It is probably a safe bet to say that many of the blog’s readers settle in to enjoy these posts with a cup (or, on anticipated longer days after long nights, carafe) of coffee. Readers in California may soon be drinking coffees with warning labels – no, not of the Jackie Chiles Java World “Caution: Hot!” variety – but a cancer warning, courtesy of Proposition 65 (“Prop 65”). Coffee consumers are a passionate bunch, so the recent Los Angeles Superior Court proposed ruling to this effect has been widely publicized. Readers may not be familiar, however, with another recent Prop 65 ruling, one with an arguably better outcome for product manufacturers. That’s why I’m here today.

The outcomes in drug and medical device litigation often turn on the label. Regardless of how detailed a warning is, in what font and size it’s printed, and whether it comes in a bold, black box, plaintiffs always insist that the warnings were insufficient. They sometimes base their position on nothing more than attorney argument, and often they cite isolated information that is against the great weight of authority, such as an anecdotal case report or an outlier study with small sample sizes and inconclusive results.

Thankfully, the Eastern District of California recently recognized that requiring a manufacturer to include a cancer warning based on the questionable finding of a single organization, when all other regulatory and governmental bodies had found the opposite, would violate the manufacturer’s First Amendment rights by forcing it to say something that was false, and with which it disagreed. Nat’l Assoc. of Wheat Growers v. Zeise, et al., Civ. No. 2:17-2401, 2018 WL 1071168, at *7 (E.D. Cal. Feb. 26, 2018). Before the court was a motion for preliminary injunction, requesting the court do two things: (1) stop the State of California from identifying glyphosate on a list of cancer-causing products; and (2) enjoin the warning requirement of Prop 65 from being enforced against Plaintiffs with regards to glyphosate. Id. at *1.

Before we get into the court’s reasoning, some background on Prop 65. Officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, Prop 65 purports to protect California’s drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm, and requires businesses to inform Californians about exposures to such chemicals. Under Prop 65, the Governor of California is required to publish a list of chemicals “known to the State” to cause cancer, as determined by certain outside entities. Id. Prop 65 also prohibits any person in the course of doing business from knowingly and intentionally exposing anyone to the listed chemicals without a prior “clear and reasonable” warning. Id. The prohibition, and corresponding warning requirement, takes effect 12 months after the chemical has been listed. Id. Private persons are authorized to file suit to enforce Prop 65, adding to the overwarning problem.

Glyphosate is a widely-used herbicide used to control weeds in various settings. Id. at *1, n.1. Glyphosate can even be used on coffee plantations. But I digress. Plaintiffs or their members sell glyphosate-based herbicides, use glyphosate in their cultivation of crops that are incorporated into food products sold in California, or process such crops into food products sold in California. Id. In 2015, the International Agency for Research on Cancer (“IARC”) of the World Health Organization (“WHO”) classified glyphosate as “probably carcinogenic” to humans based on evidence that it increased cancer rates in animal studies and limited evidence that it could cause cancer in humans. Id. at *2. In this case, the IARC is the outlier. Several other organizations, including the United States Environmental Protection Agency (“EPA”) and other agencies within WHO found no evidence that glyphosate causes cancer. Id. Still, relying on the IARC’s “probably carcinogenic” classification, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) issued a Notice of Intent to List Glyphosate in November 2015 and subsequently began listing glyphosate as a chemical known to state of California to cause cancer in July 2017. Id. The warning requirement would therefore take effect in July 2018. Id.

After finding that Plaintiffs’ First Amendment claim was ripe for the court’s consideration, the court turned to the issue of injunctive relief. Injunctive relief, “an extraordinary and drastic remedy,” requires that the moving party establish several familiar elements: (1) it is likely to succeed on the merits, (2) it is likely to suffer irreparable harm in the absence of preliminary relief, (3) the balance of equities in tips in its favor, and (4) an injunction is in the public interest. Id.

Regarding the likelihood of success on the merits, the court first distinguished between the State’s listing of glyphosate as a chemical “known to” cause cancer and the subsequent warning requirement. The former is government speech; the latter is commercial speech. Id. at *5. This distinction is significant because the “[t]he Free Speech Clause restricts government regulation of private speech; it does not regulate government speech.” Id. (citing Pleasant Grove City v. Summum, 555 U.S. 460, 467 (2009). So, while Plaintiffs could not demonstrate likelihood of success on the merits with regards to the listing of glyphosate, a different analysis was required for the warning requirement itself, which would have the effect of compelling commercial speech – the labeling of a product. Id.

Commercial speakers receive protection of the First Amendment, subject to some limitations. The government may require commercial speakers to disclose “purely factual and uncontroversial information” about commercial products or services, as long as the “disclosure requirements are reasonably related” to a substantial government interest and are neither “unjustified [n]or unduly burdensome.” Id. (citing In Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626, 651 (1985)). As explained above, only the IARC found that the evidence warranted branding glyphosate as “probably carcinogenic.” On the other hand, the court noted that

…the EPA has reviewed studies regarding the carcinogenicity of glyphosate multiple times and has determined each time that there was no or insufficient evidence that glyphosate causes cancer, most recently in September 2016. Several international agencies have likewise concluded that there is insufficient evidence that glyphosate causes cancer, including the European Commission’s Health and Consumer Protection Directorate–General, multiple divisions of the World Health Organization besides the IARC, and Germany’s lead consumer health and safety regulator.

Id. at *7. Based on the great preponderance of scientific opinion, the court reasoned that it was “inherently misleading for a warning to state that a chemical is known to the state of California to cause cancer based on the finding of one organization … when apparently all other regulatory and governmental bodies have found the opposite, including the EPA.” Id. Accordingly, the court found that “here, given the heavy weight of evidence in the record that glyphosate is not in fact known to cause cancer, the required warning is factually inaccurate and controversial.” Id.

After finding that the required warning would be false and misleading, the court found the scales tipped in Plaintiffs’ favor on the issues of irreparable harm, balancing of the equities, and public interest factors. The court granted Plaintiffs’ request for a preliminary injunction enjoining the warning requirement of Prop 65. Jackie Chiles would agree that requiring such a warning would be an infringement on Plaintiffs’ constitutional rights. That’s outrageous, egregious, preposterous!

Remember, as well, that the First Amendment equally applies to tort litigation. The blog has discussed the product liability implications of New York Times Co. v. Sullivan, 376 U.S. 254, 265 (1964), several times. This is another such instance. To the extent that, as in Nat’l Assoc. of Wheat Growers v. Zeise, the First Amendment prevents the government from forcing a product manufacturer to “speak” falsely based on the results of an outlier study, it equally precludes private plaintiffs from seeking damages for a manufacturer’s failure to include the same false information on a product warning.

Where might that come in useful?