Today we address two more cooked-up—literally—Valisure cases, Bodunde v. Walgreens Boots Alliance, Inc., No. 1:24-CV-00985-JLT-SAB, 2025 WL 1411306 (E.D. Cal. May 15, 2025), and Navarro v. Walgreens Boots Alliance, Inc., No. 1:24-CV-00290-JLT-SAB, 2025 WL 1411406 (E.D. Cal. May 15, 2025).

These two cases involve legally identical magistrate recommendations that Defendant’s motions to dismiss be granted.  The cases are part of a putative consumer fraud class action regarding the sale of Walgreens’s over-the-counter benzol peroxide (“BPO”) acne treatment drug products. The complaint incorporated allegations in an FDA citizen petition filed by Valisure, an entity well known to readers of the Blog by now (see here, here, and here, to name a few), stating that it had tested the BPO products and found high levels of benzene when stored at above-ambient temperatures.  Valisure reached this result by “incubating” the products at 122 degrees Fahrenheit for 18 days.  Earlier this year, we discussed the FDA’s response to that petition.  In short, the FDA was not impressed.  FDA tested 95 BPO-containing acne products, and more than 90% of tested products had undetectable or extremely low levels of benzene; FDA initiated a limited number of voluntary recalls for the small number of products with elevated benzene levels, and even in those, only specific lot numbers.  Undeterred, Plaintiffs here brought claims under various consumer fraud and deceptive trade practices statutes, unjust enrichment, and breach of implied warranty of merchantability.  Walgreens moved to dismiss for lack of standing and failure to state a claim.

Standing

Walgreens asserted that Plaintiffs lacked Article III standing because they did not allege that the BPO products they purchased actually contained benzene; therefore, there was no injury-in-fact.  

The court held this argument was disposed of by the Ninth Circuit’s recent decision in Bowen v. Energizer Holdings, Inc., 118 F.4th 1134 (9th Cir. 2024).  In Bowen—a case involving allegations of benzene in sunscreen—the court held that under a theory of economic harm, a plaintiff must only prove that he or she “paid more for the product than she otherwise would have paid or bought it when she otherwise would not have done so” absent the alleged false representation or non-disclosure.  Id. at 1147 (cleaned up).  The court concluded that standard was met by the plaintiffs’ allegations.  Bodunde, 2025 WL 1411306 at * 9; Navarro, 2025 WL 1411406 at *8.

Preemption

Walgreens also argued that the claims were expressly and impliedly preempted by the FDCA.

With respect to OTC drugs like the BPO products, the FDCA has a broad express preemption prohibiting any state requirement “(1) that relates to the regulation of a [nonprescription drug]; and (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under” the FDCA. 21 U.S.C. § 379r(a). OTC acne products are governed by a comprehensive set of FDA regulations called a monograph that contains specific requirements for labeling and expressly permits BPO in these products in an amount from 2.5-10%. Under the regulations, if a product complies with the monograph it “is generally recognized as safe and effective and is not misbranded.” Id. at § 333.301.

However, the express preemption provision does not bar state law claims that impose identical or “parallel” requirements to FDA regulations. Bodunde, 2025 WL 1411306 at * 11; Navarro, 2025 WL 1411406 at *10 (citing Riegel v. Medtronic, 552 U.S. 312, 330 (2008)).  The claim here was that the BPO products were misbranded by omission: they did not disclose or warn that the products contain or might contain benzene.  The court correctly concluded that “federal labeling regulations do not require such a statement, so Plaintiffs’ claims, insofar as they grounded on this basis, are expressly preempted.”  Bodunde, 2025 WL 1411306 at *12; Navarro, 2025 WL 1411406 at *11.  The acne monograph specifically lists BPO as a permissible active ingredient and does not require manufacturers to include any warning about benzene.  Any added warning about benzene would be an “additional” requirement of state law and is expressly preempted.  Id.

The court also rejected the claim that benzene should have been listed as an inactive ingredient.  Inactive ingredients are “any component other than an active ingredient.” 21 C.F.R. § 201.66(b)(8).  Benzene would not qualify as a component because it was not “intended for use in the manufacture of a drug product.” 21 C.F.R. § 210.3(b)(3).  “[B]ecause Walgreens did not intend for benzene to end up in its BPO products, claims based on this theory are preempted.”  Bodunde, 2025 WL 1411306 at *12; Navarro, 2025 WL 1411406, *12.

The court then considered a parallel claim based on violation of  “Current Good Manufacturing Practice” regulations, which concern manufacturing processes and operations.  This is where the court went awry.  Without much discussion, the court found that “to the extent Plaintiffs’ state law claims are parallel claims brought for violations of CGMPs, those claims are not categorically preempted.”  Bodunde, 2025 WL 1411306 at *14; Navarro, 2025 WL 1411406 at *14.  These allegations were based on the vaguest cCGMPs possible (having “written procedures” for “process controls”).  In part, the court relied on the Ninth Circuit’s Davidson decision, which we lamented here, which allows FDCA enforcement laundered through state laws.  In this case, those state laws were state consumer or “little FDCA” statutes, even though it’s not clear here what actionable facts could support such a claim.

In Bodunde, Walgreens also argued that Plaintiffs’ claim was barred by the Illinois consumer fraud statute’s “safe harbor” provision.  The court declined to apply this exception, holding that the fact that federal law allows for the omission of benzene warnings does not make it “specifically authorized.”  Bodunde, 2025 WL 1411306 at *14.

Fraud

Walgreens also attacked Plaintiffs’ fraud claim as not alleging the “when,” “where,” and “how” as required by Rule 9(b).  Although the court found that the “when” and “where” were there, it agreed with Walgreens that the complaints lacked allegations of the “how.”  “While Plaintiffs have listed at least 22 CGMPs that Walgreens purportedly violated, the Court finds that Plaintiffs have not alleged facts that either establish that Walgreens allegedly violated the subject CGMPs, or even if Walgreens did violate the CGMPs, how those violations ultimately deceived Plaintiffs.”  Bodunde, 2025 WL 1411306 at *15; Navarro, 2025 WL 1411406 at *15.  Plaintiffs improperly used a circular reasoning that just because benzene was found in product in the United States, there must necessarily have been a CGMP violation by Walgreens.  This type of “res ipsa loquitor” theory is not sufficient.

Primary jurisdiction and injunctive relief

Finally, the court addressed primary jurisdiction and injunctive relief.  It rejected the argument that the court should stay or dismiss the action based on the FDA’s primary jurisdiction, and it held that the argument that equitable relief is not available where there is an adequate remedy of law was premature given the failure to state a claim.

The court granted the motions to dismiss but with leave to amend in the entirety.  Right result, some wrong reasoning, which we hope the magistrate or the district judge will fix on the next round.