The news that the Trump/Barr Justice Department and EPA are attempting to come to the rescue of Monsanto in the Roundup litigation emboldened stockholders and caused concern among Roundup plaintiffs and their attorneys. Bayer stock saw its first significant uptick since the beginning of the Roundup litigation and the market reacted with general optimism after the December 20th Amicus brief was filed by the Hardeman v. Monsanto Company et. al. Trump/Barr DOJ/EPA. Apparently, Bayer stockholders are not familiar with the now common axiom “Everything Trump Touches, Fails”.
This article will clarify why Bayer stockholders have nothing to be cheer about and why Roundup Plaintiffs and there counsel should not be overly concerned with the fact that the most corrupt administration in our history has for some reason decided to come to the aide of Monsanto/Bayer.
Monsanto’s appeal in the Hardeman case raises numerous issues however, it appears to MTN that Monsanto’s ultimate goal is to use the highly questionable EPA Statements from August of 2019 to argue that all plaintiffs failure to warn claims (all cases arising under all State laws) are preempted as a result of the August of 2019 EPA action.
This article will focus on dispelling the concept that the August of 2019 EPA action could serve as a “litigation killer” and dispose of all plaintiffs’ cases currently on file alleging that Roundup caused them to suffer from Non-Hodgkin’s Lymphoma.
As a preliminary matter, any attempt to use the August of 2019 EPA Statement to dispose of all plaintiffs cases would have to rely on arguments sounding in “The EPA would not have approved the label (warnings) change plaintiffs claim were needed, if Monsanto had actually filed a formal request with the EPA to add the dispute warnings language”. Arguments sounding in what a Federal Agency would or would not have done had a manufacturer actually attempted to effectuate the disputed label change were recently foreclosed on in Merck Sharp & Dohme Corp. v. Albrecht (Fosamax). Without regard to the SCOTUS ruling in Albrecht specifically, we will focus on why any “global” failure to warn defense sounding in Federal Preemption of State Law failure to warn claims fails.
THE EPA STATEMENTS FORECLOSE ON PREEMPTION DEFENSE
Below is an exact quote from the EPA Statement (link previously provided):
Exact Quote: The EPA will no longer approve (emphasis added) product labels claiming glyphosate is known to cause cancer – a false claim that does not meet the labeling requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Note: The EPA has the power to disapprove statements (on label) that are false and misleading, the EPA does not have the power to determine that a statement that is factually true as stated is a false claim simply because the EPA disagrees with any conclusion that might be drawn from the otherwise truthful statement.
The EPAs own statements provide clear and convincing evidence that the EPA would have approved some form of cancer warning on the Roundup label prior to August of 2019 had the company requested to make such an addition to their label. Any argument by the Monsanto /Bayer defendant that the EPA would not have approved any form of cancer warning prior to August of 2019 fails in as much as the EPA did in fact approve warnings on Glyphosate products prior to August of 2019. Below are three examples, two of these examples contain language that that could not be deemed to be false and misleading and the other would likely be preempted post August of 2019.
EXAMPLE OF EPA WARNING NOT FORECLOSED ON BY AUGUST 2019 EPA ACTION
May 6, 2015 Label Excerpt:
“Carcinogenicity / Chronic Health Effects: Prolonged overexposure to glyphosate may cause effects to the liver. EPA has given glyphosate a Group E classification (evidence of non-carcinogenicity in humans). In 2015, IARC classified glyphosate as a probable human carcinogen Group 2A based on limited human evidence and some evidence in animals.”
Comment: This Statement remains true and accurate and could arguably continue to be cited by Plaintiffs as an example of a more adequate warning that the warning provided on the label of Monsanto Products. The , The Statement that “The IARC classified glyphosate as a probable human carcinogen Group 2A based on limited human evidence and some evidence in animals “ remains true to day in that the IARC did in fact make (and continues to make) the statement to this date. The fact that the EPA disagrees with the IARC statement does not render the fact that the IARC made the statement false and misleading. The Statement made on the above label example remains true to this date, the Statement is not false and misleading nor does the statement constitute a “false claim”. The IARC made the Statement, the label states that the IARC made the Statement. The label does not offer an opinion on the Statement, the label simply informs the user of the fact that the IARC made the Statement.
It would arguable be far falser and more misleading to exclude the IARC Statement, given the fact that the IARC is a worldwide recognized authority on the subject of cancer, than it would be to include the Statement. The label also includes the EPAs statements which contradict the IARC. When contradicting opinions exist between authorities, how would the end user of a product be better served (better warned) by including one authorities conclusion to the exclusion of another’s?
EXAMPLE OF WARNING SUBJECT TO PREEMPTION POST 2019
Page 6 1/10/2017 Label
Excerpt: “California Proposition 65: This product does not contain substances known to the state of California to cause cancer and/or reproductive/developmental effects.”
The above is an example of a warning that would be impacted by the August 2019 EPA action however, any argument that the EPA would not have allowed (preempt) this warning be provided to individuals who were exposed to a Monsanto Product label fails as the EPA did in fact allow this warning prior to August 2019.
ANOTHER EXAMPLE OF EPA WARNING NOT FORECLOSED ON BY AUGUST 2019 EPA ACTION
Page 4 May of 2015
Exerpt: Carcinogenicity / Chronic Health Effects: Prolonged overexposure to glyphosate may cause effects to the liver. EPA has given glyphosate a Group E classification (evidence of non-carcinogenicity in humans). Canada PMRA has classified glyphosate as non-carcinogenic. In 2015 IARC classified glyphosate as a probable human carcinogen Group 2A based on limited human evidence and some evidence in animals. Imazapyr did not cause cancer in laboratory animals. EPA has classified imazapyr as a Group E (evidence of non-carcinogenicity for humans) carcinogen.
Comment: Again, the warning that “In 2015 IARC classified glyphosate as a probable human carcinogen Group 2A based on limited human evidence and some evidence in animals” is an absolutely true statement and therefore cannot be considered false and misleading. Had the IARC not made such statement, including this language in the warning label would be false and misleading, but this is not the case.
Monsanto is likely to continue to press the relevance and importance of the August 2019 EPA Statements by attempting to conflate the doctrine(s) of Field Preemption with the Doctrine of Express Preemption under “impossibility preemption” theories. These attempts should fail in that Congress having empowered the EPA to preempt (foreclose on) States from passing laws imposing additional labeling requirements (beyond those imposed by the EPA) does not equate to Congress having Expressly Preempting Plaintiffs from arguing that a given defendants could have (it was possible) sought approval to add different, stronger, better or more adequate warnings than those the defendant actually sought to have approved by the agency.
FIELD PREEMPTION VS EXPRESS (IMPOSSIBILITY) PREEMPTION
Field occurs when Congress, without expressly declaring that state laws are preempted, nevertheless legislates in a way that is so comprehensive as to occupy the entire field of an issue.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is a United States federal law that set up the basic U.S. system of pesticide regulation to protect applicators, consumers, and the environment. Through the passage of FIFRA Congress did expressly declare that no State could impose labeling requirements in addition to those imposed under FIFRA. California’s right to impose additional labeling requirements (beyond those imposed by the EPA, is arguably foreclosed on under FIFRA.
Notwithstanding the foregoing, and as expressed by SCOTUS in the seminal case of Wyeth v. Levine, 555 US 555 – Supreme Court 2009, the maker of a Federally Regulated (as to warning labels) always remains the “master of their label”. Plaintiffs remain free to argue that the manufacturer should have submitted a label to the EPA for approval which contained a different (stronger or better) warning than that contained in the label the manufacturer submitted for approval and that their failure to do so renders the warnings provided on the label which was submitted for approval inadequate under State Law. https://www.scotusblog.com/case-files/cases/wyeth-v-levine/
The only exception to the jurisprudence found in Wyeth v. Levine arises when a manufacturer submits a specific label for approval and the EPA (or the FDA) and the agency formally rejects the change sought by the manufacturer. See Merck Sharp & Dohme Corp. v. Albrecht (Fosamax Ruling). We find no argument put forth by Monsanto sounding in “ We requested the label change plaintiffs assert was necessary to “adequately warn” and the EPA rejected our request.” See: Merck Sharp & Dohme Corp. v. Albrecht (Fosamax)
1. California (or others) Plaintiffs in which exposure to RoundUp occurred after August 2019 may not want to cite the language of California Prop 65 (related to Glyphosate) as an example of a more adequate warning.
2. The EPAs action of August 2019, should have no impact on cases in which exposure occurred before August 2019 without regard to California Prop 65 (relevant to the Hardeman case) as the EPA clearly did approve labels with warnings related to California Prop 65 prior to August 2019, including the time period in which Mr. Hardeman was exposed.
The argument that the EPA would not have approved any form of cancer warning prior to 2019 fails for the following reasons:
A. The language of the EPAs August 2019 statement is conclusive of the fact that the EPA would have approved some form of cancer warning prior to August 2019.
B. The EPA did in fact approve labels containing cancer warnings prior to August 2019 on labels submitted for EPA approval, when the manufacturer requested such approvals.
3. Warnings approved by the EPA for other glyphosate products prior to August 2019 which remain factually true, (not false nor misleading) taking into consideration the EPAs August 2019, remain available to plaintiffs to cite as “more adequate” than the warnings provided by Monsanto.
We do not argue that juries should not be allowed to consider any and all Statements made by the EPA. Of course, plaintiffs should also be allowed to conduct discovery to uncover any possible corruption, malfeasance or mistakes relevant to the EPAs statements and conclusions.
We do argue that there is no support under the law for any conclusion that once a Federal Agency makes a statement, expresses an opinion or conclusion, that litigants are foreclosed on entering evidence that contradicts the agency statements, conclusions or opinions under the circumstances relevant to this matter. The concept of “I have thus said, and therefore that which I sayeth is true” is the province and privilege of Kings. American citizens are free to challenge our own government’s lies and misrepresentations. The trier of fact holds the power to determine what is true and what is not.
We do not argue that the FIFRA (via the August 2019 action by the EPA) may not foreclose on the State of California’s right to impose the specific stronger label requirements than imposed by the EPA. We simply argue that the EPA could not (because it was not delegated the authority by congress) issue any Statement that could foreclose on all possible (stronger) warning language a plaintiff might allege would be required to render a label adequate under a given States laws, without the EPA having first having considered and rejected the exact language claimed by Plaintiff as necessary to provide an adequate warning.
We further argue that the two label examples, previously approved by the EPA, remain truthful (in no way false or misleading ) to this day and any plaintiff that puts forth this exact language as that which was needed to render the label adequate would not be arguing that the defendant be required to make a false and misleading statement and therefore the EPA is without the power to intercede on behalf of the defendant claiming that the agencies power to restrict manufacturers from making false and misleading statements extends to restricting statements that are factually true.
THE BURNING QUESTION
How desperate does Monsanto/Bayer have to be to turn to the Trump Administration for help. Then again, both Monsanto and Bayer have a history of being on the wrong side of things.
Bayer stockholders should all be hoping for a Trump re-election. If the U.S. elects a legitimate president later this year, the EPA could easily reverse course shortly thereafter.