While it’s not prescription medical product liability litigation, per se, we’ve been aghast, scratching our heads about the recent litigation firestorm surrounding the pesticide Roundup and its active ingredient, glyphosate. Despite consistent findings from every regulatory body in the world – save one (the IARC) – that this product is not a carcinogen, plaintiffs peddling a bunch of junk science in California, the litigation junk science capital of the world, have been able to dupe jurors into concluding the opposite. Between the consistent failure of lower courts to enforce the reliability standards imposed by the California Supreme Court in Sargon Enterprises, Inc. v. University of Southern California, 288 P.3d 1237 (Cal. 2012), and the Ninth Circuit’s dumbing down of Daubert in Wendell v. GlaxoSmithKline, LLC, 858 F.3d 1227 (9th Cir. 2017) (our 9th worst decision of 2017), jurors in Roundup cases have been exposed to mountains of pseudo-scientific garbage masquerading as “totality of the evidence,” with absurd results.
And then the State of California itself pops out of the clown car, asserting that its notorious Proposition 65 (the same one that recently sought to call coffee a carcinogen) requires a cancer warning on glyphosate.
Well, finally there’s an adult in the room. The Environmental Protection Agency, which has jurisdiction over product labeling for Roundup/glyphosate has taken steps to enforce its prior no-carcinogen finding. In a formal letter dated August 7, 2019, has rejected any carcinogen labeling:
Given EPA’s determination that glyphosate is “not likely to be carcinogenic to humans,” EPA considers the Proposition 65 language based on the chemical glyphosate to constitute a false and misleading statement. As such, pesticide products bearing the Proposition 65 warning statement due to the presence of glyphosate are misbranded pursuant to section 2(q)(1)(A) of FIFRA. . . . The warning statement must be removed from all product labels. . . .
EPA “Dear Registrant” letter, at 1-2. EPA thus “disagrees with the IARC’s assessment of glyphosate,” id. at 1, and in the United States, the EPA has the requisite legal authority to govern product labeling.
Further, given the EPA’s action, all the civil litigation should be preempted under the Supreme Court’s recent decision in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019). Albrecht deals with implied preemption, so its holdings apply equally to other regulatory regimes besides the FDCA – just as, in the other direction, the “genuinely equivalent” standard for parallel claims originating in FIFRA, see Bates v. Dow Agrosciences LLC, 544 U.S. 431, 454 (2005), has applied to FDCA-regulated products. See Bexis’ book §5.02[d] footnote 320 (collecting cases).
Albrecht holds, with respect to agency rejections of labeling language:
- “[T]he [agemcy] reviews [regulated] submissions and can reject label changes even after the manufacturer has made them.” 139 S. Ct. at 1679.
- “[I]n the interim, [agency’s] regulation permits changes, so a [regulated] manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law.” Id.
- “[A]gency actions that can determine the answer to the pre-emption question, of course, are [those] taken pursuant to the [agency’s] congressionally delegated authority.” Id.
- “Federal law permits [a federal agency] to communicate its disapproval of a warning . . . by formally rejecting a warning label that would have been adequate under state law.” Id. (citations omitted).
- “[W]hatever the means the [agency] uses to exercise its authority, those means must lie within the scope of the authority Congress has lawfully delegated.” Id.
It looks to us like the EPA’s letter, citing its statutory authority to reject a label as “misbranded” for being “false and misleading,” checks all of the Supreme Court’s boxes. Further, the “interim” that the Court referred to with respect to the FDA’s CBE regulation in Albrecht doesn’t exist here – we have the EPA’s formal notification that “probably carcinogenic to humans” warnings are “misleading” in light of current science.
Thus, it seems blindingly clear that the EPA has “informed the [regulated entity] that the [agency] would not approve changing the [product’s] label to include that warning.” Id. at 1678. So, even assuming this is a case “like” Levine (which, given the prior regulatory proceedings, it probably isn’t) has the EPA been “fully informed . . . of the justifications for the warning required by state law”? Id. The EPA sure thinks so:
EPA scientists have performed an independent evaluation of the available data since the IARC classification to reexamine the carcinogenic potential of glyphosate and concluded that glyphosate is “not likely to be carcinogenic to humans.” EPA considered a more extensive dataset than IARC, including studies submitted to support registration of glyphosate and studies identified by EPA in the open literature as part of a systematic review.
EPA letter at 1 (citing 2017 EPA “Issue Paper” on glyphosate and cancer). We don’t think any state-law court can re-examine the scientific basis for a federal regulatory decision under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), but in this case we doubt it matters.
Thus, comparing the EPA’s position against the Albrecht template for implied preemption, we believe that preemption should be successful in stuffing the evil genie of glyphosate cancer litigation back into regulatory bottle where it belongs.