Kroessler v. CVS Health Corp.

• Decision Date: 09 October 2020
• Docket Number: No. 19-55671,19-55671
• Citation: 977 F.3d 803
• Parties: James KROESSLER, individually, and on behalf of all others similarly situated, Plaintiff-Appellant, v. CVS HEALTH CORPORATION, Defendant-Appellee.
• Court: U.S. Court of Appeals — Ninth Circuit

977 F.3d 803

James KROESSLER, individually, and on behalf of all others similarly situated, Plaintiff-Appellant,

v.CVS HEALTH CORPORATION, Defendant-Appellee.

No. 19-55671

United States Court of Appeals, Ninth Circuit.

Argued and Submitted July 8, 2020 Pasadena, California

Filed October 9, 2020

Leslie E. Hurst (argued) and Timothy G. Blood, Blood Hurst & O'Reardon LLP, San Diego, California; Todd D. Carpenter, Carlson Lynch LLP, San Diego, California; for Plaintiff-Appellant.

Jean-Claude André (argued) and Adriane Peralta, Sidley Austin LLP, Los Angeles, California; Amy P. Lally, Sidley Austin LLP, Los Angeles, California; for Defendant-Appellee.

J. Kathleen Bond and Jennifer M.S. Adams, Amin Talati Wasserman LLP, Chicago, Illinois, for Amicus Curiae Council for Responsible Nutrition.

Before: Richard A. Paez and Bridget S. Bade, Circuit Judges, and Eric F. Melgren,^* District Judge.

MELGREN, District Judge:

Appellant James Kroessler purchased one of CVS's glucosamine-based supplements in 2017, believing it would provide the advertised joint health benefits. He sued CVS under California law, alleging that the supplement he purchased, and five additional CVS glucosamine-based supplements, did not provide the advertised benefits. He sought to certify a class of similarly situated consumers who purchased CVS's glucosamine-based supplements during the relevant limitations period. The district court dismissed the case without leave to amend, holding that federal law preempted Kroessler's California claims. For the following reasons, we reverse and remand for further proceedings.

BACKGROUND

Kroessler is a California consumer who represents a putative class that asserts claims against CVS Health Corporation ("CVS"), alleging violations of the California Unfair Competition Law ("UCL"), Cal. Bus. & Prof. Code §§ 17200 – 17210, and the California Consumer Legal Remedies Act ("CLRA"), Cal. Civ. Code §§ 1750 – 1759, as well as a common-law breach of express warranty claim.

CVS sells a line of glucosamine-based supplements. Kroessler alleges that CVS markets these supplements to consumers using express and implied messages. The express marketing message—which CVS concedes—states that CVS's glucosamine-based supplements maintain or support joint health. Kroessler alleges that the implied marketing message—which CVS contests—states that the supplements ameliorate the cardinal symptoms of arthritis, namely joint pain, discomfort, stiffness, and lack of mobility or flexibility. Kroessler alleges that the supplements do not provide the advertised benefits.

The complaint identifies six CVS glucosamine-based supplements: glucosamine maximum strength tablets, glucosamine MSM caplets, glucosamine chondroitin with MSM tablets, glucosamine chondroitin with vitamin D caplets, and glucosamine chondroitin, available in both tablets and capsules. In marketing these supplements, CVS makes various claims on the products’ labels. One label states that the supplement "[s]upports flexibility & range of motion," "help[s] support and maintain the structure of joints," and "work[s] to support joint comfort while helping to promote joint mobility." The message includes the disclaimer that it is a "DIETARY SUPPLEMENT" that "is not intended to diagnose, treat, cure, or prevent any disease" and that "[i]ndividual results may vary." Another states that the supplement "[n]ourishes cartilage and promotes comfortable joint movement" and "[s]upports cartilage health & joint comfort."

Kroessler alleges that glucosamine neither supports healthy joint function nor ameliorates joint pain, discomfort, stiffness, or other symptoms of joint disease. He claims that CVS's glucosamine-based supplements "[have] been extensively studied in large, well-conducted and published studies involving persons with and without diagnosed arthritis and [have] been proven to be ineffective at supporting or benefiting joint health, including by positively impacting the signs and symptoms of arthritis ."¹ His complaint summarizes four clinical trials conducted on persons without diagnosed arthritis, or on a mix of subjects with and without osteoarthritis, that allegedly support those contentions. He also cites numerous articles and other clinical trials concluding that glucosamine is no more effective than a placebo in preventing osteoarthritis. Kroessler alleges these studies also show that glucosamine is no more effective than a placebo at reducing joint pain, relieving joint stiffness, improving joint function, impacting joint swelling or space width loss, rebuilding joint cartilage, or relieving the symptoms of osteoarthritis or slowing their progression.

CVS moved to dismiss the complaint under Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6), arguing in pertinent part that federal law preempted Kroessler's state-law causes of action. The district court granted CVS's motion to dismiss and denied Kroessler leave to amend.

JURISDICTION AND STANDARDS OF REVIEW

The district court entered final judgment on May 16, 2019, after granting CVS's motion to dismiss Kroessler's claims. Kroessler timely filed a notice of appeal on June 12, 2019, under the Class Action Fairness Act.² 28 U.S.C. § 1332(d)(2). Accordingly, this Court has jurisdiction to review the final judgment. 28 U.S.C. § 1291.

We review de novo a district court's dismissal of a case under Rule 12(b)(6) for failure to state a claim. Marder v. Lopez , 450 F.3d 445, 448 (9th Cir. 2006). Likewise, we review de novo a district court's determination that a federal statute preempts state law claims. Niehaus v. Greyhound Lines, Inc. , 173 F.3d 1207, 1211 (9th Cir. 1999). On review, we accept the plaintiff's allegations as true and construe them in the light most favorable to the plaintiff. Gompper v. VISX, Inc. , 298 F.3d 893, 895 (9th Cir. 2002). A district court properly dismisses a complaint if the complaint fails to "plead ‘enough facts to state a claim to relief that is plausible on its face.’ " Weber v. Dep't of Veterans Affairs , 521 F.3d 1061, 1065 (9th Cir. 2008) (quoting Bell Atl. Corp. v. Twombly , 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ).

Ordinarily, we review a district court's decision to deny a party leave to amend its complaint for an abuse of discretion. Cervantes v. Countrywide Home Loans, Inc., 656 F.3d 1034, 1041 (9th Cir. 2011). However, if a district court denies leave to amend based on the futility of the amendment or inability to allege a valid cause of action, we review the decision de novo. See Leadsinger, Inc. v. BMG Music Publ'g , 512 F.3d 522, 532 (9th Cir. 2008).

DISCUSSION

We address two issues in this appeal. First, whether the district court erred in holding that the Federal Food, Drug, and Cosmetic Act ("FDCA") preempts Kroessler's California state-law causes of action. Second, whether the district court erred in dismissing Kroessler's complaint without granting him leave to amend.

I. FDCA Preemption

Congress enacted the FDCA to "promote the public health" by ensuring that "foods are safe, wholesome, sanitary, and properly labeled." 21 U.S.C. § 393(b)(2)(A). In 1990, Congress amended the FDCA with the Nutrition Labeling and Education Act ("NLEA"), 21 U.S.C. § 343 et seq ., and established new requirements governing the labeling of food, including dietary supplements. In 1994, Congress further amended the FDCA with the Dietary Supplement Health and Education Act ("DSHEA"), Pub. L. No. 103-417, 108 Stat. 4325.³ The NLEA and DSHEA together established a new category of food products—specifically, dietary supplements—that have unique safety, labeling, manufacturing, and other related standards.

All proceedings "for the enforcement, or to restrain violations, of" the FDCA must "be by and in the name of the United States." 21 U.S.C. § 337(a). Private plaintiffs may not bring actions to enforce violations of the FDCA. See POM Wonderful LLC v. Coca-Cola Co. , 573 U.S. 102, 109, 134 S.Ct. 2228, 189 L.Ed.2d 141 (2014) (citing 21 U.S.C. § 337(a) ). Instead, private plaintiffs may bring analogous state law claims as long as the FDCA does not preempt those claims. See Farm Raised Salmon Cases , 42 Cal.4th 1077, 72 Cal.Rptr.3d 112, 175 P.3d 1170, 1177 (2008).

Federal preemption can be either express or implied. See Fid. Fed. Sav. & Loan Ass'n v. de la Cuesta , 458 U.S. 141, 152–53, 102 S.Ct. 3014, 73 L.Ed.2d 664 (1982). Express preemption exists when a statute explicitly addresses preemption. Chicanos Por La Causa, Inc. v. Napolitano , 558 F.3d 856, 863 (9th Cir. 2009). "When a federal statute contains an explicit preemption provision, we are to identify the domain expressly pre-empted by that language." Id. (internal quotations omitted). The FDCA expressly preempts any state law that establishes "any requirement respecting any claim of the type described in section 343(r)(1) of this title made in the label or labeling of food that is not identical to the requirement of section 343(r) of this title." 21 U.S.C. § 343-1(a)(5). The phrase "not identical to" means "that the State requirement directly or indirectly imposes obligations or contains provisions concerning the composition or labeling of food [that] ... [a]re not imposed by or contained in the applicable [federal regulation] ... or [d]iffer from those specifically imposed by or contained in the applicable [federal regulation]." 21 C.F.R. § 100.1(c)(4). Furthermore, " § 343-1(a)(5) preempts state-law requirements for claims about dietary supplements that differ from the FDCA's requirements." Dachauer v. NBTY, Inc. , 913 F.3d 844, 848 (9th Cir. 2019). Therefore, private plaintiffs may bring only actions to enforce violations of "state laws imposing requirements identical to those contained in the FDCA." Farm Raised Salmon Cases , 72 Cal.Rptr.3d 112, 175 P.3d at 1177 (citing 21 U.S.C. §§ 337, 343-1 ).

A.

In the present case, Kroessler brings claims for violations of the California UCL and CLRA, as well as breach of express warranty. The UCL...