SOMERS v. BEIERSDORF INC (2021)

United States Court of Appeals, Ninth Circuit.2021-03-25No. No. 20-55541

Summary · law.co

Holding. The court affirmed the summary judgment because the plaintiff failed to state a claim, as she did not allege that the defendant failed to satisfy both alternative approval pathways under California Health & Safety Code § 111550.

Stacie Somers brought a lawsuit against Beiersdorf, Inc., contending that its Nivea CoQ10 Lotion constitutes a drug under federal law that was marketed without obtaining required FDA approval through the New Drug Application process. The district court granted summary judgment dismissing her claim on preemption grounds. Somers appealed, but the appellate court upheld the dismissal on a different basis: California state law does not require FDA approval exclusively. Rather, California Health & Safety Code § 111550 permits drug manufacturers to comply by obtaining approval from either the FDA or the state of California. Since Somers failed to allege that Beiersdorf had obtained neither federal nor state approval, she did not adequately plead a violation of California law. The court therefore found her complaint legally insufficient and affirmed the lower court's judgment.

Summary generated by law.co from the public-domain opinion. The opinion text itself is public domain.

Key issues

Whether a product marketed as a cosmetic can be classified as a drug under the FDCA
Interpretation of California Health & Safety Code § 111550 and its alternative approval requirements
Sufficiency of pleadings when a plaintiff relies on only one of two statutory conditions

Procedural posture

The plaintiff appealed a district court grant of summary judgment in favor of the defendant.

Authorities cited

No cited authorities resolved to law.co cases yet.

Opinion · public domain

MEMORANDUM *

Stacie Somers sued Beiersdorf, Inc., alleging that its Nivea CoQ10 Lotion is a drug that was sold without receiving federal approval under the Food, Drug, and Cosmetic Act (“FDCA”). The district court entered summary judgment in favor of Beiersdorf, ruling that Somers’ claim was impliedly preempted. Somers now appeals. We have jurisdiction pursuant to 28 U.S.C. § 1291, and we hold that Somers has failed to state a claim.

1. We review de novo the grant of summary judgment. Branch Banking & Tr. Co. v. D.M.S.I., LLC, 871 F.3d 751, 759 (9th Cir. 2017). We “may affirm summary judgment on any ground supported by the record.” Video Software Dealers Assn v. Schwarzenegger, 556 F.3d 950, 956 (9th Cir. 2009) (citation omitted).

2. Somers’ theory is as follows: Under California Health & Safety Code § 111550(a), it is unlawful to sell a drug in California unless it has obtained approval from the Food and Drug Administration (“FDA”) through the New Drug Application (“NDA”) process. Beiersdorfs product, according to Somers, is a “drug” as defined in the federal Food, Drug, and Cosmetic Act, but it never received an approved NDA. Therefore, according to Somers, Beiersdorf is selling its product unlawfully.

But Somers’ theory fails to state a claim. Under California Health & Safety Code § 111550, it is unlawful for a manufacturer to sell a drug unless “either” of the following two conditions is met. Cal. Health & Safety Code § 111550 (emphasis added). The first condition is that the product has obtained an approved NDA from the FDA. § 111550(a). The second condition is that the product has obtained new drug approval from the state of California. § 111550(b). Because a manufacturer acts lawfully so long as it meets either condition, it acts unlawfully only when it fails to meet both conditions. Yet Somers disclaimed any allegations about Beiersdorfs failure to obtain new drug approval from the state of California as required under section 111550(b). Somers has thus failed to state a claim.

AFFIRMED.