One of the cases we follow closely, with daily searches, is Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019). It’s an implied preemption case, so while we like to think we catch all the drug/device cases anyway, Albrecht can affect preemption in a wide variety of tort situations.
We’d identified one such situation before. Shortly after Albrecht was decided, we identified one non-drug/device where we thought the Supreme Court’s reasoning would have an impact. The Environmental Protection Agency (“EPA”) issued a final order last August “determin[ing] that glyphosate [the principal active ingredient in RoundUp] is not likely to be carcinogenic in humans,” so that any contrary label under California’s Proposition 65 would “misbrand” the product.
Given the Albrecht court’s focus on the twin issues of actual conflict and formal agency action, we opined that “preemption [under Albrecht] should be successful in stuffing the evil genie of glyphosate cancer litigation back into regulatory bottle where it belongs.”
Last week a California appellate court decision that, in all other respects, seemed bound and determined to ensure RoundUp’s manufacturer was held liable in precisely such a case, was confronted with the same facts we discussed in our post. See Johnson v. Monsanto Co., ___ Cal. Rptr.3d ___, 2020 WL 4047332 (Cal. App. July 20, 2020). Note: Of necessity, our discussion will refer to the original Westlaw version of the Johnson opinion, which we have uploaded here. We had to do that, because since then the court has removed its preemption discussion in Johnson from public view by declining to publish that portion of the opinion.
So what did Johnson decide on preemption that made the court want to cover its tracks like this?
That despite Johnson’s best efforts, the plaintiff’s warning claim was probably preempted under Albrecht – that’s what.
First, Johnson addresses implied preemption under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. §136. et seq. (“FIFRA”). See 2020 WL 4047332, at *16-19. Obviously, FIFRA is not directly of interest to our FDCA-oriented audience. Still, Johnson gets off on the wrong foot by claiming that the presumption against preemption “guide[s] preemption jurisprudence, id. at *16, when in fact the Supreme Court abolished that presumption in express preemption cases back in 2016. See Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016) (discussed here).
According to Johnson, express preemption under FIFRA differs depending on whether the claim is for defective design, as opposed to defective warnings. Johnson interpreted FIFRA’s express permission of state pesticide bans as permitting design defect claims as some sort of lesser included offense. Id. at *16 (“if states are permitted to ban pesticides altogether, they must be authorized to regulate a pesticide’s defective design”). Johnson cited Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), which contained no such holding. Bates held the design claims “do not qualify as requirements for ‘packaging or labeling,’” but had nothing to do with the theory now advanced in Johnson. Id. at 444 (quoting 7 U.S.C. § 136v(b)). Even if it had, Bates also applied the now-discredited presumption against preemption in an express preemption case. 544 U.S. at 432 (among “plausible” readings, the presumption created a “duty to accept the reading disfavoring pre-emption”). So the express preemption discussion of design defect in Johnson is, at best, outdated.
Second, as for warning claims, the FIFRA express preemption clause looks a lot like the FDCA’s. See 7 U.S.C. § 136v(b) (as to “labeling or packaging,” a “State shall not impose or continue in effect any requirements . . . in addition to or different from those required under this subchapter”). The first thing Johnson had to do was get around the California Supreme Court decision in Etcheverry v. Tri-Ag Service, Inc., 993 P.2d 366 (Cal. 2000), which had held:
The federal court decisions holding that FIFRA preempts state law failure-to-warn claims are numerous, consistent, pragmatic and powerfully reasoned. . . . [W]e find their analysis persuasive and reverse the judgment of the Court of Appeal reaching the contrary conclusion.
Id. at at 368.
To avoid Etcheverry, Johnson turned to Bates. Johnson drew a “parallel claims” analysis out of Bates. 2020 WL 4047332, at *18 (“a state-law labeling requirement is not pre-empted . . . if it is equivalent to, and fully consistent with, FIFRA’s misbranding provisions”) (quoting Bates, 544 U.S. at 446). Johnson concluded it didn’t have to follow Etcheverry because it was pre-Bates. However, at that point, legal theory ran headlong into the EPA’s consistent regulation of glyphosate, of which the aforementioned August, 2020 determination was only the latest of numerous rulings. We fail to see – and Johnson nowhere makes clear – what the “violation” was. The EPA simply does not require the warning plaintiff sought in Johnson.
How could Johnson get around the EPA, as well as the California Supreme Court?
By asserting that, somehow, EPA’s approval did “not have force of law.”
We recognize that [defendant] is required to seek and obtain EPA approval before changing labels for its Roundup products, and that the EPA repeatedly approved Monsanto’s labels, which do not include a cancer warning. But Bates informs us that the existence of these requirements and actions are not enough, standing alone, to preempt state failure-to-warn claims. Under FIFRA, registration of a pesticide is prima facie evidence that the pesticide and its labeling is consistent with FIFRA, but . . . [m]ultiple federal courts have held that the EPA’s registration of Roundup products does not have the force of law so as to preempt state failure-to-warn claims when those claims are premised on requirements consistent with FIFRA.
Johnson, 2020 WL 4047332, at *19 (citations omitted). Thus, Johnson’s express preemption ruling on warnings ultimately relies solely on three federal district court RoundUp cases from 2016, well before EPA’s final decision. Id.
Third, as we pointed out in our prior post, however, the world has changed. EPA has finished its regulatory review – and under Albrecht that gives rise to implied preemption. Defendant “insists in its opening brief that ‘impossibility preemption’ nonetheless bars [plaintiff’s] failure-to-warn claims because there is ‘clear, indeed dispositive, evidence that [the] EPA would have rejected a cancer warning had [defendant] proposed one.’” Id.
Enter Albrecht. During the pendency of the Johnson appeal “the U.S. Supreme Court has clarified that the question whether a federal agency would not have approved a label change (thus preempting a state-law failure-to-warn claim) is for a judge, not a jury.” Id. (citing Albrecht). Although conceding that Albrecht applied, id. at *20 (the “reasoning is applicable under FIFRA”), Johnson dodged on the basis of the relevant regulatory evidence being “largely presented for the first time on appeal.” Id. at 19.
Well, of course it was. That’s when the relevant regulatory events occurred. But EPA’s refusal to allow a cancer warning on the basis of lack of scientific evidence in 2019-2020 would a fortiori apply to all earlier times, when there was either less or the same amount of scientific evidence. Regulatory action happens at the regulators’ speed. So the defendant in Johnson:
after completing its appellate briefing, . . . filed a notice of new authority and directed the court to an August 7, 2019 EPA letter to a “Registrant” declining to approve a label that included a warning about glyphosate under Proposition 65. . . . The letter states that since the EPA has determined that glyphosate is not likely to be carcinogenic to humans, any such warning would be “false and misleading” under FIFRA.
Johnson, 2020 WL 4047332, at *19 (citations omitted). That’s the same document that our prior Albrecht post discussed. The defendant argued (as had we) that “this additional information shows not only that the EPA previously approved labels for Roundup products without cancer warnings, but also constitutes clear evidence that the agency would not approve cancer warnings for Roundup labels in the future.” Id.
Fourth, plaintiff could not get around Albrecht solely by arguing lack of express preemption. Lack of express preemption cannot “foreclose” implied preemption. Id. Johnson cited only to Freightliner Corp. v. Myrick, 514 U.S. 280, 288 (1995), for this proposition, but it is at the heart of Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), as well.
[Plaintiff] also suggests that we should be reluctant to find a pre-emptive conflict here because Congress included an express pre-emption provision. . . . To the extent [plaintiff] posits that anything other than our ordinary pre-emption principles apply under these circumstances, that contention must fail in light of our conclusion . . . that neither an express pre-emption provision nor a saving clause ‘bar[s] the ordinary working of conflict pre-emption principles.’
Id. at 353 (quoting in Geier v. American Honda Motor Co., 529 U.S. 861, 869 (2000)).
Fifth, Johnson was compelled to admit that the EPA’s August 2019 determination (and certain other documents that the defendant submitted) “arguably would support an impossibility.” 2020 WL 4047332, at *20. So, to avoid preemption, Johnson punted, declining to decide the preemption question “in the first instance. Id.
These do not strike us as factual determinations best made for the first time on appeal, especially since the EPA’s position on glyphosate labeling appears to be evolving.
Id. “It is no doubt true that the EPA currently takes the position that glyphosate is not harmful to humans and that a cancer warning on glyphosate is unnecessary. But that opinion, in the abstract, is not binding on this court.” Id. at *21. The proper result, at this point, would be to vacate and remand to the trial court to make an Albrecht preemption ruling on a full record. But that wasn’t going to happen in Johnson.
Moreover, that preemption dodge, we submit, is simply untrue. The August, 2019 determination was a final ruling that a cancer warning would cause the product at issue to be “misbranded.” That’s a “formal agency action” under Albrecht any way one views it. See National Ass’n of Wheat Growers v. Becerra, 2020 WL 3412732, at *13 (E.D. Cal. June 22, 2020) (entering permanent injunction against the aforementioned attempt by the State of California to require a Prop. 65 cancer warning on RoundUp labels).
So to preserve the plaintiff’s verdict, Johnson simply refused to take a look.
Sixth, Johnson also claimed, rather weakly given the number of years that the EPA has been considering this question, that the appellate record did not establish that the agency had been “fully informed” before reaching its decision, as required by Albrecht. Johnson, 2020 WL 4047332, at *21. Plainly, this verdict was destined to be upheld, no matter what, the EPA be damned.
Seventh, for its final gyration, Johnson held that it didn’t need to decide preemption (express or implied) at all. “[E]ven if we were to conclude that FIFRA preempted [plaintiff’s] failure-to-warn causes of action . . . such a conclusion would have no effect on [the] design defect claim, which provides an independent basis to affirm the jury’s liability determination.” Id. Thus, Johnson sought to insulate its jerry-rigged result from further appellate review. Given the amount of evidence that was undoubtedly introduced on the preempted warning claim, we doubt the simultaneous trial of that claim could possibly have been “harmless” error – but that’s outside the scope of this post.
In the convoluted fashion set out above, plaintiffs got away with one in Johnson. But that result was a one-time ticket, as even Johnson suggests. Needing more twists and turns than a Simone Biles dismount, Johnson’s evasion of Albrecht preemption ultimately rests on the non sequitur of an appellate record not containing events that only came to fruition after the matter in question was appealed. That won’t happen again – and there’s no way, short of the EPA reversing itself, that this agency position isn’t grounded in a “full” administrative record.
There are none so blind as those who refuse to see. Jer. 5:21 (King James version). We’d bet our bottom dollar that the complete administrative record necessary to support implied preemption under Albrecht will be forthcoming in any and all subsequent RoundUp litigation, and that future warning-related claims of the type at issue in Johnson will end up being preempted. No wonder the preemption discussion in Johnson ended up unpublished.