82 F.4th 35
1st Cir.2023Background
- Plaintiff Kristin DiCroce bought Lactaid lactase supplement multiple times in Massachusetts and alleges she paid a premium (about $0.11–$0.20 more per dose) because Lactaid's labeling misled her about the product's status and claims.
- DiCroce sued McNeil Nutritionals, LLC and Johnson & Johnson Consumer Inc. asserting violations of Mass. Gen. Laws ch. 93A (consumer protection), Mass. Gen. Laws ch. 266 § 91 (false advertising), and unjust enrichment based on allegedly unlawful labeling.
- Central legal contention: Lactose intolerance is a "disease," so Lactaid’s product-label claims allegedly treat a disease and thus make Lactaid a "drug" under the FDCA; DiCroce alleges the label therefore violates federal labeling law.
- District court found DiCroce’s amended complaint adequately alleged Article III injury but dismissed her consumer-protection and false-advertising claims for failure to identify a factual misrepresentation and as not deceptive to a reasonable consumer.
- On appeal the First Circuit affirmed dismissal but on different grounds: it held the state-law claims are impliedly preempted because they rest solely on alleged violations of the FDCA/DSHEA labeling regime and only the FDA may enforce that federal scheme.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Article III standing (injury in fact) | DiCroce paid more for Lactaid and was misled into purchasing — economic injury (overpayment). | Initial district challenge argued allegations were vague and not plausibly tied to purchase decisions. | Allegations of purchase plus overpayment plausibly pleaded a concrete, particularized injury; standing satisfied. |
| Whether Lactaid is a "drug" because it treats a disease | Lactose intolerance is a disease; Lactaid’s labeling treats that disease, so it is a drug under FDCA. | Lactaid is marketed as a dietary supplement and structure/function claims are permitted under DSHEA. | Court declined to decide whether lactose intolerance is a "disease" for FDCA purposes; resolution unnecessary because of preemption ruling. |
| Preemption: can plaintiff sue under state law for alleged FDCA labeling violations? | State-law consumer claims should be available to redress deceptive labeling that violates the FDCA. | FDCA (and §337(a)) vests enforcement exclusively in the federal government; state claims that hinge solely on FDCA violations are impliedly preempted. | Claims are impliedly preempted under Buckman: DiCroce’s state claims ‘‘exist solely by virtue’’ of alleged FDCA violations and therefore are barred. |
| Whether Lactaid labeling is deceptive to a reasonable consumer | Labeling and disclaimers mislead consumers about FDA approval and disease-treatment claims, inducing purchase. | Labels are not deceptive; disclaimers disclose the lack of FDA approval and reasonable consumers would not be misled. | The district court’s view that labels are not deceptive was unneeded for the appeal; First Circuit affirmed dismissal on preemption grounds. |
Key Cases Cited
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) (state-law claims premised on fraud-on-the-FDA are impliedly preempted because FDA enforcement is exclusive)
- Dumont v. Reily Foods Co., 934 F.3d 35 (1st Cir. 2019) (applied Buckman framework to food-labeling claims)
- Plourde v. Sorin Grp. USA, Inc., 23 F.4th 29 (1st Cir. 2022) (state-law claims that rest solely on FDCA violations are preempted)
- Ferrari v. Vitamin Shoppe Indus. LLC, 70 F.4th 64 (1st Cir. 2023) (DSHEA reflects congressional intent to treat dietary supplements differently from drugs)
- Spokeo, Inc. v. Robins, 578 U.S. 330 (2016) (standing requires a concrete and particularized injury)
- In re Zofran (Ondansetron) Prods. Liab. Litig., 57 F.4th 327 (1st Cir. 2023) (context on FDA drug review and FDCA purposes)