Hardeman v. Monsanto Co.
216 F. Supp. 3d 1037
N.D. Cal.2016Background
- Plaintiff Hardeman sued Monsanto alleging Roundup caused his cancer and that Monsanto failed to warn on the product label in violation of California law and FIFRA.
- Monsanto moved to dismiss, arguing Hardeman’s state-law failure-to-warn claims are preempted by FIFRA § 136v(b) because the EPA approved Roundup’s label and has concluded glyphosate is non-carcinogenic.
- Hardeman’s complaint expressly ties his California failure-to-warn claims to alleged violations of FIFRA misbranding provisions.
- Monsanto also argued strict liability design-defect claims fail under Restatement (Second) of Torts § 402A comments j and k because glyphosate is allegedly unavoidably unsafe.
- The court considered whether EPA label approval or agency findings (and nonexclusive EPA enforcement) preclude private state-law claims that mirror FIFRA misbranding standards.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether California failure-to-warn claims are preempted by FIFRA §136v(b) | Hardeman: claims are equivalent to FIFRA misbranding standards and therefore not preempted | Monsanto: state-law labeling requirements conflict with FIFRA and EPA-approved labels, so they are preempted | Not preempted — claims consistent with FIFRA (Bates) may proceed |
| Whether EPA approval of Roundup’s label immunizes Monsanto from private enforcement | Hardeman: EPA approval does not bar private enforcement of FIFRA misbranding provisions | Monsanto: EPA approval is prima facie evidence of compliance and should preempt state-law claims | EPA approval is not conclusive and does not automatically preempt private claims; private suits may challenge label adequacy |
| Whether EPA determinations that glyphosate is non-carcinogenic preempt or defeat Hardeman’s claims | Hardeman: agency FDCA or FIFRA materials cited by Monsanto do not conclusively resolve misbranding/warning issues | Monsanto: EPA findings and documents show glyphosate is not a carcinogen, so warnings are unnecessary | Agency FDCA materials do not control FIFRA preemption; cited EPA FIFRA materials lack clear legal force to preempt claims |
| Whether strict liability design-defect claims are barred by Restatement §402A comments j/k (unavoidably unsafe products) | Hardeman: alleges inadequate warnings and defective marketing/preparation, so comments j/k do not bar design-defect claims | Monsanto: glyphosate is inherently unavoidably dangerous, invoking comments j/k to bar strict liability | Comments j/k do not bar the claims here; comment k limited to properly prepared/marketed products and is applied narrowly in California, mainly in medical contexts |
Key Cases Cited
- Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (state-law labeling claims not preempted if equivalent to FIFRA misbranding standards)
- Wyeth v. Levine, 555 U.S. 555 (2009) (agency approval of labeling does not automatically preempt state-law failure-to-warn suits absent clear federal preemption)
- United States v. Mead Corp., 533 U.S. 218 (2001) (agency materials lack preemptive force absent clear rulemaking or delegated authority)
- Brown v. Superior Court, 44 Cal.3d 1049 (1988) (California’s limited adoption of Restatement comment k in medical/drug context)
- Nathan Kimmel, Inc. v. DowElanco, 275 F.3d 1199 (9th Cir. 2002) (injunctive orders forcing label changes constitute state-mandated labeling requirements)
- Indian Brand Farms, Inc. v. Novartis Crop Prot. Inc., 617 F.3d 207 (3d Cir. 2010) (mere inconsistency between state duty and EPA-approved label does not necessarily preempt state claim)
- Astiana v. Hain Celestial Group, Inc., 783 F.3d 753 (9th Cir. 2015) (scope-of-duty analysis in failure-to-warn contexts)
- Reid v. Johnson & Johnson, 780 F.3d 952 (9th Cir. 2015) (agency pronouncements lack preemptive effect absent clear legal authority)