Attorneys for a number of health care product makers continue to raise questions about the science behind the filing of multiple federal lawsuits in California accusing pharmaceutical companies and others of marketing or selling acne medications that can degrade into benzene, a carcinogen.
Plaintiff attorneys, including Los Angeles-based Wisner Baum LLP, have filed lawsuits challenging the safety of benzoyl peroxide (BPO) acne treatments against defendants Walgreens, Kenvue and Johnson & Johnson. Among them is a lawsuit filed in March by Wisner Baum against Walgreens Boots Alliance Inc. in Sacramento federal court, alleging the Walgreens BPO products were found to contain benzene levels as high as 1,600 parts per million, which would be well above the Food and Drug Administration limit of 2 parts per million.
The testing of the products occurred after the medication was “incubated to temperatures common during consumer use, handling and storage,” according to the complaint. The details about the testing, however, have been questioned by experts.
In the recently published 2024-2025 Judicial Hellholes report, the authors point out that the BPO products were heated to temperatures of 98.6 degrees Fahrenheit, 122 degrees F and 158 degrees – temperatures the report argued were well above the conditions in a typical consumer’s storage space.
The testing was carried out by a private lab based in Connecticut, Valisure LLC, which also filed a petition with the FDA asking it to recall the products due to health risks from potential benzene content. The lab’s petition argues that the temperatures used during the testing of the products – which have shelf lives of three years – were not excessive.
“Petitioner notes that 70°C (158°F) is not only a reasonable temperature that ‘the product may be exposed to during distribution and handling by consumers’ and that it is within the reported temperature range of a hot car where many consumers may store or transport an acne treatment product, but it is also calculated to be the three-year accelerated stability equivalent of 43 days,” the petition states.
Valisure argued that the product should have shown stability for at least 43 days at the temperature of 158 degrees, but that was not the case.
Attorneys have attempted to poke holes in the Valisure research. Abbie Eliasberg Fuchs and Dan Strecker of the New York-based Harris Beach law firm, point out that some of the lab’s assertions in its petition, including the conclusion that benzene was detected in 94 of 99 products at room temperature, were not repeated in the lab’s subsequent peer-reviewed article.
“Assertions that could not pass peer review warrant skepticism,” the attorneys said in an email to the Southern California Record. “Valisure espouses theories about benzene risk that are championed by experts with deep connections to the plaintiff benzene litigation bar, and Valisure cites those experts for support.”
Attorneys Fuchs and Strecker also indicated that an opinion article and peer-reviewed study in the Journal of Academic Dermatology that were published after Valisure’s report demonstrate that the benzene content in the BPO products – if it exists at all – is not significant from a health and safety perspective. Clinicians should continue to prescribe these products, according to the article.
Those defending against such BPO lawsuits could allege the plaintiffs cannot demonstrate that the products they purchased actually contained an unsafe level of benzene, the attorneys said, adding that courts have accepted such arguments in other consumer products litigation.
“Parties should also be aware that just because benzene may cause a certain cancer at very high doses, it does not mean that benzene at lower doses can cause cancer,” attorneys Fuchs and Strecker said. “And simply because an illness follows exposure does not mean the exposure caused the illness.”
In the Eastern District of California lawsuit, the plaintiffs are asking the court for class-action status, a determination that the defendant violated state consumer protection laws, an injunction to stop the defendant from selling the products, disgorgement of profits, compensatory and punitive damages, and reimbursement of attorney fees and legal costs.