The recent EPA actions related to Paraquat and Parkinson’s disease have caught the attention of the plaintiff bar, resulting in firms actively pursuing these cases.
It may come as a surprise to some that a significant number of “one off” cases have been brought, alleging injury caused by a FIFRA-regulated product, resulting in verdicts for plaintiffs- without reliance on any predicate action taken by the EPA.
The recent attention attracted by the EPA actions related to Paraquat should be a wake-up call to the plaintiffs’ bar. Paraquat is the tip of a very large iceberg. Plaintiffs’ firms should be reviewing cases for almost every product on the EPA’s Restricted Use List (RUP) for a host of injury categories specific to each product and product category.
Mass Tort Nexus will be hosting a series of Whiteboard Wednesday sessions beginning on Wednesday, April 21st (register here) intended to provide plaintiff firms with the background and education necessary to acquire and represent plaintiffs in the Paraquat litigation, as well as litigations against makers of other FIFRA-regulated products that are ripe and awaiting action.
In the first session we will cover:
- How and why the makers of FIFRA-regulated products (including Paraquat) have systematically failed to warn with specificity regarding adverse events (injuries) known to be caused by their products. The why is simple, the plaintiffs’ bar has yet to step up to protect the millions of people injured by these products. It is time to dispense with the one-off cases and show the industry the force for change that can be brought about by mass litigation, Paraquat and beyond!
- Why no EPA action is needed for plaintiffs suffering from one of these adverse events, in order for said plaintiff to prevail in product liability action against the maker of a FIFRA-regulated product that has failed to warn with specificity (see case example below Ferebee v. Chevron Chemical Co).
- Why changes in 40 C.F.R. § 152.81, in combination with the plain language of 40 CFR § 152.46 no longer support the reasoning of those Courts that have found preemption of state law Failure to Warn claims under FIFRA.
- Why it was necessary for the EPA to change the language of 40 C.F.R. § 152.81 after many courts ignored the brief filed by the United States Attorney General in Etcheverry v. Tri-Ag, 993 P. 2d 366 – Cal: Supreme Court 2000. Despite the Amicus brief filed by the AG, plainly stating in part:
- The effect of the changes in 40 C.F.R. § 152.81 in light of the SCOTUS ruling in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 – Supreme Court 2019.
- 6. Why the approval of a label by the EPA is no more conclusive of the adequacy of the warnings provided therein, than is the approval of a label submitted to the FDA by a drug maker. The duty to provide adequate warnings (with specificity) always falls upon the manufacturer of the product, without regard to whether the product is regulated by the FDCA or FIFRA (EPA).
“When a pesticide is registered, the manufacturer must submit the proposed label to the EPA for approval. The label must be “adequate to protect health and the environment,” see 7 U.S.C. § 136(q)(1)(G), and “likely to be read and understood” See 7 U.S.C. § 136(q)(1)(E).”
“When an environmental hazard exists from the pesticide, precautionary language stating the nature of the hazard and the appropriate precautions to avoid potential accident, injury, or damage is required. § 156.10(h)(2)(ii).”
*Note: The word ‘pesticide’ is used generally in regulation and statute to describe all FIFRA regulated products.
BACKGROUND FOR FIRST SESSION
The remainder of this article, we will review Ferebee v. Chevron Chemical Co. and why those Courts that have followed the reasoning of Ferebee “got it right” and why those Courts that found contrary to Ferebee may have to revisit their rulings in light of the changes to 40 CFR § 152.81 combined with the EPA’s state reasons for implementing said changes.
Ferebee v. Chevron Chemical Co.
The Ferebee case was initially filed by Mr. Ferebee and then continued as a survival action after Mr. Ferebee’s pulmonary fibrosis caused his death prior to the case reaching trial.
Richard Ferebee was an agricultural worker at the Beltsville Agricultural Research Center (BARC), an installation of the United States Department of Agriculture located in Beltsville, Maryland.
The complaint alleged that Mr. Ferebee contracted pulmonary fibrosis resulting from long-term skin exposure to dilute solutions of paraquat.
The lower court denied defendants’ FIFRA-based preemption motions as well as other motions filed by Defendants to avoid the case reaching a jury.
At trial, the attorneys representing the Ferebee family put forth two experts in support of their contention that Paraquat was the cause of Mr. Ferebee’s pulmonary fibrosis. The first witness was a Pulmonologist that treated Mr. Ferebee prior to his death. The second was a physician employed by the National Institute of Health.
The Ferebee attorneys further argued that while the Paraquat label did contain some general health warnings, the fact that Paraquat was known to potentially cause pulmonary fibrosis posed a duty on the Defendant to specifically warn, relevant to pulmonary fibrosis.
Chevron’s expert witnesses testified intra alia; that although Paraquat could cause pulmonary fibrosis, it was not possible for Mr. Ferebee to have been exposed via skin absorption in amounts sufficient to cause pulmonary fibrosis.
The jury found Chevron’s arguments unavailing and rendered judgement and award in favor of the Ferebee family.
Chevron unsuccessfully appealed:
Ferebee v. Chevron Chemical Co., 552 F. Supp. 1293 – Dist. Court, Dist. of Columbia 1982
Ferebee v. Chevron Chemical Co., 736 F. 2d 1529 – Court of Appeals, Dist. of Columbia Circuit 1984
SCOTUS cert. denied, 469 U.S. 1062, 105 S.Ct. 545, 83 L.Ed.2d 432 (1985).
DID CHEVRON CHANGE THEIR LABEL POST-FEREBEE?
One might think that post-Ferebee, all makers of Paraquat products would have filed original or supplemental registrations with the FDA, adding a specific warning related to pulmonary fibrosis, to their labels.
Despite the verdict in Ferebee, as well as other cases, including cases arising from pulmonary fibrosis to this day, not a single maker of a Paraquat product provides a warning specific to pulmonary fibrosis, to date.
Additionally, despite the CDC listing all the following adverse events potentially caused by Paraquat exposure, not a single maker of the products specifically warns of any of these adverse events in their labeling:
- Heart failure
- Kidney failure
- Liver failure
- Lung scarring
- Acute Kidney failure
- Fast heart rate
- Injury to the heart
- Liver failure
- Lung scarring (evolves more quickly than when small to medium amounts have been ingested)
- Muscle weakness
- Pulmonary edema (fluid in the lungs)
- Respiratory (breathing) failure, possibly leading to death
- If a person survives the toxic effects of Paraquat poisoning, long-term lung damage (scarring) is highly likely. Other long-term effects may also occur, including kidney failure, heart failure, and esophageal strictures (scarring of the swallowing tube that makes it hard for a person to swallow).
The CDC also lists the exposure routes that can lead to these injuries which include: inhalation, skin absorption, ingestion, skin and/or eye contact.
Bear in mind, this is just the CDC list of injuries known to be caused by Paraquat, no warning on the label of any product. There are 221 other RUP categories of products known to cause injuries of various types.
RETHINKING FIFRA PREEMPTION
The SCOTUS ruling in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 – Supreme Court 2019 combined with the changes in 40 CFR § 152.81, provide significant arguments that the various Court rulings that have found contrary to Ferebee on preemption, many no longer be apt case law.
40 CFR § 152.46 provides a process similar to the Changes Being Affected (CBE) process (pharmaceuticals), which allows the registrant to unilaterally make a change to their labeling prior to the EPA approving the change. A registrant may make a change to their label and begin marketing the subject product under the new labeling as soon as the EPA receives notification of the change (before the EPA approves or disapproves the change). As is true of the CBE process, the EPA has the power to instruct the registrant to remove or alter the unilaterally implemented change after the fact, if the agency finds reason to do so.
Prior to 2014, 40 CFR § 152.81 included a list of the types of changes a registrant could make without prior approval pursuant to § 152.46. Citing the fact that the EPA never intended for the list contained in § 152.81 to be all inclusive, the EPA began the process of removing the list from the language of § 152.81 in November of 2010. The list was removed from §152.81 in 2014.
Currently, read in combination, 40 CFR § 152.46 and §152.81 allows registrants to make changes pursuant to 40 CFR § 152.46 so long as the changes, “…have no potential to cause unreasonable adverse effects on the environment.”
“Unreasonable adverse effects on the environment” are defined as, “any unreasonable risk to man (emphasis added) or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.” Id. § 136(bb) and 7 U.S.C. § 136a(c)(5).
Considering the foregoing, in combination with the SCOTUS decision in Albrecht, makers of FIFRA-regulated products are likely to have little success in arguing that any obstacle (impossibility) exists with regard to adding a “more specific warning” related to specific diseases and injuries known to be caused by their products.