ARGUMENT

A. Introduction

The principal flaw in defendants' argument is their failure to acknowledge the sea change in preemption jurisprudence brought about by the Supreme Court's ruling in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). In the district court, defendants moved for and were granted summary judgment on Ms. Lescs' claims--negligence, misrepresentation, and implied warranty of merchantability for defective design due to inadequate warnings--on the ground that they were preempted by the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), 7 U.S.C. §§ 136 et seq. But in light of Medtronic, affixing an Environmental Protection Agency ("EPA")-approved label to a pesticide does not insulate a registrant from common-law claims.

This conclusion is compelled by Medtronic's unanimous holding that the preemption provision of the Medical Device Amendments ("MDA"), 21 U.S.C. § 360k--identical to FIFRA's preemption provision, 7 U.S.C. § 136v(b), in all relevant respects--does not preempt state common-law causes of action for violations of federal requirements when the duties imposed by state law parallel the duties imposed by federal requirements. As shown below, Ms. Lescs' argument stands unrefuted by defendants and their amici.

Ms. Lescs also demonstrated that, in addition to her claims based on enforcement of federal standards, FIFRA does not preempt her common-law failure-to-warn claims because of the change Medtronic effected on the preemption landscape. In short, the general duties imposed by Ms. Lescs' state-law claims do not conflict with, and thus are not preempted by, the general duties imposed on pesticide registrants by FIFRA--a conclusion confirmed by the striking similarity between the "substantial equivalence" procedures under which the medical device in Medtronic was marketed and the registration history and statutory scheme at issue in this case.

As to matters unrelated to preemption, defendant Dow argues that Ms. Lescs failed to come forward with admissible evidence to support certain elements of her implied warranty claims for defective design based on industry standards, government standards, and consumer expectations. Nothing in the record, however, indicates that the district court ruled on the admissibility of much of the evidence that Ms. Lescs presented to support these claims. Accordingly, this Court should reverse and remand this part of the case for further proceedings. Furthermore, on many claims--not only implied warranty, but also misrepresentation and negligent testing--defendants seek affirmance of summary judgment on grounds not presented to the district court and make arguments not raised below. In fairness, Ms. Lescs should not be required to respond to these matters for the first time on appeal. Defendants can raise such arguments on remand, if they choose.

Before turning to specific consideration of the arguments of defendants, two general replies are in order. First, although defendants rely heavily on non-binding lower-court case law and on pre-Medtronic precedent of this Court to support their position on preemption (e.g., Defs.' Br. at 4­5, 5­7), Ms. Lescs' opening brief showed that those precedents are based on a misinterpretation of the preemption jurisprudence set forth in Medtronic and a misinterpretation of FIFRA.

Second, the importance of taking a fresh look at statutory language was driven home recently when the Supreme Court reversed longstanding federal practice and the unanimous view of the federal appellate and trial courts concerning the multi-district litigation statute, 28 U.S.C. § 1407, because they were at odds with the statute's text. See Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 118 S. Ct. 956 (1998). Moreover, in the context of preemption of state-law damages claims--indeed, in the context of FIFRA's preemption provision--this Court has not hesitated to come to a different conclusion from the view of other courts after taking a hard look at the statute and precedent. See Lowe v. Sporicidin Int'l, 47 F.3d 124, 128­30 (4th Cir. 1995) (reaffirming precedent of Worm v. American Cyanamid Co., 5 F.3d 744 (4th Cir. 1993) ("Worm II"), that § 136v(b) does not preempt state-law claims for breach of some FIFRA-created duties and rejecting view of other circuits). Although precedent is important in the analysis of this (or any other) case, the significance of non-binding authority must ultimately be judged on the strength of its analysis. As shown in Ms. Lescs' opening brief and as further demonstrated below, she has the better of the argument.

B. FIFRA does not preempt Ms. Lescs' state common-law claims for violations of federal requirements.

As Ms. Lescs' opening brief explained, Medtronic held unanimously that a plaintiff could sue under state law for "violations of common-law duties when those duties parallel federal requirements." Medtronic, 518 U.S. at 495 (part V of plurality opinion); id. at 508 (Breyer, J., concurring in part and concurring in judgment) (joining part V of plurality opinion); id. at 513 (O'Connor, J., concurring in part and dissenting in part) (agreeing that state-law claims seeking damages for violation of federal requirements are not preempted). Rather than disputing that this was, indeed, the unanimous holding of Medtronic, defendants argue that this holding does not apply in the FIFRA context. Defendants' arguments are not persuasive.

First, it is important to emphasize that the first rationale stated by Medtronic's five-justice majority (and the only rationale stated by the other four justices, see 518 U.S. at 513) for this holding is entirely general. That rationale by itself textually and logically supports the Court's holding. This rationale concerns solely whether such a state common-law damages action for violating federal requirements would impose a requirement that is "different from, or in addition to" a federal requirement. 21 U.S.C. § 360k(a)(1). The Court held that it would not:

                Nothing in § 360k denies [a state] the right to provide a traditional damages remedy for violations of common-law
                duties when those duties parallel federal requirements. . . . [because] such additional elements of the state-law cause of
                action would make the state requirements narrower, not broader, than the federal requirement. . . . 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.

Medtronic, 518 U.S. at 495. There is no meaningful difference between the MDA preemption provision and § 136v(b) of FIFRA, which also preempts state "requirements" that are "in addition to or different from" FIFRA requirements. This holding, therefore, and this stand-alone rationale are directly applicable to FIFRA.

Defendants seek to avoid this issue by focusing on the second rationale of the Court's holding, which was the "substantial weight" the Court gave to the Food and Drug Administration's ("FDA") view that state common-law claims based on violations of state-law duties equal or substantially identical to requirements imposed under federal law were not preempted. Medtronic, 518 U.S. at 496­97. In fleshing out this second rationale, the Court characterized its interpretation of § 360k as being "substantially informed" by agency regulations, since the agency had been given a "unique role" by Congress in determining the statute's preemptive effect. Id. at 495­96. Setting aside the question of the legal significance of the terms "substantial weight" and "substantially informed," this second rationale simply has nothing to do with, and is textually and logically independent of, the Court's first rationale. Indeed, the independence of the first rationale is further buttressed by the fact that this Court has already held, without any reference to the EPA's interpretation of FIFRA's preemption clause, that a plaintiff's suit under state law for a violation of FIFRA-created duties unrelated to labeling is not preempted. See Lowe, 47 F.3d at 128­30; Worm II, 5 F.3d at 748; Worm v. American Cyanamid Co., 978 F.2d 1301, 1308 (4th Cir. 1992) ("Worm I").(1)

Second, Ms. Lescs' opening brief (e.g., at 4­5) explained that a registrant has an ongoing duty under FIFRA to revise a label to ensure that a pesticide is not misbranded. While defendants claim (Defs.' Br. at 18 n.7) that FIFRA imposes no such duty, this claim is erroneous not only because it disregards the plain language of the statutory scheme, but because it would negate the authority of the EPA itself to take certain enforcement actions against registrants for selling or distributing misbranded pesticides. FIFRA unambiguously prohibits "false or misleading" statements on a pesticide's labeling, 7 U.S.C. § 136(q)(1)(A), and it requires warnings or cautions "adequate to protect health and the environment," id. § 136(q)(1)(G). A pesticide that violates these provisions is "misbranded." Id. § 136(q)(1). The statute also makes unlawful the sale or distribution of a misbranded pesticide. Id. § 136j(a)(1)(E). Furthermore, registration is not a defense to an EPA enforcement proceeding. Id. § 136a(f)(2). Therefore, EPA approval of the label of a registered pesticide does not insulate the label for all time from EPA enforcement proceedings based on false or misleading statements on the label or on inadequate label warnings. Similarly, under Lowe and Worm II, as confirmed by Medtronic, a plaintiff who alleges that she was injured by a pesticide can bring a state common-law damages action for violation of these federal requirements.

Third, defendants argue that permitting common-law damages actions for violations of federal requirements would impermissibly allow a jury to review the EPA's approval of the label, thereby destroying the uniformity that § 136v(b) was enacted to ensure. Jury review of agency determinations is, defendants add, virtually indistinguishable from recognizing a private right of action for violations of FIFRA. The defendant in Medtronic, however, made precisely those arguments. See Br. Cross-Resp't Medtronic, Inc. at 43, Medtronic, Inc. v. Lohr (Nos. 95-754, 95-886), 1996 WL 144167, *43 (U.S. Mar. 29, 1996) ("It is most unlikely that Congress intended to foreclose private enforcement of federal norms but to allow states to permit such private enforcement of identical norms under state law."); id. at 44, 1996 WL 144167, *44 ("The inability of courts to ensure consistency in practice would create an irregular pattern of liability exposure for device manufacturers, undermining the congressional intent to impose uniform requirements."); id. ("There is no reason to expect that a lay jury or state judge interpreting a federal requirement necessarily would reach the same conclusion as the FDA. . . ."); see generally id. at 38­46, 1996 WL 144167, *38­*46. As discussed above, the Court unanimously rejected these arguments. In sum, therefore, FIFRA does not preempt common-law claims based on state-law duties that parallel federal requirements.(2)

C. FIFRA does not preempt any of Ms. Lescs' common-law claims for any other reason.

The fundamental flaw in defendants' argument is their failure to recognize that Medtronic effected a basic change in the preemption landscape. This flaw is particularly striking in light of the fact that this Court has already recognized the significant narrowing of the scope of preemption that took place in Medtronic. In Duvall v. Bristol-Myers-Squibb Co., 103 F.3d 324 (4th Cir. 1996), a case which the Supreme Court had vacated and remanded to this Court for further consideration in light of Medtronic, this Court construed the MDA preemption provision narrowly, holding that it did not preempt the plaintiff's state-law claims relating to the design, manufacture, marketing, and sale of the product; failure to warn; and breach of implied warranties. See 103 F.3d at 327, 330. This Court thus overruled its earlier opinion in the case, which had held that the plain language of § 360k(a) preempted these claims. See id. at 326­27.

Federal regulation of Dursban under FIFRA is strikingly similar to federal regulation of the medical devices that allegedly caused the plaintiffs' injuries in Medtronic and Duvall. The MDA, passed in 1976, includes a "grandfathering" provision that permits pre-1976 devices to remain on the market without FDA approval until the agency initiates and completes the full premarket approval ("PMA") process. Medtronic, 518 U.S. at 478. At issue in Medtronic and Duvall were medical devices that had been placed on the market pursuant to a provision of the MDA that permits medical devices that are "substantially equivalent" to such grandfathered devices to avoid the PMA process. Id. at 478, 480; Duvall, 103 F.3d at 328. Similarly, the registration of chlorpyrifos, the active ingredient in Dursban, was grandfathered when the basic FIFRA regulatory regime now in force was enacted in 1972; as of January 1997, it had not yet been reregistered, so the EPA has not yet determined whether it meets the post-1972 requirements for registration. Opening Br. at 6­8.(3)

Therefore, a medical device that is marketed pursuant to the "substantial equivalence" process is in an uncertain position: At some time, such a device must go through the PMA process and risk non-approval by the FDA. Dursban and other pesticides with chlorpyrifos are in a similar position of uncertainty, in that their continued registration hinges on chlorpyrifos' successful completion of full scientific review by the EPA in the reregistration process.(4)

Defendants argue that, unlike the one-time review for "substantial equivalence" purposes under the MDA, which is completed in an average of twenty review-hours, chlorpyrifos has been under broad and stringent EPA review for thirty-three years. This argument, however, confuses the issue of EPA review of an active ingredient for reregistration purposes with the issue of EPA review of a proposed pesticide label. Defendants are silent on the issue of how much time the EPA spends reviewing a proposed label--which is the asserted basis for preemption here. Similarly, the fact that Dursban was initially separately registered in 1981 is of no consequence because the registration of chlorpyrifos, the active ingredient in Dursban, was grandfathered into FIFRA in 1972 and Dursban's continued registration is entirely dependent on the fate of chlorpyrifos in the reregistration process. In short, the concern that animated the Supreme Court's preemption analysis in Medtronic--that "pre-emption occur only where a particular state requirement threatens to interfere with a specific federal interest," 518 U.S. at 500--and that led it to hold that the common-law claims in that case were not preempted, is just as applicable to Ms. Lescs' claims. Thus, section 136v(b) does not preempt any of her state common-law causes of action.

Furthermore, a key feature of the statutory and regulatory regime by which the EPA approves pesticide labeling is the control that the manufacturer exercises over the substantive content of the label's warnings. As Ms. Lescs explained in her opening brief (at 3­5), while the EPA may demand certain signal words and precautionary statements on labels, it is the registrant, not the EPA, which bears responsibility for drafting the label. The manufacturer submits efficacy, health, and environmental data to the agency to support the claims made on and for the label and pursuant to which the EPA may demand some precise wording on the label. In light of this feature of the FIFRA scheme, defendants' analogy to Cipollone is particularly inapt.

At issue in Cipollone was whether the preemption provision of the Public Health Cigarette Smoking Act of 1969, Pub. L. No. 91-222, 84 Stat. 87 ("1969 Act"), preempted state common-law damages actions.(5) Section 5(b) of the 1969 Act provided that "[n]o requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any [properly labeled] cigarettes." Cipollone, 505 U.S. at 515. The plurality opinion held that state common-law damages actions for failure to warn were preempted "requirements" under this provision, but that claims for express warranty and for fraudulent misrepresentation based on concealment of material facts not related to advertising or promotion were not preempted. Id. at 524­29; see also Opening Br. at 28­29.

The critical difference between the 1969 Act and the MDA or FIFRA is that the 1969 Act mandated the entire warning on a cigarette package. See Cipollone, 505 U.S. at 508 & n.1. In other words, Congress or a federal agency did not devise this warning based on a statutorily-prescribed procedure in which cigarette manufacturers submitted data to the government to support the claims made, nor could a cigarette manufacturer have changed the warning in light of a jury verdict based on the warning's inadequacy. Under the MDA's "substantial equivalence" procedures, by contrast, the FDA approves medical devices for marketing based on its evaluation of data submitted by the manufacturer. Medtronic, 518 U.S. at 477­79. Similarly, under FIFRA, the EPA approves a pesticide label based on its evaluation of a manufacturer's submissions. 7 U.S.C. § 136a(c)(1), (3), (5), (6). Furthermore, if a pesticide registrant comes to believe that a label's warnings are inadequate, the registrant can simply submit a new label to the EPA for approval to cure the defect. See id. § 136a(f)(1); 40 C.F.R. § 152.44. Therefore, a pesticide registrant, unlike a cigarette manufacturer, has considerable recourse if a jury finds its label to be inadequate.(6)

In short, neither FIFRA nor the EPA "mandates" the warnings on labels in the same sense in which Congress mandated the precise content of the warnings on cigarette packages in the 1969 Act. Cf. Duvall, 103 F.3d at 332 (holding that express warranty claim based on oral representations is preempted by MDA § 360k to extent that claim is based on "FDA-mandated labeling, packaging, or advertising"). Compare 21 C.F.R. § 801.109 (1995) (general MDA labeling requirements that Medtronic held too general to warrant preemption) with 21 C.F.R. § 801.430 (1997) (setting forth exact text of FDA-mandated label for tampons). The record in this case is devoid of any evidence that the EPA required all or part of the warnings on Dursban's label. But even if the EPA had required certain warnings on Dursban's label, such a "mandate" would be categorically different from the mandates at issue in Cipollone because of the central role played by pesticide registrants in devising their labels and the EPA's dependence on data submitted by registrants in deciding what modifications to make to, and whether to approve, proposed pesticide labeling. Thus, the EPA no more mandates the warnings on pesticide labels than the FDA mandates the design of "substantially equivalent" medical devices. In light of these factors and the strong presumption against preemption of state authority over matters concerning public health and safety, Hillsborough County v. Automated Med. Labs., Inc., 471 U.S. 707, 715­16 (1985), Ms. Lescs' duty-to-warn claims are not preempted under either Cipollone or Medtronic.

D. Defendants impermissibly seek affirmance on alternative grounds on which they did not move for summary judgment in the district court.

Defendants moved for summary judgment in the district court principally on two grounds: (1) preemption, i.e., that Ms. Lescs' claims were preempted as a matter of law because the evidence showed that the Dursban applied to her home carried an EPA-approved label, and that defendants made no statements that substantially differed from the labeling, and (2) an alleged lack of evidence to support some elements of her claims for breach of the implied warranties of merchantability.(7) Defendants nevertheless contend (Defs. Br. at 1, 22) that this Court may affirm the judgment of the district court on the alternative ground that there is an absence of admissible evidence to support any of Ms. Lescs' claims. Although it is true that an appellate court may affirm on grounds not reached by the district court in its ruling, such grounds must have been raised below in summary judgment proceedings so that the nonmoving party is on notice that she has been put to her proofs on the issue. See Dennison v. County of Frederick, 921 F.2d 50, 53 (4th Cir. 1990). As shown below, defendants impermissibly raise for the first time on appeal issues with respect to two of Ms. Lescs' claims--negligent testing and misrepresentation--that they did not raise in the court below, where they moved for summary judgment on those claims solely on preemption grounds.

1. Negligent testing.

Defendants did not even to mention Ms. Lescs' negligent testing claim in its summary judgment briefing in the court below, let alone present a factual argument on this theory.(8) Nor did the district court refer to this claim in its summary judgment opinion. JA 497­511. Because the district court held that all of Ms. Lescs' negligence claims were preempted, the court below apparently characterized the negligent testing claim as a failure-to-warn claim and held that it was preempted. See JA 499­500, 501­02. "Claims for negligent testing," however, "are not preempted" by FIFRA. Worm II, 5 F.3d at 747. Defendants do not contest that they failed to move for summary judgment on the negligent testing claim on any ground other than preemption (see Defs.' Br. at 37­38).

Instead, defendants argue (Defs. Br. at 37­38) for the first time on appeal (1) that negligent testing is an "incomplete tort" because it is subsumed within the torts of defective design or failure to warn, and (2) that the negligent testing claim fails for lack of proof. Defendants did not make these arguments or move for summary judgment on these grounds as to this claim in the district court. Accordingly, they cannot do so for the first time on appeal.(9)

2. Misrepresentation

For reasons discussed in Ms. Lescs' opening brief (at 18­29) and in Parts B and C above, Ms. Lescs' misrepresentation claims are not preempted by FIFRA. In addition, as a factual matter, because her claims arise from representations that "substantially differ[ed]" from the label, they are not preempted even under the pre-Medtronic law of this Circuit. See Lowe, 47 F.3d at 130. The only basis for defendants' summary judgment motion on this claim that they also raise on appeal is preemption, i.e., whether the Dursban applied to her home carried an EPA-approved label and whether defendants' representations substantially differed from the label. See Defs.' Br. Supp. Mot. Regarding Fed. Preemption, filed Mar. 5, 1997, at 27­30; JA 399. As we now show, the district court erred in granting summary judgment on the misrepresentation claim. See also Opening Br. 27­29.

First, a Hughes secretary informed Ms. Lescs that the fumes were "not dangerous," JA 195, and Hughes stated that it was "safe to move in," JA 219. Both statements violated 40 C.F.R. § 156.10(a)(5)(ix), which prohibits claims as to the safety of a pesticide. Although defendants now argue that Ms. Lescs must prove these statements to be untrue, defendants failed to move for summary judgment on this ground and thus cannot raise it for the first time on appeal. Defendants also contend that the jury rejected Ms. Lescs' claim that the fumes were not dangerous (Defs.' Br. at 39­40); the jury, however, found only that Hughes did not negligently apply the pesticide, JA 512­13, a finding that relates to the nature of Hughes' conduct, and not to the danger of the fumes.

Second, a Dow employee gave Ms. Lescs instructions on how to decontaminate her home. JA 188­94, 219. She attempted to follow these instruction, but abandoned the attempt because she became ill from exposure to the pesticide. JA 188­89, 200. Although defendants now argue for the first time that Ms. Lescs produced no evidence that the house was "contaminated" (Defs.' Br. at 39), defendants failed to move for summary judgment on this basis, see Defs.' Br. Supp. Mot. Regarding Fed. Preemption, filed Mar. 5, 1997, at 27­30, and whether a house is "contaminated" is a different factual question than whether a pesticide was "misapplied." Even if there were nothing improper about the way that Dursban was applied to Ms. Lescs' home, it does not follow that one could not be injured in attempting to clean up even properly-applied Dursban or that the house was not "contaminated" in this sense. This issue of fact is for the jury--and an issue that defendants did not raise in the court below.

E. The judgment of the district court on Ms. Lescs' implied warranty claims should be reversed and remanded for further proceedings.

Ms. Lescs showed in her opening brief (at 31­38) that the court below misconstrued Virginia law on her implied warranty claims, and she presented evidence to the district court to support these claims. For example, contrary to defendants' contentions (Defs.' Br. at 24­25), Ms. Lescs offered testimony that Dursban is unreasonably dangerous, as is evident from examining the whole of Steven Tvedten's testimony on this issue, and not just the snippets quoted by defendants. Tvedten testified that "there is no safe chronic exposure level" to Dursban. Tvedten Dep. at 35 ln. 22.(10) He also testified that as of August 1993, he believed that Dursban's use inside a dwelling should be discontinued. Id. at 47 ln. 21 to 48 ln. 25. Furthermore, when asked whether he believed that it was "okay" to apply Dursban in accordance with the label that existed in 1988, he answered, "No." Id. at 71 lns. 15­21. Thus, even interpreting his statement (quoted by defendants) that he believed "that at the time if [Dursban] would have been applied according to the label and labeling, there would have been no problem," JA 167, in a light unfavorable to the plaintiff and bereft of the context of the entire line of questioning on this issue, this statement, at worst, is in conflict with his other testimony at that deposition.(11) But in reviewing a summary judgment motion, the evidence is to be viewed in the light most favorable to the nonmoving party, and all internal conflicts in it are to be resolved in the nonmoving party's favor. Overstreet v. Kentucky Cent. Life Ins. Co., 950 F.2d 931, 937 (4th Cir. 1991). Thus, Ms. Lescs produced evidence that Dursban was unreasonably dangerous.(12)

Another example: Defendants contend that Ms. Lescs produced no evidence of industry standards to support her implied warranty claim. As discussed in her opening brief (at 33­34), however, Ms. Lescs offered the Chemical Manufacturers Association Responsible Care Progress Report for 1995­1996 (the "Report") in opposition to defendants' summary judgment motion. Leaving aside the admissibility issues for a moment, to which we return below, defendants contend (Defs. Br. at 26­27) that the standards established by the Report are not the kind of "industry standards" that would support a design defect claim because they are only "aspirational goals." But whether the standards are merely "aspirational goals," and not "industry standards" the violation of which would support a design defect claim, however, is a question of fact on which defendants present no evidence other than the assertions in their appellate brief. The cases from which defendants lift choice phrases to support their position simply do not address this issue. In addition, although defendants correctly state that Ms. Lescs must show evidence of industry standards as they existed at the time of the application in 1988, defendants have a duty of candor to this Court to acknowledge that at least some elements of the Responsible Care program were initiated in 1988, as the website of defendant's amicus the Chemical Manufacturers Association ("CMA") shows. See <http://www.cmahq.com/cmaprograms/programs_index.html>> (visited July 6, 1998) (listing Guiding Principles of Responsible Care Initiative).

Returning to the admissibility issue, defendants contend that the Report is hearsay and that it was not authenticated. As to authenticity, the reference to the Guiding Principles of Responsible Care Initiative on CMA's website demonstrates the Report's authenticity, and defendants do not, and cannot, claim otherwise. The hearsay objection, moreover, was not made in the district court, where defendants moved to strike the Report solely on the ground that it lacked "appropriate evidentiary foundations." Dckt. No. 107, ¶ 15.(13)

The dispute over the admissibility of the Report, and, more generally, whether the district court accepted this document in evidence (Defs.' Br. at 26), raises a broader issue in this appeal. It is not clear how the court below treated the Report and the other exhibits that Ms. Lescs filed with it.(14) Although defendants filed a motion to strike the brief and its supporting exhibits, the record is bereft of any order granting or denying this motion. Moreover, to appellant's knowledge, the district court's summary judgment opinion does not refer to the Report or to any other exhibits submitted with it that the parties had not submitted to the court with other papers.(15) It is Ms. Lescs' position that these exhibits and the brief that accompanied them are part of the record and that the district court failed adequately to address the issues they raise, but she acknowledges that she cannot say as a matter of law that this is the case.

In short, there are genuine issues of fact as to Ms. Lescs' implied warranty claims--not only as to the two issues discussed above (at pp. 14­16, supra), but also as to other issues that she raised in the district court, see Dckt. No. 103, at, e.g., 29­46. The district court, however, neither addressed the substance of these issues nor ruled on defendants' motion to strike. Although defendants appear to suggest (Defs.' Br. at 22) that the district court implicitly granted their motion to strike due to its finding that her implied warranty claims were either preempted or "fail based on an utter lack of admissible evidence brought forth by Plaintiff," JA 503, given the uncertainty regarding what was admitted in evidence at the summary judgment stage, such a suggestion begs the question as to whether the motion to strike was granted.

To be sure, this Court has rejected the argument that district courts should accept unsworn, unauthenticated summary judgment documents that are "probative," Orsi v. Kirkwood, 999 F.2d 86, 90­92 (4th Cir. 1993); however, in Orsi, the district court expressly refused to consider the unauthenticated evidence, id. at 88. In this case, by contrast, no ruling appears on the record. Moreover, there is precedent for permitting the district court to exercise its discretion to allow a plaintiff to cure such purely formal deficiencies. See Liberty Mut. Ins. Co. v. Rotches Pork Packers, Inc., 969 F.2d 1384, 1389 (2d Cir. 1992) (holding that summary judgment ought not be entered when evidence that is defective in form is sufficient to apprise court of important and relevant information); Whitaker v. Coleman, 115 F.2d 305, 307 (5th Cir. 1940) (holding that trial judge erred in excluding an unauthenticated testimony transcript at summary judgment stage and in refusing continuance so that authenticating evidence could be gathered because transcript apprised court of relevant and important evidence); Haupt v. International Harvester Co., 582 F. Supp. 545, 548 (N.D. Ill. 1984) (holding that proper procedure is for district court to give non-movant additional time to cure merely formal deficiencies in affidavit submitted in opposition to summary judgment motion).

A court of appeals is not the appropriate forum for resolving these issues in the first instance. Accordingly, the judgment of the district court on the implied warranty claims should be reversed because of the errors of law set forth in our opening brief (at 30­38) and remanded to the district court for further proceedings.

F. The district court abused its discretion in failing to rule on Ms. Lescs' second motion to compel.

Nothing in the record shows that the district court ever ruled on Ms. Lescs' second motion to compel that was filed on May 17, 1996. This discovery dispute arose out of Dow's nonproduction of documents requested during the period for discovery, which was originally ordered to be completed by March 1, 1996 (although discovery continued after that date). See JA 78, 88­90, 108­09, 136. Although, as noted by defendants (Defs.' Br. at 40), the district court did deny Ms. Lescs' "motion to reopen discovery," JA 391 (emphasis added), that order does not even refer to Ms. Lescs' second motion to compel of the previous year, but rather expressly refers only to her motion to reopen discovery filed on April 14, 1997. See Dckt. No. 93. Defendants contend (Defs.' Br. at 40) that, at one point early in a March 10, 1997 hearing--a hearing at which Ms. Lescs was not present due to illness--Ms. Lescs' trial counsel "conceded" that Dow had made some or all of the disputed documents available to Ms. Lescs. See JA 353. Her trial counsel, however, later corrected that statement based on an intervening conversation with Ms. Lescs. See Mar. 10, 1997 Hr'g Tr. at 134­36. In short, defendants do not point to any ruling in which the district court denied Ms. Lescs' second motion to compel.

A motion to compel arising out of discovery requests made prior to the discovery cut-off date does not become a motion to "reopen" discovery simply because a court is called on to rule after the close of the discovery period. Thus, as set forth in our opening brief (at 38­39), the district court abused its discretion in not ruling on the motion to compel.

G. Conclusion

For reasons stated above and our opening brief, the judgment of the district court should be reversed.

Respectfully submitted,
 

Douglas L. Stevick

Brian Wolfman

Public Citizen Litigation Group

1600 Twentieth Street, N.W.

Washington, DC 20009­1001

(202) 588­1000

July 9, 1998

1. Justice O'Connor's partial concurrence/partial dissent in Medtronic points out the difficulties in determining whether the Court, in allowing its interpretation of § 360k to be "informed" by the agency's interpretation, did or did not "defer" to the agency's interpretation. 518 U.S. at 509, 511­12. In any event, as noted in the text, even the four dissenting justices, who did not give any weight to the FDA's preemption views, agreed with the majority that state common-law suits seeking to enforce federal requirements are not "different from, or in addition to" federal requirements and, therefore, are not preempted.

2. Defendants claim (Defs.' Br. at 15) that application of this Circuit's post-Medtronic authority forbids state action which would interfere with a Congressionally-authorized agency determination. For this proposition, they rely on United States v. Virginia, 139 F.3d 984 (4th Cir. 1998). No express preemption clause was at issue in Virginia, however; rather, it was a conflict preemption case involving the extent to which state positive-law registration and licensing requirements for private investigators conflicted with federal regulations governing the qualifications of investigators who perform background checks for the Federal Bureau of Investigation. See id. at 985­86, 988. Virginia is simply irrelevant to this case--indeed, it does not even cite Medtronic, Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), or any similar tort preemption case. See 139 F.3d at 985­90.

3. As with "grandfathered" and "substantially equivalent" medical devices, Congress anticipated, wrongly as it turned out, that pesticide reregistration would be accomplished swiftly. Compare Medtronic, 518 U.S. at 479­80 with Opening Br. at 6­8.

4. As explained in Ms. Lescs' opening brief (at 8­10), the EPA has repeatedly found data gaps in chlorpyrifos' testing and studies during the reregistration process and has recently established a "Blue Ribbon Panel," in part due to EPA analysis of the untimely "adverse incident effect reports," to provide scientific direction for study design for further epidemiological research into the effects of chlorpyrifos exposure. Delays in reregistration are thus partly due to Dow's conduct.

5. Also at issue was the 1965 version of the preemption clause, which provided that "[n]o statement relating to smoking and health" shall be "required" in the advertising, or on the packaging, of properly labeled cigarettes." Cipollone, 505 U.S. at 514, 518. The Court held that this provision preempted positive-law regulation of cigarette labels and advertising and not common-law damages actions. Id. at 518­20.

6. A label is not cast in stone. When one looks only at the parts of the record referred to in Ms. Lescs' opening brief (at 7­8, 11, and citations to record therein), it is evident that Dursban had different labels in 1981, 1986, and 1992.

7. See JA 223­29 (especially ¶¶ 9­10 at JA 226­27); Defs.' Br. Supp. Mot. Regarding Fed. Preemption, filed Mar. 5, 1997, at 1­53 (especially summary at 52­53); Dckt. No. 97; Defs.' Reply Br. Supp. Fed. Preemption, filed July 1, 1997; Defs. Letter Br., filed July 21, 1997; Dckt. No. 102; Dckt. No. 111.

8. See papers cited in footnote 7, supra.

9. Defendants cite to no Virginia precedent that holds that a negligent testing claim is subsumed within the torts of defective design and failure to warn (Defs.' Br. at 38 (citing Fla. and Minn. cases)), and Ms. Lescs has found no such Virginia case. In any event, this issue should be resolved in the first instance by the district court.

10. For the full context for this statement, see Tvedten Dep., filed May 30, 1996, at 34 ln.24 to 36 ln. 11.

11. For the full context for this quotation, see Tvedten Dep. at 69 ln.2 to 74 ln. 7.

12. While defendant also cites (Defs.' Br. at 23­24, 25 n.9) a Tvedten affidavit that the district court expressly rejected, JA 503, and the deposition testimony of Dr. Jurinski, Ms. Lescs has not relied on this evidence in her appeal.

13. Although this motion also incorporated by reference Dow's arguments in an earlier motion to strike another document submitted earlier by Ms. Lescs, the relevant section of that earlier motion to strike, despite the words "Inadmissible Hearsay" in the section heading, in substance addresses only authentication and foundation issues, and not hearsay. Dckt. No. 101, at 2­4. Moreover, it is not uncommon in summary judgment proceedings for a court to defer rulings on admissibility.

14. The exhibits are filed at Dckt. No. 104; the brief that accompanies them is filed at Dckt. No. 103.

15. In brief, the district court's failure to address evidentiary issues can be seen by comparing the references to the record in the court's summary judgment opinion, JA 497­510, with the list of exhibits submitted of which the report was one, see Dckt. No. 104, and other evidence submitted to the district court, see Ex. B to Defs.' Mot. Dismiss of Apr. 26, 1995; Dckt. No. 55; Exs. to Defs.' Br. Supp. Mot. Regarding Fed. Preemption, filed Mar. 5, 1997; Exs. to Dckt. No. 87; Exs. to Dckt. No. 98; Exs. to Dckt. No. 106.