51 F.4th 1358
11th Cir.2022Background
- John Carson used Roundup® for ~30 years and was diagnosed with malignant fibrous histiocytoma in 2016; he sued Monsanto in 2017 alleging Georgia common-law claims including failure to warn.
- Carson filed four counts (design defect, failure to warn, negligence, breach of implied warranties); the district court dismissed or found preempted several claims and entered judgment on the pleadings as to the failure-to-warn claim (Count II).
- The district court held Carson’s failure-to-warn claim was preempted under FIFRA because the EPA had approved Roundup’s label and classified glyphosate as "not likely to be carcinogenic."
- On appeal, the Eleventh Circuit reviewed the judgment-on-the-pleadings de novo and assessed federal preemption under FIFRA and whether EPA action carried the "force of law."
- The Eleventh Circuit concluded FIFRA’s statutory labeling requirements do not expressly preempt Georgia law and that EPA registration/related documents did not have sufficient formality under United States v. Mead to carry the force of federal law.
- Result: the Eleventh Circuit reversed the district court and remanded, holding Carson’s Georgia failure-to-warn claim is not preempted.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FIFRA (express preemption §136v(b)) bars Georgia failure-to-warn claims | Carson: Georgia common-law claim enforces duties that are not "in addition to or different from" FIFRA labeling requirements | Monsanto: FIFRA/ EPA label approval creates a federal labeling scheme that preempts state-law failure-to-warn claims | Held: FIFRA statutes alone do not expressly preempt; Georgia duty is not broader than FIFRA and thus not expressly preempted |
| Whether EPA label registration and related documents carry the "force of law" (Mead) | Carson: EPA registration and guidance lack the formality to bind and therefore cannot preempt state law | Monsanto: EPA registration, reviews, and agency documents show EPA has spoken and prevent state-law warnings that contradict EPA findings | Held: EPA registration and cited documents lack Mead-required formality (no notice-and-comment rulemaking or formal adjudication); they do not carry force of law |
| Whether EPA classification of glyphosate as "not likely to be carcinogenic" precludes state-law claims | Carson: EPA findings are not binding and do not preempt state-law failure-to-warn | Monsanto: EPA conclusion that glyphosate is not carcinogenic means state-law labeling that contradicts EPA is preempted | Held: EPA conclusions do not, by themselves, preempt state-law claims because the EPA actions cited are not binding federal law |
| Implied (impossibility) preemption — can Monsanto comply with both federal and state requirements? | Carson: EPA has not indicated it would reject a state-required warning; impossibility not established | Monsanto: Compliance with both sets of requirements is impossible if Georgia requires a carcinogenicity warning | Held: Court did not reach implied preemption in detail because the threshold (agency action with force of law) was not met; argument not decided further |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (FDA approval does not automatically preempt state-law failure-to-warn claims; preemption requires agency action with binding effect)
- Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (interpreting FIFRA’s state-authority and express-preemption provisions; states may regulate unless inconsistent with FIFRA)
- United States v. Mead Corp., 533 U.S. 218 (2001) (agency action must have sufficient formality to carry the "force of law" for preemption)
- Hardeeman v. Monsanto Co., 997 F.3d 941 (9th Cir. 2021) (EPA approval of Roundup label does not preclude a judge or jury from finding the label violates FIFRA)
- Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (agency indications about whether it would accept state-required labeling are central to implied-preemption analysis)
- Marrache v. Bacardi U.S.A., Inc., 17 F.4th 1084 (11th Cir. 2021) (Supremacy Clause preemption applies only to agency action that constitutes federal law)