Defending Benzoyl Peroxide Acne Product/Benzene Litigation

This year, a laboratory issued a report in which it claims to have tested over-the-counter and prescription acne products containing benzoyl peroxide and found what it deemed to be “unacceptably high” levels of benzene. In certain doses and circumstances, benzene can be carcinogenic. Shortly thereafter, dozens of class action lawsuits, alleging consumer-protection, misrepresentation, and similar theories were filed in federal courts in multiple states against manufacturers and suppliers of these products. More such claims can be expected, as well as personal injury lawsuits alleging these products caused cancer. In defending these personal injury lawsuits, defendants should understand the flaws in the laboratory’s findings and assumptions, appreciate the body of scientific literature that undermines causation theories, and employ the legal defenses available to them.

Benzene Litigation Claims

The laboratory, Valisure, claims to have discovered that out of 99 benzoyl peroxide acne products tested (83 over the counter), 94 contained benzene at room temperature, “many” above the 2 parts per million (“ppm”) concentration limit set by the FDA. Additionally, Valisure performed “incubation testing” on a subset of the products. After heating to 37 degrees Celsius (98.6 degrees Fahrenheit), over time the benzene levels generally increased above the 2 ppm limit, with some exceeding 40 ppm after 28 days. Valisure attributed the increase to breakdown of the benzoyl peroxide into its molecular components, including benzene. After heating to 50 degrees Celsius (122 degrees Fahrenheit), benzene levels increased much higher, with levels in some products exceeding 800 ppm after 21 days. Valisure heated some of the more “stable” products (those that showed less or no increase at lower temperatures) to 70 degrees Celsius (158 degrees Fahrenheit, the “temperature of a hot car”). These products also showed increased benzene concentrations, with some exceeding 2 ppm and two exceeding 8 ppm after 18 days. Valisure estimated that in a hot car, resulting airborne benzene levels (distinguishable from the liquid concentrations already discussed) could be 400 parts per billion (“ppb”) (0.4 ppm).

Potential Personal Injury Litigation

Valisure promptly filed a citizen petition asking the FDA to investigate and recall these benzoyl peroxide acne products. The class-action litigation, all citing Valisure’s findings, followed. In a victory for the defense, the Judicial Panel on Multidistrict Litigation recently denied plaintiffs’ request to establish an MDL consolidating the class-actions, which are currently pending in federal district court in California, New York, Illinois, and elsewhere.

Valisure has resorted to similar tactics in the past after purporting to find benzene in antiperspirants, aerosol dry shampoo, antifungal products and sunscreen. These actions gave rise to personal injury litigation. For example, a plaintiff claimed in Georgia federal court that benzene in sunscreen tested by Valisure caused her to develop acute lymphoblastic leukemia (“ALL”). See Cascio v. Johnson & Johnson, et al., 2024 WL 693489 (ND Ga. Feb. 20, 2024). In August 2024, it was announced that a North Carolina District Court personal injury lawsuit, in which a father alleged his 14-year old son died from acute myeloid leukemia (“AML”) caused by benzene in defendant’s sunscreen, would be settled. Personal injury claims arising from Valisure’s report on benzoyl peroxide acne products can be expected.

Defenses of Benzene Litigation

It takes more than the mere presence of benzene to establish causation. It must also be established that (1) the type of cancer in question can actually be caused by benzene (general causation) and (2) the benzene exposures in question were sufficient to, and did cause, that cancer (specific causation). For example, the literature supporting the theory that benzene is capable of causing ALL, the alleged disease in Cascio, is vastly different than that supporting benzene’s ability to cause AML, the alleged disease in the North Carolina follows. Valisure’s statements espouse scientifically flawed theories advocated by the plaintiff bar and their experts (and cite at least one well-traveled plaintiff expert), claiming there is “no safe dose,” and “any” benzene exposure increases the risk of cancer. But there is overwhelming scientific evidence to the contrary. That evidence indicates that these levels, trace in the original products and undoubtedly still trace even after exposure to abnormal temperatures for extended periods of time, do not pose a human health risk.

Indeed, peer-reviewed literature has already cast doubt on the notion that the type of benzene exposure that might result from these products is significant from a health and safety perspective. In a research letter published in the peer-reviewed Journal of Academic Dermatology, the authors observed that in general, transdermal benzene absorption is thought to be minimal. The authors analyzed blood-benzene levels in persons reporting use of these products and compared them to blood-benzene levels in persons who did not use these products. The authors found no difference in blood-benzene levels.

Other assertions that might be made by plaintiffs can be challenged. For example, Valisure estimates that in a hot car (158 degrees Fahrenheit) containing benzoyl peroxide acne products, benzene levels could reach 400 ppb (0.4 ppm), then compares that to the EPA estimates that lifetime exposure of 0.4 ppb for a lifetime “can lead” to one additional cancer case in 100,000 people. Valisure states that therefore, these products could cause “1,000 times this US EPA limit.” Among other ready criticisms, Valisure’s assertion obscures the fact that virtually no person would ever experience these conditions — proximity to benzoyl peroxide acne products at an extraordinarily high, presumably fatal air temperature for 18 days — let alone for a lifetime.

Also of note, Valisure published some of its findings in a peer-reviewed journal. But not all of Valisure’s claims appear in the peer-vetted study — for example, the claims about and detail relating to the allegedly elevated benzene content at room temperature. Likewise, Valisure cites the plaintiff expert in its citizen petition, not the peer-reviewed study. An opinion piece published in the same dermatology journal criticized Valisure, citing published concerns about Valisure’s methodology and the opacity of Valisure’s data, and called on Valisure to release additional data to allow its claims to be adequately evaluated. The piece does not recommend clinicians stop prescribing these products.

Moreover, the Valisure findings may not be representative of the product generally, or the product at points in time prior to, or after, the Valisure study, when a given plaintiff may claim to have allegedly used it. In other words, merely finding “elevated” benzene levels in one container of a product does not indicate that other containers of that product have or had similar amounts of benzene.

The court in Cascio, the sunscreen case, used this reasoning in its opinion granting the defendant’s motion to dismiss. The court held plaintiffs failed to plausibly allege causation because they did not show the batches of sunscreen they claimed to have used actually contained benzene. The court reasoned that the mere presence of benzene in one batch of defendant’s sunscreen products did not extend to the batches plaintiffs allegedly used. The court also held that the existence of a recall does not establish a defect. Defendants in current and future lawsuits can leverage similar arguments.

Conclusion

Careful, critical reading of the laboratory’s reports, understanding the scientific literature, and familiarity with causation defenses will be valuable tools in defending any personal injury litigation that may arise from the report on benzene content of benzoyl peroxide acne products. Scientifically, general and/or specific causation may be readily disputable. Understanding the flawed assumptions made by the laboratory — and litigants relying on the laboratory — will be critical. And challenging causation theories as early as the pleading stage could lead to dismissals.