Bayer Statement on Monsanto’s Summary Judgment and Specific Causation Daubert Motions

January 4, 2019 – The following is Bayer’s statement regarding Monsanto’s motion for summary judgment and specific causation Daubert motions in the Hardeman, Stevick and Gebeyehou v. Monsanto Co. cases, each of which is pending in the MDL in the U.S. District Court for the Northern District of California before Judge Vince Chhabria. In a previous ruling on general causation Daubert motions, the same Court characterized the science in this litigation as “shaky” and noted the plaintiffs would face a “daunting challenge” in proving the specific causation requirement of their cases.

“Bayer believes all of these cases should be dismissed on summary judgment because plaintiffs have failed to put forward reliable and admissible expert testimony on specific medical causation, which is essential to support their claims. In addition, Bayer has urged the court to grant summary judgment because the claims in all of these cases are preempted by federal law and on several other grounds:

• “The express preemption clause contained in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), preempts Plaintiffs’ warning-based claims because those claims impose ‘requirements’ that are ‘in addition to or different from’ FIFRA’s misbranding requirements for misuse labeling. Specifically, California’s failure to warn law imposes a labeling requirement to warn for potential risks resulting from ‘misuses’ that are ‘reasonably foreseeable,’ which can include potential and hypothetical misuses, a standard that is more expansive than FIFRA’s requirement to warn for potential risks resulting from ‘misuses’ that are ‘widespread and commonly recognized.’

• “Additionally, plaintiffs’ state law-based warning and design claims cannot proceed under impossibility preemption because the Environmental Protection Agency (EPA) specifically requires pre-approval before Monsanto can change the formulation or ‘precautionary statements’ on the labels of these products. Federal law preempts state law ‘where it is impossible for a private party to comply with both state and federal requirements.’ In these cases, it is impossible for Monsanto to independently comply with both the purported state law requirement to change the design and label of Roundup, and FIFRA’s regulatory scheme that requires prior approval by EPA.

• “Plaintiffs also cannot establish that the alleged cancer risks they allege Monsanto should have warned about were ‘known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge at the time of manufacture and distribution.’ All three plaintiffs allege that their exposures to Roundup stopped before IARC’s 2015 classification of glyphosate as a potential carcinogen, which they claim was the change in the narrative that gives rise to their claims. Throughout their period of the plaintiffs’ exposure, it is indisputable that the ‘prevailing best scientific and medical knowledge’ did not support an association between Roundup and cancer.

• “Plaintiffs’ punitive damage claims also cannot meet the demanding ‘malice’ standard required under California law given the science, medical and regulatory consensus that existed at the time of plaintiffs’ exposure.

“Bayer also has moved to exclude the testimony of plaintiffs’ proposed specific causation experts, Drs. Nabhan, Shusov, and Weisenburger, because they offer outcome-driven litigation conclusions that fail to

meet the scientific reliability requirements under Daubert. The opinions of the three proposed experts rely on a common differential diagnosis analysis, and all have the same disqualifying flaws:

• “First, they rule in Roundup as a cause for a common cancer that has no known cause in the vast majority of cases, using a cherry-picked subset of epidemiological data unadjusted for other pesticide exposures. Meanwhile, they cannot point to any peer-reviewed, published data that demonstrates Roundup has an odds ratio, or relative risk, of over 2.0 which, under Ninth Circuit precedent, is required to establish specific causation as a matter of law.

• “Second, they rule out all other potential causes purely based on their say-so, including unknown causes and plaintiffs’ specific risk factors such as Hepatitis C and B, radiation exposure and age. Significantly, their reasoning for ruling out non-Roundup causes, if applied faithfully and consistently, would require them to rule out Roundup as well.

• “They then reach the litigation-driven conclusion that Roundup was the medical cause of these plaintiffs’ cancer, despite the fact that none of the plaintiffs’ treating physicians nor their oncologists concluded that Roundup was the cause of their cancer.

“In addition, Bayer has moved to exclude the testimony of plaintiffs’ regulatory expert, Dr. Charles Benbrook, an agricultural economist whose opinions were largely excluded in Johnson. The Company also has moved to exclude plaintiffs’ proposed economic expert, Dr. James Mills, who has done nothing more than review publicly available financial information to testify about Monsanto’s ability to pay punitive damages.

“There is an extensive body of research on glyphosate and Bayer’s glyphosate-based herbicides, including more than 800 rigorous studies submitted to EPA, European and other regulators in connection with the registration process, that confirms that these products are safe when used as directed. The independent 2018 National Cancer Institute supported Agricultural Health Study, the largest and most recent epidemiologic study conducted, which followed over 50,000 licensed pesticide applicators for more than 20 years, found no association between glyphosate-based herbicides and cancer. Additionally, EPA’s 2017 post-IARC cancer risk assessment examined more than 100 studies the agency considered relevant and concluded that glyphosate is ‘not likely to be carcinogenic to humans,’ its most favorable rating. Since IARC’s assessment in 2015, regulators and health authorities around the world (including the U.S. EPA, European Food Safety Authorities (EFSA), European Chemicals Agency (ECHA), German BfR, and Australian, Canadian, Korean, New Zealand and Japanese regulatory authorities, as well as the Joint FAO/WHO Meeting on Pesticide Residues (JMPR)) have reaffirmed that glyphosate-based products are safe when used as directed and that glyphosate is not carcinogenic.”