With new regulations on the horizon, manufacturers need to be aware of the potential litigation risks related to perfluoroalkyl and polyfluoroalkyl substances (PFAS). As we previously discussed, the U.S. Environmental Protection Agency (EPA) announced last month its new proposed National Primary Drinking Water Regulations for PFAS, which would significantly affect states and public water utilities.¹ It is important to recognize, however, that the scientific developments that led to the proposed regulations are also likely to influence the litigation risks for any company that uses PFAS or sells products containing detectable levels of PFAS. 

PFAS are a class of more than 12,000 fluorinated chemicals that are commonly used in thousands of industrial and consumer products primarily due to their oil and water repellency.² These properties, however, also cause these chemicals to break down slowly over time, to persist in the environment, and to build up in people and animals, which is why they are often called “forever” chemicals.³ PFAS are found in drinking water, soil, food, food packaging, furniture, clothing, cleaning products, sealants, paints, nonstick cookware, shampoo, dental floss, and cosmetics, among many other products.⁴ PFAS are not equivalent in terms of safety concern. 

Although there has been public attention on the health hazards of PFAS contamination for over two decades, recent regulatory and media attention has resulted in heightened concerns.⁵ These concerns are driven, for example, by findings that most people in the United States have been exposed to PFAS via ingestion or inhalation, including potentially from simply “[u]sing products made with PFAS or that are packaged in materials containing PFAS.”⁶ Further fueling health-related concerns and regulatory efforts is the recent determination that PFAS materials may be far more hazardous than originally thought. For example, the EPA concluded that perfluorooctanic acid (PFOA)—historically one of the most common PFAS—is a likely carcinogen.⁷ The National Academy of Sciences also concluded that there is sufficient evidence of an association between PFAS and kidney cancer and acknowledged a possible association with breast cancer.⁸ Similarly, the California Office of Environmental Health Hazard Assessment listed PFAS as a chemical known to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly known as “Proposition 65”).⁹  As a result of the large number of chemicals that are classified as PFAS, generalizations regarding the potential hazards associated with PFAS exposure further complicates the analysis of how to manage health concerns.

Medical monitoring and personal injury claims based on health conditions caused by PFAS exposure have been common for a number of years, but the scope of litigation has expanded recently as the subject of PFAS, generally, receives more and more public attention. For example, even without alleging actual physical injuries, plaintiffs’ attorneys launched numerous consumer class actions against product manufacturers and retailers for allegedly failing to disclose PFAS content in their products. These actions targeted a wide variety of unsuspecting defendants, including fast food retailers and manufacturers of dental floss, feminine hygiene products, cosmetics, and waterproof fabrics, just to name a few.

These cases in particular present unique issues as a result of the lack of an alleged physical injury, including questions of Article III standing and insufficient methods for modeling damages. Some plaintiffs are also using questionable test methods analyzing for total fluorine content and making unsupported assumptions regarding PFAS content and exposure based on such analyses. Historically, where plaintiffs allege having actual injury from toxic substances, the determination that a chemical is carcinogenic has made it much easier for plaintiffs’ attorneys to maintain claims by alleging that there is no safe level of exposure to a carcinogen.  Accordingly, if past is prologue, the determination that certain PFAS chemicals may be associated with certain forms of cancer is likely to lead to personal injury claims by consumer plaintiffs, including cases alleging that low-level exposures from PFAS-containing products contributed in causing their cancers. 

Looking ahead, any company that makes or sells products containing PFAS, as well as utilities and others responsible for removing PFAS from water supplies, should be diligent in monitoring the PFAS content of the products they use and sell. With increased litigation currently and on the horizon, companies using PFAS of any kind should conduct a detailed review of their insurance policies, consult product labeling experts, and monitor regulatory developments.

FOOTNOTES

¹ NAT’L ACADS. OF SCI., ENG’G, & MED., GUIDANCE ON PFAS EXPOSURE, TESTING, AND CLINICAL FOLLOW-UP 1 (2022), https://nap.nationalacademies.org/read/26156/chapter/1.

² PFAS Explained, ENV’T PROT. AGENCY, https://www.epa.gov/pfas/pfas-explained (last updated Apr. 28, 2022); Our Current Understanding of Human Health and Environmental Risks of PFAS, ENV’T PROT. AGENCY, https://www.epa.gov/pfas/our-current-understanding-human-health-and-environmental-risks-pfas (last updated Mar. 16, 2023) [hereinafter Our Current Understanding].

³ Our Current Understanding, supra note 3.

⁴ NAT’L ACADS OF SCI., ENG’G, & MED., supra note 2, at 1.

⁵ Our Current Understanding, supra note 3.

⁶ Historically, PFOA and perfluorooctane sulfonate have been the most common, and most studied PFAS, but they have been phased out in the United States and replaced with other PFAS, including what are often referred to as “GenX Chemicals.” See Drinking Water Health Advisory: Hexafluoropropylene Oxide (HFPO) Dimer Acid (CASRN 13252-13-6) and HFPO Dimer Acid Ammonium Salt (CASRN 62037-80-3), Also Known as “GenX Chemicals”, ENV’T PROT. AGENCY (June 2022), https://www.epa.gov/system/files/documents/2022-06/drinking-water-genx-2022.pdf.

⁷ NAT’L ACADS. OF SCI., ENG’G, & MED., supra note 2, at 1.

⁸ Notice to Interested Parties Chemical Listed Effective February 25, 2022 as Known to the State of California to Cause Cancer: Perfluorooctanoic Acid, CALI. OFFICE OF ENV’T HEALTH HAZARD ASSESSMENT (Feb. 25, 2022), https://oehha.ca.gov/proposition-65/crnr/notice-interested-parties-chemical-listed-effective-february-25-2022-known-state.