Smith v. Hi-Tech Pharm., Inc.

Citation364 Ga.App. 476,875 S.E.2d 454
Decision Date24 June 2022
Docket NumberA22A0170
Parties SMITH v. HI-TECH PHARMACEUTICALS, INC.
CourtUnited States Court of Appeals (Georgia)

Matthew Scott Harman, Atlanta, Eric Scott Fredricksonm, Christopher T. Nidel, for Appellant.

Eileen Elizabeth H. Rumfelt, Atlanta, Meredith Corey Lee, Robert Foust Parsley, C. Crew Townsend, for Appellee.

Brown, Judge.

Shawn Smith filed this single-count action against Hi-Tech Pharmaceuticals, Inc., under the District of Columbia Consumer Procedures and Protection Act ("DC CPPA"), alleging that the labels of certain Hi-Tech dietary supplements are misleading to consumers. The trial court granted Hi-Tech's motion for judgment on the pleadings, concluding that Smith's claims are preempted by the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., and that his complaint raises issues within the primary jurisdiction of the Food and Drug Administration ("FDA"), and dismissed Smith's complaint with prejudice. Smith appeals from this order. For the following reasons, we reverse in part, affirm in part, vacate the judgment, and remand the case to the trial court to dismiss Smith's complaint without prejudice.

On appeal from a grant of judgment on the pleadings, we conduct a de novo review of the trial court's order to determine whether the undisputed facts appearing from the pleadings entitle the movant to judgment as a matter of law. The grant of a motion for judgment on the pleadings under OCGA § 9-11-12 (c) is proper only where there is a complete failure to state a cause of action or defense. For purposes of the motion, all well-pleaded material allegations by the nonmovant are taken as true, and all denials by the movant are taken as false. But the trial court need not adopt a party's legal conclusions based on these facts.

(Citation and punctuation omitted.) BCM Constr. Group v. Williams , 353 Ga. App. 811, 811-812, 840 S.E.2d 51 (2020). "A motion for judgment on the pleadings should be granted only if the moving party is clearly entitled to judgment." (Citation and punctuation omitted.) Polo Golf & Country Club Homeowners Assn. v. Cunard , 306 Ga. 788, 792 (2), 833 S.E.2d 505 (2019).

According to Smith's complaint, he was a resident of the District of Columbia who purchased Hi-Tech's product, "Hyperdrive 3.0+," which contains oxilofrine, also called methylsynephrine.1 "This purchase included the purpose of testing and evaluating whether Hyperdrive 3.0+ or any other product sold by [Hi-Tech] with methylsynephrine have been unlawfully and deceptively sold[.]" Smith alleges that Hi-Tech manufactures and distributes dietary supplements in the United States which contain methylsynephrine, which is "an unapproved drug ingredient" and "illegal supplement ingredient," and which may pose health risks to consumers. According to the complaint, the FDA issued warning letters to seven companies regarding products marketed as dietary supplements who list methylsynephrine as a dietary ingredient because methylsynephrine does not meet the FDCA's definition of a dietary ingredient. Thus, Smith alleges, the inclusion of methylsynephrine in Hyperdrive 3.0+ and other Hi-Tech products is a deceptive and unlawful trade practice because it creates a tendency to mislead reasonable consumers in the District of Columbia.

Smith brought a claim under the DC CPPA, "act[ing] for the benefit of the [g]eneral [p]ublic as a Private Attorney General," claiming that Hi-Tech (a) failed to state material facts regarding the product's contents that tend to mislead by omitting that methylsynephrine is an unapproved drug that has been linked to adverse health events and omitting that consumption of the product in accordance with the label includes an unapproved drug ingredient at concentrations or dosages suitable for prescriptive medical purposes; (b) misrepresents a material fact in claiming that Hyperdrive 3.0+ is a " ‘synergistic blend of potent herbal derivatives’ which it is not"; (c) "[u]ses innuendo or ambiguity as to a material fact regarding the product's contents, because consumers may confuse ‘methylsynephrine’ with ‘synephrine,’ a legal supplement ingredient"; (d) sells consumer goods in a condition or manner not consistent with that warranted by operation of the DC CPPA in that Hyperdrive 3.0+ is not merchantable; and (e) "sells consumer goods in a condition or manner not consistent with operation or requirement of federal law." Smith sought actual damages, statutory damages, punitive damages, injunctive relief, and attorney fees for himself and all others similarly situated.

Hi-Tech filed a motion for judgment on the pleadings, arguing that Smith's claims are impliedly preempted by the FDCA based on the United States Supreme Court's decision in Buckman Co. v. Plaintiffs' Legal Committee , 531 U. S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). Hi-Tech alternatively argued that the trial court should dismiss Smith's claim in deference to the FDA under the doctrine of primary jurisdiction. The trial court concluded that Smith's complaint is preempted by federal law and raises issues within the primary jurisdiction of the FDA and dismissed Smith's complaint with prejudice.

Smith appeals from this order, and contends, in related enumerations of error, that the trial court erred in concluding that his claims are impliedly preempted by the FDCA and in finding that the doctrine of primary jurisdiction applies to his claims. We conclude that Smith's claims are not subject to preemption, either express or implied, but do fall within the primary jurisdiction of the FDA.

1. Preemption. "The preemption doctrine is a product of the Supremacy Clause, see U. S. Const., Art. VI, Cl. 2, which invalidates state laws that interfere with, or are contrary to, federal law." (Citation and punctuation omitted.) Fox v. Norfolk S. Corp. , 342 Ga. App. 38, 43 (1), 802 S.E.2d 319 (2017). See also Reis v. OOIDA Risk Retention Group , 303 Ga. 659, 660, 814 S.E.2d 338 (2018).

Whether federal statutes or regulations preempt state law is a question of congressional intent. Congress — through federal laws and regulations — may effectively preempt state law in three ways: (1) express preemption; (2) field preemption (regulating the field so extensively that Congress clearly intends the subject area to be controlled only by federal law); and (3) implied (or conflict) preemption.

(Citation and punctuation omitted.) Gentry v. Volkswagen of America , 238 Ga. App. 785, 787 (2), 521 S.E.2d 13 (1999). "Express preemption is present when Congress's intent to preempt state law is explicitly stated in the statute's language." (Citation and punctuation omitted.) Canale v. Colgate-Palmolive Co. , 258 F.Supp.3d 312, 319 (II) (B) (S.D. N.Y. 2017). "A court's inquiry into the scope of a statute's pre-emptive effect is guided by the rule that the purpose of Congress is the ultimate touchstone in every pre[ ]emption case." (Citations and punctuation omitted.) Altria Group v. Good , 555 U. S. 70, 76 (II), 129 S.Ct. 538, 172 L.Ed.2d 398 (2008). Whether federal law preempts state law claims is reviewed de novo. Gentry , 238 Ga. App. at 786, 521 S.E.2d 13. With this in mind, we turn to the federal statute at issue.

The Federal Food, Drug, and Cosmetic Act

The FDCA, 21 U.S.C. § 301 et seq., as amended by the Nutrition Labeling and Education Act ("NLEA"), 21 U.S.C. § 343 et seq., governs the labeling of food, including dietary supplements.2 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." Kroessler v. CVS Health Corp. , 977 F.3d 803, 808 (I) (9th Cir. 2020). See also 21 U.S.C. § 321 (ff) ("a dietary supplement shall be deemed to be a food within the meaning of this chapter").

"To ensure nationwide uniformity in labeling standards, Congress has prohibited states from directly or indirectly establishing under any authority or continuing in effect any labeling requirement for dietary supplements that is not identical to the requirements articulated in § 343 (r). § 343-1 (a)." Ferrari v. Vitamin Shoppe , No. CV 17-10475-GAO, 2022 WL 974048, at *2 (III) (A) (D. Mass. March 31, 2022). See also Kroessler , 977 F.3d at 808 (I) ("Private plaintiffs may not bring actions to enforce violations of the FDCA. Instead, private plaintiffs may bring analogous state law claims as long as the FDCA does not preempt those claims.") (citations omitted). FDA regulations define the term "not identical to" as follows:

"Not identical to" does not refer to the specific words in the requirement but instead means that the State requirement directly or indirectly imposes obligations or contains provisions concerning the composition or labeling of food, or concerning a food container, that: (i) Are not imposed by or contained in the applicable provision [or regulation] ...; or (ii) Differ from those specifically imposed by or contained in the applicable provision [or regulation.]

21 C.F.R. § 100.1 (c) (4). The preemption provision added by the NLEA "has been repeatedly interpreted not to preempt requirements imposed by state law that effectively parallel or mirror the relevant sections of the NLEA." (Citation, punctuation, and emphasis omitted.) Hughes v. Ester C Co. , 99 F.Supp.3d 278, 284 (III) (E.D. N.Y. 2015). Additionally, "a state statute mirroring its federal counterpart does not impose any additional requirement merely by providing a damage remedy for conduct that would otherwise violate federal law, even if the federal statute provides no private right of action." Ackerman v. Coca-Cola Co. , No. CV-09-0395 (JG) (RML), 2010 WL 2925955, at *6 (E.D. N.Y. July 21, 2010), citing Bates v. Dow Agrosciences , 544 U. S. 431, 432, 125 S.Ct. 1788, 161 L.Ed.2d 687 (2005) (preemption of additional requirements "does not...

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