David Schaffner, Jr. v. Monsanto Corp
113 F.4th 364
3rd Cir.2024Background
- Plaintiffs (David and Theresa Schaffner) sued Monsanto alleging Pennsylvania common-law failure-to-warn for omitting a cancer warning from Roundup's label (they allege exposure caused non-Hodgkin’s lymphoma).
- FIFRA contains an express preemption clause (7 U.S.C. § 136v(b)) barring state labeling/packaging requirements that are "in addition to or different from" federal requirements; EPA oversees pesticide registration and approves a product's proposed label (the Preapproved Label).
- EPA repeatedly reviewed glyphosate and, through the registration process, approved Roundup labels that omitted the alleged cancer warning; 40 C.F.R. § 152.44(a) (the Preapproval Regulation) prohibits distributing a product with a modified label without EPA approval.
- EPA guidance (PRN 98-10) and 40 C.F.R. § 152.46 limit what may be changed by notification and generally preclude adding precautionary statements by notification.
- MDL/earlier proceedings: MDL Court and Ninth Circuit in Hardeman rejected Monsanto’s express-preemption defense; other circuits (Eleventh) have also addressed the issue in Carson. In the Western District of Pennsylvania the parties stipulated judgment for plaintiffs while Monsanto reserved the right to appeal; Third Circuit reviews preemption de novo.
Issues
| Issue | Plaintiff's Argument (Schaffner) | Defendant's Argument (Monsanto) | Held |
|---|---|---|---|
| Whether FIFRA's express preemption (§136v(b)) bars a state-law duty to include the cancer warning on Roundup | State misbranding statute (and PA products-liability duty) is equivalent to FIFRA's misbranding prohibition; registration does not insulate misbranding claims | EPA's Preapproval Regulation and the EPA's approval of Roundup's Preapproved Label (which omitted the cancer warning) create a federal "requirement"; a state duty to add the warning diverges and is preempted | Held preempted: the Federal Comparator must include EPA regulations that give content to FIFRA (here §152.44/Preapproval Regulation), and the PA duty is not equivalent, so preempted |
| Whether prior Ninth Circuit decision in Hardeman binds this Court by law-of-the-case or issue preclusion | Hardeman's rejection of preemption should preclude relitigation | Preclusion in MDL context doesn't bind different actions; Third Circuit may re-evaluate | Held: law-of-the-case inapplicable (different cases); issue preclusion declined under Restatement (Second) §29(7) because the issue is a pure legal question and fairness/discretion counseled relitigation |
| Whether EPA actions must have the 'force of law' (Mead) to supply the federal 'requirement' for preemption | Only agency actions with Mead-level force of law can establish the federal requirement that preempts state law | The Preapproval Regulation is a notice-and-comment legislative rule and thus a federal requirement; registration/regulatory scheme can give content for preemption | Held: agency legislative rule (§152.44) is a binding federal requirement for preemption purposes; individualized EPA findings are distinct but the regulation itself matters |
| Whether FIFRA's §136a(f)(2) (registration not a defense to FIFRA violations) prevents using registration/approval as a federal comparator | Registration cannot be dispositive; registration does not immunize misbranding claims, so state law survives | Registration shapes the content of federal requirements (via §152.44); registration is not a per se defense but does inform what federal law requires | Held: §136a(f)(2) means registration is not a dispositive defense to misbranding, but registration and the Preapproval Regulation still define federal labeling requirements for preemption comparison |
Key Cases Cited
- Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (adopts parallel-requirements test; state labeling duties measured against relevant EPA regulations that give content to misbranding standards)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (premarket approval/agency approval can create federal 'requirements' relevant to preemption)
- Ruckelshaus v. Monsanto Co., 467 U.S. 986 (1984) (FIFRA is a comprehensive federal regulatory scheme over pesticides)
- Wyeth v. Levine, 555 U.S. 555 (2009) (discussion of implied preemption and agency 'force of law' concepts in preemption context)
- United States v. Mead Corp., 533 U.S. 218 (2001) (framework for when agency action has 'force of law'—discussed by parties)
- Indian Brand Farms, Inc. v. Novartis Crop Protection Inc., 617 F.3d 207 (3d Cir. 2010) (Third Circuit's prior FIFRA preemption discussion)
- Hardeman v. Monsanto Co., 997 F.3d 941 (9th Cir. 2021) (Ninth Circuit decision rejecting Monsanto's express-preemption argument in MDL litigation)
- Carson v. Monsanto Co., 92 F.4th 980 (11th Cir. 2024) (Eleventh Circuit en banc/panel analysis addressing the role of agency action and preemption under FIFRA)