It might seem that we talk about preemption incessantly on this blog, but a pretty good opinion from a pretty important jurisdiction went unremarked by us last September. We’ll rectify that right now. Call it an end of year clean up session.
The decision in Howard v. Alchemee, LLC, 2024 U.S. Dist. LEXIS 169359 (C.D. Cal. Sept. 20, 20240, actually addresses three California no-injury class actions alleging that certain over the counter (OTC) acne medicines were contaminated with carcinogenic benzene. The plaintiffs claimed that the manufacturers failed to warn that the active ingredient (BPO) in their acne products degrades into benzene under normal use, handling, and storage conditions. The plaintiffs did not allege any specific adverse events from benzene. They simply wanted their money back.
By the way, guess who says they found the benzene in the products? It was that good, old “independent” lab, Valisure — which proceeded to file a citizen’s petition with the FDA seeking action against BPO products. Sound familiar?
The defendants filed a motion to dismiss, based on lack of standing and on preemption. The former argument got rid of the request for an injunction, but not the request for money.
The latter argument was more successful. The court dismissed the actions with prejudice because they were expressly preempted by federal law. The “broad” OTC preemption clause precludes any claims that would have state law establish any requirement “that is different from or in addition to, or that is otherwise not identical with, a requirement under” the Food, Drug, and Cosmetics Act (FDCA). OTC acne drugs are governed by a Food and Drug Administration (FDA) monograph. The monograph expressly permits BPO in specified amounts. Compliance with the monograph means the product is “generally recognized as safe” (GRAS) and not misbranded. Thus, the plaintiffs’ claims are “fundamentally at odds” with the monograph for these products.
Further, the plaintiffs in these actions did not allege anything about the particular products they used. They cited no testing of their products. (This seems to be a theme in cases involving Valisure.) Essentially, the plaintiffs suggested that all BPO products contain benzene. The court interpreted the plaintiffs’ position as not “genuinely seeking a warning that the product unsafe – which would be stark enough – but rather are pursuing a ban on selling what they believe is an ‘adulterated,’ illegal product.” The plaintiffs’ claims were an attack on the FDA’s GRAS findings and constituted an attempt to make state law ban the defendants’ products.
The plaintiffs attempted to disclaim any beef with the FDA by suggesting that the FDA was ignorant of BPO’s dangers. But the plaintiffs’ complaint was replete with allegations “that the scientific community has known of BPO’s degradation into benzene for almost 90 years.” Sometimes plaintiff story-telling comes back to hurt them. The Howard court also cites Ninth Circuit authority noting the “scientific expertise of the FDA.”
In addition, there was a fatal flaw in the plaintiffs’ demand that benzene be disclosed on the product labels. Benzene does not fit the definition of an active or inactive ingredient. It is not a “purposefully added component of the drug.” Put simply, breakdown products are not disclosable under the FDCA.
The plaintiffs attempted to borrow the parallel claim exception from medical device law, even though such borrowing is generally questionable and the plaintiffs could not specifically find a parallel to a FDA requirement. First, there was no true parallel to the FDCA’s general misbranding provision because the monograph deals with ingredients specifically, and the plaintiffs did not claim any violation of the monograph. In any event, omitting a warning not required by the FDA cannot equal misbranding. Without a specific, affirmative violation of misbranding provisions, the misbranding notion as a generality cannot support a parallel claim. Second, the plaintiffs’ claim cannot add up to a parallel violation of “adulteration.” State laws prohibiting misleading advertisements on which the plaintiffs relied on these cases are not parallel or identical to the FDCA’s prohibition against selling adulterated drugs.
In sum, the plaintiffs endeavored to force the acne medicine manufacturers to make disclosures that would conflict with the FDA’s determination that BPO was safe and effective. Because the plaintiffs’ claims “would impose requirements that differ from and are in addition to those on the FDCA, they are preempted.”