Opinion ID: 152639
Heading Depth: 1
Heading Rank: 4

Heading: The Failure-to-Warn Claim

Text: Plaintiffs seek to impose liability on Novartis for failing to warn of dangers to their crops from tank mixing AG600 with the fungicides Captan and Captec. Plaintiffs contend that FIFRA requires labels to contain sufficient warnings, see 7 U.S.C. § 136(q)(1), and, accordingly, that their failure-to-warn claim would only impose labeling requirements equivalent and parallel to those of FIFRA, not labeling requirements in addition to or different from those of FIFRA. We note at the outset that prior to the Supreme Court's decision in Bates, several of our sister Courts of Appeals held that failure-to-warn claims based on inadequate labeling were pre-empted by FIFRA, on the reasoning that [i]n order to prevail on... failure to warn claim[s], [plaintiffs] would have to prove that [product] labels [approved by the EPA] contained insufficient information and that different labels were warranted, and so [a]warding damages on the[se] ... claim[s] would therefore be tantamount to allowing the state[s]... to regulate pesticide labeling indirectly, an action which is specifically prohibited by § 136v(b). Taylor AG Indus. v. Pure-Gro, 54 F.3d 555, 560 (9th Cir.1995); see also Bice v. Leslie's Poolmart, Inc., 39 F.3d 887, 888 (8th Cir.1994) (holding that failure-to-warn claims are preempted by FIFRA because actual agency approval eliminates any possible claims under state tort law for failure to comply with federal [labeling] requirements) (internal quotation omitted); MacDonald v. Monsanto Co., 27 F.3d 1021, 1025 (5th Cir.1994) (holding that the express language of FIFRA clearly indicates that Congress intended that the federal act preempt conflicting state law, including state common law tort claims of failure-to-warn); Ark.-Platte & Gulf P'ship v. Van Waters & Rogers, Inc., 981 F.2d 1177, 1179 (10th Cir.1993) (To the extent that state tort claims in this case require a showing that defendants' labeling and packaging should have included additional, different, or alternatively stated warnings from those required under FIFRA, they would be expressly preempted.); Worm v. Am. Cyanamid Co., 5 F.3d 744, 748 (4th Cir. 1993) (The [plaintiffs'] argument that their state law claims are based on duties not inconsistent with those imposed by FIFRA has no merit ..., [because] to argue that the warnings on the label are inadequate is to seek to hold the label to a standard different from the federal one.). However, Bates introduced a different analysis of FIFRA preemption, one that compels us to depart from this pre- Bates precedent. As we have earlier explained, the Bates Court made clear that failure-to-warn claims were not preempted unless they would impose a requirement  in addition to or different from  those required by FIFRA. Bates, 544 U.S. at 447, 125 S.Ct. 1788. It stressed that it was thus endorsing a `parallel requirements' reading of § 136v(b) which preserved state law duties that are consistent with those imposed by FIFRA, whether or not state law provides a remedy that FIFRA did not provide. [12] Id. The Court noted that [p]rivate remedies that enforce federal misbranding requirements would seem to aid, rather than hinder, the functioning of FIFRA. Id. at 451, 125 S.Ct. 1788. Also, as earlier noted, the Bates Court, because of insufficient briefing, remanded the case to the Court of Appeals to determine whether the plaintiffs' failure-to-warn claim would impose any requirements in addition to or different from the requirements under FIFRA. In doing so, it provided guidance which we find helpful here. First of all, the remand established that mere inconsistency between the duty imposed by state law and the content of a manufacturer's labeling approved by the EPA at registration did not necessarily mean that the state law duty was preempted. [13] We must look to the requirements imposed by FIFRA. Accordingly, the Court suggested that, on remand, the Court of Appeals look to whether the failure-to-warn claim was not equivalent to FIFRA's misbranding standards. Id. at 453 n. 27, 125 S.Ct. 1788. If equivalency is found between the claim and the statutory text, the Court should determine whether there are any EPA regulations that further refine those general standards in any way that is relevant to petitioners' allegations. Id. [14] To the extent that EPA [has] promulgate[d] such regulations ..., they will necessarily affect the scope of preemption under § 136v(b). Id. at 453 n. 28, 125 S.Ct. 1788. FIFRA's misbranding provisions require warning[s] or caution statement[s] which may be necessary ... to protect health and the environment. 7 U.S.C. § 136(q)(1)(G). The term `environment' includes water, air, land, and all plants and man and other animals living therein.... 7 U.S.C. § 136(j); Kuiper, 131 F.3d at 664; Etcheverry, 93 Cal.Rptr.2d 36, 993 P.2d at 375. The NJPLA imposes liability on a manufacturer where the product causing the harm was not reasonably fit, suitable or safe for its intended purpose because it... failed to contain adequate warnings or instructions. N.J. Stat. Ann. § 2A:58C-2. This provision has been interpreted as consistent with Section 2 of The Restatement (Third) of Torts: Product Liability, i.e., liability is imposed for inadequate warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable... warnings ... and the omissions of the ... warnings renders the product not reasonably safe. In the context of this case, this does not appear to us to impose a duty inconsistent with or in addition to the duty imposed by the text of the warning provisions of FIFRA's misbranding requirements. Moreover, Novartis does not purport to have identified any duty imposed by New Jersey law that does not come within this statutory text. Nor has Novartis identified any EPA regulations that further refine those general standards in any way that is relevant to Plaintiffs' allegations. Bates, 544 U.S. at 453 n. 27, 125 S.Ct. 1788. And we have found none. [15] Rather, Novartis's response to Plaintiffs' parallel requirements interpretation of the state law and FIFRA is an EPA Notice of Revised Policy on Label Claims for Tank Mixing issued in January 1982. As its title indicates, the revised policy is directed to applications for registration where the proposed label, unlike that of AG600, claims that the product is suitable for tank mixing. Under the revised policy, the EPA will usually approve tank mix label claims without supporting compatibility and residue data if certain specified conditions are met, including: (2) The chemical characteristics of all products to be used in the mix are such that no incompatibility or potentiation is likely to occur. (The Agency reserves the right to request appropriate data if it determines that a problem could arise.) Pesticide Registration (PR) Notice 82-1 (Jan. 12, 1982). While this policy revision was not applicable to AG600, Novartis finds it to be of controlling significance because its discussion of the Background of the policy revision contains the following statements: In the past, the Agency has required that applications for new registration or for amended registration involving claims for tank mixing the pesticide product with another pesticide product be supported by compatibility data and, if the mixture is to be used on a food or feed crop, by residue data demonstrating that the mixture would not result in residues higher than the tolerance established for each active ingredient. However, in cases where the pesticide labels are silent on the matter of tank mixing, applicators have been permitted to use tank mixes at their own risk if the sites or crops on which the mix is to be used are registered sites and crops for all the pesticides contained in the mix and if all pertinent limitations, use directions, and precautions are followed. Id. (emphasis added). For Novartis, this statement establishes that the EPA regards FIFRA as imposing no label requirements for a warning of an unreasonable risk of plant damage from tank mixing so long as no tank mixing claim is made. Novartis therefore concludes that Plaintiffs' failure-to-warn claim imposes a labeling requirement not required by FIFRA. We are not persuaded. Bates teaches that there is a strong presumption against preemption of state law: Even if Dow had offered us a plausible alternative reading of § 136v(b) indeed, even if its alternative were just as plausible as our reading of that text we would nevertheless have a duty to accept the reading that disfavors preemption. [B]ecause the States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly pre-empt statelaw causes of action. Medtronic, 518 U.S. at 485, 116 S.Ct. 2240. In areas of traditional state regulation, we assume that a federal statute has not supplanted state law unless Congress has made such an intention `clear and manifest.' New York State Conference of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 514 U.S. 645, 655 [115 S.Ct. 1671, 131 L.Ed.2d 695] (1995) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 [67 S.Ct. 1146, 91 L.Ed. 1447] (1947)). Bates, 544 U.S. at 449, 125 S.Ct. 1788. Given this admonition, we would be most reluctant to base a preemption holding on a background observation of the kind relied upon by Novartis. More importantly, however, this observation does not relate to the labeling requirements for manufacturers. Rather, it is addressed to what applicators have been permitted to do where the manufacturers' label makes no claim concerning tank mixing. The duty of manufacturers under FIFRA is to avoid misbranding, and that duty is not limited to the claims they make for their products. Indeed, the fact that the EPA does not share Novartis's view of the limitation on its duty to warn is apparent from the fact that, after Plaintiffs' crop damage was called to the attention of the EPA, it required that a warning of risk of tank mixing be added to the AG600 label, even though the label continued to contain no claim of tank mixing. The NJPLA imposes a requirement for a warning of risk to property which is consistent with Section 2 of the Restatement (Third) of Torts: Products Liability. That requirement is thus not an extraordinary one. It is consistent in scope with the generally accepted commercial expectation. Moreover, we note that FIFRA expressly endorses a concept quite similar to New Jersey's duty to warn of risks associated with objectively foreseeable uses. Section 136a(c)(5) provides in part as follows: (5) Approval of registration The Administrator shall register a pesticide if the Administrator determines that, when considered with any restrictions imposed under subsection (d) (A) its composition is such as to warrant the proposed claims for it; (B) its labeling and other material required to be submitted comply with the requirements of this Act; (C) it will perform its intended function without unreasonable adverse effects on the environment; and (D) when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment. 7 U.S.C. § 136a(c)(5) (emphasis added). We find it significant that Congress found it advisable to include the provisions of (D) in addition to the intended function provisions of (C). Given that Congress in FIFRA imposed a generalized duty to include in one's labeling any warning statement necessary to protect plant life and the fact that the EPA has not seen fit to narrow that duty, we find no basis for concluding that New Jersey law imposes a duty to warn different than or in addition to the scope of the requirement imposed by FIFRA. The District Court's judgment regarding Plaintiffs' failure-to-warn claim will be reversed. [16]