Recently, a three-judge panel of the US Court of Appeals for the Sixth Circuit granted interlocutory review of an enormous class action that could significantly impact the future of PFAS litigation. The decision came as defendants in Hardwick v. 3M, currently before the US District Court for the Southern District of Ohio, appealed the district court’s decision certifying what may be the largest class of plaintiffs in history. The forthcoming ruling is of particular import because it has the potential to be a landmark ruling for class actions and considerably affect the future of PFAS litigation.

Filed in 2018, named plaintiff Kevin Hardwick, a former firefighter, alleges exposure to PFAS from his gear and the fire suppressant used in his line of work. At the time, plaintiff sought nationwide certification of a class consisting of “any individual residing within the United States… with 0.05 parts per trillion (ppt) or more of PFOA and at least 0.05 ppt or more of any other PFAS in their blood serum.” For context, many reports indicate the proposed class potentially consists of 95% of the US population.

Earlier this year, the Ohio district court limited class certification to all Ohio residents who have “0.05 parts per trillion (ppt) PFOA (C-8) and at least 0.05 ppt of any other PFAS in their blood serum.” The district court explained this was the most appropriate step because, while Ohio recognizes medical monitoring claims, a number of other states do not recognize such a claim.  That said, the court also stated it might expand the class to other states that also recognize these claims. Even reducing the class to only Ohio residents results in a certified class of at least 11 million people, making it the largest class action in history.

Interestingly, the lawsuit does not seek monetary damages. Rather, plaintiffs seek injunctive relief through the establishment of a science panel to study the adverse impact of PFAS on human health, as well as medical monitoring for its affected class members.

Given the potential for massive liability due to the size of this class certification and the relief sought, defendants appealed the court’s class certification. Defendant’s arguments focused on class standing, cohesiveness, and the relief sought.

In its Order, the Sixth Circuit addressed several issues it found concerning regarding the district court’s decision. Addressing Article III standing, the Sixth Circuit found that the presence of PFAS in a plaintiff’s blood could potentially qualify as an injury-in-fact, due in part to Ohio’s recognition of medical monitoring claims after exposure to toxic substances and plaintiff analogizing the claim to battery. However, the court felt the relief sought—a science panel and medical monitoring—presented issues with regard to redressability as it would not do anything to address the presence of PFAS in plaintiff’s blood, nor prevent more from entering it. Further, the court also found plaintiff’s lack of evidentiary proof of a causal connection between his alleged injuries and the conduct of the defendants presented issues in terms of traceability.

Next, the court noted its concerns with the class certification, finding the fact that class members were likely exposed to PFAS “in different ways, in different amounts, and at different times” to be at odds with the commonality requirement for class certification and principles of class cohesiveness.

Lastly, the court addressed tertiary issues it found to be particularly important in its decision to review the district court’s class certification. The Sixth Circuit stated that a class certification of this magnitude creates a “reverse death knell” scenario “where the certification decision threatens such massive liability that it induces defendants to settle rather than defend the action on its merits.” Additionally, the court also felt it important to mention that, as stated in its ruling, the district court was considering expanding the class, which “underscores the need for a second look.” In sum, the Sixth Circuit found that defendants’ arguments presented “unsettled and important questions,” and granted their appeal for interlocutory review.

Nonetheless, the Sixth Circuit cautioned that resolution of whether the class may go forward presently awaits the merit panel’s review. Specifically, the court stated “[W]e hold merely that when a district court certifies one of the largest class actions in history, predicated on a questionable theory of standing and a refusal to apply a cohesion requirement endorsed by seven courts of appeals, to authorize pursuit of an ill-defined remedy that sits uneasily with traditional constraints on the equity power and threatens massive liability, such a decision warrants further review.”

If this class certification is approved, it could open the flood gates to the filing of similar cases in other jurisdictions, with more defendants added to the litigation. The impact would be massive, not only on manufacturers of PFAS, but also the downstream companies that manufactured, sold, and/or used products that contained PFAS, that may be pursued in later litigation for their alleged contribution to environmental PFAS exposure. Hence, considering the expansive impact this anticipated class certification ruling may have, we recommend that all companies that may have manufactured, sold, and/or used a product that contained PFAS closely monitor this case and other similar matters to assess potential liability.

In recent years, state and federal agencies have either passed or proposed increasingly stringent regulations regarding the use of per-fluoroalkyl and poly-fluoroalkyl substances (PFAS) in consumer products. Not surprisingly, the state of California has been at the forefront of these efforts. California’s place at the forefront of PFAS regulation continues, as the California legislature recently passed three new bills—AB 2771, AB 1817, and AB 2247—seeking to eliminate the use of PFAS in textiles and cosmetics.

AB 2771 would prohibit the manufacture, sale or marketing of any cosmetic product that contains intentionally added PFAS. AB 1817 would prohibit the manufacturing, distribution or marketing of any new textile article—including clothing—that contains regulated PFAS. AB 1817 also requires a manufacturer of textiles to provide customers or suppliers a certificate of compliance stating that the product does not contain regulated PFAS. Lastly, AB 2247 would require any manufacturer of PFAS or a product containing intentionally added PFAS to register the PFAS or the product containing intentionally added PFAS into a publicly accessible data collection interface. Violations of the reporting requirement would be subject to civil penalties and other enforcement provisions.

Governor Newsom is expected to sign the bills into law no later than September 30, 2022. If passed, these bills will go into effect January 1, 2025, with the exception of AB 2247, which would go into effect July 1, 2026.

However, even if these bills are passed, it is yet to be seen whether these bills will withstand judicial scrutiny given they are, arguably, at odds with federal law. The US Federal Drug and Food Administration—the federal agency charged with regulating the food, drug, and cosmetics industry—has not banned PFAS from any of the products under its purview. In fact, the FDA has specifically approved some types of PFAS for use in certain food contact applications, reflecting a governmental determination that there is a reasonable certainty that no harm will come from their use in the applications for which they have been approved. As such, it is expected that manufacturers of these products may challenge the enforcement of these statutes.

Notwithstanding the potential conflict between California and federal law, companies involved in the manufacture and sale of PFAS-containing cosmetics and textiles—including clothes and carpeting materials—should actively research alternatives to PFAS in their products right now. Businesses simply cannot assume that California’s new laws will be unenforceable, particularly with the EPA’s stated intent to further regulate PFAS. Should businesses fail to prepare, they could risk losing product sales in California, the world’s fifth largest economy.

On August 26, 2022, the US Environmental Protection Agency (EPA) announced proposed rulemaking to designate two types of per- and poly-fluoroalkyl substances (PFAS) as “hazardous chemicals” under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA).

PFAS are a class of man-made chemicals widely used as surfactants in industrial and consumer products, including but not limited to: firefighting foam, cosmetics, clothing, cookware, and carpeting. They are known for their bio-persistence, and, unlike most other chemicals, do not “break down” in the human body when consumed. The EPA’s proposal specifically applies to perfluorooctanoic acid (PFOA), and perfluorooctanessulfonic acid (PFOS), two of the most commonly used types of PFAS.

In the news release announcing the proposed rulemaking, the EPA states that its proposal “is based on significant evidence that PFOA and PFOS may present a substantial danger to human health or welfare or the environment.” The EPA goes on to claim: “PFOA and PFOS can accumulate and persist in the human body for long periods of time and evidence from laboratory and human epidemiology studies indicates that exposure to PFOA and/or PFOS may lead to cancer, reproductive, developmental, cardiovascular, liver, and immunological effects.”

While the language used by the EPA and other regulators strongly suggests to the public there is a medical consensus that PFAS exposure causes cancer and other adverse health effects, this is not the case. Despite the fact that PFAS have been widely and heavily used for decades in the United States, no epidemiological study to date has found a “causal effect”—versus an “association”—between PFAS exposure and cancer. A “causal effect,” in contrast to an “association,” is demonstrated where exposure to a particular substance shows a statistically significant increase in the number of certain health outcomes, such as cancer, as compared to what would be expected in a non-exposed population.

The EPA’s proposed designation of PFOA and PFOS as “hazardous substances” under CERCLA, if passed, is significant for a number of reasons. Companies who continue to manufacture and sell products containing PFOA or PFOS will be required to monitor and report releases of the chemical to the government, and will be regulated by the Department of Transportation under the Hazardous Materials Transportation Act.

Perhaps most significantly, designating both PFOA and PFOS as “hazardous” chemicals under CERCLA will lead to potentially limitless liability for some of the country’s biggest industries, including aviation, plastics, and oil. Under CERCLA, the Federal Government may order any party found responsible for contaminating land with a “hazardous” substance to pay for the costs of clean-up. The Federal government can—and more often than not does—cast a very wide net in assigning liability for the costs of remediating and/or removing hazardous substances from a designated site. For example, businesses or individuals may be apportioned liability under CERCLA simply for purchasing land known to be a source of prior contamination, for exercising “substantial control” over activities at the facility where the contamination occurred, or for transporting the hazardous substances. (Kaiser Aluminum & Chemical Corp. v. Catellus Development Corp. (976 F.2d 1338 (9th Circ. 1992; US. v. Bestfoods, 524 U.S. 51 (1998)). CERCLA penalties may also be applied retroactively, meaning that those contributing to the use of PFAS at a designated site can be held responsible for all or a portion of the clean-up costs even if the contamination occurred prior to PFAS being listed as a hazardous substance, or even prior to the passage of CERCLA itself. (US v. Monsanto, 858 F.2d 160 (4th Cir. 1988).

It is important to note that the EPA’s proposed designation will not become effective immediately. The proposed rulemaking is subject to the delays of public notice and comments requirements of the Administrative Procedure Act. Finally, given the lack of medical consensus as to whether PFOA and PFOS cause disease, versus the high cost of remediation, it is almost certain that the proposed rulemaking will be challenged in court by one or more members of the affected industries.

In June 2022, the Environmental Protection Agency (EPA) released new lifetime health advisories (LHAs) for per-fluoroalkyl and poly-fluoroalkyl chemicals (PFAS). PFAS are a type of man-made chemicals found in many industrial and consumer products, soil and drinking water. According to the EPA, the new LHAs for PFAS in drinking water are “the level of drinking water contamination below which adverse health effects are not expected to occur.” The new LHAs for PFAS are 3,000 to 17,000 times lower than the previous 2016 levels, which now means that even the amount of PFAS found in rainwater is considered “unsafe.” While the LHAs are not binding regulations, they do provide guidance to federal, state and local governments in developing binding regulations, including those for future Maximum Contaminant Levels (MCLs).

The scientific basis for these drastic reductions in the LHAs has been called into question. In fact, the American Chemistry Council (ACC) recently filed suit against the EPA seeking to challenge the new LHAs for PFAS, noting that “EPA’s revised [LHAs] for PFOA and PFOS reflect a failure of the Agency to follow its accepted practice for ensuring the scientific integrity of its process.” Although the EPA acknowledges that drinking water standards for PFAS must be based on the best available science, ACC alleges that the EPA relied upon data, which was not peer-reviewed by the Agency’s Science Advisory Board when it published its new LHAs. Interestingly, the EPA even admits on its own website that there is not a full understanding of how to detect and measure PFAS in water, the extent of human PFAS exposure, the degree to which PFAS may adversely affect people, or how PFAS can be eliminated from drinking water supplies. Despite these unknowns, the EPA nonetheless promulgated LHAs which are so low and cannot be detected by current EPA methods, further calling into question the scientific validity of the Agency’s LHAs. In addition to the suit filed by ACC, there have been multiple lawsuits[1] which seek to overturn the LHAs on two grounds: there no definitive studies that demonstrate PFAS actually causes any adverse health effects in humans; and even those studies that suggest a link between PFAS exposure and human health problems are unable to determine a minimum level of exposure where such health effects, if any, are expected to occur.

Although the LHAs are unenforceable, they will likely serve as the foundation for future federal, state and local regulation of PFAS. While it is critical to protect human life, any effort to quantify maximum safe levels of exposure must be based on sound science, as any regulations will have a profound impact on the US economy and virtually every industry. For example, regulations that lower the MCLs or ban the use of PFAS[2] could derail President Biden’s plan to return semiconductor manufacturing to the US, as a large production of advanced semiconductors requires PFAS. Moreover, unnecessarily low regulatory levels or bans could harm renewable energy efforts and negatively impact the aerospace, automotive, building and construction, electronics, and pharmaceutical industries, to name a few, as there are no practical substitutes for many PFAS applications.

While the EPA’s stated mission is to protect people and the environment from significant health risks, it is critically important that the EPA base its actions, including promulgation of LHAs and future regulations, on sound scientific principles. Failure to do so could overstate the risks associated with particular PFAS chemicals, and have a profound negative effect on the US economy without any analogous positive impact on human health.

[1] The Chemours Company (“Chemours”) recently filed suit against the EPA challenging its LHA for GenX PFAS chemicals, claiming that the EPA relied on bad science in establishing the LHA.  Specifically, Chemours accused EPA of using scientific data that its own peer reviewers call “extreme” and “excessive.”

[2] Maine has adopted a policy to ban all uses of PFAS, while eleven states have taken action to eliminate PFAS in food packaging. Additionally, six states are eliminating PFAs in textiles and three states will eliminate PFAS in cosmetics.

Author Elizabeth Gross is an MG+M intern who is currently studying environmental science.

For many years, per- and polyfluoroalkyl substances (PFAS) have been ubiquitous in American commerce and industry. That ubiquitous use, and the fact that PFAS chemicals do not break down in the environment, has led to the presence of PFAS in groundwater to varying degrees throughout the country. As a result, the US Environmental Protection Agency (EPA) has turned its full attention to PFAS regulation. In fact, EPA issued a PFAS Strategic Roadmap that sets timelines by which EPA plans to take specific actions, as it states, “to safeguard public health, protect the environment, and hold polluters accountable.” Pursuant to the Roadmap, the EPA issued interim health advisories on June 15, 2022, in which they advised that the safe lifetime drinking level for PFAS chemicals are as low as .004 parts per trillion (ppt) for perfluorooctanoic acid (PFOA) and .02 ppt for perfluorooctane sulfonic acid (PFOS). To put that in context, one should understand that a level of .004 ppt equates to 1 drop out of 4.5 billion gallons of water., and that such miniscule levels are undetectable by current testing instruments, essentially making it zero.

According to the EPA, its interim health advisories are determined based on review of all available science by the EPA’s Science Advisory Board. It is unclear, however, on what the Science Advisory Board relied in reaching its conclusions concerning the level of exposure at which to set the advisory limit, as there is not only no current epidemiological studies that demonstrate that PFAS chemicals actually cause any adverse health consequences, there are certainly no scientific studies that support a level of exposure near zero.

The EPA’s interim health advisories are not regulations, and are not enforceable. They do, however, portend the maximum contaminant levels (MCLs) that the EPA is considering and may eventually enact for drinking water. The EPA is scheduled to issue its proposed regulatory level in fall 2022—only months away—and the rule is expected to go into effect in 2023.

In setting the MCLs, the EPA attempts get the MCL as close to the health advisory limit as feasible. Unlike with health advisories, though, the EPA must prepare a health risk reduction and cost analysis (HRRCA), which takes into account the quantifiable and non-quantifiable benefits that will result from the proposed standard, as well as the increased costs that will result from the proposed drinking water standard. It does not, however, require EPA to consider the benefits in the use of PFAS, including improved safety, durability and fuel efficiency in applications such as cars, airplanes, buildings and electronics, not to mention firefighting where its use is still mandated.

Should the EPA enact drinking water standards near the current health advisory limits, it is likely that the vast majority, if not all, water systems in the United States will require costly remediation. The State of New York estimates that remediation of PFAS in the state’s drinking water to a level of 4 parts per trillion, a standard 1,000 time less strict than the amount proposed by the EPA’s health advisory, would cost $1.5 billion for start-up costs and $78 million annually. In addition, Orange County, California, (one of 58 counties in the State of California) estimates that bringing PFAS levels in the county down to the state’s 10 ppt (2,500 times higher than the health advisory) would cost $1 billion. Based on these estimates, the cost of remediation across the country is expected to be in the tens, if not hundreds, of billions of dollars. The federal government has, however, only made $1 billion available for states to remediate PFAS from their water systems. While additional funds will likely be available from state governments, those are not expected to cover the enormous costs associated with bringing all water systems into compliance, which could result in public water systems going offline, with the resulting loss of public drinking water. In response, a number of states, counties, cities and other providers of drinking water have brought suit against the manufacturers of PFAS chemicals and in some cases against manufacturers of a small number of products that contained PFAS in order to recover the costs associated with drinking water remediation and/or mitigation.

Manufacturers of products that currently contain or previously contained PFAS would be wise to stay in tune with the actions of the EPA as it proposes MCLs for various PFAS chemicals. As more and more public water suppliers and owners of private wells are faced with the exorbitant costs of remediating drinking water that will surely arise once the EPA sets its MCLs (and states follow suit), many will be forced to bring suit to recover those costs. Many of those litigants are likely to cast a wide net in search of entities, including those companies that included PFAS in its products, to help pay for that remediation.