Right this moment we deal with two extra cooked-up—actually—Valisure circumstances, Bodunde v. Walgreens Boots Alliance, Inc., No. 1:24-CV-00985-JLT-SAB, 2025 WL 1411306 (E.D. Cal. Could 15, 2025), and Navarro v. Walgreens Boots Alliance, Inc., No. 1:24-CV-00290-JLT-SAB, 2025 WL 1411406 (E.D. Cal. Could 15, 2025).
These two circumstances contain legally an identical Justice of the Peace suggestions that Defendant’s motions to dismiss be granted. The circumstances are a part of a putative shopper fraud class motion concerning the sale of Walgreens’s over-the-counter benzol peroxide (“BPO”) zits remedy drug merchandise. The grievance included allegations in an FDA citizen petition filed by Valisure, an entity well-known to readers of the Weblog by now (see right here, right here, and right here, to call just a few), stating that it had examined the BPO merchandise and located excessive ranges of benzene when saved at above-ambient temperatures. Valisure reached this outcome by “incubating” the merchandise at 122 levels Fahrenheit for 18 days.  Earlier this 12 months, we mentioned the FDA’s response to that petition. Briefly, the FDA was not impressed. FDA examined 95 BPO-containing zits merchandise, and greater than 90% of examined merchandise had undetectable or extraordinarily low ranges of benzene; FDA initiated a restricted variety of voluntary recollects for the small variety of merchandise with elevated benzene ranges, and even in these, solely particular lot numbers. Undeterred, Plaintiffs right here introduced claims beneath varied shopper fraud and misleading commerce practices statutes, unjust enrichment, and breach of implied guarantee of merchantability.  Walgreens moved to dismiss for lack of standing and failure to state a declare.
Standing
Walgreens asserted that Plaintiffs lacked Article III standing as a result of they didn’t allege that the BPO merchandise they bought really contained benzene; due to this fact, there was no injury-in-fact. Â
The court docket held this argument was disposed of by the Ninth Circuit’s latest determination in Bowen v. Energizer Holdings, Inc., 118 F.4th 1134 (ninth Cir. 2024).  In Bowen—a case involving allegations of benzene in sunscreen—the court docket held that beneath a idea of financial hurt, a plaintiff should solely show that she or he “paid extra for the product than she in any other case would have paid or purchased it when she in any other case wouldn’t have finished so” absent the alleged false illustration or non-disclosure.  Id. at 1147 (cleaned up).  The court docket concluded that customary was met by the plaintiffs’ allegations.  Bodunde, 2025 WL 1411306 at * 9; Navarro, 2025 WL 1411406 at *8.
Preemption
Walgreens additionally argued that the claims had been expressly and impliedly preempted by the FDCA.
With respect to OTC medication just like the BPO merchandise, the FDCA has a broad specific preemption prohibiting any state requirement “(1) that pertains to the regulation of a [nonprescription drug]; and (2) that’s totally different from or along with, or that’s in any other case not an identical with, a requirement beneath” the FDCA. 21 U.S.C. § 379r(a). OTC zits merchandise are ruled by a complete set of FDA rules known as a monograph that incorporates particular necessities for labeling and expressly permits BPO in these merchandise in an quantity from 2.5-10%. Underneath the rules, if a product complies with the monograph it “is mostly acknowledged as protected and efficient and isn’t misbranded.” Id. at § 333.301.
Nevertheless, the specific preemption provision doesn’t bar state regulation claims that impose an identical or “parallel” necessities to FDA rules. Bodunde, 2025 WL 1411306 at * 11; Navarro, 2025 WL 1411406 at *10 (citing Riegel v. Medtronic, 552 U.S. 312, 330 (2008)). The declare right here was that the BPO merchandise had been misbranded by omission: they didn’t disclose or warn that the merchandise include or may include benzene.  The court docket appropriately concluded that “federal labeling rules don’t require such a press release, so Plaintiffs’ claims, insofar as they grounded on this foundation, are expressly preempted.”  Bodunde, 2025 WL 1411306 at *12; Navarro, 2025 WL 1411406 at *11.  The zits monograph particularly lists BPO as a permissible energetic ingredient and doesn’t require producers to incorporate any warning about benzene.  Any added warning about benzene can be an “extra” requirement of state regulation and is expressly preempted. Id.
The court docket additionally rejected the declare that benzene ought to have been listed as an inactive ingredient.  Inactive components are “any element aside from an energetic ingredient.” 21 C.F.R. § 201.66(b)(8).  Benzene wouldn’t qualify as a element as a result of it was not “supposed to be used within the manufacture of a drug product.” 21 C.F.R. § 210.3(b)(3).  “[B]ecause Walgreens didn’t intend for benzene to finish up in its BPO merchandise, claims based mostly on this idea are preempted.”  Bodunde, 2025 WL 1411306 at *12; Navarro, 2025 WL 1411406, *12.
The court docket then thought-about a parallel declare based mostly on violation of  “Present Good Manufacturing Observe” rules, which concern manufacturing processes and operations.  That is the place the court docket went awry.  With out a lot dialogue, the court docket discovered that “to the extent Plaintiffs’ state regulation claims are parallel claims introduced for violations of CGMPs, these claims should not categorically preempted.”  Bodunde, 2025 WL 1411306 at *14; Navarro, 2025 WL 1411406 at *14.  These allegations had been based mostly on the vaguest cCGMPs potential (having “written procedures” for “course of controls”).  Partially, the court docket relied on the Ninth Circuit’s Davidson determination, which we lamented right here, which permits FDCA enforcement laundered by state legal guidelines. On this case, these state legal guidelines had been state shopper or “little FDCA” statutes, though it’s not clear right here what actionable info may help such a declare.
In Bodunde, Walgreens additionally argued that Plaintiffs’ declare was barred by the Illinois shopper fraud statute’s “protected harbor” provision.  The court docket declined to use this exception, holding that the truth that federal regulation permits for the omission of benzene warnings doesn’t make it “particularly licensed.” Bodunde, 2025 WL 1411306 at *14.
Fraud
Walgreens additionally attacked Plaintiffs’ fraud declare as not alleging the “when,” “the place,” and “how” as required by Rule 9(b).  Though the court docket discovered that the “when” and “the place” had been there, it agreed with Walgreens that the complaints lacked allegations of the “how.”  “Whereas Plaintiffs have listed no less than 22 CGMPs that Walgreens purportedly violated, the Courtroom finds that Plaintiffs haven’t alleged info that both set up that Walgreens allegedly violated the topic CGMPs, or even when Walgreens did violate the CGMPs, how these violations finally deceived Plaintiffs.”  Bodunde, 2025 WL 1411306 at *15; Navarro, 2025 WL 1411406 at *15.  Plaintiffs improperly used a round reasoning that simply because benzene was present in product in the USA, there should essentially have been a CGMP violation by Walgreens.  Any such “res ipsa loquitor” idea just isn’t adequate.
Major jurisdiction and injunctive reduction
Lastly, the court docket addressed main jurisdiction and injunctive reduction.  It rejected the argument that the court docket ought to keep or dismiss the motion based mostly on the FDA’s main jurisdiction, and it held that the argument that equitable reduction just isn’t obtainable the place there may be an sufficient treatment of regulation was untimely given the failure to state a declare.
The court docket granted the motions to dismiss however with go away to amend within the entirety. Â Proper outcome, some fallacious reasoning, which we hope the Justice of the Peace or the district choose will repair on the following spherical.
