This appeal involves a products liability case under Virginia law. The appellant, Cecile M. Lescs, alleges that she was injured by Dursban TC ("Dursban"), a pesticide manufactured by appellee Dow Chemical Company ("Dow") and applied to her home by appellee William R. Hughes, Inc. ("Hughes"), an exterminating company. Although Ms. Lescs brought negligence claims against Dow for negligent failure to warn and instruct, negligence per se, and negligent testing, the district court construed all of these claims as claims for negligent failure to warn or instruct and held that they were preempted by the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), 7 U.S.C. §§ 136­136y. The district court also held that FIFRA preempted Ms. Lescs' claim for misrepresentation and some of her claims for breach of the implied warranty of merchantability against Dow, as well as her claims for negligence (except negligent application of the pesticide) and misrepresentation against Hughes.(1)

The principal issue on appeal is whether the district court erred in ruling that FIFRA preempts Ms. Lescs' state-law claims. Her appeal also addresses the district court's ruling under Virginia law that she failed to produce adequate evidence in opposition to Dow's motion for summary judgment on the implied warranty claim.

STATEMENT OF SUBJECT MATTER AND APPELLATE JURISDICTION

The district court had jurisdiction under 28 U.S.C. § 1332(a). Ms. Lescs is a citizen of West Virginia. Joint Appendix ("JA") 497. Dow is a Delaware corporation, and Hughes is a citizen of Virginia. JA 497. Ms. Lescs sought compensatory and punitive damages in excess of the jurisdictional amount. See JA 51.

On September 23, 1997, the district court entered final judgment in favor of all defendants as to all claims and all parties. See JA 512­13. Ms. Lescs appealed from that order on October 16, 1997. JA 515. The district court denied Ms. Lescs' final post-trial motion on October 10, 1997. JA 514. Ms. Lescs timely filed her second amended notice of appeal on October 30, 1997. JA 516. This Court has jurisdiction under 28 U.S.C. § 1291.

STATEMENT OF THE ISSUES

1. Whether the district court erred in holding that FIFRA preempted Ms. Lescs' state-law claims against Dow for negligence, breach of the implied warranty of merchantability, and misrepresentation based on the injuries she suffered from the application of Dursban to her home.

2. Whether the district court erred in holding that FIFRA preempted Ms. Lescs' claims against Hughes for negligence and misrepresentation.

3. Whether the district court erred in granting summary judgment in favor of Dow on Ms. Lescs' claim for breach of the implied warranty of merchantability on Virginia-law grounds.

4. Whether the district court erred in failing to rule on Ms. Lescs' second motion to compel production of documents by Dow.

STATEMENT OF THE CASE

A. Legal and Administrative Background

1. The FIFRA Scheme

FIFRA's preemption provision provides that no state shall "impose or continue in effect any requirements for labeling or packaging in addition to or different from those required" by FIFRA. 7 U.S.C. § 136v(b). This provision can be construed only in the context of FIFRA's substantive requirements. FIFRA is the federal component of a tripartite scheme in which pesticides are regulated at the federal, state, and local levels. See Wisconsin Public Intervenor v. Mortier, 501 U.S. 597, 601 (1991). FIFRA requires that the federal Environmental Protection Agency ("EPA") make certain regulatory decisions regarding pesticides, but the Act rarely forbids a state or local government from supplementing EPA decisions. Although states generally may not permit the sale or use of any pesticide not registered with the EPA, states may regulate or even ban the sale and use of a federally registered pesticide. See id. 7 U.S.C. §§ 136a(a), 136v(a). In this way, federal pesticide regulation establishes a floor that generally may be exceeded by additional state regulations.

Importantly, FIFRA registration is not an "affirmative permit scheme for the actual use of pesticides." Mortier, 501 U.S. at 613. Furthermore, unlike federal statutes governing cigarettes and smokeless tobacco, cf. 15 U.S.C. §§ 1333, 4402(a)(1), FIFRA does not mandate precise wording for pesticide labels. Nor do the EPA's regulations dictate the specific language to be used for the majority of pesticide labels, although the regulations do prohibit claims on the label "as to the safety of the pesticide or its ingredients," even if the label contains a qualifying phrase such as "when used as directed," 40 C.F.R. § 156.10(a)(5)(ix). Rather, as part of an application for a pesticide registration, the manufacturer submits not only efficacy, health, and environmental data, but also a draft label. 7 U.S.C. § 136a(c)(1)(C) & (D); 40 C.F.R. § 152.50(e). In this regard, the EPA has made clear that "[t]he registrant must take responsibility for quality control of the product's composition and for adequate labeling describing the product, its hazards and uses." 53 Fed. Reg. 15,956 (May 4, 1988).(2)

The EPA registers a pesticide if it determines that the label and other material meet FIFRA's requirements. 7 U.S.C. § 136a(c)(5); 40 C.F.R. § 152.112. In brief, these requirements are that the pesticide's composition is such as to warrant the claims made for it, that its labeling and other required materials comply with FIFRA's requirements, that it will perform its intended function without unreasonable adverse effects on the environment, and that it will not generally cause unreasonable adverse effects on the environment when used in accordance with widespread and commonly recognized practice. 7 U.S.C. § 136a(c)(5)(A)­(D). Pesticide labels must contain an EPA registration number; the registrant's name and address; the pesticide's name, brand, or trademark; the net weight or other measure of content; the use classification of the pesticide; an ingredient statement; directions for use; and a warning or cautionary statement that is adequate to protect health and the environment. Id. §§ 136(q)(1)(D), (F), (G) & (2)(A)­(D); 40 C.F.R. § 156.10(a)(1). Any information required under FIFRA to be on a pesticide's label must be prominently and conspicuously placed in comparison to other labeling information that is not federally mandated. See 7 U.S.C. § 136(q)(1)(E); 40 C.F.R. § 156.10(a)(2).

Compliance with FIFRA's general labeling requirements does not necessarily satisfy the registrant's FIFRA (or other) obligations. To the contrary, a pesticide is misbranded if, despite the EPA's registration of the pesticide and acceptance of the label, it fails to contain whatever additional warnings are needed to protect against unreasonable adverse health and environmental effects. 7 U.S.C. § 136(q)(1)(F) & (G). As to directions for use, pesticide labels must contain directions necessary to effectuate the product's intended purpose and adequate to protect against fraud, personal injury, and unreasonable health and environmental effects. Id. § 136(q)(1)(F); 40 C.F.R. § 156.10(i)(1)(i).

Because the EPA depends so heavily on registrant submissions, FIFRA imposes continuing obligations on registrants to submit complete, up-to-date information. Of particular importance are registrants' ongoing obligation to provide to the EPA in "adverse effects incident reports" all factual information that they have regarding unreasonable adverse environmental effects, see 7 U.S.C. § 136d(a)(2), and ongoing obligation to ensure that the labeling complies with FIFRA, see id. §§ 136(q), 136j(a)(1)(E). EPA policy requires that adverse effects incident reports be filed within thirty days of the registrant's learning of the incident. 44 Fed. Reg. 40,716, 40,717 (July 12, 1979).

Accordingly, registrants must make whatever label changes are required to comply with FIFRA. In this regard, FIFRA provides that "[i]f the labeling or formulation for a pesticide is changed, the registration shall be amended to reflect such change if the Administrator determines that the change will not violate any provision of this [Act]." 7 U.S.C. § 136a(f)(1). In other words, the onus for deciding whether a label change is necessary falls on the registrant, which must draft the revised label and submit it to the EPA for review. See 40 C.F.R. § 152.44. Moreover, many label revisions require only EPA notification, not agency approval. Id. § 152.46(a). Some label revisions do not even require EPA notification. Id. §§ 152.46(b), 152.130(b) & (c), 152.132(d)(5).

Although § 136v(b) preempts state "labeling or packaging" requirements "in addition to or different from" FIFRA requirements, the Act expressly leaves manufacturers of registered pesticides many other unrestricted means of conveying information to purchasers and users. For example, EPA regulations identify the following means of conveying information: "[b]rochures, pamphlets, circulars and similar material offered to purchasers at the point of sale or by direct mail; [n]ewspapers, magazines, newsletters and other material in circulation or available to the public; [b]roadcast media such as radio and television; [t]elephone advertising; [and] [b]illboards and posters." 40 C.F.R. § 152.168(b) (subsection numbers omitted). Unlike labeling, manufacturers do not submit such materials to the EPA as part of the registration process.(3)

If a pesticide label contains false or misleading statements or lacks directions for use and warnings that are adequate to protect health and the environment, the pesticide is misbranded. 7 U.S.C. §§ 136(q)(1)(A), (F), (G), 136j(a)(1)(E). In an administrative action to cancel a pesticide's registration or to seize or bar use or sale, EPA registration is not a defense. Id. §§ 136(q)(1)(A), 136a(f)(2). Violations warranting EPA action include labeling that lacks required information and products that cause unreasonable environmental effects even when used as directed on the label. See id. §§ 136j & 136k; see also id. § 136l (authorizing civil and criminal penalties for FIFRA violations).

FIFRA provides no damages remedy to compensate individuals who suffer injuries from pesticides.

2. The Registration of Dursban Under FIFRA

Dursban is the pesticide which was applied to Ms. Lescs' home to extinguish termites and which she alleges caused her injuries. JA 498. At the time of Ms. Lescs' injuries, Dow manufactured Dursban and held its EPA registration. JA 54, 498. The active ingredient in Dursban is chlorpyrifos. JA 437.

Chlorpyrifos was first registered in 1965 under an older version of FIFRA. See JA 437. The 1972 amendments to FIFRA, which established the basic registration and regulatory regime now in effect, "grandfathered" the registrations of all pesticides that had been registered prior to 1972. See Federal Environmental Pesticide Control Act of 1972, Pub. L. No. 92-516, § 4(c)(1)­(2), 1972 U.S.C.C.A.N. (86 Stat. 973) 1139, 1170. Because chlorpyrifos was first registered in 1965, its registration was "grandfathered." The 1972 act also provided, however, that the EPA was to re-register "grandfathered" pesticides after the promulgation of implementing regulations no later than four years after the Act's enactment. Id. § 4(c)(2). Thus, the EPA was permitted to publish guidelines specifying the kinds of information which would be required to support the registration or re-registration of a pesticide. Pub. L. No. 92-516, § 2, 1972 U.S.C.C.A.N. (86 Stat.) 1139, 1148 (codified as amended at 7 U.S.C. § 136a(c)(2)(A)); see also 7 U.S.C. § 136(z) (defining "registration" to include "reregistration").

The four-year re-registration deadline for older pesticides proved unworkable. See H.R. Report No. 663, 95th Cong., 2d Sess. 18 (1978), reprinted in 1978 U.S.C.C.A.N. 1988, 1991. Indeed, by 1988, the EPA had re-registered at most five active ingredients, and the General Accounting Office estimated that the re-registration process would not be completed until 2024. H.R. Rep. No. 939, 100th Cong., 2d Sess. 28­29 (1988), reprinted in 1988 U.S.C.C.A.N. 3474, 3477­78. Accordingly, Congress amended FIFRA in 1988 to establish mandatory time requirements for the re-registration of pesticides. Id. at 29. The 1988 amendments also provide for an accelerated re-registration program in which the EPA is to re-register each pesticide with an active ingredient that was first registered prior to November 1, 1984 (such as chlorpyrifos-containing Dursban), pursuant to a five-phase program. Id.; 7 U.S.C. § 136a-1(a) & (b). Only upon completion of the fifth phase, after the EPA Administrator has determined that an older pesticide "meets the requirements of section 136a(c)(5)," is such an older pesticide reregistered. 7 U.S.C. § 136a-1(g)(2)(C).

The EPA registered Dursban on February 12, 1981 and has approved the submitted labels. JA 54. As part of this "initial registration process" for Dursban and in support of Dursban's "initial registration standard," Dow submitted toxicological and other scientific data on Dursban to the EPA. JA 384. This registration, however, was not a final reregistration of chlorpyrifos, Dursban's active ingredient, which as of January 1997 still had not been reregistered. JA 271. As a "grandfathered" pesticide that has not yet been reregistered, therefore, chlorpyrifos has not yet satisfied the more stringent requirements for registration that were established when FIFRA was amended in 1972.

FIFRA empowers the EPA to compel a registrant to submit additional toxicological testing data to maintain in effect a pesticide's registration. See 7 U.S.C. § 136a(c)(2)(B). Such an action by the EPA Administrator is often called a "data call-in." On February 23, 1984, the EPA required Dow to submit additional indoor air monitoring data for chlorpyrifos' use as a termiticide. JA 405. On September 28, 1984, the EPA issued a data call-in on chlorpyrifos for, among other things, indoor air applications, acute inhalation studies, general metabolism studies, and dissipation studies. JA 405, 415­16. In June of 1989, after finding that six studies submitted in response to the 1984 Registration Standard were "wholly unacceptable," JA 422, the EPA issued a third data call-in for chlorpyrifos. JA 417­21. The EPA had noted that Dow had not submitted an analysis of the possible formation during Dursban's manufacturing process of impurities of toxicological concern. JA 424­27. The data call-in further indicated that data gaps on the toxicity of chlorpyrifos remained in an array of areas relating to human exposure. JA 420. In 1991, after the ownership for Dursban's registration had been transferred from Dow to DowElanco in December 1989, JA 384, the EPA issued yet another data call-in which stated that:

                The Agency has reviewed data submitted in response to the 1984 Registration Standard, and has reevaluated its position
                on data needed to support the continued registration of Chlorpyrifos.

. . . .

The Agency has concluded that additional data on Chlorpyrifos are needed in all discipline areas. . . . These data are needed for the Agency to conduct a comprehensive review of Chlorpyrifos for reregistration, including a reassessment of tolerances.

JA 435 (emphasis added).

In addition to these EPA-recognized data gaps, in late 1994 it was revealed that between 1984 and 1988, when Ms. Lescs was injured by the application of Dursban to her home, Dow had failed timely to report nearly 100 incidents of unreasonable adverse affects from chlorpyrifos to the EPA. See JA 389.(4) These incidents were not reported to the EPA until late 1994--in some cases more than ten years after they occurred. See JA 389. Such nonreporting is a violation of FIFRA and EPA requirements that such "adverse effects incident reports" be filed within thirty days of the incident. See 7 U.S.C. §§ 136d(a)(2), 136j(a)(2)(N); 44 Feg. Reg. at 40,717; see also JA 254­62 (complaint filed in 1995 by EPA against DowElanco for failing timely to file with EPA reports of 288 incidents involving unreasonable adverse health effects of chlorpyrifos).(5)

Because the EPA regards the timely filing of adverse effect incident reports as "particularly important since human testing is not done, and such reports may document effects not seen in animal studies," JA 440, the Agency took drastic measures in response to the untimely filings. First, it initiated a review of the late filings on chlorpyrifos, to be followed by a comprehensive risk assessment of the chemical. JA 443. The EPA warned that it might reduce application rates (i.e., require a reduction in the concentration of chlorpyrifos in the water-based solution applied by the exterminator), modify labels, or cancel uses of chlorpyrifos if its review and risk assessment identified exposure situations that posed an unreasonable risk to public health or the environment. JA 443. An EPA review of chlorpyrifos poisoning data finalized in January 1997, including the untimely 136d(a)(2) reports, concluded that chlorpyrifos may be a significant cause of chronic neurobehavioral effects. See JA 319, 341. The agency therefore recommended a prospective epidemiologic study of chronic health effects associated with chlorpyrifos and analysis of whether odor is a significant factor in symptoms associated with exposure to Dursban to determine whether further restrictions of chlorpyrifos use were warranted. JA 282­83. The EPA review also found, after analyzing the untimely § 136d(a)(2) submissions, that DowElanco had incorrectly stated that it was unaware of symptoms of organophosphate poisoning having occurred with the use of chlorpyrifos. JA 313. Indeed, the EPA review suggested that such incorrect statements may "have been responsible for some of the significant poisonings reported by DowElanco and others." JA 313.

Second, after completing this review, the EPA took specific risk-reducing measures. For example, the EPA and DowElanco reached a ten-point agreement relating to the use and labeling of pesticides with chlorpyrifos as the active ingredient that required further epidemiological research into the effects of exposure to chlorpyrifos and established a "Blue Ribbon Panel" to provide scientific direction for study design. JA 271­78. Third, the EPA, rather than relying solely on registrants of pesticides with chlorpyrifos as the active ingredient to submit adverse effect incident reports to it, began to encourage individuals who had experienced such adverse health effects to report them directly to the Agency, JA 438, 439, and it designed a special reporting form for those individuals, see JA 445­48. Finally, the EPA mandated labeling changes for soil treatment termiticide products such as Dursban. See JA 449­465.

B. Statement of the Facts

1. The Extermination of Ms. Lescs' Home and Subsequent Injuries

On September 27, 1988, Ms. Lescs agreed to purchase a home in Winchester, Virginia. JA 498. The seller contracted with Hughes to exterminate the house in connection with the closing. JA 498. On November 21, 1988, Hughes treated the home for termites. JA 498. Part of the treatment involved injecting Dursban into the floor of the basement and the exterior walls of the house. JA 498.

At the time when Dursban was applied to Ms. Lescs' home, there were technically and economically feasible alternative methods for termite extermination. Ms. Lescs' expert Steven Tvedten, who had worked as an exterminator, testified that he had used spot treatment in 1988 with both sodium borates and Dursban in the interior of a home to combat termites and that he never did a complete treatment of the interior of a home with Dursban. JA 159, 503. He also stated that, when he discontinued use of Dursban in 1993, he used a range of alternatives to combat termites, including mechanical alteration, integrated pest management techniques, cellulose removal, sanitation and habitat reduction, and boric acid bromate. JA 155, 159. Furthermore, Dursban's label for post-construction applications of the pesticide to existing buildings and materials was changed by 1992 to permit a reduction in the concentration of Dursban in the water-based solution used in its application. The 1992 Dursban label permitted applicators to reduce the concentration for post-construction applications by 50 percent from the concentration specified on the label in effect when Dursban was applied to Ms. Lescs' home. See JA 58, 384, 172, 173.

On November 23, 1998, the date on which Ms. Lescs closed on her house, she visited the residence. JA 498. She noticed a foul-smelling odor. See JA 219, 498. Ms. Lescs called Hughes twice before moving in to inquire about the odor; a secretary at the office assured her that the fumes were not dangerous. JA 195, 200­02. From November 24, 1988, through January 25, 1989, she regularly visited the home to clean and to perform minor repairs. JA 498.

Ms. Lescs moved in on January 25, 1989. JA 498. After she moved in, Ms. Lescs alleges that she suffered "acute and chronic effects" from exposure to Dursban in her house, including "neurologic, pulmonary, respiratory, hematologic, immune, gastrointestinal, dermal, emotional and mental effects." JA 34. While she was living in the home, her pet dog died. See JA 197­98. On April 14, 1989, Ms. Lescs moved out of the house because of all of the maladies that she was suffering from the contamination. JA 199, 498.

After she moved out, Ms. Lescs continued to attempt to decontaminate her house. JA 188, 213, 214, 219­20. She called Dow for instructions on decontamination and spoke with Ken Rose, a Dow employee who was the technical expert on Dursban. JA 189, 219. Mr. Rose informed her that she could decontaminate the home by using a basic solution, buying some Cheer-brand detergent, and wiping down the walls with the Cheer-based solution several times. JA 193­94, 219­20. Ms. Lescs tried to decontaminate the upstairs bedroom as Mr. Rose advised. JA 188­89. The Dow employee did not warn her to use protective clothing while doing this, JA 220, and she quickly abandoned the attempt because of adverse physical effects. JA 188­89, 200. The label for Dursban at that time did not state that one could wipe down surfaces using a Cheer-based basic solution to decontaminate, but the label did admonish applicators to wear protective clothing when using or handling the product to help avoid exposure to the eyes and skin. JA 57­60.

2. The Lawsuit Against Dow and Hughes

Ms. Lescs filed suit in 1990 in Virginia state court to recover damages for the injuries she suffered as a result of Dursban's application to her home. See JA 498. On June 6, 1994, she took a voluntary non-suit of that action. JA 498­99. On December 5, 1994, she filed the action that is the subject of this appeal in the U.S. District Court for the Western District of Virginia. JA 499.

Ms. Lescs named as defendants, among others, Dow, which manufactured the Dursban that was applied to her home; Hughes, which applied the pesticide to her home; and William R. Hughes individually, who was the principal of Hughes. See JA 27­29. Ms. Lescs brought claims against all defendants for negligence, misrepresentation, strict liability, breach of the implied warranty of merchantability, and breach of the implied warranty of fitness for a particular purpose. JA 38­47, 48. She also sued the Hughes defendants for breach of contract. JA 47­48.

By order date April 11, 1995, the district court adopted all discovery taken in the Virginia state court action. JA 52. On June 5, 1995, the district court dismissed with prejudice Ms. Lescs' claims against all defendants save Dow, Hughes, and William R. Hughes individually. JA 63. The district court also dismissed Ms. Lescs' claim in strict liability against the remaining defendants on the ground that Virginia law does not recognize such a cause of action. JA 63, 69­70. Ms. Lescs does not appeal from this order.

In April of 1996, after additional discovery, Dow, Hughes, and William R. Hughes individually moved to exclude the testimony of four of Ms. Lescs' experts and for summary judgment on the issue of causation. JA 125­27. On November 14, 1996, the district court denied the motion to strike the expert witnesses and the motion for summary judgment and set the case for trial, finding that "[g]enuine issues of material fact remain in this case." JA 221. Appellees have not cross-appealed from this order.

The defendants then moved for summary judgment on the ground that FIFRA preempted most of Ms. Lescs' state-law claims. JA 223­27.The defendants also argued that Ms. Lescs had not come forward with evidence sufficient to make out a prima facie case for breach of the implied warranty of merchantability. Hughes and William R. Hughes individually also moved for partial summary judgment on Ms. Lescs' claim that they had negligently applied the pesticide. JA 398­99.

The district court granted Dow's motion for summary judgment in full and dismissed Dow from the case. JA 511. The court also granted the Hughes defendants' motions for summary judgment as to all claims except the negligent application claim. JA 511. By order entered September 23, 1997, the district court entered final judgment in favor of all defendants as to all claims. JA 512­13.(6)

C. The District Court's Rulings

The district court's rulings on the motions for summary judgment fall into two categories: preemption-based and state-law-based. With respect to preemption, the court below characterized all of Ms. Lescs' state-law negligence claims as negligent failure to warn and negligent failure to instruct claims, even though she has a claim for negligent testing. See JA 499­500, 501. Noting that Dow had placed an EPA-approved label on the Dursban applied to Ms. Lescs' home, the district court held that the claim for negligent failure to warn was preempted because "FIFRA 'preempt[s] conflicting state law causes of action that impose a duty to provide a warning in addition to or different from federally established labeling requirements.'" JA 500 (quoting Worm v. American Cyanamid Co., 5 F.3d 744, 745 (4th Cir. 1993) ("Worm II")). For the same reason, the court held that FIFRA preempts Ms. Lescs' claim for breach of the implied warranty of merchantability based on inadequate warnings concerning the pesticide's hazardous properties. JA 506.

The court also held that FIFRA preempts Ms. Lescs' claims for negligence per se on the ground that these claims were inconsistent with EPA approval of Dursban's label, JA 502, and the court ruled that Ms. Lescs' misrepresentation claims were preempted by FIFRA for the same reason, see JA 507. Finally, as to Ms. Lescs' claim that appellees breached the implied warranty of merchantability by manufacturing and selling a pesticide that was unreasonably dangerous in design based on consumer expectations, the court held that the claim was preempted because a consumer could not expect a product to perform more safely than the government-mandated warnings on its label indicate. JA 504­05.

The district court also granted summary judgment on Ms. Lescs' claim for breach of the implied warranty of merchantability on state-law grounds. JA 502­06. Those grounds, taken up in more detail in the Argument section below, generally revolve around the district court's belief that Ms. Lescs had not produced adequate evidence to withstand Dow's motion for summary judgment.

SUMMARY OF THE ARGUMENT

I. FIFRA's preemption provision states that no state shall "impose or continue in effect any requirements for labeling or packaging in addition to or different from" those required by FIFRA. 7 U.S.C. § 136v(b). When construed in light of the strong presumption against preemption of the state's police powers over the health and safety of its citizens, § 136v(b) does not preempt any of Ms. Lescs' state-law claims.

This conclusion is compelled by the Supreme Court's holding in Medtronic, Inc. v. Lohr, 116 S. Ct. 2240 (1996), which involved preemption under the Medical Device Amendments of 1976 ("MDA"). Looking to the operative language of the MDA's preemption provision--which is virtually identical to the operative language of FIFRA's preemption provision--the Court held that preemption could occur only where a particular state requirement threatened to interfere with a specific federal interest. In considering label-based failure-to-warn claims, the Court ruled that the MDA and its implementing regulations embodied important, but entirely generic, regulatory concerns that the MDA preemption provision had not been designed to displace. In considering other general state common-law duties, such as the duties at issue in a negligent manufacturing claim, the Court held that they were not preempted because they had not been developed specifically with reference to medical devices. Like the good manufacturing and general labeling requirements at issue in Medtronic, FIFRA's labeling requirements, and the state-law duties that Ms. Lescs' seeks to impose on appellees, are entirely general in nature. Medtronic's holding that such claims are not preempted is thus directly applicable to this case, and none of Ms. Lescs' label-based state-law claims are preempted.

Medtronic also unanimously held that manufacturing and labeling claims are not preempted to the extent that they rest on claims that the manufacturer failed to comply with state-law duties that are not "different from, or in addition to" the requirements imposed under federal law. Accordingly, where a state-law damages claim alleges a failure to comply with FIFRA requirements or a failure to comply with a common-law duty that is equivalent to a FIFRA requirement, FIFRA § 136v(b) does not preempt that claim. Here, Ms. Lescs brought a state-law claim that appellees negligently failed to comply with their FIFRA-created duties, such as the duty not to misbrand their pesticides by including false or misleading information on the label. Under the holding of Medtronic, these negligence claims, whether stated as negligence per se claims or as ordinary state-law negligence claims that parallel federal requirements, are not preempted.

For similar reasons, under Medtronic and precedent of this Court, FIFRA does not preempt Ms. Lescs' state-law claims for misrepresentation, negligent testing, and breach of the implied warranty of merchantability that are based on state-law and FIFRA-created duties that do not relate to a pesticide's labeling, such as the duty not to manufacture unreasonably dangerous products. Therefore, FIFRA preempts none of Ms. Lescs' state-law claims, and all of the district court's preemption rulings should be reversed.

II. The district court also held that Ms. Lescs had failed to produce sufficient evidence to withstand summary judgment on her claims for breach of the implied warranty of merchantability based on Dow's manufacture and sale of a pesticide that was unreasonably dangerous in design because it violated government and industry standards. This ruling was erroneous. Ms. Lescs produced evidence that Dow violated government standards in manufacturing Dursban in the form of Dow's misbranding of the pesticide and its failure timely to inform the EPA of incidents of adverse health effects suffered by individuals who had been exposed to Dursban. Ms. Lescs also produced evidence that Dow violated industry safety standards in the marketing of Dursban by inadequately testing chlorpyrifos-based products; by not revealing the actual risks associated with Dursban; by failing to report the pesticide's adverse effects on human health to the EPA; and by incorporating into Dursban a chemical that was designed for industrial use only, and not for use in or around dwellings. Furthermore, contrary to the district court's ruling, Ms. Lescs was not required by Virginia law to produce evidence of an alternative design for the pesticide, and even if Virginia law did have such a requirement, she presented evidence of alternative design to the district court.

The district court also ruled, as an alternative ground for summary judgment, that Virginia's "sophisticated user" defense to claims for breach of the implied warranty of merchantability precluded recovery by Ms. Lescs. The sophisticated user defense permits a manufacturer to rely on the employer/purchaser of a hazardous product to protect its own employees from harm if the employer/purchaser has equal knowledge of the product's dangers. This defense is not applicable to Ms. Lescs' claims because she produced evidence that Hughes, the exterminator, did not have equal knowledge with Dow of Dursban's dangers, and because she was not an employee of Hughes.

III. The district court abused its discretion in not ruling on Ms.Lescs' second motion to compel production of documents by Dow. This error forced Ms. Lescs to respond to Dow's summary judgment motion without being given a fair opportunity to discover relevant evidence.

ARGUMENT

Standard of Review

The Court reviews a grant of summary judgment de novo, and it must consider facts in the light most favorable to the nonmoving party and draw all justifiable inferences in that party's favor. Akers v. Caperton, 998 F.2d 220, 224 (4th Cir. 1993). The nonmoving party--here, Ms. Lescs-- is entitled "to have the credibility of h[er] evidence as forecast assumed, h[er] version of all that is in dispute accepted, [and] all internal conflicts in it resolved favorably to h[er]." Charbonnages de France v. Smith, 597 F.2d 406, 414 (4th Cir. 1979).

Argument

I. FIFRA DOES NOT PREEMPT ANY OF MS. LESCS' STATE-LAW CLAIMS.

As we argue below, FIFRA does not preempt any of Ms. Lescs' claims under Virginia law. Under the Supremacy Clause of the federal constitution, U.S. Const. art. VI, § 2, Congress "can nullify conflicting state or local actions." Worm v. American Cyanamid Co., 970 F.2d 1301, 1304 (4th Cir. 1992) ("Worm I"). Three basic principles govern preemption analysis. First, Congress can expressly or impliedly preempt state authority in a particular field, or, "[i]n the absence of an express congressional command, state law is preempted if that law actually conflicts with federal law or if federal law so thoroughly occupies a legislative field as to make reasonable the inference that Congress left no room for the States to supplement it." Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992) (citations and quotation omitted). The purpose of Congress, however, "is the ultimate touchstone in every preemption case." Medtronic, 116 S. Ct. at 2250 (internal quotation marks omitted). Congressional intent is discerned from the language of the preemption statute and the surrounding statutory framework, and from the structure and purpose of the statute as a whole. Id. at 2250­51.

Second, there is a strong presumption against preemption: When Congress has legislated in a field traditionally occupied by the states, a court must begin with the assumption that the historic police powers of the states were not to be superseded by the federal statute unless that was the "clear and manifest purpose of Congress." Id. at 2250 (quotation omitted). This presumption against the ouster of state law applies with particular force where, as here, state prerogatives over the health and safety of its citizens are at issue. See Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230­31 (1947). This assumption applies not only to "the question whether Congress intended any pre-emption at all," but also to "the scope of its intended invalidation of state law." Medtronic, 116 S. Ct. at 2250 (emphasis in original).

Third, the presumption against preemption is at its zenith where the state's power to provide its injured citizens with compensation through its tort system is at stake. Thus, the Supreme Court has been loathe to ascribe to Congress an intent to deny "all means of judicial recourse for those injured by illegal conduct." Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251 (1984); see also Cipollone, 505 U.S. at 518 ("there is no general inherent conflict between federal pre-emption of state warning requirements and the continued vitality of state common-law damages actions").

A. The Worm Line of Precedent Has Been Modified in Part by Medtronic.

Because Congressional intent is the "ultimate touchstone" of preemption analysis, we turn first to the language of FIFRA's preemption provision, 7 U.S.C. § 136v(b), which provides that "[a] State shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter." Under the decisions of this Court prior to Medtronic, § 136v(b) would preempt Ms. Lescs' claims under Virginia law that the FIFRA-required labels or warnings were inadequate. Worm I, 970 F.2d at 1308; Lowe v. Sporicidin Int'l, 47 F.3d 124, 129 & n.4 (4th Cir. 1995). The Supreme Court's decision in Medtronic, however, changes the landscape of preemption analysis. Although even after Medtronic other courts have held that state-law claims that would require warnings or labeling inconsistent with FIFRA were preempted, see, e.g., Kuiper v. American Cyanamid Co., 131 F.3d 656 (7th Cir. 1997), petition for cert. filed, 66 U.S.L.W. 3647 (U.S. Mar. 31, 1998), those decisions have erred in their analysis of Medtronic.

Medtronic changes the preemption landscape for two related reasons. First, the operative language of the preemption provision at issue in Medtronic is virtually identical to the operative language of § 136v(b). Medtronic involved § 521(a) of the Medical Device Amendments of 1976 ("MDA"), 21 U.S.C. § 360k(a), which provides for preemption of state "requirement[s]" that are "different from, or in addition to" the federal requirements applicable to medical devices. 116 S. Ct. at 2248. Like the MDA, FIFRA preempts only certain state "requirements" that are "in addition to or different from" those required under the Act. 7 U.S.C. § 136v(b). Indeed, the MDA preemption provision, which deals with requirements relating to medical "devices," casts a wider net than its FIFRA counterpart, which preempts only certain "labeling and packaging" requirements.

Second, looking to the general language of the MDA's preemption provision, Medtronic identified an "overarching concern that pre-emption occur only where a particular state requirement threatens to interfere with a specific federal interest." 116 S. Ct. at 2257. Here, FIFRA specifically allows state and local governments to play an active role in pesticide regulation. See 7 U.S.C. § 136v(a). More specifically, in considering the labeling-based failure-to-warn claims, Medtronic made "a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement to determine whether they fall within the intended pre-emptive scope of the statute and regulations." Medtronic, 116 S. Ct. at 2257­58. The Court reviewed the federal labeling and manufacturing requirements applicable to medical devices--21 C.F.R. § 801.109, 21 C.F.R. Part 820--and, although at least as comprehensive as the labeling requirements under FIFRA, held that they were "important but entirely generic" regulatory concerns, not the type of concerns that § 360k(a) was "designed to protect from potentially contradictory state requirements." See Medtronic, 116 S. Ct. at 2258; see also id. at 2264 (O'Connor, J., concurring in part and dissenting in part) (charactering FDA's good manufacturing practices regulations as "comprehensive" and FDA's labeling requirements as "extensive"). Similarly, the general state common-law duties at issue in Medtronic, i.e., the duties at issue in claims for negligent manufacturing and failure to warn, were not specifically developed with reference to medical devices. Id. Thus, the Court held that those duties were not the kind of requirements that Congress or the FDA feared might impede the FDA's implementation and enforcement of the MDA. Id.; cf. JA 61­62 (stating conclusion of EPA's Administrator for Pesticides and Toxic Substances that EPA "would clearly prefer the legal interpretation that FIFRA does not preempt state tort actions" because private lawsuits are effective tool for augmenting EPA's limited regulatory resources).

Like the good manufacturing requirements and general labeling requirements at issue in Medtronic, FIFRA's labeling requirements are general. The manufacturer, not the EPA, devises the label and drafts its specific substantive content in accordance with the Act's general standards. See 7 U.S.C. § 136a(c)(1)(C). Pesticide registrants are obliged under FIFRA to update their labels to ensure that they are not misleading and that they contain warnings adequate to protect human health and the environment, see 7 U.S.C. §§ 136(q), 136j(a)(1)(E)--obligations that are, again, entirely general. Furthermore, these general standards under FIFRA are no different in any relevant sense from general state common-law duties to warn. For example, the FIFRA duty to ensure that a label contains warnings adequate to protect human health is couched at the same level of generality as the Virginia common-law duty under the implied warranty of merchantability to supply adequate warnings of a product's dangerous properties. See Featherall v. Firestone Tire & Rubber Co., 252 S.E.2d 358, 369 (Va. 1979) (manufacturer is liable for negligent failure to warn if he knows or has reason to know that product is or is likely to be dangerous for use for which it is supplied).

In short, the general duties under FIFRA are analogous to the general good manufacturing and labeling rules under the MDA. The Medtronic court held that because these general rules merely mimicked general common-law standards, the preemption provision of the MDA--the operative language of which, again, is virtually identical to FIFRA § 136v(b)--did not preempt state common-law standards. Medtronic's holding is thus directly applicable to this case, and none of Ms. Lescs' label-based state-law claims are preempted.

B. Ms. Lescs Can Proceed Under Virginia Common-Law Theories to Enforce Federal Standards.

Even apart from the question of whether FIFRA preempts state-law label-based claims, this Court has held that if a "state imposes a duty to improve a product or to maintain a label in accordance with the federal standards . . . FIFRA does not preempt." Worm I, 970 F.2d at 1309. The state remedy may take the form of "common law liability." Lowe, 47 F.3d at 130. Furthermore, Medtronic unanimously held that manufacturing and labeling claims are not preempted to the extent that they rest on claims that the manufacturer negligently failed to comply with state-law duties not "different from, or in addition to" requirements imposed under federal law. 116 S. Ct. at 2255­56; accord id. at 2264 (O'Connor, J., concurring in part and dissenting in part). Accordingly, where a state-law damages claim alleges a failure to comply with a federal requirement or a failure to comply with a common-law duty that is equivalent to a federal requirement, the phrase "in addition to or different from" of § 136v(b) does not preempt, and in fact preserves, that claim.

Ms. Lescs' claims on her theories of misbranding and failure to warn can be characterized both as ordinary negligence claims premised on state-law duties that are the same as or parallel federal requirements and as traditional claims of negligence per se for appellees' violations of the law, i.e., their failure to follow federal requirements. The parties addressed the issue of negligence per se in the district court. See, e.g., JA 41­43, 239­43, 364. In addition, Ms. Lescs brought a state-law cause of action for breach of the implied warranty of merchantability under the theory that the pesticide lacked adequate warnings of its dangerous properties. JA 506. The district court appears to have held that Ms. Lescs' label-based negligence claims were preempted because there was no "evidence that Dow ever made any claims outside of the label such that it could be held liable for breach of a 'FIFRA-created duty.'" JA 502 (quoting Lowe, 47 F.3d at 130). As to the implied-warranty-of-merchantability claim based on inadequate warnings, the court held that it was preempted because it rested on "a failure to warn or communicate about a product through its labeling." JA 506 (citing Worm II, 5 F.3d at 747).(7)

In ruling that a defendant could be liable for breach of a FIFRA-created duty only if the defendant made claims outside the label, the district court erred. Under Medtronic, a defendant may be liable for breach of any FIFRA-created duty for which state law provides a remedy, not just for breach of the subset of FIFRA-created duties that relate to claims made outside the label. See Medtronic, 116 S. Ct. at 2255­56. In this regard, FIFRA sets forth two types of duties. The first are the general requirements set out in the statute and the regulations. For example, it is unlawful for any person to sell or distribute a pesticide that is misbranded, i.e., whose label contains false or misleading statements or lacks directions for use and warnings that are adequate to protect health and the environment. See 7 U.S.C. §§ 136(q)(1)(A), (F), (G); 136j(a)(1)(E). Ms. Lescs' cause of action for negligent failure to warn is a claim that Dursban was misbranded in violation of these provisions. Claims based on these general requirements, therefore, are not preempted against either appellee.

FIFRA and the EPA regulations also set forth other, more specific duties that appellees violated. The regulations prohibit a label from making claims about the safety of a pesticide, even if those claims are accompanied by disclaimers to the effect of "when used as directed," 40 C.F.R. § 156.10(a)(5)(ix), and the statute prohibits the sale or distribution of "any registered pesticide if any claims made for it as part of its distribution or sale substantially differ from any claims made for it as part of the statement required in connection with its registration," 7 U.S.C. § 136j(a)(1)(B). As described more fully above, these provisions were violated when employees of both Dow and Hughes told Ms. Lescs that the Dursban was safe. See JA 195, 200­02, 210­11, 507. FIFRA also requires registrants to file reports with the EPA regarding "unreasonable adverse effects on the environment of the pesticide," 7 U.S.C. § 136d(a)(2), and the failure to do so is unlawful, id. § 136j(a)(2)(N). Dow failed to file adverse effect incident reports on approximately 100 incidents of human health effects caused by Dursban from 1984 to the time of Ms. Lescs' injury. See JA 389. Ms. Lescs also produced evidence of the drastic measures that the EPA took upon receiving these untimely reports, such as requiring further toxicological data on chlorpyrifos, making substantial changes to labels for pesticides containing chlorpyrifos, and soliciting information directly from the public on chlorpyrifos-related adverse health incidents. See JA 271­78, 438­40, 443, 445­65.

Appellees argued in the district court that permitting a cause of action under state law for violation of FIFRA-created duties is inconsistent with the absence of a private right of action under FIFRA. This Court expressly rejected that argument in Worm I and held, to the contrary, that the absence of a private right of action underscores the preservation of at least some state-law tort claims:

                We find support for our strict standard in determining whether a conflict exists in the recognition that FIFRA does not
                explicitly create a federal right of action to compensate persons who may be injured by misleadingly labeled pesticides.
                For "[i]t is difficult to believe that Congress would, without comment, remove all means of judicial recourse for those
                injured by illegal conduct."

970 F.2d at 1309 (quoting Silkwood, 464 U.S. at 251). Similarly, in Medtronic, the manufacturer made the same argument--that the Food, Drug, and Cosmetic Act's ("FDCA") lack of an "express or private right of action" and the FDCA's placing responsibility for instituting civil and criminal enforcement proceedings with the federal government, 21 U.S.C. § 337, signified Congress's intent to bar state-law claims for breach of FDCA-created duties. Brief for Cross-Respondent Medtronic, Inc. at 43, Medtronic, Inc. v. Lohr (Nos. 95-754, 95-886), 1996 WL 144167, *43 (U.S. Mar. 29, 1996). The Supreme Court unanimously rejected the manufacturer's argument, holding that "[i]t is clear that the Lohrs' allegations may include claims that Medtronic has, to the extent that they exist, violated FDA regulations," and that the Lohrs could make those claims "[e]ven if it may be necessary as a matter of Florida law to prove that those violations were the result of negligent conduct, or that they created an unreasonable hazard for users of the product." Medtronic, 116 S. Ct. at 2255; accord id. at 2264 (O'Connor, J., concurring in part and dissenting in part). Indeed, rather than flouting FIFRA, a state-law damages remedy "merely provides another reason for manufacturers to comply with identical existing 'requirements' under federal law." Id. at 2255.

In short, FIFRA does not preempt Ms. Lescs' state-law claims for breach of FIFRA-created duties, whether framed as ordinary negligent failure to warn and misbranding, as traditional negligence per se, or as breach of the implied warranty of merchantability based on inadequate warnings of hazardous properties. Because these claims are based on duties imposed by FIFRA, they are not "in addition to or different from" FIFRA "requirements." Thus, even if the court were correct in characterizing all of Ms. Lescs' negligence claims as labeling claims, they would not be preempted.

C. Ms. Lescs' Non-Labeling Claims Are Not Preempted Under Section 136v(b).

Section 136v(b) applies only to state requirements "for labeling or packaging." Thus, FIFRA does not preempt state-law--whether positive law or common law--that is not based on inadequacies in the label. As this Court stated in Worm I, 970 F.2d at 1307, "[w]hatever might be said with regard to some common law actions, we fail to see how a state-imposed standard of care relating to product design, manufacture, testing, and the like, can qualify as a labeling requirement under FIFRA." In addition to her claims based on appellees' violations of FIFRA-created duties, Ms. Lescs raised three non-label-based claims that she pursues on appeal: for misrepresentation, for negligent testing, and for breach of the implied warranty of merchantability.

1. Misrepresentation

Ms. Lescs claims that both Dow and Hughes made misrepresentations about the safety of Dursban. JA 37, 46­47. Under the law of this Circuit, a cause of action for breach of a FIFRA-created duty is not preempted if the cause of action arises out of claims made about a pesticide in connection with its sale or distribution that "substantially differ" from claims made for the pesticide in connection with its registration. Lowe, 47 F.3d at 130 (quoting 7 U.S.C. § 136j(a)(1)(B), which declares unlawful such "substantially differ[ing]" claims). Relying on Lowe, the court below held that Ms. Lescs' misrepresentation claim was preempted because there was no evidence that the statements made by the Dow representative, Mr. Rose, substantially differed from claims made for Dursban as part of the statement required in connection with its registration: "Plaintiff's own deposition testimony reveals that Mr. Rose only expressed an opinion that, if properly applied, Dursban was safe for residential use. (Deposition of Cecile Lescs, at 305­06)." JA 507.

The district court erred in two respects. First, for the reasons discussed in Part B above, Medtronic establishes that FIFRA does not preempt a labeling-based claim even if the representations are consistent with claims on the label.

Second, apart from Medtronic, FIFRA does not preempt the misrepresentation claims because Dow's statements did, in fact, "substantially differ" from Dursban's labeling. See Lowe, 47 F.3d at 130. As to the claim against Dow, the court misapplied Lowe to the deposition testimony that it cited. A pesticide label is misbranded if it contains "[c]laims as to the safety of the pesticide or its ingredients, including statements such as 'safe' . . . with or without such a qualifying phrase as 'when used as directed.'" 40 C.F.R. § 156.10(a)(5)(ix). In stating that Dursban was "okay" to be applied as it was applied to Ms. Lescs' home, JA 306, Mr. Rose, the technical expert on Dursban with whom Ms. Lescs spoke, made a statement that was not only "substantially different" from the label, but in fact is specifically prohibited by regulation. As to the claim against Hughes, Ms. Lescs presented evidence that she called Hughes' office before moving in to inquire about the fumes from Dursban in her home. JA 200­02. A secretary at Hughes' office told Ms. Lescs that the fumes were not dangerous. JA 195, 219. Because Hughes' secretary made prohibited claims about the safety of Dursban, and because these claims "substantially differed" from the statements on the label, see Lowe, 47 F.3d at 130, FIFRA does not preempt this claim.

Ms. Lescs had previously presented evidence that Mr. Rose had made other representations that substantially differed from the label in effect at that time. When Ms. Lescs spoke with Mr. Rose after moving out of the house for instructions on decontaminating her home, he told her to use a basic solution and buy some Cheer detergent and to wipe down the walls with that several times. JA 188­94, 219. She attempted to decontaminate her upstairs bedroom pursuant to his instructions, but abandoned the attempt due to adverse physical effects. JA 188­89, 200. The label on Dursban at the time that it was applied to Ms. Lescs' home, however, says nothing about decontaminating a residence in any manner, let alone by wiping down surfaces with a Cheer-based basic solution. See JA 57­60. Claims based on these statements are not preempted.

Cipollone lends further support to the proposition that FIFRA does not preempt Ms. Lescs' misrepresentation claims. In that case, the Court considered whether the preemption provision of the Public Health Cigarette Smoking Act of 1969, Pub. L. No. 91-222, § 5(b), 1970 U.S.C.C.A.N. (84 Stat.) 93, 95 (codified as amended at 15 U.S.C. § 1334(b)), which preempted the imposition of state-law "requirement[s] or prohibition[s] . . . with respect to the advertising or promotion of cigarettes," preempted a state-law claim for fraudulent misrepresentation. Cipollone, 505 U.S. at 528. The Court held that the statute did not because "[s]uch claims are predicated not on a duty 'based on smoking and health' but rather on a more general obligation--the duty not to deceive." Id. at 528­29 (plurality opinion) (quoting statute); see also id. at 542­43 (Blackmun, J., Kennedy, J., and Souter, J., concurring in part, concurring in judgment, and dissenting in part). Similarly, in this case, Ms. Lescs' misrepresentation claims are based on the general duty not to deceive. They are not preempted.

2. Negligent Testing

Ms. Lescs also brought a claim against Dow for negligent testing of Dursban. See JA 42; see also JA 347­48 (arguing that claims for negligent testing and manufacturing are not preempted by FIFRA). To the extent that Dow addressed this claim at all in its motion for summary judgment, Dow characterized the claim as a form of negligent failure to warn or instruct. See JA 227. The court below agreed with this characterization and held that Ms. Lescs' negligence claim was entirely preempted. See JA 499­502. But, with all respect, simply saying that a claim for negligent testing is a claim for failure to warn does not make it so. Ms. Lescs claims that Dow's testing of Dursban was negligent in failing to reveal safety hazards that would have led the company not to market Dursban or to market safer alternatives for household use, not to change its label. This allegation simply is not a claim for negligent failure to warn. Because "[c]laims for negligent testing, manufacturing, and formulating . . . are not preempted," Worm II, 5 F.3d at 747, the district court erred in characterizing Ms. Lescs' claim for negligent testing as a claim for negligent failure to warn and in granting summary judgment for Dow on Ms. Lescs' negligence claim in its entirety.

3. Implied Warranty of Merchantability

The district court held that Ms. Lescs' implied-warranty-of-merchantability claim based on Dursban's unreasonably dangerous design under the standard of consumer expectations was preempted by FIFRA.(8) Her claim was preempted, the district court ruled, because Dursban had been approved by the EPA in 1981 and carried an EPA-approved label; to permit her claim to go forward "would allow the anomalous circumstance that a consumer is entitled to expect a product to perform more safely than its government-mandated warning indicate" and represent an unwarranted end-run around preemption. JA 505. That ruling is incorrect.

Ms. Lescs' design-defect claim has nothing to do with the labeling or packaging of Dursban and thus is not preempted by § 136v(b). Rather, Ms. Lescs' claim is that Dow marketed a product that was designed improperly and, as a result, caused her injuries--a problem that no label, no matter how comprehensive, could have cured. The "consumer expectations" standard under Virginia law is an objective standard that simply defines the duty imposed on manufacturers generally, see Alevromagiros v Hechinger Co., 993 F.2d 417, 420­21 (4th Cir. 1993), and thus is unrelated to how a product is labeled after it leaves the manufacturer's plant, see Bly v. Otis Elevator Co., 713 F.2d 1040, 1045 (4th Cir. 1983) (implied warranty theory focuses on whether product is unreasonably dangerous, whereas negligent design theory focuses on whether manufacturer's conduct was unreasonable). Therefore, the district court's merging of duty-to-warn and design-defect claims is directly at odds with Worm I, which expressly found design-defect claims outside FIFRA's preemptive scope. See 970 F.2d at 1307.

Furthermore, the Ninth Circuit in Papike v. Tambrands, Inc., 107 F.3d 737 (1997), did not hold, as was suggested by the district court, that the Medical Device Amendments preempt state-law design-defect claims that contain a "consumer expectations" component. Papike addressed preemption issues only with respect to state-law failure-to-warn claims. See 107 F.3d at 740­42. The Ninth Circuit upheld dismissal of the design defect claim not on the basis of preemption, but because a consumer could not, as a matter of California law, expect a product to perform more safely than its government-mandated warnings indicate. See id. at 743. Papike is therefore not applicable here because a pesticide manufacturer has an ongoing obligation under FIFRA to revise its label to ensure that the pesticide is not misbranded, see 7 U.S.C. §§ 136(q)(1), 136j(a)(1)(E), and because this case involves Virginia, not California, law.

Because Dow moved for summary judgment on the consumer expectations issue solely on the grounds that the consumer expectations claim was preempted and that Ms. Lescs had not produced evidence of a suitable alternative design for the pesticide, see JA 231­33, the district court's decision on this issue should be reversed and the case remanded.

II. THERE ARE NO OTHER GROUNDS FOR AFFIRMANCE WITH RESPECT TO MS. LESCS' CLAIM FOR BREACH OF THE IMPLIED WARRANTY OF MERCHANTABILITY.

In addition to holding that Ms. Lescs' claim for breach of the implied warranty of merchantability was preempted, the court below also held that she failed to produce admissible evidence for elements of this claim. JA 503. This holding was erroneous.

Under Virginia law,