Williams v. Galderma Labs.

• Court: U.S. District Court — Northern District of Illinois
• Writing for the Court: Lindsay C. Jenkins, United States District Judge
• Docket Number: 24 CV 2222
• Decision Date: 17 September 2024
• Citation: Williams v. Galderma Labs., 24 CV 2222 (N.D. Ill. Sep 17, 2024)
• Parties: Skylar Williams, individually and on behalf of all others similarly situated Plaintiff, v. Galderma Laboratories, L.P., Defendant.
• topic: Commercial Litigation,Administrative Law,Health Law

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Skylar Williams, individually and on behalf of all others similarly situated Plaintiff, v. Galderma Laboratories, L.P., Defendant.

No. 24 CV 2222

United States District Court, N.D. Illinois, Eastern Division

September 17, 2024

MEMORANDUM OPINION AND ORDER

Lindsay C. Jenkins, United States District Judge

Skylar Williams has sued Galderma Laboratories, L.P., alleging that the benzoyl peroxide in Galderma's Differin line of acne treatments degrades into benzene, a carcinogenic impurity rendering Differin adulterated and misbranded. And because adulterated products are worthless, Galderma's sale of Differin to unaware consumers violates various state consumer protection statutes, including the Illinois Consumer Fraud and Deceptive Trade Practices Act (“ICFA”). Before the Court is Galderma's motion to dismiss, which primarily argues Williams's claims are preempted because Galderma complies with federal law in the manufacturing and labeling of Differin. For the following reasons, the motion is denied. Williams's ICFA claim may proceed on the theory benzene exists in Differin because Galderma does not adhere to current good manufacturing practices.

I. Background

Galderma manufactures, markets, and sells various over-the-counter (“OTC”) acne treatment drugs under its Differin brand. [Dkt. 1 ¶¶ 1, 12, 18-19.] The active ingredient in all Differin products is benzoyl peroxide (“BPO”). [Id.] Skylar Williams purchased Differin 5% BPO cream cleanser from a Walgreens in Illinois at some point in 2023. [Id. ¶ 9.] While shopping, Williams reviewed the product's label and noticed it “contained no representation that [it] contained or risked containing benzene.” [Id. ¶ 10.]

On March 6, 2024, Valisure LLC, an analytical laboratory, announced that its testing revealed BPO in acne treatments is unstable at high temperatures and degrades into benzene, a known carcinogen. [Id. ¶¶ 37-38.] The tests involved exposing acne products with BPO, including the Differin product Williams purchased, to at least 37°C (98 degrees Fahrenheit) for several weeks at a time. Valisure then measured the amount of benzene in the product, and found it was well above the 2 parts per million permitted by the FDA. [Id. ¶¶ 41-42.] According to Valisure, “the benzene in benzoyl peroxide products is coming from the benzoyl peroxide itself” as opposed to “impurities” in “contaminated ingredients.” [Id. ¶ 40.] That is, “the specific problem with benzene in benzoyl peroxide products does not appear to be a contamination issue from a specific ingredient, but instead the inherent instability of the benzoyl peroxide molecule that breaks down and forms benzene.” [Id. ¶ 43.]

Armed with Valisure's findings, Williams sued Galderma. Williams alleges that the latent but inherent presence of benzene in Differin establishes Galderma did not comply with the Food and Drug Administration's (“FDA”) current Good Manufacturing Practices (“cGMPs”), which would make the drugs misbranded and adulterated in violation of the Food, Drug and Cosmetics Act (“FDCA”), 21 U.S.C. § 301 et seq., as well as analogous state statutes and regulations. [Id. ¶¶ 49-60.]

Williams further alleges Differin was misbranded because its label does not mention benzene, either as a warning or as an ingredient. [Id. ¶¶ 61, 71.] Williams contends that she would not have purchased (or at least paid less for) Differin had she known she was purchasing an adulterated or misbranded product. [Id. ¶¶ 65, 68-69.] Williams argues Galderma's conduct constitutes both unfair and deceptive practices under ICFA, violates other state consumer protection statutes for the classes she hopes to represent, and that Galderma was unjustly enriched through the sale of Differin. [Dkt. 1 at 26-31.]^[1]Galderma now moves to dismiss the complaint. [Dkt. 21.]

II. Legal Standard

At the motion to dismiss stage, the Court takes well-pleaded factual allegations as true and draws reasonable inferences in favor of the plaintiff. Choice v. Kohn L. Firm, S.C., 77 F.4th 636, 638 (7th Cir. 2023); Reardon v. Danley, 74 F.4th 825, 82627 (7th Cir. 2023). “To survive a motion to dismiss under Rule 12(b)(6), plaintiff's complaint must allege facts which, when taken as true, plausibly suggest that the plaintiff has a right to relief, raising that possibility above a speculative level.” Cochran v. Ill. State Toll Highway Auth., 828 F.3d 597, 599 (7th Cir. 2016) (cleaned up). This occurs when “the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Garrard v. Rust-Oleum Corp., 575 F.Supp.3d 995, 999 (N.D. Ill. 2021) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (internal citations omitted)).

III. Analysis

Galderma argues Williams's ICFA claim should be dismissed for two reasons. First, it is preempted because Galderma complied with all applicable federal law while manufacturing and labeling Differin. Second, it fails on the merits because Williams has not adequately alleged which cGMPs Galderma did not follow and how that caused Differin to contain benzene. And because her ICFA claim fails, so too must her other claims. The Court reviews each in turn.

A. Preemption

Galderma contends Williams's ICFA claim is preempted by federal law. Preemption is grounded in the Constitution's Supremacy Clause, and Congress has the authority to define how broadly its enactments preclude state law. Novotney v. Walgreen Co., 683 F.Supp.3d 785, 788-89 (N.D. Ill. 2023) (citing English v. Gen Elec. Co., 496 U.S. 72, 78 (1990)). Preemption is an affirmative defense, which plaintiffs need not anticipate or circumvent in their pleadings. Bausch v. Stryker Corp., 630 F.3d 546, 561 (7th Cir. 2010). However, if “the allegations of the complaint itself set forth everything necessary to satisfy” preemption, then dismissal at the pleading stage is appropriate. Sidney Hillman Health Ctr. of Rochester v. Abbott Lab'ys, Inc., 782 F.3d 922, 928 (7th Cir. 2015).

The FDCA governs the manufacturing, marketing, and labeling of OTC drugs such as Differin. 21 U.S.C. § 301 et seq. The FDCA's preemptive power is strong: states are prohibited from enforcing legislation that would impose requirements on drug manufacturers that are “different from ... in addition to, or ... otherwise not identical with, a requirement under the” FDCA. 21 U.S.C. § 379r(a); see also Harris v. Topco Assocs., LLC, 538 F.Supp.3d 826, 831 (N.D. Ill. 2021) (a plaintiff's right to bring state-law claims in this area “is tightly circumscribed by the FDCA's express preemption of state-law theories that impose requirements ‘not identical' to its own requirements”) (quoting Benson v. Fannie May Confections Brands, Inc., 944 F.3d 639, 645 (7th Cir. 2019)). But preemption only extends to manufacturers that comply with federal law; state-law claims that are premised on a “parallel” violation of federal law may proceed. Medtronic v. Lohr, 518 U.S. 470, 495 (1996) (claims based on state law are permissible where the statute's duties “parallel federal requirements”); Bausch, 630 F.3d 546, at 552; Barnes v. Unilever United States Inc., 2023 WL 2456385, at *5 (N.D. Ill. Mar. 11, 2023).

Put differently, whether Williams's ICFA claims are preempted turns on whether she has alleged Galderma's conduct is inconsistent with federal law. Williams points to three purported failures: (1) Galderma did not warn consumers of the presence of benzene on Differin's label; (2) Galderma did not list benzene as an inactive ingredient on the label; and (3) the presence of benzene in Differin is the result of Galderma not following cGMPs.

1. Benzene on the Label

Williams argues that Differin is misbranded under the FDCA because its label does not disclose or warn that it contains benzene. [Dkt. 26 at 12.] Federal labeling regulations do not require such a statement, however, so her ICFA claim on this basis is preempted.

The FDA is vested with “authority to promulgate regulations for the efficient enforcement” of the FDCA. 21 U.S.C. § 371(a); 21 U.S.C. § 393; see also Novotney, 683 F.Supp.3d at 789. Pursuant to this authority, the FDA allows manufacturers of OTC drugs to sell products without FDA review so long as the manufacturer adheres to the relevant monograph. 21 C.F.R. § 330.10. A monograph is a “recipe”; a “detailed regulation ... for each therapeutic class of OTC drug products” that “sets out the FDA-approved active ingredients for a given therapeutic class of OTC drugs and provides the conditions under which each active ingredient is” generally recognized as safe and effective by the FDA. NRDC v. FDA, 710 F.3d 71, 75 (2d Cir. 2013). That is, for each drug type-such as OTC acne treatments-the FDA delineates approved active ingredients, and accompanying labeling and other requirements to which manufacturers must adhere. This process allows the FDA to provide comprehensive parameters for a certain class of drugs instead of approving each drug individually.

The upshot of these regulations is that a drug that complies with all monograph requirements is not misbranded. 21 C.F.R. § 330.10(a)(1) (“The Commissioner shall ... evaluate the safety and effectiveness of OTC drugs, to review OTC drug labeling, and to advise him on the promulgation of monographs establishing conditions under which OTC drugs are generally recognized as safe and effective and not misbranded”); see also 21 C.F.R. § 333.301(a) (“An over-the-counter acne drug product in a form suitable for topical application is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each general condition established in § 330.1 of this chapter.”)

The relevant monograph for acne drugs lists BPO as a permitted active ingredient...