The Evolution of Benzene Litigation & Considerations for Product Manufacturers

Benzene may not be a household name, but in the last few years, this chemical compound has garnered public attention for its presence in everyday products and its potential cancer risks. Since discovered over two centuries ago, benzene has been used to manufacture plastics, dyes, adhesives, gasoline, cleaning products, and personal care products. With the U.S. Food and Drug Administration (FDA) phasing the ingredient out of pharmaceutical use in the next two years, benzene–in its multiple forms–will continue to be a topic of public concern, monitoring, and litigation.

This blog post discusses the origin of benzene litigation, how third-party research and subsequent citizens petitions drive modern benzene claims, and steps manufacturers can consider in assessing risk and preparing to defend against potential benzene lawsuits.

What is Benzene?

Benzene (C6H6) is a colorless or light-yellow organic chemical compound that is liquid at room temperature. Formed from both natural processes and industrial production, it is widely used in the United States and ranks in the top 20 chemicals for production volume. Benzene is primarily used as a solvent in the manufacturing and pharmaceutical industries, as both a starting material and an intermediate in the synthesis of other chemical compounds.

In 1986, the U.S. Environmental Protection Agency (EPA) first identified benzene as a human carcinogen—associating the chemical with leukemia, other blood-related cancers, blood disorders, immune disorders, fertility complications, and bone marrow damage. Similarly, the FDA classifies benzene as a Class 1 solvent—a known or strongly suspected human carcinogen—and has done so since 2018. Under FDA regulations, this classification means the use of benzene in the manufacture of drugs should be avoided where possible and is otherwise limited to two parts per million.

However, in the pharmaceutical context, determining whether a drug contains benzene is nuanced. Specifically, when benzene itself is an ingredient, it is easily identified. Still, the FDA identified other potential sources that may (under certain conditions) result in the presence of benzene, such as sodium benzoate, benzoyl peroxide, and other “hydrocarbons.”

The Origin of Benzene Litigation: Occupational Exposure

Litigation regarding benzene exposure began in the 1960s, with suits alleging the development of cancer and blood disorders because of occupational exposure. These plaintiffs, exposed to benzene while working in industrial settings, were largely unsuccessful until after EPA’s carcinogenicity classification in 1986. In the four decades since the EPA designated benzene as a human carcinogen, benzene occupational exposure litigation has become commonplace and has garnered more favorable verdicts for plaintiffs.

The Modern Benzene Litigation: Consumer Products and Now Pharmaceuticals

In the last three years, benzene litigation has evolved—with media coverage, third-party research, and plaintiffs’ counsel advertising driving new varieties of benzene lawsuits outside of occupational exposures. This trajectory is typical. It is common in products liability litigation that the body of science developed in connection with occupational exposures (which are at higher concentrations and longer durations than an ordinary consumer would ever be exposed to) is then misused to support non-occupational exposure litigation. Courts will often consider the epidemiological studies derived from occupational exposures enough to satisfy the threshold requirement to demonstrate general causation in non-occupational exposure cases.

With specific respect to consumer benzene litigation, there has been an additional driver (beyond this usual trajectory): citizens petitions, influenced largely by third-party research conducted by Valisure, a New Haven, Connecticut-based technology company. Specifically, in March 2021 Valisure filed a citizens petition based on its detection of high levels of benzene in several brands of hand sanitizer. In May 2021, Valisure did the same with respect to several brands of sunscreen. Later that year, plaintiffs’ attorneys filed several class actions against hand sanitizer and sunscreen manufacturers, and companies initiated various FDA recalls.

In March 2024, Valisure’s published benzene “research” went beyond benzene and focused on the theory that the drug ingredient benzoyl peroxide decomposes to become benzene under certain conditions. The petition argues that the products are fundamentally unstable and can thermally decompose to benzene. Valisure requested the FDA investigate and pull all benzoyl peroxide products from the market. No recalls of benzoyl peroxide products have been made at this time.

Though the FDA has not issued any recalls, attorneys have filed over a dozen class action lawsuits against personal-care product manufacturers whose products allegedly contain benzene via thermally decomposed benzoyl peroxide. Notably, in August 2024, the Judicial Panel on Multidistrict Litigation denied the request to consolidate these benzoyl peroxide cases into an MDL, noting the number of distinct named defendants and product lines and that each product at issue varied with respect to the quantity of benzoyl peroxide and how the companies package, store, label, and market the products.

Valisure’s influence on FDA action and the resultant litigation likely is not going anywhere. Indeed, the FDA met with Valisure representatives on June 3, 2024, to “hear about Valisure’s business and future plans to share information about appropriate analytical testing approaches for the work that Valisure does.”

Benzene again made headlines recently on Bloomberg, alleging that benzene has been found in generic store-brand Guaifenesin (Mucinex®) products sold by pharmacies. The report suggests that while both the name brand and generic medicines use carbomers to create an extended-release phenomenon, the generic uses a cheaper carbomer made with benzene. On September 4, 2024 (less than one month after the Bloomberg article), a proposed class action lawsuit was filed in federal court concerning generic Guaifenesin.

Manufacturer Considerations

This is likely just the beginning for benzene media coverage, research, and litigation in the consumer product and pharmaceutical arenas. Independent labs and regulatory agencies will have their eyes on benzene, and more products may be identified for potential risks.

There are several important proactive measures that consumer product and pharmaceutical manufacturers can consider against this specific backdrop of the development and evolution of benzene litigation. First, manufacturers should consider proactively conducting litigation risk assessments to determine what products they manufacture or distribute that contain benzene or chemicals that can degrade into benzene. Second, it may be necessary to examine the manufacturing processes of any suppliers to ensure there are no vulnerabilities in the supply chain related to benzene and the quality of the ingredients used. Third, manufacturers should review their product labeling and consider whether warnings for storage of their products that may degrade into benzene are adequate. Utilizing outside counsel for these assessments can be valuable for several reasons, ranging from outside counsel’s particularized knowledge and understanding of the plaintiffs’ bar strategies and to ensure that attorney-client privilege and work-product doctrines adequately protect actions taken in anticipation of litigation.

Another consideration to forestall class actions against FDA-regulated products more generally would be to closely review consumer-facing marketing for exposures, including potential misrepresentations and unintended warranties. Tracking FDA-approved language in marketing can also help strengthen the defense that any attack on such marketing is preempted.

Now, more than ever, it is important for manufacturers to conduct detailed risk-mitigation and best-practices assessments, comply with regulatory expectations in light of established and emerging regulations, and remain vigilant about potential Benzene-related claims and litigation.

Authored by Lori G. Cohen (Vice Chair), Sydney Fairchild Williamson (Shareholder), and Julia Martin (Associate) of Greenberg Traurig, LLP’s Pharmaceutical, Medical Device & Health Care Litigation Group in Atlanta, Georgia.

Greenberg Traurig, LLP’s Pharmaceutical, Medical Device & Health Care Litigation Practice is a premier life sciences litigation team, involved in pharmaceutical and medical device industries’ top mass torts and class actions. As national, regional, trial, and settlement counsel for industry leaders, GT’s team routinely tries cases involving cutting-edge medical and scientific issues. Distinguished by its depth of experience and thorough understanding of the industry, this nationwide team of 130+ litigators deliver top-of-class client service. More recently, GT has assembled a cross-functional litigation team that meets the unique needs of environmental toxic tort cases that implicate the life science industry such as medical device sterilization with ethylene oxide. www.gtlaw.com