A short and sweet report today on Lowe v. Walgreens Boots All., Inc., 2021 WL 4772293 (N.D. Cal. 2021), a recent decision dismissing a putative class action that sought to assert a variety of California state-law claims against the sellers of a generic drug based on the drug’s labeling. The court dismissed three of the plaintiff’s claims as preempted, and the fourth for not stating a claim under state law. The decision is not only correct but also suggests a useful practice tip when motions to dismiss implicate FDA-approved drugs and devices.
The plaintiff alleged that she had purchased a foam form of minoxidil, the generic form of Rogaine, which is used to treat hair loss. The drug, a 5% solution, was packaged as “Treatment for Women” and was, according to its label, intended to be applied once daily. The defendant also sold another 5% minoxidil foam solution, which was packaged as “Treatment for Men” and was, according to its label, intended to be applied twice daily. According to the plaintiff, the minoxidil product intended for women cost nearly 1.5 times what the product intended for men cost even though both contained the same active ingredient and same formulation.
Describing the price differential as “a ‘pink tax’ on female consumers,” the plaintiff claimed that the defendants’ “advertisements, marketing representations, and labeling of the [two products] are misleading and likely to deceive a reasonable consumer into believing that the Women’s Product is unique or specially formulated to make it appropriate for women, as opposed to the cheaper but substantively identical Men’s Product.” 2021 WL 4772293, at *1.
Based on those allegations, the plaintiff asserted claims under California’s Unfair Competition Law, False Advertising Law, Consumer Legal Remedies Act, and Unruh Civil Rights Act.
The defendants moved to dismiss, arguing that federal law preempted each of the plaintiff’s claims, and that Unruh Act simply didn’t apply to the facts alleged, because it does not cover consumer goods. In support of their motion, the defendants asked the court to take judicial notice of Rogaine’s FDA approval letters, which contain the text of the drug’s FDA-approved labeling.
The court granted the motion.
First, it held that the Food, Drug, and Cosmetic Act and its implementing regulations preempted plaintiff’s unfair-competition, false-advertising, and consumer-protection claims. Citing the FDCA provisions governing drug labels and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), the court explained that a generic drug label must always “exactly mirror” the label of its branded counterpart and that federal law thus “preempts state laws requiring changes to the labeling of generic drugs.” 2021 WL 4772293, at *4. Having taken judicial notice of Rogaine’s FDA approval letters, which contain the drug’s FDA-approved labeling, the court compared that labeling to the labeling of the defendants’ generic versions and found that the generic labeling “mirrored” the branded drug’s FDA-approved labeling. Id. at *3–4. Because federal law required that to be the case, the court held that federal law preempted the plaintiff’s “claims that Defendants’ labels must be different to comply with state law duties.” Id. at *4.
The court easily brushed aside as “unavailing” the plaintiff’s “argument that Mensing and Bartlett are inapposite because different state laws—governing failure to warn and design defect—were at issue in those cases.” 2021 WL 4772293, at *4. The court explained that “[w]here simultaneous compliance with federal and state law is impossible, federal law reigns supreme, regardless of the nature of the state statue at issue.” Id.
There is nothing special about that holding; it is a straightforward application of Mensing, Bartlett, and decades of federal preemption jurisprudence.
Worth noting is that judicial notice of the branded drug’s FDA-approved labeling played an important part in the court’s analysis. The plaintiff had pleaded the content of the generic label but not the content of the branded label. Thus, judicial notice of the branded label was necessary before the court could compare the two and determine that plaintiff’s claims rested on a state-law duty to deviate from the branded label.
When asked, courts regularly take judicial notice of FDA-approval letters and FDA-approved labeling when, as in this case, they are “publicly available.” 2021 WL 4772293, at *4; see, e.g., Funk v. Stryker Corp., 631 F.3d 777, 783 (5th Cir. 2011); Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994, 1014 (S.D. Ohio 2016); Scianneaux v. St. Jude Med. S.C., Inc., 961 F. Supp. 2d 808, 812 (E.D. La. 2013). Defendants should remember to ask. Some defendants fear that citing judicially noticeable materials outside the complaint will cause a court to convert a motion to dismiss into a motion for summary judgment. But such concerns are overblown. On motions to dismiss, courts may consider not only what is within the four corners of the complaint but also any attached exhibit, any document incorporated by reference, and any fact subject to judicial notice. See 5B Fed. Prac. & Proc. Civ. § 1357 (3d ed.) (collecting cases).
After holding the plaintiff’s unfair-competition, false-advertising, and consumer-protection claims preempted, it turned to the plaintiff’s claim under California’s Unruh Act, which states:
All persons within the jurisdiction of this state are free and equal, and no matter what their sex, race, color, religion, ancestry, national origin, disability, medical condition, genetic information, marital status, sexual orientation, citizenship, primary language, or immigration status are entitled to the full and equal accommodations, advantages, facilities, privileges, or services in all business establishments of every kind whatsoever.
Cal. Civ. Code § 51(b). Without considering whether the claim was preempted, the court held that it did not apply to a claim based to allegedly “discriminatory pricing” of goods because “both the plain language and the legislative history of the Unruh Act reveal that the Unruh Act does not apply to goods.” 2021 WL 4772293, at *4.
With that, the court granted the defendants’ motion to dismiss.
This article was written by Andrew Tauber of Winston & Strawn LLP.