Dawn-Marie Hawkins James E. Hawkins v. Leslie's Pool Mart, Inc

MANSMANN, Circuit Judge,

dissenting.

Although I join in Parts I (except as to its affirmance as to labeling-based claims) and 11(B) of the majority’s opinion and agree with the majority’s holding in Part 11(A) that claims based on labeling actually reviewed and approved by the Environmental Protection Agency and claims based on matters addressed therein are preempted under the Federal Insecticide, Fungicide and Rodenticide Act, I must nonetheless dissent from the majority’s determination that Plaintiffs-Appellants’ (collectively, “Hawkins”) claims based on opening directions on the top of the package are also preempted.

Hawkins contends that Mrs. Hawkins was injured as a result of following allegedly faulty opening instructions provided on the top of the container of pool chlori-nator tablets supplied by Defendant-Ap-pellee Leslie’s Pool Mart (“Leslie’s”).1 The majority rejects Hawkins’s attempt to distinguish these instructions from other package labeling as “hair-splitting” because, under FIFRA, “labeling” includes all “written, printed or graphic matter” accompanying the product, wherever it appears on the container.2 While it is un*256doubtedly true that the instructions on the top of the package constitute labeling and are subject to EPA regulation under FI-FRA, I believe that the majority has misconstrued Hawkins’s argument. Hawkins contends that claims based on the package top opening instructions escape preemption not because of the instructions’ location but because they were never reviewed and approved by the EPA.

The majority appears to have rejected Hawkins’s real argument concerning the opening instructions on factual, rather than legal, grounds. According to the majority, “[t]he record ... makes clear that the EPA scrutinized Leslie’s Pool Mart’s proposed labels....” Majority Opinion at pp. 251-52; see also Majority Opinion at p. 255 (“[T]he EPA carefully reviewed- all printed matter that accompanied the chlo-rinator tablets... .”).3 There is, however, no demonstration in the record that the EPA reviewed and approved the package top instructions at issue. As the party with the burden of proof on its affirmative defense of preemption,4 Leslie’s is responsible for this deficiency in the record. Cf. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 254, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) (on motion for summary judgment, evidence is to be read in light most favorable to the non-moving party).5 Moreover, Hawkins expressly asserts that the top opening instructions were not part of the EPA approved labeling,6 and Leslie’s has not disputed this assertion.7

In the present posture of this case, ie., on review of summary judgment, I believe we must assume that the package top instructions were not reviewed and approved by the EPA. Thus, EPA approval gave rise to requirements only with respect to the storage and general handling instructions on the approved labels. Because no statutory or regulatory provision governs the content of opening instructions, I would hold that in the absence of agency review and approval there is no applicable federal “requirement” to which a state law duty as to claims for faulty opening instructions may be different or additional, and therefore there is no preemption under FI-FRA.8 Moreover, as the majority indicates *257and as Leslie’s concedes, the inclusion of unapproved labeling material — unilaterally added by the manufacturer — is itself a violation of FIFRA and its implementing regulations.9 State law causes of action which provide a remedy for conduct that violates FIFRA are not preempted. See, Worm v. American Cyanamid Co., 5 F.3d 744, 748 (4th Cir.1993) (“If a state elects to recognize that a breach of a FIFRA-created duty forms the basis for a state remedy, ... it is permitted to do so by 7 U.S.C. § 136v(b).”).10 Cf. Medtronic, 518 U.S. at 495, 116 S.Ct. at 2255 (“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.”).

For these reasons, I believe that Hawkins should be permitted on remand to pursue claims based on the opening instructions if indeed they were not reviewed and approved by the EPA. I express no opinion on whether Hawkins would be able to establish that a defect in those instructions caused her injuries. Because I conclude, however, that FIFRA does not preempt such a claim in these circumstances, I respectfully dissent from this aspect of the majority’s opinion.

. The printed material on top of the container begins with the following:

TO OPEN: PLACE COIN IN GROOVE-PRY AND LIFT LID OFF

. See Majority Opinion at p. 249 (rejecting Hawkins’s ”attempt[] to make the distinction that her claim is based not on the label, but *256on instructions placed on the lid of the container”).

. But see Majority Opinion at p. 252 (acknowledging that "the approved instructions and warnings do not specify how the user is to pry the lid off the container”).

. See, e.g., Williams v. Ashland Eng’g Co., 45 F.3d 588, 592 n. 7 (1st Cir.), cert. denied, 516 U.S. 807, 116 S.Ct. 51, 133 L.Ed.2d 16 (1995) (recognizing that federal preemption is affirmative defense as to which defendant has burden of proof).

. See also Avirgan v. Hull, 691 F.Supp. 1357, 1368 (S.D.Fla.1988) (when defendant moving for summary judgment bears burden of proof because he is asserting affirmative defense, "he must establish beyond peradventure all of the essential elements of the ... defense to warrant judgment in his favor”).

. See Brief of Appellants at 12 (alleging that front and back EPA registered labels do not refer to opening or closing, while the package lid instructions — not registered with the EPA — do). Hawkins specifically asserts that "The allegedly defective directions on the lid are neither required nor approved under FI-FRA, nor registered with EPA.” Id.

. Indeed, the documentation provided by Leslie’s in its Appendix appears to support Hawkins’s assertion. See Appendix at 13a-16a (Affidavit of Cynthia G. Watts, Leslie’s Vice President and General Counsel, attaching as Exhibit A "a true and accurate copy of the original label for Leslie’s Chlorinator Tablets 1” approved by the EPA in August 1975”). Exhibit A consists of two pages (15a-16a)the front and back labels of the container, each stamped as "ACCEPTED” under FIFRA on August 19, 1975; Appendix at 37a-39a (a portion of Exhibit C, correspondence from the EPA during Leslie's process of modifying and reregistering its labels, showing that Leslie's Certification with Respect to Citation of Data submitted in its application for registration attached two labels only — front and back); Appendix at 60a-62a (Exhibit E, the EPA’s Notice of Reregistration issued on June 20, 1994, which again contains two labels only — front and back).

. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (holding that preemption depends upon agency *257promulgation of a relevant requirement); see also Majority Opinion at p. 248 (explaining that "pre-emptive effect of FIFRA is dependent on agency regulations”); 7 U.S.C. § 136v(b) (prohibiting slate imposed labeling or packaging requirements that are "in addition to or different from those required under this subchapter”).

. See Brief of Appellee at 11 (citing 7 U.S.C. § 136j(a)(2)(A) and observing that "Thus, no one in the chain of commerce is free to add additional warnings, information or instructions on its own after a particular label has been approved by the EPA.”); see also Majority Opinion at p. 250 ("FIFRA disallows any changes to any EPA-approved label unless the EPA approves the change.”).

. See also Moss v. Parles Corp., 985 F.2d 736, 741 (4th Cir.1993) (following 'Worm in concluding that FHSA does not preempt claim for non-compliance with federally mandated labeling requirements); Nat’l Bank of Commerce of El Dorado v. Kimberly-Clark Corp., 38 F.3d 988, 993 (8th Cir.1994) (“We agree with the conclusions of the Worm and Moss courts and of the district courts cited above that when a statute only preempts state requirements that are different from or in addition to those imposed by federal law, plaintiffs may still recover under state tort law when defendants fail to comply with federal requirements.”).