After two colossal failures, Bayer AG finally got a golden ticket from a U.S. Court of Appeals making it certain that the ongoing fight over glyphosate warning labels falls into the lap of the Supreme Court.

If nothing else, Bayer is prescient.

Bayer announced its acquisition of Monsanto, maker of Roundup and its active ingredient glyphosate in 2016, and completed the $63 billion dollar takeover two years later. Since then it’s been one huge rolling fight over whether Bayer bears liability for injury due to glyphosate exposure.

In recent years, plaintiffs have increasingly claimed that Bayer failed to warn them of the risks of using Roundup, often citing a 2015 International Agency for Research on Cancer study that concluded glyphosate was “probably carcinogenic to humans” — a decision Bayer outright rejects as does the EPA.

The judicial linchpin of failure-to-warn lawsuits surrounds interpretation of the Federal Insecticide, Fungicide, and Rodenticide Act.

FIFRA is the primary law regulating pesticides in the United States. Under FIFRA, the Environmental Protection Agency must approve a warning label before a pesticide can be sold to consumers. The EPA is tasked with determining whether a particular pesticide, when used as detailed on its label, is safe from unreasonable adverse effects on the environment. FIFRA defines said effects as “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.”

Once a label receives EPA approval, FIFRA law says the label can only be modified through an application for amended registration. The law goes on to say that states aren’t allowed to modify an EPA-approved/FIFRA-issued pesticide warning label.

But there’s a sticky wicket that’s been primarily responsible for all those pesticide warning label lawsuits against Bayer. FIFRA also prohibits the sale of any pesticide that is “misbranded.” Under FIFRA, misbranded warning labels fail to contain a warning or caution statement that may be necessary to protect health and environment.

The bottom line: to be sold, pesticides must have required health and safety warnings.

Misbranding has become the claim du jour for plaintiffs, who routinely argue in state courts that defendants failed to warn on labels that use of their pesticides could result in health injuries. 

How that happens is a little tricky but stay with me. Pesticide plaintiffs argue that if a company violated state failure-to-warn laws, the company also violated FIFRA’s misbranding ban. That’s to say, FIFRA prohibitions on misbranding and failure-to-warn claims run parallel to each other.

Big Ag defendants counter that the idea of misbranding is utter nonsense because states are specifically prohibited by FIFRA from adding to or changing an EPA-approved warning label.

Until now, Bayer hasn’t received a favorable ruling on the issue of misbranding. This past February, the 11th Circuit Court of Appeals ruled for the plaintiffs, judging failure-to-warn claims do run parallel to FIFRA’s misbranding prohibition. That followed on the heels of a 2021 Ninth Circuit Court of Appeals ruling in Hardeman v. Monsanto, which found for the defendants on the same grounds.

Now comes a new ruling from the Third Circuit Court of Appeals that disagrees with the earlier Ninth and Eleventh Court of Appeals decisions.

The current lawsuit revolves around two Pennsylvanians — David Schaffner, Jr. and Theresa Sue Schaffner — who claim the state failed to warn them of cancer risks of Monsanto’s/Bayer’s glyphosate-based weedkiller Roundup. But the Third Circuit ruled FIFRA does, in fact, preempt pesticide state law failure-to-warn misbranding lawsuits:

“Because regulations promulgated to implement FIFRA require the health warnings on a pesticide’s label to conform to the proposed label approved by the EPA during the registration process (the ‘Pre Approved Label’), and because during Roundup’s registration process the EPA approved proposed labels omitting a cancer warning following an extensive review of scientific evidence concerning Roundup’s possible carcinogenicity, we conclude that the alleged state-law duty to include the Cancer Warning on Roundup’s label (the ‘Pa. Duty to Warn’) imposes requirements that are different from those imposed under FIFRA, and that it is therefore preempted by FIFRA.”

Which means Bayer is likely finalizing a writ of certiorari for the Supreme Court now that there is a split at the court of appeals level. I think there likely will be four votes for granting cert given the need for clarification over misbranding, which may have implications far beyond agricultural pesticides.

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