David Schaffner, Jr. v. Monsanto CorpDavid Schaffner, Jr. v. Monsanto Corp
Michael X. Imbroscio
David M. Zionts [ARGUED]
Covington & Burling
850 10th Street NW
One City Center
Washington, DC 20001
Kenneth L. Marshall
Bryan Cave Leighton Paisner
Three Embarcadero Center
7th Floor
San Francisco, CA 94111
Counsel for Appellant
Shannen W. Coffin
Sara Beth Watson
Mark C. Savignac
Steptoe & Johnson
1330 Connecticut Avenue NW
Washington, DC 20036
Counsel for Amicus Curiae Croplife America in Support of Appellant
William R. Stein
Alex Bedrosyan
Hughes Hubbard & Reed
1775 I Street NW
Suite 600
Washington, DC 20006
Counsel for Amici Curiae Chamber of Commerce of the United States of America, Pharmaceutical Research and Manufacturers of America, and Products Liability Advisory Council Inc. in Support of Appellant
Charles L. Becker [ARGUED]
Ruxandra M. Laidacker
Tobias L. Milrood
Kline & Specter
1525 Locust Street
19th Floor
Philadelphia, PA 19102
Adrian N. Roe
First Floor
428 Boulevard of the Allies
Pittsburgh, PA 15219
Michael D. Simon
Law Office of Michael D. Simon
2520 Mosside Boulevard
Monroeville, PA 15146
Counsel for Appellees
Patti A. Goldman
Earthjustice Legal Defense Fund
810 Third Avenue
Suite 610
Seattle, WA 98104
Alexis Andiman
Peter Lehner
Earthjustice
48 Wall Street, 19th Fl.
New York, NY 10043
Carrie Apfel
Earthjustice
1001 G Street NW, Suite 1000
Washington, DC 20001
Alisa Coe
Earthjustice
111 S Martin Luther King Jr. Blvd
Tallahassee, FL 32301
Counsel for Amici Curiae Farmworker Association of Florida, Farmworker Justice, Migrant Clinicians Network, Pesticide Action Network, United Farm Workers, and UFW Foundation in Support of Appellees
Leah M. Nicholls
Public Justice
1620 L Street NW
Suite 360
Washington, DC 20036
Jeffrey R. White
American Association for Justice
777 6th Street NW
Suite 200
Washington, DC 20001
Counsel for Amici Curiae Public Justice and the American Association for Justice in Support of Appellees
Adina H. Rosenbaum
Allison M. Zieve
Public Citizen Litigation Group
1600 20th Street NW
Washington, DC 20009
Counsel for Amicus Curiae Public Citizen in Support of Appellees
Robin L. Greenwald
James J. Bilsborrow
Weitz & Luxenberg
700 Broadway
New York, NY 10003
Counsel for Amicus Curiae Roundup MLD Co-Lead Counsel in Support of Appellees
OPINION OF THE COURT
CHAGARES, Chief Judge.
This appeal presents the question of whether, once the Environmental Protection
judgment in the Schaffners’ favor that was stipulated to by the parties and entered by the District Court reflected a prior ruling, issued during consolidated multi-district pretrial proceedings held in an out-of-circuit judicial district, that FIFRA did not preempt state-law tort duties to include the Cancer Warning on the Roundup label. We will therefore reverse the judgment of the District Court.
We first provide background in Part I, addressing pesticide regulation under FIFRA, the dispute over Roundup‘s carcinogenicity, and the Schaffners’ claims in this case, then we discuss our jurisdiction and the standard of review in Part II. In Part III, we consider and reject the Schaffners’ arguments that certain doctrines require our decision in this case to conform to the prior rejection of Monsanto‘s preemption theory by other courts in other litigation. Instead, we conclude that we must independently interpret FIFRA‘s express preemption scheme ourselves. We present our interpretation in Part IV, applying it to conclude that the Schaffners’ claims are expressly preempted by FIFRA. An EPA regulation promulgated pursuant to FIFRA (the “Preapproval Regulation“) prohibits modifying the health warnings included on a pesticide‘s Preapproved Label, see
I. Background2
A. FIFRA
FIFRA is a “comprehensive regulatory statute” that governs “the use, as well as the sale and labeling, of pesticides; regulate[s] pesticides produced and sold in both intrastate and interstate commerce; provide[s] for review, cancellation, and suspension of registration; and [gives the] EPA . . . enforcement authority.” Ruckelshaus v. Monsanto Co., 467 U.S. 986, 991-92 (1984). FIFRA both regulates pesticides directly and grants the EPA additional authority to supervise the pesticide industry. One such direct regulation is FIFRA‘s prohibition on distributing or selling “any pesticide which is . . . misbranded.”
The pesticide registration process is among the methods through which FIFRA authorizes the EPA to supervise the pesticide industry. FIFRA prohibits the distribution or sale of any pesticide that has not been registered,
with the EPA, see generally
The information submitted to the EPA during a pesticide‘s registration process under FIFRA determines in part how the pesticide may be marketed following its registration. For example, when it is distributed or sold, a registered pesticide‘s composition may not differ from the composition described in the statement submitted as part of its application for registration.
The EPA‘s supervision of a pesticide does not end once it approves an application to register that pesticide. In the 1988 amendments to FIFRA, see generally Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988, Pub. L. No. 100-532, 102 Stat. 2654, Congress required the EPA to reregister any pesticide (save for those falling within certain exceptions not relevant here) with an active ingredient contained in a pesticide first registered before November 1984. See
B. Roundup
In 1974, Monsanto introduced the pesticide Roundup, a weed-killer that employs glyphosate as its active ingredient. Since then, the EPA has repeatedly evaluated the health risks posed by glyphosate. It first assessed the carcinogenicity of glyphosate in 1985, when it classified the chemical as “possibly carcinogenic to humans.” Joint Appendix (“JA“) 43, 954. The following year, a scientific advisory panel concluded that glyphosate‘s human carcinogenicity could not yet be classified and suggested a review of additional data. Following the submission of further studies, in 1991 the EPA reclassified glyphosate as a chemical for which there exists “evidence of non-carcinogenicity for humans.” JA 955. It has not altered that conclusion since. More recently, its Cancer Assessment Review Committee reviewed scientific data about glyphosate in 2015 and concluded that the pesticide was “not likely to be carcinogenic to humans.” Id. And in January 2020, it issued an interim decision in its review of glyphosate‘s registration, finding once again that glyphosate is not likely to be carcinogenic to humans. That portion of the EPA‘s interim decision has since been vacated by the Court of Appeals for the Ninth Circuit. Nat. Res. Def. Council v. U.S. Env‘t Prot. Agency, 38 F.4th 34, 45 (9th Cir. 2022).
Others have disagreed with the EPA‘s view that glyphosate is not carcinogenic, however. The International Agency for Research on Cancer (“IARC“), which forms part of the World Health Organization, concluded in 2015 than glyphosate is probably carcinogenic to humans. See Kathryn Z. Guyton et al., Carcinogenicity of Tetrachlorvinphos, Malathion, Palathion, Diazinon, and Glyphosate, 16 Lancet Oncology 490 (2015) (announcing the IARC‘s conclusion); Int‘l Agency for Rsch. on Cancer, World Health Org., IARC Monographs on the Evaluation of Carcinogenic Risks to Humans No. 112: Some Organophosphate Insecticides and Herbicides 321-99 (2017). The IARC further noted that non-Hodgkin‘s lymphoma is among the types of cancer most closely associated with glyphosate.
Following the IARC‘s announcement of its findings, plaintiffs across the United States began filing lawsuits against Monsanto
In October 2016, the Judicial Panel on Multi-District Litigation (“JPML“) responded to the growing wave of Roundup litigation by centralizing pretrial proceedings for lawsuits alleging that Roundup can cause non-Hodgkin‘s lymphoma and that Monsanto had failed to warn adequately of that risk. In re Roundup Prods. Liab. Litig., 214 F. Supp. 3d at 1347-48. As the venue for the MDL, the JPML chose the United States District Court for the Northern District of California (the “MDL Court“) — the same court that had already heard, and rejected, Monsanto‘s express preemption argument.3 Id. at 1348. The first bellwether trial was later held
before the MDL Court featuring the same plaintiff, Edwin Hardeman, against whom Monsanto had first raised its express preemption arguments in 2016. See Hardeman v. Monsanto Co. (Hardeman II), 997 F.3d 941, 950 (9th Cir. 2021). At that trial, a jury found Monsanto liable for failing to warn of Roundup‘s carcinogenicity. Id. It awarded compensatory damages of over $5 million and punitive damages of $75 million, the latter of which were reduced to $20 million by the MDL Court. Id. Monsanto appealed that judgment on multiple grounds, including by challenging the MDL Court‘s rejection of its preemption arguments. Id. The Court of Appeals for the Ninth Circuit affirmed, holding that FIFRA did not preempt the California duty to warn that Monsanto was found liable for violating. Id. The Supreme Court denied Monsanto‘s petition fоr certiorari. Monsanto Co. v. Hardeman, 142 S. Ct. 2834 (2022).
While the JPML centralized pretrial proceedings for Roundup cases involving non-Hodgkin‘s lymphoma, cases involving other types of cancer remained in the districts in which they were filed. Among them is Carson v. Monsanto Co., which was filed in the Southern District of Georgia in December 2015, and which involves malignant fibrous histiocytoma rather than non-Hodgkin‘s lymphoma. See Carson v. Monsanto Co., (Carson I), 508 F. Supp. 3d 1369, 1373 (S.D. Ga. 2020). In Carson I, Monsanto moved for judgment on the pleadings using the same express-preemption arguments that the MDL Court had rejected in Hardeman I, and the district court dismissed the plaintiff‘s failure-to-warn claim on the grounds that it was expressly preempted by FIFRA. Id.
As the present case does not concern California law, Monsanto unsurprisingly has not raised that argument before this Court.
at 1375-76. The plaintiff appealed after amending his complaint to withdraw the claims that remained. See Carson v. Monsanto Co. (Carson II), 51 F.4th 1358, 1361 (11th Cir. 2022).4 A panel of the Court of
C. The Schaffners
David Schaffner, Jr. was diagnosed with non-Hodgkin‘s lymphoma in 2006. Prior to his diagnosis, he was exposed to Roundup both in his work as a professional landscaper and in
his capacity as a property owner. Theresa Sue Schaffner, his wife, suffered loss of consortium due to Mr. Schaffner‘s illness. In May 2019, the Schaffners filed a lawsuit against Monsanto in the Court of Common Pleas of Allegheny County, Pennsylvania, asserting six state-law causes of action, including one for failure to warn. Monsanto removed the case to the United States District Court for the Western District of Pennsylvania in October 2019, and the following month the JPML transferred the case to the Northern District of California. Because the MDL court had instructed the parties not to relitigate issues that it had already decided, Monsanto moved for summary judgment on preemption grounds merely by incorporating its earlier briefing before the MDL Court on that question, and the Schaffners opposed the motion on the same basis. The MDL Court denied the motion for the same reasons that it had relied upon in its earlier rejection of Monsanto‘s arguments. It then filed a suggestion of remand to the Western District of Pennsylvania, and the case was remanded to that court in March 2022.
Following the remand, the parties consented for all further proceedings in the District Court to be held before Chief Magistrate Judge Cynthia Reed Eddy pursuant to
the parties remained adverse and in disagreement with respect to those orders, they had reached a settlement with respect to all other aspects of the suit, and Monsanto had agreed to pay the Schaffners an amount that would depend on the ultimate result of the appeal. Pursuant to that stipulation, the District
II. Jurisdiction and Standard of Review
The District Court had jurisdiction over the Schaffners’ claims under
In an appeal taken once “final judgment has been entered, . . . claims of district court error at any stage of the litigation may be ventilated.” Dupree v. Younger, 598 U.S. 729, 734 (2023) (quoting Quackenbush v. Allstate Ins. Co., 517 U.S. 706, 712 (1996)). Monsanto‘s appeal therefore draws in question the MDL Court‘s order denying its motion for summary judgment on preclusion grounds. That order, in turn, incorporated by reference the MDL Court‘s prior order rejecting certain of Monsanto‘s preclusion arguments with respect to other cases that also formed part of the MDL. And that earlier order itself incorporated by reference an even earlier order also rejecting Monsanto‘s preemption arguments, which the MDL Court issued in Hardeman before pre-trial proceedings in that case were centralized with others in the MDL. Consequently, the MDL Court‘s rulings on preemption are properly before us in this appeal. We review questions of preemption de novo. Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 687 (3d Cir. 2016).
III. The Effect of Hardeman II
Before considering Monsanto‘s contention that FIFRA preempts the Pa. Duty to Warn, however, we first address the Schaffners’ two arguments that the Court of Appeals for the Ninth Circuit‘s rejection of Monsanto‘s position in Hardeman II binds us in this case. Schaffner Br. 47-55. Neither argument is compelling.
We begin with the law-of-the-case doctrine, under which “one panel of an appellate court generally will not reconsider questions that another panel has decided on a prior appeal in the same case.” In re Phila. Litig., 158 F.3d 711, 717 (3d Cir. 1998). The Court of Appeals for the Ninth Circuit decided in Hardeman II that FIFRA does not preempt a state-law failure-to-warn сlaim premised on the omission of the Cancer Warning from Roundup‘s label. 997 F.3d at 954-60. The Schaffners therefore conclude that this Court should not reconsider the question. Schaffner Br. 53-54. The law-of-the-case doctrine, however, applies only when a question has been decided in “a prior appeal in the same case.” In re Phila. Litig., 158 F.3d at 717 (emphasis added). As we recently held in Home Depot USA, Inc. v. Lafarge North America, Inc., 59 F.4th 55 (3d Cir. 2022), “[c]ases centralized in an MDL ‘retain their separate identities’ unless they choose to proceed on a consolidated ‘master’ complaint,” and the law-of-the-case doctrine therefore cannot be applied across distinct actions in an MDL. Id. at 61 (quoting Gelboim v. Bank of Am. Corp., 574 U.S. 405, 413 & n.3 (2015)). Because Hardeman and the present case remain distinct despite having been centralized in the same MDL, a holding issued in the former is not binding as the law of the case upon this Court.
We next turn to issue preclusion, which “prevents parties from relitigating an issue that has already been actually litigated.” Peloro v. United States, 488 F.3d 163, 174 (3d Cir. 2007).6 There are four general “prerequisites for the
application of issue preclusion“: “(1) the issue sought to be precluded is the same as that involved in the prior action; (2) that issue was actually litigated; (3) it was determined by a final and valid judgment; and (4) the determination was essential to the prior judgment.” Nat‘l R.R. Passenger Corp. v. Pa. Pub. Util. Comm‘n, 288 F.3d 519, 525 (3d Cir. 2002) (cleaned up). The Schaffners argue that each of these four is met, Schaffner Br. 49-52, and Monsanto does not appear to dispute the point, see Monsanto Reply 21-26.
Even when those four prerequisites are met, however, issue preclusion “is subject to a number of equitable exceptions designed to assure that the doctrine is applied in a manner that will serve the twin goals of fairness and efficient use of private and public litigation resources.” Nat‘l R.R. Passenger Corp., 288 F.3d at 525. The scope of a court‘s equitable discretion depends on whether all parties to the subsequent case were also parties to the prior one, which is referred to as mutuality, and on whether preclusion favors the plaintiff or the defendant in
using this Court‘s own precedents, not California law, see Schaffner Br. 48-49; Monsanto Reply 21-26, we decline to consider whether California law should govern. See Williams v. BASF Catalysts LLC, 765 F.3d 306, 316 (3d Cir. 2014) (holding that by briefing and relying on one sovereign‘s law, a party waives any argument that the law of a different sovereign should apply, as while “litigants may not waive issues that go to the power of the courts to hear a case,” “choice-of-law questions do not go to the court‘s jurisdiction“); Hammersmith v. TIG Ins. Co., 480 F.3d 220, 227 n.2 (3d Cir. 2007) (“Because the parties only argued the choice-of-law issue with respect to New York and Pennsylvania, we will not consider Texas in our choice-of-law analysis.“).
the second suit, which distinguishes offensive uses of preclusion from defensive ones. Id. The application of issue preclusion in favor of the Schaffners would be offensive and non-mutual, as the Schaffners are the plaintiffs, and they were not parties in Hardeman. Courts enjoy particularly broad discretion in deciding whether to employ issue preclusion in offensive, non-mutual contexts. Jean Alexander Cosmetics, Inc. v. L‘Oreal USA, Inc., 458 F.3d 244, 249 (3d Cir. 2006) (citing Parklane Hosiery Co. v. Shore, 439 U.S. 322, 331 (1979)).
To identify which equitable factors should guide a court‘s application of issue preclusion in general, we have relied upon
reasons, risks impeding a court from discharging “its function of developing the law.” Id. cmt. i. Furthermore,
This consideration is especially pertinent when . . . the issue was determined in an appellate court whose jurisdiction is coordinate with or subordinate to that of an appellate court to which the second action can be taken; or when the issue is of general interest and has not been resolved by the highest appellate court that can resolve it.
Id. The Second Restatement therefore advises that “the rule of preclusion should ordinarily be superseded” when either of those circumstances is present. Id.
These principles have been applied by multiple other United States Courts of Appeals, see, e.g., In re Westmoreland Coal Co., 968 F.3d 526, 532 (5th Cir. 2020); Pharm. Care Mgmt. Ass‘n v. District of Columbia, 522 F.3d 443, 446-47 (D.C. Cir. 2008); Af-Cap, Inc. v. Chevron Overseas (Congo) Ltd., 475 F.3d 1080, 1086 (9th Cir. 2007); Chi. Truck Drivers, Helpers, & Warehouse Union (Indep.) Pension Fund v. Century Motor Freight, Inc., 125 F.3d 526, 531 (7th Cir. 1997), as well as by the highest courts of multiple states, see Planned Parenthood of the Heartland, Inc. v. Reynolds ex rel. State, 975 N.W.2d 710, 729-30 (Iowa 2022); NIPSCO Indus. Grp. v. N. Ind. Pub. Serv. Co., 100 N.E.3d 234, 244-45 (Ind. 2018); Bowen ex rel. Doe v. Arnold, 502 S.W.3d 102, 117 (Tenn. 2016). And we are unaware of any decision of such a court that has considered these principles and either rejected them as invalid or expressly declined to apply them to facts analogous to those before us now. We join this consensus and hold that section 29(7) of the Second Restatement, along with its elaboration in comment i to that section, identifies an equitable factor that courts may consider in deciding whether to apply issue preclusion non-mutually. Applying the principles articulated in that section, we conclude that both circumstances requiring that “the rule of preclusion should ordinarily be superseded,” Restatement (Second) of Judgments § 29 cmt. i, are present. The appellate courts to which appeals were taken in Hardeman and in this case — respectively, the Court of Appeals for the Ninth Circuit and this Court — have coordinate jurisdiction. See Hoffman v. Blaski, 363 U.S. 335, 340 n.9 (1960). And the issue presented by this case, which is clearly of general interest, has yet to be decided by the highest court capable of resolving it — the United States Supreme Court. We
IV. Express Preemption Under FIFRA
The provision of FIFRA governing “uniformity” provides that no state shall “impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter.”
In Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), the Supreme Court held that a requirement imposed under state law must meet two conditions to be preempted by
To answer that question, we follow the approach outlined in Bates, where the Supreme Court explained how courts must determine whether a state-law requirement is preempted under
The parties’ primary disagreement in this case lies in how they identify the federal requirement that must be compared with the Pa. Duty to Warn in applying the parallel-requirements test (the “Federal Comparator“). The parties do not challenge each other‘s interpretation of the Pa. Duty to Warn, nor do they analyze equivalence differently between it and the Federal Comparator once the latter is identified. See Monsanto Br. 37-39; Schaffner Br. 30-31. To decide this case, then, we must first determine the content of the Federal Comparatоr, then apply the parallel-requirements test by comparing it with the Pa. Duty to Warn.
According to the Schaffners, the Federal Comparator incorporates only FIFRA‘s statutory prohibition on misbranding. Schaffner Br. 29. FIFRA prohibits the distribution or sale of a pesticide that is “misbranded,”
Monsanto argues instead that the Federal Comparator must incorporate the Preapproval Regulation,
Must the Pa. Duty to Warn be equivalent to a Federal Comparator incorporating only the requirement that pesticides not be misbranded under the statutory definition of that term, as the Schaffners claim? Or must it be equivalent to a Federal Comparator also incorporating the omission of the Cancer Warning from Roundup‘s Preapproved Label, as Monsanto claims? This dispute, which lies at the core of the parties’ disagreement, forms the focus of our analysis in this opinion. EPA regulations govern different parts of a pesticide label differently, so our holding does not generalize to all state-law claims involving pesticide labeling. But with respect to the Cancer Warning, we hold that Monsanto is correct.
Our analysis proceeds in three steps. First, in Part IV(A), we examine “EPA regulations that give content to FIFRA‘s misbranding standards.”9 Bates, 544 U.S. at 453. We conclude that the Preapproval Regulation,
A. Modifications to Pesticide Labels
FIFRA “pre-empts any statutory or common-law rule that would impose a labeling requirement that diverges from those set out in FIFRA and its implementing regulations.” Bates, 544 U.S. at 452 (emphasis added). We thus first examine the EPA regulations that govern pesticide labeling under FIFRA. FIFRA authorizes the EPA Administrator “to prescribe regulations to carry out the provisions of this subchapter.”
The Preapproval Regulation contains an exception, however. Only “[i]f an application for amended registration is required” must an applicаtion for amended registration be approved before the modified pesticide may be sold or distributed.
The Schaffners rely on section 152.46‘s provision that “a manufacturer can make minor modifications to labeling that have ‘no potential to cause unreasonable adverse effects to the environment’ without prior EPA approval if EPA is notified of the change.” Schaffner Br. 46 (quoting
EPA may determine that certain minor modifications to registration having no potential to cause unreasonable adverse effects to the environment may be accomplished by notification to the Agency, without requiring that the registrant obtain Agency approval. If EPA so determines, it will issue procedures following an opportunity for public comment describing the types of modifications permitted by notification and any conditions and procedures for submitting notifications.
We therefore turn to the policies that the EPA has issued pursuant to its authority under
The EPA understandably accepted the proposed modification as non-precautionary legal information, since the substance of that modification was to provide pesticide users with information about a determination made under California law. That is readily distinguishable from the Cancer Warning here, the substance of which is the finding of carcinogenicity itself. Put more simply, the Schaffners conflate the legal information that a state has made a particular determination with the non-legal substance of that determination, which, in our view, is clearly precautionary. Thus, unlike the notice considered by the court in Hardeman II, the Cancer Warning is not “minor” information that may be added by notification under PRN 98-10, and Monsanto could not have added it without running afoul of the Preapproval Regulation.
More generally, we also do not believe that courts may avoid the task of interpreting sources of law such as
This interpretation of PRN 98-10 is further reinforced by the EPA regulation
The present version of
Because the addition of the Cancer Warning to Roundup‘s label would involve a change in the precautionary statements on its Preapproved Label, modification by notification was unavailable under
B. Requirements Under FIFRA
Roundup‘s Preapproved Label omitted the Cancer Warning, and the Preapproval Regulation prohibited Monsanto from
First, the Preapproval Regulation satisfies the definition of “requirement” that the Supreme Court adopted in Bates. “A requirement is a rule of law that must be obeyed.” Bates, 544 U.S. at 445. And “[r]ules issued through the notice-and-comment process,” such as
Indeed, in Bates the Supreme Court expressly identified EPA regulations as a source of “requirements” for the purposes of preemption under FIFRA. 544 U.S. at 452-54.
To be sure, while some EPA regulations directly identify the contents that labels must contain, the Preapproval Regulation instead only requires a pesticide‘s label to bear the contents contained in its Preapproved Label, whatever those contents may be. The regulation itself does not directly identify any particular label contents as permitted, prohibited, or required. In Bates, the Court‘s analysis suggested that a “requirement” under
Our holding that the Preapproval Regulation imposes a “requirement” for purposes of preemption receives further support from the Supreme Court‘s preemption analysis in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Riegel did not directly concern FIFRA or any of its provisions, including
requirement for a medical device “which is different from, or in addition to, any requirement applicable under this chapter to the device,”
Because the Court‘s decision in Riegel turned on the preemptive effect of a regulatory scheme similar to the system of pesticide registration created by FIFRA, and because the two statutes’ preemption provisions themselves are so similar, the Court‘s analysis in that case sheds light on how we should analyze preemption under FIFRA. In Riegel, the Court applied the parallel-requirements test (in substance if not in name), just as we must do here, by separately identifying federal and state “requirements,” then comparing them to determine whether they were equivalent. 552 U.S. at 321-22; see also Bates, 544 U.S. at 447-48 (relying on precedents interpreting the MDA in holding that the parallel-requirements test governs preemption under FIFRA). To “determine whether the Federal Government ha[d] established requirements applicable to” the challenged device, Riegel, 552 U.S. at 321, the Court focused on the MDA‘s system for premarket approval, analyzing in particular whether the prohibition on modifying a medical device once the FDA had reviewed and approved it for safety established a “requirement” for the purposes of preemption under the MDA. Id. at 322-23. And its conclusions and reasoning shed light on whether, in general, a “requirement” exists within the meaning of a similar preemption provision, such as FIFRA‘s, where an agency reviews regulated products for safety before they may be marketed, then prohibits modifications of those products absent an additional safety review.
The Court held in Riegel that premarket approval does establish “requirements” for purposes of the MDA‘s preemption provision. Id. at 322 (“Premarket approval . . . imposes ‘requirements’ under the MDA . . . .“). Its holding rested squarely on the two regulatory elements common to both premarket approval under the MDA and pesticide registration under FIFRA — namely, the safety review that regulated products must undergo before they are marketed, and the prohibition on subsequent modifications of such products once they are reviewed and approved. As the Court explained, “the FDA may grant premarket approval only after it determines that a device offers a reasonable assurance of safety and effectiveness,” and “the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.” Id. at 323. The process of premarket approval substantively restricts which medical devices may be sold by requiring a reasonable assurance of safety and effectiveness, the Court reasoned, and therefore the preapproval regulations limiting modifications to a medical device that has received premarket approval also substantively restrict which medical devices may be sold. No requirement would have existed were medical devices permitted to “take any particular form for any particular reason.” Id. (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996)); see also Lohr, 518 U.S. at 492-94. But a requirement existed for purposes of preemption because a medical device must take a certain specific form following premarket approval.
The analysis of “requirements” adopted in Riegel carries over to FIFRA. If the prohibition on modifying medical devices following their approval for safety establishes “requirements” for medical devices, then FIFRA‘s regulatory approach, which employs the same two elements, should
C. Applying the Parallel-Requirements Test
As we have explained, the Supreme Court in Bates held that lower courts should apply section 136v(b) using the parallel-requirements test, identifying the relevant state and federal labeling requirements then comparing the two to determine whether they are equivalent. But our analysis of FIFRA and its implementing regulations has revealed that FIFRA‘s labeling requirements are articulated at two distinct levels of generality. On the one hand, under the broad statutory definition of misbranding, a pesticide is misbranded simply if its label omits a warning necessary for safe use; no specifically identified warning is required to be included or omitted. See
When state tort law and a federal statute seem to impose equivalent requirements, but a federal regulation gives different content to that apparently equivalent requirement, should a court articulate the Federal Comparator at the broader statutory level of generality or the more specific regulatory level of generality? That question determines what Federal Comparator we must employ when applying the parallel-requirements test in this case. Should we ask whether the Pa. Duty to Warn is equivalent to FIFRA‘s broad statutory requirement that labels contain all necessary warnings, or whether it is equivalent to the specific regulatory requirement that a pesticide‘s label must contain particular contents included on its Preapproved Label, including the precautionary statements?
We hold that under both Bates and section 136v(b) itself federal requirements must be articulated at the more specific level when identifying the Federal Comparator in applying the parallel-requirements test. If EPA regulations specifically identify the contents required to be included on a pesticide label, a state-law requirement is preempted unless it is equivalent to that specific regulatory requirement. The state-law duty cannot survive preemption simply because its standard of liability is equivalent to the broad statutory definition of misbranding. We therefore apply the parallel-requirements test in this case by comparing the Pa. Duty to Warn with a Federal Comparator that incorporates the Preapproval Regulation.
The principal holding articulated in Bates was that the parallel-requirements test governs preemption under section 136v(b). The Supreme Court did not itself apply that test to the plaintiffs’ claims, but rather remanded for the Court of Appeals to do so. Bates, 544 U.S. at 452-53. Nonetheless, the Court provided guidance concerning how the parallel-requirements test was to be applied on remand. Aftеr explaining that “a state-law labeling requirement must in fact be equivalent to a requirement under FIFRA in order to survive pre-emption,” id. at 453, the Court provided two illustrations of state failure-to-warn claims that would not be equivalent to the relevant Federal Comparator and would therefore be preempted. One example involved a “failure-to-warn claim alleging that a given pesticide‘s label should have stated ‘DANGER’ instead of the more subdued ‘CAUTION.‘” Id. In order to apply the parallel-requirements test to such a claim, the Court explained, “[s]tate-law requirements must also be measured against any relevant EPA regulations that give content to FIFRA‘s misbranding standards.” Id. A state-law requirement to employ ‘DANGER’ on a pesticide label would thus be preempted were it “inconsistent with
The Court‘s analysis of section 156.64 in Bates indicates that the parallel-requirements test should be applied using more specific EPA regulations requiring pesticide labels to bear particular contents, where such regulations exist, rather than using the broad statutory definition of misbranding. Under the latter approach, which the Schaffners adopt, alleged liability
be pre-empted because it is inconsistent with
Like the regulation the Court discussed in Bates, which requires specific signal words such as “CAUTION” or “DANGER” to appear on labels for different types of pesticides, see
The Court explained in Bates that whether a state-law duty allegedly requiring the use of ‘DANGER’ rather than
Even were we not bound by Bates, section 136v(b) itself indicates that the parallel-requirements test should be applied by comparing state-law requirements to a Federal Comparator that incorporates content-giving regulations rather than to one based solely upon the broad statutory definition of misbranding. The Supreme Court has “oft-repeated” its comment that “‘[t]he purpose of Congress is the ultimate touchstone’ in every pre-emption case.” Lohr, 518 U.S. at 485 (alteration in original) (quoting Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 (1963)). Thus, our “understanding of the scope of a pre-emption statute,” such as section 136v(b), “must rest primarily on a fair understanding of congressional purpose.” Id. at 485-86 (quotation marks omitted). We draw that understanding of congressional purpose primarily from the text of the statute and from its surrounding framework. Id. at 486
Here, Congress has made the purpose of section 136v(b) transparent by titling it “Uniformity.”
The level of generality at which a rule is framed often affects the degree of uniformity in how it will be applied on different occasions. Different interpreters may apply a vague, broad rule differently given the same facts, while they are likely to apply a specific, precise rule more consistently. Because misbranding is defined by statute as the omission of warnings “necessary . . . to protect health,”
The parallel-requirements test affects the uniformity of state-law labeling requirements by determining which state-law duties FIFRA preempts. If state-law duties to warn can survive preemption so long as they are equivalent to the broad statutory definition of misbranding, then FIFRA would not preempt state-law duties to warn that simply require the inclusion of all warnings necessary to protect health. State-law duties framed in these vague and broad terms would produce considerable heterogeneity, not uniformity, in the labels that pesticides are required to bear, for different factfinders deciding different individual cases might reasonably disagree about whether a particular warning was necessary to protect health. But if the parallel-requirements test were applied to preempt any state-law duty that is not equivalent to EPA regulations requiring pesticide labels to bear certain specific contents, then state-law duties to warn would likely be considerably more uniform, for different factfinders are unlikely to disagree about whether a рesticide label bears the specific contents required by regulation.
Congress‘s aim of instituting uniform rules for pesticide labeling would thus be realized more effectively were state-law requirements “measured against any relevant EPA regulations that give content to FIFRA‘s misbranding standards,” Bates, 544 U.S. at 453, rather than against the statutory definition of misbranding itself. Where no such regulations exist, of course the parallel-requirements test can only be applied using the statutory definition, despite any consequent risk of heterogeneous state-law labeling requirements. But the Preapproval Regulation gives content to the broad misbranding standard by specifically requiring a pesticide‘s label to bear the particular precautionary statements on its Preapproved Label. We therefore apply the parallel-requirements test using a Federal Comparator that incorporates that specific regulatory requirement.
* * * * *
The parties reach different conclusions as to whether section 136v(b) preempts the Pa. Duty to Warn because they identify the Federal Comparator differently in applying the parallel-requirements test. We have concluded that the test must be applied by comparing the Pa. Duty to Warn with a Federal Comparator that incorporates the Preapproval Regulation. That question having been resolved, only the straightforward task of making the comparison remains. Monsanto‘s omission of the Cancer Warning from the Roundup label allegedly violated the Pa. Duty to Warn. But it did not breach the Preapproval Regulation — and thus the Federal Comparator — because Roundup‘s Preapproved Label omitted the Cancer Warning. As Monsanto‘s alleged violation of the Pa. Duty to Warn did not constitute a violation of the Federal Comparator, the two requirements are not equivalent, the parallel-requirements test is not satisfied, and the Schaffners’ claim for failure to warn is preempted under section 136v(b).
V. The Schaffners’ Counterarguments
The Schaffners’ counterarguments ultimately fail to persuade us of their claim that the Pa. Duty to Warn cannot be preempted by virtue of the omission of the Cancer Warning from Roundup‘s Preapproved Label.
The Schaffners first cite the discussion of Bates found in Indian Brand Farms, Inc. v. Novartis Crop Protection Inc., 617 F.3d 207 (3d Cir. 2010), one of our few precedents addressing preemption under FIFRA. The pesticide label alleged in Bates to violate state law conformed to that pesticide‘s Preapproved Label. See Bates, 544 U.S. at 434-35. When interpreting Bates in Indian Brand Farms, therefore, we commented that the Supreme Court‘s decision to remand that case to the Court of Appeals rather than to reverse “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.” Indian Brand Farms, 617 F.3d at 222. Citing that statement, the Schaffners argue that a state-law duty cannot be preempted simply because it requires a warning that was not included on a pesticide‘s Preapproved Label. Schaffner Br. 33.
Our comment in Indian Brand Farms is consistent with our holding today and with the reasoning that supports it. As we explained in Indian Brand Farms, the fact that a pesticide‘s Preapproved Label differs from the label allegedly required by state law “[does] not necessarily mean that the state law duty was preempted.” Id. (emphasis added). As a result, state law may, in some circumstances, require a pesticide‘s label to bear particular contents that were excluded from its Preapproved Label. Our reasoning in this opinion fully respects that principle. We do not hold that FIFRA necessarily preempts any state-law duty requiring modification to a pesticide‘s Preapproved Label. Rather, we hold only that such duties may sometimes be preempted, including in the circumstances of this case.
First, given the Supreme Court‘s explicit explanation in Bates for its choice to vacate rather than reverse, we read that disposition — and our commentary on it in Indian Brand Farms — to address only the preemptive effect of
The Court‘s choice to vacate rather than reverse in Bates plausibly indicates that section 136v(b) does not on its own preempt all state-law duties to include a warning that was omitted from a pesticide‘s Preapproved Label. But the Court expressly did not consider whether state law would be preempted under section 136v(b) in light of requirements imposed through EPA regulation: it “ha[d] not received
In turn, our discussion of Bates in Indian Brand Farms was consistent with the Court‘s express explanation for its disposition in Bates. The discrepancy between a pesticide‘s Preapproved Label and the label allegedly required by state law does not “necessarily” result in the state law‘s being preempted, as we explained in Indian Brand Farms, see 617 F.3d at 222, in that section 136v(b) does not of its own force preempt all such state-law duties. Instead, to quote the very next sentence of our opinion in Indian Brand Farms, “[w]e must look to the requirements imposed by FIFRA.” Id. And, of course, those requirements may depend on the regulations the EPA has promulgated: whether FIFRA preempts state-law duties to modify a pesticide‘s Preapproved Label will depend on whether those state-law requirements are in addition to or different from the content-giving regulatory requirements that the EPA has promulgated. By noting that FIFRA does not “necessarily” preempt state-law duties requiring modification to a pesticide‘s Preapproved Label, our opinion in Indian Brand Farms merely recognized the possibility that such duties would not be preempted — a possibility that may or may not be realized depending on what regulations the EPA enacts. Our FIFRA preemption analysis in this case thus is consistent with Indian Brand Farms, as it rests specifically on the Preapproval Regulation. We do not take section 136v(b) automatically to preempt any state-law duty that would require modification of a pesticide‘s Preapproved Label, regardless of what regulatory requirements actually have been imposed under FIFRA.
Furthermore, our holding today would be consistent with our comment in Indian Brand Farms even were we to interpret it as addressing the preemptive effect of the regulations promulgated pursuant to FIFRA, not just of section 136v(b) on its own. We do not today endorse the claim, rejected in Indian Brand Farms, that any state-law duty requiring modification of a pesticide‘s Preapproved Label is preempted. See 617 F.3d at 222. The Pa. Duty to Warn, we have held, is preempted by virtue of the Preapproval Regulation. And the Preapproval Regulation does not prohibit all modifications tо a pesticide‘s Preapproved Label; rather, as discussed above, it carves out an exception for modifications by notification (and without notification) authorized under
We do not hold the Schaffners’ claim for failure to warn to be preempted on the grounds, properly rejected in Indian Brand Farms, that any such claim is “necessarily” preempted if it would require a modification to the pesticide‘s Preapproved Label. Rather, as we explained in Indian Brand Farms, when applying section 136v(b) “[w]e must look to the requirements imposed by FIFRA.” 617 F.3d at 222. The opinion in Indian Brand Farms thus continues its analysis by examining the text of the statute and of applicable agency actions in order to identify the relevant requirements, just as we have done here. We conclude that the Schaffners’ claim is preempted because of the specific requirement imposed through the Preapproval Regulation, which prohibits the modification of a pesticide‘s Preapproved Label without further approval unless the exception for modification by notification (or without notification) applies.
B. 7 U.S.C. § 136a(f)(2)
The Schaffners next claim that FIFRA itself does not allow the EPA‘s registration of a pesticide to affect the preemption of state-law duties under that statute. Under FIFRA,
[i]n no event shall registration of an article be construed as a defense for the commission of any offense under this subchapter. As long as no cancellation proceedings are in effect registration of a pesticide shall be prima facie evidence that the pesticide, its labeling and packaging comply with the registration provisions of the subchapter.
We agree with the Schaffners that EPA registration cannot be “dispositive of FIFRA compliance.” Schaffner Br. 33. Because section 136a(f)(2) provides that registration cannot constitute a defense to a violation of FIFRA, a pesticide otherwise liable for violating FIFRA cannot defeat liability simply because it is registered.17
concluded that under the Preapproval Regulation the EPA‘s approval of a proposed label “give[s] content to FIFRA‘s misbranding standards,” Bates, 544 U.S. at 453, as the pesticide‘s label must conform to its Preapprovеd Label with respect to precautionary statements. A pesticide can still be misbranded despite being registered.18 The EPA‘s registration of a pesticide is therefore not dispositive as to whether it is misbranded, as section 136a(f)(2) would forbid. Rather, registration affects the content of the requirements imposed under FIFRA, as registration determines what label the pesticide must bear (at least in certain respects). And while section 136a(f)(2) indicates that registration cannot itself be a defense to a charge of misbranding, we do not understand it to indicate that the registration process cannot play any role in determining the content of a requirement imposed under FIFRA, the only role we have assigned it in this opinion.
C. Mead and the Force of Law
The Schaffners’ final argument begins with the claim that only EPA actions with the “force of law” may exert preemptive force under section 136v(b) by giving content to a Federal Comparator used in applying the parallel-requirements test. Schaffner Br. 37, 39. Relying on the Supreme Court‘s analysis of the “force of law” in United States v. Mead Corp., 533 U.S. 218, 229-30 (2001),19 they then conclude — as did our colleagues on the Courts of Appeals for the Ninth and Eleventh Circuits — that because the EPA actions Monsanto relies upon in its preemption arguments lacked the force of law, they cannot affect the content of the Federal Comparator we must compare to the Pa. Duty to Warn. Schaffner Br. 35-37, 39; Carson IV, 92 F.4th at 993; Carson II, 51 F.4th at 1362-65; Hardeman II, 997 F.3d at 956-57.
In Carson II and Hardeman II, the key premise in these arguments — that section 136v(b) bestows preemptive force only on
preempt state law pursuant to an express preemption provision. Carson III, 74 F.4th at 1267-68. Instead, when Congress has expressly authorized the preemption of state law by statute, “the meaning of the express-preemption provision . . . triggers preemption.” Id. at 1268. Thus, “[o]ur role when confronted with an express-preemption provision is to apply the text that embodies Congress‘s decision.” Id. We have already concluded that the Preapproval Regulation establishes a “requirement” under FIFRA‘s express preemption provision,
has decreed in the text of that provision that federal “requirements” have preemptive force, see id., no further analysis is necessary.
VI. Conclusion
We conclude that neither issue preclusion nor administrative law provides a basis upon which to affirm the MDL Court‘s ruling that the Schaffners’ failure-to-warn claim is not preempted under FIFRA. As to issue preclusion, we adopt section 29(7) of the Second Restatement. A court has discretion to decline to apply issue preclusion if the “issue is one of law and treating it as conclusively determined would inappropriately foreclose opportunity for obtaining reconsideration of the legal rule upon which it was based.” Restatement (Second) of Judgments § 29(7) (Am. L. Inst. 1982). For that reason, we do not apply issue preclusion in this case. The complex subject of preemption under FIFRA has not been comprehensively analyzed
As to those preemption arguments, our analysis differs from that of the MDL Court — and of our colleagues in other courts who have agreed with its conclusion — chiefly in how we define the Federal Comparator that must be employed in applying the parallel-requirements test. We hold that the Preapproval Regulation prohibits modifying the health warnings on a pesticide‘s Preapproved Label, including by adding the Cancer Warning; that this prohibition constitutes a “requirement” for the purposes of section 136v(b); and that when we apply the parallel-requirements test the Federal Comparator must incorporate this regulatory requirement rather than incorporating only the statutory definition of misbranding. This approach best achieves Congress‘s stated aim of uniformity in pesticide labeling. And the parallel-requirements test is not satisfied when the Pa. Duty to Warn and the Federal Comparator are compared under this approach: they are not equivalent because Monsanto‘s alleged violation of the Pa. Duty to Warn did not constitute a violation of the Preapproval Regulation. We thus conclude that the Schaffners’ failure-to-warn claim is preempted under section 136v(b).
For these reasons, we will reverse the judgment of the District Court.