In re Roundup Prods. Liab. Litig.
364 F. Supp. 3d 1085
N.D. Cal.2019Background
- Plaintiffs are three bellwether claimants alleging that Monsanto's Roundup (glyphosate) caused non-Hodgkin lymphoma and that Monsanto failed to warn and acted egregiously.
- Monsanto moved for summary judgment on multiple grounds: express preemption, implied (impossibility) preemption, insufficiency of failure-to-warn evidence, and insufficiency of punitive-damages evidence; it also moved on statute-of-limitations grounds as to one plaintiff (Gebeyehou).
- The Court previously denied Monsanto's FIFRA express-preemption argument; Monsanto advanced a new theory tying warnings to "widespread and commonly recognized" uses.
- Monsanto relied on FDCA preemption precedent to argue impossibility preemption (that it cannot alter label or design without EPA approval).
- Plaintiffs rely on evidence (including epidemiology and expert testimony) that glyphosate was a knowable risk when plaintiffs used Roundup and on evidence of Monsanto's conduct to support punitive damages.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Express preemption under FIFRA | State-law failure-to-warn and design claims are consistent with FIFRA and allowed | FIFRA limits warnings to "widespread and commonly recognized" uses, so state law is broader and preempted | Court rejects Monsanto's new reading; California law not expressly preempted |
| Impossibility (implied) preemption | State duties do not make it impossible to comply with FIFRA; Bates permits state regulation including bans | FDCA cases show manufacturers cannot change labels without federal approval, creating impossibility | Court finds Monsanto's reliance on FDCA cases misplaced; Bates and FIFRA's scheme allow state regulation, so no impossibility preemption |
| Sufficiency of failure-to-warn evidence | Plaintiffs produced expert opinions and contemporaneous scientific evidence showing risk was known or knowable | Monsanto says epidemiology does not support known/knowable risk and points to lack of competent evidence | Court finds plaintiffs presented sufficient evidence (including expert testimony and studies) to survive summary judgment |
| Sufficiency of punitive-damages evidence | Evidence shows Monsanto prioritized PR and undermined critics, supporting malice or conscious disregard | Monsanto contests adequacy of evidence to show egregious conduct | Court concludes there is sufficient evidence for a jury to consider punitive damages |
Key Cases Cited
- Bates v. Dow Agrosciences LLC, 544 U.S. 431 (states may impose labeling requirements consistent with FIFRA and FIFRA does not preempt certain state-law claims)
- Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (impossibility preemption where compliance with both state and federal obligations is impossible)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (pre-emption analysis under FDCA for generic drug labeling)
- Wyeth v. Levine, 555 U.S. 555 (state-law failure-to-warn claims for drugs and preemption analysis)
- English v. Gen. Elec. Co., 496 U.S. 72 (impossibility preemption standard)
- Hardeman v. Monsanto Co., 216 F. Supp. 3d 1037 (earlier district-court opinion rejecting FIFRA express-preemption defense and addressing causation and expert testimony)
- Valentine v. Baxter Healthcare Corp., 68 Cal. App. 4th 1467 (California standard on whether risk was "known or knowable" for failure-to-warn claims)