Hardeman v. Monsanto Co.

• Citation: 997 F.3d 941
• Decision Date: 14 May 2021
• Docket Number: Nos. 19-16636,19-16708,s. 19-16636
• Parties: Edwin HARDEMAN, Plaintiff-Appellee/Cross-Appellant, v. MONSANTO COMPANY, Defendant-Appellant/Cross-Appellee.
• Court: United States Courts of Appeals. United States Court of Appeals (9th Circuit)

997 F.3d 941

Edwin HARDEMAN, Plaintiff-Appellee/Cross-Appellant,

v.MONSANTO COMPANY, Defendant-Appellant/Cross-Appellee.

Nos. 19-16636

19-16708

United States Court of Appeals, Ninth Circuit.

Argued and Submitted October 23, 2020 San Francisco, California

Filed May 14, 2021

R. NELSON, Circuit Judge:

Monsanto Company manufactures Roundup, a pesticide with the active ingredient glyphosate. Since 2015, thousands of cancer victims have sued Monsanto in state and federal court, alleging that Roundup caused their non-Hodgkin's lymphoma. This appeal arises out of the first bellwether trial for the federal cases consolidated in a multidistrict litigation.

The jury returned a verdict in favor of plaintiff Edwin Hardeman, awarding him $5,267,634.10 in compensatory damages and $75 million in punitive damages. The district court reduced the jury's punitive damages award to $20 million.

Monsanto appeals, arguing the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA") preempts Hardeman's failure-to-warn claims; the district court made a series of evidentiary and jury instruction errors; the district court erred in denying judgment as a matter of law; and the punitive damages award violates California law and the Due Process Clause. Hardeman cross-appeals, arguing the jury's $75 million punitive damages award was constitutional.

We affirm the district court and hold that (1) Hardeman's state failure-to-warn claims are not preempted by FIFRA; (2) the district court ultimately applied the correct standard from Daubert v. Merrell Dow Pharmaceuticals, Inc. , 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), and did not abuse its discretion in admitting Hardeman's expert testimony; (3) the district court did not abuse its discretion in admitting the International Agency for Research on Cancer's classification of glyphosate as probably carcinogenic and three regulatory rejections of that classification but excluding evidence from other regulatory bodies; (4) the district court's jury instruction on causation, though erroneous, was harmless; (5) Monsanto was properly denied judgment as a matter of law because evidence shows the carcinogenic risk of glyphosate was knowable at the time of Hardeman's exposure; and (6) evidence supports a punitive damages award, punitive damages were properly reduced, and the reduced award—while close to the outer limits—is constitutional.

I

A

Under FIFRA, the United States Environmental Protection Agency ("EPA") enforces "the use, ... sale[,] and labeling[ ] of pesticides." Bates v. Dow Agrosciences LLC , 544 U.S. 431, 437, 125 S.Ct. 1788, 161 L.Ed.2d 687 (2005) (citation omitted). A state may "not impose or continue in effect any requirements for labeling or packaging in addition to or different from those" required by FIFRA. 7 U.S.C. § 136v(b).

FIFRA requires pesticide manufacturers to register their products with EPA. 7 U.S.C. § 136a(a). EPA makes registration determinations after considering available scientific data, § 136a(c)(1)(F), (c)(2)(A) ; 40 C.F.R. § 158.500, and FIFRA requires EPA to re-review a pesticide's registration, including its effects on human health, every fifteen years, § 136a(g)(1)(A). FIFRA states, however, that "[i]n no event shall registration of an article be construed as a defense for the commission of any offense under this subchapter." § 136a(f)(2). Rather, "[a]s long as no cancellation proceedings are in effect," registration of a pesticide is merely "prima facie evidence that the pesticide, its labeling and packaging comply with the registration provisions of the subchapter." Id.

EPA can also institute cancellation proceedings, 7 U.S.C. § 136d(b), or take other enforcement action against the manufacturer of a registered pesticide if the agency determines the product is "misbranded." Bates , 544 U.S. at 439, 125 S.Ct. 1788. Remedies for misbranding include civil and criminal penalties. Id. at 439 n.11, 125 S.Ct. 1788 (citing 7 U.S.C. § 136l). A duly registered pesticide can be misbranded if the label "does not contain adequate instructions for use, or if its label omits necessary warnings or cautionary statements." Bates , 544 U.S. at 438, 125 S.Ct. 1788 (citation omitted). "Because it is unlawful under the statute to sell a pesticide that is registered but nevertheless misbranded, manufacturers have a continuing obligation to adhere to FIFRA's labeling requirements." Id. (citations omitted). This obligation includes a duty to seek approval to amend a label that does not contain all "necessary warnings or cautionary statements." Id. (citation omitted).

Starting in 1974, EPA registered pesticides containing glyphosate, the active ingredient in Roundup.¹ EPA, Glyphosate Proposed Interim Registration Review Decision 4 (Apr. 2019) ("Proposed Interim Registration Review "). In 1985, an EPA review of a mouse study found "[g]lyphosate was oncogenic in male mice," causing rare tumors. EPA classified glyphosate as a possible human carcinogen. Since then, however, EPA has repeatedly approved the use of glyphosate as a pesticide, each time concluding that it is not likely to be carcinogenic to humans. See Nat'l Fam. Farm Coal. v. EPA , 966 F.3d 893, 905 (9th Cir. 2020).

In the early 1990s, EPA reevaluated glyphosate's effects on human health as part of its regular review of glyphosate's registration. After considering numerous carcinogenicity studies in rats and mice—including new evidence submitted by Monsanto—EPA changed its designation of glyphosate to a "Group E carcinogen" signifying "evidence of noncarcinogenicity in humans."

In 2015, a working group at the International Agency for Research on Cancer ("IARC"), an agency of the World Health Organization, issued a report classifying glyphosate as a "Group 2A" agent, meaning it is "probably carcinogenic to humans" based on glyphosate's "limited evidence" of cancer in humans and "sufficient evidence" of cancer in experimental animals. IARC's classification was a "hazard identification," the first step of a public health assessment designed to identify cancer hazards. That hazard determination asked whether glyphosate "is capable of causing cancer under some circumstances," but did not include a "risk assessment" gauging the carcinogenic effects from real-world human exposure. Since IARC's classification, other national and international agencies charged with reviewing pesticides—such as the European Union's European Chemicals Agency ("ECA"), European Food Safety Authority ("EFSA"), and the national health authorities of Australia, Canada, Germany, and New Zealand—have reported that scientific evidence does not show glyphosate causes cancer.

When the IARC report was released, EPA was conducting its registration review of glyphosate, during which it examined various scientific studies, including those IARC considered. In 2017, EPA published its proposed conclusion: Glyphosate was not likely to be carcinogenic to humans. But, that same year, pursuant to Proposition 65, California law categorized glyphosate as a chemical known to the state to cause cancer. Cal. Off. of Env't Health Hazard Assessment, Glyphosate , ("Glyphosate Proposition 65"), https://oehha.ca.gov/proposition-65/chemicals/glyphosate. That classification triggered a state law requirement to attach a warning label to glyphosate products. See id. ; Cal. Health & Safety Code § 25249.6.

In April 2019—one month after the jury verdict in this case—EPA noted that commenters "expressed concerns that glyphosate formulations are more toxic than glyphosate alone." Proposed Interim Registration Review at 10. EPA explained that "there are few research projects that have attempted to directly compare technical grade glyphosate to the formulations under the same experimental design," but "[i]f at any time, information becomes available that indicates adverse human health effects of concern for exposure to glyphosate or its formulations, EPA intends to review it and determine the appropriate regulatory action." Id. at 11.

About five months after the jury verdict, EPA issued a letter to all registrants of glyphosate-containing products. Letter from Michael L. Goodis, EPA, Office of Pesticide Programs (Aug. 7, 2019) ("2019 letter"). The 2019 letter was not the product of any formal proceeding, was not published in the Federal Register, did not cite any new scientific findings, and took no position on whether Roundup causes cancer. Instead, this letter challenged California's inclusion of glyphosate in Proposition 65 as contrary to "EPA's determination that glyphosate is ‘not likely to be carcinogenic to humans.’ " Id. at 1. Given this determination, EPA "considers the Proposition 65 warning language" that glyphosate is carcinogenic "to constitute a false and misleading statement" that violates FIFRA's prohibition against "misbranded" substances. Id. 1–2 (citing § 136(q)(1)(A) ). The letter concluded with EPA instructing registrants to remove such warning statements from labels of glyphosate-based pesticides. Id. at 2.

B

In 2016, Hardeman sued Monsanto alleging that his use of Roundup—which started in the 1980s and ended in 2012—led to his diagnosis of non-Hodgkin's lymphoma ("NHL") in early 2015. Hardeman's case is one of approximately 5,000 in federal court alleging that Roundup causes NHL. The Judicial Panel on Multidistrict Litigation consolidated those cases for pretrial proceedings in the Northern District of California. Hardeman's case was the first of these consolidated cases to go to trial.

NHL is a cancer that affects white blood cells in the immune system. Approximately 70% or more of NHL cases are idiopathic, meaning they develop for unknown reasons. However, some causes of NHL—such as hepatitis C ("HCV")—are well established. Hardeman had HCV for 25 to 40 years before developing NHL.

Hardeman alleged Monsanto's failure to warn him of the carcinogenic risks of Roundup caused his NHL. Monsanto moved to dismiss, arguing that Hardeman's claims were preempted by FIFRA given...