Bayer Urges Ninth Circuit to Reverse Verdict in Hardeman Glyphosate Case
Says State Failure-To-Warn Claims Are Preempted;
Court Made Reversible Errors Dealing With Causation
Whippany, N.J., December 16, 2019 – Monsanto told the Ninth Circuit Court of Appeals in its opening appeal brief that the verdict in Hardeman v. Monsanto should be reversed because the failure-to-warn claims at the center of the case are preempted by federal law, and the trial court committed a host of reversible evidentiary and instructional errors relating to causation. These serious errors enabled Hardeman to pitch unreliable expert causation testimony to the jury and improperly inflate IARC’s hazard assessment even though regulators worldwide have rejected it. This prejudice was then compounded by the district court’s flawed jury instruction, which combined two conflicting causation theories contrary to California law.
Monsanto also argues in its brief that the Court should direct judgment in its favor as a matter of law on the failure-to-warn claims because the prevailing science at the time of Hardeman’s exposure did not show that Roundup caused cancer nor establish a duty to warn. Finally, Monsanto argues that a company cannot be assessed quadruple punitive damages for marketing a legal product with an EPA-approved label when the vast majority of scientists and regulators worldwide have concluded it is not carcinogenic.
The Hardeman “verdict defies both expert regulatory judgment and sound science,” the company argues. “This Court should reverse, and make clear that a manufacturer cannot be forced by state law to add a warning to its products that federal law would deem illegal; that expert testimony dependent on fundamental methodological flaws cannot be sufficient to take such a speculative case to the jury; and that a manufacturer cannot be punished for doing something that was perfectly legal both at the time and now.”
Below is additional background on key issues from Monsanto’s appellate brief:
- Preemption. Hardeman’s state-law failure-to-warn case is preempted by federal law. FIFRA gives EPA the authority to regulate pesticide labeling and prohibits states from imposing any labeling requirement “in addition to or different from” federal requirements. Because EPA has consistently approved the sale of glyphosate without a cancer warning and has stated that including such a warning on the label would render the product misbranded, any state-imposed cancer warning is expressly preempted. Moreover, given EPA’s repeated conclusion that glyphosate does not pose a risk of cancer in humans and its recent instruction that glyphosate manufacturers may not add the warning Hardeman seeks, the warning is impliedly preempted as well, for it would be impossible for Monsanto to comply with both state and federal law.
- Errors in Admitting Expert Evidence. Hardeman’s suit should never have gone to the jury because his expert opinions on the central issue in the case—whether glyphosate caused his illness—should not have been admitted. The district court allowed this unreliable evidence under the mistaken belief that the Ninth Circuit applies a lenient Daubert standard. But Daubert does not allow expert testimony that is dependent on fundamental methodological flaws and contradicts reliable scientific evidence. On general causation, the court allowed testimony selectively relying on flawed epidemiology studies that deviated from basic statistical norms — not accounting for NHL’s latency, not controlling for confounding pesticides, or not showing a statistically significant association. On specific causation, the court allowed Hardeman’s experts to engage in differential diagnosis in an unreliable manner, deeming exposure to glyphosate to be a cause of Hardeman’s NHL—without adequately addressing the facts that 70% of NHL cases have no known cause and that Hardeman had lived with hepatitis C, a well-established cause of the disease, for decades.
- IARC-Related Error. The district court made a serious error by admitting IARC’s classification of glyphosate and compounded the error by refusing to allow Monsanto to admit evidence of the worldwide regulatory consensus rejecting IARC’s conclusion. This left the jury with the mistaken impression that IARC’s and EPA’s conclusions were equally valid, despite the fact that virtually every regulatory agency that studied the issue—including two European Union agencies and the national regulatory authorities of Australia, Canada, Germany, Japan, and New Zealand—had expressly rejected IARC’s determination.
- Flawed Jury Instructions. The district court erroneously instructed the jury on both a theory of “but-for causation” and a theory of “concurrent independent causes.” The court first told the jury that if it concluded Hardeman would have developed NHL regardless of Monsanto’s actions, it could not find Monsanto liable—and then, two sentences later, told it just the opposite. The district court issued that instruction even though Hardeman presented no evidence of concurrent independent causes and California jury instructions, recognizing the theories are inherently contradictory, do not allow jurors to be instructed on the two theories in the same case.
Leading health regulators around the world have repeatedly concluded that Bayer’s glyphosate-based herbicides can be used safely as directed and that glyphosate is not carcinogenic, based on an extensive body of science spanning more than 40 years, including more than 100 studies EPA considered relevant to its cancer risk analysis, and more than 800 safety studies overall submitted to regulators. EPA’s April 30, 2019, proposed interim registration review decision reaffirmed that ‘glyphosate is not a carcinogen’ and that there are ‘no risks to public health when glyphosate is used in accordance with its current label.
“Bayer stands behind these products and will continue to vigorously defend them.”
For more information on Roundup, visit https://www.bayer.com/en/glyphosate-roundup.aspx.
For more information on the Roundup litigation, visit http://www.glyphosatelitigationfacts.com/main/