Admittedly, we sometimes feel like a broken record playing the same song over and over. But doesn’t everyone have that favorite album that they can put on a loop and never get tired of?  (Prince’s Purple Rain; The Beatles 1967-1970; Elton John’s Two Rooms). For the DDL blog, that album would be preemption because it is just so full of unforgettable hits – Buckman, Riegel, Mensing.  The list goes on and on.

And we can’t help that plaintiffs themselves are stuck on replay.  They seem to be playing their OTC products album a lot recently and their favorite track–benzene.  But to plaintiffs’ ears decisions on alleged benzene contamination in OTC products, like in acne medications and sunscreen, should sound more like dirges than ditties. Birdsong v. Walgreen’s Inc., 2025 WL 1446400 (N.D. Ill. May 20, 2025), beats that familiar refrain, only this time plaintiffs were a proposed class of purchasers of generic extended-release mucous relief medications.

Unlike many of the prior benzene cases, Birdsong is not based on “independent testing” (ha) by Valisure laboratories.  Rather, extended-release medications can be created with an ingredient called carbomer, which is sometimes produced using benzene as a solvent.  As a result, traces of benzene may remain in the carbomer and thus in the medication.  Id. at *1.

While the decision does not come right out and say so, it appears that the use of benzene in the production of carbomer is known and permitted by the FDA.  Id.  So, it really isn’t surprising that Birdsong joins the many proposed OTC class actions dismissed based on express preemption. 

But before we get to that, we’ll acknowledge that the court did not agree with defendant’s standing argument which was based on plaintiffs’ failure to identify which of defendant’s extended-release mucous relief medications they used and defendant’s contention that not all of those medications include a carbomer made with benzene.  However, that is not what plaintiffs alleged. Their complaint alleged that all of defendant’s products in this category used “benzene containing components” and therefore all are contaminated.  Accepting that allegation as true, the court found plaintiffs had stated a plausible claim for which they had standing.  Id.

That turned out to be a hollow victory.  For OTC drugs, the Food, Drug, and Cosmetic Act (“FDCA”) expressly preempts state law requirements that are “different from or in addition, to, or that [are] otherwise not identical with” the federal requirements under the FDCA.  Id. at *2 (quoting 21 U.S.C. § 379r).  Plaintiffs advanced two theories to support their claim that under state law defendant breached its duty to notify consumers about the risk of benzene in its products.

First plaintiffs alleged that defendant failed to include benzene as an ingredient on the label.  The FDCA provides that only “active ingredients” and “inactive ingredients” may be listed on the labeling.  Looking at how the FDA defines those terms, the court concluded that benzene is neither because it is not an “intended” component.  Therefore, any claim that benzene should have been included is different from federal requirements and preempted.  Id. 

Second, plaintiffs alleged that defendant “made affirmative misrepresentations about product safety” in its marketing.  But plaintiffs’ alleged affirmative misrepresentations were solely based on defendant’s failure to disclose the presence of benzene:

Plaintiffs and consumers do not know, and did not have a reason to know, that [the mucus medication products they] purchased were contaminated with Benzene.

Id. Thus, plaintiffs’ “affirmative” claims were “not factually different” from their non-disclosure claims.  Making them preempted as well.    Id. at *3.

Cue up the preemption/benzene soundtrack—it’s not new but it’s music to our ears.