Health Law Daily Wrap Up, ADVERTISING (FOOD, DRUG & MEDICAL DEVICES)—N.D. Ill.: Alleged unfair practice claim from presence of benzene in Differin acne products survives dismissal, (Sep 20, 2024)

By Seth Abrams, J.D., M.A.

The consumer, however, was only permitted to proceed on a theory that the failure to comply with the FDA’s current Good Manufacturing Practices was an unfair practice under ICFA.

The federal district court in Chicago denied defendant Galderma Laboratories, L.P.’s motion to dismiss a putative class action by plaintiff Skylar Williams. While the court found that several theories were preempted by federal law, the consumer’s claim under the Illinois Consumer Fraud and Deceptive Trade Practices Act (“ICFA”) was permitted under the theory that Galderma does not adhere to the FDA’s current Good Manufacturing Practices. The court also found that the consumer’s claims under consumer protection laws of other states and unjust enrichment also survived dismissal (Williams v. Galderma Laboratories, L.P., No. 1:24-cv-02222 (N.D. Ill. Sept. 17, 2024)).

Background. Galderma manufactures, markets, and sells various OTC acne treatment drugs under its Differin brand. The active ingredient in these products is benzoyl peroxide. The consumer purchased one of the products from a Walgreens in Illinois in 2023. She reviewed the label and saw “no representation that it contained or risked containing benzene.”

In March 2024, Valisure LLC announced that it had tested acne products containing benzoyl peroxide, including the Differin products, and found that they are unstable at high temperatures and the benzoyl peroxide degrades into benzene. According to Valisure, “the specific problem with benzene in benzoyl peroxide products does not appear to be a contamination issue, but instead the inherent instability of the benzoyl peroxide molecule that breaks down and forms benzene.”

The consumer sued Galderma based on Valisure’s findings alleging that the benzoyl peroxide in Galderma’s Differin line degrades into benzene, a carcinogenic impurity, rendering Differin adulterated and misbranded. She alleged that the “latent but inherent presence of benzene” established that Galderma did not comply with the FDA’s current Good Manufacturing Practices (“cGMPs”). According to the consumer, the presence of benzene in these amounts violates the ICFA and other state consumer protection statutes because adulterated products are worthless.

Preemption. Galderma argued that the consumer’s ICFA claim was preempted by federal law. The court agreed, in part. It noted that “whether the consumer’s ICFA claims are preempted turns on whether the consumer alleged Galderma’s conduct is inconsistent with federal law.” The consumer raised three potential areas of Galderma’s inconsistent conduct. First is the contention that “Galderma did not warn consumers of the presence of benzene on Differin’s label.” The court noted that federal labeling regulations do not require disclosure or warning that a product contains benzene. As a result, the consumer’s ICFA claim is preempted on the basis of a warning on the label. This would be an “addition” not required by federal law. Second is the assertion that “Galderma did not list benzene as an inactive ingredient on the label.” Because Galderma did not “intend for benzene to end up in Differin,” this argument failed as well. Benzene was not found to be a component of the product. The ICFA claim could not proceed to the extent that it was based on benzene not being listed as an inactive ingredient on Differin’s label.

The third basis is that the “presence of benzene in Differin is the result of Galderma not following cGMPs.” However, a state-law claim based on this theory is “not preempted because it alleges a violation of federal law; drugs are considered adulterated when not manufactured in accordance with cGMPs.” Galderma argued that the consumer did not “adequately allege [that] Galderma failed to comply with cGMPs or how that failure caused her harm.” The court found that she did because it concluded that she adequately alleged that Galderma did not comply with cGMPs. The ICFA claim was thus not preempted based on Galderma’s alleged failure to comply with cGMPs.

Merits of ICFA Claim. The consumer contended that “Galderma’s failure to adhere to cGMPs in manufacturing Differin is the reason Differin contains benzene.” Galderma argued that dismissal is required because the consumer did not allege “which cGMP regulations Galderma violated, and how that violation led to benzene in Differin.” However, the court noted that “reviewing the complaint as a whole and drawing reasonable inferences” in the consumer’s favor, the court found she had met her pleading burden. The consumer alleged that the scientific community has known for at least 30 years that benzoyl peroxide can decompose into benzene at warm temperatures and that “the presence of certain antioxidants can retard benzene formation.” She asserted that when placed at a “temperature equivalent to the inside of a human body or a storage container for a few weeks,” benzene became present at concentrations well above FDA-approved levels. The court agreed with the consumer that given this known link between benzoyl peroxide and benzene, “Galderma could not have complied with cGMP testing and safety requirements because had they done so, Galderma would have detected benzene.”

Other consumer protection laws. The court found because the ICFA claim survived, the other claims made under consumer protection laws of other states survived dismissal as well. This also pertained to the consumer’s claim for unjust enrichment.

The Case is No. 1:24-cv-02222.

Judge: Jenkins, L.

Attorneys: John Hunter Bryson (Milberg Coleman Bryson Phillips Grossman, PLLC) for Skylar Williams. Anand Agneshwar (Arnold & Porter Kaye Scholer LLP) for Galderma Laboratories, LP.

Companies: Galderma Laboratories, LP

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