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A federal district court in Arizona has vacated the registrations for dicamba products XtendiMax, Engenia, and Tavium, finding that the U.S. EPA violated pesticide registration procedures when it approved the product registrations in 2020. As a result of the decision in Center for Biological Diversity v. EPA, the dicamba products are no longer legally authorized for use and application in the U.S. Although there will likely be appeal of the decision, the new ruling creates uncertainty over the use of dicamba products for the upcoming crop season.
History of the case
If the court’s ruling feels familiar, that’s because it is a repeat of a 2020 Ninth Circuit Court of Appeals decision in National Family Farm Coalition v. EPA (Monsanto). In that case, the court vacated the first “conditional” dicamba product registrations granted by the EPA in 2018. The court found that the EPA had “substantially understated” and failed to acknowledge the risks of dicamba’s volatility and its effects on non-users. The EPA then cancelled the product registrations in June of 2020, but allowed producers to use “existing stocks” of already purchased products to apply the products until July 31, 2020. The Ohio Department of Agriculture shortened that timeline in Ohio due to growing conditions within the state, prohibiting applications of dicamba after June 30, 2020.
Bayer, BASF, and Syngenta immediately revised the label application instructions and restrictions for their dicamba products and resubmitted their registration requests to the EPA. In October of 2020, the EPA granted the applications and issued “unconditional” five-year registrations for over-the-top applications (OTT) of the products on cotton and soybean crops. The EPA did not provide a notice and opportunity for the public to submit comments before it made the registration decision. The National Family Farm Coalition, Pesticide Action Network, Center for Food Safety, and Center for Biological Diversity filed the current lawsuit, claiming that the EPA violated federal law by granting the unconditional registrations without a notice and comment period.
The court’s reasoning in this case
EPA’s error. The primary basis for the court’s decision is the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Section 136a(c)(4), which contains the notice and comment requirement for registration of a “new use” of a pesticide or herbicide. It states that the EPA:
“. . . shall publish in the Federal Register. . . a notice of each application for registration of any pesticide that contains any new active ingredient or if it would entail a changed use pattern. The notice shall provide for a period of 30 days in which any Federal agency or any other interested person may comment.”
FIFRA further states that a “new use” of a product means, in part, “any additional use pattern that would result in a significant increase in the level of exposure, or a change in the route of exposure, to the active ingredient of man or other organisms.”
The EPA took the position that it did not have to provide the FIFRA notice and a comment period because the 2020 registration requests were not applications for a “new use” since EPA had previously approved the products. The court strongly disagreed, however, emphasizing the previous court decision that had vacated those registrations because the EPA had failed to fully consider the risks of the products. The EPA’s conclusion that the 2020 registrations were not for a new use “is so implausible that the Court cannot ascribe it to be a mere difference in view,” the court stated. Stakeholders who would be affected by the dicamba registrations should have had an opportunity to “meaningfully weigh in during the decision-making process before EPA concluded whether OTT dicamba has unreasonable adverse effects on the environment,” said the court.
Remedy for the error. The court explained that upon finding an agency has violated federal law, the presumed remedy a court must grant is to vacate the agency’s action. The law requires that only in limited circumstances, when equity requires it, should a court remand without vacating an agency decision. There are two factors the law requires a court to review in determining the remedy: the seriousness of the agency’s error and the disruptive consequences of vacating the agency’s decision. The court’s next step was to review those two factors and determine whether it should remand the issue with or without vacating the dicamba registrations.
Examining the first factor, the court concluded that the EPA’s error was “very serious” because it was likely that, had the agency considered field studies, data, and other information that would have been submitted during the comment period, the EPA’s registration decision likely would have differed from the decision it made to grant the five-year unconditional registration. The history of the dicamba registrations were important to the court, and the judge noted that there had not been a notice and comment period for stakeholders who were opposed to approving dicamba products since 2016, when the EPA considered the original registration. The court reiterated a long list of field studies, incident reports, and data generated since 2016 that the agency could have considered had it provided a comment period. Noting that the EPA was “highly confident that control measures would eliminate dicamba offsite movement to only a minimal effect,” the court pointed to years of incident reports on dicamba offsite movement and concluded:
“This Court believes hearing from all stakeholders is likely to change the OTT dicamba registrations at least from unconditional to conditional, with data gathering requirements reinstated. Hearing from non-users of OTT dicamba may change the EPA’s circular approach to assessing costs for risks from OTT dicamba offsite movement. Instead of simply concluding there is no risk and, therefore, no costs to these stakeholders, EPA is likely to include the costs to these stakeholders when balancing the risks and benefits for OTT dicamba. Accordingly, the Court finds the EPA’s procedural error to unconditionally issue the “new use” 2020 dicamba registration, without notice and comment, was serious.”
The court then examined the second factor, the disruptive consequences of vacating the agency’s decision. The court recognized the benefits of dicamba products to the agricultural industry and that growers, through no fault of their own, would be in the difficult position of finding legal herbicides to protect their crops if the dicamba registrations were vacated. Nevertheless, the court agreed with the reasoning in the previous dicamba case, National Family Farm Coalition v. EPA (Monsanto), that the seriousness of the EPA’s failure to assess the risks and costs for non-users of dicamba warranted vacating the registration despite the disruptive consequences.
What happens next?
There are two issues to watch now in the wake of the court’s decision. First is whether the EPA will appeal the federal district court’s decision. The appeal would go the Ninth Circuit Court of Appeals, the same appellate court that reviewed the decision in the first dicamba appeal, National Family Farm Coalition v. EPA (Monsanto). If the EPA also requests a stay, the appeal would put the federal district court’s decision on hold.
If there is not an appeal, the second issue to watch for is how the EPA and state agencies will direct the use of existing stocks of dicamba products. The EPA could use its authority to allow continued use of existing stocks of dicamba products until a certain date, as it did in the previous case. If the EPA does issue an existing stocks order, states could also address the extent of existing stocks use within their borders, as Ohio did in the previous case.
Follow the Ohio Ag Law Blog for continued legal information about Center for Biological Diversity v. EPA and review the federal district court’s opinion through this link. Ohio growers should also refer to information from OSU’s Weed Science Extension Specialist, Dr. Allyssa Essman, available through OSU’s C.O.R.N. newsletter.
Tags: dicamba, EPA, center for biological diversity, bayer
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A jury recently returned a verdict awarding a California couple $2.055 billion (yes, billion) in damages after the couple alleged that the glyphosate in Roundup caused their cancer. This is the third California jury to be convinced that the Monsanto herbicide, which was acquired by Bayer last year, caused or substantially contributed to a cancer diagnosis of non-Hodgkin lymphoma. A lot has happened since we last reported on these lawsuits HERE and HERE, so it is time to look at the glyphosate lawsuits, jury verdicts, and the larger debate.
Thousands of glyphosate lawsuits have been filed against Monsanto/Bayer. Over 13,000 cases have been filed alleging almost the same thing: that a plaintiff’s cancer was caused by the glyphosate in Roundup. About two years ago there were only a few hundred such cases. News stories about large jury verdicts have caught people’s attention, as have commercials that some law firms have aired to find clients for this type of litigation. The vast majority of these cases have been brought in state courts, which have a reputation for being somewhat quicker than federal courts, but there are still over a thousand in federal courts across the country. So far, only three of these cases have reached a jury, and all have been in California.
First California jury awarded a plaintiff $289 million. Dewayne Johnson was a school groundskeeper who routinely used Roundup as part of his job. He was diagnosed with non-Hodgkin’s lymphoma in 2014, and believed that his diagnosis was a result of at least two prior incidents where he was soaked with Roundup. His lawsuit against Monsanto in California state court was chosen to be the first case to be tried before a jury because his doctors did not expect him to live for much longer.
The San Francisco jury sided with Mr. Johnson and awarded him $39 million in compensatory damages, and $250 million in punitive damages. Compensatory damages are meant to directly compensate for harm, and can include medical expenses, lost wages, and emotional distress. Punitive damages, on the other hand, are meant to punish the party in the wrong and deter a similar course of conduct in the future. The judge in the case ultimately reduced the punitive damages to match the compensatory damages, leaving Mr. Johnson with a potential $78 million recovery. However, the decision is on appeal.
Second California jury awarded a plaintiff $80 million. Edwin Hardeman sprayed Roundup on his property for about three decades. In 2014, he was diagnosed with non-Hodgkin’s lymphoma, and decided to file a lawsuit two years later after learning about research connecting his form of cancer to Roundup use. His lawsuit was the first to be heard in federal court. This San Francisco jury awarded Mr. Hardeman $5.8 million in compensatory damages, and $75 million in punitive damages. However, the decision is also on appeal.
Third California jury awarded the plaintiffs $2.055 billion. The first two cases certainly sent shock waves through the news, but the size of this third jury award sent more than just shock. The plaintiffs, Alva and Alberta Pilliod, are a California couple who were diagnosed with non-Hodgkin’s lymphoma within four years of each other. The jury awarded the couple $55 million in compensatory damages, along with $1 billion in punitive damages each. Bayer has promised to appeal this decision as well.
Will the parties ultimately get these punitive damages? It is hard to answer this question just yet, but it is likely that the punitive damages awards will be reduced. Courts are often hesitant about awarding punitive damages absent bad intentions by the party being punished, and few verdicts result in a punitive damages award. When they are awarded, there are constitutional limitations on how large the award can be. The U.S. Supreme Court has said that a punitive damages award that exceeds a compensatory damages award by more than a single digit multiplier likely violates a party’s due process rights and is not likely to be upheld. This means that if a punitive damages award exceeds nine or ten times the compensatory damages, courts are to look at that jury’s decision with a high level of suspicion. However, such an award could ultimately be awarded if the evidence of bad intent merits such an award, and if such award is necessary to deter future bad acts.
Bayer’s first hope on appeal is to have the jury decisions invalidated altogether by arguing that the juries were incorrect in linking these plaintiff’s cancer to their prior use of Roundup. In order to succeed, it must prove that the decisions of the three juries were against the “manifest weight of the evidence,” meaning that they relied too much on one pile of evidence leaning one way while ignoring a mountain of evidence going the other way. If it can succeed on this, then it would not have to pay damages to the plaintiffs. However, this can be a high burden for an appellant to satisfy because of our legal system’s deference to juries. If Bayer cannot succeed on avoiding fault, it would still argue that the jury awards are excessive.
In the first case, the initial jury award had a single digit multiplier of roughly six; however, the judge viewed even that multiplier as excessive and reduced the punitive damages award to match the compensatory damages award. In the second case, the initial jury award had a multiplier of over twelve, which could give Bayer a strong argument on appeal if it is ultimately determined that it must pay the plaintiffs. However, Bayer is also challenging the basis of the jury’s decision on appeal.
The third case is simply on a different level. The $2 billion in punitive damages is 36 times the compensatory damages awarded to the couple. The trial judge may respond like the first trial judge and reduce the compensatory damages award; however, that is not a guarantee. What is likely a guarantee is that Bayer will appeal.
Does glyphosate cause non-Hodgkins lymphoma? This question will continue to be a debate for years, and we as attorneys are not in the best spot to make any sorts of determinations based on the scientific research. The U.S. Environmental Protection Agency and a number of scientific studies say no; however, the World Health Organization said in 2015 that glyphosate was “probably carcinogenic to humans.” It was that announcement, and some research that followed, which triggered the wave of lawsuits we see today. Bayer is using the first set of research to defend its product, while the plaintiffs are using the second set of research to attack Roundup. The attorneys in the first three cases tried to undercut Bayer’s use of EPA and university research by arguing Monsanto had influenced the first set of research in a manner favorable to it.
For better or worse, what matters in a jury trial is less what the science says, and more what the jury believes the science says. So far, three California juries have been convinced that there is enough science to say that glyphosate caused or contributed to the cancer of four plaintiffs. The first non-California cases are beginning to be scheduled for later this year, including in Monsanto’s former home in St. Louis. As of now, it remains to be seen whether the first three cases will be the outliers or the norms for the glyphosate litigation nationwide.
Tags: glyphosate, bayer, Monsanto, roundup, punitive damages
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