Regulatory developments—and considerable media attention—concerning exposure to chemicals and other harmful environmental substances, some from consumer goods, continue to generate waves of litigation: consumer class actions alleging improper labeling, personal injury claims regarding cancer and other diseases, and more.
Many times, these cases are spearheaded by plaintiffs’ lawyers alleging previously unrecognized hazards, as with ethylene oxide (EO) and polyfluoroalkyl substances (PFAS). In other instances, the cases involve substances that have been recognized as hazardous, but the litigation focuses on a new class of defendants. Informed product manufacturers should take heed of the evolving litigation around potential exposure to these chemicals and substances, old and new, that allegedly present immediate or long-term health problems.
Ethylene Oxide
EO is a versatile compound used to make ethylene glycol and many consumer products, including household cleaners and personal care items. It’s also used to sterilize medical equipment and other plastics sensitive to heat or steam.
In 1990, Congress amended the Clean Air Act to regulate EO as a “hazardous air pollutant.” More recently, the U.S. Environmental Protection Agency (EPA) produced its 2016 Integrated Risk Information System (IRIS) Assessment, in which it determined EO is 60 times more toxic than previous estimates and “carcinogenic to humans.” On August 22, 2018, the EPA released its 2014 National Air Toxics Assessment as a screening tool to help state and local air-quality agencies identify emission sources for further study, incorporating the IRIS Assessment’s risk values. It classified EO as a “regional cancer risk driver,” designating a number of census tracts as posing potential increased cancer risk due to EO emissions.
EO lawsuits frequently target commercial sterilizers that use EO to treat medical devices when steam cannot be used, as well as industrial manufacturers that use EO in their operations. On September 19, 2022, a Cook County, Illinois, jury awarded $363 million to a plaintiff who alleged that she contracted breast cancer because of EO emissions from a Sterigenics facility in Willowbrook, Illinois. (Sterigenics is a globally active industrial sterilization company.) Less than two months later, though, a different Cook County jury returned a defense verdict against a plaintiff who alleged that Sterigenics’ EO emissions from the same facility caused her acute T-cell lymphoblastic leukemia.
Following those verdicts, defendants reached a tentative $408 million settlement to resolve hundreds of other pending claims, but that provides no certainty about where such litigation is headed. While toxic torts related to EO continue, and scientific debate persists, these verdicts demonstrate the potential risk to companies that use EO, even in relatively small amounts.
Polyfluoroalkyl Substances
PFAS are a class of fluorinated chemicals used in a variety of consumer products. Some refer to them as “forever chemicals” due to their high resistance to degradation over time. Recent regulations and media coverage have led to a significant increase in attention from the plaintiffs’ bar. Such scrutiny is being bolstered by findings of alleged ubiquitous exposure to PFAS from the use of products made or packaged with them, as well as the new proposed EPA National Primary Drinking Water Regulations, which would set a “maximum contaminant level” that water utilities may not exceed.
Claims due to alleged exposure from consumer goods are on the rise and likely to increase."
Plaintiffs’ lawyers will in all likelihood have further incentive to pursue such claims after the June 2023 settlement of up to $12.5 billion by 3M with water-provider claimants. Along with these cases, PFAS litigation often concerns allegations of failure to warn and consumer class action, as well as medical monitoring claims. Attorneys will likely continue to assert that cancer diagnoses are linked to PFAS, and lawsuit filings on behalf of consumers alleging low-dose exposure may accelerate.
Other Chemicals and Substances
Benzene is a colorless liquid used in the manufacture of plastics, resins, rubber lubricants, drugs and pesticides; it was classified as a carcinogen by the EPA in 1986. Recent studies by a private laboratory relating to products including samples of sunscreen and dry shampoo have shown benzene levels in excess of current guidelines.
Although the reliability of these kinds of studies is subject to challenge, litigation related to product labeling and even personal injury claims due to alleged benzene exposure from consumer goods are on the rise and likely to increase in their wake.
In addition, a recent investigative report concerning lead in telecom cables could also prompt both medical monitoring litigation and personal injury claims. Plaintiffs’ lawyers may look to sue on behalf of employees working with lead-sheathed cables and communities in which such cables are present.
Litigation related to industrial incidents, particularly fires, has also increased significantly of late. These incidents have sparked various personal injury, medical monitoring and property damage claims, including class actions, even in situations where there has been no indication of a release or exposure exceeding regulatory levels.
Insurance Coverage Considerations for Emerging Litigation
As all this new litigation emerges, so do disputes regarding insurers’ coverage obligations to defend and indemnify policyholders from these potential liabilities. Companies targeted by these new claims should focus first on the following three things:
- Identify all potentially responsive policies that may respond to toxic tort liabilities, including general liability insurance policies and pollution legal liability insurance. For liabilities that may date back decades, policyholders should also consider whether any policies from predecessor sites or operating entities may be implicated. Insurance archaeologists, along with outside counsel, can assist with efforts to research, locate and potentially reconstruct historical insurance policies.
- Policyholders, guided by counsel, should consider the application of any potential policy exclusions that insurers may raise in an effort to limit or preclude coverage. Insurers faced with significant coverage obligations typically raise myriad coverage defenses, often without regard to their ultimate merit.
- Finally, to maximize access to potential coverage, policyholders should act promptly to provide notice under all potentially responsive policies once faced with a new claim. They should also consult with experienced coverage counsel to help identify and analyze potentially responsive policies.
Looking Ahead
All manufacturers should be mindful of the evolving regulatory and litigation landscape as it relates to the chemicals and substances they use in their operations. The use of chemicals or substances not previously thought to present hazards may actually present significant litigation risks in the future as regulations and health standards become stricter and seek to push acceptable levels near zero. As a result, any company using such substances should consult with outside counsel to ensure its prepared to meet its regulatory obligations and defend against any litigation that arises.
David A. Fusco is a litigation partner in K&L Gates’ Pittsburgh office and a Practice Group Coordinator for the Mass Tort & Product Liability practice group. He maintains an active trial practice concentrating in the areas of class actions, complex commercial litigation, mass tort and product liability, with an emphasis on defending manufacturers in claims related to alleged toxic substances.
Tara Pehush is a litigation partner in the firm’s New York office and a Practice Group Coordinator for the Mass Tort & Product Liability practice group. With a focus on the commercial and industrial manufacturing industries, she splits her practice between litigating and arbitrating toxic tort, products liability and commercial disputes and providing clients with strategic counseling in a variety of areas, including risk management and litigation needs, to help them achieve their current and long-term business objectives.
Vincenzo Chimera is counsel in the firm's Chicago office and a member of the Mass Tort & Product Liability and Commercial Disputes practice groups. He concentrates his practice on toxic tort matters, including defense of occupational disease cases and asbestos litigation.
Laura Veith is an associate in the firm’s Pittsburgh office and a member of the Commercial Disputes and Insurance Recovery & Counseling practice groups. She concentrates her practice in the area of commercial litigation, with a particular focus in insurance coverage and complex commercial litigation and is experienced in many stages of litigation in state and federal courts across the country.
