The Rapid Dissolution of Sapienza v. Albertson’s Companies, Inc.
Mital Patel & Francisco Cabrera López*
I. Why It Made the List
Sapienza v. Albertson’s Companies, Inc. makes the list of “top food and drug cases” in 2022 because the court shut down yet another improper effort by the plaintiffs’ bar to turn an alleged labeling case related to an FDA-regulated product into a consumer class action. It is illustrative of two trends. The first is the continuing efforts by class action attorneys to test the bounds of state consumer protection statutes as it relates to over-the-counter (OTC) drugs and medical devices. The second is an expansion of efforts by consumers attempting civil action redress relating to alleged labeling of regulated products. Sapienza is nearly a textbook case of why and how regulated products are managed and how and why the labeling of such products is not properly addressed by traditional consumer class actions.
The key issue in Sapienza was the labeling statements regarding the speed of release for a pain medication. According to supposed “independent testing” by the plaintiff, this OTC acetaminophen marketed as “rapid release” allegedly dissolved slower than cheaper non-“rapid release” products. Despite the FDA standards that govern the labeling of such OTC drugs, including dissolution standards, Sapienza, a Massachusetts resident, sought to represent a nationwide class for supposedly being deceived into paying a price premium for the “rapid release” drug. Sapienza’s own “independent testing” confirmed the OTC drug met the FDA’s dissolution standards. To hold the defendants liable would be to impose “requirements” that are “different from or in addition” to those adopted by FDA, and thus the court held the claims were expressly preempted under the Federal Food, Drug, and Cosmetic Act (FDCA). The rest of the complaint consisted of the usual boilerplate economic loss/“premium” pricing claims. Because Sapienza asserted economic loss, rather than personal injury claims, the “product liability” exception to OTC express preemption in 21 U.S.C. § 379r(a) was applicable, and as a result, Sapienza was duly dispatched on a motion to dismiss, rather than lingering until summary judgment like several other similar cases—or escaping preemption altogether as in In re Acetaminophen—ASD-ADHD Products Liability Litigation, 2022 WL 17348351 (S.D.N.Y. Nov. 14, 2022).
Sapienza asserted six consumer fraud-type claims against several defendants that manufactured and distributed acetaminophen, a popular pain reliever sold generically by many retailers. She claimed the defendants, grocery store operators Albertsons Companies, misrepresented the OTC drug as “rapid release” because independent testing demonstrated it dissolved slower than a comparable non-“rapid release” version. According to her, she and a putative nationwide class would not have purchased the drug had they not been deceived by the “rapid release” language.
The supermarket chain moved to dismiss all six of Sapienza’s claims, arguing that the drug met the definition of “immediate release” and “rapidly dissolving” given by FDA and thus the claims were preempted by the National Uniformity for Nonprescription Drugs provision of the FDCA, which states the following:
[N]o State or political subdivision of a State may establish or continue in effect any requirement—
(1) that relates to the regulation of a drug that is not subject to the requirements of section 353(b)(1) or 353(f)(1)(A) of this title [i.e., an over-the-counter drug like the one at issue in Sapienza]; and
(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter . . . .
“Requirements” subject to preemption include successful common law claims, like those asserted by Sapienza.
In its motion to dismiss, the defendants explained the FDA’s thorough regulatory scheme governing the labeling of OTC drugs. Through a 1988 tentative final monograph (TFM) that had the full force and effect as a final monograph, FDA established the “conditions under which a category of [OTC] drugs or specific OTC drugs [including acetaminophen] are generally recognized as safe and effective and not misbranded.” These conditions included the labeling and disclosure requirements for acetaminophen—the drug at issue in Sapienza. The TFM also incorporated dissolution standards for acetaminophen promulgated in the United States Pharmacopeia (USP).
The USP identified acetaminophen tablets as “immediate release” if the tablet dissolves by at least 80% after thirty minutes. Separately, an FDA guidance identified acetaminophen tablets as “rapidly dissolving” if it dissolved more than 85% or more within thirty minutes, and “very rapidly dissolving” if it dissolved more than 85% or more within fifteen minutes.
Thus, fatal to Sapienza’s claims was her own alleged independent testing that confirmed the subject acetaminophen dissolved by 85% in twelve minutes. In other words, the OTC drug she claimed was deceiving complied with standards adopted by FDA and could be called “immediate release,” “rapidly dissolving,” or “very rapidly dissolving” under FDA regulations and guidance. Holding defendants to a different standard would clearly impose standards “different from or in addition to” federal standards, so Sapienza’s claims were expressly preempted.
Sapienza unsuccessfully argued her claims should not be preempted because the USP and FDA guidance relied on by the defendants did not sanction the specific phrase “rapid release.” The court rebuffed the argument, emphasizing that “FDA preemption regulates dissolution standards generally – the subject matter of Sapienza’s state-law claims – even if the words slightly differ.” This “commonsense interpretation” was supported by recent case law, which held similar claims attacking marketing statements as misleading were expressly preempted under comparable preemption provisions because “while the FDA may not have considered the exact language . . . it had clearly addressed the substance of the claims at issue.” The court noted the that other products not so labeled “may dissolve just as (or even more) rapidly is no more relevant as a comparison than is a bag of ice labeled ‘frozen’ as opposed to one simply branded as ‘ice.’”
The court was also not convinced by the inapposite case law Sapienza cited to argue that “rapid release” would need to appear verbatim in FDA and USP regulations for preemption to apply. In Lee, a putative class action asserted consumer fraud claims based on a food manufacturer’s label that stated a product was “100% Natural” when, in fact, it contained genetically modified organisms. The manufacturer argued that the plaintiff’s claims were preempted because FDA had an “informal policy not to restrict the use of the term natural.” The court there disagreed because the informal policy was not the same as defining “natural” and had never become binding. In Sapienza, on the other hand, the TFM that adopted the USP standards that the subject acetaminophen complied with had been formally adopted by congressional fiat.
Lastly, the court described the unworkable consequences of Sapienza’s argument that preemption should only apply if the challenged phrase appeared verbatim in FDA regulations. FDA would have to list every possible permutation of similar words to have preemptive effect, which would undermine the FDCA’s express preemption provision (and thus, Congress’ intent). Permitting Sapienza’s argument would also undermine “the latitude Congress gives agencies to have authority over matters in which they have subject matter expertise – here the FDA’s responsibility to evaluate and regulate drugs.”
This case, and others like it, inform and limit the ways consumer class action lawyers and consumers themselves can seek redress for labeling and other product issues. Where FDA has been involved in the specific qualities of a product or language for labeling, typical class actions will not fly.
Sapienza emphasizes the importance of preemption for FDA-regulated products:
Congress’s adoption of a preemptive scheme . . . ensures that the legal rules governing complex areas of the economy or products are formulated by expert regulators with a broad national perspective and needed scientific or technical expertise, rather than by decision makers—such as municipal officials, elected state judges, and lay juries—who may have a far more parochial perspective and limited set of information.
This preemptive scheme is even more important in the context of potential class actions, where the threat of large nationwide classes can be devastating for business and innovation.
Decisions on the preemptive scope of FDA regulations have been slow to grow in consumer class action false advertising cases, including in food labeling cases, because courts tend to dismiss these cases on other grounds. Sapienza adds to a growing body of case law in which courts have applied the doctrine of preemption when a label claim that complies with federal regulations is nonetheless challenged on grounds that it is misleading to consumers that companies can rely on to shield themselves from threats of class action suits.
* Mital Patel is an associate in the New York office of Foley Hoag LLP, where she focuses her practice on intellectual property matters including false advertising and patent litigation as well as complex commercial litigation. Francisco Cabrera López is an associate in Foley Hoag LLP’s Trademark, Copyright & Unfair Competition Litigation Practice. His practice focuses on trademark, copyright, false advertising, First Amendment, and domain name matters.
 No. CV 22-10968-RGS, 2022 WL 17404919 (D. Mass. Dec. 2, 2022).
 Sapienza, 2022 WL 17404919, at *1.
 Id. at *1–3.
 Id. at *3.
 Id. at *1.
 21 U.S.C. § 379r(a) (emphasis added).
 See Cipollone v. Liggett Grp., 505 U.S. 504, 521 (1992).
 Sapienza, 2022 WL 17404919, at *2.
 Id. at *3.
 Id. (citations omitted).
 Lee v. Conagra Brands, Inc., 958 F.3d 70, 74 (1st Cir. 2020).
 Id. at 77.
 Sapienza, 2022 WL 17404919, at *4.
 See, e.g., Barreto v. Westbrae Nat., Inc., 518 F. Supp. 3d 795, 806 (S.D.N.Y. 2021) (“Because the Court concludes that the product’s labeling would not mislead a reasonable consumer, . . . [i]t is unnecessary to reach Westbrae’s argument that Barreto’s state claims are preempted by federal law.”); Bernstein v. Conopco, Inc., No. 3:21-cv-10160-KAR, 2022 U.S. Dist. LEXIS 106579, at *14 (D. Mass. June 15, 2022) (“Because the court has determined that Plaintiff has not stated a claim for a violation of Chapter 93A, it need not reach the question of whether the Product label violates the FDCA, as Plaintiff contends.”).
 Campbell v. Ariz. Beverages USA LLC, No. 22-cv-02752-JST, 2023 U.S. Dist. LEXIS 60515, at *9–10 (N.D. Cal. Mar. 31, 2023) (holding false advertising claims preempted to the extent they challenge claims or language required by federal regulations); Chong v. Kind LLC, 585 F. Supp. 3d 1215, 1219–20 (N.D. Cal. 2022); Reid v. Johnson & Johnson, 780 F.3d 952, 959 (9th Cir. 2015) (“The preemption analysis turns on whether the challenged statements are authorized by the FDA’s regulations or other pronouncements of similar legal effect.”); Henry v. Gerber Prods. Co., No. 3:15-cv-02201-HZ, 2016 U.S. Dist. LEXIS 52638, at *23 (D. Or. Apr. 18, 2016) (“Courts have repeatedly found that state law claims challenging ‘natural flavors’ labels, accompanied by images or names of fruit, are preempted, because such labeling references the characterizing flavor of the food and is permitted by § 101.22.”); Hi-Tech Pharms., Inc. v. HBS Int’l Corp., 910 F.3d 1186, 1195–96 (11th Cir. 2018) (holding that state law claims were preempted if viable because plaintiff did not dispute that the labeling at issue complied with federal regulations); Reynolds v. Wal-Mart Stores, Inc., No. 4:14CV381-MW/CAS, 2015 U.S. Dist. LEXIS 53405, 2015 WL 1879615, at *12 (N.D. Fla. Apr. 23, 2015) (“[W]here challenged conduct is expressly required or permitted by FDA regulations, the claims fall within the core of the preemption provision because they would ‘impose different requirements on precisely those aspects . . . that the FDA had approved.’” (quoting Altria Grp., Inc. v. Good, 555 U.S. 70, 86, 129 S. Ct. 538, 172 L. Ed. 2d 398 (2008)); In re PepsiCo, Inc., Bottled Water Mktg. & Sales Pracs. Litig., 588 F. Supp. 2d 527, 537 (S.D.N.Y. Dec. 8, 2008) (granting motion to dismiss state law claims alleging mislabeling of bottled water on preemption grounds because bottled water label “complies with the FDCA’s requirements”); Savalli v. Gerber Prods. Co., No. 15-61554-CIV-ZLOCH, 2016 U.S. Dist. LEXIS 138014, at *10 (S.D. Fla. Sept. 20, 2016); Willard v. Tropicana Mfg. Co., 577 F. Supp. 3d 814, 830 (N.D. Ill. 2021).