respect, it appears as though much confusion has been alleviated with respect to preemption analysis.
A survey of national jurisprudence in the wake of Bates reveals reasonably widespread accord with the decision and a willingness to extend it beyond the realm of FIFRA and into other areas of federal regulation. (125) Of twenty opinions which have devoted more than a paragraph to a discussion of Bates, only one has reached a contrary result.
In Mills v. Giant of Maryland, L.L.C., (126) lactose intolerant plaintiffs sued milk producers under negligence and product liability theories. The basis for the suit was that the plaintiffs--who were unaware that they were lactose intolerant--suffered gas, bloating and other symptoms and were not warned of the possibility of such symptoms. Defendants responded by suggesting that the applicable provisions of the National Labeling & Education Act and Food, Drug and Cosmetics Act preempted plaintiff's state law claims.
The district court for the District of Columbia distinguished the Bates decision in that it addressed FIFRA and not the NDEA or FDCA and thus was "moored tightly to the [FIFRA] preemption clause at issue." (127) The court went on to hold that the scope of the FDCA's preemption clause was much broader than FIFRA's because it prohibited any additional state law requirements as opposed to merely those for labeling or packing. (128) "Accordingly," the court explained, "the concern that plaintiff's common law claims lie beyond the reach of FDCA's preemption clause are not as acute as they were in Bates." (129)
What Has Changed?
It is difficult to fathom from a practical perspective that the various manufacturers of pesticides have routinely taken to the practice of distributing harmful products under the belief that FIFRA shielded them from liability. After all, such manufacturers would be voted out of business simply by economic forces. In today's fast-paced economy, it behooves no manufacturer to mistreat its customers; thus, while several commentators postulated that Bates would open the floodgates of litigation, it appears as though there was not so much water on the other side of the gates as they expected.
There are, however, three areas of the law which have clearly been shaped by the Bates decision.
1. Summary Judgment and Removal
Bates appears to have cautioned the courts to be more cautious with respect to dispositions of motions for summary judgment and motions to remand. As the court made it clear that claims for defective design, defective manufacture, negligent testing, breach of express warranty, and improper trade practices are not requirements which conflict with FIFRA and thus are not preempted, suits alleging such claims against pesticide manufacturers should be less of a slam-dunk for summary judgment than in the past. The Bates standard places defendants in a position of having to prove that the state law claims of plaintiffs impose additional requirements beyond federal law (and are thus preempted).
This same requirement has given plaintiffs additional traction when seeking motions to remand after removal to federal court, as some courts have held that plaintiffs who allege state-law causes of action without a clear invocation of federal remedies are not amenable to federal subject matter jurisdiction merely because their claims are paralleled by federal requirements.
2. Deference to Agency Opinions
An interesting corollary to the main holding in Bates has been a weakening of the deference normally accorded to agency opinions. A recent position change by the FDA remarkably parallels that of the EPA with respect to FIFRA and has recently sparked some controversy. In 2006, the FDA announced in a preamble to a new drug labeling rule that failure to warn and other state-law tort claims against drug manufacturers were preempted by federal law. (130) When the FDA first proposed the labeling rule in 2000, it specifically stated that it would not preempt state law. (131) In response, both commentators and jurists have cited Bates for the proposition that agency determinations are entitled to little deference when they evidence a sharp break from prior agency policy. (132)
In McNellis ex rel DeAngelis, (133) plaintiffs sued under a failure to warn theory, seeking damages for adverse reactions to a prescription drug. The defendant responded with a motion for summary judgment which alleged that the plaintiffs' claims were preempted by the FDCA. Based on 21 C.F.R. [section] 314.70(c)(6)--an FDA regulation which allows a pharmaceutical manufacturer to strengthen warnings while FDA approval is being sought--the court found that if plaintiffs could prove to the fact finder that the defendant had reasonable evidence of adverse side effects, then the enhanced warning which plaintiffs sought would not be preempted by the FDCA. (134) Thus, the motion was denied.
Defendants appealed, citing new evidence which it felt would aid the court in reconsidering the intent of 21 C.F.R. [section] 314.70. The "new evidence" was the FDA agency document which espoused the agency's opinion that the FDCA preempted state law in the area of products liability. The district court for New Jersey commented on the FDA's policy shift and explained that "[b]ecause of the unexplained change in position, under the rule in Bates ... this Court must give less deference to the FDA's interpretation of its regulations." (135) Accordingly, the motion for summary judgment was upheld and the plaintiffs were allowed to proceed with their state law claims.
3. Health-Related Personal Injuries and FIFRA
There remains one interesting area of the Bates decision which has eluded judicial review thus far. No court has yet held that the relatively wide reprieve from preemption granted by the Bates Court is limited in scope to claims involving property damage due to product inefficacy. The EPA still vigorously occupies the field of safety testing and takes great steps to ensure that the pesticides it registers bear appropriate labels to warn the public against any inherent health or environmental risks associated with the product. Precisely the opposite is true with respect to pesticide efficacy testing; in fact, the EPA expressly disclaims any endorsement of efficacy. Because of this, a large part of the Bates reasoning rests upon the common-sense notion that there must be some type of efficacy regulation, and if the task will not fall to the EPA then it should fall to state courts. Perhaps the same cannot be said for areas in which a federal regulatory body has unequivocally set out to perform that task itself.
(1) 544 U.S. 431 (2005).
(2) 7 U.S.C. [section] 136 (2007).
(3) Philip Karmel, Toxic Torts: Preemption After Bates v. Dow Agrosciences, N.Y.L.J., June 28, 2005, at 3.
(5) Kim Ly, Bates v. Dow Agrosciences: Overcoming Federal Preemption and Giving the People a Voice, 26 J. NAT'L ASS'N ADMIN. L. JUDGES 297, 305 (2006).
(6) Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947).
(7) Malone v. White Motor Corp., 435 U.S. 497 (1978) (quoting Retail Clerks v. Shermerhorn, 375 U.S. 96 (1963)).
(8) 505 U.S. 88 (1992).
(9) Jones v. Rath Packaging Co., 430 U.S. 519 (1977). See also EMC Corp. v. Holliday, 498 U.S. 52, 56-57 (1990) (Congress's intent to preempt a law "may be either express or implied, and [preemption] is compelled whether Congress's command is explicitly stated in the statute's language or implicitly contained in its structure and purpose").
(10) See ERWIN CHEMERINSKY, CONSTITUTIONAL LAW: PRINCIPLES AND POLICIES 378 (2d ed. 2002).
(11) Pacific Gas & Electric. Co. v. State Energy Resources Conservation and Development Comm'n, 461 U.S. 190, 204 (1983).
(12) Fidelity Fed. Sav. & Loan Assn. v. De la Cuesta, 458 U.S. 141 (1982) (quoting Rice, 331 U.S. at 230).
(13) English v. General Electric Co., 496 U.S. 72, 79 (1990) (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).
(14) 505 U.S. 504 (1992).
(15) 15 U.S.C [subsection] 1331-1340 (2005) (as amended).
(16) Cipollone, 505 U.S. at 514 (citing 15 U.S.C. [section] 1331: "It is the policy of the Congress, and the purpose of this chapter, to establish a comprehensive Federal program to deal with cigarette labeling and advertising with respect to any relationship between smoking and health, whereby--(1) the public may be adequately informed that cigarette smoking may be hazardous to health by inclusion of a warning to that effect on each package of cigarettes; and (2) commerce and the national economy may be (A) protected to the maximum extent consistent with this declared policy and (B) not impeded by diverse, nonuniform, and confusing cigarette labeling and advertising regulations with respect to any relationship between smoking and health.").
(17) The Supreme Court analyzed the language in the original 1965 version of CLAA as well as the current version enacted in 1969. Section 5 of the 1965 Act stated in pertinent part: "(a) No statement relating to smoking and health, other than the statement required by section 4 of this Act, shall be required on any cigarette package. (b) No statement relating to smoking and health shall be required in the advertising of any cigarettes the packages of which are labeled in conformity with the provisions of this Act." In 1969, Congress enacted the Public Health Cigarette Smoking Act which amended the 1965 Act in several ways. Most importantly, the 1969 Act modified the preemption provision.
(18) 15 U.S.C. [section] 1334 (2007).
(19) Cipollone, 505 U.S. at 519.
(20) Id. at 521.
(22) Justice Scalia is joined by Justice Thomas in decrying this statutory construction. Cipollone, 505 U.S. at 544.
(23) Id. at 521 (quoting San Diego Building Trades Council v. Garmon, 359 U.S. 236 (1959)).
(24) Id. at 523.
(27) Id. at 524.
(25) Id. at 525.
(29) Jean Macchiaroli Eggen, The Normalization of Product Preemption Doctrine, 57 AL. L. REV. 725, 734 (2006).
(30) However, three years after Cipollone the Supreme Court decided Freightliner Corp. v. Myrick, 514 U.S. 280 (1995), in which the Court considered both express and implied preemption in the context of the National Traffic and Motor Vehicle Safety Act of 1966--which contained both a preemption provision and a savings clause. This created some discord as it appeared to countermand Cipollone. This became relevant in several post-Medtronic cases as discussed in this article.
(31) 518 U.S. 470 (1996).
(32) Specifically, 21 U.S.C. [section] 351 et seq. (as amended).
(33) Medtronic, 518 U.S. at 486.
(34) 21 U.S.C. [section] 360k.
(35) 15 U.S.C. [section] 1334(b).
(36) 21 U.S.C. [section] 360k(a).
(37) Medtronic, 518 U.S. at 486 (quoting 90 Stat. 539 (preamble to Act)).
(39) Id. at 493-94.
(40) Medtronic, 518 U.S. at 489, 116 S.Ct. at 2252 ("Unlike the statute at issue in Cipollone, [section] 360k refers to "requirements' many times throughout its text. In each instance, the word is linked with language suggesting that its focus is device-specific enactments of positive law by legislative or administrative bodies, not the application of general rules of common law by judges and juries.").
(41) Id. at 497-502.
(42) Id. at 491 ("There is, to the best of our knowledge, nothing in the hearings, the Committee Reports, or the debates suggesting that any proponent of the legislation intended a sweeping preemption of traditional common law remedies against manufacturers ... If Congress intended such a result, its failure even to hint at it is spectacularly odd, particularly since Members of both Houses were acutely aware of ongoing product liability litigation.").
(43) Id. at 496 ("Unlike the statute construed in Cipollone, for instance, preemption under the MDA does not arise directly as a result of the enactment of the statute; rather, in most cases a state law will be preempted only to the extent that the FDA has promulgated a relevant federal 'requirement.'").
(44) Id. at 495 ("Nothing in [section] 360k denies Florida the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements ... The presence of a damages remedy does not amount to the additional or different 'requirement' that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing 'requirements' under federal law.").
(45) Gade v. National Solid Wastes Management Association, 505 U.S. 88, 111 (1992) (Kennedy, J., concurring in judgment and concurring in part).
(46) 529 U.S. 861 (2000).
(47) Id. at 886.
(48) 531 U.S. 341 (2001).
(49) Id. at 348.
(50) See e.g., Didier v. Drexel Chemical Co., 938 P.2d 364 (Wash. App. Div. 3 1997); Kuiper v. American Cyanamid Co., 906 F.Supp. 1378 (E.D. Wis. 1997); Barnes v. Sandoz Crop Protection Corp., 938 P.2d 95 (Ariz. App. Div. 2 1997); E.I. DuPont de Nemours and Co. v. Aquamar, S.A., 2004 WL 625761 (Fla. Dist Ct. App. 4th Dist. 2004); Ackles v. Luttrell, 561 N.W.2d 573 (Neb. 1997), cert. denied, 118 S.Ct. 329.
(51) See e.g., McAlpine v. Rhone-Poulenc Ag. Co., 947 P.2d 474 (Mont. 1997).
(52) Walker v. American Cyanamid Co., 948 P.2d 1123 (Idaho 1997).
(53) 7 U.S.C. [subsection] 136a(c)(1)(C), (F).
(54) 7 U.S.C. [section] 136a(c)(5)(A). Note that the efficacy standard has been waived pursuant to a grant from Congress.
(55) 7 U.S.C. [section][section] 136a(c)(5)(C), (D); [section] 136(bb).
(56) 7 U.S.C. [section] 136a(c)(5)(B); 40 C.F.R. [section] 152.l 12(f) (2005). A pesticide is "misbranded" when its label contains a statement that is "false and misleading in any particular," including false and misleading statements regarding product efficacy. 7 U.S.C. [section] 136(q)(1)(A); 40 C.F.R. [section] 156.10(a)(5)(ii). A pesticide is also considered "misbranded" when there is an absence of adequate instructions for use or an absence of necessary warnings or cautionary statements on the label. 7 U.S.C. [subsection] 136(q)(1)(F), (G).
(57) 7 U.S.C. [section] 136a(c)(5).
(58) 40 C.F.R. [section] 158.640(b) (2005).
(59) 7 U.S.C. [section] 136v (2005).
(61) For pre-1996 cases holding that FIFRA preempts where state law claims are "related to label," see Higgins v. Monsanto Co., 862 F. Supp. 751 (N.D.N.Y. 1994) (if any of the elements of an action require a finding that the labeling or warnings were inadequate, those claims are pre-empted); King v. E.I. DuPont De Nemours and Co., 996 F.2d 1346 (1st Cir. 1993), cert. dismissed, 510 U.S. 985 (1993); Kenepp v. American Edwards Laboratories, 859 F. Supp. 809 (E.D. Pa. 1994); Lowe v. Sporicidin Intern., 47 F.3d 124 (4th Cir. 1995) (concluding, however, that only those state laws that impose or effect different or additional labeling requirements are pre-empted); Allen v. Pennco Engineering Co., 847 F. Supp. 1315 (M.D. La. 1994), related reference, 1996 WL 858033 (M.D. La. 1996) and related reference, 102 F.3d 194 (5th Cir. 1996); Gibson v. Dow Chemical Co., 842 F. Supp. 938 (E.D. Ky. 1992); Kinser v. Ciba-Geigy Corp., 837 F. Supp. 217 (W.D. Ky. 1993); Shaw v. Dow Brands, Inc., 994 F.2d 364 (7th Cir. 1993), rehearing denied, (July 13, 1993) (in action alleging strict liability and negligence for failure to warn of dangerous side effects of chemicals in bathroom cleaner, state common-law tort actions were pre-empted by FIFRA and therefore plaintiff may not bring damages action claiming label on cleaner was defective); Bice v. Leslie's Poolmart, Inc., 39 F.3d 887 (8th Cir. 1994); Young v. American Cyanamid Co., 786 F. Supp. 781 (E.D. Ark. 1991); DerGazarian v. Dow Chemical Co., 836 F. Supp. 1429 (W.D. Ark. 1993); Casper v. E.I. Du Pont De Nemours and Co., 806 F. Supp. 903 (E.D. Wash. 1992); Trinity Mountain Seed Co. v. MSD Agvet, a Div. of Merck & Co., Inc., 844 F. Supp. 597 (D. Idaho 1994); Arkansas-Platte & Gulf Partnership v. Van Waters & Rogers, Inc., 981 F.2d 1177 (10th Cir. 1993), rehearing denied, (Feb. 9, 1993) and related reference, 886 F. Supp. 762 (D. Colo. 1995); Taylor AG Indust. v. Pure-Gro, 54 F.3d 555 (9th Cir. 1995); Quad R Farms v. American Cyanamid Co., 840 F.Supp. 694 (D.C. Minn. 1993); Hopkins v. Ciba-Geigy Corp., 432 S.E.2d 142 (N.C. App. 1993) (state common-law claims based on failure to provide adequate warning labels on herbicide are preempted by FIFRA as long as product's labeling complies with FIFRA); Trinity Mountain Seed Co. v. MSD Agvet, 844 F.Supp. 597 (D. Idaho 1994); Arkansas Platte & Gulf Partnership v. Van Waters & Rogers, 959 F.2d 158 (10th Cir. 1992); Papas v. Upjohn Co., 926 F.2d 1019 (11th Cir. 1991); Kennan v. Dow Chemical Co., 717 F.Supp. 799 (M.D. Fla. 1989); Little v. Dow Chemical Co., 559 N.Y.S.2d 788 (1990); Davidson v. Velsicol Chemical Corp., 834 P.2d 931 (Nev. 1992); Eyl v. Ciba-Geigy Corp., 650 N.W.2d 744 (Neb. 2002); Warner v. American Flouride Corp., 616 N.Y.S.2d 534 (2d Dept. 1994).
For pre-1996 cases which still uphold general preemption but allow negligent testing / defective manufacturing lawsuits, see Worm v. American Cyanamid Co., 5 F.3d 744 (4th Cir. 1993) (F1FRA preempts state law claims which are related to the label; however, negligent testing and defective manufacture are not related to labeling); Higgins v. Monsanto Co., 862 F.Supp. 751 (N.D.N.Y. 1994) (while state tort claims are preempted by FIFRA when they relate to product labeling, the torts of negligent testing and defective manufacturing are not related to labeling); Kennan v. Dow Chemical Co., 717 F. Supp. 799 (M.D. Fla. 1989) (a claim was pre-empted where it was based on the alleged failure to warn, because a state court jury verdict would have had the effect of "regulating" warning label content).
For pre-1996 cases holding that FIFRA does not preempt state tort claims which are not related to labeling, see Dow Chemical Co. v. Ebling ex rel. Ebling, 753 N.E.2d 633 (Ind. 2001) (Permitting state tort claim based on failure to communicate information contained in EPA-approved label to consumers did not frustrate purpose of FIFRA or render compliance with both state and federal law impossible): Burke v. Dow Chemical Co., 797 F.Supp. 1128 (E.D.N.Y 1992); Grenier v. Vermont Log Bldgs., Inc., 96 F.3d 559 (1st Cir. 1996); Chemical Specialties Mfrs. Ass'n, Inc. v. Allenby, 958 F.2d 941 (9th Cir. 1992).
For pre-1996 cases holding that FIFRA does not preempt even where the claims are related to labeling, see Ferebee v. Chevron Chemical Co., 736 F.2d 1529 (1984), cert. denied, 105 S.Ct. 545 (fact that EPA had determined that label was adequate for purposes of FIFRA did not compel jury to find that label was adequate for purposes of state tort law); Sternhagen v. Dow Co., 711 F.Supp. 1027 (D. Mont 1989) (where defendant manufacturer admitted that plaintiff could not have discovered through the exercise of reasonable diligence that the pesticide could cause him to develop non-Hodgkins lymphoma, allegations of strict liability were legally sufficient to establish a claim); Roberts v. Dow Chemical Co., 702 F.Supp. 195 (N.D. Ill. 1988) (EPA's conclusion that label met requirements of FIFRA did not compel finding that label was also adequate for purposes of state tort law); Wilson v. Chevron Chemical Co., 1988 U.S. Dist. LEXIS 4457 (S.D.N.Y. 1988) (widow's suit for wrongful death of husband not preempted by FIFRA); Cox v. Velsicol Chemical Corp., 704 F.Supp. 85 (E.D. Pa. 1989) (state tort claims involving failure to give adequate warnings or instructions about the risks associated with the use of the manufacturer's chlordane products which allegedly caused death of plaintiff's decedent were neither expressly nor impliedly preempted by FIFRA); Villai v. Terminix International, Inc., 692 F.Supp. 568 (E.D. Pa. 1988) (FIFRA does not preempt failure to warn claim since success by plaintiff would provide no incentive to defendants or any other seller to alter labeling or packaging, but rather would encourage compliance with federal and state regulations).
Finally, for pre-1996 cases which apply state law against pesticide manufacturers with little or no discussion of FIFRA, see Kleven v. Geigy Agricultural Chemicals, 227 N.W.2d 566 (Minn. 1975); Wenner v. Gulf Oil Corp., 264 N.W.2d 374 (Minn. 1978); Jesko v. Stauffer Chemical Co., 558 P.2d 55 (App. 1976); Eichenberger v. Wilhelm 244 N.W.2d 691 (N.D. 1976); Herrick v. Monsanto Co., 874 F.2d 594 (8th Cir. 1989); Willoughby v. Ciba-Geigy Corp., 601 S.W.2d 385 (Tex. App. 9th Dist. 1979): Hill v. BASF Wyandotte Corp. 782 F.2d 1212 (4th Cir. 1986); Lowe v. E.I. DuPont de Nemours & Co., 802 F.2d 310 (8th Cir. 1986); John Norton Farms, Inc. v. Todagco, 177 Cal. Rptr. 215 (4th Dist. 1981); Casadabun v. Bel Chemical & Supply Co., 322 So.2d 854 (La. App. 1975); Hale Farms, Inc. v. American Cyanamid Co., 580 So.2d 684 (La. App. 2d Cir. 1991), cert. denied, 586 So.2d 537 (La. 1991); Peteet v. Dow Chemical Co., 868 F.2d 1428 (5th Cir. 1989), cert. denied, 110 S.Ct. 328 (manufacturer liable for personal injuries sustained by U.S. Forest Service employee who developed Hodgkin's Disease); Malensky v. Mobay Chemical Corp., 799 P.2d 683 (Oregon 1990), review denied, 311 Or. 187; Stiltjes v. Ridco Exterminating Co., 347 S.E.2d 568 (Ga. 1986) (manufacturer of pesticide is strictly liable under Georgia wrongful death statute for death of individual caused by inhaling pesticides to same extent as manufacturer is strictly liable under Georgia strict liability statute for injury to person or property, including failure to give adequate warning).
(62) This reactionary stance by the EPA may have been prompted by the Cipollone decision which fueled the pro-preemption stance in courts throughout the nation. This notice was published just thirteen days before the United States Supreme Court published its decision in Medtronic.
(63) The United States Environmental Protection Agency, Pesticide Regulation Notice 96-4(I) (1996).
(65) PR Notice 96-4(II)(A).
(66) Id. (quoting 44 Fed. Reg. 27932, 27938 (col. 3) (May 11, 1979)).
(67) Medtronic v. Lohr, 518 U.S. 477 (1996). The renunciation of efficacy testing is by the EPA is remarkably similar to the statutory exemption for pre-market approval of medical devices by the FDA for the device at issue in Medtronic.
(68) Id. at 47.
(69) Hart v. Bayer, 199 F.3d 239 (5th Cir. 1999); Etcheverry v. Tri-Ag Service, Inc., 993 P.2d 366 (Ca. 2000).
(70) Brief Amicus Curiae for the United States in Support of Appellants, 1999 WL 33607265 (1999) (hereinafter, "Hart Brief").
(71) Hart Brief.
(72) Hart Brief.
(73) Compare to Medtronic, 518 U.S. at 489.
(74) Brief Amicus Curiae for the United States in Support of Appellants (hereafter Etcheverry Brief), http://www.pestlaw.com/x/courts/etcheverry.html (last visited March 29, 2007, requires free registration).
(75) Etcheverry Brief.
(76) Medtronic, 518 U.S. at 489.
(77) Etcheverry Brier, n. 10.
(79) Compare to Medtronic, 518 U.S. at 491.
(80) Etcheverry Brief.
(81) Etcheverry Brief.
(82) Etcheverry Brief.
(83) Etcheverry Brief.
(84) 79 S.W.3d 21 (Tex. 2002).
(85) Brief for the United States as Amicus Curiae (hereafter "Geye Brief"), http://www.usdoj.gov/osg/briefs/2002/2pet/6invit/2002-0367.pet.ami.inv.pdf (last visited March 29, 2007).
(86) Geye Brief.
(87) Geye Brief.
(88) Brief for the United States as Amicus Curiae (hereinafter "Bates Brief") at 9-10 available at http://www.usdoj.gov/osg/briefs/2003/2pet/6invit/osg/ 2003-0388.pet.ami.inv.pdf (last visited March 29, 2007).
(89) Bates Brief, at 10-11 ("The statutory term 'any requirements' includes both positive state regulation and indirect regulation through state common-law tort actions ... All state labeling requirements, regardless of their source, are preempted.").
(90) Bates Brief, at 18-19 ("Even if a Court were to give weight to the legislative history, it would find that it demonstrates no positive intent to preserve tort actions.").
(91) Bates Brief, at 10.
(92) Justice Scalia commented on this reversal at the oral argument of the Bates case: Bates v. Dow
Justice Scalia: This is a new position for the Government, isn't it?
Ms. Blatt (EPA): Yes, we have-Justice
Scalia: You used to take the opposite position.
Ms. Blatt: That's right.
Justice Scalia: And we're dealing here, as nobody has mentioned it, but there there's a clear statement rule for preemption, isn't there? Doesn't the preemption of--of traditional State powers have to be clear in the statute?
Ms. Blatt: We we think subsection (b) is unambiguous in preempting any statement.
Justice Scalia: It's--it's ambiguous enough that the Government--the chief beneficiary of the of the supposed preemption didn't see it. It used to come out the other way. How can you possibly say it's clear?
Ms. Blatt: Well, the agency is allowed to change it position and we realize
Justice Scalia: I understand. It's--it's welcome to change it, but it it's one thing to change it. It's another thing to change it and come in to say that the question is clear.
Transcript, 2005 WL 148903 at 39-40.
(93) TEX. BUS. & COM. CODE ANN. [section] 17.505(a) (2002).
(94) Bates, 125 S.Ct. at 1793
(95) The term "pH" stands for pondus hydrogenii (potential hydrogen) and refers to the acidity of the soil.
(96) See Bates, 125 S.Ct. at 1793 ("EPA approved a 'supplemental' label that was for '[d]istribution and [u]se [o]nly in the states of New Mexico, Oklahoma and Texas,' the three States in which peanut farmers experienced crop damage. This new label contained the following warning: 'Do not apply Strongarm to soils with a pH of 7.2 or greater.'" citations omitted).
(97) Dow Agrosciences, LLC v. Bates, 332 F.3d 323, 329 (5th Cir. 2003) (citing Hart v. Bayer Corp., 199 F.3d 239, 244 (5th Cir. 2000)).
(98) Dow, 332 F.3d at 329 (citing Andrus v. AgrEvo USA Co., 178 F.3d 395, 398 (5th Cir. 1999) (explaining that the term "any requirements" encompasses both positive state enactments as well as common-law causes of action)).
(99) Id. (citing MacDonald v. Monsanto, 27 F.3d 1021, 1025 (5th Cir. 1994) (different requirements may be imposed when a court authorizes a damage award against a manufacturer that has the "undeniable practical effect" of inducting a manufacturer to alter the product or label to avoid liability)).
(100) Id. at 330.
(101) Id. at 331.
(102) Id. (citing Andrus, 178 F.3d at 399).
(104) Occasionally--though rarely--the law produces absurd results. See Charles Dickens, Oliver Twist (Bantam 1981) ("If the law supposes that," said Mr. Bumble, "the law is a ass, a idiot.")
(105) 7 U.S.C. [section] 136v (2005).
(106) Bates, 125 S.Ct. at 1798.
(107) Id. ("That [section] 136v(b) may pre-empt judge-made rules, as well as statutes and regulations, says nothing about the scope of that pre-emption.").
(108) Id. at 1798 (citing Cipollone, 505 U.S. 521).
(111) Cipollone, 505 U.S. at 525.
(112) Bates, 125 S.Ct. at 1798-1799.
(113) Id. at 1799.
(116) Id. at 1801 (citing Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251 (1984)).
(117) Id. at 1800.
(119) Id. at 1802.
(120) Id. at 1804. This decision abrogates Grenier v. Vermont Log Buildings, Inc., 96 F.3d 559: Kuiper v. American Cyanamid Co., 131 F.3d 656; Netland v. Hess & Clark, Inc., 284 F.3d 656.
(121) Id. at 1799-1800.
(122) Id. at 1804.
(123) Id. at 1803.
(124) Bates, 125 S.Ct. at 807 (THOMAS, J., concurring in the judgment in part and dissenting in part) (citing Camps Newfound / Owatonna, Inc. v. Town of Harrison, 520 U.S. 564, 617(1997); quoting Gade v. National Solid Waste Management Assn., 505 U.S. 88 (1992)).
(125) Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006) (negligent manufacturing claims not preempted under the Medical Device Amendments to the Food, Drug and Cosmetic Act); Mortellite v. Novartis Crop Protection, Inc., 460 F.3d 483 (3rd Cir. 2006) (negligent misrepresentation, fraud, and state statutory claims were not preempted by FIFRA); McMullen v. Medtronic, Inc., 421 F.2d 482 (7th Cir. 2005) (while state laws and common law duties which impose requirements that parallel federal regulations are not preempted, a state law claim premised on a post-sale duty to warn imposes a requirement that is in addition to federal requirements under the MDA and is thus preempted); Wuebker v. Wilbur-Ellis Co., 418 F.3d 883 (8th Cir. 2005) (state law products liability claims are not preempted by FIFRA); Metrophones Telecommunications, Inc. v. Global Crossing Telecommunications, Inc., 423 F.3d 1056 (9th Cir. 2005) (state law claims predicated on breach of implied contract was not preempted by the Communications Act); Gougler v. Sirius Products, Inc., 370 F.Supp.2d 1185 (S.D. Ala. 2005) (design defect claim was not preempted by the Federal Hazardous Substances Act); City of Livingston v. Dow Chemical Co., 2005 WL 2463916 (N.D. Cal. 2005) (plaintiffs' state-law claims for labeling violations based on failure to warn did not necessarily implicate FIFRA, thus defendant's motion to remove was improper); Booth v. Board of Regents, 2005 WL 2099246 (M.D. Ga. 2005) (FIFRA does not preempt the State of Georgia from providing its own remedy for an alleged labeling violation based on fraud/misrepresentation and breach of express warranty); Bayer CropScience, L.P.v. Booth, 2005 WL 2138759 (M.D. Ga. 2005) (plaintiffs may proceed solely under state law as fraud claims are not preempted by FIFRA); Reyes v. McDonald's Corp., 2006 WL 3253579 (N.D. Ill. 2006) (the Nutrition Labeling in Education Act does not preempt state law where plaintiffs seek to enforce parallel requirements); Vermont Pure Holdings, Ltd. V. Nestle Waters North America, 2006 WL 839486 (D. Mass. 2006) (FDCA does not preempt state law where state law creates parallel requirements); McNellis ex rel DeAngelis v. Pfizer, Inc., 2006 WL 2819046 (D.N.J. 2006) (FDCA does not preempt failure to warn claims based on state law); Fox v. Cheminova, Inc., 387 F.Supp.2d 160 (E.D.N.Y. 2005) (FIFRA does not preempt state statutory or common law rules which are consistent with federal requirements; however, summary judgment will not be granted where the equivalency of the state law rules is at issue); In re methyl Tertiary Butyl Ether (MTBE) Products Liability Litigation, 457 F.Supp.2d 324 (S.D.N.Y. 2006) (state tort claims are not preempted by the Clean Air Act); People v. Union Pacific R. Co., 141 Cal.App.4th 1228 (Cal.App. 3d Dist. 2006) (Hazardous Materials Transportation Act did not preempt state statutes which imposed parallel requirements); Turner v. Chevron U.S.A., Inc., 2006 WL 1314013 (Cal.App. 2d Dist. 2006) (FIFRA does not preempt a state law strict liability claim); Brazil v. Sara Lee Corp., 2006 WL 181597 (Cal.App. 4th Dist. 2006) (state law claims premised on breach of express warranty and state deceptive labeling standards are not preempted by FIFRA); Peterson v. BASF Corp., 711 N.W.2d 470 (Minn. 2006) (FIFRA does not preempt state law claims of fraud and misrepresentation); Baker v. St. Jude Medical, S.C., Inc., 178 S.W.3d 127 (Tex.App. 1st Dist. 2005) (distinguishing Medtronic v. Lohr on the basis that Bates established that state common law remedies could create additional requirements; holding plaintiffs state law products liability claim preempted under the MDA/FDCA as it would call for the imposition of "additional" requirements under the specific facts at issue).
(126) 441 F.Supp.2d 104 (D.D.C. 2006).
(127) Id. at 107.
(128) Id. at 108.
(130) 71 Fed. Reg. 3922 (Jan. 24, 2006).
(131) 65 Fed. Reg. 81,082, 81,103 (Dec. 22, 2000).
(132) See Leslie A. Brueckner and Leslie A. Bailey, Much Ado About Very Little, 28 NATIONAL LAW JOURNAL 22, Col. 1 (5/1/2006).
(133) 2006 WL 2819046 (D.N.J. 2006).
(134) Id. at 2.
(135) Id. at 9.
A partner of Montgomery, Barnett, Brown, Read, Hammond & Mintz, L.L.P., IADC member Elizabeth Ryan is engaged in general civil litigation practice with concentration in admiralty, environmental and insurance defense and coverage, and pharmaceutical and medical device law. She has broad litigation experience in toxic tort, class action, maritime personal injury and property damages, personal property damage arising out of fire, products liability, pharmaceuticals, interstate transportation of hazardous substances, and the sale of same by maritime transporters.
William M. Davis is an associate at Montgomery, Barnett, Brown, Read, Hammond & Mintz, L.L.P., having joined the firm in 2006. Focusing primarily on commercial litigation, Mr. Davis holds a B.S. in International Business from Auburn University as well as a Juris Doctor and Bachelor of Civil Law from The Louisiana State University Paul M. Hebert Law Center in Baton Rouge.…